practiced. They are based on the principle that there is a possible
risk of disease transmission from any patient, patient sample, or
interaction with infectious material. For Standard Precautions,
guidance follows that a certain set of controls should be implemented
to reduce infectious disease transmission regardless of the diagnosis
of the patient, in part because there is always baseline risk that is
not necessarily either obvious or detectable. These precautions include
controls such as improved hand hygiene, use of personal protective
equipment, cleaning of equipment, environmental controls, handling of
bed linens, changing work practices, and patient placement. When used
in concert, these approaches protect workers from potential exposure to
infectious agents.
    The Isolation Guidelines' second tier of precautions, Transmission-
Based Precautions, takes into consideration the transmission mechanism
of specific diseases and complements Standard Precautions to better
protect workers from the presence of known or suspected infectious
agents. For instance, SARS-CoV-2, the infectious agent that causes
COVID-19, is considered to be mainly transmissible through the droplet
route in most settings (though there is evidence for airborne
transmission as noted throughout this preamble). Droplet transmission
occurs by the direct spray of large droplets onto conjunctiva or mucous
membranes (e.g., the lining of the nose or mouth) of a susceptible host
when an infected person sneezes, talks, or coughs. Droplet precautions
are a suite of layered controls that are designed to prevent the direct
spray of infectious material and supplement the suite of layered
controls used for Standard Precautions. They are designed to protect
workers from infectious agents that can be expelled in large
respiratory droplets from infected individuals. These added
interventions are implemented when infection is known or suspected and
include placing patients in single rooms or physically distant within
the same room, increased mask usage, and limiting patient movement.
COVID-19 is considered capable of spreading through multiple routes of
transmission, including airborne. Thus, the CDC recommends respiratory
protection, isolation gowns, and gloves in healthcare settings to
protect workers in those settings.
    While a suite of layered controls is appropriate for controlling
infectious diseases, it is important to use the hierarchy of controls
when choosing which controls to include and the order in which to
implement them. Briefly, the hierarchy of controls refers to the
concept that the best way to control for hazards is to preferentially
utilize the most effective before complementing with less effective
controls.\19\ Ideally, the hazard is eliminated, which would likely
mean using an option such as conducting a telehealth visit outside of a
patient care setting with respect to COVID-19 to ensure that there is
no shared workspace and thus no potential for employee exposure to
COVID-19. When a telehealth visit is not possible, workers must be
protected through the implementation of controls. Outside the realm of
infection control, the utilization of an engineering control or a
change in on-site work practices could alone effectively minimize a
hazard in many cases. However, infection prevention failures often are
not apparent until an outbreak occurs, resulting in many infected
workers. Therefore, it is important for employers to not only adhere to
the hierarchy of controls when identifying controls to implement, but
also to augment layers of feasible engineering controls (e.g., adequate
ventilation, barriers) with administrative and work practice controls
(e.g., physical distancing, cleaning, disinfection, telework, schedule
modification, health screening). Personal protective equipment (e.g.,
gloves, respirators, and facemasks) can provide the final layer of
control. This approach is consistent with both OSHA and CDC guidance
for protecting workers and the public from COVID-19.
---------------------------------------------------------------------------

    \19\ The hierarchy of controls is a longstanding occupational
safety practice and OSHA policy. Under its hierarchy of controls
policy reflected in a number of standards, OSHA typically only
allows employers to rely on respirators or other PPE to the extent
that engineering controls to eliminate the hazard are not feasible.
See, e.g., Sec. Sec.  1910.134(a) (respiratory protection) and
1926.103 (respiratory protection); 1910.1000(e) (air contaminants);
1910.95(b) (occupational noise exposure) and 1926.101 (hearing
protection).
---------------------------------------------------------------------------

    In addition to the broad recognition and implementation of layered
controls to protect against infectious diseases, a recent study
elucidated the effectiveness of isolated and layered controls, with
respect to close contacts amidst several community COVID-19 outbreaks
in Thailand (Doung-ngern et al., September 14, 2020). While individual
controls, such as wearing a face covering or maintaining at least a
minimum distance from others, significantly reduced cases (28% and 40%,
respectively), the researchers concluded

that a layered approach would be expected to reduce infections by 84%.
    Several similar studies evaluated the importance of layering
controls during the 2002/2003 SARS outbreak caused by SARS-CoV-1, which
is a different strain of the same species of virus as the virus that
causes COVID-19 (SARS-CoV-2) and has some similar characteristics;
importantly, both viruses are strains of the same viral species and
exhibit the same modes of transmission. Researchers assessed five Hong
Kong hospitals on how the utilization of interventions affected SARS
transmission (Seto et al., May 3, 2003). In total, the study evaluated
244 workers on their compliance with wearing masks, gowns, and gloves
as well as adhering to hand hygiene protocols. Among the 69 workers who
fully complied with the layered controls, there were no infections.
However, 13 of 185 workers who used only some of the interventions were
infected. The researchers concluded that the combined practice of
droplet and contact precautions together significantly reduced the risk
of infection from exposures to SARS-infected individuals.
    Another study investigated the approaches taken to reduce SARS-CoV-
1 transmission in hospitals in Taiwan during the 2003 portion of the
outbreak (Yen et al., February 12, 2010). Researchers surveyed forty-
eight Taiwanese hospitals that provided care for 664 SARS-CoV-1
patients, including 119 healthcare workers, to determine which controls
each hospital implemented. Control measures included isolation of fever
patients in the Emergency Department (ED), installation of handwashing
stations in the ED, routing patients from the ED to an isolation ward,
installation of fever screen stations in the ED, and installation of
handwashing stations throughout the hospital. Analysis showed that
while early SARS-CoV-1 case identification at fever screening stations
outside the hospital could reduce transmission inside the hospital by
half, combining that intervention with other interventions could almost
double that reduction.
    A modeling effort to simulate an epidemic of seasonal influenza at
a hypothetical hospital in Ann Arbor, Michigan, found that different
interventions used in a layered approach would result in a greater
predicted reduction in nosocomial cases (i.e., healthcare-associated
infections) (Blanco et al., June 1, 2016). The study evaluated six
different intervention techniques thought to be effective against
influenza, including hand hygiene, employee vaccination, patient pre-
vaccination, patient isolation, therapies (e.g., antibody treatments,
steroids), and face coverings. The researchers found, based on the
model, that while no individual intervention exceeded a 27% percent
reduction in cases, utilizing all controls would prevent half of all
cases. While this model employed influenza as the vehicle to examine
the effectiveness of layered protections, it gives no reason to believe
that this approach would not be equally effective for other viruses
such as SARS-CoV-2.
    In 2016, the World Health Organization, a specialized agency of the
United Nations that is focused on international public health (WHO,
2016), addressed the use of layering interventions to reduce infections
in performed systematic reviews in its ``Guidelines on Core Components
of Infection Prevention and Control Programmes at the National and
Acute Health Care Facility Level.'' OSHA's perspective of layered
interventions (e.g., engineering controls, work practice controls,
personal protective equipment, training) is consistent with what the
WHO Guidelines define as ``multimodality.'' WHO defines multimodality
as follows:

    A [layered] strategy comprises several elements or components
(three or more; usually five, http://www.ihi.org/topics/bundles/Pages/default.aspx) implemented in an integrated way with the aim of
improving an outcome and changing behavior. It includes tools, such
as bundles and checklists, developed by multidisciplinary teams that
take into account local conditions. The five most common components
include: (i) System change (availability of the appropriate
infrastructure and supplies to enable infection prevention and
control good practices); (ii) education and training of health care
workers and key players (for example, managers); (iii) monitoring
infrastructures, practices, processes, outcomes and providing data
feedback; (iv) reminders in the workplace/communications; and (v)
culture change within the establishment or the strengthening of a
safety climate.

    The WHO guidelines strongly recommend practicing multimodality/
layered interventions to reduce infections based on WHO's systematic
review of implementation efforts at facility-level and national scales.
Based on a systematic review of 44 studies on implementing infection
control practices at the facility level, and another systematic review
of 14 studies on the success of National rollout programs using layered
strategies, WHO concluded that using layered strategies was effective
in improving infection prevention and control practices and reducing
hospital-acquired illnesses (WHO, 2016).
    Vaccination does not eliminate the need for layered controls for
healthcare workers exposed to COVID-19 patients, which can result in
exposures that are more frequent and potentially carrying higher viral
loads than those faced in workplaces not engaged in COVID-19 patient
care. The Director of the CDC's National Institute for Occupational
Health (NIOSH) recently wrote to OSHA that layers of control are still
needed for vaccinated healthcare workers who remain at ``particularly
elevated risk of being infected'' while treating COVID-19 patients:
``The available evidence shows that healthcare workers are continuing
to become infected with SARS-CoV-2, the virus that causes COVID-19,
including both vaccinated and unvaccinated workers . . . Regardless of
vaccination status, healthcare workers need additional protections such
as respirators and other personal protective equipment (PPE) during
care of patients with suspected or confirmed COVID-19.'' (Howard, May
22, 2021). Further, a recent CDC study found that despite the positive
impact on the roll-out of large-scale vaccination programs on reducing
the transmission of COVID-19, a decline in non-pharmaceutical
interventions (NPIs; e.g., physical distancing, face covering use) may
result in a resurgence of cases (Borchering, May 5, 2021). The authors
concluded that vaccination coverage in addition to compliance with
mitigation strategies are essential to minimize COVID-19 transmission
and prevent surges in hospitalizations and deaths. Thus, to effectively
control COVID-19 transmission to those who are not vaccinated or
immune, an increase in vaccination coverage in addition to NPIs, such
as physical distancing, are crucial.
    Based on the above evidence, OSHA is requiring in the ETS that
healthcare employers must not only implement the individual infection
prevention measures discussed in the following sections, but also layer
their controls to protect workers from the COVID-19 hazard due to the
additional protection provided to workers when multiple control
measures are combined.
References
Blanco, N et al., (2016, June 1). What Transmission Precautions Best
Control Influenza Spread in a Hospital. American Journal of
Epidemiology 183 (11): 1045-1054. https://doi.org/10.1093/aje/kwv293. (Blanco et al., June 1, 2016).
Borchering, RK et al., (2021, May 5). Modeling of Future COVID-19
Cases, Hospitalizations, and Deaths, by Vaccination Rates and

Nonpharmaceutical Intervention Scenarios--United States, April-
September 2021. MMWR Morb Mortal Wkly Rep. ePub: 5 May 2021. doi:
http://dx.doi.org/10.15585/mmwr.mm7019e3. (Borchering, May 5, 2021).
Centers for Disease Control and Prevention (CDC). (2012). An
Introduction to Applied Epidemiology and Biostatistics, Lesson 1:
Introduction to Epidemiology, Section 10: Chain of Infection. In:
Principles of Epidemiology in Public Health Practice, Third Edition:
http://www.cdc.gov/ophss/csels/dsepd/SS1978/Lesson1/Section10.html.
(CDC, 2012).
Doung-ngern, P et al., (2020, September 14). Case-control Study of
Use of Personal Protective Measures and Risk for SARS Coronavirus 2
Infection, Thailand. Emerg In Dis 26, 11: 2607-2616. https://doi.org/10.3201/eid2611.203003. (Doung-ngern et al., September 14,
2020) .
Hospital Infection Control Practices Advisory Committee (HICPAC).
(1996, January 1). Guideline for isolation precautions in hospitals.
Infection Control and Hospital Epidemiology 17(1): 53-80. (HICPAC,
January 1, 1996).
Howard, J. (2021, May 22). ``Response to request for an assessment
by the National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services, of the current hazards facing healthcare
workers from Coronavirus Disease-2019 (COVID-19).'' (Howard, May 22,
2021).
Reason, J. (1990, April 12). The Contribution of Latent Human
Failures to the Breakdown of Complex Systems. Philosophical
Transactions of the Royal Society London B327475 B327484. https://dol.org/10.1098/rstb.1990.0090. (Reason et al., April 12, 1990).
Reason, J et al., (2006, October 30). Revisiting the Swiss Cheese
Model of Accidents. EUROCONTROL Experimental Centre, Note No. 13/06.
(Reason et al., October 30, 2006).
Rusnak, JM et al., (2004, July 31). Management guidelines for
laboratory exposures to agents of bioterrorism. Journal of
Occupational and Environmental Medicine 46(8): 791-800. doi:
10.1097/01.jom.0000135536.13097.8a. (Rusnak et al., July 31, 2004).
Seto, WH et al., (2003, May 3). Effectiveness of precautions against
droplets and contact in prevention of nosocomial transmission of
severe acute respiratory syndrome (SARS). The Lancet 361(9368):
1519-1520. https://doi.org/10.1016/s0140-6736(03)13168-6. (Seto et
al., May 3, 2003).
Siegel, J, Rhinehart, E, Jackson M, Chiarello, L, and the Healthcare
Infection Control Practices Advisory Committee. (2007). 2007
Guideline for isolation precautions: preventing transmission of
infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
World Health Organization (WHO). (2016). Guidelines on Core
Components of Infection Prevention and Control Programmes at the
National and Acute Health Care Facility Level. https://www.who.int/gpsc/ipc-components-guidelines/en/. (WHO, 2016).
Yen, MY et al., (2010, February 12). Quantitative evaluation of
infection control models in the prevention of nosocomial
transmission of SARS virus to healthcare workers: implication to
nosocomial viral infection control for healthcare workers.
Scandinavian Journal of Infectious Diseases 42: 510-515. https://10.3109/00365540903582400. (Yen et al., February 12, 2010).

