by the Healthcare ETS where more than one person is present. Crafting a
multi-layered standard that is comprehensive and feasible for all

covered work settings, including mixed settings of vaccinated and
unvaccinated workers, is an extraordinarily challenging and complicated
undertaking, yet the grave danger that COVID-19 poses to unvaccinated
workers obliges the agency to act as quickly possible. As discussed
above, OSHA has identified vaccination as the single most efficient and
effective means for removing an unvaccinated worker from the grave
danger.
    Given the urgency of the rulemaking, and the singular effectiveness
of vaccination in removing unvaccinated workers from the grave danger,
OSHA is promulgating this ETS to immediately address the grave danger
that COVID-19 poses to unvaccinated workers by strongly encouraging
vaccination. As discussed in Pertinent Legal Authority (Section II. of
this preamble), a ``grave danger'' represents a risk greater than the
``significant risk'' that OSHA must show in order to promulgate a
permanent standard under section 6(b) of the OSH Act, 29 U.S.C. 655(b).
OSHA will consider whether it is necessary to require additional
controls to avert a significant risk of harm in the rulemaking
proceedings that follow this ETS. OSHA directs employers to its
website, www.osha.gov/coronavirus, and the CDC's website, www.cdc.gov/coronavirus, for guidance on the engineering, administrative, and other
exposure controls that may be effective and appropriate for their
workplace.
    OSHA expects that, by strongly encouraging vaccination, this ETS
will have a positive impact on worker health. As discussed above,
millions of workers remain unvaccinated and are presently exposed to
risks of hospitalization and death many times higher than their
vaccinated coworkers. Although predicting the health impact of this ETS
is particularly challenging, given the ever-changing nature of the
pandemic and the many factors that may motivate workers to become fully
vaccinated, OSHA has attempted to quantify the potential number of
hospitalizations and fatalities that this ETS could avert by increasing
workforce vaccination rates (see OSHA, October 2021c). OSHA has
estimated that, as a result of the ETS, over 6,500 fewer currently
unvaccinated workers will die from COVID-19 over the next six months.
OSHA also estimates that this ETS will prevent over 250,000 currently
unvaccinated workers from being hospitalized during that same time
period. Even if OSHA's estimate does not prove to be precisely
accurate, OSHA is confident that this ETS will save hundreds of lives
and prevent thousands of workers from becoming severely ill.
a. OSHA Finds It Necessary To Strongly Encourage Vaccination
    Despite the proven safety and efficacy of the available COVID-19
vaccines, many workers remain unvaccinated and are currently exposed to
a grave danger. As discussed in Grave Danger (Section III.A. of this
preamble), countless COVID-19 outbreaks have occurred in myriad work
settings where employees come into contact with others, and in recent
weeks, the majority of states in the U.S. have experienced what CDC
defines as high or substantial community transmission, indicating that
there is a clear risk of the virus being introduced into and
circulating in workplaces (CDC, October 18, 2021--Community
Transmission Rates). As of October 18, 2021, more than 184 million
people in the United States have been fully vaccinated, but only 68.5%
of people ages 18 years or older are fully vaccinated (CDC, October 18,
2021--Fully Vaccinated). OSHA has estimated that approximately 62.4%
percent of adults aged 18-74 within the scope of this ETS are either
fully vaccinated or received their first vaccine dose during the
previous two weeks, leaving approximately 31.7 million unvaccinated
(i.e., not fully vaccinated and did not receive a first dose with in
the past two weeks) (see Economic Analysis, Section IV.B. of this
preamble, Table IV.B.7). Meanwhile, the rate of new vaccinations has
slowed considerably; on October 15, 2021, the 7-day moving average
number of administered vaccine doses reported to the CDC per day was
841,731 doses, a steep reduction from the peak 3,448,156 dose average
that the CDC reported on April 11, 2021 (CDC, October 18, 2021--Weekly
Review).
    Given the pervasiveness of the virus in workplaces across the
country and the unparalleled efficacy of vaccines at preventing serious
health effects, OSHA finds it necessary to strongly encourage
vaccination. Encouraging vaccination is principally necessary to reduce
the likelihood that workers who are infected by the SARS-CoV-2 virus
will suffer the worst outcomes of an infection (hospitalization and
death). Put simply, the single best method for protecting an
unvaccinated worker from the serious health consequences of a COVID-19
infection is for that worker to become fully vaccinated.
    Additionally, encouraging vaccination is necessary to reduce the
overall prevalence of the SARS-CoV-2 virus at workplaces. Because
vaccinated workers are less likely than unvaccinated workers to be
infected by the virus, they are less likely to spread the virus to
others at their workplace, including to unvaccinated coworkers.
Increasing workforce vaccination rates will therefore reduce the risk
that unvaccinated workers will be infected by a coworker.
    Evidence shows that mandating vaccination has proven to be an
effective method for increasing vaccination rates, and that vaccination
mandates have generally been more effective than merely encouraging
vaccination. Significant numbers of workers would get vaccinated if
their employers required it, and many workers who were vaccinated over
the last four months were motivated by their employer requiring
vaccination. The Kaiser Family Foundation (KFF) vaccine monitor, an
ongoing research project tracking the public's attitudes and
experiences with COVID-19 vaccinations, conducted a survey from
September 13 to September 22, 2021, among a nationally representative
random digit dial telephone sample of 1,519 adults ages 18 and older,
and found that those who received their first dose of a COVID-19
vaccine after June 1, 2021 were motivated by mandates of various sorts,
including one in five (19%) who say a major reason was that their
employer required it (KFF, September 2021). A survey conducted by
Change Research from August 30 to September 2, 2021 regarding
Americans' views on COVID-19 vaccines found that among the 1,775
respondents, ``one of the things that was most likely to lead someone
to get vaccinated was if their employer required it'' (Towey, September
27, 2021).
    Vaccine mandates imposed by state governments and large employers
have also demonstrated the effectiveness of mandates in increasing
vaccination rates. For example, when Tyson Foods announced its
vaccination requirement in early August 2021, only 45% of its workforce
had received a vaccination dose, but as of September 30, 2021, the New
York Times reported that has increased to 91% (White House, October 7,
2021; Hirsch, September 30, 2021). Similarly, United Airlines reported
that 97% of its U.S.-based employees were fully vaccinated against
COVID-19 within a week of the deadline of the company's vaccination
mandate, and the 3% who were not fully vaccinated included several
employees who sought a medical or religious exemption from vaccination
(The Associated Press, September 22, 2021). In Washington State, the
weekly vaccination rate increased 34% after the Governor announced
vaccine requirements for

state workers (White House, October 7, 2021). The success of these
COVID-19 vaccination mandates comports with the National Safety
Council's recent finding that employers that instituted a COVID-19
vaccination mandate produced a 35% increase in employee vaccination
(NSC, September 2021). Similarly, the White House recently reported
that its analysis of vaccination requirements imposed by healthcare
systems, educational institutions, public-sector agencies, and private
businesses demonstrated that such requirements increased their
vaccination rates by more than 20 percentage points and have routinely
seen their share of fully vaccinated workers rise above 90 percent
(White House, October 7, 2021).
    Given the effectiveness of vaccination mandates in increasing
vaccination rates, OSHA expects that, in most instances, an employer
implementing a policy that requires all employees to be vaccinated will
be the most effective approach for increasing the vaccination rate of
its employees and ensuring that they have the best protection available
against the worst consequences of a COVID-19 infection. Although OSHA
may well have the authority to impose a vaccination mandate, OSHA has
decided against pursuing strict vaccination requirement and has instead
crafted the ETS to strongly encourage vaccination. Employers are in the
best position to understand their workforces and the approach that will
work most effectively with them to secure employee cooperation and
protection. OSHA's traditional practice when including medical
procedures, such as medical surveillance testing and vaccinations, in
its health standards has been to require the employer to make the
medical procedure available to employees, and has viewed mandating
those procedures as a measure to avoid if possible. For example, when
the agency promulgated its standard regulating occupational exposure to
lead, OSHA considered mandating that employees participate in physical
examinations and biological monitoring, but ultimately required
employers to make them available to employees (see 43 FR 54354, 54450
(Nov. 21, 1978)). OSHA decided against mandating those procedures in
part because it believed a voluntary approach would elicit more
effective employee participation in the medical program and in part
because of the agency's concerns about the Government intruding into a
private and sensitive area of workers' lives (43 FR at 54450-51). OSHA
has followed that same approach of requiring employers to ``provide''
or ``make available'' medical procedures to employees in numerous
subsequent standards, such as the standards for asbestos (29 CFR
1910.1001), benzene (1910.1028), cotton dust (1910.1043), and
formaldehyde (1910.1048).
    OSHA adhered to this approach when it promulgated the Bloodborne
Pathogens standard. The agency considered mandating a Hepatitis B
vaccination, but instead required employers to make the Hepatitis B
vaccination available to employees. 56 FR 64004, 64155 (Dec. 6, 1991);
29 CFR 1910.1030(f)(1)(i), (f)(2)(i). OSHA explained that the agency
may have the legal authority to mandate vaccination, but believed that,
under the circumstances, a voluntary vaccination program would ``foster
greater employee cooperation and trust in the system'' and ``enhance [
] compliance while respecting individuals' beliefs and rights to
privacy.'' 56 FR at 64155.
    In keeping with this traditional practice, the agency has stopped
short of including a strict vaccination mandate with no alternative
compliance option in this ETS. OSHA has never done so, and if it were
to take that step, OSHA believes it more prudent to do so where the
agency has ample time to fully assess the potential ramifications of
imposing a vaccination mandate on covered employers and employees.
Here, exigent circumstances demand that OSHA take immediate action to
protect workers from the grave danger posed by COVID-19, but OSHA has
not had a full opportunity to study the potential spectrum of impacts
on employers and employees, including the economic and health impacts,
that would occur if OSHA imposed a strict vaccination mandate with no
alternative compliance option. Moreover, employers in their unique
workplace settings may be best situated to understand their workforce
and the strategies that will maximize worker protection while
minimizing workplace disruptions. These considerations persuade the
agency that this ETS should afford employers some flexibility in the
form of an alternative option to strictly mandating vaccination. In
light of the unique and grave danger posed by COVID-19, OSHA has
requested comment on whether a strict vaccination mandate is warranted
and the agency will consider all the information it receives as it
determines how to proceed with this rulemaking (see Request for
Comment, Section I.B. of this preamble).
    Although this ETS does not impose a strict vaccination mandate,
OSHA has determined that, to adequately address the grave danger that
COVID-19 poses to unvaccinated workers, a more proactive approach is
necessary than simply requiring employers to make vaccination available
to employees. None of the standards that OSHA promulgated prior to this
year concerned an infectious agent as readily transmissible as COVID-
19. Standards like the Lead standard do not concern infectious agents
that can be transmitted between individuals at a workplace;
accordingly, the medical procedures that employers are required to make
available under those standards are solely aimed at protecting the
health of the worker who is undergoing the procedure. The Bloodborne
Pathogens standard concerned exposure to infectious biological agents
(Hepatitis B and HIV) that can be transmitted between individuals, but
the potential for those agents to be transmitted between workers is
minimal in comparison to the SARS-CoV-2 virus; Hepatitis B and HIV are
transmitted through blood and certain body fluids, whereas the SARS-
CoV-2 virus spreads through respiratory droplets that can travel
through the air from worker-to-worker (see Grave Danger, Section III.A.
of this preamble). Vaccination against COVID-19 is thus particularly
important in reducing the potential for workers to become infected and
spread the virus to others at the workplace, in addition to protecting
the worker from severe health outcomes if they are infected. Moreover,
the ease with which the SARS-CoV-2 virus spreads between workers makes
it more urgent for workers to be vaccinated, and this urgency
contributes to the agency's decision to strongly encourage vaccination.
    Accordingly, to further the goal of increasing workforce
vaccination rates, this ETS requires employers to implement a mandatory
vaccination policy unless they adopt a policy in which employees may
either be fully vaccinated or regularly tested for COVID-19 and wear a
face covering in most situations when they work near other individuals.
Employers have the duty under the OSH Act to provide safe workplaces to
their employees, including protecting employees from known hazards by
complying with occupational safety and health standards (see 29 U.S.C.
654), and this ETS therefore provides employers with two compliance
options for protecting unvaccinated workers from the grave danger posed
by COVID-19. But while this ETS offers employers a choice in how to
comply, OSHA has presented implementation of a vaccination mandate as
the preferred compliance

