Occupational Exposure to COVID-19; Emergency Temporary Standard
Federal RegisterJun 21, 2021
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Part 1910
[Docket No. OSHA-2020-0004]
RIN 1218-AD36
Occupational Exposure to COVID-19; 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 healthcare and healthcare support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present. During the period of the emergency standard, covered healthcare employers must develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace. Covered employers must also implement other requirements to reduce transmission of COVID-19 in their workplaces, related to the following: Patient screening and management; Standard and Transmission-Based Precautions; personal protective equipment (PPE), including facemasks or respirators; controls for aerosol-generating procedures; physical distancing of at least six feet, when feasible; physical barriers; cleaning and disinfection; ventilation; health screening and medical management; training; anti-retaliation; recordkeeping; and reporting. The standard encourages vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects. It also encourages use of respirators, where respirators are used in lieu of required facemasks, by including a mini respiratory protection program that applies to such use. Finally, the standard exempts from coverage certain workplaces where all employees are fully vaccinated and individuals with possible COVID-19 are prohibited from entry; and it exempts from some of the requirements of the standard fully vaccinated employees in well-defined areas where there is no reasonable expectation that individuals with COVID-19 will be present.
DATES:
Effective dates:
The rule is effective June 21, 2021. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of June 21, 2021.
Compliance dates:
Compliance dates for specific provisions are in 29 CFR 1910.502(s). Employers must comply with all requirements of this section, except for requirements in paragraphs (i), (k), and (n) by July 6, 2021. Employers must comply with the requirements in paragraphs (i), (k), and (n) by July 21, 2021.
Comments due:
Written comments, including comments on any aspect of this ETS and whether this ETS should become a final rule, must be submitted by July 21, 2021 in Docket No. OSHA-2020-0004. Comments on the information collection determination described in Section VII.K of the preamble (OMB Review under the Paperwork Reduction Act of 1995) may be submitted by August 20, 2021 in Docket Number OSHA-2021-003.
ADDRESSES:
In accordance with 28 U.S.C. 2112(a), the agency designates Edmund C. Baird, Associate Solicitor of Labor 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-2020-0004, 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-2020-0004). 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-2020-0004 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, Director, Office of Communications, U.S. Department of Labor; telephone (202) 693-1999; email
meilinger.francis2@dol.gov.
For technical inquiries:
Contact Andrew Levinson, Directorate of Standards and Guidance, U.S. Department of Labor; telephone (202) 693-1950.
SUPPLEMENTARY INFORMATION:
The preamble to the ETS on occupational exposure to COVID-19 follows this outline:
Table of Contents
I. Executive Summary
II. History of COVID-19
III. Pertinent Legal Authority
IV. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
V. Need for Specific Provisions of the ETS
VI. Feasibility
A. Technological Feasibility
B. Economic Feasibility
VII. Additional Requirements
VIII. Summary and Explanation of the ETS
Authority and Signature
I. 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 exposed 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 III of this preamble).
For the first time in its 50-year history, OSHA faces a new hazard so grave that it has killed nearly 600,000
people in the United States in barely over a year, and infected millions more (CDC, May 24, 2021a). And the impact of this new illness has been borne disproportionately by the healthcare and healthcare support workers tasked with caring for those infected by this disease. As of May 24, 2021, over 491,816 healthcare workers have contracted COVID-19, and more than 1,600 of those workers have died (CDC, May 24, 2021b). OSHA has determined that employee exposure to this new hazard, SARS-CoV-2 (the virus that causes COVID-19), presents a grave danger to workers in all healthcare settings in the United States and its territories where people with COVID-19 are reasonably expected to be present. This finding of grave danger is based on the science of how the virus spreads and the elevated risk in workplaces where COVID-19 patients are cared for, as well as the adverse health effects suffered by those diagnosed with COVID-19, as discussed in
Grave Danger
(Section IV.A. of this preamble).
OSHA has also determined that an ETS is necessary to protect healthcare and healthcare support employees in covered healthcare settings from exposures to SARS-CoV-2, as discussed in
Need for the ETS
(Section IV.B. of this preamble). Workers face a particularly elevated risk of exposure to SARS-CoV-2 in settings where patients with suspected or confirmed COVID-19 receive treatment or where patients with undiagnosed illnesses come for treatment (
e.g.,
emergency rooms, urgent care centers), especially when providing care or services directly to those patients. Through its enforcement efforts to date, OSHA has encountered significant obstacles, revealing that existing standards, regulations, and the OSH Act's General Duty Clause are inadequate to address the COVID-19 hazard for employees covered by this ETS. The agency has determined that a COVID-19 ETS is necessary to address these inadequacies. Additionally, as states and localities have taken increasingly more divergent approaches to COVID-19 workplace regulation—ranging from states with their own COVID-19 ETSs to states with no workplace protections at all—it has become clear that a Federal standard is needed to ensure sufficient protection for healthcare employees in all states.
The development of safe and highly effective vaccines and the on-going nationwide distribution of these vaccines are encouraging milestones in the nation's response to COVID-19. OSHA recognizes the promise of vaccines to protect workers, but as of the time of the promulgation of the ETS, vaccination has not eliminated the grave danger presented by the SARS-CoV-2 virus to the entire healthcare workforce. Indeed, approximately a quarter of healthcare workers have not yet completed COVID-19 vaccination (King et al., April 24, 2021). Nonetheless, vaccination is critical in combatting COVID-19, and the standard requires employers to provide paid leave to employees so that they can be vaccinated and recover from any side effects. Additionally, certain workplaces and well-defined areas where all employees are fully vaccinated are exempted from all of the standard's requirements, and certain fully vaccinated workers are exempted from several of the standard's requirements. OSHA will continue to monitor trends in COVID-19 infections and deaths as more of the workforce and the general population become vaccinated 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 the ETS, as appropriate.