B. COVID-19 Plan

    An effective COVID-19 plan is modeled on the core components of
safety and health programs, which utilize a systematic approach to
reduce injuries and illnesses in the workplace. The occupational safety
and health community uses various names to describe this type of
systematic approach (e.g., safety and health programs, safety and
health management systems, and injury and illness prevention programs)
and uses the terms ``plans'' and ``programs'' interchangeably. An
effective safety and health program involves proactively and
continuously identifying and mitigating hazards, before employees are
injured or develop disease. The approach involves trained employees and
managers working together to identify and address issues before the
issues become a problem. Such an approach helps employers meet their
obligation under the OSH Act to provide employees a place of employment
free from recognized hazards (OSHA, January 2012; OSHA, October 18,
2016). The COVID-19 plan required by this ETS encompasses the core
components of this type of safety and health programs. Developing and
implementing a COVID-19 plan is an essential part of an effective
response to the COVID-19 hazards present in the workplace because the
process involves identifying employees who are at risk of exposure to
the virus and determining how they can be effectively protected from
developing COVID-19 using a multi-layered approach.
    Many companies that have received awards for their safety and
health accomplishments have credited safety and health programs for
their success. Because of the value, effectiveness, and feasibility of
such programs, many countries throughout North America, Asia, and
Europe require employers to implement programs to prevent injury and
illness. Numerous studies and data sources provide evidence of such
programs improving safety and health management practices and
performance which leads to reductions in injury, illness, and
fatalities. For example, a review of the impact of implementation of
safety and health programs in eight states showed a reduction of injury
and illness rates ranging from 9% to more than 60% (OSHA, January
2012). In three of these states with mandatory injury and illness
prevention programs, workplace fatality rates were up to 31% lower than
the national average (OSHA, January 2012).
    OSHA has traditionally identified seven core elements of successful
safety and health programs including (1) management leadership, (2)
worker participation, (3) hazard identification and assessment, (4)
hazard prevention and controls, (5) evaluation and improvement, (6)
coordination and communication at multi-employer sites, and (7)
education and training (OSHA, January 2012; OSHA, October 18, 2016).
The COVID-19 plan required by this ETS was developed with these
elements in mind. The first core element, management leadership,
involves a demonstrated commitment to establishing a safety and health
culture and continuously improving safety and health in the workplace.
A commitment to health and safety is demonstrated by implementing a
clear plan for preventing illness and injury, and communicating the
plan to all employees (including contractors and temporary staff).
Designating a coordinator to track progress of the plan and ensure that
all aspects of the plan are implemented further demonstrates
management's commitment to employee safety and health (OSHA, 2005;
OSHA, January 2012; OSHA, October 18, 2016).
    The second, and one of the most important components of a safety
and health program, is the participation of trained and knowledgeable
employees, including those employed by other employers (e.g.,
contractors, temporary staff). Employees provide unique perspective and
expertise because they are often the most knowledgeable people about
the hazards associated with their jobs and how those hazards can be
controlled. Employees who are trained to recognize hazards and
appropriate controls to address those hazards and know that they can
speak freely to employers, can provide valuable input on hazards that
need to be addressed, which can lead to a reduction in hazards or
exposure to hazards. They can also provide input on improvements that
are needed to protections that have already been implemented. An
emphasis on employee participation is consistent with the OSH Act, OSHA
standards, and

OSHA enforcement policies and procedures, which recognize the rights
and roles of workers and their representatives in matters of workplace
safety and health (OSHA, 2005; OSHA, January 2012; OSHA, October 18,
2016).
    The third core element of a safety and health program approach is
hazard identification and assessment. To be most effective, hazard
assessments must be conducted as a team approach with management,
coordinators, and employees involved in the hazard assessment process
(e.g., identifying potential hazards) and the development and
implementation of the COVID-19 plan. An assessment to identify safety
and health hazards can include surveying the facility to observe
employee work habits and evaluating employee input from surveys or
meeting minutes. Specifically, the risk of exposure to biological
hazards, such as the COVID-19 virus, can be assessed by determining if
workers could be exposed (e.g., through close contact with patients,
co-workers, or members of the public; contact with contaminated
surfaces, objects, or waste) and if controls are present to mitigate
those risks (OSHA, 2005; OSHA, October 18, 2016). While a standard can
specify controls applicable to particular hazards, the hazard
assessment can help identify where controls are needed in specific
areas of a particular worksite.
    The fourth core element of an effective workplace safety and health
program approach is hazard prevention and control, which involves teams
of managers, coordinators, and employees assessing if a hazard can be
eliminated (e.g., by working at home to eliminate potential virus
exposure in the workplace). When hazards cannot be eliminated, the
hazard prevention process considers which hazards can be controlled by
implementing work practices (e.g., regular cleaning, disinfecting,
physical distancing) or controls (e.g., physical barriers, improvements
to the ventilation system). Additionally, the process of hazard
prevention and control determines if PPE is required as part of a
multi-layered strategy to protect workers from infectious biological
agents (OSHA, 2005; OSHA, October 18, 2016). The controls may function
more effectively when implemented in the most targeted manner following
a hazard assessment and team-based evaluation.
    The fifth core element of an effective safety and health program
approach is evaluation and improvement. Safety and health programs
require periodic evaluation to ensure they are implemented as intended
and continue to achieve the goal of preventing injury and illness. This
re-evaluation can reduce hazards, or result in improvements in controls
to help reduce hazards. Managers have the prime responsibility for
ensuring the effectiveness of the program but managers should work as a
team with coordinators and employees to continually monitor the
worksite to identify what is and is not working and make adjustments to
improve worker safety and health measures (OSHA, January 2012; OSHA,
October 18, 2016).
    The sixth core element of an effective safety and health program
approach is communication and coordination between host employers,
contractors, and staffing agencies. Because the employees of one
employer may expose employees of a different employer to a hazard, this
communication is essential to protecting all employees. An effective
program ensures that before employees go to a host worksite, both the
host employer and staffing agencies communicate about hazards on the
worksite, procedures for controlling hazards, and how to resolve any
conflicts that could affect employee safety and health (e.g., who will
provide PPE). The exchange of information about each employer's plans
can help reduce exposures by identifying areas where one employer may
need to provide additional protections (barriers, timing of workshifts,
etc.) to its employees. Additionally, exchanging contact information
between employers can facilitate worker protection in case they need to
report hazards or illnesses that may occur (OSHA, October 18, 2016). In
order to reduce COVID-19 transmission in the workplace, it will be
particularly important for employers to have clear plans about how they
can quickly alert other employers if a worker at a multi-employer site
subsequently tests positive for COVID-19 and was in close contact with
workers of other employers.
    The seventh core element of an effective safety and health program
is education and training. Education and training ensures that
employees, supervisors, and managers are able to recognize and control
hazards, allowing them to work more safely and contribute to the
development and implementation of the safety and health program (OSHA,
2005; OSHA, January 2012; OSHA, October 18, 2016). Later in this Need
for Specific Provisions section there is a detailed explanation about
the need for training as a separate control to minimize COVID-19
transmission.
    The effectiveness of a safety and health program approach in
preventing injury and illnesses is recognized by a number of
authoritative bodies. In its Total Worker Health program, the National
Institute for Occupational Safety and Health (NIOSH) lists a number of
core elements that are consistent with OSHA's safety and health program
approaches, including demonstrating leadership commitment to safety and
health, eliminating or reducing safety and health hazards, and
promoting and supporting employee involvement (NIOSH, December 2016).
    The International Organization for Standardization (ISO) developed
ISO 45001, a consensus standard to help organizations implement a
safety and health management system (ISO, 2018). ISO notes that key
potential benefits of the system include reduced workplace incidents,
establishment of a health and safety culture by encouraging active
involvement of employees in ensuring their health and safety,
reinforcement of leadership commitment to health and safety, and
improved ability to comply with regulatory requirements.
    The American National Standards Institute (ANSI) and American
Society of Safety Professionals (ASSP) also developed a health and
safety management systems standard for the purpose of reducing hazards
and risk in a systematic manner, based on a team approach that includes
management commitment and employee involvement, with an emphasis on
continual improvement (ANSI/ASSP, 2019). ANSI/ASSP note the widespread
acceptance that safety and health management systems can improve
occupational safety and health performance. (Id.) They further
highlight OSHA reports of improved safety and health performance by
companies who implement programs that rely on management system
principles (e.g., the Voluntary Protection Program), and that major
professional safety and health organizations support management systems
as effective in improving safety and health. As further proof that
safety and health management systems are valuable, they note that many
large and small organizations within the U.S. and internationally are
implementing these systems.
    Based on the best available evidence, OSHA concludes that a COVID-
19 plan that is modeled on the safety and health program principles
discussed above, implemented by a COVID-19 coordinator, influenced by
employee input, and continuously evaluated, is an effective tool to
ensure comprehensive identification and mitigation of COVID-19 hazards.
As a result, OSHA concludes that a COVID-19 plan will reduce the
incidence of COVID-19 in

the workplace by helping to ensure that all effective measures are
implemented as part of a multi-layered strategy to minimize employee
exposure to COVID-19.
References
American National Standards Institute (ANSI)/American Society of
Safety Professionals (ASSP). (2019). ANSI/ASSP Z10.0-2019.
Occupational Health and Safety Management Systems. (ANSI/ASSP,
2019).
International Organization for Standardization (ISO). (2018).
Occupational health and safety. ISO 45001. (ISO, 2018).
National Institute for Occupational Safety and Health (NIOSH).
(2016, December). Fundamentals of total worker health approaches:
essential elements for advancing worker safety, health, and well-
being. Publication no. 2017-112. https://www.cdc.gov/niosh/docs/2017-112/pdfs/2017_112.pdf. (NIOSH, December 2016).
Occupational Safety and Health Administration (OSHA). (2005). Small
Business Handbook. Small Business Safety and Health Management
Series. OSHA 2209 02R 2005. https://www.osha.gov/sites/default/files/publications/small-business.pdf. (OSHA, 2005).
Occupational Safety and Health Administration (OSHA). (2012,
January). Injury and Illness Prevention Programs. White Paper.
https://www.osha.gov/dsg/InjuryIllnessPreventionProgramsWhitePaper.html. (OSHA, January
2012).
Occupational Safety and Health Administration (OSHA). (2016, October
18). Recommended Practices for Safety and Health Programs. OSHA
3885. https://www.osha.gov/sites/default/files/publications/OSHA3885.pdf. (OSHA, October 18, 2016).

C. Patient Screening and Management

    Limited contact with potentially infectious persons is a
cornerstone of COVID-19 pandemic management. For example, screening and
triage of everyone entering a healthcare setting is an essential means
of identifying those individuals who have symptoms that could indicate
infection with the SARS-CoV-2 virus (CDC, February 23, 2021). Persons
with such symptoms can then be triaged appropriately to minimize
exposure risk to employees. CDC guidance provides a number of
approaches for screening and triage, including screening at entry,
separate triage areas for patients desiring evaluation for COVID-19
concerns, and electronic pre-screening prior to arrival (CDC, February
23, 2021). Once identified, potentially infected individuals can then
be isolated for evaluation, testing, and treatment. Triage increases
the likelihood of implementation of the appropriate level of personal
protective equipment for employees and other protections required for
exposure to potentially infectious patients. Patient segregation in
healthcare settings also reduces nosocomial (healthcare-acquired)
infections for employees. Inpatients continue to require regular re-
evaluation for COVID-19 symptoms.\20\
---------------------------------------------------------------------------

    \20\ Limiting and monitoring points of entry to the setting will
also help limit contact with potentially infectious persons. For
further discussion, see the Need for Specific Provisions for
Physical Distancing.
---------------------------------------------------------------------------

    Symptoms-based screening is a standard component of infection
control. This approach was recommended during the 2003 SARS epidemic
(caused by SARS-CoV-1, a different strain of SARS) and is routinely
recommended for airborne infections such as M. tuberculosis and
measles, and as a general practice in infection control programs
(Siegel et al., 2007). Because SARS-CoV-2 can be transmitted by
individuals who are infected but do not have symptoms (asymptomatic and
presymptomatic transmission), symptom-based screening will not identify
all infectious individuals (Viswanathan et al., September 15, 2020).
However, persons with symptoms early in their SARS-CoV-2 infection are
among the most infectious (Cevik et al., November 19, 2020). Therefore,
symptom-based screening will identify some of the highest-risk
individuals for SARS-CoV-2 transmission and thereby reduce the risk to
workers.
References
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Cevik, M. et al., (2020, November). SARS-CoV-2, SARS-CoV, and MERS-
CoV viral load dynamics, duration of viral shedding, and
infectiousness: A systematic review and meta-analysis. Lancet
Microbe 2021; 2: e13-22. https://doi.org/10.1016/S2666-5247(20)30172-5. (Cevik et al., November 19, 2020).
Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L.
(2007). Guideline for isolation precautions: Preventing transmission
of infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
Viswanathan, M. et al., (2020, September 15). Universal screening
for SARS-CoV-2 infection: A rapid review. Cochrane Database of
Systematic Reviews, Issue 9. Art. No.: CD013718. DOI: 10.1002/
14651858.CD013718. (Viswanathan et al., September 15, 2020).