option; as discussed above, vaccine mandates have proven to be
effective in increasing vaccination rates, and OSHA expects that, in
most instances, implementing a vaccination mandate will be the most
effective method for increasing a workforce's vaccination rate. As
discussed below, OSHA also recognizes that requiring that all employees
be vaccinated provides more protection to vaccinated workers than
regularly testing unvaccinated workers for COVID-19 and requiring them
to wear face coverings when they work near others. This ETS will
preempt inconsistent state and local requirements, including
requirements that ban or limit employers' authority to require
vaccination (see the Summary and Explanation for paragraph (a), Section
VI.A. of this preamble), and will therefore provide the necessary legal
authorization to covered employers to implement mandatory vaccination
policies, if they choose to comply in this preferred manner.
    Although the ETS does not require all covered employers to
implement a mandatory vaccination policy, OSHA expects that employers
that choose that compliance option will enjoy advantages that employers
that opt out of the vaccination mandate option will not. Most
obviously, employers with a mandatory vaccination policy will enjoy a
dramatically reduced risk that their employees will become severely ill
or die of a COVID-19 infection. In addition, employers who implement a
vaccination mandate will likely have fewer workers temporarily removed
from the workplace due to a COVID-19 positive test; this rule requires
all covered employers to remove from the workplace any employee who
tests positive for COVID-19 or receives a diagnosis of COVID-19 (see
the Summary and Explanation for paragraph (h), Section VI.H. of this
preamble), and because vaccinated workers are less likely than
unvaccinated workers to be infected by the virus, OSHA expects
employers with a mandatory vaccination policy will be statistically
less likely to be obliged to remove a COVID-positive employee from the
workplace in accordance with paragraph (h)(2). Additionally, only
employers who decline to implement a mandatory vaccination program are
required by the rule to assume the administrative burden necessary to
ensure that unvaccinated workers are regularly tested for COVID-19 and
wear face coverings when they work near others.
    Where employers opt out of implementing a mandatory vaccination
program, the ETS encourages employees to elect to be fully vaccinated.
As discussed in the Summary and Explanation for paragraph (f) (Section
VI.F. of this preamble), the ETS requires all covered employers to
support vaccination by providing employees with reasonable time,
including up to four hours of paid time, to receive each vaccination
dose, and reasonable time and paid sick leave to recover from
vaccination side effects. Many workers have been deterred from
receiving vaccination by fears of missing work and/or losing pay to
obtain vaccination and/or recover from side effects (see Section VI.F.
of this preamble; see, e.g., KFF, May 6, 2021; KFF, May 17, 2021), and
OSHA finds that this employer support is necessary to ensure that
employees can become fully vaccinated without concern that they will be
sacrificing pay or their jobs to do so.
    All covered employers are required by the ETS to bear the cost of
providing up to four hours of paid time and reasonable paid sick leave
needed to support vaccination, but where an employee chooses to remain
unvaccinated, the ETS does not require employers to pay for the costs
associated with regular COVID-19 testing or the use of face coverings
(see the Summary and Explanation for paragraphs (g) and (i), Sections
VI.G. and VI.I. of this preamble). In some cases, employers may be
required to pay testing and/or face covering costs under other federal
or state laws or collective bargaining obligations, and some may choose
to do so even without such a mandate, but otherwise employees will be
required to bear the costs if they choose to be regularly tested and
wear a face covering in lieu of vaccination.
    This ETS more strongly encourages vaccination than the June 2021
Healthcare ETS. OSHA designed the Healthcare ETS, which addresses the
grave danger that COVID-19 poses workers in specific health care
settings where COVID-19-positive individuals are reasonably likely to
be present, to encourage vaccination (see 86 FR at 32415, 32423, 32565,
32597). Specifically, the Healthcare ETS encourages vaccination by
requiring employers to provide employees reasonable and paid time to
receive vaccination doses and recover from side effects (29 CFR
1910.502(m)), and by exempting from its scope ``well-defined hospital
ambulatory care settings where all employees are fully vaccinated'' and
all non-employees are screened and denied entry if they are suspected
or confirmed to have COVID-19 (1910.502(a)(2)(iv)) and ``home
healthcare settings where all employees are fully vaccinated'' and all
nonemployees at that location are screened prior to employee entry so
that people with suspected or confirmed COVID-19 are not present
(1910.502 (a)(2)(v)).
    Similar to the Healthcare ETS, this ETS requires employers to
support vaccination by providing employees with reasonable time,
including up to four hours of paid time, to receive vaccination, and
reasonable time and paid sick leave to recover from vaccination side
effects (see discussion above and the Summary and Explanation for
paragraph (f), Section VI.F. of this preamble). However, as discussed
above, this ETS goes further and expressly requires the implementation
of a mandatory vaccination policy, unless the employer implements an
alternative policy that requires unvaccinated workers to be regularly
tested for COVID-19 and to wear face coverings in most situations when
they work near others. While nothing in the Healthcare ETS prohibits
covered employers from implementing a mandatory vaccination policy,
this ETS presents the implementation of a mandatory vaccination policy
as a preferred compliance option, and will preempt inconsistent state
and local requirements that ban or limit employers' authority to
require vaccination. Additionally, where the employer opts out of
implementing a mandatory vaccination policy, and the employee opts out
of vaccination, this ETS places no obligation on the employer to pay
for costs associated with the regular testing of unvaccinated workers
for COVID-19 or their use of face coverings, which will provide a
financial incentive for some employees to be fully vaccinated.
    OSHA finds it necessary to more strongly encourage vaccination in
this ETS than in the Healthcare ETS in the manner described above. The
Healthcare ETS's provisions that encouraged vaccination were packaged
with a comprehensive infection prevention program that was tailored to
the specific healthcare work settings to which the ETS applied,
including a suite of layered and overlapping controls. In contrast,
OSHA is promulgating this ETS to address the grave danger that COVID-19
now poses to all unvaccinated workers who work indoors and in the
presence of others. As mentioned above, crafting a comprehensive and
multi-layered standard that is comprehensive and feasible for the
myriad work settings to which this ETS will apply, including workplaces
as diverse as schools, restaurants, retail settings, offices, prisons,
and factories, is an

extraordinarily challenging and complicated undertaking.
    Exigent circumstances require OSHA to immediately promulgate this
ETS to protect unvaccinated workers, and vaccination is the single most
efficient and effective method for removing unvaccinated workers from
the grave danger. Given the urgency of the rulemaking and the singular
efficacy of vaccination, OSHA has decided against including
comprehensive and multilayered exposure controls in this ETS, and is
instead focusing the ETS on strongly encouraging vaccination. Strongly
encouraging vaccination is thus critical to the effectiveness of this
ETS at protecting unvaccinated workers from the grave danger. In
Request for Comment (Section I.B. of this preamble), OSHA seeks
information on what additional measures, if any, should be required to
protect employees against COVID-19.
    Moreover, stronger encouragement of vaccination is needed in this
ETS than in the Healthcare ETS because workers who are protected by the
Healthcare ETS are more likely to be vaccinated and/or subject to a
vaccination mandate. The Healthcare ETS, 29 CFR 1910.502, focused on
healthcare work settings where COVID-19 is reasonably expected to be
present, and, this ETS does not apply in settings where any employee
provides healthcare services or healthcare support services while they
are covered by the requirements of 29 CFR 1910.502 (see the Summary and
Explanation for paragraph (b), Section VI.B. of this preamble).
Evidence shows that workers in settings covered by Sec.  1910.502
already have a high rate of vaccination. As of July 2021, healthcare
workers had a higher rate of vaccination than non-healthcare workers
(Lazer et al., August, 2021), and many healthcare workers are currently
subject to vaccination mandates. Twenty-two states and the District of
Columbia have instituted vaccination mandates that are applicable to
healthcare workers (NASHP, October 1, 2021), and nearly 300 hospitals
and broader health systems have implemented vaccine mandates for their
employees (Renton et al., October 14, 2021). The White House reported
that almost 2,500 hospitals, 40% of all U.S. hospitals, across all 50
states, the District of Columbia, and Puerto Rico, have announced
vaccination requirements for their workforce, and noted numerous
examples of highly successful mandates in those workplaces (White
House, October 7, 2021). News reports attest that many of these
vaccination mandates have had great success in increasing the
vaccination rate of the targeted healthcare workers (Goldberg, July 9,
2021; Otterman and Goldstein, September 28, 2021; Hubler, September 30,
2021; Beer, October 4, 2021). Even more healthcare workers covered by
29 CFR 1910.502 will be subject to a vaccination mandate under the
Centers for Medicare & Medicaid Services (CMS) rule published elsewhere
in this issue of the Federal Register that requires COVID-19
vaccinations for workers in most healthcare settings that receive
Medicare or Medicaid reimbursement, including but not limited to
hospitals, dialysis facilities, ambulatory surgical settings, and home
health agencies. This CMS rule applies to at least 76,000 providers
(i.e., employers) and covers a majority of healthcare workers across
the country. OSHA expects that the combination of incentives to
vaccination in the Healthcare ETS and vaccination mandates applicable
to healthcare workers will leave few healthcare workers within the
scope of the Healthcare ETS unvaccinated.
b. Unvaccinated Workers Must Be Regularly Tested for COVID-19 and Use
Face Coverings
    As discussed above, this ETS presumptively requires employers to
implement a mandatory vaccination policy, but permits employers to opt
out of that requirement. Nonetheless, the grave danger that COVID-19
poses to unvaccinated workers demands that alternative protective
measures be taken at workplaces where the employer does not implement a
mandatory vaccination policy. Given that the SARS-CoV-2 virus is highly
contagious, transmitted easily through the air, and can lead to severe
and/or fatal outcomes in unvaccinated workers, it is critical that
employers who do not require their employees to be vaccinated implement
controls to mitigate the potential for COVID-19 outbreaks to occur. As
discussed above, and in Grave Danger (Section III.A. of this preamble),
unvaccinated workers are more likely than vaccinated workers to be
infected with COVID-19 and transmit the virus to others, and thus pose
a heightened risk of spreading the virus at the workplace, including to
other unvaccinated workers.
    To reduce the risk that unvaccinated workers will spread COVID-19
at the workplace, this rule requires employers that do not implement a
mandatory vaccination policy to ensure that unvaccinated workers who
report to a workplace where others are present are tested at least once
a week for COVID-19. As discussed in the Summary and Explanation for
paragraph (g) (Section VI.G. of this preamble), it is well-established
that, by identifying and isolating infected individuals, regularly
testing individuals for COVID-19 infection can be an effective method
for reducing virus transmission. Regularly testing unvaccinated workers
is essential because SARS-CoV-2 infection is often attributable to
asymptomatic or presymptomatic transmission (Bender et al., February
18, 2021; Byambasuren et al., December 11, 2020; Johansson et al.,
January 7, 2021; Klompas et al., September 2021). In accordance with
the CDC's recommendations, OSHA has set the minimum frequency of
testing at 7 days because the agency expects that it will be effective
in slowing the spread of COVID-19, while taking into account associated
cost considerations (see the Summary and Explanation for paragraph (g),
Section VI.G. of this preamble). As noted in the Request for Comment
(Section I.B. of this preamble), OSHA is gathering additional
information about whether OSHA should require testing more often than
on a weekly basis.
    The requirement for unvaccinated workers to be regularly tested for
COVID-19 operates in tandem with paragraph (h)(2), which requires that
all employers remove from the workplace any employee who receives a
positive COVID-19 test, or a COVID-19 diagnosis (see the Summary and
Explanation for paragraph (h), Section VI.H. of this preamble).
Paragraph (h)(2) ensures that the COVID-19-positive employee will be
isolated from the workplace until it is safe for the employee to
return, and also allows the employee to seek medical care sooner and
reduce the likelihood that they will suffer the most severe
consequences of an infection (e.g., by seeking monoclonal antibody
treatment). The combination of the testing and medical removal
provisions will reduce the likelihood that an unvaccinated worker who
has been infected with COVID-19, including those who are not
experiencing symptoms of infection, will be permitted to spread the
virus to others at the workplace, including unvaccinated coworkers.
    Additionally, OSHA finds it necessary to require employers that do
not implement a mandatory vaccination policy to ensure that
unvaccinated workers wear face coverings in most situations when they
are working near others. This reflects OSHA's recognition that
regularly testing unvaccinated workers for COVID-19 will not be 100%
effective in identifying infected workers before they enter the
workplace. Most obviously, testing employees once a week will not
prevent an unvaccinated

worker from exposing others at the workplace if the worker becomes
infected and reports to the workplace in between their weekly tests.
And, even if the rule required unvaccinated workers to be tested more
frequently than once a week, infected persons may still be missed,
particularly in areas with high community spread (Chin et al.,
September 9, 2020).
    Accordingly, requiring unvaccinated workers to wear face coverings
in most situations when they are working near others will further
mitigate the potential for unvaccinated workers to spread the virus at
the workplace. As discussed in the Summary and Explanation for
paragraph (i) (Section VI.I. of this preamble), it is well-established
that face coverings provide effective source control; that is, they
largely prevent respiratory droplets emitted by the wearer of the face
covering from spreading to others, and thus make it significantly less
likely that the person wearing the mask will transmit the virus, if
they are infected. Face coverings are also believed to provide the
wearer some limited protection from exposure to the respiratory
droplets of co-workers and others (e.g., customers) (CDC, May 7, 2021),
but the principal benefit of face coverings is to significantly reduce
the wearer's ability to spread the virus. By requiring unvaccinated
workers to wear face coverings, this rule significantly reduces the
likelihood that an infected unvaccinated worker who enters the
workplace despite the testing requirements will spread the virus to
others, including unvaccinated coworkers.
    OSHA acknowledges that regularly testing unvaccinated workers for
COVID-19 and requiring them to wear face coverings when they work near
others is less protective of unvaccinated workers than simply requiring
all workers to be vaccinated. To be sure, OSHA strongly prefers that
employers adopt a mandatory vaccination policy, as vaccination is
singularly effective at protecting workers from the severe consequences
that can result from a COVID-19 infection. And, where employers do not
adopt a mandatory vaccination policy, employers may also consider
alternative feasible measures that would remove employees who remain
unvaccinated from the scope of this ETS, such as increasing telework
(see the Summary and Explanation for paragraph (b), Section VI.B. of
this preamble). Nonetheless, as discussed above, OSHA has not imposed a
strict vaccination mandate on all covered employees who work in the
presence of others and not exclusively outdoors, given that the agency
has never previously used its authority to strictly mandate
vaccination, and the exigent and extraordinary circumstances driving
this emergency rulemaking have not afforded OSHA a full opportunity to
assess the potential ramifications of including a strict vaccination
mandate in this rule. Given these circumstances, and employers' unique
understanding of the compliance approaches that will best increase
vaccination rates among their workforce, OSHA has designed a rule that
preserves a limited degree of employer flexibility, and strongly
encourages, but does not strictly require, vaccination. OSHA has
requested comment in this ETS on whether a strict vaccination mandate
would be appropriate and the agency will consider those comments as it
determines how to proceed with this rulemaking.