To protect workers in the meantime, however, a multi-layered approach to controlling occupational exposures to SARS-CoV-2 in healthcare workplaces is required. As discussed in the
Need for Specific Provisions
(Section V of this preamble), OSHA relied on the best available science for its decisions concerning appropriate provisions for the ETS and its determinations regarding the kind and degree of protective actions needed to protect against exposure to SARS-CoV-2 at work and the feasibility of instituting these provisions. More specifically, the agency's analysis demonstrates that an effective COVID-19 control program must utilize a suite of overlapping controls in a layered approach to protect workers from workplace exposure to SARS-CoV-2. OSHA emphasizes that the infection control practices required by the ETS are most effective when used together; however, they are also each individually protective.
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 VI of this preamble). Table I.-1, which is derived from material presented in Section VI of this preamble, provides a summary of OSHA's best estimate of the costs and benefits of the rule using a discount rate of 3 percent. The specific requirements of the ETS are outlined and described in the
Summary and Explanation
(Section VIII of this preamble). OSHA requests comments on the provisions of the ETS and whether it should be adopted as a permanent standard.
ER21JN21.000
II. History of COVID-19
The global pandemic of respiratory disease (coronavirus disease 2019 or “COVID-19”) caused by a novel coronavirus (SARS-CoV-2) has been taking an enormous toll on individuals, workplaces, and governments around the world since early 2020. According to the World Health Organization (WHO), as of May 24, 2021, there had been 166,860,081 confirmed cases of COVID-19 globally, resulting in more than 3,459,996 deaths (WHO, May 24, 2021). In the United States as of the same date, the CDC reported over 32,947,548 cases in the United States and over 587,342 deaths due to the disease (CDC, May 24, 2021a; CDC, May 24, 2021c). Among healthcare workers specifically, as of May 24, 2021, 491,816 healthcare workers in the United States had contracted COVID-19, and at least 1,611 of those workers had died; both of those figures are likely an undercount (CDC, May 24, 2021b).
The first confirmed case of COVID-19 was identified in the Hubei Province of China in December of 2019 (Chen et al., August 6, 2020). On December 31, 2019, China reported to the WHO that it had identified several influenza-like cases of unknown cause in Wuhan, China (WHO, January 5, 2020). Soon, COVID-19 infections had spread throughout Asia, Europe, and North and South America. By February 2020, 58 other countries had reported COVID-19 cases (WHO, March 1, 2020). By March 2020, widespread local transmission of the virus was established in 88 countries. Because of the widespread transmission and severity of the disease, along with what the WHO described as alarming levels of inaction, the WHO officially declared COVID-19 a pandemic on March 11, 2020 (WHO, March 11, 2020).
The first reported case of COVID-19 in the United States was in the state of Washington, on January 21, 2020, in a person who had returned from Wuhan, China on January 15, 2020 (CDC, January 21, 2020). On January 31, 2020, the COVID-19 outbreak was declared to be a U.S. public health emergency (US DHHS, January 31, 2020). After the initial report of the virus in January 2020, a steep increase in COVID-19 cases in the U.S. was observed though March and early April. In the six weeks between March 1, 2020 and April 12, 2020, the 7-day moving average of new cases rose from only 57 to 31,779 (CDC, May 24, 2021d). The President declared the COVID-19 outbreak a national emergency on March 13, 2020 (The White House, March 13, 2020). As of March 19, 2020, all 50 states and the District of Columbia had declared emergencies related to the pandemic
(NGA, March 19, 2020; NGA, December 4, 2020; Ayanian, June 3, 2020).
The U.S. Food and Drug Administration (FDA) issued or expanded emergency use authorizations (EUAs) for three COVID-19 vaccines between December 2020 and May 2021. Currently, everyone in the United States age 12 and older is eligible to receive a COVID-19 vaccine. As of May 24, 2021, the CDC reported that 163,907,827 people had received at least one dose of vaccine and 130,615,797 people were fully vaccinated, representing 45 percent and 32.8 percent of the total U.S. population, respectively (CDC, May 24, 2021e). Vaccination rates are higher among people ages 65 and older than among the rest of the population.
Despite the relatively rapid distribution of vaccines in many areas of the U.S., a substantial proportion of the working age population remains unvaccinated and susceptible to COVID-19 infection, including approximately a quarter of all healthcare and healthcare support workers (King et al., April 24, 2021). And, as discussed in more detail in
Grave Danger
(Section IV.A. of this preamble), because workers in healthcare settings where COVID-19 patients are treated continue to have regular exposure to SARS-CoV-2 and any variants that develop, they remain at an elevated risk of contracting COVID-19 regardless of vaccination status. Therefore, OSHA has determined that a grave danger to healthcare and healthcare support workers remains, despite the fully-vaccinated status of some workers, and that an ETS is necessary to address this danger (see
Grave Danger
and
Need for the ETS
(Sections IV.A. and IV.B. of this preamble)).
References
Ayanian, JZ. (2020, June 3).
Taking shelter from the COVID storm.
JAMA Health Forum.
https://jamanetwork.com/channels/health-forum/fullarticle/2766931.
(Ayanian, June 3, 2020).
Centers for Disease Control and Prevention (CDC). (2020, January 21).