D. Standard and Transmission-Based Precautions

    Standard and Transmission-Based Precautions are well-accepted as
important to controlling disease transmission (HICPAC, December 27,
2018; CDC, January 7, 2016). It should be noted that during times of
significant transmission, such as during this pandemic, additional
protections are needed to supplement the basic level of recommended
precautions and practices in these guidelines. For instance, wearing at
least a facemask regardless of interaction with known or suspected
infectious patients is needed during the pandemic (CDC, February 23,
2021).
    Standard Precautions refers to infection prevention practices,
implemented in healthcare settings, where the presence of an infectious
agent is assumed (i.e., without the suspicion or confirmation of
exposure). The use of Standard Precautions thus relies on the
assumption that all patients, patient samples, potentially contaminated
materials (e.g., patient laundry, medical waste), and human remains in
healthcare settings are potentially infected or colonized with an
infectious agent(s). For example, Standard Precautions would include
appropriate hand hygiene and use of personal protective equipment as
well as practices to ensure respiratory hygiene, sharps safety, safe
injection practices, and sterilization and disinfection of equipment
and surfaces (CDC, February 23, 2021).
    Transmission-Based Precautions add an additional layer of
protection to Standard Precautions. Transmission-Based Precautions
refers to those good infection prevention practices, used in tandem
with Standard Precautions that are based on the way an infectious
agent(s) may be transmitted. These precautions are needed, for example,
when treating a patient where it is suspected or confirmed that the
patient may be infected or colonized with agents that are infectious
through specific routes of exposure (Siegel et al., 2007). For example,
handwashing and safe handling of sharps (needles, etc.) are routine
Standard Precautions. An infectious agent capable of airborne
transmission through aerosols would require patient care in an airborne
infection isolation room (AIIR), if available, under Transmission-Based
Precautions.
    Even before a patient is treated, certain Transmission-Based
Precautions

can be critical to protecting healthcare workers. For example, one
typical precaution is that patients and visitors who enter a waiting
room before being seen or triaged must wear facemasks, or face
coverings, as a source control device to prevent them from spreading
airborne droplets near the employees. These source control devices may
also be critical to reducing the likelihood that COVID-19 is spread as
the patients are transported from the admission area to a treatment
area.
    The critical need for implementing Standard and Transmission-Based
Precautions in healthcare settings is evident in the Healthcare
Infection Control Practices Advisory Committee's (HICPAC's) 2017 Core
Infection Prevention and Control Practices for Safe Healthcare Delivery
in All Settings.\21\ The core practices included in that document
include Standard and Transmission-Based Precautions, which, HICPAC
recommended, need to be implemented in all settings where healthcare is
delivered.
---------------------------------------------------------------------------

    \21\ HICPAC is a federal advisory committee that provides
guidance to the CDC and the Secretary of the Department of Health
and Human Services (HHS) regarding the practice of infection
control. In March 2013, CDC charged HICPAC with a review of existing
CDC guidelines to identify all recommendations that warrant
inclusion as core practices. In response, a HICPAC workgroup was
formed that contained representatives from the following stakeholder
organizations: America's Essential Hospitals, the Association for
Professionals in Infection Control and Epidemiology (APIC), the
Council of State and Territorial Epidemiologists (CSTE), the Public
Health Agency of Canada (PHAC), the Society for Healthcare
Epidemiology of America (SHEA), and the Society of Hospital Medicine
(SHM) (HICPAC, March 15, 2017). This process resulted in HICPAC's
Core Infection Prevention and Control Practices for Safe Healthcare
Delivery in All Settings.
---------------------------------------------------------------------------

    That Standard and Transmission-Based Precautions are a long-
standing and essential element of infection control in healthcare
industries is also evidenced by the CDC's 2007 Guideline for Isolation
Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings, which incorporate Standard and Transmission-Based Precautions
into their recommendations. This 2007 Guideline updated 1996
guidelines, which introduced the concept of Standard Precautions and
also noted the existence of infection control recommendations dating
back to 1970 (Siegel et al., 2007).
    Both Standard and Transmission-Based Precautions are recommended by
the CDC for healthcare personnel during the COVID-19 pandemic (CDC,
February 23, 2021). The CDC considers healthcare personnel (HCP) to
include all paid and unpaid persons serving in healthcare settings who
have the potential for direct or indirect exposure to patients or
infectious materials, including body substances (e.g., blood, tissue,
and specific body fluids); contaminated medical supplies, devices, and
equipment; contaminated environmental surfaces; or contaminated air.
HCP include, but are not limited to, emergency medical service
personnel, nurses, nursing assistants, home healthcare personnel,
physicians, technicians, therapists, phlebotomists, pharmacists,
students and trainees, contractual staff not employed by the healthcare
facility, and persons not directly involved in patient care, but who
could be exposed to infectious agents that can be transmitted in the
healthcare setting (e.g., clerical, dietary, environmental services,
laundry, security, engineering and facilities management,
administrative, billing, and volunteer personnel).
    The CDC also has recommendations for protection of workers in
industries associated with healthcare. According to the CDC's Interim
Infection Prevention and Control Recommendations for Healthcare
Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic
(incorporated by reference, Sec.  1910.509), on-site management of
laundry, food service utensils, and medical waste should also be
performed in accordance with routine procedures (CDC, February 23,
2021).
    The work of the College of American Pathologists (CAP) illustrates
the importance of taking core precautionary measures in healthcare
industries during the pandemic. CAP has provided recommendations for
staff protection during the COVID-19 pandemic. For example, CAP has
provided COVID-19-specific autopsy recommendations which include
biosafety considerations such as performing autopsies on COVID-19-
positive cases in an airborne infection isolation room (College of
American Pathologists, February 2, 2021).\22\
---------------------------------------------------------------------------

    \22\ CAP is known for its peer-based Laboratory Accreditation
Program. The Centers for Medicare & Medicaid Services (CMS) allows a
CAP inspection in lieu of a CMS inspection. CAP inspections have a
similar status with a number of other leading healthcare and
biomedical laboratory authorities including the Joint Commission,
United Network for Organ Sharing, the National Marrow Donor Program,
the Foundation for the Accreditation of Cellular Therapies, and many
state agencies (College of American Pathologists, February 1,
2021b). CAP has worked with the CMS to implement virtual laboratory
inspections allowing labs to remain in compliance with Clinical
Laboratory Improvement Amendments regulations (College of American
Pathologists, February 1, 2021a).
---------------------------------------------------------------------------

    The Standard and Transmission-Based Precautions required by the ETS
only extend to exposure to SARS-CoV-2 and COVID-19 protection. The
agency does not intend the ETS to apply to other workplace hazards.
References
Centers for Disease Control and Prevention (CDC). (2016, January 7).
Transmission-based precautions. https://www.cdc.gov/infectioncontrol/basics/transmission-based-precautions.html. (CDC,
January 7, 2016).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
College of American Pathologists. (2021, February 2). Amended COVID-
19 autopsy guideline statement from the CAP Autopsy Committee.
https://documents.cap.org/documents/COVID-Autopsy-Statement.pdf.
(College of American Pathologists, February 2, 2021).
Healthcare Infection Control Practices Advisory Committee (HICPAC).
(2018, December 27). Core infection prevention and control practices
for safe healthcare delivery in all settings. https://www.cdc.gov/hicpac/recommendations/core-practices.html. (HICPAC, December 27,
2018).
Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L.
(2007). Guideline for isolation precautions: Preventing transmission
of infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).

E. Personal Protective Equipment (PPE)

    As previously discussed in Grave Danger (Section IV.A. of the
preamble), COVID-19 infections occur mainly through exposure to
respiratory droplets (referred to as droplet transmission) when a
person is in close contact with someone who has COVID-19. COVID-19 can
sometimes also be spread by airborne transmission (CDC, May 13, 2021).
As the CDC explains, when people with COVID-19 cough, sneeze, sing,
talk, or breathe, they produce respiratory droplets, which can travel a
limited distance--thereby potentially infecting people within close
physical proximity--before falling out of the air due to gravity.
Facemasks, face coverings, and face shields are all devices used for
their role in reducing the risk of droplet, and potentially airborne,
transmission of COVID-19 primarily at the source. Additional discussion
on the efficacy of each device, and the need for facemasks and face
shields specifically, is explained below. (Respirator use is also
included in the ETS and more information on the

need for respirators to prevent the spread of COVID-19 is discussed in
the Need for Specific Provisions for Respirators, further below.)
    Well-fitting facemasks, not face coverings, are the baseline
requirement in healthcare settings because of their fluid resistant
qualities (discussed in detail below). However, the role of facemasks
and face coverings are otherwise similar in source control and personal
protection for the wearer. OSHA's position on the importance of face
coverings and facemasks is supported by a substantial body of evidence.
Consistent and correct use of face coverings and facemasks is widely
recognized and scientifically supported as an important evidence-based
strategy for COVID-19 control. Accordingly, with specific exceptions
relevant to outdoor areas and vaccinated persons, the CDC recommends
everyone two years of age and older wear a face covering in public
settings and when around people outside of their household (CDC, April
19, 2021). And, on January 21, 2021, President Biden issued Executive
Order 13998, which recognizes the use of face coverings or facemasks as
a necessary, science-based public health measure to prevent the spread
of COVID-19, and therefore directed regulatory action to require that
they be worn in compliance with CDC guidance while traveling on public
transportation (e.g., buses, trains, subway) and while at airports
(Executive Order 13998, 86 FR 7205, 7205 (Jan. 21, 2021); CDC, February
2, 2021). Similarly, the World Health Organization (WHO) has recognized
face coverings as a key measure in suppressing COVID-19 transmission,
and thus, saving lives. The WHO observes that face coverings (and
facemasks) serve two purposes, to both protect healthy people from
acquiring COVID-19 and to prevent sick people from further spreading it
(WHO, December 1, 2020).
I. Need for Facemasks
    Facemasks are simple bi-directional barriers that tend to keep
droplets, and to a lesser extent airborne particulates, on the side of
the filter from which they originate. The term ``facemask,'' as used in
this ETS, is defined as a surgical, medical procedure, dental, or
isolation mask that is FDA-cleared, FDA-authorized, or offered or
distributed as described in an FDA enforcement policy. These are most
commonly referred to as ``surgical masks'' or ``medical procedure
masks.'' As previously mentioned, facemasks reduce the risk of droplet
transmission through their dual function as both source control and
personal protection (OSHA, January 28, 2021; Siegel et al., 2007). In
healthcare settings, facemasks have long been recognized as an
important method of source control for preventing the spread of
infectious agents transmitted via respiratory droplets (e.g., in the
operating room to prevent provider saliva and respiratory secretions
from contaminating the surgical field and infecting patients). However,
facemasks do not filter out very small airborne particles and do not
provide complete protection even from larger particles because the mask
seal is not tight (FDA, December 7, 2020).
    Facemasks are designed and regulated through various FDA processes
to protect the person wearing them. Not all devices that resemble
facemasks are FDA-cleared or authorized. To receive FDA clearance,
manufacturers are required to submit an FDA premarket notification
(also known as a 510(k) notification) for new products. Data in the
510(k) submission must show that the facemask is substantially
equivalent to a facemask already on the market in terms of safety and
effectiveness. Facemasks are tested for fluid resistance, filtration
efficiency (particulate filtration efficiency and bacterial filtration
efficiency), differential pressure, flammability and biocompatibility
(FDA, July 14, 2004).\23\
---------------------------------------------------------------------------