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Food and Drug Administration (FDA). (2020, December 11). Emergency
use authorization for an unapproved product review memorandum
(Pfizer-BioNTech COVID-19 vaccine/BNT 162b2 mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine. (FDA, December 11,
2020)
Food and Drug Administration (FDA). (2020, December 18). Emergency
use authorization for an unapproved product review memorandum
(Moderna COVID-19 vaccine/mRNA-1273). https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccine. (FDA, December 18, 2020)
Food and Drug Administration (FDA). (2021, February 26). Janssen
COVID-19 vaccine. Vaccines and Related Biological Products Advisory
Committee February 26, 2021 Meeting Briefing Document. https://www.fda.gov/media/146219/download. (FDA, February 26, 2021)
Goldberg C. (2021, July 9). Hospital Vaccine Mandates Suggest
Success in Boosting U.S. Shots. Bloomberg News. https://www.bloomberg.com/news/articles/2021-07-09/early-mandates-boost-worker-vaccine-rates-prompt-few-to-quit. (Goldberg, July 9, 2021)
Hirsch L. (2021, September 30). After Mandate, 91% of Tyson Workers
Are Vaccinated. https://www.nytimes.com/2021/09/30/business/tyson-foods-vaccination-mandate-rate.html. (Hirsch, September 30, 2021)
Hubler S. (2021, September 30). `Mandates Are Working': Employer
Ultimatums Life Vaccination Rates, So Far. The New York Times.
https://www.nytimes.com/2021/09/30/us/california-vaccine-mandate-health-care.html. (Hubler, September 30, 2021)
Johansson MA et al., (2021, January 7). SARS-CoV-2 transmission from
people without COVID-19 symptoms. JAMA Network Open. 4(1): e2035057.
doi:10.1001/jamanetworkopen.2020.35057. (Johansson et al., January
7, 2021)
Kaiser Family Foundation (KFF). (2021, May 6). KFF COVID-19 Vaccine
Monitor: April 2021. https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-april-2021/. (KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May 17). How employer actions
could facilitate equity in COVID-19 vaccinations. https://www.kff.org/policy-watch/how-employer-actions-could-facilitate-equity-in-covid-19-vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021, September). Does The Public
Want To Get A COVID-19 Vaccine? When? https://www.kff.org/coronavirus-covid-19/dashboard/kff-covid-19-vaccine-monitor-dashboard/?utm_source=web&utm_medium=trending&utm_campaign=COVID-19-vaccine-monitor#messagesandinformation. (KFF, September 2021)

Klompas M et al. (2021, September). The case for mandating COVID-19
vaccines for health care workers. Annals of Internal Medicine.
https://doi.org/10.7326/M21-2366. (Klompas et al., September 2021)
Lazer D et al. (2021, August). The COVID States Project: A 50-State
COVID-19 Survey Report #62: COVID-19 Vaccine Attitudes Among
Healthcare Workers. http://news.northeastern.edu/uploads/COVID19%20CONSORTIUM%20REPORT%2062%20HCW%20August%202021.pdf. (Lazer
et al., August, 2021)
National Academy for State Health Policy (NASHP). (2021, October 1).
State Efforts to Ban or Enforce COVID-19 Vaccine Mandates and
Passports. https://www.nashp.org/state-lawmakers-submit-bills-to-ban-employer-vaccine-mandates/. (NASHP, October 1, 2021)
National Safety Council (NSC). (2021, September). A Year in Review,
and What's Next: COVID-19 Employer Approaches and Worker
Experiences. https://www.nsc.org/faforms/safer-year-one-final-report. (NSC, September 2021)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)
Otterman S and Goldstein J. (2021, September 28). Thousands of N.Y.
Health Care Workers Get Vaccinated Ahead of Deadline. The New York
Times. https://www.nytimes.com/2021/09/28/nyregion/vaccine-health-care-workers-mandate.html. (Otterman and Goldstein, September 28,
2021)
Renton B et al. (2021, October 14). New: Hospital Vaccine Mandate
Tracker. Global Epidemics, Brown School of Public Health. https://globalepidemics.org/2021/07/24/new-hospital-vaccine-mandate-tracker/
. (Renton et al., October 14, 2021)
Scobie HM et al. (2021, September 17). Monitoring Incidence of
COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination
Status--13 U.S. Jurisdictions, April 4-July 17, 2021. MMWR Morb
Mortal Wkly Rep 2021; 70: early release. https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e1.htm. (Scobie et al., September 17, 2021)
The Associated Press. (2021, September 22). United Airlines says 97%
of US employees have been vaccinated. https://www.wifr.com/2021/09/22/united-airlines-say-97-us-employees-have-been-vaccinated/. (The
Associated Press, September 22, 2021)
Towey R. (2021, September 27). CNBC poll shows very little will
persuade unvaccinated Americans to get Covid shots. https://www.cnbc.com/2021/09/10/cnbc-poll-shows-very-little-will-persuade-unvaccinated-americans-to-get-covid-shots.html. (Towey, September
27, 2021)
White House. (2021, October 7). White House Report: Vaccination
Requirements Are Helping Vaccinate More People, Protect Americans
from COVID-19, and Strengthen the Economy. https://www.whitehouse.gov/wp-content/uploads/2021/10/Vaccination-Requirements-Report.pdf. (White House, October 7, 2021)
III. No Other Agency Action is Adequate To Protect Employees Against
Grave Danger
    OSHA's experience to date shows that the agency's existing tools
are inadequate to meet the grave danger posed by COVID-19 to
unvaccinated workers not covered by the Healthcare ETS. OSHA has
determined that its existing standards, regulations, the OSH Act's
General Duty Clause, and non-mandatory guidance will not adequately
promote the most effective means to protect these workers: Vaccination.
The agency has determined that this ETS is necessary to address these
inadequacies. Multiple developments support this change in approach.
First, large numbers of employees are continuing to contract COVID-19
and die. (See Grave Danger, Section III.A. of this preamble). Further,
based on a thorough review of its existing approach to protecting
employees from COVID-19 and the current state of the pandemic, OSHA
finds that existing OSHA standards, regulations, the General Duty
Clause, and non-mandatory guidance are not adequate to protect
employees outside healthcare from COVID-19. The Preamble to the
Healthcare ETS includes a detailed analysis demonstrating the
inadequacy of existing tools in the healthcare industry. See 86 FR
32414-32423. In general, the same analysis applies here. The reasons
existing tools were inadequate to protect healthcare workers apply in
other industry sectors as well. The Healthcare ETS itself, while
necessary to protect healthcare workers, of course applies only to that
industry. Finally, the numerous guidance products published by other
entities, such as CDC, are not adequate to protect employees because
they are not enforceable; there is no penalty for noncompliance. 86 FR
at 32415. Even as the CDC has increasingly recommended vaccination to
protect from the dangers of transmission and severe illness related to
the SARS-CoV-2 virus, vaccination rates remain uneven around the
country. (CDC, September 9, 2021; Leonhardt, September 7, 2021; KFF,
October 6, 2021; McPhillips and Cohen, May 19, 2021).
    The need for this ETS is also reflected in the number of states and
localities that have issued their own mandatory standards in
recognition that OSHA's existing measures (including non-mandatory
guidance, compliance assistance, and enforcement of existing standards)
have failed to prevent the spread of the virus in workplaces.
Additionally, as mentioned previously, other states have banned certain
employers from implementing workplace vaccination mandates or from
verifying an employee's vaccination status or from requiring face
coverings. A national standard is necessary to establish clear
requirements regarding vaccination, testing and face coverings that
will protect employees in all states and preempt state or local
ordinances that prevent employers from implementing necessary
protections.
a. The Current Standards and Regulations Are Inadequate
    In the Healthcare ETS, OSHA considered its enforcement efforts with
regard to existing standards and regulations that OSHA had identified
as potentially applicable to occupational exposure to SARS-CoV-2.
OSHA's analysis in Section IV of the Healthcare ETS, 86 FR 32376,
32416-17 and hereby included in the record of this ETS,\18\ is
applicable here in considering the need for this ETS, which covers a
much broader set of employers in all industries. There OSHA found that
none of the existing OSHA standards could sufficiently abate the hazard
posed by COVID-19 in healthcare settings. Here again OSHA concludes
that the potentially applicable existing standards are insufficient to
address the grave danger faced by workers covered by this ETS. None of
the current standards, even if more rigorously enforced, can
sufficiently address this cross-industry hazard of national proportions
to abate the grave danger posed by COVID-19 or lead to the same
benefits that this ETS will achieve. See Asbestos Info. Ass'n/N. Am. v.
Occupational Safety & Health Admin., 727 F.2d 415, 427 (5th Cir. 1984)
(``[M]uch of the claimed benefit could be obtained simply by enforcing
the current standard.'').
---------------------------------------------------------------------------

    \18\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------

    Through its enforcement guidance, OSHA identified a number of
current standards and regulations that might apply when workers have
occupational exposure to SARS-CoV-2, most of which are the same
standards OSHA considered in the Healthcare ETS. (Updated Interim
Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19))
(OSHA, July 7, 2021). OSHA has also cited the Hazard communication
standard (29 CFR 1910.1200) during COVID-19 investigations.
Accordingly, a list of