First travel-related case of 2019 novel coronavirus detected in United States. https://www.cdc.gov/media/releases/2020/p0121-novel-coronavirus-travel-case.html.
(CDC, January 21, 2020).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory: Trends in Total COVID-19 Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
(CDC, May 24, 2021a)
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
(CDC, May 24, 2021b)
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory: Trends in Total COVID-19 Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
(CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, May 24).
COVID data tracker. Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory: Daily Trends in Number of COVID-19 Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
(CDC, May 24, 2021d).
Centers for Disease Control and Prevention (CDC). (2021e, May 24).
COVID-19 Vaccinations in the United States. https://covid.cdc.gov/covid-data-tracker/#vaccinations.
(CDC, May 24, 2021e).
Chen, Y.-T, et al., (2020, August 6). An examination on the transmission of COVID-19 and the effect of response strategies: A comparative analysis. International Journal of Environmental Research and Public Health 17(16):5687.
https://www.mdpi.com/1660-4601/17/16/5687.
(Chen et al., August 6, 2020).
King, WC, et al., (2021, April 24). COVID-19 vaccine hesitancy January-March 2021 among 18-64 year old US adults by employment and occupation. medRxiv;
https://www.medrxiv.org/content/10.1101/2021.04.20.21255821v3.
(King et al., April 24, 2021).
National Governor's Association (NGA). (2020, March 19).
Coronavirus:what you need to know. https://www.nga.org/coronavirus/.
(NGA, March 19, 2020).
National Governor's Association (NGA). (2020, December 4).
Summary of state pandemic mitigation actions. https://www.nga.org/coronavirus-mitigation-actions/.
(NGA, December 4, 2020).
The White House. (2020, March 13).
Proclamation on declaring a national emergency concerning the novel coronavirus disease (COVID-19) outbreak.
https://web.archive.org/web/20200313234554/https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
(The White House, March 13, 2020).
United States Department of Health and Human Services (US DHHS). (2020, January 31).
Determination that a public health emergency exists.
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
(US DHHS, January 31, 2020).
World Health Organization (WHO). (2020, January 5).
Emergencies preparedness, response—Pneumonia of unknown cause—China. Disease outbreak news. https://www.who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/.
(WHO, January 5, 2020).
World Health Organization (WHO). (2020, March 1).
Coronavirus disease 2019 (COVID-19) situation report—41.
https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200301-sitrep-41-covid-19.pdf?sfvrsn=6768306d_2.
(WHO, March 1, 2020).
World Health Organization (WHO). (2020, March 11).
Coronavirus disease 2019 (COVID-19) situation report—51. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200311-sitrep-51-covid-19.pdf?sfvrsn=1ba62e57_10.
(WHO, March 11, 2020).
World Health Organization (WHO). (2021, May 24).
WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/table.
(WHO, May 24, 2021).
III. Pertinent Legal Authority
The purpose of the Occupational Safety and Health Act of 1970 (OSH Act), 29 U.S.C. 651
et seq.,
is “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources.” 29 U.S.C. 651(b). To this end, Congress authorized the Secretary of Labor (Secretary) to promulgate and enforce occupational safety and health standards under sections 6(b) and (c) of the OSH Act.
1
29 U.S.C. 655(b). These provisions provide bases for issuing occupational safety and health standards under the Act. Once OSHA has established as a threshold matter that a health standard is necessary under section 6(b) or (c)—
i.e.,
to reduce a significant risk of material health impairment, or a grave danger to employee health—the Act gives the Secretary “almost unlimited discretion to devise means to achieve the congressionally mandated goal” of protecting employee health, subject to the constraints of feasibility. See
United Steelworkers of Am.
v.
Marshall,
647 F.2d 1189, 1230 (D.C. Cir. 1981). A standard's individual requirements need only be “reasonably related” to the purpose of ensuring a safe and healthful working environment. Id. at 1237, 1241; see also
Forging Industry Ass'n
v.
Sec'y of Labor,
773 F.2d 1436, 1447 (4th Cir. 1985). OSHA's authority to regulate employers is hedged by constitutional considerations and, pursuant to section 4(b)(1) of the OSH Act, the regulations and enforcement policies of other
federal agencies.
Chao
v.
Mallard Bay Drilling, Inc.,
534 U.S. 235, 241 (2002).
1
The Secretary has delegated most of his duties under the OSH Act to the Assistant Secretary of Labor for Occupational Safety and Health. Secretary's Order 08-2020, 85 FR 58393 (Sept. 18, 2020). This section uses the terms Secretary and OSHA interchangeably.
The OSH 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., Inc.
v.
Donovan,
452 U.S. 490, 514 (1981);
Phelps Dodge Corp.
v.
OSHRC,
725 F.2d 1237, 1239-40 (9th Cir. 1984); see also
Sec'y of Labor
v.
Beverly Healthcare-Hillview,
541 F.3d 193 (3d Cir. 2008). Furthermore, 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.
The OSH Act states that the Secretary “shall” issue an emergency temporary standard (ETS) if he finds 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 he determines 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. For that reason, ETSs have been referred to as the “most dramatic weapon in [OSHA's] arsenal.”
Asbestos Info. Ass'n/N. Am.
v.
OSHA,
727 F.2d 415, 426 (5th Cir. 1984).
The Secretary must issue an ETS in situations where employees are exposed to a “grave danger” and immediate action is necessary to protect those employees from such danger. 29 U.S.C. 655(c)(1);
Pub. Citizen Health Research Grp.
v.
Auchter,
702 F.2d 1150, 1156 (D.C. Cir. 1983). The determination of what exact level of risk constitutes a “grave danger” is a “policy consideration that belongs, in the first instance, to the Agency.”
