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Rule2021-23643

COVID-19 Vaccination and Testing; Emergency Temporary Standard

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Published

November 5, 2021

Effective

November 5, 2021

Issuing agencies

Labor DepartmentOccupational Safety and Health Administration

Abstract

The Occupational Safety and Health Administration (OSHA) is issuing an emergency temporary standard (ETS) to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination. Covered employers must develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination.

Full Text

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[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Rules and Regulations]
[Pages 61402-61555]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-23643]

[[Page 61401]]

Vol. 86

Friday,

No. 212

November 5, 2021

Part II

Department of Labor

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Occupational Safety and Health Administration

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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29 CFR Parts 1910, 1915, 1917, et al.

42 Parts 416, 418, 441, et al.

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COVID-19 Vaccination and Testing; Emergency Temporary Standard;
Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff
Vaccination; Interim Final Rules

Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 /
Rules and Regulations

[[Page 61402]]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1915, 1917, 1918, 1926, and 1928

[Docket No. OSHA-2021-0007]
RIN 1218-AD42

COVID-19 Vaccination and Testing; Emergency Temporary Standard

AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.

ACTION: Interim final rule; request for comments.

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SUMMARY: The Occupational Safety and Health Administration (OSHA) is
issuing an emergency temporary standard (ETS) to protect unvaccinated
employees of large employers (100 or more employees) from the risk of
contracting COVID-19 by strongly encouraging vaccination. Covered
employers must develop, implement, and enforce a mandatory COVID-19
vaccination policy, with an exception for employers that instead adopt
a policy requiring employees to either get vaccinated or elect to
undergo regular COVID-19 testing and wear a face covering at work in
lieu of vaccination.

DATES: The rule is effective November 5, 2021. The incorporation by
reference of certain publications listed in the rule is approved by the
Director of the Federal Register as of November 5, 2021.
Compliance dates: Compliance dates for specific provisions are in
29 CFR 1910.501(m).
Comments: Written comments, including comments on any aspect of
this ETS and whether this ETS should become a final rule, must be
submitted by December 6, 2021 in Docket No. OSHA-2021-0007. Comments on
the information collection determination described in Additional
Requirements (Section V.K. of this preamble) (OMB review under the
Paperwork Reduction Act of 1995) may be submitted by January 4, 2022 in
Docket No. OSHA-2021-0008.

ADDRESSES: In accordance with 28 U.S.C. 2112(a), the Agency designates
Edmund C. Baird, the Associate Solicitor for Occupational Safety and
Health, Office of the Solicitor, U.S. Department of Labor, to receive
petitions for review of the ETS. Service can be accomplished by email
to zzSOL-Covid19-<a href="/cdn-cgi/l/email-protection#5510010615313a397b323a23">[email&#160;protected]</a>.
Written comments. You may submit comments and attachments,
identified by Docket No. OSHA-2021-0007, electronically at
<a href="http://www.regulations.gov">www.regulations.gov</a>, which is the Federal e-Rulemaking Portal. Follow
the online instructions for making electronic submissions.
Instructions: All submissions must include the agency's name and
the docket number for this rulemaking (Docket No. OSHA-2021-0007). All
comments, including any personal information you provide, are placed in
the public docket without change and may be made available online at
<a href="http://www.regulations.gov">www.regulations.gov</a>. Therefore, OSHA cautions commenters about
submitting information they do not want made available to the public,
or submitting materials that contain personal information (either about
themselves or others), such as Social Security Numbers and birthdates.
Docket: To read or download comments or other material in the
docket, go to Docket No. OSHA-2021-0007 at <a href="http://www.regulations.gov">www.regulations.gov</a>. All
comments and submissions are listed in the <a href="http://www.regulations.gov">www.regulations.gov</a> index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through that website. All comments and
submissions, including copyrighted material, are available for
inspection through the OSHA Docket Office. Documents submitted to the
docket by OSHA or stakeholders are assigned document identification
numbers (Document ID) for easy identification and retrieval. The full
Document ID is the docket number plus a unique four-digit code. OSHA is
identifying supporting information in this ETS by author name and
publication year, when appropriate. This information can be used to
search for a supporting document in the docket at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Contact the OSHA Docket Office at 202-693-2350
(TTY number: 877-889-5627) for assistance in locating docket
submissions.

FOR FURTHER INFORMATION CONTACT:
General information and press inquiries: Contact Frank Meilinger,
OSHA Office of Communications, U.S. Department of Labor; telephone
(202) 693-1999; email <a href="/cdn-cgi/l/email-protection#2a6579626b69454747596a4e4546044d455c">[email&#160;protected]</a>.
For technical inquiries: Contact Andrew Levinson, OSHA Directorate
of Standards and Guidance, U.S. Department of Labor; telephone (202)
693-1950; email <a href="/cdn-cgi/l/email-protection#83c6d7d0c3e7ecefade4ecf5">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION: The preamble to the ETS on COVID-19
vaccination and testing follows this outline:

Table of Contents

I. Executive Summary and Request for Comment
A. Executive Summary
B. Request for Comment
II. Pertinent Legal Authority
III. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
IV. Feasibility
A. Technological Feasibility
B. Economic Analysis
V. Additional Requirements
VI. Summary and Explanation
A. Purpose
B. Scope and Application
C. Definitions
D. Employer Policy on Vaccination
E. Determination of Employee Vaccination Status
F. Employer Support for Employee Vaccination
G. COVID-19 Testing for Employees Who Are Not Fully Vaccinated
H. Employee Notification to Employer of a Positive COVID-19 Test
and Removal
I. Face Coverings
J. Information Provided to Employees
K. Reporting COVID-19 Fatalities and Hospitalizations to OSHA
L. Availability of Records
M. Dates
N. Severability
O. Incorporation by Reference
VII. Authority and Signature

I. Executive Summary and Request for Comment

A. Executive Summary

This ETS is based on the requirements of the Occupational Safety
and Health Act (OSH Act or Act) and legal precedent arising under the
Act. Under section 6(c)(1) of the OSH Act, 29 U.S.C. 655(c)(1), OSHA
shall issue an ETS if the agency determines that employees are subject
to grave danger from exposure to substances or agents determined to be
toxic or physically harmful or from new hazards, and an ETS is
necessary to protect employees from such danger. These legal
requirements are more fully discussed in Pertinent Legal Authority
(Section II. of this preamble). This ETS does not apply to workplaces
subject to E.O. 14042 on Requiring Coronavirus Disease 2019 Vaccination
for Federal Contractors. In addition, OSHA will treat federal agencies'
compliance with E.O. 14043, and the Safer Federal Workforce Task Force
guidance issued under section 4(e) of Executive Order 13991 and section
2 of Executive Order 14043, as sufficient to meet their obligations
under the OSH Act and E.O. 12196.
COVID-19 has killed over 725,000 people in the United States in
less than two years, and infected millions more (CDC, October 18,
2021--Cumulative US Deaths). The pandemic continues to affect workers
and workplaces. While COVID-19 vaccines authorized or

[[Page 61403]]

approved by the U.S. Food and Drug Administration (FDA) effectively
protect vaccinated individuals against severe illness and death from
COVID-19, unvaccinated individuals remain at much higher risk of severe
health outcomes from COVID-19. Further, unvaccinated workers are much
more likely to contract and transmit COVID-19 in the workplace than
vaccinated workers. OSHA has determined that many employees in the U.S.
who are not fully vaccinated against COVID-19 face grave danger from
exposure to SARS-CoV-2 in the workplace. This finding of grave danger
is based on the severe health consequences associated with exposure to
the virus along with evidence demonstrating the transmissibility of the
virus in the workplace and the prevalence of infections in employee
populations, as discussed in Grave Danger (Section III.A. of this
preamble).
OSHA has also determined that an ETS is necessary to protect
unvaccinated workers from the risk of contracting COVID-19 at work, as
discussed in Need for the ETS (Section III.B. of this preamble). At the
present time, workers are becoming seriously ill and dying as a result
of occupational exposures to COVID-19, when a simple measure,
vaccination, can largely prevent those deaths and illnesses. The ETS
protects these workers through the most effective and efficient control
available--vaccination--and further protects workers who remain
unvaccinated through required regular testing, use of face coverings,
and removal of all infected employees from the workplace. OSHA also
concludes, based on its enforcement experience during the pandemic to
date, that continued reliance on existing standards and regulations,
the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1), and
workplace 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.
OSHA will continue to monitor trends in COVID-19 infections and
death as more of the workforce and the general population become fully
vaccinated against COVID-19 and the pandemic continues to evolve. Where
OSHA finds a grave danger from the virus no longer exists for the
covered workforce (or some portion thereof), or new information
indicates a change in measures necessary to address the grave danger,
OSHA will update this ETS, as appropriate.
This ETS applies to employers with a total of 100 or more employees
at any time the standard is in effect. In light of the unique
occupational safety and health dangers presented by COVID-19, and
against the backdrop of the uncertain economic environment of a
pandemic, OSHA is proceeding in a stepwise fashion in addressing the
emergency this rule covers. OSHA is confident that employers with 100
or more employees have the administrative capacity to implement the
standard's requirements promptly, but is less confident that smaller
employers can do so without undue disruption. OSHA needs additional
time to assess the capacity of smaller employers, and is seeking
comment to help the agency make that determination. Nonetheless, the
agency is acting to protect workers now in adopting a standard that
will reach two-thirds of all private-sector workers in the nation,
including those working in the largest facilities, where the most
deadly outbreaks of COVID-19 can occur.
The agency has also evaluated the feasibility of this ETS and has
determined that the requirements of the ETS are both economically and
technologically feasible, as outlined in Feasibility (Section IV. of
this preamble). The specific requirements of the ETS are outlined and
described in Summary and Explanation (Section VI. of this preamble).

B. Request for Comment

Although this ETS takes effect immediately, it also serves as a
proposal under Section 6(b) of the OSH Act (29 U.S.C. 655(b)) for a
final standard. Accordingly, OSHA seeks comment on all aspects of this
ETS and whether it should be adopted as a final standard. OSHA
encourages commenters to explain why they prefer or disfavor particular
policy choices, and include any relevant studies, experiences,
anecdotes or other information that may help support the comment. In
particular, OSHA seeks comments on the following topics:
1. Employers with fewer than 100 employees. As noted above and
fully discussed in the Summary and Explanation for Scope and
Application (Section VI.B. of this preamble), OSHA has implemented a
100-employee threshold for the requirements of this standard to focus
the ETS on companies that OSHA is confident will have sufficient
administrative systems in place to comply quickly with the ETS. The
agency is moving in a stepwise fashion on the short timeline
necessitated by the danger presented by COVID-19 while soliciting
stakeholder comment and additional information to determine whether to
adjust the scope of the ETS to address smaller employers in the future.
OSHA seeks information about the ability of employers with fewer than
100 employees to implement COVID-19 vaccination and/or testing
programs. Have you instituted vaccination mandates (with or without
alternatives), or requirements for regular COVID-19 testing or face
covering use? What have been the benefits of your approach? What
challenges have you had or could you foresee in implementing such
programs? Is there anything specific to your industry, or the size of
your business, that poses particular obstacles in implementing the
requirements in this standard? How much time would it take, what types
of costs would you incur, and how much would it cost for you to
implement such requirements?
2. Significant Risk. If OSHA were to finalize a rule based on this
ETS, it would be a standard adopted under 6(b) of the OSH Act, which
requires a finding of significant risk from exposure to COVID-19. As
discussed more fully in Pertinent Legal Authority (Section II. of this
preamble), this is a lower showing of risk than grave danger, the
finding required to issue a 6(c) emergency temporary standard. How
should the scope of the rule change to address the significant risk
posed by COVID-19 in the workplace? Should portions of the rule, such
as face coverings, apply to fully vaccinated persons?
3. Prior COVID-19 infections. OSHA determined that workers who have
been infected with COVID-19 but have not been fully vaccinated still
face a grave danger from workplace exposure to SARS-CoV-2. This is an
area of ongoing scientific inquiry. Given scientific uncertainty and
limitations in testing for infection and immunity, OSHA is concerned
that it would be infeasible for employers to operationalize a standard
that would permit or require an exception from vaccination or testing
and face covering based on prior infection with COVID-19. Is there
additional scientific information on this topic that OSHA should
consider as it determines whether to proceed with a permanent rule?
In particular, what scientific criteria can be used to determine
whether a given employee is sufficiently protected against reinfection?
Are there any temporal limits associated with this criteria to account
for potential reductions in immunity over time? Do you require
employees to provide verification of infection with COVID-19? If so,
what kinds of verification do you accept (i.e., PCR testing, antigen
testing, etc.)? What challenges have you

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experienced, if any, in operationalizing such an exception?
4. Experience with COVID-19 vaccination policies. Should OSHA
impose a strict vaccination mandate (i.e., all employers required to
implement mandatory vaccination policies as defined in this ETS) with
no alternative compliance option? OSHA seeks information on COVID-19
vaccination policies that employers have implemented to protect
workers. If you have implemented a COVID-19 vaccination policy:
(a) When did you implement it, and what does your policy require?
Was vaccination mandatory or voluntary under the policy? Do you offer
vaccinations on site? What costs associated with vaccination did you
cover under the policy? What percentage of your workforce was
vaccinated as a result? Do you offer paid leave for receiving a
vaccination? If vaccination is mandatory, have employees been resistant
and if so what steps were required to enforce the policy?
(b) How did you verify that employees were vaccinated? Are there
other reliable means of vaccination verification not addressed by the
ETS that should be included? Did you allow attestation where the
employee could not find other proof, and if so, have you experienced
any difficulties with this approach? Have you experienced any issues
with falsified records of vaccination, and if so, how did you deal with
them?
(c) Have you experienced a decrease in infection rates or outbreaks
after implementing this policy?
(d) If you have received any requests for reasonable accommodation
from vaccination, what strategies did you implement to address the
accommodation and ensure worker safety (e.g., telework, working in
isolation, regular testing and the use of face coverings)?
5. COVID-19 testing and removal. OSHA seeks information on COVID-19
testing and removal practices implemented to protect workers.
(a) Do you have a testing and removal policy in your workplace and,
if so, what does it require? How often do you require testing and what
types of testing do you use (e.g., at-home tests, tests performed at
laboratories, tests performed at your worksites)? What costs have you
incurred as part of your testing and removal policies? Do you have
difficulty in finding adequate availability of tests? How often? Have
you experienced any issues with falsified test results, and if so, how
did you deal with them? Have you experienced other difficulties in
implementing a testing and removal scheme, including the length of time
to obtain COVID-19 test results? Do you offer paid leave for testing?
(b) How often have you detected and removed COVID-19 positive
employees from the workplace under this policy? Do you provide paid
leave and job protection to employees you remove for this reason?
(c) Should OSHA require testing more often than on a weekly basis?
6. Face coverings. As discussed in the Summary and Explanation for
Face Coverings (Section VI.I. of this preamble), ASTM released a
specification standard on February 15, 2021, to establish a national
standard baseline for barrier face coverings (ASTM F3502-21). Should
OSHA require the use of face coverings meeting the ASTM F3502-21
standard instead of the face coverings specified by the ETS? If so,
should OSHA also require that such face coverings meet the NIOSH
Workplace Performance or Workplace Performance Plus criteria (see CDC,
September 23, 2021)? Are there particular workplace settings in which
face coverings meeting one standard should be favored over another? Are
there alternative criteria OSHA should consider for face coverings
instead of the F3502-21 standard or NIOSH Workplace Performance or
Workplace Performance Plus criteria? Is there sufficient capacity to
supply face coverings meeting F3502-01 and/or NIOSH Workplace
Performance or Workplace Performance Plus criteria to all employees
covered by the ETS? What costs have you incurred as part of supplying
employees with face coverings meeting the appropriate criteria?
7. Other controls. This ETS requires employees to either be fully
vaccinated against COVID-19 or be tested weekly and wear face
coverings, based on the type of policy their employer adopts. It stops
short of requiring the full suite of workplace controls against SARS-
CoV-2 transmission recommended by OSHA and the CDC, including
distancing, barriers, ventilation, and sanitation. As OSHA explained in
Need for the ETS (Section III.B. of this preamble), OSHA has determined
that it needs more information before imposing these requirements on
the entire scope of industries and employers covered by the standard.
OSHA is interested in hearing from employers about their experience in
implementing a full suite of workplace controls against COVID-19.
What measures have you taken to protect employees against COVID-19
in your workplace? Are there controls that you attempted to employ but
found ineffective or infeasible? What are they? Why did you conclude
that they were they ineffective or infeasible; for example, are there
particular aspects of your workplace or industry that make certain
controls infeasible? Do you require both fully vaccinated and
unvaccinated employees to comply with these controls? Have you
experienced a reduction in infection rates or outbreaks since
implementing these controls?
8. Educational materials. Have you implemented any policies or
provided any information that has been helpful in encouraging an
employee to be vaccinated?
9. Feasibility and health impacts. Do you have any experience or
data that would inform OSHA's estimates in its economic feasibility
analysis or any of the assumptions or estimates used in OSHA's
identification of the number of hospitalizations prevented and lives
saved from its health impacts analysis (see OSHA, October 2021c)?