potentially applicable standards and regulations follows:
     29 CFR part 1904, Recording and Reporting Occupational
Injuries and Illnesses. This regulation requires certain employers to
keep records of work-related fatalities, injuries, and illnesses and
report them to the government in specific circumstances.
     29 CFR 1910.132, General requirements--Personal Protective
Equipment (PPE). This standard requires that appropriate PPE, including
PPE for eyes, face, head, and extremities, protective clothing,
respiratory devices, and protective shields and barriers, be provided,
used, and maintained in a sanitary and reliable condition.
     29 CFR 1910.134, Respiratory protection. This standard
requires that employers provide, and ensure the use of, appropriate
respiratory protection when necessary to protect employee health.
     29 CFR 1910.141, Sanitation. This standard applies to
permanent places of employment and contains, among other requirements,
general housekeeping and waste disposal requirements.
     29 CFR 1910.145, Specification for accident prevention
signs and tags. This standard requires the use of biological hazard
signs and tags, in addition to other types of accident prevention signs
and tags.
     29 CFR Subpart U--COVID-19 Emergency Temporary Standard.
The Healthcare ETS, promulgated on June 21, 2021 includes various
controls (patient screening and management, respirators and other PPE,
limiting exposure to aerosol-generating procedures, physical
distancing, physical barriers, cleaning, disinfection, ventilation,
health screening and medical management, access to vaccination, anti-
retaliation provisions, and medical removal protection) to address the
grave danger posed by COVID-19 to healthcare workers.
     29 CFR 1910.1020, Access to employee exposure and medical
records. This standard requires that employers provide employees and
their designated representatives access to relevant exposure and
medical records.
     29 CFR 1910.1200, Hazard communication. This standard
requires employers to keep Safety Data Sheets (SDS) for chemical
hazards, provide SDSs to employees and their representatives when
requested, and train employees about those hazards. The standard does
not apply to biological hazards, but hazard communication becomes an
issue for the SARS-CoV-2 virus when chemicals are used to disinfect
surfaces.
    OSHA again finds that none of these existing standards provide for
the types of workplace controls that are necessary to combat the grave
danger addressed by this ETS. First, none of the listed potentially
applicable standards require vaccination against SARS-CoV-2, the most
efficient and effective control to combat the grave danger posed by the
virus. (The Bloodborne Pathogen Standard requires that the hepatitis B
vaccine be made available to certain employees, but that is not that is
not relevant here, since the hepatitis vaccine provides no protection
against COVID-19). Nor are the additional safety measures included in
this ETS--vaccination verification, screening testing, face coverings,
and medical removal of COVID-19 positive workers-- required by existing
standards other than OSHA's Healthcare ETS (covering employees exempted
from this new ETS while the Healthcare ETS is in effect).
    Second, because existing standards do not contain provisions
specifically targeted at the COVID-19 hazard, it may be difficult for
employers and employees to determine what particular COVID-19 safety
measures are required by existing standards, or how the separate
standards are expected to work together as applied to COVID-19. An ETS
that contains provisions specifically addressing COVID-19 hazards in
covered workplaces will provide clear instructions. More certainty will
lead to more compliance, and more compliance will lead to improved
protection of employees covered by this standard.
    Third, requirements in some standards may be appropriate for other
situations but simply do not contemplate COVID-19 and fail to address
important aspects of the hazard. For example, the general sanitation
standard requires employers to provide warm water, soap, and towels
that can be used in hand washing, but does not require disinfection or
provision of hand sanitizer where handwashing facilities cannot be made
readily available. See 86 FR 32417. Although the sanitation standard
might appear at first glance to be relevant here, it simply does not
require the types of controls that would, even if more rigorously
enforced, sufficiently reduce the threat of COVID-19 in the workplace.
As such, OSHA affirms its previous determination that some of the
above-listed standards--including the sanitation standard--are in
practice too difficult to apply to the COVID-19 hazard and have never
been cited in COVID enforcement. 86 FR 32416.
    Fourth, existing recordkeeping and reporting regulations do not
adequately allow the employer or the agency to assess the full scope of
COVID-19 workplace exposures and protection. OSHA's general
recordkeeping regulations were not written with the nature of COVID-19
transmission or illness in mind. In order to adequately understand and
thereby control the spread of COVID-19 in the workforce, it is critical
that the employer has records of employees' vaccination status, and of
the testing undergone by employees who do not receive vaccination, and
that it knows of all cases of COVID-19 occurring among employees.
However, such information is outside of the scope of OSHA's existing
recordkeeping requirements, which are limited to injuries or illnesses
that the employer knows to be work-related.
    Moreover, existing reporting regulations do not adequately ensure
that OSHA has the full picture of the impact of COVID-19 because those
regulations only require employers to report in-patient
hospitalizations that occur within 24 hours of the work-related
incident and to report fatalities that occur within thirty days of the
work-related incident. 86 FR at 32417. Many COVID-19 infections will
not result in hospitalization or death until well after these limited
reporting periods. Under existing regulations, such cases are not
required to be reported to OSHA, which limits the agency's ability to
fully understand the impact of COVID-19 on the workforce. 86 FR 32417.
This ETS includes a provision, paragraph (k), that removes the time
limitation on reporting for COVID-19 cases.
    In conclusion, OSHA's experience has demonstrated that existing
standards and regulations are inadequate to address the current COVID-
19 hazard.
b. The General Duty Clause Is Inadequate To Meet the Current Crisis
    Section 5(a)(1) of the OSH Act, or the General Duty Clause,
provides the general mandate that each employer ``furnish to each of
[its] employees employment and a place of employment which are free
from recognized hazards that are causing or are likely to cause death
or serious physical harm to [its] employees.'' 29 U.S.C. 654(a)(1). For
General Duty Clause citations to be upheld, OSHA must demonstrate
elements of proof that are supplementary to, and can be more difficult
to show than, the elements of proof required for violations of specific
standards, where a hazard is presumed. Specifically, to prove a
violation of the General Duty Clause, OSHA needs to

establish--in each individual case--that: (1) An activity or condition
in the employer's workplace presented a hazard to an employee; (2) the
hazard was recognized; (3) the hazard was causing or was likely to
cause death or serious physical harm; and (4) feasible means to
eliminate or materially reduce the hazard existed. BHC Nw. Psychiatric
Hosp., LLC v. Sec'y of Labor, 951 F.3d 558, 563 (D.C. Cir. 2020). OSHA
often relies on the General Duty Clause to fill gaps where specific
standards do not address a hazard and OSHA enforces it through case-by-
case adjudicative proceedings. See United States v. Strum, 84 F.3d 1, 5
(1st Cir. 1996).
    OSHA has previously found the General Duty Clause to be inadequate
to protect employees from dangers posed by infectious agents. In
promulgating the bloodborne pathogens standard, OSHA explained that
enforcement under the General Duty Clause was insufficient to protect
employees from the serious hazards those pathogens present. 56 FR 64007
(December 6, 1991). In the recently promulgated Healthcare ETS, OSHA
found that the General Duty Clause was insufficient to protect
healthcare workers from the grave danger they faced as well. 86 FR
32418. While OSHA initially attempted to use the General Duty Clause to
protect employees across all industries from COVID-19-related hazards,
OSHA's experience has demonstrated that the Clause is grossly
inadequate to protect employees covered by this ETS from the grave
danger posed by COVID-19 in the workplace. As explained more fully
below, OSHA finds this ETS is necessary to protect employees from the
hazards of COVID-19.
    As an initial matter, the General Duty Clause does not provide
employers with specific requirements to follow or a roadmap for
implementing appropriate abatement measures. The ETS, however, provides
a clear statement of what OSHA expects employers to do to protect
workers, thus facilitating better compliance. The General Duty Clause
is so named because it imposes a general duty to keep the workplace
free of recognized serious hazards; the ETS, in contrast, lays out
clear requirements for employers to implement vaccination policies
including vaccination verification, support for employee vaccination,
screening testing and face coverings for unvaccinated workers, and
medical removal of COVID-19 positive employees. Conveying obligations
as clearly and specifically as possible makes it much more likely that
employers will comply with those obligations and thereby protect
workers from COVID-19 hazards. See, e.g., Integra Health Mgmt., Inc.,
2019 WL 1142920, at *7 n.10 (No. 13-1124, 2019) (noting that standards
``give clear notice of what is required of the regulated community'');
56 FR 64007 (``because the standard is much more specific than the
current requirements [general standards and the general duty clause],
employers and employees are given more guidance in carrying out the
goal of reducing the risks of occupational exposure to bloodborne
pathogens'').
    Moreover, several characteristics of General Duty Clause
enforcement actions make them an inadequate means to address hazards
associated with COVID-19. First, it would be virtually impossible for
OSHA to require and enforce the most important worker-protective
elements of the ETS (such as vaccination and testing) under the General
Duty Clause. Second, OSHA's burden of proof for establishing a General
Duty Clause violation is heavier than for standards violations. Third,
promulgating an ETS will enable OSHA to issue more meaningful penalties
for willful and egregious violations, thus creating effective
deterrence against employers who intentionally disregard their
obligations under the Act or demonstrate plain indifference to employee
safety. As discussed in more detail below, all of these considerations
demonstrate OSHA's need to promulgate this ETS in order to protect
unvaccinated workers covered by this standard from hazards posed by
COVID-19.

The General Duty Clause is ill-suited to requiring employers to adopt
vaccination and testing policies, like those required by the ETS

    Because the General Duty Clause requires OSHA to establish the
existence and feasibility of abatement measures that can materially
reduce a hazard, it is difficult for OSHA to use the clause to require
specific control measures where an employer is doing something, but not
what the Secretary has determined is needed to fully address the
serious hazard. See, e.g., Waldon Health Care Center, 16 BNA OSHC 1052,
1993 WL 119662 at * (No. 89-2804, 1993) (vacating OSHA citation
requiring pre-exposure hepatitis B vaccination under General Duty
Clause by finding that although vaccination would more fully reduce the
hazard, the employer's chosen means of abatement were sufficient);
Brown & Root, Inc., Power Plant Div., 8 BNA OSHC 2140, 1980 WL 10668 at
*5 (No. 76-1296, 1980) (``[T]he employer may defend against a section
5(a)(1) citation by asserting that it was using a method of abatement
other than the one suggested by the Secretary.'').
    Further, even where OSHA establishes a violation of the General
Duty Clause, the employer is under no obligation to implement the
feasible means of abatement proven by OSHA as part of its prima facie
case. Cyrus Mines Corp., 11 OSH Cas. (BNA) 1063, 1982 WL 22717, at *4
(No. 76-616, 1983) (``[The employer] is not required to adopt the
abatement method suggested by the Secretary, even one found feasible by
the Commission; it may satisfy its duty to comply with the standard by
using any feasible method that is appropriate to abate the
violation.''); Brown & Root, Inc., Power Plant Div., 1980 WL 10668 at
*5. Thus, even in cases where OSHA prevails, the employer need not
necessarily implement the specific abatement measure(s) OSHA
established would materially reduce the hazard. The employer could
select alternative controls and then it would be up to OSHA, if it
wished to cite the employer again, to establish that the recognized
hazard continued to exist and that its preferred controls could
materially reduce the hazard even further.
    Given the severity and pervasiveness of the COVID-19 hazard, OSHA
has determined that the specific abatement measures provided in this
ETS are necessary to protect workers from grave danger. Under the
General Duty Clause alone, it would be nearly impossible to require
employers to provide these specific measures, and even then, it could
only be on a case-by-case enforcement basis. Considering the magnitude
and ubiquity of the danger that SARS-CoV-2 poses to workers across the
country, the case-by-case adjudicatory regime set up through the
General Duty Clause is simply not adequate to combat the risk of severe
illness and death caused by the virus.
General Duty Clause Citations Impose a Heavy Litigation Burden on OSHA
    Under the General Duty Clause OSHA must prove that there is a
recognized hazard, i.e., a workplace condition or practice to which
employees are exposed, creating the potential for death or serious
physical harm to employees. See SeaWorld of Florida LLC v. Perez, 748
F.3d 1202, 1207 (D.C. Cir. 2014); Integra Health Management, 2019 WL
1142920, at *5. Whether a particular workplace condition or practice is
a ``recognized hazard'' under the General Duty Clause is a question of
fact that must be decided in each individual case. See SeaWorld of
Florida LLC, 748 F.3d at 1208. In the case of a COVID-19-related
citation, this means showing

not just that the virus is a hazard as a general matter--a fairly
indisputable point--but also that the specific conditions in the cited
workplace, such as unvaccinated, unmasked employees working in close
proximity to other employees for extended periods, create a COVID-19-
related hazard.
    In contrast, an OSHA standard that requires or prohibits specific
conditions or practices establishes the existence of a hazard. See
Harry C. Crooker & Sons, Inc. v. Occupational Safety & Health Rev.
Comm'n, 537 F.3d 79, 85 (1st Cir. 2008); Bunge Corp. v. Sec'y of Labor,
638 F.2d 831, 834 (5th Cir. 1981). Thus, in enforcement proceedings
under OSHA standards, as opposed to the General Duty Clause, ``the
Secretary need not prove that the violative conditions are actually
hazardous.'' Modern Drop Forge Co. v. Sec'y of Labor, 683 F.2d 1105,
1114 (7th Cir. 1982). With OSHA's finding that the hazard of exposure
to COVID-19 can exist for unvaccinated workers in all covered
workplaces (see Grave Danger, Section III.A. of this preamble), the ETS
will eliminate the burden to repeatedly prove, workplace by workplace,
the existence of a COVID-19 hazard under the General Duty Clause.
    One of the most significant advantages to standards like the ETS
that establish the existence of the hazard at the rulemaking stage is
that the Secretary can require specific abatement measures without
having to prove that a specific cited workplace is already
hazardous.\19\ In contrast, as discussed above, under the General Duty
Clause the Secretary cannot require abatement before proving in the
enforcement proceeding that an existing condition at the workplace is
hazardous. For example, in a challenge to OSHA's Grain Handling
Standard, which was promulgated in part to protect employees from the
risk of fire and explosion from accumulations of grain dust, the Fifth
Circuit acknowledged OSHA's inability to effectively protect employees
from these hazards under the General Duty Clause in upholding, in large
part, the standard. See Nat'l Grain & Feed Ass'n v. Occupational Safety
& Health Admin., 866 F.2d 717, 721 (5th Cir. 1988) (noting Secretary's
difficulty in proving explosion hazards of grain handling under General
Duty Clause). Although OSHA had attempted to address fire and explosion
hazards in the grain handling industry under the General Duty Clause,
``employers generally were successful in arguing that OSHA had not
proved that the specific condition cited could cause a fire or
explosion.'' Id. at 721 & n.6 (citing cases holding that OSHA failed to
establish a fire or explosion hazard under the General Duty Clause).
The Grain Handling Standard, in contrast, established specific limits
on accumulations of grain dust based on its combustible and explosive
nature, and the standard allowed OSHA to cite employers for exceeding
those limits without the need to prove at the enforcement stage that
each cited accumulation was likely to cause a fire or explosion. See
id. at 725-26.
---------------------------------------------------------------------------