Asbestos Info. Ass'n,
727 F.2d at 425 (accepting OSHA's determination that eighty lives at risk over six months was a grave danger);
Indus. Union Dep't, AFL-CIO
v.
Am. Petroleum Inst.,
448 U.S. 607, 655 n.62 (1980). However, a “grave danger” represents a risk greater than the “significant risk” that OSHA must show in order to promulgate a permanent standard under section 6(b) of the OSH Act, 29 U.S.C. 655(b).
Int'l Union, United Auto., Aerospace, & Agr. Implement Workers of Am., UAW
v.
Donovan,
590 F. Supp. 747, 755-56 (D.D.C. 1984), adopted, 756 F.2d 162 (D.C. Cir. 1985); see also
Indus. Union Dep't, AFL-CIO,
448 U.S. at 640 n.45 (noting the distinction between the standard for risk findings in permanent standards and ETSs).
In determining the type of health effects that may constitute a “grave danger” under the OSH Act, the Fifth Circuit emphasized “the danger of incurable, permanent, or fatal consequences to workers, as opposed to easily curable and fleeting effects on their health.”
Fla. Peach Growers Ass'n, Inc.
v.
U.S. Dep't of Labor,
489 F.2d 120, 132 (5th Cir. 1974). Although the findings of grave danger and necessity must be based on evidence of “
actual,
prevailing industrial conditions,” see
Int'l Union,
590 F. Supp. at 751, OSHA need not wait for deaths to occur before promulgating an ETS, see
Fla. Peach Growers Ass'n.,
489 F.2d at 130. When OSHA determines that exposure to a particular hazard would pose a grave danger to workers, OSHA can assume an exposure to a grave danger wherever that hazard is present in a workplace.
Dry Color Mfrs. Ass'n, Inc.
v.
Department of Labor,
486 F.2d 98, 102 n.3 (3d Cir. 1973). In demonstrating that an ETS is necessary, the Fifth Circuit considered whether OSHA had shown that there were no other means of addressing the risk than 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).
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.
American Dental Ass'n
v.
Martin,
984 F.2d 823, 831 (7th Cir. 1993) (“the duty of a reviewing court of generalist judges is merely to patrol the boundary of reasonableness”). These determinations are “essentially legislative and rooted in inferences from complex scientific and factual data.”
Pub. Citizen Health Research Grp.,
702 F.2d at 1156. The agency is not required to support its conclusions “with anything approaching scientific certainty” and has the “prerogative to choose between conflicting evidence.”
Indus. Union Dep't, AFL-CIO,
448 U.S. at 656;
Asbestos Info. Ass'n,
727 F.2d at 425.
The determinations of the Secretary in issuing standards under section 6 of the OSH Act, including ETSs, must be affirmed if supported by “substantial evidence in the record considered as a whole.” 29 U.S.C. 655(f). The Supreme Court described substantial evidence as “ `such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.' ”
Am. Textile Mfrs. Inst.,
452 U.S. at 522-23 (quoting
Universal Camera Corp.
v.
NLRB,
340 U.S. 474, 477 (1951)). The Court also noted that “ `the possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency's finding from being supported by substantial evidence.' ”
Am. Textile Mfrs. Inst.,
452 U.S. at 523 (quoting
Consolo
v.
FMC,
383 U.S. 607, 620 (1966)). The Fifth Circuit, recognizing the size and complexity of the rulemaking record before it in the case of OSHA's ETS for organophosphorus pesticides, stated that a court's function in reviewing an ETS to determine whether it meets the substantial evidence standard is “basically [to] determine whether the 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).
It is crucial to note that the language of section 6(c)(1) is not discretionary: The Secretary “shall” provide for an ETS when OSHA makes the prerequisite findings of grave danger and necessity.
Pub. Citizen Health Research Grp.,
702 F.2d at 1156 (noting the mandatory language of section 6(c)). OSHA is entitled to great deference in its determinations, and it must also account for “the fact that `the interests at stake are not merely economic interests in a license or a rate structure, but personal interests in life and health.' ” Id. (quoting
Wellford
v.
Ruckelshaus,
439 F.2d 598, 601 (D.C. Cir. 1971)).
IV. Rationale for the ETS
A. Grave Danger
I. Introduction
On January 31, 2020, the Secretary of Health and Human Services (HHS) declared COVID-19 to be a public health emergency in the U.S. under section 319 of the Public Health Service Act. The World Health Organization declared COVID-19 to be a global health emergency on the same day. President Donald Trump declared the COVID-19 outbreak to be a national emergency on March 13, 2020 (The White House, March 13, 2020). HHS renewed its declaration of COVID-19 as a public health emergency effective April 21, 2021 (HHS, April 15, 2021).
2
2
HHS declarations of public health emergencies last for 90 days and then can be considered for renewal (
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
).
Consistent with these declarations, and in carrying out its legal duties under the OSH Act, OSHA has determined that healthcare employees face a grave danger from the new hazard of workplace exposures to SARS-CoV-2 except under a limited number of situations (
e.g.,
a fully vaccinated workforce in a breakroom).
3
The virus is both a physically harmful agent and a new hazard, and it can cause severe illness, persistent health effects, and death (morbidity and mortality, respectively) from the subsequent development of the disease, COVID-19.