References

Centers for Disease Control and Prevention (CDC). (2021, October
18). COVID Data Tracker. <a href="https://covid.cdc.gov/covid-data-tracker/">https://covid.cdc.gov/covid-data-tracker/</a>.
(CDC, October 18, 2021)
Centers for Disease Control and Prevention (CDC). (2021, September
23). Types of Masks and Respirators. <a href="https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html">https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html</a>.
(CDC, September 23, 2021)
Occupational Safety and Health Administration (OSHA). (2021c,
October). Health Impacts of the COVID-19 Vaccination and Testing
ETS. (OSHA, October 2021c)

II. Pertinent Legal Authority

The purpose of the Occupational Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. 651 et seq., is ``to assure so far as possible every
working man and woman in the Nation safe and healthful working
conditions and to preserve our human resources.'' 29 U.S.C. 651(b). To
this end, Congress authorized the Secretary of Labor (Secretary) to
promulgate and enforce occupational safety and health standards under
sections 6(b) and (c) of the OSH Act.\1\ 29 U.S.C. 655(b). These
provisions provide bases for issuing occupational safety and health
standards under the Act. Once OSHA has established as a threshold
matter that a health standard is necessary under section 6(b) or (c)--
i.e., to reduce

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a significant risk of material health impairment, or a grave danger to
employee health--the Act gives the Secretary ``almost unlimited
discretion to devise means to achieve the congressionally mandated
goal'' of protecting employee health, subject to the constraints of
feasibility. See United Steelworkers of Am. v. Marshall, 647 F.2d 1189,
1230 (D.C. Cir. 1981). A standard's individual requirements need only
be ``reasonably related'' to the purpose of ensuring a safe and
healthful working environment. Id. at 1237, 1241; see also Forging
Indus. Ass'n v. Sec'y of Labor, 773 F.2d 1436, 1447 (4th Cir. 1985).
OSHA's authority to regulate employers is hedged by constitutional
considerations and, pursuant to section 4(b)(1) of the OSH Act, the
regulations and enforcement policies of other federal agencies. See,
e.g., Chao v. Mallard Bay Drilling, Inc., 534 U.S. 235, 241 (2002).
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\1\ The Secretary has delegated most of his duties under the OSH
Act to the Assistant Secretary of Labor for Occupational Safety and
Health. Secretary's Order 08-2020, 85 FR 58393 (Sept. 18, 2020).
This section uses the terms Secretary and OSHA interchangeably.
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The OSH Act in section 6(c)(1) states that the Secretary ``shall''
issue an emergency temporary standard (ETS) upon a finding that the ETS
is necessary to address a grave danger to workers. See 29 U.S.C.
655(c). In particular, the Secretary shall provide, without regard to
the requirements of chapter 5, title 5, United States Code, for an
emergency temporary standard to take immediate effect upon publication
in the Federal Register if the Secretary makes two determinations: That
employees are exposed to grave danger from exposure to substances or
agents determined to be toxic or physically harmful or from new
hazards, and that such emergency standard is necessary to protect
employees from such danger. 29 U.S.C. 655(c)(1). A separate section of
the OSH Act, section 8(c), authorizes the Secretary to prescribe
regulations requiring employers to make, keep, and preserve records
that are necessary or appropriate for the enforcement of the Act. 29
U.S.C. 657(c)(1). Section 8(c) also provides that the Secretary shall
require employers to keep records of, and report, work-related deaths
and illnesses. 29 U.S.C. 657(c)(2).
The ETS provision, section 6(c)(1), exempts the Secretary from
procedural requirements contained in the OSH Act and the Administrative
Procedure Act, including those for public notice, comments, and a
rulemaking hearing. See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C. 552, 553.
The Secretary must issue an ETS in situations where employees are
exposed to a ``grave danger'' and immediate action is necessary to
protect those employees from such danger. 29 U.S.C. 655(c)(1); Pub.
Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156 (D.C. Cir.
1983). The determination of what exact level of risk constitutes a
``grave danger'' is a ``policy consideration that belongs, in the first
instance, to the Agency.'' Asbestos Info. Ass'n, 727 F.2d at 425
(accepting OSHA's determination that eighty lives at risk over six
months was a grave danger); Indus. Union Dep't, AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 655 n.62 (1980). However, 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). Int'l Union, United
Auto., Aerospace, & Agr. Implement Workers of Am., UAW v. Donovan, 590
F. Supp. 747, 755-56 (D.D.C. 1984), adopted, 756 F.2d 162 (D.C. Cir.
1985); see also Indus. Union Dep't, AFL-CIO, 448 U.S. at 640 n.45
(noting the distinction between the standard for risk findings in
permanent standards and ETSs).
In determining the type of health effects that may constitute a
``grave danger'' under the OSH Act, the Fifth Circuit emphasized ``the
danger of incurable, permanent, or fatal consequences to workers, as
opposed to easily curable and fleeting effects on their health.'' Fla.
Peach Growers Ass'n, Inc. v. U. S. Dep't of Labor, 489 F.2d 120, 132
(5th Cir. 1974). Although the findings of grave danger and necessity
must be based on evidence of ``actual, prevailing industrial
conditions,'' see Int'l Union, 590 F. Supp. at 751, when OSHA
determines that exposure to a particular hazard would pose a grave
danger to workers, OSHA can assume an exposure to a grave danger
wherever that hazard is present in a workplace. Dry Color Mfrs. Ass'n,
Inc. v. Dep't of Labor, 486 F.2d 98, 102 n.3 (3d Cir. 1973).
In demonstrating whether OSHA had shown that an ETS is necessary,
the Fifth Circuit considered whether OSHA had another available means
of addressing the risk that would not require an ETS. Asbestos Info.
Ass'n, 727 F.2d at 426 (holding that necessity had not been proven
where OSHA could have increased enforcement of already-existing
standards to address the grave risk to workers from asbestos exposure).
Additionally, a standard must be both economically and technologically
feasible in order to be ``reasonably necessary and appropriate'' under
section 3(8) and, by inference, ``necessary'' under section 6(c)(1)(B)
of the Act. Cf. Am. Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S. 490,
513 n.31 (1981) (noting ``any standard that was not economically or
technologically feasible would a fortiori not be `reasonably necessary
or appropriate' '' as required by the OSH Act's definition of
``occupational safety and health standard'' in section 3(8)); see also
Florida Peach Growers, 489 F.2d at 130 (recognizing that the
promulgation of any standard, including an ETS, must account for its
economic effect). However, given that section 6(c) is aimed at enabling
OSHA to protect workers in emergency situations, the agency is not
required to make a feasibility showing with the same rigor as in
ordinary section 6(b) rulemaking. Asbestos Info. Ass'n, 727 F.2d at 424
n.18.
On judicial review of an ETS, OSHA is entitled to great deference
on the determinations of grave danger and necessity required under
section 6(c)(1). See, e.g., Pub. Citizen Health Research Grp., 702 F.2d
at 1156; Asbestos Info. Ass'n, 727 F.2d at 422 (judicial review of
these legislative determinations requires deference to the agency); cf.
Am. Dental Ass'n v. Martin, 984 F.2d 823, 831 (7th Cir. 1993) (``the
duty of a reviewing court of generalist judges is merely to patrol the
boundary of reasonableness''). These determinations are ``essentially
legislative and rooted in inferences from complex scientific and
factual data.'' Pub. Citizen Health Research Grp., 702 F.2d at 1156.
The agency is not required to support its conclusions ``with anything
approaching scientific certainty,'' Indus. Union Dep't, AFL-CIO, 448
U.S. at 656, and has the ``prerogative to choose between conflicting
evidence.'' Asbestos Info. Ass'n, 727 F.2d at 425.
The determinations of the Secretary in issuing standards under
section 6 of the OSH Act, including ETSs, must be affirmed if supported
by ``substantial evidence in the record considered as a whole.'' 29
U.S.C. 655(f). The Supreme Court described substantial evidence as
``such relevant evidence as a reasonable mind might accept as adequate
to support a conclusion.'' Am. Textile Mfrs. Inst., 452 U.S. at 522-23
(quoting Universal Camera Corp. v. NLRB, 340 U.S. 474, 477 (1951)). The
Court also noted that ``the possibility of drawing two inconsistent
conclusions from the evidence does not prevent an administrative
agency's finding from being supported by substantial evidence.'' Id. at
523 (quoting Consolo v. FMC, 383 U.S. 607, 620 (1966)). The Fifth
Circuit, recognizing the size and complexity of the rulemaking record
before it in the case of OSHA's ETS for organophosphorus pesticides,
stated that a court's function in reviewing an ETS to determine whether
it meets the substantial evidence standard is ``basically [to]
determine whether the

[[Page 61406]]

Secretary carried out his essentially legislative task in a manner
reasonable under the state of the record before him.'' Fla Peach
Growers Ass'n, 489 F.2d at 129.
Although Congress waived the ordinary rulemaking procedures in the
interest of ``permitting rapid action to meet emergencies,'' section
6(e) of the OSH Act, 29 U.S.C. 655(e), requires OSHA to include a
statement of reasons for its action when it issues any standard. Dry
Color Mfrs., 486 F.2d at 105-06 (finding OSHA's statement of reasons
inadequate). By requiring the agency to articulate its reasons for
issuing an ETS, the requirement acts as ``an essential safeguard to
emergency temporary standard-setting.'' Id. at 106. However, the Third
Circuit noted that it did not require justification of ``every
substance, type of use or production technique,'' but rather a
``general explanation'' of why the standard is necessary. Id. at 107.
ETSs are, by design, temporary in nature. Under section 6(c)(3), an
ETS serves as a proposal for a permanent standard in accordance with
section 6(b) of the OSH Act (permanent standards), and the Act calls
for the permanent standard to be finalized within six months after
publication of the ETS. 29 U.S.C. 655(c)(3); see Fla. Peach Growers
Ass'n, 489 F.2d at 124. The ETS is effective ``until superseded by a
standard promulgated in accordance with'' section 6(c)(3). 29 U.S.C.
655(c)(2).
Section 6(c)(1) states that the Secretary ``shall'' provide for an
ETS when OSHA makes the prerequisite findings of grave danger and
necessity. See Pub. Citizen Health Research Grp., 702 F.2d at 1156
(noting the mandatory language of section 6(c)). OSHA is entitled to
great deference in its determinations, and it must also account for
``the fact that `the interests at stake are not merely economic
interests in a license or a rate structure, but personal interests in
life and health.' '' Id. (quoting Wellford v. Ruckelshaus, 439 F.2d
598, 601 (D.C. Cir. 1971)).
When OSHA issues a standard pursuant to section 6--whether
permanent or an ETS--section 18 of the OSH Act provides that OSHA's
standard preempts any state occupational safety or health standard
``relating to [the same] occupational safety or health issue'' as the
Federal standard. 29 U.S.C. 667(b); see also Gade v. Nat'l Solid Wastes
Mgmt. Ass'n, 505 U.S. 88, 97 (1992). A state can avoid preemption only
if it submits, and receives Federal approval for, a state plan for the
development and enforcement of standards pursuant to section 18 of the
Act, which must be ``at least as effective'' as the Federal standards.
29 U.S.C. 667; Indus. Truck Ass'n v. Henry, 125 F.3d 1305, 1311 (9th
Cir. 1997). However, the OSH Act does not preempt state laws of
``general applicability'' that regulate workers and non-workers alike,
so long as they do not conflict with an OSHA standard. Gade, 505 U.S.
at 107.
As discussed in detail elsewhere in this preamble, OSHA has
determined that a grave danger exists necessitating a new ETS (see
Grave Danger and Need for the ETS, Sections III.A. and III.B. of this
preamble), and that compliance with this ETS is feasible for covered
employers (see Feasibility, Section IV. of this preamble). OSHA has
also provided a more detailed explanation of each provision of this ETS
in Summary and Explanation (Section VI. of this preamble). In addition,
OSHA wishes to provide here some general guidance on its legal
authority to regulate COVID-19 hazards, and for particular provisions
of this ETS.
As a threshold matter, OSHA's authority to regulate workplace
exposure to biological hazards like SARS-CoV-2 is well-established.
Section 6(b)(5) of the OSH Act uses similar language to section
6(c)(1)(A): The former sets forth requirements for promulgating
permanent standards addressing ``toxic materials or harmful physical
agents,'' and the latter authorizes OSHA to promulgate an ETS
addressing ``substances or agents determined to be toxic or physically
harmful'' (as well as ``new hazards''). OSHA has consistently
identified biological hazards similar to SARS-CoV-2, as well as SARS-
CoV-2 itself, to be ``toxic materials or harmful physical agents''
under the Act. Indeed, in its exposure and medical records access
regulation, OSHA has defined ``toxic materials or harmful physical
agents'' to include ``any . . . biological agent (bacteria, virus,
fungus, etc.)'' for which there is evidence that it poses a chronic or
acute health hazard. 29 CFR 1910.1020(c)(13). And in addition to
previously regulating exposure to SARS-CoV-2 as a new and physically
harmful agent in the Healthcare ETS (see, e.g., 86 FR at 32381), OSHA
has also previously regulated biological hazards like SARS-CoV-2 as
health hazards under section 6(b)(5), for example in the Bloodborne
Pathogens (BBP) standard, 29 CFR 1910.1030, which addresses workplace
exposure to HIV and Hepatitis B. The BBP standard was upheld (except as
to application in certain limited industries) in American Dental
Association, which observed that ``the infectious character'' of the
regulated bloodborne diseases might warrant ``more regulation than
would be necessary in the case of a noncommunicable disease.'' 984 F.2d
at 826. In addition, in the preamble to the respiratory protection
standard, 29 CFR 1910.134, which was also promulgated under section
6(b)(5), ``OSHA emphasize[d] that [the] respiratory protection standard
does apply to biological hazards.'' Respiratory Protection, 63 FR 1152-
01, 1180 (Jan. 8, 1998) (citing Mahone Grain Corp., 10 BNA OSHC 1275
(No. 77-3041, 1981)).
In addition to being a physically harmful agent covered by section
6(c)(1)(A), SARS-CoV-2 is also, without question, a ``new hazard''
covered by this provision, as discussed in more detail in Grave Danger
(Section III.A. of this preamble). SARS-CoV-2 was not known to exist
until January 2020, and since then more than 725,000 people have died
from COVID-19 in the U.S. alone (CDC, October 18, 2021--Cumulative US
Deaths).
Turning to specific provisions of this standard, the vaccination
requirements in this ETS are also well within the bounds of OSHA's
authority. Vaccination can be a critical tool in the pursuit of health
and safety goals, particularly in response to an infectious and highly
communicable disease. See, e.g., Jacobson v. Commonwealth of Mass., 197
U.S. 11, 27-28 (1905) (recognizing use of smallpox vaccine as a
reasonable measure to protect public health and safety); Klaassen v.
Trustees of Ind. Univ., 7 F.4th 592, 593 (7th Cir. 2021) (citing
Jacobson and noting that vaccination may be an appropriate safety
measure against SARS-CoV-2 as ``[v]accination protects not only the
vaccinated persons but also those who come in contact with them''). And
the OSH Act itself explicitly acknowledges that such treatments might
be necessary, in some circumstances. 29 U.S.C. 669(a)(5) (providing in
the Act's provisions on research and related activities conducted by
the Secretary of Health and Human Services to aid OSHA in its
formulation of health and safety standards that ``[n]othing in this or
any other provision of this Act shall be deemed to authorize or require
medical examination, immunization, or treatment for those who object
thereto on religious grounds, except where such is necessary for the
protection of the health or safety of others.'' (emphasis added)). In
recognition of the health and safety benefits provided by vaccination,
OSHA has previously exercised its authority to promulgate vaccine-
related requirements in the COVID-19 Healthcare ETS (29 CFR
1910.502(m))

[[Page 61407]]

and the BBP standard (29 CFR 1910.1030(f)). The BBP standard
illustrates congressional understanding that the statutory delegation
of authority to OSHA to issue standards includes authority for vaccine
provisions, where appropriate. See Public Law 102-170, Title I, Section
100, 105 Stat. 1107 (1991) (directing OSHA to complete the BBP
rulemaking by a date certain, and providing that if OSHA did not do so,
the proposed rule, which included a vaccine provision, would become the
final standard).
Additionally, OSHA's authority to require employers to bear the
costs of particular provisions of a standard is solidly grounded in the
OSH Act. The Act reflects Congress's determination that the costs of
compliance with the Act and OSHA standards are part of the cost of
doing business and OSHA may foreclose employers from shifting those
costs to employees. See Am. Textile Mfrs. Inst., 452 U.S. at 514;
Phelps Dodge Corp. v. OSHRC, 725 F.2d 1237, 1239-40 (9th Cir. 1984);
see also Sec'y of Labor v. Beverly Healthcare-Hillview, 541 F.3d 193
(3d Cir. 2008). Consistent with this authority, OSHA has largely
required employers to bear the costs of the provisions of this ETS,
including the typical costs associated with vaccination. The allocation
of vaccination costs to employers in this ETS is similar to OSHA's
treatment of vaccine-related costs in the COVID-19 Healthcare ETS and
the BBP standards. See 29 CFR 1910.502(m), (p); 29 CFR
1910.1030(f)(1)(ii)(A).
The OSH Act provides OSHA with discretion, however, to decide
whether to impose certain costs--such as those related to medical
examinations or other tests--on employers ``[w]here [it determines that
such costs are] appropriate.'' 29 U.S.C. 655(b)(7). OSHA has determined
that for purposes of this ETS, it would not be ``appropriate'' to
impose on employers any costs associated with COVID-19 testing for
employees who choose not to be vaccinated. For most of the agency's
existing standards containing medical testing and removal provisions,
OSHA has found it necessary to impose the costs of such provisions on
employers in order to remove barriers to employee participation in
medical examinations that are critical to effectuating the standards'
safety and health protections. See United Steelworkers of Am., 647 F.2d
at 1229-31, 1237-38. However, as explained in greater detail elsewhere
in this preamble (see Need for the ETS, Section III.B. of this
preamble), the ETS's safety and health protections are best effectuated
by employee vaccination, not testing. Accordingly, OSHA only requires
employers to bear the costs of employee compliance with the preferred,
and more protective, vaccination provision, but not costs associated
with testing. The agency does not believe it appropriate to impose the
costs of testing on an employer where an employee has made an
individual choice to pursue a less protective option. For the same
reasons, OSHA has also determined that it is not appropriate to require
employers to pay for face coverings for employees who choose not to be
vaccinated.\2\
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\2\ OSHA notes that while the ETS does not impose these testing
or face covering costs on employers, in some circumstances employers
may be required to pay for the costs related to testing and/or face
coverings by other laws, regulations, or collectively negotiated
agreements. OSHA has no authority under the OSH Act to determine
whether such obligations under other laws, regulations, or
agreements might exist.
---------------------------------------------------------------------------

Finally, the Act and its legislative history ``both demonstrate
unmistakably'' OSHA's authority to require employers to temporarily
remove workers from the workplace to prevent exposure to a health
hazard. United Steelworkers of Am., 647 F.2d at 1230. And again, this
is an authority OSHA has repeatedly exercised in prior standards,
including in: COVID-19 Healthcare ETS (29 CFR 1910.502); Lead (29 CFR
1910.1025); Cadmium (29 CFR 1910.1027); Benzene (29 CFR 1910.1028);
Formaldehyde (29 CFR 1910.1048); Methylenedianiline (29 CFR 1910.1050);
Methylene Chloride (29 CFR 1910.1052); and Beryllium (29 CFR
1910.1024). It is equally appropriate to impose that obligation here.
For all of these reasons, as well as those explained more fully in
other areas of this preamble, OSHA has the authority--and obligation--
to promulgate this ETS.