    \19\ ``The Act does not wait for an employee to die or become
injured. It authorizes the promulgation of health and safety
standards and the issuance of citations in the hope that these will
act to prevent deaths and injuries from ever occurring.'' Whirlpool
Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also Arkansas-Best
Freight Sys., Inc. v. Occupational Safety & Health Rev. Comm'n, 529
F.2d 649, 653 (8th Cir. 1976) (noting that the ``[OSH] Act is
intended to prevent the first injury'').
---------------------------------------------------------------------------

    The same logic applies to COVID-19 hazards. Given OSHA's burden
under the General Duty Clause to prove that conditions at the cited
workplace are hazardous, it is difficult for OSHA to ensure necessary
abatement before individual employee lives and health are unnecessarily
endangered by exposure to COVID-19, despite widespread evidence of the
grave danger posed by worker exposure to COVID-19. Indeed, despite
publishing a voluminous collection of COVID-19 guidance online and
receiving and investigating thousands of complaints, OSHA did not
believe it could justify the issuance of more than 20 COVID-19 related
General Duty Clause citations over the entire span of the pandemic so
far, because of the quantum of proof the Secretary must amass under the
General Duty Clause. Unlike enforcement under the General Duty Clause,
this ETS allows OSHA to cite employers for each protective requirement
they fail to implement without the need to wait for employee infection
or death to prove in an enforcement proceeding that the particular
cited workplace was hazardous without that particular measure in place.
Thus, this ETS, which covers millions of workers nation-wide, is
significantly preferable to the General Duty Clause with respect to
such a highly transmissible virus because the inability to prevent a
single exposure can quickly result in an exponential increase in
exposures and illnesses or fatalities even at a single worksite.
    An additional limitation of the General Duty Clause is that proving
that there are feasible means to materially reduce a recognized hazard
typically requires testimony from an expert witness in each separate
case, which limits OSHA's ability to prosecute these cases as broadly
as needed to protect workers, in light of the expense involved. See,
e.g., Integra Health Management, 2019 WL 1142920, at *13 (requiring
expert witness to prove proposed abatement measures would materially
reduce hazard). In contrast, where an OSHA standard specifies the means
of compliance, the agency has already made the necessary technical
determinations in the rulemaking and therefore does not need to
establish feasibility of compliance as part of its prima facie case in
an enforcement proceeding. See, e.g., A.J. McNulty & Co. v. Sec'y of
Labor, 283 F.3d 328, 334 (D.C. Cir. 2002); S. Colorado Prestress Co. v.
Occupational Safety & Health Rev. Comm'n, 586 F.2d 1342, 1351 (10th
Cir. 1978). Preventing the initial exposure and protecting as many
workers as quickly as possible is especially critical in the context of
COVID-19 because, as explained in Grave Danger, Section III.A. of this
preamble, it can spread so easily in workplaces.

The ETS will also permit OSHA to achieve meaningful deterrence when
necessary to address willful or egregious failures to protect employees
against the COVID-19 hazard

    As described above, in contrast to the broad language of the
General Duty Clause, this ETS will prescribe specific measures
employers covered by this standard must implement. This specificity
will make it easier for OSHA to determine whether an employer has
intentionally disregarded its obligations or exhibited a plain
indifference to employee safety or health. In such instances, OSHA can
classify the citations as ``willful,'' allowing it to propose higher
penalties, with increased deterrent effects. In promulgating the
Healthcare ETS, OSHA noted that early in the pandemic, shifting
guidance on the safety measures employers should take to protect their
employees from COVID-19 created ambiguity regarding employers' specific
obligations. Thus, OSHA could not readily determine whether a
particular employer had ``intentionally'' disregarded obligations that
were not yet clear. And, even as the guidance began to stabilize,
OSHA's ability to determine ``intentional disregard'' or ``plain
indifference'' was difficult, for example, when an employer took some
steps address the COVID-19 hazard. 86 FR 32420. The Healthcare ETS
largely resolved this issue for employers covered by that standard, by
laying out clearly what parameters to put in place to protect
healthcare workers. However, this general challenge persists in OSHA's

attempts at enforcement in other industries.
    Further, OSHA has adopted its ``egregious violation'' policy to
impose sufficiently large penalties that achieve appropriate deterrence
against bad actor employers who willfully disregard their obligation to
protect their employees when certain aggravating circumstances are
present, such as a large number of injuries or illnesses, bad faith, or
an extensive history of noncompliance (OSHA Directive CPL 02-00-080
(October 21, 1990)). Its purpose is to increase the deterrent impact of
OSHA's enforcement activity. This policy utilizes OSHA's authority to
issue a separate penalty for each instance of noncompliance with an
OSHA standard, such as each employee lacking the same required
protections, or each workstation lacking the same required controls. It
can be more difficult to use this policy under the General Duty Clause
because the Fifth Circuit and the Occupational Safety and Health Review
Commission have held that, under the General Duty Clause, OSHA may only
cite a hazardous condition once, regardless of its scope or the number
of workers affected. Reich v. Arcadian Corp., 110 F.3d 1192, 1199 (5th
Cir. 1997). Thus, even where OSHA finds that an employer willfully
failed to protect a large number of employees from a COVID-19 hazard,
OSHA might not be able to cite the employer on a per-instance basis for
failing to protect each of its employees. The provisions of this ETS
have been intentionally drafted to make clear OSHA's authority to
separately cite employers for each instance of the employer's failure
to protect employees and for each affected employee, where appropriate.
    By providing needed clarity, the ETS will facilitate ``willful''
and ``egregious'' determinations that are critical enforcement tools
OSHA can use to adequately address violations by employers who have
shown a conscious disregard for the health and safety of their workers
in response to the pandemic. Without the necessary clarity, OSHA has
been limited in its ability to impose penalties high enough to motivate
the very large employers who are unlikely to be deterred by penalty
assessments of tens of thousands of dollars, but whose noncompliance
can endanger thousands of workers. Indeed, OSHA has only been able to
issue two COVID-19-related ``willful'' citations and no ``egregious''
citations since the start of the pandemic because of the challenges
described above.
    For all of the reasons described above, and after over a year of
attempting to use the General Duty Clause to address this widespread
hazard, OSHA finds that the General Duty Clause is not an adequate
enforcement tool to protect employees covered by this standard from the
grave danger posed by COVID-19.
c. OSHA and Other Entity Guidance Is Insufficient
    OSHA has issued numerous non-mandatory guidance products to advise
employers on how to protect workers from SARS-CoV-2 infection (see
https://www.osha.gov/coronavirus). Even the most comprehensive guidance
makes clear, as it must, that the guidance itself imposes no new legal
obligations, and that its recommendations are ``advisory in nature.''
(See OSHA's online guidance, Protecting Workers: Guidance on Mitigating
and Preventing the Spread of COVID-19 in the Workplace (OSHA, Updated
August 13, 2021); and OSHA's earlier 35-page booklet, Guidance on
Preparing Workplaces for COVID-19, (OSHA, March 9, 2020)). This
guidance, as well as guidance products issued by other government
agencies and organizations, including the CDC, the Centers for Medicare
& Medicaid Services (CMS), the Institute of Medicine (IOM), and the
World Health Organization (WHO), help protect employees to the extent
that employers voluntarily choose to implement the practices they
recommend. Unfortunately, OSHA's experience and the continued spread of
COVID-19 throughout the country shows that does not happen consistently
or rigorously enough, resulting in inadequate protection for employees.
For example, the CDC has strongly recommended vaccination since
vaccines became widely available earlier in the year, but many
employees have yet to take this simple step, which would protect
themselves and their co-workers from the danger of COVID-19.
    As documented in numerous peer-reviewed scientific publications,
CDC, IOM, and WHO have recognized a lack of compliance with non-
mandatory recommended infection-control practices (Siegel et al., 2007;
IOM, 2009; WHO, 2009). As noted in the preamble to the Healthcare ETS,
OSHA was aware of these findings when it previously concluded that an
ETS was not necessary, but at the time of that conclusion, the agency
erroneously believed that it would be able to effectively use the non-
mandatory guidance as a basis for establishing the mandatory
requirements of the General Duty Clause, and informing employers of
their compliance obligations under existing standards. 86 FR 32421. As
explained above, that has not proven to be an effective strategy.
Moreover, when OSHA made its initial necessity determination at the
beginning of the pandemic, it made an assumption that given the
unprecedented nature of the COVID-19 pandemic, there would be an
unusual level of widespread voluntary compliance by the regulated
community with COVID-19-related safety guidelines. (See, e.g., DOL, May
29, 2020 at 20 (observing that ``[n]ever in the last century have the
American people been as mindful, wary, and cautious about a health risk
as they are now with respect to COVID-19,'' and that many ``protective
measures are being implemented voluntarily, as reflected in a plethora
of industry guidelines, company-specific plans, and other sources'')).
    Since that time, however, developments have led OSHA to conclude
that the same uneven compliance documented by CDC, IOM, and WHO is also
occurring for the COVID-19 guidance issued by OSHA and other agencies.
For example, rising ``COVID fatigue'' or ``pandemic fatigue'' has been
reported for nearly a year already--i.e., a decrease in voluntary use
of COVID-19 mitigation measures over time (Meichtry et al., October 26,
2020; Silva and Martin, November 14, 2020; Belanger and Leander,
December 9, 2020; Millard, February 18, 2021). Other reasons that
people have not followed COVID-19 guidance include fear of financial
loss; skepticism about the danger posed by COVID-19; and even a simple
human tendency, called ``psychological reactance,'' to resist curbs on
personal freedoms, i.e., an urge to do the opposite of what somebody
tells you to do (Belanger and Leander, December 9, 2020; Markman, April
20, 2020). OSHA is seeing evidence of these trends in its COVID-19
enforcement. For example, although OSHA has issued guidance since the
spring of 2020 encouraging the use of physical distancing and barriers
as a means of protecting employees at fixed work locations, there have
been a number of news reports indicating that employers ignore that
guidance (Romo, November 19, 2020; Richards, May 5, 2020; Lynch, July
9, 2020). This was evidenced by a cross-sectional study performed from
late summer to early fall of 2020 in New York and New Jersey that found
non-compliance and widespread inconsistencies in COVID-19 response
programs (Koshy et al., February 4, 2021). Indeed, OSHA continues to
receive complaints and referrals attesting to such workplace practices.

(OSHA, October 17, 2021). Worse, some employers must now deal with
employees who not only have yet to be vaccinated but compound the
danger by hiding their unvaccinated status and declining to wear source
protection that would identify them as unvaccinated, even though it
could provide some protection to their coworkers, in workplaces where
there is a stigma attached to being unvaccinated. (Ember and Murphy
Marcos, August 7, 2021). This ETS contains notification and vaccine
verification requirements that address these avoidant behaviors and
mitigate the hazard of undisclosed exposure and transmission (see the
Summary and Explanation for paragraphs (e), (g), and (h), Sections
VI.E., VI.G., and VI.H. of this preamble).
    OSHA's more recent guidance update encourages employers to
facilitate employee vaccination by providing paid time off and
encourages testing and masks for unvaccinated workers. However, as
discussed previously, vaccination rates remain inconsistent across the
country and have slowed significantly since the spring of 2021. And
infection rates remain high, especially among the unvaccinated. It is
clear, as discussed previously, that voluntary self-regulation by
employers will not sufficiently reduce the danger that COVID-19 poses
in workplaces covered by this standard. As noted in the White House
Report on vaccination requirements released on October 7, at this time
only 25% of businesses have vaccine mandates in place (White House,
October 7, 2021). Since this ETS and other federal efforts to require
vaccination were announced more private and public sector institutions
have begun to prepare to implement vaccination requirements, further
demonstrating the need for this rule as an impetus for employer action
(White House, October 7, 2021).
    The high number of COVID-19-related complaints and reports that
OSHA continues to receive on a regular basis suggests a lack of
widespread compliance with existing voluntary guidance: From March 2020
to October 2021, OSHA has continued to receive hundreds of COVID-19-
related complaints every month, including over 400 complaints during
the month of August 2021, and over 450 complaints to date in the month
of September (OSHA, October 11, 2021). And, as of October 17, OSHA has
received 223 additional COVID-19-related complaints. (OSHA, October 17,
2021). If guidance were followed more strictly, or if there were enough
voluntary compliance with steps to prevent illness, OSHA would expect
to see a significant reduction in COVID-19-related complaints from
employees.
    The dramatic increases in the percentage of the population that
contracted the virus during the summer of 2021 indicates a continued
risk of COVID-19 transmission in workplace settings (for more
information on the prevalence of COVID-19 see Grave Danger, Section
III.A. of this preamble) despite OSHA's publication of numerous
specific and comprehensive guidance documents. OSHA has found that
neither reliance on voluntary action by employers nor OSHA non-
mandatory guidance is an adequate substitute for specific, mandatory
workplace standards at the federal level. Public Citizen v. Auchter,
702 F.2d 1150 at 1153 (voluntary action by employers ``alerted and
responsive'' to new health data is not an adequate substitute for
government action).
d. A Uniform Nationwide Response to the Pandemic Is Necessary To
Protect Workers
    As the pandemic has continued in the United States, there has been
increasing recognition of the need for a more consistent national
approach (GAO, September, 2020; Budryk, November 17, 2020; Horsley, May
1, 2020; DOL OIG, February 25, 2021). Many employers have advised OSHA
that they would welcome a nationwide ETS. For example, in its October
9, 2020 petition for a COVID-19 ETS, ORCHSE Strategies, LLC explained
that it is ``imperative'' that OSHA issue an ETS to provide employers
one standardized set of requirements to address safety and health for
their workers (ORCHSE, October 9, 2020). This group of prominent
business representatives explained that an ETS would eliminate
confusion and unnecessary burden on workplaces that are struggling to
understand how best to protect their employees in the face of confusing
and differing requirements across states and localities.
    The lack of a national standard on this hazard has led to
increasing imbalance in state and local regulation, a problem that OSHA
already identified as concerning in its Healthcare ETS. See 86 FR 32413
(``The resulting patchwork of state and local regulations led to
inadequate and varying levels of protection for workers across the
country, and has caused problems for many employees and businesses.'')
Since the Healthcare ETS was published, states and localities have
taken increasingly more divergent approaches to COVID-19 vaccination,
vaccination verification, screening testing, and the use of face
coverings in the workplace. Currently, the spectrum ranges from states
and localities requiring vaccine mandates and face coverings to states
prohibiting or restricting them, with many states falling somewhere in
between. Due to uneven approaches to vaccination across the country,
states with the lowest rates of vaccination have COVID-19 infection
rates four times as high as in states with the highest vaccine rates.
(Leonhardt, September 7, 2021). Given that thousands of working age
people continue to be infected with COVID-19 each week, many of whom
will become hospitalized or die, OSHA recognizes that a patchwork
approach to worker safety has not been successful in mitigating this
infectious disease outbreak (CDC, October 18, 2021--Cases, By Age). It
has become clear that a Federal standard, by way of this ETS, is
necessary to provide clear and consistent protection to employees
across the country. As explained in Pertinent Legal Authority (Section
II. of this preamble) and the Summary and Explanation for paragraph (a)
(Section VI.A. of this preamble), OSHA has the authority to
comprehensively address the issue(s) described in this ETS, and the
standard is intended to preempt conflicting state and local laws.
    In sum, based on its enforcement experience during the pandemic to
date, OSHA concludes that continued reliance on existing standards and
regulations, the General Duty Clause, and guidance, in lieu of an ETS,
is not adequate to protect unvaccinated employees from the grave danger
of being infected by, and suffering death or serious health
consequences from, COVID-19.