4
OSHA bases its grave danger determination on evidence demonstrating the lethality of the disease, the serious physical and psychiatric health effects of COVID-19 morbidity (in mild-to-moderate as well as in severe cases), and the transmissibility of the disease in healthcare settings where people with COVID-19 are reasonably expected to be present. The protections of this ETS—which will apply, with some exceptions, to healthcare settings where people may share space with COVID-19 patients or interact with others who do—are designed to protect employees from infection with SARS-CoV-2 and from the dire, sometimes fatal, consequences of such infection.
3
References in this preamble to healthcare employees and healthcare workers indicate those employees covered by the protections in the ETS, including employees providing healthcare support services.
4
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 these two terms interchangeably in some parts of this preamble.
The fact that COVID-19 is not a uniquely work-related hazard does not change the determination that it is a grave danger to which employees are exposed, nor does it excuse employers from their duty to protect employees from the occupational transmission of SARS-CoV-2. The OSH Act is intended to “assure so far as possible every working man and woman in the Nation safe and healthful working conditions,” 29 U.S.C. 651(b), and there is nothing in the Act to suggest that its protections do not extend to hazards which might occur outside of the workplace as well as within. Indeed, COVID-19 is not the first hazard that OSHA has regulated that occurs both inside and outside the workplace. For example, the hazard of noise is not unique to the workplace, but the Fourth Circuit has upheld OSHA's Occupational Noise Exposure standard, 29 CFR 1910.95 (
Forging Industry Ass'n
v.
Secretary,
773 F.2d 1437, 1444 (4th Cir. 1985)). Diseases caused by bloodborne pathogens, including HIV/AIDS and hepatitis B, are also not unique to the workplace, but the Seventh Circuit upheld the majority of OSHA's Bloodborne Pathogens standard, 29 CFR 1910.1030 (
Am. Dental Ass'n
v.
Martin,
984 F.2d 823 (7th Cir. 1993)). 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, healthcare employees providing care directly to known or suspected COVID-19 patients are required to have close contact with infected individuals, and other employees in those settings also work in an environment in which they have little control over their ability to limit contact with individuals who may be infected with COVID-19 even when not engaged in direct patient care. Accordingly, even though SARS-CoV-2 is a hazard to which employees are exposed both inside and outside the workplace, healthcare employees in workplaces where individuals with suspected or confirmed COVID-19 receive care have limited ability to avoid exposure resulting from a work setting where those individuals are present. OSHA has a mandate to protect employees from hazards they are exposed to at work, even if they may be exposed to similar hazards before and after work.
As described above in Section III, Legal Authority, “grave danger” indicates a risk that is more than “significant” (
Int'l Union, United Auto., Aerospace, & Agr. Implement Workers of Am., UAW
v.
Donovan,
590 F. Supp. 747, 755-56 (D.D.C. 1984);
Indus. Union Dep't, AFL-CIO
v.
Am. Petroleum Inst.,
448 U.S. 607, 640 n.45, 655 (1980) (stating that a rate of 1 worker in 1,000 workers suffering a given health effect constitutes a “significant” risk)). “Grave danger,” according to one court, refers to “the danger of incurable, permanent, or fatal consequences to workers, as opposed to easily curable and fleeting effects on their health” (
Fla. Peach Growers Ass'n, Inc.
v.
U. S. Dep't of Labor,
489 F.2d 120, 132 (5th Cir. 1974)). Fleeting effects were described as nausea, excessive salivation, perspiration, or blurred vision and were considered so minor that they often went unreported, which is in contrast to the adverse health effects of cases of COVID-19, which are formally referenced as ranging from “mild” to “critical.”
5
Beyond this, however, “the determination of what constitutes a risk worthy of Agency action is a policy consideration that belongs, in the first instance, to the Agency” (
Asbestos Info.
Ass'n/N. Am.
v.
OSHA,
727 F.2d 415, 425 (5th Cir. 1984)).
5
Definitions of severity of COVID-19 illness used in this document are found in the National Institutes of Health's COVID-19 treatment guidelines (
https://www.covid19treatmentguidelines.nih.gov/overview/clinical-spectrum/
) (NIH, December 17, 2020).
In the context of ordinary 6(b) rulemaking, the Supreme Court has said that the OSH Act is not a “mathematical straitjacket,” nor does it require the agency to support its findings “with anything approaching scientific certainty,” particularly when operating on the “frontiers of scientific knowledge” (
Indus. Union Dep't, AFL-CIO
v.
Am. Petroleum Inst.,
448 U.S. 607, 656, 100 S. Ct. 2844, 2871, 65 L. Ed. 2d 1010 (1980)). Courts reviewing OSHA's determination of grave danger do so with “great deference” (
Pub. Citizen Health Research Grp.
v.
Auchter,
702 F.2d 1150, 1156 (D.C. Cir. 1983)). In one case, the Fifth Circuit, in reviewing an OSHA ETS for asbestos, declined to question the agency's finding that 80 worker lives at risk over six months constituted a grave danger (
Asbestos Info. Ass'n/N. Am.,
727 F.2d at 424). In stark contrast, as of May 24, 2021, 1,611 healthcare personnel have died (out of 491,816 healthcare COVID-19 cases where healthcare personnel status and death status is known by the CDC) (May 24, 2021a). This is likely an undercount of cases and deaths as the healthcare personnel status is not known for 81.63% of cases and death status is unknown in 20.42% of cases where healthcare personnel status is known. OSHA estimates that this rule would save almost 800 worker lives over the course of the next six months as noted in Table I.-1 in the
Executive Summary.
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.
