COVID-19 Vaccination and Testing; Emergency Temporary Standard

Federal RegisterNov 5, 2021

Ask Donna

What actually matters in this document.

Text

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.

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-ETS@dol.gov.

Written comments.

You may submit comments and attachments, identified by Docket No. OSHA-2021-0007, electronically at

www.regulations.gov,

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

www.regulations.gov.

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

www.regulations.gov.

All comments and submissions are listed in the

www.regulations.gov

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

http://www.regulations.gov.

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

OSHAComms@dol.gov.

For technical inquiries:

Contact Andrew Levinson, OSHA Directorate of Standards and Guidance, U.S. Department of Labor; telephone (202) 693-1950; email

ETS@dol.gov.

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

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

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?

(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?

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.

https://covid.cdc.gov/covid-data-tracker/.

(CDC, October 18, 2021)

Centers for Disease Control and Prevention (CDC). (2021, September 23). Types of Masks and Respirators.

https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/types-of-masks.html.

(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.

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

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.

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

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

Mallard Bay Drilling, Inc.,

534 U.S. 235, 241 (2002).

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.

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.

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

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

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.

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.

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.

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

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.

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

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

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

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

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

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

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

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))

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.

OSHRC

, 725 F.2d 1237, 1239-40 (9th Cir. 1984); see also

Sec'y of Labor

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.

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

Centers for Disease Control and Prevention (CDC). (2021, October 18). COVID Data Tracker.

https://covid.cdc.gov/covid-data-tracker/.

(CDC, October 18, 2021)

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.

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.

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.

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.

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

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

Martin

, 984 F.2d 823 (7th Cir. 1993)). OSHA's Sanitation

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

Donovan

, 590 F. Supp. 747, 755-56 (D.D.C. 1984);

Indus. Union Dep't, AFL-CIO

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.

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,”

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.

OSHA

, 727 F.2d 415, 425 (5th Cir. 1984)).

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

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.

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

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.

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

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

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

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

). 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

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.

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.

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

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).

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.

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.

Dep't of Labor

, 486 F.2d 98, 102 n.3 (3d Cir. 1973) (holding that when OSHA determines a substance poses a grave

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

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

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.

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%).

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

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

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 (Hetemäki 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.

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; Hetemäki 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.

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.

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).

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.

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,

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

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.

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.

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.

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

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

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,

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

This text is long and has been trimmed here. Open the source document for the complete record.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.