References

III. Rationale for the ETS

A. Grave Danger

I. Introduction
Section 6(c)(1) of the OSH Act requires the Secretary to issue an
ETS in situations where employees are exposed to a ``grave danger'' and
immediate action is necessary to protect those employees from such
danger (29 U.S.C. 655(c)(1)). Consistent with its legal duties, OSHA is
issuing this ETS to address the grave danger posed by occupational
exposure to SARS-CoV-2, the virus that causes COVID-19.\3\ OSHA has
determined that occupational exposure to SARS-CoV-2, including the
Delta variant (B.1.617.2 and AY lineages), presents a grave danger to
unvaccinated workers in the U.S., with several exceptions explained
below.\4\ This finding of grave danger is based on the science of how
the virus spreads, the transmissibility of the disease in workplaces,
and the serious adverse health effects, including death, that can be
suffered by those who are diagnosed with COVID-19. The protections of
this ETS--which will apply, with some limitations, to a broad range of
workplace settings where exposure to SARS-CoV-2 may occur--are designed
to protect employees from infection with SARS-CoV-2 and from the dire,
sometimes fatal, consequences of such infection.
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\3\ OSHA is defining the grave danger as workplace exposure to
SARS-CoV-2, the virus that causes the development of COVID-19.
COVID-19 is the disease that can occur in people exposed to SARS-
CoV-2, and that leads to the health effects described in this
section. This distinction applies despite OSHA's use of the terms
SARS-CoV-2 and COVID-19 interchangeably in some parts of this
preamble.
\4\ OSHA refers to the grave danger from occupational exposure
to SARS-CoV-2 throughout this document. Those references are
intended to encompass exposure to SARS-CoV-2 and all variants of
SARS-CoV-2, including the Delta variant.
---------------------------------------------------------------------------

The fact that COVID-19 is not a uniquely work-related hazard does
not change the determination that it is a grave danger to which
employees are exposed, nor does it excuse employers from their duty to
protect employees from the occupational transmission of SARS-CoV-2. The
OSH Act is intended to ``assure so far as possible every working man
and woman in the Nation safe and healthful working conditions'' (29
U.S.C. 651(b)), and there is nothing in the Act to suggest that its
protections do not extend to hazards which might occur outside of the
workplace as well as within. Indeed, COVID-19 is not the first hazard
that OSHA has regulated that occurs both inside and outside the
workplace. For example, the hazard of noise is not unique to the
workplace, but the Fourth Circuit has upheld OSHA's Occupational Noise
Exposure standard (29 CFR 1910.95) (Forging Industry Ass'n v. Sec' of
Labor, 773 F.2d 1437, 1444 (4th Cir. 1985)). Diseases caused by
bloodborne pathogens, including HIV/AIDS and hepatitis B, are also not
unique to the workplace, but the Seventh Circuit upheld the majority of
OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) (Am. Dental
Ass'n v. Martin, 984 F.2d 823 (7th Cir. 1993)). OSHA's Sanitation

[[Page 61408]]

standard, 29 CFR 1910.141, which requires measures such as cleaning,
waste disposal, potable water, toilets, and washing facilities,
addresses hazards that exist everywhere--both within and outside of
workplaces. Moreover, employees have more freedom to control their
environment outside of work, and to make decisions about their behavior
and their contact with others to better minimize their risk of
exposure. However, during the workday, while under the control of their
employer, workers may have little ability to limit contact with
coworkers, clients, members of the public, patients, and others, any
one of whom could represent a source of exposure to SARS-CoV-2. OSHA
has a mandate to protect employees from hazards they are exposed to at
work, even if they may be exposed to similar hazards outside of work.
As described above in Pertinent Legal Authority (Section II. of
this preamble), ``grave danger'' indicates a risk that is more than
``significant'' (Int'l Union, United Auto., Aerospace, & Agr. Implement
Workers of Am., UAW v. Donovan, 590 F. Supp. 747, 755-56 (D.D.C. 1984);
Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 640
n.45, 655 (1980) (stating that a rate of 1 worker in 1,000 workers
suffering a given health effect constitutes a ``significant'' risk)).
``Grave danger,'' according to one court, refers to ``the danger of
incurable, permanent, or fatal consequences to workers, as opposed to
easily curable and fleeting effects on their health'' (Fla. Peach
Growers Ass'n, Inc. v. U.S. Dep't of Labor, 489 F.2d 120, 132 (5th Cir.
1974)). Fleeting effects were described as nausea, excessive
salivation, perspiration, or blurred vision and were considered so
minor that they often went unreported; these effects are in stark
contrast with the adverse health effects of COVID-19 infections, which
are formally referenced as ranging from ``mild'' to ``critical,'' \5\
but which can involve significant illness, hospital stays, ICU care,
death, and long-term health complications for survivors. Beyond this,
however, ``the determination of what constitutes a risk worthy of
Agency action is a policy consideration that belongs, in the first
instance, to the Agency'' (Asbestos Info. Ass'n/N. Am. v. OSHA, 727
F.2d 415, 425 (5th Cir. 1984)).
---------------------------------------------------------------------------

\5\ See the definitions for the different levels of severity of
COVID-19 illness in the National Institutes of Health's COVID-19
treatment guidelines (NIH, October 12, 2021).
---------------------------------------------------------------------------

In the context of ordinary 6(b) rulemaking, the Supreme Court has
said that the OSH Act is not a ``mathematical straitjacket,'' nor does
it require the agency to support its findings ``with anything
approaching scientific certainty,'' particularly when operating on the
``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
Am. Petroleum Inst., 448 U.S. 607, 655-56 (1980)). Courts reviewing
OSHA's determination of grave danger do so with ``great deference''
(Pub. Citizen Health Research Grp. v. Auchter, 702 F.2d 1150, 1156
(D.C. Cir. 1983)). In one case, the Fifth Circuit, in reviewing an OSHA
ETS for asbestos, declined to question the agency's finding that 80
worker lives at risk nationwide over six months constituted a grave
danger (Asbestos Info. Ass'n/N. Am., 727 F.2d at 424). OSHA estimates
that this ETS would save over 6,500 worker lives and prevent over
250,000 hospitalizations over the course of the next six months (OSHA,
October 2021c). Here, the mortality and morbidity risk to employees
from COVID-19 is so dire that the grave danger from exposures to SARS-
CoV-2 is clear.
SARS-CoV-2 is both a physically harmful agent and a new hazard (see
29 U.S.C. 655(c)(1)(A)). The majority of OSHA's previous ETSs addressed
toxic substances that had been familiar to the agency for many years
prior to issuance of the ETS. OSHA's Healthcare ETS, issued in response
to COVID-19 earlier this year, is one notable exception. In most cases,
OSHA's ETSs were issued in response to new information about substances
that had been used in workplaces for decades (e.g., Vinyl Chloride (39
FR 12342 (April 5, 1974)); Benzene (42 FR 22516 (May 3, 1977)); 1,2-
Dibromo-3-chloropropane (42 FR 45536 (Sept. 9, 1977))). In some cases,
the hazards of the toxic substance were already so well established
that OSHA promulgated an ETS simply to update an existing standard
(e.g., Vinyl cyanide (43 FR 2586 (Jan. 17, 1978))). The COVID-19
Healthcare ETS, which was issued in June 2021, was the sole instance in
which OSHA issued an ETS to address a grave danger from a substance
that had only recently come into existence. Although that action by the
agency was challenged, the case has not gone to briefing (see United
Food & Commercial Workers Int'l Union, AFL-CIO, CLC and AFL-CIO v.
OSHA, Dep't of Labor, D.C. Circuit No. 21-1143). Thus, no court has had
occasion to examine OSHA's authority under section (6)(c) of the OSH
Act (29 U.S.C. 655(c)) to address a grave danger from a ``new hazard.''
Yet by any measure, SARS-CoV-2 is a new hazard. Unlike any of the
hazards addressed in previous ETSs, there were no documented cases of
SARS-CoV-2 infections in the United States until January 2020. Since
then, more than 725,000 people have died in the U.S. alone (CDC,
October 18, 2021--Cumulative US Deaths). The pandemic continues to
affect workers and workplaces, with workplace exposures leading to
further exposures among workers' families and communities. Clearly,
SARS-CoV-2 is both a physically harmful agent and a new hazard that
presents a grave danger to workers in the U.S.
Published on June 21, 2021, OSHA's Healthcare ETS (86 FR 32376) was
written in response to the grave danger posed to healthcare workers in
the United States who faced a heightened risk of infection from COVID-
19. In the healthcare ETS, OSHA described its finding of grave danger
for healthcare and healthcare support service workers (see 86 FR 32381-
32412). OSHA now finds that all unvaccinated workers, with some
exceptions, face a grave danger from the SARS-CoV-2 virus.\6\
---------------------------------------------------------------------------

\6\ When OSHA refers to ``unvaccinated'' individuals in its
grave danger finding, it means all individuals who are not fully
vaccinated against COVID-19, i.e., those who are completely
unvaccinated and those who are partially vaccinated.
---------------------------------------------------------------------------

II. Nature of the Disease
The health effects of symptomatic COVID-19 illness can range from
mild disease consisting of fever or chills, cough, and shortness of
breath to severe disease. Severe cases can involve respiratory failure,
blood clots, long-term cardiovascular and neurological effects, and
organ damage, which can lead to hospitalization, ICU admission, and
death (see 86 FR 32383-32388; NINDS, September 2, 2021). Even in the
short time since the Healthcare ETS's publication in June 2021, the
risk posed by COVID-19 has changed meaningfully. Since OSHA considered
the impact of COVID-19 when promulgating the Healthcare ETS, over
135,000 additional Americans have died from COVID-19, and over 933,000
have been hospitalized, (CDC, October 18, 2021--Cumulative US Deaths;
CDC, May 28, 2021; CDC, October 18, 2021--Weekly Review). In August
2021, COVID-19 was the third leading cause of death in the United
States, trailing only heart disease and cancer (Ortaliza et al., August
27, 2021). By September 20, 2021, COVID-19 had killed as many Americans
as the 1918-1919 flu pandemic (Johnson, September 20, 2021).
While the Healthcare ETS addresses the risk of illness and death
from

[[Page 61409]]

COVID-19 as the SARS-CoV-2 virus continues to change over time, it does
not specifically address the increases in infectiousness and
transmission, and the potentially more severe health effects, related
to the Delta variant. The rapid rise to predominance of the Delta
variant in the U.S. occurred shortly after the ETS was published. At
this time, the widespread prevalence of the Delta variant and its
increased transmissibility have resulted in increased risk of exposure
and disease relative to the previously-dominant strains of the SARS-
CoV-2 virus. Adding to the information covered in the Healthcare ETS,
the following sections provide a brief review of SARS-CoV-2 and
describe the characteristics of the Delta variant that are different
from previous versions of SARS-CoV-2 and have changed the risks posed
by COVID-19. The agency specifically references the material presented
in the Healthcare ETS, which is still relevant to this analysis, to
support OSHA's finding of grave danger. Taken together, the information
available to OSHA demonstrates that SARS-CoV-2 poses a grave danger to
unvaccinated workers across all industry sectors.
a. Variants of SARS-CoV-2
Viral mutations have been a serious concern of scientists, public
health experts, and policymakers from the beginning of the COVID-19
pandemic. Viral mutations can affect how a virus interacts with a
cell--altering the virus's transmissibility, infection severity, and
sensitivity to vaccines. The U.S. government's SARS-CoV-2 Interagency
Group has a variant classification scheme that defines four classes of
SARS-CoV-2 variants: Variants Being Monitored (VBM), Variants of
Interest (VOI), Variants of Concern (VOC), and Variants of High
Consequence (VOHC). These variant designations are based on their
``proportions at the national and regional levels and the potential or
known impact of the constellation of mutations on the effectiveness of
medical countermeasures, severity of disease, and ability to spread
from person to person'' (CDC, October 4, 2021), with VOIs considered
less serious than VOCs and VOCs considered less serious than VOHCs. As
of early October 2021, the CDC was monitoring 10 VBMs--Alpha (B.1.1.7,
Q.1-Q.8), Beta (B.1.351, B.1.351.2, B.1.351.3), Gamma (P.1, P.1.1,
P.1.2), Epsilon (B.1.427 and B.1.429), Eta (B.1.525), Iota (B.1.526),
Kappa (B.1.617.1), B.1.617.3, Mu (B.1.621, B.1.621.1), and Zeta (P.2)--
and one VOC--Delta (B.1.617.2 and AY.1 sublineages)--in the U.S. (CDC,
October 4, 2021). CDC defines a VOC as ``[a] variant for which there is
evidence of an increase in transmissibility, more severe disease (e.g.,
increased hospitalizations or deaths), significant reduction in
neutralization by antibodies generated during previous infection or
vaccination, reduced effectiveness of treatments or vaccines, or
diagnostic detection failures'' (CDC, October 4, 2021).
While the proportions of SARS-CoV-2 variants in the United States
have shifted over time (CDC, May 24, 2021c; CDC, October 18, 2021--
Variant Proportions, July through October 2021), the primary variant
that drove COVID-19 transmission in the late Winter and Spring of 2021
was the Alpha variant. The CDC noted that Alpha is associated with an
increase in transmission, as well as potentially increased incidences
of hospitalization and death, compared to the predominant variants
before its emergence (CDC, October 4, 2021; Pascall et al., August 24,
2021; Julin et al., September 22, 2021). As Alpha transmission subsided
in the United States during the late Spring and early Summer of 2021,
Delta emerged and quickly became the predominant variant in the U.S. by
July 3, 2021 (CDC, October 18, 2021--Variant Proportions, July through
October 2021). Delta now accounts for more than 99% of circulating
virus nationwide (CDC, October 18, 2021--Variant Proportions, July
through October 2021).
FDA authorized and approved COVID-19 vaccines currently work well
against all of these variants; however, there are differences in
various variants' ability to spread and the likelihood of infection to
cause severe illness. Data on the Beta and Gamma variants do not
indicate that infections from these variants caused more severe illness
or death than other VOCs. Data on the Alpha variant does indicate its
ability to cause more severe illness and death in infected individuals.
And some data on the Delta variant suggests that the Delta variant may
cause more severe illness than previous variants, including Alpha, in
unvaccinated individuals (CDC, October 4, 2021).
The emergence of the Delta variant, along with other VOCs, has
resulted in a more deadly pandemic (Fisman and Tuite, July 12, 2021).
While the Delta variant is the most transmissible SARS-CoV-2 variant to
date, the possibility remains for the rise of future VOCs, and even
more dangerous VOHCs, as the virus continues to spread and mutate.
Inadequate vaccination rates and the abundance of transmission create
an environment that can foster the development of new variants that
could be similarly, or even more, disruptive (Liu and Rocklov, August,
4, 2021). In this context, it is critical that OSHA address the grave
danger from COVID-19 that unvaccinated workers are currently facing by
requiring vaccination and the other measures included in this rule, in
order to significantly slow the transmission of COVID-19 in workers and
workplaces and mitigate the rise of future variants.
b. Transmission
SARS-CoV-2 is a highly transmissible virus, regardless of variant.
Since the first case was detected in the U.S., there have been close to
45 million reported cases of COVID-19, affecting every state and
territory, with thousands more infected each day (CDC, October 18,
2021--Cumulative US Cases), and some indication that these numbers
continue to underestimate the full burden of disease (CDC, July 27,
2021). According to the CDC, the primary way the SARS-CoV-2 virus
spreads from an infected person to others is through the respiratory
droplets that are produced when an infected person coughs, sneezes,
sings, talks, or breathes (CDC, May 7, 2021). Infection could then
occur when another person breathes in the virus. Most commonly this
occurs when people are in close contact with one another in indoor
spaces (within approximately six feet for at least fifteen minutes)
(CDC, August 13, 2021). Additionally, airborne transmission may occur
in indoor spaces without adequate ventilation where small respiratory
particles are able to remain suspended in the air and accumulate (CDC,
May 7, 2021; Fennelly, July 24, 2020). While scientists' understanding
of the Delta variant's virology is evolving and remains at the frontier
of science, current data shows that the routes of transmission remain
the same for all currently-identified SARS-CoV-2 variants. In addition,
all variants can be transmitted by people who are pre-symptomatic
(i.e., people who are infected but do not yet feel sick) or
asymptomatic (i.e., people who are infected but never feel any symptoms
of COVID-19), as well as those who are symptomatic. Pre-symptomatic and
asymptomatic transmission continue to pose serious challenges to
containing the spread of COVID-19. For more extensive information on
transmission routes, as well as pre-symptomatic and asymptomatic
transmission, see the preamble to the Healthcare ETS (86 FR

[[Page 61410]]

32392-32396), which is hereby included in the record of this ETS.\7\
---------------------------------------------------------------------------

\7\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------

The Delta variant is transmitted from infectious individuals via
the same routes as previous variants, but is much more transmissible.
Specifically, Delta differs from previous dominant variants of SARS-
CoV-2 in terms of the amplification of viral particles expelled from
infected individuals. Testing of Delta-infected individuals indicates
that their viral loads are--on average--approximately 1,000x greater
than those of the SARS-CoV-2 variants from the first COVID-19 wave in
early 2020. This finding suggests much faster replication of viral
particles during early infection with the Delta variant, resulting in
greater infectiousness (contagiousness) when compared to earlier
versions of SARS-CoV-2 (Li et al., July 12, 2021).
The transmissibility of viruses is measured in part by the average
number of subsequently-infected people (or secondary cases) that are
expected to occur from each existing case (often referred to as
R<INF>0</INF>). Several comparisons of the transmissibility of the
initial SARS-CoV-2 variants to the Delta variant have shown that Delta
is approximately twice as transmissible (contagious) as previous
versions of SARS-CoV-2 (CDC, August 26, 2021; Riou and Althaus, January
30, 2020; Li et al., July 12, 2021; Liu and Rocklov, August, 4, 2021),
likely the result of higher initial viral loads during the pre-
symptomatic phase (Li et al., July 12, 2021). In addition, as described
further below, data on Delta shows that both unvaccinated and
vaccinated individuals are more likely to transmit Delta than previous
variants (Liu and Rocklov, August, 4, 2021; Eyre et al., September 29,
2021), making it especially dangerous to those who remain unvaccinated.
c. Health Effects
COVID-19 infections can lead to death. As reported in the
Healthcare ETS, by May 24, 2021, there had been 587,432 deaths and
32,947,548 million infections in the U.S. alone (CDC, May 24, 2021a;
CDC, May 24, 2021b). At that point in the pandemic, 1.8 out of every
1,000 people in the U.S. had died from COVID-19 (CDC, May 24, 2021a).
Since then, reported cases have increased to 44,857,861 and the number
of deaths has increased to 723,205 (CDC, October 18, 2021- Cumulative
US Cases; Cumulative US Deaths). By September 2021, an astounding 1 in
500 Americans had died from COVID-19 (Keating, September 15, 2021).
Updated mortality data \8\ currently indicate that people of working
age (18-64 years old) now have a 1 in 202 chance of dying when they
contract the disease, with the risk much higher (1 in 72) for those
aged 50-64 (CDC, October 18, 2021--Demographic Trends, Cases by Age
Group; CDC, October 18, 2021--Demographic Trends, Deaths by Age Group).
For a more in-depth description of the health effects resulting from
SARS-CoV-2 infection, see the preamble to the Healthcare ETS (86 FR
32383-32392), which is hereby included in the record of this ETS.\9\
---------------------------------------------------------------------------