OSHA's previous ETSs addressed physically harmful agents that had been familiar to the agency for many years prior to the ETS. In most cases, the 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)). In no case did OSHA claim that an ETS was required to address a grave danger from a substance that had only recently come into existence. Thus, no court has had occasion to separately 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, SARS-CoV-2 was not known to exist until January 2020. Since then, more than 3 million people have died worldwide and nearly 600,000 people have died in the U.S. alone (WHO, May 24, 2021; CDC, May 24, 2021b). This monumental tragedy is largely handled by healthcare employees who provide care for those who are ill and dying, leading to introduction of the virus not only in their daily lives in the community but also in their workplace, and more than a thousand healthcare workers have died from COVID-19. Clearly, exposure to SARS-CoV-2 is a new hazard that presents a grave danger to workers in the U.S.
In the following sections within
Grave Danger,
OSHA summarizes the best available scientific evidence on employee exposure to SARS-CoV-2 and shows how that evidence establishes COVID-19 to be a grave danger to healthcare employees. OSHA's determination that there is a grave danger to healthcare employees rests on the severe health consequences of COVID-19, the high risk to employees of developing the disease as a result of transmission of SARS-CoV-2 in the workplace, and that these workplace settings provide direct care to known or suspected COVID-19 cases. With respect to the health consequences of COVID-19, OSHA finds a grave danger to employees based on mortality data showing unvaccinated people of working age (18-64 years old) have a 1 in 217 chance of dying when they contract the disease (May 24, 2021c; May 24, 2021d). When broken down by age range, that includes a 1 in 788 chance of dying for those aged 30-39, a 1 in 292 chance of dying for those aged 40-49, and as much as a 1 in 78 chance of dying for those aged 50-64 (May 24, 2021c; May 24, 2021d). Furthermore, workers in racial and ethnic minority groups are often over-represented in many healthcare occupations and face higher risks for SARS-CoV-2 exposure and infection, as noted in a study on workers in Massachusetts (Hawkins, June 15, 2020) and discussed in more detail in the section “Observed Disparities in Risk Based on Race and Ethnicity,” below. While vaccination greatly reduces adverse health outcomes to healthcare workers, it does not eliminate the grave danger faced by vaccinated healthcare workers in settings where patients with suspected or confirmed COVID-19 receive treatment (CDC, April 27, 2021; Howard, May 22, 2021).
OSHA also finds a grave danger based on the severity and prevalence of other health effects caused by COVID-19, short of death. While some SARS-CoV-2 infections are asymptomatic, even the cases labeled “mild” by the CDC involve symptoms that far exceed in severity the group of symptoms dismissed in the
Florida Peach Growers Ass'n
decision as not rising to the level of grave danger required by the OSH Act (
i.e.,
minor cases of nausea, excessive salivation, perspiration, or blurred vision) (489 F.2d at 132). Even “mild” cases of COVID-19—where hypoxia (low oxygen in the tissues) is not present—require isolation and may require medical intervention and multiple weeks of recuperation, while severe cases of COVID-19 typically require hospitalization and a long recovery period (see the section on “Health Effects,” below). For example, in a study of 1,733 patients, three quarters of remaining hospitalized cases and approximately half of all symptomatic cases resulted in the individual continuing to experience at least one symptom (
e.g.,
fatigue, breathing difficulties) at least six months after initial infection (Huang et al., January 8, 2021; Klein et al., February 15, 2021). These cases might be referred to as “long COVID” because symptoms persist long after recovery from the initial illness, and could potentially be significant enough to negatively affect an individual's ability to work or perform other everyday activities.
Finally, OSHA concludes that the serious and potentially fatal consequences of COVID-19 pose a particular threat to employees, as the nature of SARS-CoV-2 transmission readily enables the virus to spread when employees are working in spaces shared with others (
e.g.,
co-workers, patients, visitors), a common characteristic of healthcare settings where direct care is provided. While not every setting is represented in the evidence that OSHA has assembled, the best available evidence illustrates that clusters and outbreaks
6
of COVID-19 have occurred in a wide variety of occupations in healthcare settings. The scientific
evidence of SARS-CoV-2 transmission, presented below, makes clear that the virus can be spread wherever an infectious person is present and shares space with other people, and OSHA therefore expects transmission across healthcare workplaces where known or suspected COVID-19 patients are treated (see
Dry Color Mfrs. Ass'n, Inc.
v.
Dep't of Labor,
486 F.2d 98, 102 n.3 (3d Cir. 1973) (holding that when OSHA determines a substance poses a grave danger to workers, OSHA can assume an exposure to a grave danger wherever that substance is present in a workplace)). OSHA's conclusion that there is a grave danger to which employees are specifically exposed is further supported by evidence demonstrating the widespread prevalence of the disease across the country generally. As of May 2021, over 32 million cases of COVID-19 have been reported in the United States (CDC, May 24, 2021e). Over 1 in 11 people of working age have been reported infected (cases for individuals age 18-64, CDC, May 24, 2021d; estimated number of people ages 15-64, Census Bureau, June 25, 2020). And data shows that employees across a myriad of workplace settings have suffered death and serious illness from COVID-19 through the duration of the pandemic (WSDH and WLNI, December 17, 2020; Allan-Blitz et al., December 11, 2020; Marshall et al., June 30, 2020).
7
From May 18, 2021 to May 24, 2021, COVID-19 resulted in 4,216 cases and nine deaths for healthcare personnel each day (CDC, May 18, 2021; CDC, May 24, 2021a). Thus, COVID-19 continues to present a grave danger to the nation's healthcare employees.