    \23\ Medical devices are subject to premarket review through
risk-based classification under the Federal Food, Drug, and Cosmetic
Act. Premarket approval (PMA) applies to the highest-risk, Class III
devices, and 510(k) notification applies to most Class II and some
Class I devices. Under the 510(k) notification pathway, FDA
determines whether the device is substantially equivalent to a
lawfully marketed predicate device. Medical device manufacturers are
required to submit a 510(k) notification if they intend to introduce
a device into commercial distribution for the first time or
reintroduce a device that will be significantly changed or modified
to the extent that its safety or effectiveness could be affected.
Such change or modification could relate to the design, material,
chemical composition, energy source, manufacturing process, or
intended use. For more information, see https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device and https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances.
---------------------------------------------------------------------------

    Research developed during the current SARS-CoV-2 pandemic provides
evidence of the protection afforded by facemasks. First, a universal
surgical masking requirement for all healthcare workers and patients
was implemented in Spring 2020 in the Mass General Brigham healthcare
system, which is the largest in Massachusetts (Wang et al., July 14,
2020). Based on daily infection rates among healthcare workers, the
authors found that universal masking was associated with a
significantly lower rate of SARS-CoV-2 positivity. Although the authors
noted that other interventions, such as restricting visitors, were also
put in place, they concluded that their results supported universal
masking as part of a multi-pronged infection reduction strategy in
healthcare settings.
    Second, a systematic review and meta-analysis evaluated research on
healthcare workers exposed to SARS-CoV-2, as well as the SARS and
Middle East respiratory syndrome (MERS) viruses (Chu et al., June 27,
2020). Six studies compared the odds of infection in those who wore
surgical or similar facemasks compared to those who did not wear any
facemask; four of the six studies were on healthcare workers and all
six were from the 2003 SARS epidemic. Participants who wore surgical or
similar facemasks had only a third of the infection risk of those who
did not wear any facemask.
    Third, a review of respiratory protection for healthcare workers
during pandemics noted that surgical mask material has been shown to
protect against more than 95% of viral aerosols under laboratory
conditions (Garcia-Godoy et al., May 5, 2020). The authors also
reviewed research showing that surgical masks reduced aerosolized
influenza exposure by an average of six-fold, depending on mask
design.\24\
---------------------------------------------------------------------------

    \24\ For a discussion of the efficacy of respirators over
facemasks for protection against aerosolized particles, please see
the respirator discussion in the Need for Specific Provisions
section, below.
---------------------------------------------------------------------------

    Finally, in one epidemiological study, a specialized team of
contact tracers at Duke University Health System in North Carolina
categorized recorded COVID-19 cases among their healthcare workers
(Seidelman et al., June 25, 2020). Of the cases that were categorized
as healthcare-acquired (meaning acquired as a result of either an
unmasked exposure for greater than 10 minutes at less than 6 feet to
another healthcare worker who was symptomatic and tested positive for
the virus, or an exposure to a COVID-19-positive patient while not
wearing all CDC-recommended PPE or while there was a breach in PPE),
70% were linked to an unmasked exposure to another healthcare worker.
    Although cloth face coverings have gained widespread use outside of
healthcare settings during this pandemic, OSHA has determined that
cloth face coverings do not offer sufficient protection for covered
healthcare workers for multiple reasons. First, cloth face coverings,
as defined by the CDC, encompass such a wide variety of coverings that
there is no assurance

of any consistent protection to the wearer, and even source protection
can vary significantly depending on the construction and fit of the
face covering. Second, a number of studies suggest that, properly worn
over the nose and mouth, facemasks provide better protection than face
coverings, which is an important consideration in healthcare settings
where there are regular, known exposures to COVID-19-positive persons.
For example, one randomized trial of cloth face coverings compared
rates of clinical respiratory illness, influenza-like illness, and
laboratory-confirmed respiratory virus infections in 1,607 healthcare
workers in 14 hospitals in Vietnam (MacIntyre et al., March 26, 2015).
Infection risks were statistically higher in the cloth face covering
group compared to the facemask group: The risk of influenza-like
illness was 6.6 times higher, and the risk of laboratory-confirmed
respiratory virus infection was 1.7 times higher, in those who wore
cloth face coverings compared to those who wore facemasks. Another
study which reviewed respiratory protection for healthcare workers
during pandemics showed greater protection from surgical masks compared
to face coverings (Garcia-Godoy et al., May 5, 2020). Finally, Ueki et
al., (June 25, 2020) evaluated the effectiveness of cotton face
coverings, facemasks, and N95s (a commonly used respirator) in
preventing transmission of SARS-CoV-2 using a laboratory experimental
setting with manikins. The researchers found that all offerings
provided some measure of protection as source control, limiting
droplets expelled from both infected and uninfected wearers, but that
facemasks and N95s provided better protection than cotton face
coverings. Specifically, the researchers found that when spaced roughly
20 inches apart, if both an infected and uninfected individual were
wearing a cotton face covering, the uninfected person reduced
inhalation of infectious virus by 67%. But if both individuals were
wearing facemasks, exposure was reduced by 76% and when an infected
individual was wearing an N95, exposure was reduced by 96%.
    Third, cloth face coverings do not function as a barrier to protect
employees from hazards such as splashes or large droplets of blood or
bodily fluids, which is a common hazard in healthcare settings. And
finally, OSHA has previously established that medical facemasks are
essential PPE for many workers in healthcare, as enforced under both
the PPE standard (29 CFR 1910.132) and more specifically, the
Bloodborne Pathogens standard (29 CFR 1910.1030).
    Given the health outcomes related to COVID-19 and the exposure
characteristics found in healthcare settings (e.g., splashes or large
droplets of blood or bodily fluids), OSHA has determined that cloth
face coverings are not appropriate for workers in these settings.
Research clearly indicates that facemasks provide essential protection
for workers in covered healthcare settings.
II. Need for Face Shields
    The term ``face shield,'' as used in this ETS, is a device
typically made of clear plastic, that covers the wearer's eyes, nose,
and mouth, wraps around the sides of the wearer's face, and extends
below the wearer's chin. Face shields have long been recognized as
effective in preventing splashes, splatters, and sprays of bodily
fluids and have a role in preventing the primary route of droplet
transmission, although not aerosolized transmission. As explained
above, OSHA has determined based on the best available evidence that
facemask usage is a necessary protective measure to prevent the spread
of COVID-19 for any covered employee. However, the use of face shields,
a less protective barrier, is permitted to either supplement facemasks
where there is a particular risk of droplet exposure, or as an
alternative option in certain limited circumstances where facemask
usage is not feasible.
    Face shields are proven to provide some protection to the wearer
from exposure to droplets, and OSHA has long considered face shields to
be PPE under the general PPE standard (29 CFR 1910.132) and the Eye and
Face Protection standard (29 CFR 1910.133) for protection of the face
and eyes from splashes and sprays. The potential protective value of
face shields against droplet transmission is supported by a 2014 study,
in which NIOSH investigated the effectiveness of face shields in
preventing the transmission of viral respiratory diseases. The purpose
of the study was to quantify exposure of cough aerosol droplets and
examine the efficacy of face shields in reducing this exposure.
Although face shields were not found to be effective against smaller
particles, which can remain airborne for extended periods and can
easily flow around a face shield to be inhaled, the face shields were
effective in blocking larger aerosol particles (median size of 8.5
[micro]M). Face shields worn over a respirator also reduced surface
contamination of the respirator by 97%. The study's final conclusion
was that face shields can be a useful complement to respiratory
protections; however, they cannot be used as a substitute for
respiratory protection, when needed (Lindsley et al., June 27, 2014). A
recent update of the Lindsley study (Lindsley et al., January 7, 2021)
found that face shields blocked only 2% of aerosol produced by
coughing. These findings suggest that face shields might be a relevant
form of protection in healthcare settings to protect employees from
droplet exposure when they could have close contact with individuals
who are potentially infected with COVID-19.
    Face shields have proven less effective as a method of source
control or a method of personal protection than facemasks. For example,
in considering face shields' value as source control, Verma et al.,
(June 30, 2020) observed the effect of a face shield on respiratory
droplets produced by simulating coughs or sneezes with a manikin. The
face shield initially blocked the forward motion of the droplet stream,
but droplets were then able to flow around the shield and into the
surrounding area. The study authors concluded that face shields alone
may not be as effective in blocking droplets.
    In another study, Stephenson et al., (February 12, 2021) evaluated
the effectiveness of face coverings, facemasks, and face shields in
reducing droplet transmission. Breathing was simulated in two manikin
heads (a transmitter and receiver) that were placed four feet apart.
Artificial saliva containing a marker simulating viral genetic material
was used to generate droplets from the transmitter head. The
researchers found that face coverings, facemasks, and face shields all
reduced the amount of surrogate genetic material measured in the
environment and the amount that reached the receiver manikin head at
four feet. While face shields reduced surrogate genetic material by
98.6% in the environment and 95.2% at the receiver, genetic material
was still deposited downward in the immediate area of the transmitter,
suggesting that use of face shields without a facemask could result in
a contamination of shared surfaces. This limits the effectiveness of
face shields alone as a method of source control for shared workspaces.
Additionally, face shields used as personal protective devices showed
that the face shields protected the wearer from large cough aerosols
directed at the face, but were much less effective against smaller
aerosols which were able to flow around the edges of the shield and be
inhaled (Lindsley et al., June 27, 2014).
    Based on this evidence, OSHA has determined that face shields are
not

generally appropriate as a substitute for a facemask because they are
less effective at reducing the risk of droplet and potential airborne
transmission. However, face shields do offer some protection from
droplet transmission and are, accordingly, required by the ETS to be
used in any circumstance where, for example, an individual may not be
able to wear a facemask due to a medical condition or due to other
hazards (e.g., heat stress, arc flash fire hazards). In such limited
(and often temporary) situations, a face shield may be the most
effective measure to add a layer of protection to reduce workers'
overall COVID-19 transmission risk, particularly when combined with
other protective measures.
    Additionally, OSHA recognizes that face shields can provide some
additional protection when used in addition to a facemask by protecting
the wearer's eyes and preventing their facemask from being contaminated
with respiratory droplets from other persons. This additional
protection may be particularly useful for employees who cannot avoid
close contact with others or are unable to work behind barriers.
Accordingly, the ETS allows employers to require face shields in
addition to facemasks where employment circumstances might warrant the
additional protection.
    OSHA has always considered recognized consensus standards, with
design and construction specifications, when determining the PPE
requirements of the agency's standards, as required by the OSH Act (29
U.S.C. 655(b)(8)) and the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).
    The agency has already incorporated by reference the ANSI/ISEA
Z87.1, Occupational and Educational Personal Eye and Face Protection
Devices consensus standard for face shields in its Eye and Face
Protection standard (29 CFR 1910.133). In this ETS the agency will
incorporate by reference more recent editions of the ANSI/ISEA standard
than are currently provided for in the existing standard. Additionally,
for the limited purpose of complying with the ETS, the agency will also
allow any face shield that meets the criteria outlined in the
definition of ``face shield'' found in the definition sections of the
ETS. That is: (1) Certified to the ANSI/ISEA Z87.1-2010, 2015, or 2020
standard; or (2) covers the wearer's eyes, nose, and mouth to protect
from splashes, sprays, and spatter of body fluids, wraps around the
sides of the wearer's face (i.e., temple-to-temple), and extends below
the wearer's chin. Any face shield that is worn for the purpose of
complying with any OSHA standard other than Subpart U must still meet
the requirements of 29 CFR 1910.133.
III. Need for Other Types of PPE
    Gloves and gowns (overgarments) are the two most common types of
PPE used in healthcare settings. A major principle of Standard
Precautions is that all blood and body fluids, whether from a patient,
patient sample, or infectious material, may contain transmissible
infectious agents (Siegel et al., 2007). Therefore, gloves and gowns
(overgarments) are required for certain examinations and all
procedures. These include everything from venipuncture to removing
medical waste to intubation. Similarly, gowns or similar protective
clothing are necessary for any activities in which splashes or clothing
contamination is possible. This applies as part of Standard Precautions
as well as for care of patients on Contact Precautions where
unintentional contact with contaminated environmental surfaces must be
avoided (Siegel et al., 2007).
    Eye protection in the form of goggles or face shields (as discussed
above) can be used with facemasks to protect mucous membranes (eyes,
nose, and mouth) in situations where, for example, sprays of blood or
body fluids are possible. CDC recommends that healthcare workers wear
eye protection during patient care encounters to ensure eyes are
protected from infectious bodily fluids (CDC, February 23, 2021).
IV. Conclusion
    In closing, the best available experimental and epidemiological
data support consistent use of facemasks in healthcare work settings to
reduce the spread of COVID-19 through droplet transmission. Adopting
facemask policies is necessary, as part of a multi-layered strategy
combined with other non-pharmaceutical interventions such as physical
distancing, hand hygiene, and adequate ventilation, to protect
employees from COVID-19. Based on the proven effectiveness of facemask
use and the effectiveness of face shields in preventing contamination
of facemasks and protecting the eyes when there is a particular risk of
droplet exposure, OSHA's COVID-19 ETS includes necessary provisions for
required use of facemasks and face shields (e.g., either as a
complementary device or in such circumstances where it is not
appropriate or possible to wear a facemask). The ETS also requires
additional PPE, such as gloves, gowns, and eye protection, in certain
limited circumstances where there is likely exposure to persons with
COVID-19.
References
Centers for Disease Control and Prevention (CDC). (2021, February
2). Order under Section 361 of the Public Health Service Act (42
U.S.C. 264) and 42 Code of Federal Regulations 70.2, 71.31(b),
71.32(b). Federal Register notice: wearing of face masks while on
conveyances and at transportation hubs. https://www.cdc.gov/quarantine/masks/mask-travel-guidance.html. (CDC, February 2, 2021).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the Coronavirus Disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, April 19).
Guidance for Wearing Masks. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover-guidance.html. (CDC,
April 19, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Chu, DK et al., (2020, June 27). Physical Distancing, Face Masks,
and Eye Protection to Prevent Person-to-Person Transmission of SARS-
CoV-2 and COVID-19: a systematic review and meta-analysis. The
Lancet 395: 1973-1987. https://doi.org/10.1016/. (Chu et al., June
27, 2020).
Food and Drug Administration (FDA). (2004, July 14). Guidance for
industry and FDA staff. Surgical masks--premarket notification
[510(k)] submissions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surgical-masks-premarket-notification-510k-submissions. (FDA, July 14, 2004).
Food and Drug Administration (FDA). (2020, December 7). N95
respirators, surgical masks, and face masks. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-surgical-masks-and-face-masks#s2. (FDA, December 7,
2020).
Garcia-Godoy, L. et al., (2020, May 5). Facial protection for
healthcare workers during pandemics: A scoping review. BMJ global
health, 5(5), e002553. https://doi.org/10.1136/bmjgh-2020-002553.
(Garcia-Godoy et al., May 5, 2020).
Lindsley, W. et al., (2014, June 27). Efficacy of face shields
against cough aerosol droplets from a cough simulator. Journal of
Occupational and Environmental Hygiene, 11(8), 509-518. doi:
10.1080/15459624.2013.877591. (Lindsley et al., June 27, 2014).
Lindsley, W. et al., (2021, January 7). Efficacy of face masks, neck
gaiters and face shields for reducing the expulsion of simulated
cough-generated aerosols. Aerosol Science and Technology, DOI:

10.1080/02786826.2020.1862409. (Lindsley et al., January 7, 2021).
MacIntyre, C. et al., (2015, March 26). A cluster randomised trial
of cloth masks compared with medical masks in healthcare workers.
BMJ Open 2015; 5: e006577. doi: 10.1136/bmjopen-2014-006577.
(MacIntyre et al., March 26, 2015).
Occupational Safety and Health Administration (OSHA). (2021, January
28). Frequently asked questions COVID-19. https://www.osha.gov/coronavirus/faqs. (OSHA, January 28, 2021).
Seidelman, J. et al., (2020, June 25). Universal masking is an
effective strategy to flatten the severe acute respiratory
coronavirus virus 2 (SARS-CoV-2) healthcare worker epidemiologic
curve. Infection Control & Hospital Epidemiology, 41(12), 1466-1467.
doi: 10.1017/ice.2020.313. (Seidelman et al., June 25, 2020).
Siegel, J, Rhinehart, E, Jackson, M, Chiarello, L, and the
Healthcare Infection Control Practices Advisory Committee. (2007).
2007 Guideline for isolation precautions: preventing transmission of
infectious agents in healthcare settings. https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf. (Siegel
et al., 2007).
Stephenson, T. et al., (2021, February 12). Evaluation of facial
protection against close-contact droplet transmission. MedRxiv. doi:
10.1101/2<IP_ADDRESS>51443. (Stephenson et al., February 12, 2021).
Ueki, H et al., (2020, June 25). Effectiveness of face masks in
preventing airborne transmission of SARS-CoV-2. mSphere 5: e00637-
20. https://doi.org/10.1128/mSphere.00637-20. (Ueki et al., June 25,
2020).
Verma, S. et al., (2020, June 30). Visualizing the effectiveness of
face masks in obstructing respiratory jets. Physics of Fluids,
32(6), 061708. doi: https://doi.org/10.1063/5.0016018. (Verma et
al., June 30, 2020).
Wang, X. et al., (2020, July 14). Association between universal
masking in a health care system and SARS-CoV-2 positivity among
health care workers. Journal of the American Medical Association,
324(7), 703-704. doi: 10.1001/jama.2020.12897. (Wang et al., July
14, 2020).
World Health Organization (WHO). (2020, December 1). Mask use in the
context of COVID-19. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public/when-and-how-to-use-masks. (WHO,
December 1, 2020).

F. Respirators

I. Respirator Use in Healthcare
    As noted in Grave Danger (Section IV.A. of the preamble), it is
well-accepted that COVID-19 might spread through airborne transmission
during aerosol-generating procedures (AGPs) such as intubation.
Moreover, outside of AGP scenarios, CDC has noted growing evidence that
airborne droplets and particles can remain suspended in air, travel
distances beyond 6 feet, and be breathed in by others (CDC, May 13,
2021). Grave Danger (Section IV.A. of the preamble) notes studies
showing that infectious viral particles have been collected at
distances as far as 4.8 meters away from a COVID-19 patient (Lednicky
et al., September 11, 2020), and airborne COVID-19 infection has been
identified in a Massachusetts hospital (Klompas et al., February 9,
2021). Accordingly, the CDC recommends the use of airborne Transmission
Precautions, including the use of respirators, for any healthcare
workers caring for patients with suspected or confirmed COVID-19 (CDC,
March 12, 2020). This airborne transmission risk is in addition to the
risks associated with contact and droplet transmission. Respirators
have long been recognized as an effective and mandatory means of
controlling airborne transmissible diseases and the use of this
personal protective equipment is regulated under OSHA's Respiratory
Protection standard (29 CFR 1910.134).
    The CDC has issued core guidelines for when ``healthcare
personnel'' should use respiratory protection against COVID-19
infection (see Interim Infection Prevention and Control Recommendations
for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19)
Pandemic (CDC, February 23, 2021)). These recommendations have been
based on the most currently available information about COVID-19, such
as how the virus spreads, and are applicable to all healthcare settings
in the U.S. In the guidance, the CDC defines ``healthcare settings'' as
places where healthcare is delivered, including but not limited to:
acute care facilities, long-term acute care facilities, inpatient
rehabilitation facilities, nursing homes, assisted living facilities,
home healthcare, vehicles where healthcare is delivered (e.g., mobile
clinics), and outpatient facilities (e.g., dialysis centers, physician
offices). In addition, the CDC provides examples of ``healthcare
personnel,'' which include emergency medical service personnel, nurses,
nursing assistants, home healthcare personnel, physicians, technicians,
therapists, phlebotomists, pharmacists, students and trainees,
contractual staff not employed by the healthcare facility, and persons
not directly involved in patient care, but who could be exposed to
infectious agents that can be transmitted in the healthcare setting
(e.g., clerical, dietary, environmental services, laundry, security,
engineering and facilities management, administrative, billing, and
volunteer personnel).
    The CDC describes who is at greatest risk for COVID-19 infection in
a set of FAQs designed for healthcare workers (CDC, March 4, 2021). In
the FAQs, the CDC notes that those currently at greatest risk of COVID-
19 infection are persons who have had prolonged, unprotected close
contact (i.e., within 6 feet for a combined total of 15 minutes or
longer in a 24 hour period) with a patient with confirmed COVID-19,
regardless of whether the patient has symptoms. Moreover, according to
the CDC, persons frequently in congregate healthcare settings (e.g.,
nursing homes, assisted living facilities) are at increased risk of
acquiring infection because of the increased likelihood of close
contact. In the FAQs, the CDC also reports that current data suggest
that close-range aerosol transmission by droplet and inhalation, and
contact followed by self-delivery to the eyes, nose, or mouth are
likely routes of transmission for COVID-19, and that long-range aerosol
transmission, has not been a feature of the virus. The CDC further
explains that potential routes of close-range transmission include
splashes and sprays of infectious material onto mucous membranes and
inhalation of infectious virions (i.e., the active, infectious form of
a virus) exhaled by an infected person, but that the relative
contribution of each of these is not known for COVID-19.
    As the CDC states in the FAQs (CDC, March 4, 2021), although
facemasks are routinely used for the care of patients with common viral
respiratory infections, N95 filtering facepiece respirators or
equivalent (e.g., elastomeric half-mask respirators) or higher-level
(e.g., full facepiece respirators or PAPRs) respirators are routinely
recommended to protect healthcare workers from emerging pathogens like
the virus that causes COVID-19, which have the potential for
transmission via small particles. The CDC further advises that while
facemasks will provide barrier protection against droplet sprays
contacting mucous membranes of the nose and mouth, they are not
designed to protect wearers from inhaling small particles. Because of
this, the CDC recommends the use of respirators for close-contact care
of patients with suspected or confirmed COVID-19. The CDC recommends
that N95 filtering facepiece respirators (FFRs) and higher-level
respirators, such as other disposable FFRs, powered air-purifying
respirators (PAPRs), and elastomeric respirators, should be used when
both barrier and respiratory protection is

needed for healthcare workers because respirators provide better fit
and filtration characteristics.
    The CDC recommendations in Interim Infection Prevention and Control
Recommendations for Healthcare Personnel During the Coronavirus Disease
2019 (COVID-19) Pandemic are divided into two separate categories.
These include: (1) Recommended infection prevention and control
practices when caring for a patient with suspected or confirmed COVID-
19; and (2) recommended routine infection prevention and control
practices during the COVID-19 pandemic (CDC, February 23, 2021).
    A topic of interest related to the selection and use of respirators
is their dual role as both personal protective equipment for the wearer
and also source control to reduce the potential for transmission of
potentially infectious exhaled air to others. While many filtering
facepiece respirators do not have an exhalation valve, other filtering
facepiece respirators do. The other ``higher-level'' respirators
referenced above, and in CDC guidance (e.g., half or full facepiece
elastomeric respirators and PAPRs), do have exhalation valves. An
exhalation valve is a portal in the respirator to allow unfiltered air
to leave the respirator in order to reduce breathing resistance for the
wearer and reduce moisture and heat buildup inside the respirator.
While the exhalation valve does allow some particles to escape through
the valve, it is important to compare the performance of a respirator
with an exhalation valve to other acceptable forms of source control in
order to determine if there are actually reduced levels of
effectiveness. NIOSH studied this issue and released a technical report
entitled ``Filtering Facepiece Respirators with an Exhalation Valve:
Measurements of Filtration Efficiency to Evaluate Their Potential for
Source Control'' (NIOSH, December 2020). In the report, NIOSH concluded
that respirators with exhalation valves were equally effective as
facemasks:

this study found that unmitigated FFRs with an exhalation valve that
were tested in an outward position (with particles traveling in the
direction of exhalation) have a wide range of penetration, emitting
between <1% and 55%. Further testing could measure greater particle
penetration. Even without mitigation, FFRs with exhalation valves
can reduce 0.35-[micro]m MMAD particle emissions more consistently
than surgical masks, procedure masks, cloth face coverings, or
fabric from cotton t-shirts; . . . FFRs with an exhalation valve
provide respiratory protection to the wearer, and this study
demonstrates that they can also reduce 0.35-[micro]m MMAD particle
emissions to levels similar to or better than those provided by
surgical masks and unregulated barrier face coverings.