\8\ Risk of death is based on averages from reported CDC data.
Risks of hospitalization and death are much higher in unvaccinated
individuals, as discussed further in Grave Danger, Section III.A.IV.
Vaccines Effectively Reduce Severe Health Outcomes from and
Transmission of SARS-CoV-2.
\9\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------

Apart from fatal cases, COVID-19 can cause serious illness,
including long-lasting effects on health. Many patients who become ill
with COVID-19 require hospitalization. Indeed, updated CDC
hospitalization and mortality data indicate that working age Americans
(18-64 years old) now have a 1 in 14 chance of hospitalization when
infected with COVID-19 (CDC, October 18, 2021--Demographic Trends,
Cases by Age; Total Hospitalizations, by Age). Those who are
hospitalized frequently need supplemental oxygen and treatment for the
disease's most common complications, which include pneumonia,
respiratory failure, acute respiratory distress syndrome (ARDS), acute
kidney injury, sepsis, myocardial injury, arrhythmias, and blood clots.
One study, which included 35,502 inpatients nationwide, determined that
the median length of hospital stay was 6 days, unless the cases
required ICU treatment. For those cases, ICU stays were on median 5
days in addition to the time spent hospitalized outside of the ICU
(Rosenthal et al., December 10, 2020). Another study that assessed
hospital length of stay for COVID-19 patients in England estimated that
a non-ICU hospital stay averaged between 8 and 9 days, but those
estimates ranged from approximately 12 to 18 days when patients were
admitted to the ICU (Vekaria et al., July 22, 2021). Moreover, given
that SARS-CoV-2 is still a novel virus, the severity of long-term
health effects--such as ``post-COVID conditions''--are not yet fully
understood.
Many members of the workforce are at increased risk of death and
severe disease from COVID-19 because of their age or pre-existing
health conditions. The comorbidities that further exacerbate COVID-19
infections are common among adults of working age in the U.S. For
instance, 46.1% of individuals with cancer are in the 20-64 year old
age range (NCI, April 29, 2015), and over 40% of working age adults are
obese (Hales et al., February 2020). Disease severity is also likely
exacerbated by long-standing healthcare inequities experienced by
members of many racial and economic demographics (CDC, April 19, 2021).
Recent data suggests that Delta variant infections may result in
even more severe illness and a higher frequency of death than previous
COVID-19 variants due to Delta's increased transmissibility, virulence,
and immune escape (Fisman and Tuite, July 12, 2021). Symptomatic Delta
variant infections do occur in fully vaccinated people (Mlcochova et
al., June 22, 2021; Musser et al., July 22, 2021); however, as reported
by the CDC (CDC, August 26, 2021), the vast majority of the continuing
instances of severe and fatal COVID-19 infections are occurring in
unvaccinated persons (discussed further in Grave Danger, Section
III.A.IV. Vaccines Effectively Reduce Severe Outcomes from and
Transmission of SARS-CoV-2). An assessment of Delta-related hospital
admissions in Scotland found that hospitalizations were approximately
doubled in patients with the Delta variant when compared to the Alpha
variant (Sheikh et al., June 4, 2021). A similar study conducted using
a retrospective cohort in Ontario, Canada compared the virulence of
novel SARS-CoV-2 variants and found that the incidences of
hospitalization, ICU admission, and death were more pronounced with the
Delta variant than any other SARS-CoV-2 variant (Fisman and Tuite, July
12, 2021). A large national cohort study that included all Alpha and
Delta SARS-CoV-2 patients in England between March 29 and May 23, 2021
found a ``higher hospital admission or emergency care attendance risk
for patients with COVID-19 infected with the Delta variant compared
with the Alpha variant,'' suggesting that Delta outbreaks--especially
amongst unvaccinated populations--may lead to more severe health
consequences and an equivalent or greater burden on healthcare services
than the Alpha variant (Twohig et al., August 27, 2021). However, one
more recent study examining data from several U.S. states demonstrated
a significant increase in hospitalization from the pre-Delta to the
Delta period, which may be related to increased transmissibility of
Delta rather than

[[Page 61411]]

more severe health outcomes (Taylor et al., October 22, 2021).
III. Impact on the Workplace
SARS-CoV-2 is readily transmissible in workplaces because they are
areas where multiple people come into contact with one another, often
for extended periods of time. When employees report to their workplace,
they may regularly come into contact with co-workers, the public,
delivery people, patients, and any other people who enter the
workplace. Workplace factors that exacerbate the risk of transmission
of SARS-CoV-2 include working in indoor settings, working in poorly-
ventilated areas, and spending hours in close proximity with others.
Full-time employees typically spend 8 hours or more at work each shift,
more time than they spend anywhere else but where they live. Employees
work in proximity to others in workplaces that were not originally
designed to keep people six feet away from other people and that may
make it difficult for employees to perform work tasks while maintaining
a six-foot distance from others. Even in the cases where workers can do
most of their work from, for example, a private office within a
workplace, they share common areas like hallways, restrooms, lunch
rooms and meeting rooms. Furthermore, many work areas are poorly
ventilated (Allen and Ibrahim, May 25, 2021; Lewis, March 30, 2021). An
additional factor that exacerbates the risk of transmission of SARS-
CoV-2 is interacting with or caring for people with suspected or
confirmed COVID-19; this was a primary driver of OSHA's determination
of grave danger for healthcare workers in the Healthcare ETS (see 86 FR
32381-32383). 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).
Although COVID-19 is not exclusively an occupational disease, it is
evident from research accrued since the beginning of the pandemic that
SARS-CoV-2 transmission can and does occur in workplaces, affecting
employees and their lives, health, and livelihoods. This continues to
be true for the Delta variant, with its increased transmissibility and
potentially more severe health effects. This section describes some of
the clusters, outbreaks, and other occurrences of workplace COVID-19
cases that government agencies, researchers, and journalists have
described, and the widespread effects of SARS-CoV-2 in industry sectors
across the national economy. While the focus is on more recent data
reflecting the impact of the Delta variant, evidence of workplace
transmission that occurred prior to the emergence of the Delta variant
is also presented.
The workplace-based clusters described below provide evidence that
workplaces in a wide range of industries have been affected by COVID-
19, that many employees face exposure to infected people in their
workspaces, and that SARS-CoV-2 transmission is occurring in the
workplace, including during the recent period where the Delta variant
has predominated. Although the presence of a cluster on its own does
not necessarily establish that the cluster is work-related (i.e., a
result of transmission at the worksite), many state investigation
reports and published studies provide evidence that transmission is
work related by documenting that infections at a workplace occurred
within 14-days (the incubation period for the virus) of each other and
ruling out the possibility that transmission occurred outside the
workplace. In addition, the information below demonstrates that
exposures to SARS-CoV-2 happen regularly in a wide variety of different
types of workplaces.
The basis for OSHA's grave danger finding is that employees can be
exposed to the virus in almost any work setting; that exposure to SARS-
CoV-2 can lead to infection (CDC, September 21, 2021); and that
infection in turn can cause death or serious impairment of health,
especially in those who are unvaccinated (see Section III.A.IV.
Vaccines Effectively Reduce Severe Health Outcomes from and
Transmission of SARS-CoV-2). The information described in this section
supports OSHA's finding that employees who work in spaces shared by
others are at risk of exposure to SARS-CoV-2. The degree of risk from
droplet-based transmission may vary based on the duration of close
proximity to a person infected with SARS-CoV-2, including the Delta
variant, but the simple and brief act of sneezing, coughing, talking,
or even breathing can significantly increase the risk of transmission
if controls are not in place. SARS-CoV-2, including the Delta variant,
might also be spread through airborne particles under certain
conditions, particularly in enclosed settings with inadequate
ventilation, which are common characteristics of some workplaces.
The peer-reviewed scientific journal articles, government reports,
and news articles described below establish the widespread prevalence
of COVID-19 among employees, beginning with a description of the recent
impact from the Delta variant. OSHA's findings are based primarily on
the evidence from peer-reviewed scientific journal articles and
government reports. However, peer review for scientific journal
articles and the assembly of information for government reports and
other official sources of information take time, and therefore those
sources do not always reflect the most up-to-date information (Chan et
al., December 14, 2010). In addition, while state and local health
departments can report workplace outbreaks to CDC, the agency does not
provide summary statistics by workplace so that those outbreaks can be
tracked on a national level. In the context of the COVID-19 pandemic,
given the recent impacts due to the Delta variant and the emergence of
new information on a daily basis, it is critical for OSHA to rely on
the most up-to-date information available. Therefore, OSHA has
occasionally supplemented peer-reviewed data and government reports
with additional information on occupational outbreaks contained in
other sources of media (e.g., newspapers, digital media, and
information submitted to or obtained by private organizations).\10\ The
reported information from other sources can provide further evidence of
the impact of an emerging and changing disease, especially for
industries that are not well represented in the peer-reviewed
scientific literature. Together, these sources of information represent
the best available evidence of the impact on employees of the pandemic
thus far.
---------------------------------------------------------------------------

\10\ OSHA did not make findings based solely on non-peer-
reviewed sources such as news articles, but the agency found that
those sources can sometimes provide useful information when
considered with more robust sources.
---------------------------------------------------------------------------

The information described herein illustrates a significant number
of infections among employees in a variety of industries, with
virtually every state continuing to experience what CDC defines as high
or substantial community transmission related to the recent surge of
the Delta variant. The industries and types of workplaces described are
not the only ones in which a grave danger exists. The science of
transmission does not vary by industry or by type of workplace. OSHA
therefore expects transmission to occur in diverse workplaces all
across the country (see Dry Color Mfrs. Ass'n, Inc. v. Dep't of Labor,
486 F.2d 98, 102 n.3 (3d Cir. 1973) (holding that when OSHA determines
a substance poses a grave

[[Page 61412]]

danger to workers, OSHA can assume an exposure to a grave danger exists
wherever that substance is present in a workplace)). In addition, the
severity of COVID-19 does not depend on where an employee is infected;
an employee exposed to SARS-CoV-2 might die whether exposed while
working at a meat packing facility, a retail establishment, or an
office (see Grave Danger, Section III.A.V.b. Employees Who Work
Exclusively Outside, below, for a discussion of the risk of exposure in
outdoor workplaces).
a. General Impact on Workers
Data on SARS-CoV-2 infections, illnesses, and deaths among
employees in general industry, agriculture, construction, and maritime
support OSHA's finding that COVID-19 poses a grave danger to employees
in these sectors across the U.S. economy. This section summarizes
studies and reports of COVID-19 illness and fatalities in a wide range
of workplaces across those industry sectors. Not all workplace settings
are discussed; nor is the data available to do so. However, the
characteristics of the various affected workplaces--such as indoor work
settings; contact with coworkers, clients, or members of the public;
and sharing space with others for prolonged periods of time--indicate
that exposures to SARS-CoV-2 are occurring in a wide variety of work
settings across all industries. Therefore, most employees who work in
the presence of other people (e.g., co-workers, customers, visitors)
need to be protected.
While there is no comprehensive source of nationwide workplace
infection data, reports from states and communities on outbreaks
related to workplaces provide key, up-to-date data that illustrate the
likelihood of employee exposure to SARS-CoV-2 at workplaces throughout
the U.S. OSHA identified a number of recent reports from various
regions of the country that together demonstrate the impact that SARS-
CoV-2 can have on a variety of workplaces, including in service
industries (e.g., restaurants, grocery and other retail stores, fitness
centers, hospitality, casinos, salons), corrections, warehousing,
childcare, schools, offices, homeless shelters, transportation, mail/
shipping/delivery services, cleaning services, emergency services/
response, waste management, construction, agriculture, food packaging/
processing, and healthcare. Deaths are reported in many studies
performed prior to the emergence of the Delta variant but, because the
Delta outbreak is so recent and deaths can occur weeks after infection,
the number of deaths from recent infections might be underestimated.
Some of the reports include cumulative data representing various phases
of the pandemic, beginning prior to the availability of vaccines and
continuing through the recent surge of the Delta variant. In addition,
some studies report investigations of recent outbreaks, which provide
insight on the impact of the Delta variant as well as impacts
associated with the current vaccination status of workers.
The Washington State Department of Health (WSDH) reports outbreaks
occurring in non-healthcare workplaces (WSDH, September 8, 2021). In
non-healthcare workplaces, outbreaks are defined as two or more
laboratory confirmed cases of COVID-19, with at least two cases
reporting symptom onset within 14 days of each other, and plausible
epidemiological evidence of transmission in a shared location other
than a household. As of September 4, 2021, WSDH reported 5,247
outbreaks in approximately 40 different types of non-healthcare work
settings. During the week of August 29 through September 4, 2021, WSDH
identified 137 separate workplace outbreaks. The types of non-medical
workplace settings that represented more than 5% of the total outbreaks
during that week included food service/restaurants, childcare, schools,
retail, grocery, and shelter/homeless services. Other types of non-
healthcare settings where outbreaks occurred recently included non-food
and food manufacturing, construction, professional services/office
based, agriculture/produce packing, transportation/shipping delivery,
government agencies/facilities, leisure hospitality/recreation,
corrections, utilities, warehousing, facility/domestic cleaning
services, youth sports/activities, camps, and public safety. Over the
course of the pandemic, outbreaks have also been observed at bars/
nightclubs, hotels, and fishing/commercial seafood vessels.
The Oregon Health Authority (OHA) publishes a weekly report
detailing outbreaks directly related to work settings. OHA
epidemiologists consider cases to be part of a workplace outbreak when
clusters form with respect to space and time, within a plausible
incubation period for the virus, and their investigation does not
uncover an alternative source for the outbreak. For privacy reasons,
OHA only reports outbreaks with 5 or more cases in workplaces with 30
or more people. OHA reported a total of 26,013 cases and 135 deaths
related to workplace outbreaks as of September 1, 2021. As of September
1, 2021, OHA was investigating more than 124 active workplace outbreaks
(OHA, September 1, 2021). Those outbreaks occurred in a wide variety of
industries including correctional facilities, emergency services, waste
management, schools and child care, retail and grocery stores,
restaurants, warehousing, agriculture, food processing/packaging,
construction, healthcare, mail and delivery services, office locations,
utilities, transportation, and others.
Tennessee Department of Health was investigating 557 active COVID-
19 clusters as of September 8, 2021 (TDH, September 8, 2021). Clusters
are defined as two or more laboratory confirmed COVID-19 cases linked
to the same location or event that is not a household exposure. The
clusters occurred in 13 types of settings, 10 of which were workplace
settings. Outbreaks at workplaces represented more than half of the
total active outbreaks in the state at that time. Settings comprising
more than 5% of total clusters included assisted care living
facilities, nursing homes, and correctional facilities. Other types of
workplaces where outbreaks occurred included bars, construction, farms,
homeless shelters, and industrial settings.
The North Carolina Department of Health and Human Services reports
cumulative numbers of clusters, cases, and deaths for workers in
poultry processing facilities (beginning in April of 2020) and other
types of workplaces (beginning in May of 2020) (NCDHHS, August 30,
2021). Clusters are defined as a minimum of 5 cases with illness onset
or initial positive results within a 14-day period and plausible
epidemiological linkage between the cases. Plausible epidemiological
linkage means that multiple cases were in the same general setting
during the same time period (e.g., same shift, same physical area) and
that a more likely source of exposure is not identified (e.g.,
household contact or close contact to a confirmed case in another
setting). During that time period of April/May 2020 through August 30,
2021, workplaces \11\ were associated with nearly 80% of the 1,969
clusters and 27,097 cases observed and nearly 40% of the 167 deaths
related to the clusters. Cumulative numbers of cluster-associated
deaths were highest in meat and poultry processing (25 of 5,351 cases),
followed by healthcare (10 of 1,036 cases), government services and
manufacturing (5 of 1,048 cases and 5 of

[[Page 61413]]

1,856 cases, respectively), and restaurants and childcare (3 of 421
cases and 3 of 1,943 cases, respectively). Recently, in July of 2021,
the number of cases associated with workplace clusters began increasing
in several different types of work settings, including meat processing,
manufacturing, retail, restaurants, childcare, schools, and higher
education.
---------------------------------------------------------------------------

\11\ NCDHHS identifies a ``workplace'' category in their report
(e.g., agriculture, construction), but OSHA includes other settings
where employees would be present (e.g., retail, restaurants,
childcare, healthcare).
---------------------------------------------------------------------------