References

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Rule Breakers? Scientific American. https://www.scientificamerican.com/article/what-motivates-covid-rule-breakers/. (Belanger and Leander, December 9, 2020)
Budryk Z. (2020, November 17). Fauci calls for `a uniform approach'
to coronavirus pandemic. The Hill. https://thehill.com/policy/healthcare/526378-fauci-calls-for-a-uniform-approach-to-the-coronavirus-pandemic?rl=1. (Budryk, November 17, 2020)
Centers for Disease Control and Prevention (CDC). (2021, September
9). Your COVID-19 Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/your-vaccination.html. (CDC, September 9, 2021)
Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/.
(CDC, October 18, 2021)

Ember S and Murphy Marcos C. (2021, August 7). They Don't Want the
Shot. They Don't Want Colleagues to Know. The New York Times.
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2021)
Government Accountability Office (GAO). (2020, September). COVID-19:
Federal Efforts Could Be Strengthened by Timely and Concerted
Actions. https://www.gao.gov/assets/710/709934.pdf. (GAO, September
2020)
Horsley S. (2020, May 1). U.S. Workplace Safety Rules Missing in the
Pandemic. National Public Radio. https://www.npr.org/2020/05/01/849212026/it-s-the-wild-west-u-s-workplace-safety-rules-missing-in-the-pandemic. (Horsley, May 1, 2020)
Institute of Medicine (IOM). (2009). Respiratory Protection for
Healthcare Workers in a Workplace Against Novel H1N1 Influenza A: A
letter report. The National Academies Press. http://www.nap.edu/catalog/12748.html. (IOM, 2009)
Kaiser Family Foundation (KFF). (2021, October 6). Latest Data on
COVID-19 Vaccinations by Race/Ethnicity. https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-by-race-ethnicity/. (KFF, October 6, 2021)
Koshy K et al., (February 4, 2021). Perspectives of region II OSHA
authorized safety and health trainers about initial COVID-19
response programs. Safety Science 138. https://doi.org/10.1016/j.ssci.2021.105193. (Koshy et al., February 4, 2021)
Leonhardt D. (2021, September 7). One in 5,000. The New York Times.
https://www.nytimes.com/2021/09/07/briefing/risk-breakthrough-infections-delta.html. (Leonhardt, September 7, 2021)
Lynch R. (2020, July 9). Orange County to crack down on gyms that
ignore Covid-19 safety guidelines. Orlando Business Journal. https://www.bizjournals.com/orlando/news/2020/07/09/orange-county-gyms-could-face-scrutiny-for-not.html. (Lynch, July 9, 2020)
Markman A. (2020, April 20). Why are there still so many coronavirus
skeptics? Fast Company. https://www.fastcompany.com/90492518/why-are-there-still-so-many-coronavirus-skeptics. (Markman, April 20,
2020)
McPhillips D and Cohen E. (2021, May 19). Uneven vaccination rates
across the US linked to COVID-19 case trends, worry experts. CNN
Health. https://www.cnn.com/2021/05/19/health/uneven-vaccination-rates-covid-19-trends/index.html. (McPhillips and Cohen, May 19,
2021)
Meichtry S et al. (2020, October 26). Pandemic Fatigue is Real--And
It's Spreading; Collective exhaustion with coronavirus restrictions
has emerged as a formidable adversary for governments. The Wall
Street Journal. https://www.wsj.com/articles/pandemic-fatigue-is-realand-its-spreading-11603704601. (Meichtry et al., October 26,
2020)
Millard E. (2021, February 18). How to not let pandemic fatigue turn
into pandemic burnout. Everyday Health. https://www.everydayhealth.com/coronavirus/how-to-not-let-pandemic-fatigue-turn-into-pandemic-burnout/. (Millard, February 18, 2021)
Occupational Safety and Health Administration (OSHA). (2020, March
9). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
March 9, 2020
Occupational Safety and Health Administration (OSHA). (2021, July
7). Updated Interim Enforcement Response Plan for Coronavirus
Disease 2019 (COVID-19). https://www.osha.gov/laws-regs/standardinterpretations/2021-07-07. (OSHA, July 7, 2021)
Occupational Safety and Health Administration (OSHA). (2021, August
13). Guidance on Preparing Workplaces for Covid-19. https://www.osha.gov/sites/default/files/publications/OSHA3990.pdf. (OSHA,
August 13, 2021)
Occupational Safety and Health Administration (OSHA). (2021, August
13). Protecting Workers: Guidance on Mitigating and Preventing the
Spread of COVID-19 in the Workplace. https://www.osha.gov/coronavirus/safework. (OSHA, Updated August 13, 2021)
Occupational Safety and Health Administration (OSHA). (2021, October
17). Summary Data for Federal and State Programs--Enforcement.
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(OSHA, October 17, 2021)
ORCHSE Strategies. (2020, October 9). ``Petition to the U.S.
Department of Labor--Occupational Safety and Health Administration
(OSHA) for an Emergency Temporary Standard (ETS) for Infectious
Disease.'' (ORCHSE, October 9, 2020)
Richards C. (2020, May 5). 2 Utah County businesses told staff to
ignore COVID-19 guidelines, resulting in 68 positive cases. Daily
Herald. https://www.heraldextra.com/news/local/2-utah-county-businesses-told-staff-to-ignore-covid-19-guidelines-resulting-in-68-positive/article_d8426991-a693-5879-9d88-f9e094aef5b5.html.
(Richards, May 5, 2020)
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allegedly betting if workers would contract COVID. National Public
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(Romo, November 19, 2020)
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Infection Control Practices Advisory Committee. (2007). 2007
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et al., 2007)
Silva C and Martin M. (2020, November 14). U.S. Surgeon General
Blames ``Pandemic Fatigue'' for Recent COVID-19 Surge. NPR. https://www.npr.org/sections/coronavirus-live-updates/2020/11/14/934986232/u-s-surgeon-general-blames-pandemic-fatigue-for-recent-covid-19-surge. (Silva and Martin, November 14, 2020)
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General (OIG). (2021, February 25). COVID-19: Increased Worksite
Complaints and Reduced OSHA Inspections Leave U.S. Workers' Safety
at Increased Risk. http://www.oig.dol.gov/public/reports/oa/2021/19-21-003-10-105.pdf. (DOL OIG, February 25, 2021)
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American Federation Of Labor And Congress Of Industrial
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requirements are helping vaccinate more people, protect Americans
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Hygiene in Health Care: A Summary--First Global Patient Safety
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IV. Conclusion
    This pandemic continues to take a massive toll on American society,
and addressing it requires a comprehensive national response. This ETS
is part of that response. OSHA shares the nation's hope for the promise
of recovery created by the vaccines. But in the meantime, it recognizes
that we have not yet succeeded in defeating the virus, and that many
workers across the country are in grave danger. Therefore, this ETS,
with mitigation measures emphasizing worker vaccination, is necessary.
Although OSHA finds it necessary to institute specific mitigation
measures for the immediate future, the agency can adjust as conditions
change. Even after issuing an ETS, OSHA retains the flexibility to
update the ETS to adjust to the subsequent evolution of CDC workplace
guidance. This ETS addresses (and incorporates as a main component) the
major development in infection control over the last year--the
development and growing implementation of COVID-19 vaccines. Going
forward, further developments can be addressed through OSHA's

authority to modify the ETS if needed, or to terminate it entirely if
vaccination and other efforts end the current emergency. However, at
this point in time, the available evidence indicates that the ETS is
necessary to protect unvaccinated employees across the country from the
grave danger of COVID-19.

IV. Feasibility

A. Technological Feasibility

    This section presents an overview of the technological feasibility
assessment for OSHA's Emergency Temporary Standard (ETS) for COVID-19
that requires all employers with 100 or more employees to ensure that
all employees are fully vaccinated unless they implement a policy
requiring employees to undergo testing for COVID-19 at least once every
seven days and wear face coverings.
    Technological feasibility has been interpreted broadly to mean
``capable of being done'' (Am. Textile Mfrs. Inst. v. Donovan, 452 U.S.
490, 509-510 (1981)). A standard is technologically feasible if the
protective measures it requires already exist, can be brought into
existence with available technology, or can be created with technology
that can reasonably be expected to be developed, i.e., technology that
``looms on today's horizon'' (United Steelworkers of Am., AFL-CIO-CLC
v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980) (Lead I)); Amer. Iron
& Steel Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (Lead II);
American Iron and Steel Inst. v. OSHA, 577 F.2d 825 (3d Cir. 1978)).
Courts have also interpreted technological feasibility to mean that a
typical firm in each affected industry or application group will
reasonably be able to implement the requirements of the standard in
most operations most of the time (see Public Citizen v. OSHA, 557 F.3d
165 (3d Cir. 2009); Lead I, 647 F.2d at 1272; Lead II, 939 F.2d at
990).
    OSHA issued an ETS in June 2021 to protect healthcare and
healthcare support employees in covered healthcare settings from
exposure to SARS-CoV-2. See 86 FR 32376 (June 21, 2021) (Healthcare
ETS). OSHA found the requirements in that ETS to be technologically
feasible, including a requirement for employers to pay for vaccination
of employees that is very similar to the requirement in this new ETS.
OSHA's finding that the Healthcare ETS was technologically feasible was
primarily based on available evidence showing that most healthcare
employers, and employers across all industry sectors, had already
implemented, or were in process of implementing, procedures similar to
those required by the Healthcare ETS. Similarly, OSHA's feasibility
findings for this ETS are based on evidence that vaccination and
testing policies, along with the use of face coverings consistent with
recommendations from the CDC, have been implemented in multiple
industry sectors as testing and vaccinations were made more widely
available during the course of the pandemic.
    As discussed in Summary and Explanation (Section VI. of this
preamble), this ETS for vaccination and testing applies to all
employers with 100 or more employees, except as noted here. It does not
apply to workplaces covered under the Safer Federal Workforce Task
Force COVID-19 Workplace Safety: Guidance for Federal Contractors and
Subcontractors or settings where any employee provides healthcare
services or healthcare support services when subject to the
requirements of the Healthcare ETS (29 CFR 1910.502). It also does not
apply to employees who do not report to a workplace where other
individuals such as coworkers or customers are present, employees while
they are working from home, or employees who work exclusively outdoors.
    As noted above, OSHA has the legal duty to demonstrate that the
average employer covered by this ETS can comply with that standard in
most operations most of the time. This legal analysis is therefore
focused solely on whether employers with 100 or more employees can
comply with the standard. OSHA's rationale for that scope threshold of
100 or more employees is explained in the Summary and Explanation for
paragraph (b), Section VI.B. of this preamble.
    As discussed below, OSHA finds no technological feasibility
barriers related to compliance with the requirements in the ETS. These
requirements include establishing and implementing a written mandatory
COVID-19 vaccination policy or alternative policy requiring testing and
face coverings; determining employee vaccination status; supporting
employee vaccination by providing paid time for vaccination and time
off for recovery; ensuring that employees who are not fully vaccinated
are tested for COVID-19 at least once every seven days and wear face
coverings; and recordkeeping for employee vaccination status and
testing.
    OSHA reviewed numerous large-scale employer surveys and vaccination
and testing policies developed by employers, public health
organizations, trade association, and local, state, and federal
governmental bodies. While OSHA discusses several examples of these
plans and policies below,\20\ OSHA's feasibility determination is based
on all evidence in the rulemaking record. The majority of the survey
data and other publicly available material that OSHA reviewed pertains
to large employers with 100 or more employees.
---------------------------------------------------------------------------