    The results that NIOSH observed can be explained in two ways.
First, the majority of the leakage takes place around the seal by the
nose and mouth, and respirators are designed to provide tight seals
around the face so that there is only minimal leakage. Facemasks, on
the other hand, do not typically seal tightly to the face and thus
significant quantities of unfiltered air with small particles will also
escape through the gaps on the side and at the nose, as well as
potentially through the fabric of less protective filter materials.
Second, the level of filtration in facemasks is highly variable, so a
wide range of filter efficiencies have been acceptable under CDC
guidance. The CDC does not recommend that respirators with exhaust
valves be used as source controls, but the CDC's last updated
recommendation on this subject was published in August of 2020, four
months before the NIOSH study, and cited lack of data as the basis for
the warning against relying on such respirators (CDC, April 9, 2021b).
Therefore, the NIOSH study with its conclusion that respirators with
exhaust valves are not less adequate as source controls than other
acceptable source controls, appears to represent the best available
evidence. OSHA therefore concludes that at this time there is no basis
for OSHA to prohibit any NIOSH-approved filtering facepiece respirator
from serving as both personal protective equipment and as source
control. The NIOSH report also details methods of covering the
filtering facepiece respirator's exhalation valve in various manners to
further improve the effectiveness as source control, which OSHA
considers a recommended practice, but not strictly necessary. There are
also other methods that can be used to cover or filter the exhalation
valve of elastomeric respirators (e.g., place a medical mask over the
respirator).
II. The CDC's Recommended Infection Prevention and Control Practices
When Caring for a Patient With Suspected or Confirmed COVID-19
    The CDC recommends that healthcare personnel (including workers
that perform healthcare services and those that perform healthcare
support services) who enter the room or area of a patient with
suspected or confirmed COVID-19 adhere to Standard Precautions plus
gown, gloves, and eye protection, and also use a NIOSH-approved N95
filtering facepiece or equivalent or higher-level respirator. The CDC
notes in a set of FAQs that its recommendation to use NIOSH-approved
N95 disposable filtering facepiece or higher-level respirators when
providing care for patients with suspected or known COVID-19 is based
on the current understanding of the COVID-19 virus and related
respiratory viruses (CDC, March 10, 2021).
    As noted above, the CDC recommendations listed in Interim Infection
Prevention and Control Recommendations for Healthcare Personnel During
the Coronavirus Disease 2019 (COVID-19) Pandemic are applicable to all
U.S. settings where healthcare is delivered. To this end, the
recommendations on respirator use are repeated in a variety of
additional CDC guidelines for specific categories of healthcare
settings (e.g., nursing homes, dental settings, assisted living
facilities, home health care settings). For example, in its guidance
for nursing homes, the CDC recommends that residents with known or
suspected COVID-19 be cared for while using all recommended PPE,
including an N95 or higher-level respirator (CDC, March 29, 2021). In
addition, in its guidance for dental settings, the CDC recommends that
dental healthcare personnel who enter the room of a patient with
suspected or confirmed COVID-19 use a NIOSH-approved N95 or equivalent
or higher-level respirator, as well as other PPE (CDC, December 4,
2020). Additionally, in its guidance for assisted living facilities,
the CDC recommends an N95 or higher-level respirator for personnel for
situations where close contact with any (symptomatic or asymptomatic)
resident cannot be avoided, if COVID-19 is suspected or confirmed in a
resident of the assisted living facility (i.e., resident reports fever
or symptoms consistent with COVID-19) (CDC, May 29, 2020). Also, in its
guidance for home healthcare settings, the CDC recommends that when
home health agency personnel are involved in the care of people with
confirmed or suspected COVID-19 at their homes, the personnel adhere to
relevant infection prevention and control practices as described in the
core healthcare guidance Interim Infection Prevention and Control
Recommendations for Healthcare Personnel During the Coronavirus Disease
2019 (COVID-19) Pandemic (i.e., that they use N95 or higher-level
respirators) (CDC, October 16, 2020).
    In addition to its infection prevention and control guidelines for
healthcare personnel in healthcare settings, the CDC has issued
infection prevention and control guidelines for conducting postmortem
procedures on decedents/

human remains during the COVID-19 pandemic in Collection and Submission
of Postmortem Specimens from Deceased Persons with Confirmed or
Suspected COVID-19 (CDC, December 2, 2020). In this guidance, the CDC
recommends respirators while conducting autopsies on decedents in all
cases due to the likelihood of aerosol generation during the
performance of autopsies (CDC, December 2, 2020). The WHO has also
issued guidelines for COVID-19 infection control for aerosol-generating
procedures during autopsies. For example, WHO recommends respirators
for procedures such as the use of power saws (WHO, September 4, 2020).
    As supported by the above evidence and guidance from authoritative
bodies, OSHA has concluded that healthcare employees have a heightened
risk of COVID-19 infection when working with patients with known or
suspected COVID-19. Accordingly, in any healthcare setting where
employees are exposed to patients with known or suspected COVID-19,
whether or not AGPs are performed, employers are required to provide
N95s or higher-level respirators and follow all requirements under 29
CFR 1910.134, including medical evaluations and fit testing.
III. Applicability of the Respiratory Protection Standard to COVID-19
    OSHA's Respiratory Protection standard (29 CFR 1910.134) has
general requirements for respiratory protection for workers exposed to
respiratory hazards, including the COVID-19 virus. In the context of
the pandemic, the agency has applied the Respiratory Protection
standard to situations in healthcare settings where workers are exposed
to suspected or confirmed sources of COVID-19. OSHA's Respiratory
Protection standard has been in effect since 1998 and the purpose of
those controls have been established for decades (63 FR 1152, January
8, 1998). The standard contains requirements for the administration of
a respiratory protection program, with worksite-specific procedures,
respirator selection, employee training, fit testing, medical
evaluation, respirator use, respirator cleaning, maintenance, and
repair, among other requirements. It is important to note that the
standard applies to ``biological hazards'' (63 FR 1180, January 8,
1998). Accordingly, the agency will continue to apply the Respiratory
Protection standard to work tasks and situations in healthcare as
covered by 29 CFR 1910.502.
IV. Respirator Provisions Tailored to the COVID-19 Pandemic Will
Clarify Employer Responsibilities
    Notwithstanding the applicability of the Respiratory Protection
standard, as OSHA will explain in this discussion, it is imperative
that the ETS contain additional provisions related to the employer's
discretion to select respirators beyond what is required by 29 CFR
1910.134. These additional requirements are necessary in order to
appropriately protect workers in healthcare industries. In the Need for
the ETS (Section IV.B. of the preamble), OSHA has addressed why
existing standards in general are inadequate to address the COVID-19
hazard. In this discussion the agency focuses more specifically on how
clarifications regarding respirator need and use will help address
COVID-19 hazards.
    Many employers are confused as to when respiratory protection is
required for protection against COVID-19, leaving many unprotected
healthcare workers at high risk of becoming infected with COVID-19.
This confusion has been exacerbated by two factors. First, many
employers that need to provide respirators to protect their workers
from COVID-19 have never needed to provide respirators to their workers
in the past (e.g., many employers in the home health care or nursing
home sector), or have not had to routinely provide respirators to
certain workers in their facilities to protect them against infectious
disease hazards (e.g., the housekeeping or facilities maintenance staff
in some medical facilities). Second, there have been respirator and fit
testing supply shortages and a widespread misinterpretation by
employers of OSHA's temporary enforcement memoranda on respiratory
protection. One issue of great concern to the agency is a
misunderstanding by employers about crisis capacity strategies, which
were initially suggested by the CDC as a means to optimize supplies of
disposable N95 FFRs in healthcare settings when the alternative would
be no respiratory protection at all. Many workers report that their
employers have employed crisis capacity strategies as the de facto
daily practice, even when additional respirators were available for
use. To address these issues, the ETS contains clear mandates on when
respiratory protection is required for protection against COVID-19 and
contains a note encouraging employers to use elastomeric respirators or
PAPRs instead of filtering facepiece respirators to prevent shortages
and supply chain disruption.
    To address initial N95 FFR shortages, the CDC began to create and
issue a series of strategies to optimize supplies of disposable N95
FFRs in healthcare settings when there is limited supply (CDC, April 9,
2021a). The strategies are based on the three general strata that have
been used to describe surge capacity to prioritize measures to conserve
N95 FFR supplies along the continuum of care (Hick et al., June 1,
2009). Contingency measures (temporary measures during expected N95
shortages), and then crisis capacity measures (emergency strategies
during known shortages that are not commensurate with U.S. standards of
care), augment conventional capacity measures and are meant to be
considered and implemented sequentially. However, as the supply of
respirators for healthcare personnel has increased, the CDC and FDA
have encouraged employers to transition away from the most extreme
measures of respirator conservation, crisis and contingency capacity
strategies, to conventional use (FDA, April 9, 2021; CDC, April 9,
2021a). The use of crisis capacity strategies is likely to increase the
risk of COVID-19 exposure when compared to conventional and contingency
capacity strategies.
    The CDC's conventional capacity strategies for optimizing the
supply of N95 FFRs, which the CDC recommends be incorporated into
everyday practices, include a variety of measures, such as training on
use and indications for the use of respirators, just-in-time fit
testing, limiting respirators during training, qualitative fit testing,
and the use of alternatives to FFRs. CDC's conventional capacity
strategy recommendation is to use NIOSH-approved alternatives to N95
FFRs where feasible. These include other classes of disposable FFRs,
reusable elastomeric half-mask and full facepiece air-purifying
respirators, and reusable powered air-purifying respirators (PAPRs).
All of these alternatives provide equivalent or higher-level protection
than N95 FFRs when properly worn. To assist employers in this effort,
NIOSH maintains a searchable, online Certified Equipment List
identifying all NIOSH-approved respirators (NIOSH, n.d., retrieved on
January 11, 2021). Since they are reusable, elastomeric respirators and
PAPRs have the added advantage of being able to be disinfected,
cleaned, and reused according to manufacturers' instructions. As such,
they can be used by workers after the COVID-19 pandemic and during
future pandemics that may again create N95 FFR