Colorado Department of Public Health & Environment/Colorado State
Emergency Operations Center (CDPHE/CSEOC, September 8, 2021) reported
5,584 resolved workplace-related outbreaks involving 40,156 employee
cases and 79 employee deaths since May of 2020. The agency's current
investigations, as of September 8, 2021 included 291 active outbreaks
(not defined), with 2,865 staff cases (assumed to be cases in
employees). The majority of active outbreaks were reported in
childcare, schools, healthcare, and corrections. Active outbreaks were
also reported in construction, retail, homeless shelters, casinos,
restaurants, hotels, offices, law enforcement, manufacturing, delivery
services, and warehouses. Other types of work settings that were
affected in resolved outbreaks included warehouses, bars, government
locations, waste management, utilities, salons, emergency services,
meat processing/packaging, and postal services. From June 21, 2021 (the
date the healthcare ETS was published) through September 8, 2021, 1,469
staff cases associated with outbreaks were reported, for an average of
approximately 19 cases per day.
Similar reporting is available from Louisiana's Department of
Health (LDH, August 24, 2021), with 1,347 outbreaks and 9,130 cases
reported as of August 24, 2021. LDH defines an outbreak as 2 or more
cases among unrelated individuals who visited a site within a 14-day
period. More than three quarters of outbreaks through that date were
associated with workplaces. Workplace settings in Louisiana that
experienced more than 5% of outbreaks included day care facilities,
bars, restaurants, retail settings, industrial settings, and office
spaces. Other types of workplace settings or industries where outbreaks
occurred included casinos, gyms/fitness centers, banks, automotive
services, construction, and ships/boats.
In addition to the state data above, some published studies and
government reports provide information on recent workplaces outbreaks.
For example, 47 people, including 3 of 11 staff members, 23 gymnasts,
and 21 household contacts, contracted COVID-19 from an outbreak linked
to an Oklahoma gymnastics facility during April 15 through May 3, 2021
(Dougherty et al., July 16, 2021). All 21 of the virus samples
sequenced were determined to be the Delta variant. The majority of the
infected individuals (85%) were unvaccinated. Infections were reported
in 16 adults aged 20 years or older; two adults were hospitalized and
one required intensive care.
The state of Hawaii defines clusters as three or more confirmed or
probable cases linked to a site or event within 14 days, with no
outside exposure of cases to each other (Hawaii State, August 19,
2021). The state reported a COVID-19 cluster in July associated with a
concert at a bar that affected 16 people, including employees, band
members, and concert attendees; infections also spread to 7 household
members. Band members had performed while sick. Four of the initial 16
people and none of the household members who tested positive for COVID-
19 were fully vaccinated. The concert cluster was linked to clusters at
another workplace and another concert. The report lists additional
clusters investigated in the two weeks prior to the report; those
clusters were observed in workplace locations such as correctional
facilities, bars and nightclubs, restaurants, construction/industrial
sites, travel/lodging/tourism, schools, food suppliers, and gyms.
Additional evidence that employees are at risk of exposure to SARS-
CoV-2 in the workplace is available from published, peer-reviewed
studies that were conducted before the Delta variant emerged. Those
studies demonstrate that employees have been at risk of infection,
illness, and death throughout the COVID-19 pandemic. Because the Delta
variant is more transmissible and likely causes more severe disease
than previous variants, there is even greater potential for
unvaccinated employees to become seriously ill or die as a result of
exposure to the Delta variant.
Contreras et al. (July, 2021) examined workplace outbreaks
(excluding healthcare settings, homelessness services, and emergency
medical services) in Los Angeles county from March 19 through September
30, 2020. Workplace outbreaks were defined as 5 or more suspected or
laboratory confirmed COVID-19 cases (prior to May 29) or 3 or more
laboratory confirmed cases (after May 29) occurring within 14 days.
Nearly 60% of the 698 identified outbreaks occurred in three sectors--
manufacturing (184, 26.4%), retail trade (137, 19.6%), and
transportation and warehousing (73, 10.5%). Also notable were the 71
outbreaks in the accommodation and food services industry, which
represented 10.2% of the outbreaks. The study authors concluded that
outbreaks were larger and lasted longer at facilities with more onsite
staff.
Outbreaks in Wisconsin from March 4 through November 16, 2020 were
also examined (Pray et al., January 29, 2021). Non-household outbreaks
were defined as two or more confirmed COVID-19 cases that occurred
within 14 days in persons who attended the same facility or event and
did not share a household. During the period from March 4 through
November 16, 2020, the largest percentages of cases were associated
with outbreaks in long-term care facilities (26.8% of cases),
correctional facilities (14.9% of cases), and colleges or universities
(15% of cases). Also notable were the substantial number of cases
associated with outbreaks in food production or manufacturing
facilities (including meat processing and warehousing; 14.5% of cases)
and schools and childcare facilities (10.6% of cases).
Bui et al. (August 17, 2020) analyzed data from the Utah Department
of Health's COVID-19 case surveillance system, which included data on
workplace outbreaks. Outbreaks were defined as two or more laboratory
confirmed cases occurring within a 14 day period among coworkers in a
common workplace (e.g., same facility). During the time period between
March 6 and June 5, 2020, 277 COVID-19 outbreaks were reported, of
which 210 (76%) occurred in workplaces. The 210 workplace outbreaks
occurred in 15 of 20 industry sectors, and the industry sectors of
manufacturing (43 outbreaks, 20%), construction (32 outbreaks, 15%),
and wholesale trade (29 outbreaks, 14%) together represented nearly
half of workplace outbreaks. Other sectors that represented more than
10% of total outbreaks were retail trade (28 outbreaks, 13%) and
accommodation and food services (25 outbreaks, 12%). Incidence rates of
COVID-19 over the period of March 6 through June 5, 2020 were 339/
100,000 workers in manufacturing, 122/100,000 workers in construction,
377/100,000 workers in wholesale trade, 68/100,000 workers for retail
trade, and 78/100,000 workers for accommodation and food services. For
COVID-19 cases associated with workplace outbreaks in which
hospitalization and severity status were known (1,382 and 1,155,
respectively), the number in all sectors who were admitted to the
hospital was 85 (6%) and the number with severe outcomes (intensive
care unit admission, mechanical ventilation, or death) was 40 (3%).

[[Page 61414]]

The impact of SARS-CoV-2 exposures on employee infection, illness,
and death has also been demonstrated in studies focusing on specific
types of industries, such as those where employees have frequent
contact with each other and the public (e.g., grocery stores, bars,
fitness facilities, schools, and law enforcement/corrections). For
example, a study by Lan et al. (September 26, 2020) demonstrates the
risk of infection in service industries. The cross-sectional study
examined the risks of SARS-CoV-2 exposure and infection for employees
in a Boston, Massachusetts-area retail grocery store market. The study
tested 104 grocery store employees, of whom 20% (21 employees) were
positive for COVID-19; 76% of confirmed cases did not have symptoms.
After adjusting for gender, smoking, age, and the prevalence of COVID-
19 in the employees' residential communities, employees who had direct
customer exposure (e.g., cashiers, sales associates, cart attendants)
were 5.1 times more likely to have a positive test for COVID-19 than
employees without direct face-to-face customer exposure (e.g.,
stockers, backroom, receiving and maintenance). The infection rate of
20% among all employees was significantly higher than the rate in the
surrounding community.
In February of 2021, an event at an Illinois bar that accommodates
approximately 100 people resulted in a COVID-19 outbreak that affected
46 people, including 3 (10%) staff members, 26 (90%) patrons, and 17
secondary cases (Sami et al., April 9, 2021). People at the event
included an asymptomatic person diagnosed with COVID-19 on the previous
day and 4 symptomatic people who were later diagnosed with COVID-19.
The outbreak resulted in a school closure and the hospitalization of a
resident at a long-term care facility.
In Minnesota, 47 COVID-19 outbreaks were detected at fitness
facilities from August through November of 2020 (Suhs et al., July 23,
2021). One outbreak at a fitness facility during October through
November of 2020 resulted in 23 COVID-19 cases including 5 (22%)
employees and 18 (78%) members. A genetic analysis of specimens from 3
employees and 10 members identified 2 distinct genetic subclusters,
indicating two distinct chains of transmission among members and
employees.
School-related outbreaks were examined from December 1, 2020
through January 22, 2021 in eight public elementary schools of a
Georgia school district (Gold et al., February 26, 2021). A COVID-19
case was determined to be school-related if (1) symptom onset or a
positive test was consistent with the incubation period of the virus
following contact with an index case or a school-associated case, (2)
close contact occurred with the index case or school-associated case
while that person was infected, and (3) no known contact occurred with
an infected community or household contact in the two weeks prior to a
positive test for COVID-19. The investigators identified nine clusters
of three or more epidemiologically linked COVID-19 cases that involved
13 educators and 32 students in six of the eight elementary schools.
Approximately half of the school-associated cases involved two clusters
that began with probable transmission between educators, followed by
educator to student transmission. Eighteen of 69 household members
tested received positive results.
A number of studies demonstrate the impact of COVID-19 in law
enforcement and related fields such as corrections. For example, a
study examining COVID-19 antibodies in employees from public service
agencies in the New York City area from May through July of 2020, found
that 22.5% of participants had COVID-19 antibodies (Sami et al., March,
2021). The percentage of correctional officers found to have COVID-19
antibodies (39.2%) was the highest observed among all the occupations.
The percentages of police dispatchers, traffic officers, security
guards, and dispatchers found to have COVID-19 antibodies (29.8 to
37.3%) were among the highest levels observed in all the occupations.
The study authors noted that those jobs involve frequent or close
contact with the public or are done in places where employees work in
close proximity to their coworkers.
Wallace et al. (May 15, 2020) evaluated data on COVID-19 cases and
deaths among correctional facility employees and inmates from January
21 to April 21, 2020. Data were reported to CDC by 37 (69%) of 54 state
and territorial health department jurisdictions. Of these 37
jurisdictions, 32 (86%) reported at least one COVID-19 case from a
correctional facility. Of the 420 facilities with a case, 221 (53%)
reported cases only among staff members. In total, 4,893 COVID-19 cases
among incarcerated or detained persons and 2,778 cases among staff
members were reported (total tested not provided). Among staff member
cases, 79 hospitalizations (3%) and 15 deaths (1%) were reported. The
study authors noted that ``correctional and detention facilities face
challenges in controlling the spread of infectious diseases because of
crowded, shared environments and potential introductions by staff
members and new intakes.''
Ward et al. (June 2021) analyzed COVID-19 prevalence among
prisoners and staff in 45 states from March 31, 2020 through November
4, 2020. During that time period, COVID-19 cases in staff were 3 to 5
times higher compared to the U.S. population. Average daily increases
in cases were 42 per 100,000 prison employees, 61 per 100,000
prisoners, and 13 per 100,000 U.S. residents. On November 4, 2020,
COVID-19 prevalence for prison staff was 9,316 cases per 100,000
employees, which was 3.2 times greater than prevalence in the U.S.
population (2,900 cases per 100,000).
Kirbiyik et al. (November 6, 2020) analyzed movement through a
network-informed approach to identify likely high points of
transmission within the Cook County Jail in Chicago, IL. At that
facility, over 900 COVID-19 cases were reported across 10 housing
divisions in 13 buildings from March 1-April 30, 2020. Staff members
were required to report symptoms of COVID-19 (probable cases) or
receipt of a positive test result (confirmed cases). A total of 2,041
staff members (77% of staff) were included in the network analysis
because information was available about their shift and division
assignments, and 198 (9.7%) of those staff members had COVID-19 during
the two-month study period. Connections between staff members who had
COVID-19 were higher than expected, suggesting likely transmission
among staff members. Fewer connections than expected were observed
among detained persons with SARS-CoV-2 infections, suggesting the
effectiveness of medical isolation at reducing transmission.
The Officer Down Memorial Page, which tracks police officer
fatalities determined to be occupationally related, reported that the
majority of officer deaths for 2021 (157 of 269) were related to COVID-
19 (ODMP, September 14, 2021). For the 269 officers who died, causes of
death were not reported for each month, but the highest numbers of
monthly deaths, 52 in January and 65 in August (compared to 16 to 34
deaths on other reported months), were consistent with the winter surge
of COVID-19 and, more recently, the surge caused by the Delta variant.
The risk of COVID-19 has also been examined in industries where
employees have little contact with the public, such as construction,
and food processing, and where most exposure to

[[Page 61415]]

SARS-CoV-2 likely comes from other workers. Pasco et al. (October 29,
2020) examined the association between construction work during the
COVID-19 pandemic and community transmission and construction worker
hospitalization rates in Austin, Texas from March 13 to August 20,
2020. A ``Stay Home-Work Safe'' order enacted on March 24, 2020,
limited construction to only critical infrastructure and excluded
commercial and residential work. One week later, the Texas governor
lifted the restriction for essential workers and allowed all types of
construction work to resume, while keeping the order in place for other
workers. The authors found that resuming construction during the
shelter-in-place order led to an increase in community transmission, an
increase in hospitalizations among community members, and an increase
in hospitalizations of construction workers. By mid-July, Austin Public
Health identified at least 42 clusters (not defined) of COVID-19 cases
in the construction industry; 515 individuals were hospitalized for
COVID-19 illnesses acquired as part of these clusters, and 77 of those
reported working in construction. The study found that construction
workers had a nearly 5-fold increased risk of hospitalization in
central Texas compared with workers in other occupations. The authors'
model predicted that allowing unrestricted construction work would be
associated with an increase in COVID-19 hospitalization rates from 0.38
per 1,000 residents to 1.5 per 1,000 residents overall, and from 0.22
per 1,000 construction workers to 9.3 per 1,000 construction workers
for the construction industry specifically. The authors concluded that
stringent workplace safety measures could significantly mitigate risks
related to COVID-19 in the industry.
The meat packing and processing industries and related agricultural
and food processing sectors have also been impacted by COVID-19.
Waltenburg et al. (January, 2021) reported COVID-19 cases in employees
from meat and poultry processing facilities in 31 states from March 1
through May 31, 2020. As reported in Table 2 of that report, 28,364
employees in those facilities were confirmed to have COVID-19 by
laboratory testing and 132 died. Among the 20 states that reported
total numbers of employees, 11.4% of the workers were diagnosed with
COVID-19 (with a range of 3.1 to 27.7% of workers in individual
states). For states that reported at least one COVID-19-related death,
the percentages of employees who died in each state ranged from 0.1 to
2.4% of those with COVID-19. The authors found a high burden of disease
in persons employed at these facilities who were racial or ethnic
minorities. Higher incidence in these populations might be due to the
likelihood of these employees working in areas in the plant where
transmission risk is higher. Steinberg et al. (August 7, 2020) reported
that attack rates (i.e., the number of individuals who are infected in
comparison to the total number at risk) among production employees in
the Cut (30.2%), Conversion (30.1%), and Harvest (29.4%) departments of
a meat processing plant (where spacing between employees is less than 6
feet) were double that of salaried employees (14.8%) whose workstations
had been modified to increase physical distancing from others.
Waltenburg et al. (January, 2021) also evaluated COVID-19 incidence
in food manufacturing and agricultural settings (e.g., manufacturing or
farming involving fruits, vegetables, dairy, baked goods, eggs,
prepared foods), as reported in 30 states from March through May 2020.
In food manufacturing and farming of fruits, vegetables, dairy, and
other items, 742 workplaces were affected, including 8,978 infections
and 55 fatalities. For states that reported total numbers of employees,
the proportion of employees who developed COVID-19 in each state ranged
from 2.0 to 43.5%. For states that reported at least one death, the
percentages of deaths among cases ranged from 0.1 to 3.8%.
Porter et al. (April 30, 2021) reported that 13 COVID-19 outbreaks
occurred at Alaska seafood processing facilities and vessels (both of
which were described as high density workplaces) during the Summer and
early Fall of 2020. The 13 outbreaks involved 539 COVID-19 cases, with
2-168 cases per outbreak. Attack rates in facilities and offshore
vessels ranged from less than 5% to 75%. Outbreaks were also reported
in entry quarantine groups. Because of these outbreaks, it was
determined that vaccination of these essential workers is important and
requirements for COVID-19 prevention were updated to include smaller
quarantine groups, serial testing, and testing before transfers from
one facility or vessel to another.
Finally, two published studies analyzed death records to determine
how mortality rates among individuals in various types of workplaces
had changed during the pandemic. Chen et al. (June 4, 2021) analyzed
records of deaths occurring on or after January 1, 2016 in California
and found that mortality rates in working aged adults (18-65 years)
increased 22% during the COVID-19 pandemic period of March through
November 2020 compared to pre-pandemic periods. Relative to pre-
pandemic periods, the groups of employees experiencing the highest,
statistically significant increases in relative excess mortality were
those in food/agriculture (39% increase), transportation/logistics (31%
increase), facilities (23% increase), and manufacturing (24% increase).
Other groups that also experienced excess, statistically significant
mortality compared to pre-pandemic periods were health or emergency
workers (17% increase), retail workers (21% increase), and government
and community workers (17% increase). The study authors concluded that
certain occupational sectors were impacted disproportionally by
mortality during the pandemic and that essential work conducted in-
person is a likely avenue of infection transmission.
Hawkins et al. (January 10, 2021) examined death certificates of
individuals who died in Massachusetts between March 1 and July 31,
2020. An age-adjusted mortality rate of 16.4 per 100,000 employees was
determined from 555 death certificates that had useable occupation
information. Employees in 11 occupational groups had particularly high
mortality rates: healthcare support; transportation and material
moving; food preparation and serving; building and grounds cleaning and
maintenance; production, construction and extraction; installation/
maintenance/repair; protective services; personal care services; arts/
design/entertainment; sports/media; and community and social services.
The study authors noted that occupational groups expected to have
frequent contact with sick people, close contact with the public, and
jobs that are not practical to do from home had particularly elevated
mortality rates.
b. Healthcare Workers
As explained in the Healthcare ETS, COVID-19 presents a grave
danger to workers in all U.S. healthcare settings where people with
COVID-19 are reasonably expected to be present (86 FR 32381).
Healthcare settings covered by the Healthcare ETS primarily include
settings where people with suspected or confirmed COVID-19 are treated,
exacerbating the risk present in most workplaces. To control the higher
level of risk in those settings, OSHA determined that a suite of
workplace controls was necessary to protect all employees, whether they
are vaccinated or unvaccinated. As explained further