    \20\ While OSHA references several employers' policies, this is
not intended to serve as an endorsement of those plans or an
indication that those plans comply with the ETS. Rather, the plans
and best practice documents show that developing and implementing
policies to address employee COVID-19 vaccination in various
workplaces is capable of being done in a variety of industries, and
therefore, compliance with the ETS is technologically feasible.
---------------------------------------------------------------------------

    Additionally, OSHA thoroughly reviewed current and future
projections of the availability of COVID-19 tests, testing supplies,
and laboratory capacity. Based on a review of vaccination and testing
policies among large employers, OSHA has determined that most employers
covered by this standard across a wide range of industries have either
already implemented vaccination and testing programs and require
unvaccinated employees to wear face coverings, or are capable of
implementing programs that comply with the requirements in the ETS most
of the time. OSHA therefore finds that the standard is technologically
feasible.
I. Employer Policy on Vaccination
    Paragraph (d)(1) of the ETS requires each covered employer to
establish and implement a written mandatory vaccination policy unless
the employer adopts an alternative policy requiring COVID-19 testing
and face coverings for unvaccinated employees, which is discussed
later. To meet the definition of ``mandatory vaccination policy'' under
paragraph (c), the policy must require: Vaccination of all employees,
including all new employees as soon as practicable, other than those
employees (1) for whom a vaccine is medically contraindicated, (2) for
whom medical necessity requires a delay in vaccination, or (3) those
legally entitled to a reasonable accommodation under federal civil
rights laws because they have a disability or sincerely-held religious
beliefs, practices, or observances that conflict with the vaccination
requirement.
    OSHA requires employers to implement a mandatory vaccination
requirement, but provides an exemption for an alternative policy that
allows employees to choose either to be fully vaccinated or to be
regularly tested and wear a face covering. This compliance options mean
that the ETS is

technologically feasible if employers across various industries are
capable of implementing either policy, but nevertheless OSHA analyzes
both employer policy options to demonstrate that there are no
significant technological barriers to either approach.
    OSHA reviewed several large-scale employer surveys related to
vaccination policies across the country covering a wide range of
industry sectors. Surveys conducted by Arizona State University (ASU)
and the World Economic Forum (WEF), called COVID-19 Workplace Commons--
Keeping Workers Well, show that most employers already have some type
of vaccination policy, with more than 60 percent of surveyed employers
requiring vaccinations for some or all employees. These survey results
further support OSHA's determination that the vaccination policy
requirement is feasible.
    The ASU WEF workplace COVID-19 surveys collected information from
employers across industry sectors about their response to the COVID-19
pandemic. The results and responses from more than 1,400 companies are
publicly available through the ASU College of Health Solutions web page
COVID-19 Diagnostics Commons (ASU, October 5, 2021). Case studies from
employers are also available within the interactive dashboard on that
web page. The surveys consisted of numerous questions about workplace
pandemic response, including questions related to vaccination policies
and testing unvaccinated employees.
    The most recent COVID-19 survey data was collected between August
2, 2021 and August 20, 2021 and reported in September 2021 (accessible
through the COVID-19 Workplace Commons). More than 1,400 companies
operating 1143 facilities in 23 industry sectors were part of the
survey, the majority of which are companies of the size covered by the
ETS. Ninety percent of facilities surveyed had 100 or more employees at
their facilities, and 56% had more than 100 but less than 1,000
employees at their facilities. The industry sectors surveyed include:
Technology and software; business and professional services;
manufacturing; construction; healthcare, hospitals, and clinics; retail
stores; retail food stores; consumer retail service; energy and
utilities; nonprofit organizations; education (colleges and
universities); education (pre-K to 12); real estate and property
management; agriculture and food production; healthcare services; media
and entertainment; government and quasi-public; biotech,
pharmaceuticals, and diagnostics; restaurants and food service; hotels
and casinos; transportation, distribution, and logistics; consumer
transportation; and recreation (ASU WEF, September 2021).
    The survey responses related to vaccination policies support OSHA's
determination that it is feasible for covered employers to implement
mandatory COVID-19 vaccination policies. The survey results showed that
45% of employers surveyed require all employees to be vaccinated
against COVID-19, and an additional 16% require some of its employees
to be vaccinated against COVID-19. (ASU WEF, September 2021). Only
three percent of employers surveyed did not have a vaccination policy
at the time (ASU WEF, September 2021). While this survey covers a wide
range of industries it may not represent the percentage of companies
implementing mandatory vaccination policies in general populations but
for the feasibility purposes it demonstrates that it has and can be
done.
    OSHA also reviewed slightly older survey data, which, even though
it shows somewhat lower rates of employer vaccination mandates, still
supports OSHA's finding that such vaccination polices are feasible. In
late June 2021, the National Safety Council (NSC) conducted three
national surveys, one organizational and two workforce, of private
companies, nonprofits, legal experts, public health professionals,
medical professionals and government agencies that have addressed
workforce COVID-19 vaccinations based on best practices and proven
workplace safety strategies. The survey results show that many
employers and organizations are currently requiring employees to be
vaccinated.
    The three surveys were distributed to 300 employers and
organizations across the country and from a wide range of industries to
collect data on pandemic response, including implementation of COVID-19
vaccine policies and testing among their workforce. Of the employers
and organizations surveyed in June 2021, the NSC found that 20% were
implementing some form of a worker vaccination requirement. While OSHA
believes that the ASU WEF surveys (which included more employers and
are more recent) are better indicators of current employer vaccination
policies, the NSC surveys also support the feasibility of employer
vaccination mandates (NSC, September 2021)
    The NSC, in partnership with the Health Action Alliance (HAA) and
the Centers for Disease Control and Prevention (CDC), have developed a
multifaceted, comprehensive effort called SAFER, aimed at helping
employers prioritize health and safety as they develop plans and
polices for their employees to return to the workplace (NSC, May 17,
2021). Through SAFER, the NSC and HAA developed a web-based decision
tool to guide employers on health, legal, and other considerations to
prioritize the health and safety of workers. Due to the Delta Variant
surge of new COVID-19 cases across the United States, the NSC and HAA
revised the SAFER resources, including the online tool, to include
information about employer requirements for COVID-19 vaccinations.
These include guides for developing plans and policies to support
employee vaccination through mandates and incentives; the collection
and maintenance of COVID-19 vaccination records; and various
considerations for testing unvaccinated workers. (HAA and NSC,
September 17, 2021). The availability of these publicly-accessible
tools to help employers develop vaccination policies further reduces
any potential barriers for covered employers to establish and implement
a written policy requiring each employee to be fully vaccinated against
COVID-19, or alternatively to establish a policy allowing employees to
choose whether to be fully vaccinated or tested for COVID-19 at least
every seven days and wear face coverings.
    The HAA maintains an online list of large companies requiring
vaccinations for all or part of their workforce or customers. OSHA
reviewed the list of companies, drawn from news reports and employer
websites, with requirements for COVID-19 vaccination. Most of the
companies listed require some or all employees to be vaccinated against
COVID-19 while allowing medical exemptions or reasonable accommodations
for disability or religious reasons. There are currently 188 listed
companies across numerous industry sectors, including Amtrak, Deloitte,
Google, The Walt Disney Company, Walmart, and the U.S. Chamber of
Commerce.\21\
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    \21\ https://www.healthaction.org/resources/vaccines/covid-19-vaccines-employer-requirements-health-action-alliance?0405d6f4_page=1 (last visited October 2, 2021).
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    While healthcare employers subject to 29 CFR 1910.502 are not
covered by this ETS, a number of large healthcare employers have
implemented mandatory vaccine policies. This also shows the feasibility
of the employers implementing mandatory vaccination requirements, often
on large scales. According to the American Hospital Association (AHA),
over 1,800 hospitals

have one or more vaccination requirements in place (Becker's Hospital
Review, October 11, 2021). Large healthcare employers mandating that
their employees be vaccinated include Kaiser Permanente, the nation's
largest integrated, nonprofit health care organization with more than
216,000 employees and more than 23,000 physicians (Kaiser Permanente,
August 2, 2021); Trinity Health, one of the largest multi-institutional
Catholic health care delivery systems in the nation, with more than
123,000 employees and 90 hospitals in 22 states (Trinity Health, July
8, 2021); Sanford Health, which operates in 26 states and employs
nearly 50,000 people (Sanford Health, July 22, 2021); and Genesis
Health Care, a large U.S. nursing home chain with over 40,000 employees
working in more than 250 centers across 23 states (Genesis Health Care,
September 29, 2021).
    Under paragraph (d)(2), if employers do not establish and implement
a written mandatory vaccination policy, the employer must establish and
implement a written policy allowing any employees not subject to a
mandatory vaccination policy to either choose to be fully vaccinated or
regularly tested for COVID-19 and wear a face covering. A substantial
number of employers already have such policies in place. For example,
the ASU WEF survey shows that 30% of employers surveyed require
unvaccinated employees to participate in mandatory COVID-19 testing and
30% of employers require face coverings for unvaccinated employees (ASU
WEF, September 2021).
    OSHA also notes a number of state COVID-19 vaccination
requirements. In response to the Delta Variant surge, 19 states have
implemented written COVID-19 vaccination and testing policies for state
employees and 23 states have done so for healthcare employees (NASHP,
October 1, 2021). For example, on September 20, 2021, the Colorado
Department of Public Health and Environment (CDPHE) implemented
policies requiring state employees and personnel at health care
facilities and hospitals to be fully vaccinated against COVID-19. All
state employees must either be fully vaccinated against COVID-19 or
participate in twice-weekly testing. Employees are allowed work time to
get tested and administrative or Public Health Emergency Leave to get
vaccinated. Employees who are not fully vaccinated must wear masks
inside state facilities when they are around others. On August 30,
2021, the State Board of Health approved a vaccine requirement for
personnel in health care settings with high-risk patients. All
personnel affected by this rule needed to receive their first dose of
COVID-19 vaccine by September 30, 2021, and must be fully vaccinated by
October 31, 2021 (CDPHE, September 17, 2021).
    A number of local governments have also implemented policies
requiring COVID-19 vaccination or testing for employees. For example,
the Fulton County Board of Commissioners in Georgia recently approved a
``Vax or Test'' policy requiring employees to get vaccinated or tested
for COVID-19 each week. Since September 6, 2021, Fulton County has
required all County employees, as a condition of employment, to either
be vaccinated against COVID-19 or be tested weekly for COVID-19 unless
an employee is granted a reasonable accommodation (Fulton County
Government, September 03, 2021). The multitude of local, state, and
employer vaccination or testing mandates across the country support
OSHA's finding that such policies are feasible.
II. Determining Employee Vaccination Status
    Paragraph (e) of the ETS requires employers to determine the
vaccination status of each employee. Employers must require employees
to provide an acceptable proof of vaccination status, including whether
they are fully or partially vaccinated. As discussed in Summary and
Explanation (Section VI. of this preamble), acceptable proof of
vaccination status is: (i) The record of immunization from a health
care provider or pharmacy; (ii) a copy of the COVID-19 Vaccination
Record Card; (iii) a copy of medical records documenting the
vaccination; (iv) a copy of immunization records from a public health,
state, or tribal immunization information system; or a copy of any
other official documentation that contains the type of vaccine
administered, date(s) of administration, and the name of the health
care professional(s) or clinic site(s) administering the vaccine(s). A
signed and dated employee attestation is acceptable in instances when
an employee is unable to produce proof of vaccination. Given the
attestation option, there are no technological barriers to the
provision for proof of vaccination status. As discussed below, many
employers requiring proof of vaccination have successfully implemented
such policies even without allowing the flexibility of the attestation
option.
    The employer must maintain a record and a roster of each employee's
vaccination status. This information is subject to applicable legal
requirements for confidentiality of medical information. These records
must be preserved while the ETS is in effect. OSHA is not aware of any
technological challenges that the large employers covered by this ETS
would face with respect to collecting and maintaining records. This is
a performance-based requirement, meaning that employers have the
flexibility to structure their systems to fit within current systems,
such as those relating to personnel records, tax records, and other
sensitive or confidential records gathered and maintained by large
employers.
    A number of the surveys discussed above also show that most
employers with vaccine mandates require proof of vaccination. For
example, ASU WEF workplace COVID-19 survey from fall 2021 found that
60% of employers that required vaccinations also required proof of
vaccination from employees. The NSC study from June 2021 found that 45%
of employers with COVID-19 vaccination requirements required proof of
vaccination, such as submitting a copy of the COVID-19 vaccination
card. An additional 30% of employers surveyed verify employee
vaccination status through self-reporting based on the honor system.
    Additionally, a large-scale survey conducted by the Willis Towers
Watson consulting firm between August 18 and 25, 2021, showed that a
majority of employers currently track their employees' vaccination
status. Nearly one thousand employers responded to this survey, and
they collectively employ 9.7 million workers from industries across the
public and private sectors including manufacturing, general services,
wholesale and retail, IT and telecom, healthcare, financial services,
energy and utilities, and public sector and education (Willis Towers
Watson, June 23, 2021). Nearly six in 10 (59%) currently track their
workers' vaccination status and another 19% are planning or considering
doing so later this year. A majority (62%) of those employers who
currently track their workers' vaccination status require proof of
vaccination, such as CDC vaccination cards, while 36% rely on employees
to self-report (Willis Towers Watson, September 1, 2021).
    Other evidence in the record also supports the feasibility both of
gathering proof of vaccination and determining employees' vaccination
status. Many large employers with vaccination policies require
employees to submit proof of vaccination. For example, Tyson Foods
requires employees to submit proof of vaccination to Tyson