shortages. Consistent with this, the ETS provides in a note that, where
possible, employers are encouraged to select elastomeric respirators or
PAPRs instead of filtering facepiece respirators to prevent shortages
and supply chain disruption.
    Also consistent with this, the ETS provides in the same note that,
when there is a limited supply of filtering facepiece respirators (and
only when there is a limited supply of filtering facepiece
respirators), employers may follow the CDC's Strategies for Optimizing
the Supply of N95 Respirators (April 9, 2021a). This may include the
use of respirators beyond the manufacturer-designated shelf life for
healthcare delivery; use of respirators approved under standards used
in other countries that are similar to NIOSH-approved N95 respirators;
limited re-use of N95 FFRs; and prioritizing the use of N95 respirators
and facemasks by activity type. However, again, the FDA and CDC are
recommending healthcare personnel and facilities transition away from
crisis capacity conservation strategies, such as decontaminating or
bioburden reducing disposable respirators for reuse, due to the
increased domestic supply of new respirators. The FDA and CDC believe
there is an increased supply of respirators to transition away from
these strategies (FDA, April 9, 2021; CDC, April 9, 2021a).
    OSHA notes finally that its enforcement of the Respiratory
Protection standard has been complicated by the respirator and fit-
testing supply shortages incurred during the pandemic. In response to
these shortages, the agency issued numerous temporary enforcement
guidance memoranda allowing its Compliance Safety and Health Officers
(CSHOs) to exercise enforcement discretion when considering issuing
citations under the Respiratory Protection standard and/or the
equivalent respiratory protection provisions of other health standards
during the pandemic (OSHA, n.d., Retrieved December 22, 2020). OSHA's
temporary enforcement memoranda are aligned with CDC's Strategies for
Optimizing the Supply of N95 Respirators, which recommend a variety of
conventional, contingency, and crisis capacity control strategies, as
mentioned above (CDC, April 9, 2021a). Unfortunately, these memoranda
have been widely misinterpreted by employers, resulting in additional
confusion about OSHA's respiratory protection requirements during the
pandemic. OSHA bases this conclusion on staff expertise and experience,
as well as on reporting in news media articles (Safety + Health, April
9, 2020; Bailey and Martin, March 19, 2020). (See also Need for the ETS
(Section IV.B. of the preamble).) For example, employers have
misinterpreted the temporary enforcement guidance memoranda as offering
blanket waivers or exemptions for complying with certain provisions of
the Respiratory Protection standard (e.g., annual fit-testing
requirements). In addition, many employers did not understand that
these memoranda allow for enforcement discretion by CSHOs only in
circumstances where an employer can demonstrate that it made
unsuccessful but objectively reasonable efforts to obtain and conserve
supplies of FFRs and fit-testing supplies. While the memoranda were
intended as guidelines for CSHOs, employer misinterpretation of these
memoranda has resulted in fewer protections for workers, particularly
in healthcare industries.
    OSHA is therefore clarifying that respirators are required for the
protection of workers exposed to suspected or confirmed sources of
COVID-19 in healthcare settings, and in all of those cases the
respirators must be used in accordance with the Respiratory Protection
standard (29 CFR 1910.134). OSHA also encourages employers, where
possible, to select elastomeric respirators or PAPRs instead of
filtering facepiece respirators to prevent shortages and supply chain
disruption. Because the crisis capacity strategy is less protective,
the employer should only use crisis capacity strategies for a limited
period of time and take immediate steps to purchase and use elastomeric
respirators or PAPRs in order to prevent future shortages and further
expose their workers to the grave danger of COVID-19.
V. Conclusion
    The best available evidence demonstrates that respirator use is an
important means of reducing the likelihood of COVID-19 infection of the
wearer when used in accordance with Sec.  1910.134. Respirators are
necessary controls that provide some protection to healthcare workers
and healthcare support service workers when exposed to persons with
known or suspected COVID-19.
    Based on the above analysis, the agency concludes that it is
necessary to add into the ETS respiratory protection requirements
tailored specifically to the COVID-19 pandemic. These requirements will
assist employers in identifying when respiratory protection is required
for healthcare workers and will help address and strengthen worker
protection during the pandemic. To this end, the ETS takes a
prioritization approach to the conservation of respirators by requiring
the use of respirators only where airborne transmission is the most
likely (when employees are exposed to persons with suspected or
confirmed COVID-19, or in accordance with Standard and Transmission-
Based Precautions in healthcare settings).
    The increased certainty associated with the respirator requirements
in the healthcare section and added flexibility of allowing employers
to follow 29 CFR 1910.504 in some limited circumstances will lead to
more compliance, and more compliance will lead to improved protection
of workers. In addition, a note in the ETS will better inform employers
that they can consider selecting from other NIOSH-approved respirator
options (i.e., elastomeric respirators and PAPRs) as alternatives to
N95 FFRs for protection against COVID-19, as well as other respiratory
infections (e.g., tuberculosis, varicella, etc.) both during the
pandemic and beyond. Knowledge of alternative respiratory protection
options for healthcare employers to consider will help them choose
appropriate alternative respirators and help mitigate respirator supply
shortages.
References
Bailey, M. and Martin, J. (2020, March 19). OSHA allows healthcare
employers to suspend N95 annual fit-testing during Coronavirus
``Outbreak.'' The National Law Review. https://www.natlawreview.com/article/osha-allows-healthcare-employers-to-suspend-n95-annual-fit-testing-during. (Bailey and Martin, March 19, 2020).
Centers for Disease Control and Prevention (CDC). (2020, March 12).
What healthcare personnel should know about caring for patients with
confirmed or possible COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/caring-for-patients-H.pdf. (CDC, March 12, 2020).
Centers for Disease Control and Prevention (CDC). (2020, May 29).
Considerations for preventing spread of COVID-19 in assisted living
facilities. https://www.cdc.gov/coronavirus/2019-ncov/hcp/assisted-living.html. (CDC, May 29, 2020).
Centers for Disease Control and Prevention (CDC). (2020, October
16). Interim guidance for implementing home care of people not
requiring hospitalization for COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-home-care.html. (CDC, October 16,
2020).
Centers for Disease Control and Prevention (CDC). (2020, December
2). Collection and submission of postmortem specimens from deceased
persons with confirmed or suspected COVID-19.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-postmortem-specimens.html. (CDC, December 2, 2020).
Centers for Disease Control and Prevention (CDC). (2020, December
4). Guidance for dental settings. https://www.cdc.gov/coronavirus/2019-ncov/hcp/dental-settings.html. (CDC, December 4, 2020).
Centers for Disease Control and Prevention (CDC). (2021, February
23). Interim infection prevention and control recommendations for
healthcare personnel during the coronavirus disease 2019 (COVID-19)
pandemic. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html. (CDC, February 23, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 4).
Clinical questions about COVID-19: Questions and answers. https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html. (CDC, March 4,
2021).
Centers for Disease Control and Prevention (CDC). (2021, March 10).
Frequently asked questions about Coronavirus (COVID-19) for
laboratories. https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#Laboratory-Biosafety. (CDC, March 10, 2021).
Centers for Disease Control and Prevention (CDC). (2021, March 29).
Interim Infection Prevention and Control Recommendations to Prevent
SARS-CoV-2 Spread in Nursing Homes. https://www.cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html. (CDC, March 29, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, April 9).
Strategies for optimizing the supply of N95 respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, April 9).
Personal Protective Equipment: Questions and Answers. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirator-use-faq.html. (CDC,
April 9, 2021b).
Centers for Disease Control and Prevention (CDC). (2021, May 13).
How COVID-19 spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html. (CDC, May 13, 2021).
Food and Drug Administration (FDA). (2021, April 9). FDA Recommends
Transition from Use of Decontaminated Disposable Respirators--Letter
to Health Care Personnel and Facilities. https://www.fda.gov/medical-devices/letters-health-care-providers/fda-recommends-transition-use-decontaminated-disposable-respirators-letter-health-care-personnel-and. (FDA, April 9, 2021).
Hick, J. et al., (2009, June 1). Refining surge capacity:
Conventional, contingency, and crisis capacity. Disaster Medicine
and Public Health Preparedness, 3(2 Suppl), S59-S67. https://doi.org/10.1097/DMP.0b013e31819f1ae2. (Hick et al., June 1, 2009).
Klompas, M. et al., (2021). A SARS-CoV-2 cluster in an acute care
hospital. Annals of Internal Medicine. [Epub ahead of print 9
February 2021] https://doi.org/10.7326/M20-7567. (Klompas et al.,
February 9, 2021).
Lednicky, J. et al., (2020, September 11). Viable SARS-CoV-2 in the
air of a hospital room with COVID-19 patients. International Journal
of Infectious Diseases, 100, 476-482. doi: 10.1016/
j.ijid.2020.09.025. (Lednicky et al., September 11, 2020).
National Institute for Occupational Safety and Health (NIOSH) (2020,
December). Filtering facepiece respirators with an exhalation valve:
Measurements of filtration efficiency to evaluate their potential
for source control. By Portnoff, L., Schall, J., Brannen, J., Suhon,
N., Strickland, K., Meyers, J. DHHS (NIOSH) Publication No. 2021-
107. https://www.cdc.gov/niosh/docs/2021-107/pdfs/2021-107.pdf?id=10.26616/NIOSHPUB2021107. Retrieved January 10, 2021.
(NIOSH, December, 2020).
National Institute for Occupational Safety and Health (NIOSH).
(n.d.) Certified equipment lists. Retrieved January 11, 2021 from
https://www.cdc.gov/niosh/npptl/topics/respirators/cel/default.html.
(NIOSH, n.d., Retrieved January 11, 2021).
Occupational Safety and Health Administration (OSHA). (n.d.). COVID-
19--regulations--enforcement memoranda. Retrieved December 22, 2020
from https://www.osha.gov/coronavirus/standards#temp_enforcement_guidance. (OSHA, n.d., Retrieved December
22, 2020).
Safety + Health. (2020, April 9). OSHA allowing all employers to
suspend annual respirator fit testing. https://www.safetyandhealthmagazine.com/articles/19685-osha-allowing-all-employers-to-suspend-annual-respirator-fit-testing. (Safety +
Health, April 9, 2020).
World Health Organization (WHO). (2020, September 4). Infection
prevention and control for the safe management of a dead body in the
context of COVID-19. https://www.who.int/publications/i/item/infection-prevention-and-control-for-the-safe-management-of-a-dead-body-in-the-context-of-covid-19-interim-guidance. (WHO, September 4,
2020).

G. Mini Respiratory Protection Program

I. Introduction
    OSHA emphasizes that when respirators are required under the ETS to
protect employees against exposure to suspected or confirmed sources of
COVID-19, they must be used in accordance with the Respiratory
Protection standard (29 CFR 1910.134). Moreover, nothing in the ETS
changes an employer's obligation to identify hazards or provide a
respirator that must be used in accordance with the Respiratory
Protection standard for any other workplace hazard that might require
respiratory protection (e.g., silica, asbestos, airborne infectious
agents such as Mycobacterium tuberculosis).
    OSHA's Respiratory Protection standard requires employers to
develop and implement a comprehensive written respiratory protection
program, required worksite-specific procedures and elements that
include, but are not limited to, respirator selection and use, medical
evaluation, fit testing, respirator maintenance and care, and training.
Establishing such a program can take time to establish and require a
level of expertise that some employers do not have, particularly if
they are a covered healthcare employer that did not typically have
respiratory hazards before COVID-19 (e.g., many employers in the home
health care or nursing home sector). In such cases, these regulatory
requirements may have unintentionally prevented employers from
providing their employees with a higher level of respiratory protection
than afforded by a facemask in circumstances where it may have been
beneficial to do so.
    The ``mini respiratory protection program'' section of the ETS (29
CFR 1910.504) is designed to strengthen employee protections with a
small set of provisions for the safe use of respirators designed to be
easier and faster to implement than the more comprehensive respiratory
protection program. The ETS is addressing an emergency health crisis,
so it is critical for employers to be able to get more employee
protection in place quickly. OSHA expects that this approach will
facilitate additional employee choice for the additional protection
provided by respirators while reducing disincentives that may have
discouraged employers from allowing or voluntarily providing
respirators. A mini respirator program is therefore an important
control to protect employees from the hazard posed by COVID-19.
    The mini respiratory protection program section is primarily
intended to be used for addressing circumstances where employees are
not exposed to suspected or confirmed sources of COVID-19, but where
respirator use could offer enhanced protection to employees. Examples
include when a respirator could offer enhanced protection in
circumstances where a less protective (in terms of filtering and fit)
facemask is required under the ETS. (See 29 CFR 1910.502(f)(4).) The
decision to use a respirator in place of a facemask could be due to the
higher filter efficiency and better sealing characteristics of
respirators when compared to facemasks and/or in consideration of an
employer's determination during their hazard assessment of constraints
on their

ability to implement other ETS provisions (e.g., physical distancing
and barriers).
    If an employee uses a respirator in place of a facemask, then the
employer must ensure that the respirator is used in accordance with the
mini respiratory protection program section of the ETS or in accordance
with the Respiratory Protection standard. For example, if an employee
that is required to wear a facemask instead chooses to wear a
respirator when performing an aerosol-generating procedure (AGP) on a
patient who is not suspected or confirmed with COVID-19, the ETS only
requires the employer to ensure that the respirator is used in
accordance with the mini respiratory protection program section, rather
than in accordance with the Respiratory Protection standard, because
there is no exposure to a suspected or confirmed source of COVID-19
(see 29 CFR 1901.502(f)(4)(ii)). In contrast, employees performing AGPs
on patients with suspected or confirmed COVID-19 must be provided with
respirators that are used in accordance with the Respiratory Protection
standard (see 29 CFR 1901.502(f)(3)(i)). Additionally, employers will
still be obligated to provide a respirator that is used in accordance
with the Respiratory Protection standard for any AGPs performed on
patients suspected or confirmed with an airborne disease, such as
tuberculosis or measles.
II. Experience From the Respiratory Protection Standard (29 CFR
1910.134)
    In determining the need for a mini respiratory protection program
section, the agency considered its experience with the existing
Respiratory Protection standard. While the majority of the Respiratory
Protection standard pertains to the use of respirators that are
required for the protection of employees against airborne hazards,
there is one provision allowing, but not requiring, employers to permit
employees to wear respirators in situations where respirators are not
required for protection against airborne hazards. (See 29 CFR
1910.134(c)(2).) In establishing the requirements of this provision of
the Respiratory Protection standard, OSHA also establishes some general
concepts to guide respirator use. These concepts include: (1) That the
respirator use will not in itself create a hazard; (2) that the
employer provides the respirator user with information about the safe
use and limitations of respirators; and (3) that the respirator is
cleaned, stored, and maintained so that its use does not present a
health hazard to the user. (29 CFR 1910.134(c)(2)(i) and (ii)).
    OSHA has historically imposed a different set of requirements on
employers for when respirators are required to protect employees from
airborne hazards as compared to when they are not required for
protection against airborne hazards but are instead used voluntarily by
employees. More specifically, paragraph (c)(1) of the Respiratory
Protection standard requires employers to develop and implement a
comprehensive written respiratory protection program with required
worksite-specific procedures and elements whenever respirator use is
required by the standard. As noted earlier, these elements include, but
are not limited to, respirator selection and use, medical evaluation,
fit testing, respirator maintenance and care, and training. In
contrast, paragraph (c)(2) of the Respiratory Protection standard
requires employers to implement only a subset of these elements for the
voluntary use of respirators, greatly reducing the obligations of
employers who allow their employees to use respirators when such use is
not required for employee protection. In the 1998 rulemaking, OSHA
determined that paragraph (c)(2) is necessary because the use of
respirators may itself present a health hazard to employees who are not
medically able to wear them, who do not have adequate information to
use and care for respirators properly, and who do not understand the
limitations of respirators. Paragraph (c)(2) is intended to allow
employers flexibility to permit employees to use respirators in
situations where the employees wish to do so, without imposing the
burden of implementing an entire respirator program. At the same time,
it will help ensure that such use does not create an additional hazard
and that employees are provided with enough information to use and care
for their respirators properly (63 FR 1190, January 8, 1998).
    The vast majority of voluntary respirator use situations under the
Respiratory Protection standard have historically involved the use of
FFRs, worn merely for an employee's comfort (63 FR 1190, January 8,
1998). Examples include employees who have seasonal allergies
requesting a FFR for comfort when working outdoors and employees
requesting a FFR for comfort while sweeping a dusty floor (63 FR 1190,
January 8, 1998). In contrast, respirator use situations under this
section of the ETS will involve employers who provide a respirator or
employees who want to wear a respirator, out of an abundance of
caution, as enhanced protection against COVID-19. They may also opt to
wear respirators other than FFRs (e.g., elastomeric respirators,
PAPRs), particularly given the supply shortages of N95 FFRs experienced
during the COVID-19 pandemic. Thus, the circumstances of respirator use
in the ETS are not merely to accommodate individual conditions or
comfort, but rather in recognition of some increased risk due to
asymptomatic and pre-symptomatic transmission of COVID-19 that is not
expected to rise to the level where respirators are required for
exposure to suspected or confirmed sources of COVID-19.
    OSHA emphasizes that while the new set of requirements for
respirator use under the ETS differ in some aspects from those
specified under the Respiratory Protection standard, their intent
remains the same; that is, employers who provide respirators at the
request of their employees or who allow their employees to bring their
own respirators into the workplace must ensure that the respirator used
does not present a hazard to the health of the employee.
    In the 1998 rulemaking, OSHA concluded in the rare case where an
employee is voluntarily using other than a filtering facepiece (dust
mask) respirator (paragraph (c)(2)(ii)), the employer must implement
some of the elements of a respiratory protection program, e.g., the
medical evaluation component of the program and, if the respirator is
to be reworn, the cleaning, maintenance, and storage components. An
exception to this paragraph makes clear that, where voluntary
respirator use involves only filtering facepieces (dust masks), the
employer is not required to implement a written program. While medical
evaluation is required when employees are voluntarily wearing
respirators other than FFRs under the Respiratory Protection standard,
there are no requirements under the ETS to provide medical evaluations
for employees wearing such respirators. The agency concludes that it
would be too onerous and costly for employers to provide medical
evaluations to employees wearing elastomeric respirators or PAPRs in
place of FFRs used in accordance with crisis capacity strategies during
the short period of the ETS. However, OSHA's experience with its
Respiratory Protection standard suggests that respiratory protection
can still be effective even when subject to particular safety
provisions, but not subject to the full range of requirements. In place
of medical evaluations, the agency has included a training requirement
on how to recognize medical signs and symptoms that may