[[Page 61416]]

below, OSHA now finds that unvaccinated healthcare workers in
healthcare settings not covered by the Healthcare ETS are also at grave
danger from exposure to SARS-CoV-2, just like unvaccinated workers in
other industries. Data continue to be collected and reported for
healthcare workers, and a small number of peer-reviewed studies
demonstrate the potential impact of the Delta variant on healthcare
workers.
CDC continues to provide updates for COVID-19 cases and deaths
among healthcare personnel. However, information on healthcare
personnel status continues to be reported for only a fraction (18.91%)
of total reported cases, and death status was reported for only 82.16%
of healthcare personnel cases as of October 18, 2021 (CDC, October 18,
2021--Healthcare Personnel). Given incomplete reporting, the data from
this source represent only a fraction of actual healthcare cases and
deaths. Nevertheless, CDC reported 666,707 healthcare personnel cases
among the 6,754,306 reported cases that included information on
healthcare personnel status (9.9%) and 2,229 fatalities among the
547,769 cases that included death status (0.4%) for healthcare
employees as of October 18, 2021. This is a 26% increase in the number
of cases and a 27% increase in the number of deaths since the May 24,
2021 data reported in the ETS (CDC, October 18, 2021--Healthcare
Personnel). The Delta variant is likely responsible for the majority of
those deaths. No healthcare worker deaths were reported by CDC during
the weeks of May 30 through June 13, 2021; however, as the Delta
variant's prevalence rose after June 20, healthcare worker deaths began
increasing; they peaked during the period of August 15 through
September 12, 2021, when 34 to 36 healthcare worker deaths were
reported per week (CDC October 18, 2021--Healthcare Personnel, Deaths
by Week). Independent reporting by Kaiser Health News and The Guardian
reported more than 3,600 fatalities in health care workers as of April
2021 (Spencer and Jewett, April 8, 2021). That number is expected to be
higher at this time since the earlier figure did not include the most
recent 5 months of the pandemic, which includes the period of Delta
variant predominance.
Published studies also demonstrate that healthcare workers,
especially those who are unvaccinated, remain at risk of being infected
with SARS-CoV-2 (see Section III.A.IV. Vaccines Effectively Reduce
Severe Health Outcomes from and Transmission of SARS-CoV-2). Routine
testing of health care personnel, first responders, and other frontline
workers in eight U.S. locations in six states from December 14, 2020
through August 14, 2021 revealed 194 infections in 4,136 unvaccinated
participants (89.7% symptomatic) and 34 infections in 2,976 fully
vaccinated participants (80.6% symptomatic) (Fowlkes et al., August 27,
2021). During time periods when the Delta variant represented more than
50% of viruses sequenced, 19 infections were detected in 488
unvaccinated participants (94.7% symptomatic) and 24 infections were
detected in 2,352 vaccinated participants (75% symptomatic).
Monthly COVID-19 cases in healthcare workers were reported during
the period from March 1 to July 31, 2021 at the University of
California San Diego (UCSD) health system, which is a healthcare
provider that includes primary care services such as family medicine
and pediatrics (Keehner et al., September 1, 2021; UCSD, 2021). During
that time period, a total of 227 health care workers tested positive
for COVID-19. One hundred and nine of 130 fully vaccinated workers who
tested positive (83.8%) were symptomatic and 80 of 90 unvaccinated
workers (88.9%) were symptomatic; one unvaccinated person was
hospitalized for COVID-19 symptoms. By July of 2021, after the end of
California's mask mandate on June 15 and after the Delta variant became
dominant, the number of cases detected dramatically increased; the
Delta variant accounted for more than 95% of SARS-CoV-2 viruses
sequenced by the end of that month. During July of 2021, symptomatic
infections were detected in 94 of 16,492 fully vaccinated workers and
31 of 1,895 unvaccinated workers. Attack rates in July of 2021 were 5.7
per 1,000 fully vaccinated workers and 16.4 per 1,000 unvaccinated
workers.
In Finland, a Delta variant infection from a hospitalized patient
spread throughout the hospital and to three primary care facilities,
infecting 103 individuals, including 45 healthcare workers
(Hetem[auml]ki et al., July 29, 2021). Twenty-six of the healthcare
workers were infected at the hospital and 19 were infected at primary
care facilities. The affected health care workers included 28 with
direct patient contact (11 who were not fully vaccinated), 8
unvaccinated healthcare worker students, and 9 other staff, including
hospital cleaners and secretaries (of whom 6 were not fully
vaccinated). According to study authors, ``There was high vaccine
coverage among permanent staff in the central hospital, but lower for
HCW in primary healthcare facilities. . .'' Study authors estimated
that vaccine effectiveness against the Delta variant in healthcare
workers was approximately 88-91%, suggesting how much more extensive
the outbreak could have been if a high percentage of healthcare workers
were not fully vaccinated.
In the UK, a Delta variant infection in a healthcare worker
resulted in an outbreak in a care home that affected 16 of 21 residents
and 8 of 21 staff (Williams et al., July 8, 2021). One staff member was
hospitalized. Attack rates were 35.7% in staff who were partially
vaccinated (i.e., received their second dose of vaccine on the day that
the index case was diagnosed with COVID-19 or had only received one
vaccine dose) and 40% in staff who were not vaccinated.
Recent news stories demonstrate that outbreaks affecting staff
members are still occurring in U.S. healthcare facilities. An outbreak
that began in August, 2021 at a Washington State nursing center
resulted in infections in 22 staff members and 52 residents. In an
unrelated outbreak, a nursing facility in Hawaii reported infections in
24 employees and 54 patients (Wingate, September 24, 2021). Vaccination
rates were reported at 64.5% of residents and 37.1% of staff in the
Washington State facility and 91% of staff and more than 80% of
patients at the Hawaii facility.
COVID-19 cases were also observed in staff at ambulatory care
settings prior to emergence of the Delta variant. Over an 11-week
period beginning on March 20, 2020, 254 tests for SARS-CoV-2 were
performed on employees who had potential exposures at an outpatient
urology center in New York State (Kapoor et al., 2020). Positive test
rates in employees correlated with rates in New York State, declining
over time, from 26.1% in the early stage to 7.3% in the late stage of
the study. According to study authors, the positive test results
coincided with the implementation of infection control procedures
(e.g., symptom screening, masking, distancing, and hygiene). Positivity
rates were similar in administrative and clinical staff and the study
authors concluded that ``administrative staff in an outpatient setting
were equally--if not more--vulnerable to SARS-CoV-2 transmission when
compared with clinical staff who were more directly exposed to
patients.'' The study authors speculated that possible reasons for the
findings were that clinical staff were more familiar with PPE and that
administrative staff, especially in check-in and check-out points, tend
to work close to each other.

[[Page 61417]]

c. Conclusion for Employee Impact
The evidence described above provides examples of the impact that
exposures from SARS-CoV-2, including those involving the Delta variant,
have had on employees in general industry, agriculture, construction,
maritime, and healthcare settings. It demonstrates that SARS-CoV-2 has
spread to employees in these industries and, in many cases, infection
was linked to exposure to infected persons at the worksite (WSDH,
September 8, 2021; OHA, September 1, 2021; TDH, September 8, 2021;
NCDHHS, August 30, 2021; Hawaii State, August 19, 2021; Pray et al.,
January 29, 2021; Sami et al., April 9, 2021; Suhs et al., July 23,
2021; Gold et al., February 26, 2021; Porter et al., April 30, 2021;
Hetem[auml]ki et al., July 29, 2021; Williams et al., July 8, 2021).
The documentation of so many workplace clusters suggests that exposures
to SARS-CoV-2 occur regularly in workplaces where employees come into
contact with others. This prevalence of clusters, combined with some
evidence that many infections occurred within the 14-day incubation
period for SARS-CoV-2 and that exposures to infected persons outside
the workplace were frequently ruled out, supports the proposition that
exposures to and transmission of SARS-CoV-2 occur frequently at work.
Multiple studies demonstrate high rates of COVID infections, illnesses,
and fatalities in the wide range of occupations that require frequent
or prolonged close contact with other people, indoor work, and work in
crowded and/or poorly ventilated areas The large numbers of infected
employees suggest that SARS-CoV-2 is likely to be present in a wide
variety of workplaces, placing unvaccinated workers at risk of serious
and potentially fatal health effects.
IV. Vaccines Effectively Reduce Severe Health Outcomes From and
Transmission of SARS-CoV-2
During the course of the SARS-CoV-2 pandemic, different variants
have emerged with different characteristics that better enable
transmission and potentially cause more severe outcomes. However,
vaccines remain very effective at reducing the occurrence of COVID-19-
related severe illness, disability and death.\12\ The Delta variant is
more transmissible than previous variants, might cause more severe
illness than previous variants in unvaccinated people, and has led to
hospitalization of individuals in numbers similar to those of the
November 2020 to February 2021 surge. These changes in characteristics
have provided a clearer realization of the continuing capacity for
SARS-CoV-2 to present a grave danger to workers. However, it is well
evident that even given these changed characteristics of Delta, serious
disease and death continue to occur overwhelmingly in unvaccinated
individuals while the vaccinated are afforded great protection.\13\
---------------------------------------------------------------------------

\12\ A discussion of vaccination rates, as well as OSHA's
rationale for why vaccination is a critical means of protecting
workers from the grave danger described in this section, can be
found in Need for the ETS (Section III.B. of this preamble).
\13\ While mild cases of COVID-19 are included in the grave
danger presented by COVID-19, as stated in the Healthcare ETS (see
86 FR 32382), OSHA is focusing on the most severe health effects,
i.e., cases requiring hospitalization and cases resulting in death,
in this new rulemaking effort in order to prevent the gravest of
consequences to workers.
---------------------------------------------------------------------------

a. Impact of Vaccination on Severe Health Outcomes
There are currently three vaccines that are approved or authorized
for the prevention of COVID-19 in the U.S.: The Pfizer-BioNTech COVID-
19 vaccine (FDA approved for ages 16 and above; authorized for ages 12
and above), the FDA-authorized Moderna COVID-19 vaccine (authorized for
ages 18 and above), and the FDA-authorized Janssen COVID-19 vaccine
(also known as the Johnson & Johnson vaccine; authorized for ages 18
and above.) Pfizer-BioNTech and Moderna are mRNA vaccines that require
two primary series doses administered three weeks and one month apart,
respectively. Janssen is a viral vector vaccine administered as a
single primary vaccination dose (CDC, September 15, 2021). The vaccines
were shown to greatly exceed minimum efficacy thresholds in preventing
COVID-19 in clinical trial participants (FDA, December 11, 2020; FDA,
December 18, 2020; FDA, February 26, 2021). Data from clinical trials
for all three vaccines and observational studies for the two mRNA
vaccines clearly establish that fully vaccinated persons have a greatly
reduced risk of SARS-CoV-2 infection compared to unvaccinated
individuals. This includes severe infections requiring hospitalization
and those resulting in death. For more information about the
effectiveness of vaccines as of late Spring 2021, see 86 FR 32397,
which OSHA hereby includes in the record for this ETS.\14\
---------------------------------------------------------------------------

\14\ This adoption includes the citations in the referenced
section of the Healthcare ETS, which are also included in the docket
for this ETS.
---------------------------------------------------------------------------

Vaccines remain highly effective against hospitalization and death.
A study evaluating vaccine effectiveness at preventing hospitalization
among those with SARS-CoV-2 infections in New York found that
effectiveness did not change from May 3 to July 25, 2021 as the Alpha
variant gave way to the Delta variant (91.9-96.2% range; Rosenberg et
al., August 27, 2021). Grannis et al. used data from 187 hospitals in
nine states from June to August 2021 to evaluate the efficacy of
vaccines against hospitalization when Delta had emerged as the
predominant variant causing SARS-CoV-2 infections (September 17, 2021).
This study found that vaccines were 89% effective at preventing
hospitalization in individuals aged 18 to 74. Similarly, vaccines were
also found to be 89% effective in preventing hospitalization in a study
collecting data from five Veteran Affairs Medical Centers from July 1
to August 6, 2021, a time when most transmission was attributed to the
Delta variant (Bajema et al., September 10, 2021).
Two other studies found that, although the level of protection
provided by vaccination has decreased somewhat with the emergence of
the Delta variant, vaccines continue to provide high levels of
protection against hospitalization. In a U.S. study, researchers found
that while the Moderna and Janssen vaccines mostly maintained their
effectiveness at preventing hospitalization (going from 93% to 92%
after more than 120 days post-vaccination and 71% to 68% after more
than 28 days post-vaccination, respectively) from March to August 2021,
the effectiveness of the Pfizer-BioNTech vaccine at preventing those
severe outcomes decreased from 91% to 77% after more than 120 days
post-vaccination (Self et al., September 17, 2021). An Israeli study on
infections documented between July 11 and July 31, 2021 found a
significant decrease in vaccine efficacy for the Pfizer-BioNTech
vaccine against severe outcomes in relation to when an individual was
vaccinated, but the absolute difference was much less than what was
observed in the U.S. study (e.g., 98% effective for 40-59 year olds
vaccinated in March versus 94% effective for those in the same age
group who were vaccinated in January) (Goldberg et al., August 30,
2021).
Vaccines also remain extremely effective at preventing death. A UK
study evaluated the effectiveness of the Pfizer-BioNTech vaccine
against death and found it to be 96.3% effective against the Alpha
strain and 95.2% protective against the Delta strain (Andrews et al.,
September 21, 2021). Two Israeli studies, Haas et al. and Saciuk et
al., performed during time periods where Alpha was predominant, found
the Pfizer-BioNTech vaccine to be 96.7% and 91.1% effective,

[[Page 61418]]

respectively, against death (Haas et al., May 15, 2021; Saciuk et al.,
June 25, 2021). A California study found that the Moderna vaccine was
97.9% effective against death (Bruxvoort et al., September 2, 2021). A
study on patients served by the Veterans Health Administration found
that Pfizer-BioNTech and Moderna vaccines provided 99% effectiveness
against death (Young-Xu et al., July 14, 2021).
The risks of hospitalization and death appear to have increased for
unvaccinated individuals since the Delta variant became a common source
of infections. A study of Los Angeles County SARS-CoV-2 infections
found that vaccinations reduced hospitalization risk by a factor of 10
on May 1, 2021, when the Alpha variant was dominant, but that the risk
of hospitalization was even more greatly reduced (by a factor of 29.2)
on July 25, 2021, when the Delta variant was dominant (Griffin et al.,
August 27, 2021). This difference suggests both that vaccines continue
to provide a high level of protection against disease that results in
hospitalization and that risk has increased for those who are
unvaccinated. Similar increased risk for unvaccinated individuals was
reported in a study that evaluated hospitalization and death data from
13 U.S. jurisdictions between June 20 and July 17, 2021, a period when
the Delta variant gained prominence (Scobie et al., September 17,
2021). For unvaccinated 18 to 49 year olds, the risk of hospitalization
was 15.2 times greater, and the risk of death was 17.2 times greater,
than the risks for vaccinated people in the same age range. For
unvaccinated 50 to 64 year olds, the risk of hospitalization was 10.9
times greater, and the risk of death was 17.9 times greater, than for
those who are vaccinated. These studies illustrate that vaccination is
an extremely effective control measure to minimize severe outcomes
resulting from Delta variant infections.
b. Impact of Vaccination on Infection and Transmission
Vaccines continue to provide robust protection for vaccinated
individuals against SARS-CoV-2 infections, even though several studies
indicate that vaccine efficacy against infection may have decreased
somewhat with the emergence of the Delta variant (Fowlkes et al.,
August 27, 2021; Rosenberg et al., August 27, 2021; Nanduri et al.,
August 27, 2021; Seppala et al., September 2, 2021; Bernal et al.,
August 12, 2021). For example, vaccination was observed to reduce the
risk of infection by a factor of 8.4 on May 1, 2021, when the Alpha
variant was predominant in Los Angeles county (Griffin et al., August
27, 2021). However, the level of protection had fallen to a factor of
4.9 by July 25, 2021, when Delta made up 88% of infections in the
county. The findings from this study indicate that while vaccines
maintain robust protection against severe outcomes, protection against
infection has fallen with the increased circulation of the Delta
variant. A broader study using data from 13 U.S. jurisdictions had
similar findings, observing that the protection vaccines afforded
against infection decreased from a factor of 11.1 (i.e., vaccinated
people were 11.1 times less likely than unvaccinated people to become
infected) between April 4 and June 19, 2021, to a factor of 4.6 between
June 20 and July 17, 2021 (Scobie et al., September 17, 2021). An
additional study noted, however, that the decrease in vaccine
protectiveness against symptomatic infection from the Delta variant
could be due to the waning of immunity specifically in older
populations. Andrews et al. (September 21, 2021) found that while the
Pfizer-BioNTech vaccine effectiveness decreased from 94.1% to 67.4% in
those 65 years old and older, vaccine effectiveness for those 40 to 64
years old only decreased from 92.9% to 80.6%.
While infections themselves do not normally result in serious
illness for those who are vaccinated, evidence shows that vaccinated
individuals who become infected with the Delta variant can transmit the
disease more easily to others than with previous variants. This
development poses a great concern for the unvaccinated, who generally
do not have the protections against severe outcomes that vaccination
affords. Before Delta, vaccinated individuals were shown to have lower
estimated viral loads when infected than those who were unvaccinated,
which suggested that infected vaccinated individuals were likely not a
major concern for transmission (Levine-Tiefenbrun et al., March 29,
2021). Transmission studies prior to the emergence of Delta appear to
bear this out. A Scottish study performed during a time period when the
Alpha variant was predominant in the region, showed that a fully
vaccinated individual was 3.2 times less likely than an unvaccinated
individual to transmit the virus to unvaccinated family members (Shah
et al., September 10, 2021; supplementary appendix). A population-based
study from the Netherlands found that vaccination decreased secondary
transmission to household members from 31% to 11% (de Gier et al.,
August 5, 2021). Additionally, a study from the UK found that household
transmission decreased by as much as 50% when the infected individual
was vaccinated (Harris et al., June 23, 2021).
More recent research suggests that the Delta variant may have
reduced the level of protection vaccination affords against
transmission of the virus to others, but still significantly reduces
transmission risk in comparison to infected unvaccinated individuals. A
UK study found that fully vaccinated individuals infected by the Delta
variant are able to transmit the virus to both vaccinated and, to a
greater degree, unvaccinated persons (Singanayagam et al., September 6,
2021). Still, the rate at which transmission to unvaccinated
individuals occurred was nearly double the rate of transmission to
vaccinated individuals (35.7% compared to 19.7%). Similarly, Eyre et
al., (September 29, 2021) found that during the predominance of Alpha,
full vaccination with the Pfizer-BioNTech vaccines resulted in a
significant reduction in transmission to others (an adjusted Odds Ratio
(aOR) of 0.18, meaning that being unvaccinated increased the odds of
transmission by over five times). With the rise of the Delta variant,
that reduction in transmission to others was less than with the Alpha
variant, but still significantly more than for unvaccinated individuals
(aOR of 0.35, meaning that being unvaccinated increased the odds of
transmission by almost three times).
The greater ability for vaccinated individuals to transmit the
Delta variant of SARS-CoV-2 to others (compared to previous variants)
appears to be linked to the generation of similar viral loads (as
estimated by Ct threshold) in the vaccinated compared to the
unvaccinated (Ct threshold is the number of RT-PCR cycles that need to
be run in order to amplify the RNA enough to be detected--fewer cycles
means a greater initial amount of virus was collected) (Singanayagam et
al., September 6, 2021). This observation has been made in several
studies. A study from Israel observed that viral loads among those
infected with the Delta variant were only decreased in people who had
been vaccinated recently (within the past two months) or in those who
had recently received a booster dose (Levine-Tiefenbrun et al.,
September 1, 2021). In a study of SARS-CoV-2 infections in Los Angeles
County, performed when the Delta variant was predominant, vaccination
status did not appear to affect the estimated viral loads, suggesting
that infected individuals who are vaccinated