6
“Outbreaks” are generally defined as an increase, often sudden, in the number of cases of a disease above what is normally expected in a limited geographic area. “Clusters” are generally defined as an unusual number of cases grouped in one place that is more than expected to occur (CDC, May 18, 2012). Researchers investigating outbreaks and have to decide how to define the geographic area, while researchers investigating clusters may use a variety of strategies to determine what is “unusual.” While the terms are slightly different, their overall significance to the grave danger discussion is the same. For the studies and reports relied upon in this section, OSHA will generally use whichever term is used in the study or report itself.
7
Of note, on February 25, 2021, the Superior Court of California issued a decision denying a motion for a preliminary injunction seeking to restrain the California Occupational Safety and Health Standards Board from enforcing a COVID-19 ETS promulgated on November 30, 2020 (
Nat'l Retail Fed'n
v.
Cal. Dep't of Indus. Relations, Div. of Occupational Safety & Health,
Case Nos. CGC-20-588367, CPF-21-517344 (Cal. Super. Ct., Feb. 25, 2021)). In its decision, the court found that COVID-19 presents an emergency to employees, noting that any argument to the contrary was “fatuous” (id. at 17). The court found that “the virus spreads
any place
where persons gather and come into contact with one another—whether it happens to be an office building, a meatpacking plant, a wedding reception, a business conference, or an event in the Rose Garden of the White House. Workplaces, where employees often spend eight hours a day or more in close proximity to one another, are no exception, which of course is why the pandemic has emptied innumerable office buildings, stores, shopping centers, restaurants, and bars around the world” (id. at 17-18 (emphasis in original) (footnotes omitted)).
References
Allan-Blitz, LT et al., (2020, December 11). High frequency and prevalence of community-based asymptomatic SARS-CoV-2 infection.medRxivpre-print.
https://www.medrxiv.org/content/10.1101/2020.12.09.20246249v1.
(Allan-Blitz et al., December 11, 2020).
Centers for Disease Control and Prevention (CDC). (2021, April 27).
Updated healthcare infection prevention and control recommendation in response to COVID-19 vaccination. https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-after-vaccination.html.
(CDC, April 27, 2021).
Centers for Disease Control and Prevention (CDC). (2021, May 18).
COVID Data Tracker: Cases & deaths among healthcare personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
(CDC, May 18, 2021).
Centers for Disease Control and Prevention (CDC). (2021a, May 24).
Cases & Deaths among Healthcare Personnel. https://covid.cdc.gov/covid-data-tracker/#health-care-personnel.
(CDC, May 24, 2021a).
Centers for Disease Control and Prevention (CDC). (2021b, May 24).
COVID data tracker.
Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory: Trends in Total COVID-19 Deaths in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
(CDC, May 24, 2021b).
Centers for Disease Control and Prevention (CDC). (2021c, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported to CDC: Deaths by age group. https://covid.cdc.gov/covid-data-tracker/#demographics
(CDC, May 24, 2021c).
Centers for Disease Control and Prevention (CDC). (2021d, May 24).
Demographic Trends of COVID-19 cases and deaths in the US reported to CDC: Cases by age group. https://covid.cdc.gov/covid-data-tracker/#demographics
(CDC, May 24, 2021d).
Centers for Disease Control and Prevention (CDC). (2021e, May 24).
COVID data tracker.
Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory: Trends in Total COVID-19 Cases in the United States Reported to CDC. https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases.
(CDC, May 24, 2021e).
Census Bureau. (2020, June 25).
Annual estimates of the resident population for selected age groups by sex for the United States: April 2010 to July 1, 2019. https://www2.census.gov/programs-surveys/popest/tables/2010-2019/national/asrh/nc-est2019-agesex.xlsx.
(Census Bureau, June 25, 2020).
Hawkins, D. (2020, June 15). Differential occupational risk for COVID-19 and other infection exposure according to race and ethnicity. American Journal of Industrial Medicine 63:817-820.
https://doi.org/10.1002/ajim.23145.
(Hawkins, June 15, 2020).
Howard, J. (2021). “Response to request for an assessment by the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, of the current hazards facing healthcare workers from Coronavirus Disease-2019 (COVID-19).” (Howard, May 22, 2021).
Huang, C et al., (2021, January 8). 6-month consequences of COVID-19 in patients discharged from hospital: A cohort study. The Lancet 397:220-232.
https://doi.org/10.1016/S0140-6736(20)32656-8.
(Huang et al., January 8, 2021).
Klein, H et al., (2021, February 15). Onset, duration and unresolved symptoms, including smell and taste changes, in mild COVID-19 infections: A cohort study in Israeli patients. Clinical Microbiology and Infection 27(5):769-774.
https://doi.org/10.1016/j.cmi.2021.02.008.
(Klein et al., February 15, 2021).
Marshall, K et al., (2020, June 30). Exposure before issuance of stay-at-home orders among persons with laboratory-confirmed COVID-19—Colorado, March 2020. Morbidity and Mortality Weekly Report: 69(26):847-9. (Marshall et al., June 30, 2020).
United States Department of Health and Human Services (US DHHS). (2021, April 15).
Renewal of Determination That A Public Health Emergency Exists. https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-15April2021.aspx.
(HHS, April 15, 2021).
Washington State Department of Health and Washington State Department of Labor and Industries (WSDH and WDLI). (2020, December 17).
COVID-19 confirmed cases by industry sector.
Publication Number 421-002.
https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/data-tables/IndustrySectorReport.pdf.
(WSDH and WDLI, December 17, 2020).
The White House. (2020, March 13).
Proclamation on declaring a national emergency concerning the novel coronavirus disease (COVID-19) outbreak.
https://web.archive.org/web/20200313234554/https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
(The White House, March 13, 2020).