Foods Vaccination Verification Program in order to qualify for the
company's vaccination incentive (Tyson Foods, August 3, 2021).
Similarly, Capital One bank requires all employees, contractors,
vendors, and visitors to Capital One facilities to show proof of
vaccination. (Capital One, August 11, 2021). The International Union of
Painters and Allied Trades (IUPAT), which represents 140,000
craftspeople in the U.S. and Canada and has implemented vaccine
requirements for its members, also requires all of its own non-
bargaining unit office and field employees to show proof of
vaccination. (IUPAT, May 10, 2021).
    CVS Health, a health conglomerate with more than 300,000 employees,
including more than 40,000 physicians, pharmacists, nurses and nurse
practitioners, has mandated COVID-19 vaccination for its nurses,
pharmacists and other employees who interact with patients and requires
proof of vaccination for those employees (CVS Health, August 23, 2021).
    The surveys and employer policies reviewed by OSHA all support the
agency's finding that it is feasible for employers to determine their
employees' vaccination status and collect proof of vaccination.
III. Providing Support for Vaccination
    Paragraph (f) of the ETS requires employers to support COVID-19
vaccination for each employee by providing a reasonable amount of time
to each employee for vaccination and reasonable time and paid sick
leave to each employee for side effects experienced following
vaccination. The feasibility of paying for the time is addressed in
OSHA's economic analysis.
    This technological feasibility determination focuses on whether
employers would encounter obstacles in implementing payment policies
that would make this requirement infeasible for the large employers
covered by this ETS. OSHA has determined that there are no such
obstacles. Most significantly, OSHA has already required this type of
system for employers covered by the Healthcare ETS and nearly four
months after that ETS took effect, OSHA is not aware that employers
covered by that ETS experienced any technological compliance
difficulties with respect to that requirement. In addition, many
employers have already implemented policies such as those required to
comply with this new ETS as a way of incentivizing employee
vaccination. For example, the ASU WEF workplace COVID-19 survey from
fall 2021 found that 60% of employers surveyed offered incentives for
employees to be vaccinated. These incentives ranged from additional
paid time off, cash, the ability to bypass regular testing and/or daily
health screening requirements, and gifts. Eighteen percent of surveyed
employers already provide additional time off for COVID-19 vaccination.
Moreover, the NSC survey found that 86% of surveyed organizations had
implemented policies such as paid time off, assistance with scheduling
and transportation, and/or onsite vaccination.
    OSHA's review of plans and best practice documents from the HAA
registry and from other publicly-available sources also inform OSHA's
finding that it is feasible for large employers to support employee
vaccination (HAA, October 10, 2021). As part of this review, OSHA
analyzed the ways that employers are currently supporting employee
vaccination. One employer in the restaurant industry, the Fifty/50
Group, a Chicago-based restaurant group comprised of 14 establishments
that requires employees to be fully vaccinated, offers paid time off
for anyone getting a vaccine or feeling the mild after-effects. (Fifty/
50 Group, May 18, 2021). Another employer in the animal slaughtering
and processing industry, Tyson Foods, requires COVID-19 vaccinations
for its U.S. workforce and also offers $200 and up to four hours of
regular pay if employees are vaccinated outside of their normal shift
or through an external source (Tyson Foods, August 3, 2021). In
addition, Tyson Foods supports onsite vaccination events in
collaboration with local health departments and healthcare providers to
improve accessibility to vaccination. Tyson Foods has hosted more than
100 vaccination events at its locations across the country.
    The evidence in the record demonstrates that many employers are
already offering the types of vaccination support required by paragraph
(f). Combined with OSHA's previous finding for a similar provision in
the Healthcare ETS and the lack of compliance difficulties reported
while that ETS has been in effect, OSHA therefore finds this
requirement is technologically feasible.
IV. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
    Paragraph (g) of the ETS requires employers to ensure that
employees who are not fully vaccinated and who report at least once
every seven days to a workplace where other individuals such as
coworkers or customers are present are: (1) Tested for COVID-19 at
least once every seven days; and (2) provide documentation of the most
recent COVID-19 test result to the employer no later than the seventh
day following the date the employee last provided a test result.
Employers must also ensure that employees who are not fully vaccinated
and do not report during a period of seven or more days to a workplace
where other individuals are present are: (1) Tested for COVID-19 within
seven days prior to returning to the workplace; and (2) provide
documentation of that test result upon return to the workplace.
    Employees who are not fully vaccinated must be tested with a COVID-
19 test, which is a test for SARS-CoV-2 that is: (i) Cleared, approved,
or authorized, including in an Emergency Use Authorization (EUA) by the
U.S. Food and Drug Administration (FDA) to detect current infection
with the SARS-CoV-2 virus (e.g., a viral test); (ii) administered in
accordance with the authorized instructions; and (iii) not both self-
administered and self-read unless observed by the employer or an
authorized telehealth proctor. Examples of tests that satisfy this
requirement include tests with specimens that are processed by a
laboratory (including home or on-site collected specimens which are
processed either individually or as pooled specimens), proctored over-
the-counter tests, point of care tests, and tests where specimen
collection is either done or observed by an employer.
    COVID-19 testing has become more widely available throughout the
pandemic and as of September 2021, the FDA has authorized approximately
250 tests and collection kits that diagnose current infection with the
SARS- CoV-2 virus and may be acceptable under the ETS (FDA, September
10, 2021), and by October 1, 2021, the number of EUAs issued had grown
to 324 (FDA, October 1, 2021). The ETS permits compliance through use
of a wide range of FDA-authorized tests that are readily available, so
there is little doubt that testing itself is technologically feasible.
    This technological feasibility analysis therefore focuses on
whether testing will continue to be readily available in quantities
sufficient to meet the potential increase in testing demand while this
ETS is in place. Given the wide variety of tests that can be used to
comply with this ETS and OSHA's review of information about the
existing manufacturing and distribution capabilities of test
manufacturers, the agency does not anticipate feasibility issues
related to ensuring that

employees can get access to one of the acceptable tests within the time
frames required by the ETS.
a. Brief Overview of Testing and Administration
    COVID-19 tests that are cleared, approved, or authorized, including
in an Emergency Use Authorization (EUA), by the FDA to detect current
infection with the SARS-CoV-2 virus (e.g., a viral test) satisfy the
ETS. FDA-cleared, approved, or authorized molecular diagnostic tests
and antigen tests are permitted under the ETS when used as authorized
by the FDA and with a Clinical Laboratory Improvement Amendments of
1988 (CLIA) certification when appropriate. As described in the Summary
and Explanation for paragraph (g) (Section VI.G. of this preamble),
NAATs are a type of molecular test that detect genetic material. As of
October 14, 2021, the FDA had issued EUAs for 264 molecular COVID-19
tests including tests specified to be used ``with certain conditions of
authorization required of the manufacturer and authorized
laboratories'', 81 of which are authorized for home collection.
Additionally, the FDA has issued EUAs for 2 OTC molecular COVID-19 test
kits available without a prescription (FDA, October 14, 2021b).
    NAATs, such as real-time reverse transcription-polymerase chain
reaction (RT-PCR), have greater accuracy than antigen tests. However,
most FDA-authorized NAATs need to be processed in a laboratory
certified under the Clinical Laboratory Improvement Amendments of 1988
(referred to as a ``CLIA-certified laboratory'') with variable time to
results (~1-2 days). While the NAAT test is a more reliable test, the
antigen test is faster and less expensive.
    An antigen test is an in vitro diagnostic test used to detect
active SARS-CoV-2 infection. As of October 14, 2021, the FDA had issued
37 EUAs for COVID-19 antigen tests, including eight EUAs for over-the-
counter (OTC) antigen tests that can be used without a prescription
(FDA, October 14, 2021a).
    Administration of an antigen test that meets the definition of
COVID-19 test under this ETS falls into one of several categories: OTC
employee self-tests that are observed by employers or authorized
telehealth proctors; point-of-care (POC) or OTC tests performed by
employers with a CLIA certificate of waiver; and other FDA cleared,
approved, or authorized antigen tests that are analyzed in a CLIA
certified laboratory setting (FDA, October 14, 2021a). The FDA has
authorized POC tests that can be used at a place of employment when the
facility is operating under a CLIA certificate of waiver. A CLIA
certificate of waiver can be issued by CMS and may, when consistent
with FDA's authorization, allow a laboratory to run a SARS-CoV-2 test
outside a high or moderate complexity traditional clinical laboratory
setting (CDC, September 9, 2021). In accordance with the CLIA
certificate of waiver, the laboratory or POC testing site must use a
test authorized for that location, like an FDA EUA POC test, and must
adhere to the authorized test instructions to avoid human error.
Certain COVID-19 antigen diagnostic tests can be analyzed on-site
(where the person took the nasal swab) when that facility is operating
under a CLIA certificate of waiver, while others must be analyzed in a
CLIA certified high or moderate complexity laboratory setting. Some
COVID-19 antigen diagnostic tests are authorized for use at home,
without the need to send a sample to a laboratory. Antigen tests
generally return results in approximately 15-30 minutes. The CDC
provides training materials created by test manufacturers for POC
antigen testing and reading of results for SARS-CoV-2 (CDC, July 8,
2021).
    COVID-19 antigen diagnostic tests are found at physician offices;
urgent care facilities; pharmacies, such as CVS or Walgreens; school
health clinics; long-term care facilities and nursing homes; temporary
locations, such as drive-through sites managed by local organizations;
and other locations across the country (CDC, July 8, 2021; CVS Health,
October 2021; Walgreens, October 8, 2021). The availability of
government-offered antigen tests varies by state, and may be free or
subsidized and accessible without a prescription or physician note
(RiteAid, October 2021; Walgreens, October 2021; HHS, June 11, 2021).
The Department of Health and Human Services (HHS) provides a publicly-
available list of community-based testing locations in each state that
offer free COVID-19 testing for insured and uninsured residents (HHS,
August 17, 2021). Pharmacies and other locations often provide antigen
tests by appointment, although some will allow testing for walk-ins
(CVS Health, September 2021; Walgreens, October 8, 2021). COVID test
kits are currently available from several on-line retailers (Amazon,
October 12, 2021).
b. Testing Frequency
    The ASU WEF survey data also supports OSHA's finding that the
requirement for employees who are not fully vaccinated to be tested at
least every seven days is feasible. The ASU WEF found that 73% of
survey surveyed employers (797 employers) had testing policies for
their workforce, and 76% of those employers had implemented mandatory
testing requirements. Additionally, 25% of employers with testing
polices had implemented requirements for routine testing of a portion
of or the entire workforce, and 41% no longer require testing for fully
vaccinated employees. Of the employers that test employees, 27% of
those perform viral testing daily and 46% perform viral test once a
week. Finally, 38% of companies exclusively administer polymerase chain
reaction (PCR) tests (PCR tests are a type of NAAT), 17% exclusively
administer antigen tests, and 45% administer both. Companies administer
a range of COVID-19 tests and conduct testing at a variety of locations
(some companies use more than one location). Forty-two percent of
companies test workers at health testing laboratories, 35% test onsite
at work, 28% test at hospitals, 23% test at retail pharmacies, 13% test
at universities, 9% test at home to be sent a lab for evaluation, and
5% test at home for immediate results (ASU WEF, September 2021).
    OSHA also evaluated evidence of employers' current testing efforts
by reviewing existing COVID-19 practices developed by employers, trade