[[Page 61419]]

may be just as likely to transmit the virus (Griffin et al., August 27,
2021). Additionally, estimated viral loads did not appear to be
significantly different with respect to vaccination status in a
Wisconsin study (Riemersma et al., July 31, 2021). Regardless of viral
loads in vaccinated and unvaccinated individuals, the fact remains
clear that unvaccinated people pose a higher risk of transmission to
others than vaccinated people, simply because they are much more likely
to get COVID-19 in the first place.
These studies, however, appear to overstate increases in
transmission risk from vaccinated individuals related to the Delta
variant. From May to July 2021, UK researchers tested individuals at
random to better characterize viral load estimates in people with
asymptomatic as well as symptomatic infections; they found that
vaccination was associated with a significantly lower estimated viral
load (Elliott et al., September 10, 2021). This more comprehensive
study (i.e., Elliott et al., September 10, 2021) may have been able to
better characterize the course of infection and to incorporate
vaccinated individuals whose viral loads were decreasing quickly. The
findings in Elliott et al. are consistent with studies observing that
viral load may fall more quickly in vaccinated individuals, resulting
in a shorter infectious period and possibly fewer transmission events
(Chia et al., July 31, 2021; Eyre et al., September 29, 2021).
c. Conclusion for the Impact of Vaccines
The studies discussed above indicate that vaccines continue to
effectively protect vaccinated individuals against SARS-CoV-2
infections, while the risk of infection, hospitalization, and death
increased among unvaccinated people as the Delta variant became
predominant in the U.S. The Delta variant is even more dangerous to
unvaccinated individuals than previous variants because of the higher
transmission potential from both unvaccinated and vaccinated people.
Because unvaccinated individuals are at much higher risk of severe
health outcomes from infection with SARS-CoV-2, and also pose a greater
transmission risk to those around them, it is critical to assure that
as many people as possible are fully vaccinated in order to prevent
transmission at work.
V. Coverage of OSHA's Grave Danger Finding
Based on the information discussed above, OSHA finds that many
unvaccinated workers across the U.S. economy are facing a grave danger
of severe health effects or death from exposure to SARS-CoV-2. Fully
vaccinated workers are not included in this grave danger finding
because, as described throughout this section, those who are fully
vaccinated are much better protected from the effects of SARS-CoV-2
and, in particular, the most severe effects, than are those who are
unvaccinated.\15\ Beyond that, OSHA's grave danger determination
exempts several categories of workers based on characteristics of their
work or workplace: (1) Workers who do not report to a workplace where
other individuals are present or who telework from home; and (2)
workers who perform their work exclusively outdoors. The basis for
these exemptions is explained below. In this section, OSHA also
addresses the basis for OSHA's grave danger finding for workers who are
unvaccinated yet had a prior COVID-19 infection, and explains the
Agency's more nuanced grave danger finding in the healthcare industry.
---------------------------------------------------------------------------

\15\ The exclusion of vaccinated workers from this grave danger
finding does not mean that vaccinated workers face no risk from
exposure to SARS-CoV-2. The best available evidence clearly shows
that vaccination provides great protection from infection and severe
outcomes, but breakthrough infections do occur and vaccinated
individuals can still transmit the virus to others. In some cases,
the level of risk to vaccinated workers may even rise to the level
of a significant risk, the standard OSHA must meet for promulgation
of a permanent standard under section 6(b)(5) of the OSH Act (29
U.S.C. 655(b)(5)).
---------------------------------------------------------------------------

a. Employees Who Telework and Employees Who Do Not Report to a
Workplace Where Other People Are Present.
Employees who report to workplaces where no other people are
present face no grave danger from occupational exposure to COVID-19
because such exposure requires the presence of other people. For those
who work from their homes, or from workplaces where no other people are
present (such as a remote worksite), the chances of being exposed to
SARS-CoV-2 through a work activity are negligible. Therefore, OSHA is
exempting those workers who do not come into contact with others for
work purposes from its grave danger finding as well as the scope of the
ETS (for more information, see the Summary and Explanation for Scope
and Application, Section VI.B. of this preamble).
b. Employees Who Work Exclusively Outside
Employees who work exclusively outside face a much lower risk of
exposure to SARS-CoV-2 at work, because their workplaces typically do
not include any of the characteristics that normally enable
transmission to occur (e.g., indoors, lack of ventilation, crowding).
Bulfone et al. attributed the lower risk of transmission in outdoor
settings (i.e., open air or structures with one wall) to increased
ventilation with fresh air and a greater ability to maintain physical
distancing (November 29, 2020). While the best available evidence
firmly establishes a grave danger in indoor settings, the CDC has
stated that the risk of outdoor transmission is ``low'' (CDC, September
1, 2021) and OSHA is unable to establish a grave danger in outdoor
settings from exposure during normal work activities.
OSHA recognizes that outdoor transmission has been identified in a
few specific incidents (e.g., 2 of 7,324 cases, Qian et al., October
27, 2020). However, general reviews of transmission studies that
include large-scale and high-density outdoor gatherings indicate that
indoor transmission overwhelmingly is responsible for SARS-CoV-2
transmission. Additionally, the lack of evidence tied to specific case
studies illustrating outdoor transmission in comparison to the bevy of
case studies on indoor transmission makes it difficult to support a
conclusion that outdoor transmission rises to the level of a grave
danger.
Bulfone et al. reviewed a collection of SARS-CoV-2 studies that
evaluated infections in outdoor and indoor settings (November 29,
2020), and found that transmission is significantly less likely to
occur in outdoor settings than in indoor settings. The studies overall
found that the risk of outdoor transmission was less than 10% of the
risk of transmission in indoor settings, with three of the studies
concluding risk was 5% or less of the risk of transmission in indoor
settings. While acknowledging significant gaps in knowledge, the
authors of a different study suggested that increases in transmission
related to large events such as the Sturgis motorcycle rally may be
related to lack of local efforts to prevent transmission indoors (e.g.,
requiring the wearing of masks, closing indoor dining), rather than the
outdoor setting for the rally (Dave et al., December 2, 2020). In
contrast, transmission rates did not increase as expected following the
Summer 2020 protests on racial injustice. This outcome was attributed,
in part, to participants having been less likely to enter indoor
commercial establishments.

[[Page 61420]]

Weed and Foad (September 10, 2020) found that transmission of SARS-
CoV-2 related to large scale outdoor gatherings could be largely
attributed to individual behaviors related to that event, such as
communal travel and indoor congregation at other facilities (e.g.,
restaurants, shared accommodations), rather than to the time spent
outdoors at those gatherings. Similarly, a Public Health England
evaluation of the literature on SARS-CoV-2 and surrogate respiratory
viruses (December 18, 2020) also concluded that when transmission does
occur at outdoor events, outdoor activities were mixed with indoor
setting use. Public Health England concluded that the vast majority of
transmission happens in indoor settings, with very little evidence for
outdoor transmission.
A systemic review of SARS-CoV-2 clusters identified 201 events
through May 26, 2020 (Leclerc et al., April 28, 2021), only 4 of which
occurred at predominantly outdoor settings. For those 4 clusters, the
authors noted that they were not able to evaluate specific transmission
events and attributed it to local health agencies being overwhelmed by
the pandemic. OSHA notes that the designations of settings in this
study are somewhat generic, as outdoor construction sites will often
have indoor locations, such as mobile offices, or locations with
reduced airflow, such as areas with a roof or ceiling and two or more
walls. Regardless, this study illustrates the comparable abundance of
evidence available to evaluate SARS-CoV-2 transmission in indoor
settings versus outdoor settings.
Cevik et al. (August 1, 2021) reviewed studies on the transmission
dynamics of SARS-CoV-2 infections from large scale, contact-tracing
studies. The authors recommended that, based on the evidence that
outdoor transmission dynamics resulted in significantly fewer
infections than in indoor settings, public health entities should
greatly encourage use of outdoor settings. The researchers highlighted
a study by Nishiura et al. (April 16, 2020), who evaluated 110 cases in
Japan at the beginning of the pandemic and found that outdoor settings
reduced transmission risk by 18.7 times and reduced the risk of super-
spreader events by 32.5 times.
Agricultural workplace settings have experienced significant SARS-
CoV-2 infections. However, transmission in these settings is difficult
to characterize because many jobs in this sector include both outdoor
and indoor activities. Miller et al. (April 30, 2021) evaluated an
outbreak among farmworkers in Washington State. The researchers found
that 28% of workers with predominantly indoor tasks where they were
unable to maintain physical distance were infected, compared to 6% of
workers who performed predominantly outdoors tasks in the orchards.
Conversely, a study on farmworkers in Monterey County, California found
a significant correlation between evidence of infection and individuals
who worked in the fields as opposed to indoor work (Mora et al.,
September 15, 2021). The paper noted that infections were predominant
in individuals who lived in crowded conditions, commuted together to
the fields, and spoke at home in indigenous languages, which is
important as written health messages are often not available in all
worker languages. These papers cannot identify where or when infections
occurred in order to discern causation. The associations observed may
indicate that SARS-CoV-2 infections may be more related to aspects
related to indoor exposures outside of the work activities (e.g.,
crowded living conditions) or potentially overlooked indoor aspects
connected to outdoor work (e.g., shared commuting).
Several studies discussed below in more detail have evaluated
outdoors on-field transmission from infected participants during
football, soccer, and rugby matches. These events include repeated
close physical contact between players, without PPE or physical
distancing, over the course of fairly long events, with increased
exertion leading to greater respiratory effort and production of
respiratory droplets. These events also include opposing cohorts who
only interact during on-field activities. Therefore, these studies
provide some evidence for the low likelihood of outdoor transmission in
other workplace activities greatly impacted by the pandemic, such as in
construction.
Mack et al. (January 29, 2021) detailed the National Football
League's complex program to assess and prevent transmission, which
included devices that recorded distance and duration of interactions
with others, for the purpose of improving identification of individuals
with high-risk exposures. Although 329 positive cases were identified
among roughly 11,400 players and staff, there were no reported cases of
on-field transmission by infected players. The results led the NFL to
focus more on reducing transmission in indoor settings, including
transportation.
Egger et al. (March 18, 2021) reviewed three soccer matches
involving 18 players who had SARS-CoV-2; one match involved a team
where 44% of the players were infected. Video analysis was used to
determine the type of contact between players, such as contact to face
or hand slaps. None of the existing cases were associated with on-field
play and no secondary transmission from on-the-field contacts was
observed. Jones et al. (February 11, 2021), evaluated four rugby Super
League matches involving eight players who were found to be infected
with SARS-CoV-2. Using video footage and global positioning data, the
researchers were able to identify 28 players as high-risk contacts with
the infected players. These high-risk players together had as many as
32 tackles and were within two meters of infected players as often as
121 times during the four matches. Of the 28 players noted as high-risk
contacts, one became infected with SARS-CoV-2. However, researchers
determined that the transmission resulted from internal team outbreaks
and not from exposure on the field.
OSHA acknowledges that the risk of transmission of SARS-CoV-2 in
outdoor settings is not zero, and that there may be some low risk to
workers performing general tasks exclusively in outdoor settings.
However, where studies have been able to differentiate between indoor
and outdoor exposures, they indicate that indoor exposures are the much
more significant drivers of SARS-CoV-2 infections. Therefore, the best
available evidence at this time does not provide OSHA with the
information needed to establish SARS-CoV-2 as a grave danger for
general work activities in outdoor settings (see Int'l Union, United
Auto., Aerospace, & Agr. Implement Workers of Am., UAW, 590 F. Supp. at
755-56, describing a ``grave danger'' as a risk that is more than
``significant''). Therefore, OSHA has excluded employees who work
exclusively outdoors from the scope of this ETS (see the Summary and
Explanation for Scope and Application, Section VI.B. of this preamble).
c. Employees in Healthcare
Because OSHA issued a separate grave danger determination several
months ago for some healthcare workers, some explanation of how its
current finding applies to healthcare workers is necessary. In June
2021, OSHA issued its Healthcare ETS (86 FR 32376) after determining
that some healthcare workers faced a grave danger of infection from
SARS-CoV-2. This grave danger determination, along with the protections
of the Healthcare ETS, applied to healthcare and healthcare support
workers in settings where

[[Page 61421]]

people with suspected or confirmed cases of COVID-19 are treated, and
was based on the increased potential for transmission of the virus in
such settings (see 86 FR 32411-32412). These workers are currently
covered by the protections of the Healthcare ETS (29 CFR 1910.502).
OSHA does not have data to demonstrate that unvaccinated workers in
settings covered by the Healthcare ETS face a grave danger from SARS-
CoV-2 when the requirements of that standard are followed. However, if
the Healthcare ETS were no longer in effect, OSHA would consider the
workers who were covered by it, and who remain unvaccinated, to be at
grave danger for the reasons described in this ETS.
OSHA's new finding of grave danger applies to healthcare and
healthcare support workers who are not covered by the Healthcare ETS,
to the extent they remain unvaccinated. In this ETS, as discussed in
this section, OSHA has made a broader determination of grave danger
that applies to most unvaccinated workers, regardless of industry.
OSHA's current finding of grave danger supporting this ETS does not
depend on whether a workplace is one where people with suspected or
confirmed COVID-19 are expected to be present. Therefore, the finding
of grave danger applies to unvaccinated workers in healthcare settings
that are not covered by 29 CFR 1910.502 to the same extent it applies
to unvaccinated workers in all other industry sectors.
d. Employees Who Were Previously Infected With SARS-CoV-2
OSHA has carefully evaluated the effectiveness of previous SARS-
CoV-2 infections in providing protection against reinfection. This
section provides a detailed description of the current scientific
information in order to ascertain what the best available scientific
evidence on this topic indicates regarding the risk to individuals with
previous COVID-19 infections from exposure to SARS-CoV-2. While the
agency acknowledges that the science is evolving, OSHA finds that there
is insufficient evidence to allow the agency to consider infection-
acquired immunity to allay the grave danger of exposure to, and
reinfection from, SARS-CoV-2.
To determine whether employees with infection-induced immunity from
SARS-CoV-2 (i.e., those who were infected with SARS-CoV-2 but have not
been vaccinated) face a grave danger, OSHA reviewed the scientific
evidence on the protective effects of vaccine-induced SARS-CoV-2
immunity versus infection-induced immunity. Individual immunity to any
infectious disease, including SARS-CoV-2, is achieved through a complex
response to exposure by the immune system. This response consists of
disease-specific antibody production guided and augmented by certain
types of immune cells, such as T and B cells, which work together to
neutralize or destroy the disease-causing agent. Immune responses to
viruses like SARS-CoV-2 can be measured in several ways. For instance,
blood serum can be taken and exposed to specific proteins found on the
SARS-CoV-2 virus, in order to measure the presence of antibodies in the
blood. Another antibody test, the neutralization test, measures the
ability of the antibodies present in a serum to neutralize infectivity
and prevent cells from being infected. T cell immunity can be measured
using techniques that target a specific biomolecule that is specific to
SARS-CoV-2.
A considerable number of individuals who were previously infected
with SARS-CoV-2 do not appear to have acquired effective immunity to
the virus (Psichogiou et al., September 13, 2021; Wei et al., July 5,
2021; Cavanaugh et al., August 13, 2021). The level of protection
afforded by infection-induced immunity appears to depend on the
severity of individuals' infections. In a study from Greece,
immunogenicity was compared between healthcare workers who were
vaccinated with Pfizer-BioNTech and unvaccinated patients who acquired
a natural infection (Psichogiou et al., September 13, 2021). The
researchers found that the immune response in unvaccinated individuals
correlated to the severity of their disease. Fully vaccinated
healthcare workers had immune responses (measured as antibody levels
specific to SARS-CoV-2) that were 1.3 times greater than patients who
had critical cases of COVID-19 cases, 2.5 times greater than patients
who had moderate to severe cases, and 10.5 times greater than patients
who had asymptomatic/mild illnesses. Similarly, another study found
that 24.0% (1,742 of 7,256) of individuals who had a previous SARS-CoV-
2 infection were seronegative (i.e., did not produce antibodies in
response to the virus), suggesting that the previous infection provided
insufficient protection against future infection (Wei et al., July 5,
2021). Individuals who were seronegative were typically older, had
lower viral burdens when infected, and were more likely to be
asymptomatic. The authors posited that the immunity of those who were
seropositive (i.e., did produce antibodies in response to the virus)
would provide some measure of protection, but that these individuals
would benefit from a vaccination booster. This position appears to be
validated by a study that compared the reinfection rates of individuals
in Kentucky based on their post-recovery vaccination status (Cavanaugh
et al., August 13, 2021). Unvaccinated individuals with previous
infection were found to be 2.3 times more likely to be reinfected than
those who were vaccinated after their prior infection. These studies
demonstrate not only that those with milder infections may not be
protected against future infection, but that it is difficult to tell,
on an individual level, which individuals might have had prior
infections that conveyed protection equivalent to that provided by
vaccination.
A number of other studies indicate that fully vaccinated
individuals may be better protected against future infection than those
with previous infections. A study in Massachusetts concluded that the
immunity conveyed from a previous SARS-CoV-2 infection was effectively
equivalent to the immunity of an uninfected individual who has had only
one dose of an mRNA vaccine (Naranbhai et al., October 13, 2021). The
authors found that fully vaccinated individuals have an immune response
(i.e., antibodies and neutralization) well above the levels observed in
unvaccinated, previously-infected individuals. German researchers found
that individuals who were fully vaccinated with Pfizer-BioNTech had a
significantly greater immune response (as measured by antibody levels)
than unvaccinated individuals who had infections, concluding that
vaccination would be needed for those unvaccinated individuals to have
similar protection against infection (Herzberg et al., June 13, 2021).
Similarly, a Dutch study observed that vaccination greatly improved the
immune response (as measured by antibodies and virus-specific T cells)
of individuals who had recovered from COVID-19 (Geers et al., May 25,
2021). Planas et al. (August 12, 2021) also noted that immune response
(as measured by neutralization) to the Alpha, Beta, and Delta
(B.1.617.2) variants in unvaccinated, previously-infected individuals
was considerably less than the immune response in individuals five
weeks after their second Pfizer-BioNTech dose. When unvaccinated,
previously-infected individuals were vaccinated, their immune response
(as measured by neutralization) increased by more than an order of
magnitude. Likewise, Wang