limit or prevent the effective use of employer-provided respirators and
what to do if the employee experiences signs and symptoms (29 CFR
1910.504(d)(1)(v)), as well as a requirement for the discontinuation of
employer-provided respirator use (see 29 CFR 1910.504(d)(4)). This
requirement mandates that employees who wear employer-provided
respirators must discontinue respirator use when the employer or
supervisor reports medical signs or symptoms that are related to their
ability to use a respirator. In addition, any employee who previously
had a medical evaluation and was determined to not be medically fit to
wear a respirator should not be provided with an employer-provided
respirator under the ETS.
    The ETS does not require employers to include any of the use
requirements specified under the ETS into a written respiratory
protection program. OSHA concludes that it would be too onerous for
employers to incorporate these requirements into a written respiratory
protection program during the short period of the ETS, particularly for
those employers who have no need to have a written respiratory
protection program in place for required respirator use. OSHA
reemphasizes that the intent of the requirements in the mini
respiratory protection program are to ensure that employees are
provided with information to safely wear respirators, without imposing
the burden of additional requirements for a written respiratory
protection program on employers.
    OSHA notes that unlike the voluntary use requirements specified
under the Respiratory Protection standard, there are different
requirements for the use of employee-provided respirators as compared
to those for employer-provided respirators under the mini respiratory
protection program section. This is because the agency is requiring
employers to permit the use of employee-provided respirators. OSHA
concludes that it is necessary to permit employees to wear their own
respirators in healthcare settings given the risk for asymptomatic and
pre-symptomatic transmission and the nature of much of the work that
precludes such control measures as physical distancing and barriers.
However, the agency concludes that it would be too onerous to mandate
as many requirements for such use as are mandated when employers are
given the option of whether or not to provide employees with
respirators for use.
III. Requirements for Employee-Provided Respirators
    In the 1998 rulemaking, OSHA determined that complete training is
not required for employees using respirators voluntarily; instead, the
final rule required employers to provide the information contained in
Appendix D to the Respiratory Protection standard, entitled
``Information for Employees Using Respirators When Not Required Under
the Standard,'' to ensure that employees are informed of proper
respirator use and the limitations of respirators (63 FR 1190-1192,
January 8, 1998). Under the ETS, there is only one requirement for the
use of employee-provided respirators. This requirement is for the
employer to provide these employees with a specific notice, as
specified under paragraph (c) of the mini respiratory protection
program section. This notice is almost identical to the notice
contained in Appendix D to the Respiratory Protection standard, with
some minor changes intended only to tailor the information to the
situational needs of the COVID-19 pandemic.
IV. Requirements for Employer-Provided Respirators
    As noted above, under the ETS, the requirements for the use of
employer-provided respirators are more expansive under the mini
respiratory protection program section than the requirements for
employee-provided respirators. However, OSHA notes that employers are
not obligated by the ETS to provide employees with respirators for use
under the mini respiratory protection program section, so these
requirements are only mandated when an employer voluntarily provides
employees with respirators for use under the mini program. The
requirements include provisions pertaining to training, user seal
checks, reuse of respirators, and discontinuing use of respirators.
When employers choose to provide respirators to employees, the same
rationale applies as it did in the 1998 rulemaking requiring employers
to undertake these minimal obligations when they allow voluntary
respirator use is consistent with the fact that employers control the
working conditions of employees and are therefore responsible for
developing procedures designed to protect the health and safety of the
employees. Employers routinely develop and enforce rules and
requirements for employees to follow based on considerations of safety.
For example, although an employer allows employees discretion in the
types of clothing that may be worn on site, the employer would prohibit
the wearing of loose clothing in areas where clothing could get caught
in machinery, or prohibit the use of sleeveless shirts where there is a
potential for skin contact with hazardous materials. Similarly, if an
employer determines that improper or inappropriate respirator use
presents a hazard to the wearer, OSHA finds that the employer must
exert control over such respirator use and take steps to see that
respirators are safely used under an appropriate program (63 FR 1190-
1191, January 8, 1998).
    The training requirements for the use of employer-provided
respirators expand on the basic respirator awareness notice required
for the use of employee-provided respirators. They require the employer
to provide training on: (a) How to inspect, put on and remove, and use
a respirator; (b) the limitations and capabilities of the respirator,
particularly when the respirator has not been fit tested; (c)
procedures and schedules for storing, maintaining, and inspecting
respirators; (d) how to perform a user seal check as described in
paragraph (e) of this section; and (e) how to recognize medical signs
and symptoms that may limit or prevent the effective use of respirators
and what to do if the employee experiences signs and symptoms. These
training requirements for respirator use are similar to the training
requirements mandated under the Respiratory Protection standard for
required respirator use. (See 29 CFR 1910.134(k)). OSHA concludes that
more extensive training provisions are required for the use of
employer-supplied respirators under the ETS because such use is likely
to be based on other factors related to the risk of COVID-19, including
the ability to implement other control measure (e.g., physical
distancing and barriers).
    The user seal check requirements mandate employers to ensure that
employees conduct user seal checks and to ensure the employees correct
any problems discovered during the user seal check. This is similar to
the user seal check provision for required respirator use under the
Respiratory Protection standard. (See 1910.134(g)(1)(iii)). OSHA
concludes that ensuring that user seal checks are conducted is
necessary because employees who wear respirators are not required to be
fit tested under the ETS. OSHA notes that, in the 1998 rulemaking, OSHA
concluded that user seal checks are important in assuring that
respirators are functioning properly, and that although user seal
checks are not as objective a measure of facepiece leakage as a fit
test, they do

provide a quick and easy means of determining that a respirator is
seated properly (63 FR 1239-40, January 8, 1998). Given that employees
who choose to wear employer-provided respirators will likely be doing
so out of an abundance of caution to protect against potential airborne
transmission of SARS-CoV-2 and will not be fit tested, OSHA concludes
that it is necessary for employers to train employees how to conduct a
user seal check and to ensure that they are performed properly in order
to improve the effectiveness of the respirator.
    In the 1998 rulemaking, OSHA determined that ``if the respirators
being used voluntarily are reused, it is necessary to ensure that they
are maintained in proper condition to ensure that the employee is not
exposed to any contaminants that may be present in the facepiece, and
to prevent skin irritation and dermatitis associated with the use of a
respirator that has not been cleaned or disinfected'' (63 FR 1190,
January 8, 1998). To this end, and given the potential for supply
shortages of FFRs necessitating their reuse under certain circumstances
during the COVID-19 pandemic, OSHA concludes that it is necessary to
add specific requirements for the reuse of respirators used
voluntarily. These requirements incorporate some CDC recommendations
for the reuse of FFRs used in accordance with crisis capacity
strategies (CDC, April 9, 2021).
References
Centers for Disease Control and Prevention (CDC). (2021, April 9).
Strategies for Optimizing the Supply of N95 Respirators. https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html. (CDC, April 9, 2021).

H. Aerosol-Generating Procedures on Persons With Suspected or Confirmed
COVID-19

    As explained in more detail in Grave Danger (Section IV.A. of the
preamble), aerosol-generating procedures (AGP) are well-known to be
high-risk activities for exposure to respiratory infections. Workers in
a wide range of settings, such as emergency responders, healthcare
providers, and medical examiners performing autopsies, are at risk
during AGPs. For the purposes of the ETS, only the following procedures
are considered AGPs: Open suctioning of airways, sputum induction,
cardiopulmonary resuscitation, endotracheal intubation and extubation,
non-invasive ventilation (e.g., BiPAP, CPAP), bronchoscopy, manual
ventilation, medical/surgical/postmortem procedures using oscillating
bone saws, and dental procedures involving ultrasonic scalers, high-
speed dental handpieces, air/water syringes, air polishing, and air
abrasion. For further information on why these procedures are
considered AGPs under the ETS, please see the discussion of aerosol-
generating procedures in Section VIII, Summary and Explanation.
    The CDC provides extensive guidance for performance of AGPs (CDC,
February 23, 2021). First, exposure should be limited where possible.
The CDC recommends that the use of procedures or techniques that might
produce infectious aerosols should be minimized when feasible, as
should the number of people in the room.
    CAP has also recognized the risks involved in conducting AGPs by
recommending limiting the use of aerosol-generating tools, such as
oscillating bone saws, during autopsies on COVID-19-positive cases
(College of American Pathologists, February 2, 2021). Post-mortem
procedures using oscillating bone saws have specifically been noted as
a COVID-19-related exposure concern (Nolte et al., December 14, 2020).
The following controls are therefore recommended for autopsies
involving the use of oscillating bone saws: Isolation rooms, limiting
the number of people in the room who are exposed, negative pressure
ventilation, adequate air exchange, double door access, and use of
respirators.
    As noted in Grave Danger (Section IV.A. of the preamble), it is
well-accepted that COVID-19 may spread through infectious aerosols
during AGPs. Therefore, where these procedures must be performed, there
are two important controls for these situations: Ventilation (for
example, in the form of air infection isolation rooms (AIIR), if
available) and respiratory protection. Both of these controls are
required for AGPs in the ETS. For more information on why there is a
need to include in this ETS a requirement for respirators during
aerosol-generating procedures, please see Need for Specific Provisions
(Section V of this preamble) on Respirators.
    It is well-established that insufficient ventilation increases the
risk of airborne disease transmission; indeed, this is the foundation
for the World Health Organization recommendations on ventilation in
healthcare settings (Atkinson et al., 2009). When air is stagnant or
poorly ventilated, aerosols may increase in concentration and increase
exposure. Both a lack of ventilation and inadequate ventilation are
associated with increased infection rates of airborne diseases.
Increasing ventilation rates has been shown to decrease transmission
risk of airborne disease. Ventilation is able to direct airflow away
from uninfected individuals, which reduces risk of transmission.
    The American Society of Heating, Refrigerating and Air-Conditioning
Engineers (ASHRAE) is the authoritative organization for ventilation
standards in the U.S. The U.S. Army Corps of Engineers (USACE) has been
tasked by the U.S. Federal Emergency Management Agency with the design
and construction of alternative care sites during surges in the COVID-
19 pandemic. USACE requested that ASHRAE provide engineering guidance
for ventilation within alternative care sites. The resulting joint
ASHRAE/USACE document makes recommendations for removal of aerosols
generated by patients during AGPs and other patient care activities in
alternative care sites (ASHRAE and USACE. November 20, 2020).
Additionally, ASHRAE provides specific guidance on source control and
AIIRs related to aerosol-generating procedures during the COVID-19
pandemic (ASHRAE, January 30, 2021).
    Airborne infection isolation rooms (AIIR) are specifically designed
to control the spread of aerosols and prevent airborne transmission of
disease (Sehulster and Chinn, June 6, 2003). An AIIR has negative
pressure in comparison to accessible areas outside the room, which
causes air to flow into (rather than out of) the room from the room's
access points when they are open (e.g., an open door). When the access
points (e.g., the door) are closed and ventilation is adequate,
contaminated air cannot escape at all into the rest of the facility.
Air exhaust can be delivered directly outdoors or passed through a
special high-efficiency (HEPA) filter. In this way, AIIRs minimize