[[Page 61422]]

et al. (July 15, 2021) found that the immune response (as measured by
neutralization) of those with previous SARS-CoV-2 infection increased
by more than an order of magnitude against Alpha (B.1.1.7), Beta
(B.1.351), Iota (B.1.526), and Gamma (P.1) variants when they were
vaccinated. These studies show that infection-induced immunity may not
equal the protection afforded by vaccination and that vaccination
greatly improves the immune response of those who were previously
infected.
The aforementioned studies indicate that immunity acquired through
infection appears to be less protective than vaccination. There are
also a number of epidemiological studies that provide some evidence
that infection-acquired immunity has the potential to provide a
significant level of protection against reinfection. As OSHA discusses
in greater detail below, these studies suffer from methodological
limitations that render them inconclusive about the level of immunity
conferred by infection, and therefore OSHA is unable to establish that
such immunity eliminates grave danger. This determination is based in
three parts.
First, the epidemiological literature OSHA reviewed generally
suffers from selection bias to a degree that it serves as an unreliable
basis on which to reach a robust conclusion on whether previous
infection removes workers from grave danger. In general, the studies
described below do not account for people who had mild COVID-19
infections, leading to study findings regarding the level of protection
afforded by prior infection that are not generally applicable. Second,
the tests employed in the studies are being used in ways that they were
not originally designed to be employed. These tests are powerful tools,
but there are limitations to their use in determining if a specific
individual is, in fact, protected from the grave danger of SARS-CoV-2.
Particularly problematic is the lack of established thresholds to
determine full protection from reinfection or even a standardized
methodology to determine infection severity or immune response. Thus,
while these studies broadly establish some increase in protectiveness
against SARS-CoV-2 among the studied populations, they as yet are
unable to provide a reasonable degree of certainty on whether the
degree of protection afforded any particular individual from their
prior infection is sufficient to eliminate the grave danger from
reinfection (see Milne, et al., October 21, 2021.) Third, while the
research methodology itself creates difficulties in the context of
OSHA's grave danger inquiry, the implications of trying to apply
investigative research methodology to clinical practice are even more
challenging. The need for the development of standardized methods and
criteria for establishing sufficient immunity preclude the application
of the studies' findings to robust and reliable clinical practice.
These three rationales for OSHA's finding are described in more detail
below.
Several epidemiological studies used previous RT-PCR positive cases
to define previous infections (Hansen et al., March 27, 2021; Pilz et
al., February 11, 2021; Vitale et al., May 28, 2021; Pouwels et al.,
October 14, 2021; Braeye et al., September 15, 2021; Hall et al., April
17, 2021). RT-PCR tests, particularly in the beginning of the pandemic,
were given high priority to discern who seeking medical care was, in
fact, infected. For instance, the progression of testing from medical
needs to more of a community perspective is illustrated in Denmark
(Vrangbaek et al., April 29, 2021). Denmark, considered one of the gold
standard countries for its comprehensive testing program, missed five
infections for every one it identified in the spring of 2020 (Espenhaim
et al., August 22, 2021). Hansen et al. (March 27, 2021) depended
greatly on these first surge infection definitions to determine that
survivors had protection of 80.5% effectiveness during the second surge
in Denmark from September through December, 2020. By only noting RT-PCR
positives from the spring when testing was limited and highly focused
on health care needs, it seems apparent that the study excluded many
less severe cases (which are less likely to result in an effective
immune response against reinfection), leading to results that may
suggest greater protection is afforded by infection than in actuality.
Even by December of 2020, it appears Denmark's gold standard
comprehensive testing approach was only able to capture roughly half of
all infections. Similar systemic undercounts have also been determined
to be true in the United States where approximately three out of four
infections have never been reported (CDC, July 27, 2021b).
It is important to recognize that RT-PCR testing was not
implemented to find every infection, but was used instead to assist in
determining when medical and community interventions were necessary.
Infections without symptoms or with mild symptoms likely would not
require medical intervention and, therefore, would likely not be
identified via testing. The absence of this population that is more
vulnerable to reinfection, in these studies, undercuts their usefulness
in OSHA's grave danger analysis, because they may overestimate the
protectiveness of immunity acquired through infection.
Several other studies in regions less known for their sampling
approach than Denmark also were heavily dependent on early, limited
pandemic RT-PCR testing. An Austrian study found a roughly ten-fold
decrease in reinfection in survivors of reported infections from
February to April 30, 2020 in comparison with the general public (Pilz
et al., February 11, 2021). The authors noted that ``infections in the
first wave are likely to have been far more common than the documented
ones'' and referred to their results as a ``rough estimate.''
Researchers at the Cleveland Clinic also found a reduced rate of
reinfection in those who had a reported previous infection compared
with those with no prior infection (13.8% infection rate for those
previously uninfected and 4.9% infection rate for those previously
infected), but noted that testing was limited in that the ``Cleveland
Clinic did not test asymptomatic patients unless they were admitted to
hospital or undergoing a procedure/surgery'' (Sheehan et al., March 15,
2021). These criteria for testing create uncertainty in determining the
level of effectiveness previous infection provides against SARS-CoV-2
because many individuals with asymptomatic infections would not have
been tested. Similar issues are also found in studies on populations in
Italy, Belgium, and the UK (Vitale et al., May 28, 2021; Braeye et al.,
September 15, 2021; Pouwels et al., October 14, 2021).
To avoid the well-known problems with RT-PCRs defining previous
infection, other studies have defined previous infection as testing
positive for antibodies specific for SARS-CoV-2 (Lumley et al.,
February 11, 2021; Abu-Raddad et al., April 28, 2021; Hall et al.,
April 17, 2021). As noted above, previous infection does not
necessarily result in a seropositive outcome; one study indicated that
nearly a quarter (24%) of those infected with SARS-CoV-2 subsequently
showed no sign of an immune response in SARS-CoV-2-specific antibody
testing (Wei et al., July 5, 2021). Therefore, studies only considering
seropositive individuals are in essence studying only the individuals
most likely to have protection from reinfection. Lumley et al.
(February 11, 2021) found that those having a seropositive response had
almost an order of magnitude fewer infections (e.g., 0.11 adjusted
incidence rate ratio). Likewise, Abu-Raddad et al. (April 28,

[[Page 61423]]

2021) found that seropositive individuals were reinfected less (0.7%)
during their study period in comparison to seronegative individuals
(3.09%). In addition to the bias associated with using antibodies to
determine previous infection, the authors also noted that there may
have been issues with being able to document cases with mild or no
symptoms.
Hall et al. (April 17, 2021) cast a wider net by defining previous
infection to include both positive RT-PCR tests and seropositivity. The
researchers found that those who were considered previously infected
had an 84% lower risk of infection compared to those who were
unvaccinated with no record of infection. While the study does attempt
to capture as many previously-infected individuals as possible, this
does not actually address the weaknesses of each method. Those with
less severe infections were less likely to have sought out or been able
to get an RT-PCR test during the first surge, which is when an
overwhelming number of the previous infections were recorded in this
study (March through May, 2020). Additionally, the less severe
infections that are most likely underrepresented in the study appear to
be the ones that are less likely to produce seropositivity. Shenai et
al. (September 21, 2021) pooled several studies with the above issues
and concluded that immunity acquired through a previous infection from
SARS-CoV-2 may be as protective as, or more protective than, the
immunity afforded by vaccination to an individual without previous
infection. However, authors of several of those underlying studies used
in the analysis noted that their studies were limited by not having the
capability to fully account for asymptomatic infections (the
aforementioned Lumley et al., July 3, 2021; Gazit et al., August 25,
2021; Shrestha et al., June 19, 2021). As noted earlier, infection
severity appears to be correlated with the robustness of immunity
acquired through that infection, so the failure to account for
asymptomatic infections may mean that this finding is related to the
protection afforded by more severe disease. While pooled analyses can
be utilized to make powerful observations, those observations are
highly dependent upon the underlying studies not sharing the same
methodological weakness which, in this case, was the studies' exclusion
of asymptomatic infections.
Moreover, while the evidence suggests that severe infection may
provide significant protection against reinfection in some cases (Milne
et al., October 21, 2021), the level of protection cannot be determined
on an individual basis. The studies discussed above are based on tests
that show only whether a person was or was not infected and provide no
information about the severity of the infection. Because the studies
are likely biased towards those who had a relatively serious infection,
their findings cannot be generalized to all individuals with prior
infections.
RT-PCR and antibody testing are powerful tools with many clinical
and research applications. However, the application of these tools
cannot determine what degree of protection a particular individual has
against SARS-CoV-2 without a great deal of additional study concerning
thresholds establishing individual immunity. Therefore, these tools are
not yet able to assist OSHA in making more nuanced findings about which
workers who had COVID-19 previously are at grave danger. There is no
established threshold to determine full protection from reinfection or
a standardized methodology to determine infection severity or immune
response. Studies use Ct threshold to approximate viral loads and infer
disease severity, but that metric depends on many variables (e.g. time
of collection during infection, quality of collection, handling of
sample, specifics of the test protocol and materials, precision in
performing the protocol) that are often of far less importance when it
is used as a crude diagnostic to determine the presence of an
infection. In other words, it is reasonable to say that the lower the
Ct count, the greater the likelihood that an individual is at a lower
reinfection risk; however, the Ct count is greatly dependent on the RT-
PCR test used, and how different laboratories may run that test, which
cannot be discerned. Similarly, research needs to be done to better
identify the minimum protective threshold of anti-SARS-CoV-2 serum
neutralizing antibodies (Milne et al., October 21, 2021). Thus, these
studies currently do not allow OSHA to determine, with a reasonable
degree of certainty, how much protection employees with prior
infections have against reinfection.
Furthermore, while the research methodology itself raises
challenges in making the grave danger determination, the implications
of trying to apply investigative research methodology to clinical
practice are even more difficult. The lack of standardized methods and
standardized measures for immunity preclude their application to robust
and reliable clinical practice. One major drawback discussed above is
that, in contrast to vaccine studies where researchers know who was
vaccinated with a standardized dosing regime, scientific inquiries
likely will not be able to identify most individuals who were infected,
the degree of disease experienced for those with a confirmed infection,
and the immunity against reinfection. As of October 18, 2021, several
RT-PCR assays have been authorized without standardization or
assessment with respect to measuring disease severity (FDA, October 18,
2021). As noted above, the use of the Ct threshold to approximate viral
loads and infer disease severity is unreliable. As the FDA notes, the
same is true about antibody tests, which are considered to be poor
indicators for individuals to use to determine whether they are
protected from reinfection (FDA, May 19, 2021). There are many
different SARS-CoV-2-specific antibody tests that focus on different
specificity. Not only are the outcomes of these tests not directly
comparable to each other, but the specificity of these tests is not
related to any notion of protection against reinfection. It can be
reasonably said that a greater antibody response means a greater
likelihood of protection against infection, but, again, the science is
not clear what those thresholds are and whether a threshold would be
comparable between laboratories. At this point in time, even if OSHA
determined that some individuals with prior infections are not at grave
danger from exposure to SARS-CoV-2, there is no agreement on what
indicators of infection might be sufficient to confer this level of
immunity or how a healthcare provider or employer could document that a
certain level of immunity had been achieved.
Based on the best available evidence described above, OSHA
concludes that while some individuals who were infected with SARS-CoV-2
may have significant protection from subsequent infections, the level
of protection afforded by infection may be significantly impacted by
the severity of the infection and some previously infected individuals
may have no future protection at all. In addition, given the
limitations of the studies described above, there is considerable
uncertainty as to whether any given individual is adequately protected
against reinfection. Furthermore, the level of protection, if any,
provided by a given person's SARS-CoV-2 infection cannot be ascertained
based on currently-available testing methods. Therefore, OSHA finds
that the requirements of this ETS are necessary to protect unvaccinated
individuals who had prior SARS-CoV-2 infections from the grave danger
from exposure to SARS-CoV-2.

[[Page 61424]]

OSHA recognizes that its finding regarding infection-induced
immunity is being made in an area of inquiry that is currently on the
``frontiers of scientific knowledge'' (Indus. Union Dep't, AFL-CIO v.
Am. Petroleum Inst., 448 U.S. 607, 656 (1980)). For these reasons, OSHA
finds that those who have previously been infected with SARS-CoV-2 and
are not yet fully vaccinated are at grave danger from SARS-CoV-2
exposure and that it is necessary to protect these workers via
vaccination, or testing and the use of face coverings, under this
standard. OSHA will continue to follow developments on this issue,
however, and make appropriate adjustments to this ETS if the evidence
warrants.
VI. Conclusion.
OSHA finds that many employees in the U.S. who are not fully
vaccinated against COVID-19 face a grave danger from exposure to SARS-
CoV-2 in the workplace. OSHA's determination is based on the severe
health consequences of exposure to the virus, including death; powerful
lines of evidence demonstrating the transmissibility of the virus in
the workplace; and the prevalence of infections in employee
populations.
With respect to the grave health consequences of exposure to SARS-
CoV-2, OSHA has found that regardless of where and how exposure occurs,
COVID-19 can result in death. Even for those who survive a SARS-CoV-2
infection, the virus can cause serious, long-lasting, and potentially
permanent health effects. Serious cases of COVID-19 require
hospitalization and dramatic medical interventions, and might leave
employees with permanent and disabling health effects. Both death and
serious cases of COVID-19 requiring hospitalization provide independent
bases for OSHA's finding of grave danger. The evidence is clear that
the safe and effective vaccines authorized and/or approved for use in
the United States greatly reduce the likelihood of these severe
outcomes.
The best available evidence on the science of transmission of the
virus makes clear that SARS-CoV-2 is transmissible from person to
person in shared workplace settings. The likelihood of transmission can
be exacerbated by common characteristics of many workplaces, including
working indoors, working with others for extended periods of time, poor
ventilation, and close contact with potentially infectious individuals.
The likelihood of transmission in the workplace is also exacerbated by
the presence of unvaccinated workers, who are more likely than those
who are vaccinated to be infected and transmit the virus to others.
Every workplace SARS-CoV-2 exposure or transmission has the potential
to cause severe illness or even death, particularly in unvaccinated
workers. Taken together, the severe health consequences of COVID-19 and
the evidence of its transmission in environments characteristic of the
workplaces covered by this ETS demonstrate that exposure to SARS-CoV-2
represents a grave danger to unvaccinated employees in many workplaces
throughout the country.
The existence of a grave danger to employees from SARS-CoV-2 is
further supported by the toll the pandemic has already taken on the
nation as a whole and the number of workers who remain unvaccinated.
Although OSHA cannot state with precision the total number of workers
in our nation who have contracted COVID-19 at work and became sick or
died, COVID-19 has killed 723,205 people in the United States as of
October 18, 2021 (CDC, October 18, 2021--Cumulative US Deaths). That
death toll includes 131,478 people who were 18 to 64 years old, prime
working age (CDC, October 18, 2021--Demographic Trends, Deaths by Age
Group). OSHA estimates that there are over 26 million workers subject
to the rule who remain unvaccinated at present and therefore are in
grave danger. As a result of this ETS, the agency estimates that 72% of
them will be vaccinated (see OSHA, October 2021c).
Current mortality data shows that unvaccinated people of working
age have a 1 in 202 chance of dying when they contract COVID-19 (CDC,
October 18, 2021--Demographic Trends, Cases by Age Group; Demographic
Trends, Deaths by Age Group). As of October 18, 2021, close to 45
million people in the United States have been reported to have
infections, and thousands of new cases were being identified daily
(CDC, October 18, 2021--Daily Cases).One in 14 reported cases of COVID-
19 in people ages 18 to 64 becomes severe and requires hospitalization
(CDC, October 18, 2021--Demographic Trends, Cases by Age; Total
Hospitalizations, by Age). Moreover, public health officials agree that
these numbers fail to show the full extent of the deaths and illnesses
from this disease, and racial and ethnic minority groups are
disproportionately represented among COVID-19 cases, hospitalizations,
and deaths (CDC, December 10, 2020; CDC, May 26, 2021; Escobar et al.,
February 9, 2021; Gross et al., October 2020; McLaren, June 2020; CDC,
October 6, 2021). Given this context, OSHA is confident in its finding
that exposure to SARS-CoV-2 poses a grave danger to the employees
covered by this ETS.
The above analysis fully satisfies the OSH Act's requirements for
finding a grave danger. Although OSHA usually performs a quantitative
risk assessment based on extrapolations among exposure levels before
promulgating a health standard under section 6(b)(5) of the OSH Act (29
U.S.C. 655(b)(5)), that type of analysis is not necessary in this
situation. OSHA has most often invoked section 6(b)(5) authority to
regulate exposures to chemical hazards involving much smaller
populations, many fewer cases, extrapolations from animal evidence,
long-term exposure, and delayed effects. In those situations,
mathematical modelling is necessary to evaluate the extent of the risk
at different exposure levels. The gravity of the danger presented by a
disease with acute effects like COVID-19, on the other hand, is made
obvious by a straightforward count of deaths and illnesses caused by
the disease, which reach sums not seen in at least a century. The
evidence compiled above amply supports OSHA's finding that SARS-CoV-2
presents a grave danger in American workplaces. In the context of
ordinary 6(b) rulemaking, the Supreme Court has said that the OSH Act
is not a ``mathematical straitjacket,'' nor does it require the agency
to support its findings ``with anything approaching scientific
certainty,'' particularly when operating on the ``frontiers of
scientific knowledge'' (Indus. Union Dep't, AFL-CIO v. Am. Petroleum
Inst., 448 U.S. 607, 655-56 (1980)). This is true a fortiori in the
current national crisis, where OSHA must act to ensure employees are
adequately protected from the hazard presented by the COVID-19 pandemic
(see 29 U.S.C 655(c)(1)).The grave danger from SARS-CoV-2 represents
the biggest threat to employees in OSHA's more than 50-year history.
The threat applies to employees in all sectors covered by OSHA,
including general industry, construction, maritime, agriculture, and
healthcare. Having made the determination of grave danger, as well as
the determination that an ETS is necessary to protect employees from
exposure to SARS-CoV-2 (see Need for the ETS, Section III.B. of this
preamble), OSHA is required to issue this standard to protect employees
from getting sick or dying from COVID-19 acquired at work (see 29
U.S.C. 655(c)(1)).

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