World Health Organization (WHO). (2021, May 24).
WHO Coronavirus Disease (COVID-19) Dashboard. https://covid19.who.int/table.
(WHO, May 24, 2021).
II. Nature of the Disease
a. Health and Other Adverse Effects of COVID-19
Death From COVID-19
COVID-19 is a potentially fatal disease. As of May 24, 2021, there had been 587,432 deaths from the disease out of 32,947,548 million infections in the United States alone (CDC, May 24, 2021a; CDC, May 24, 2021b). For the U.S. population as a whole (
i.e.,
unlinked to known SARS-CoV-2
infections) as of May 24, 2021, 1.8 out of every 1,000 people have died from COVID-19 (CDC, May 24, 2021a). COVID-19 was the third leading cause of death in the United States in 2020 among those aged 45 to 84, trailing only heart disease and cancer (Woolf, January 12, 2021). During the surges in the spring and fall/winter of 2020, COVID-19 was the leading cause of death. Despite a decrease in recent weeks, the death rate remains high (7-day moving average death rate of 500 on May 23, 2021) (CDC, May 24, 2021c). Not only are healthcare employees included in these staggering figures, they are exposed to COVID-19 at a much higher frequency than the general population while providing direct care for both sick and dying COVID-19 patients during their most infectious moments.
The impact of morbidity and mortality on healthcare employees might also be underreported. The information associated with cases and deaths are incomplete. Only 18.37% of cases were reported with information on whether or not the infected individual was a healthcare employee (CDC, May 24, 2021d). For those who were identified as healthcare personnel, only 79.58% of these cases noted whether the individual survived the illness (CDC, May 24, 2021d). Despite the incomplete data, the toll on healthcare personal is clear. As of May 24, 2021, CDC reported 491,816 healthcare personnel cases (10% of cases that included information on healthcare personnel status) and 1,611 fatalities (0.4% of healthcare employee cases with known death status). This number is staggering when compared with, for example, the 2018-2019 influenza season, during which only 0.1% of known influenza infections were estimated to be fatal for the entire population (CDC, October 5, 2020).
The risk of mortality and morbidity from COVID-19 has changed, and may continue to change over time. Viruses mutate and those mutations can result in variants of concern that may be more transmissible, cause more severe illness, or impact diagnostics, treatments, or vaccines (CDC, May 5, 2021). For example, the UK's New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) issued a report on how risk might have changed with the development of a new variant there called “B.1.1.7” (February 11, 2021). The group determined that analysis from multiple different datasets indicated that B.1.1.7 infections resulted in an increased risk of hospitalization and death compared with the ancestral virus and other variants in circulation. Challen et al., (March 10, 2021) found that B.1.1.7 increased mortality risk by 64%. As virus mutations result in variants of concern, the effectiveness of medical countermeasures such as therapeutics and vaccines might be affected. Lastly, depending on the variant, potential immune escape properties of the virus may increase a person's susceptibility to reinfection.
Severe and Critical Cases of COVID-19
Apart from mortality, COVID-19 causes significant morbidity that can result in incurable, permanent, and non-fleeting consequences. As discussed below, people who become ill with COVID-19 might require hospitalization and specialized treatment, and can suffer respiratory failure, blood clots, long-term cardiovascular effects, organ damage, and significant neurological and psychiatric effects. Approximately 6.7% of COVID-19 cases are severe and require hospitalization and more specialized care (total hospitalizations and total cases, CDC, May 24, 2021e; CDC, May 24, 2021f). Given that this is a novel virus, long-term effects are still unknown. A severe case of COVID-19 is described as when the patient presents with hypoxia and is in need of oxygen therapy (NIH, April 21, 2021a). Cases become critical when respiratory failure, septic shock, and/or multiple organ dysfunction occurs.
The majority of the data currently available on the health outcomes for hospitalized patients is derived from the first surge of the pandemic between March and May of 2020. However, newer data indicates that health outcomes for hospitalized patients have changed over the course of the pandemic. A study from Emory University reviewed COVID-19 patient data from a large multi-hospital healthcare network and compared the data from the first surge early in the pandemic (March 1 to May 30, 2020) with the second surge that occurred in the summer of 2020 (June 1 to September 13, 2020) (Meena et al., March 1, 2021). The study found that during the second surge, ICU admission decreased from 38% to 30%, ventilator use decreased from 26% to 15%, and mortality decreased from 15% to 9%. The study authors postulated that improved patient outcomes during the second stage may have resulted in part from aggressive anticoagulation therapies to prevent venous thromboembolism.
Similar findings were reported in a retrospective study of 20,736 COVID-19 patients admitted to 107 hospitals in 31 states from March through November 2020 (Roth et al., May 3, 2021). The proportions of patients placed on mechanical ventilation dropped from 23.3% in March and April 2020 to 13.9% in September through November 2020. During those same respective time periods, mortality rates dropped from 19.1% to 10.8%. The reasons for the reductions in mechanical ventilation and mortality are not known, but study authors postulated that reductions in mechanical ventilation may have resulted from increased use of noninvasive ventilation, high flow nasal oxygen, and prone positioning. They hypothesized that the high patient count and staff unfamiliarity with infection control procedures that were being rapidly implemented in March and April could have accounted for the high mortality rate during that period. In addition, the authors noted that changes in pharmacology treatments occurred during that time period, but their impact on improved outcomes is not known.
This data on improvements in health outcomes between earlier and later stages of the pandemic is significant, but also demonstrates that overall health outcomes for hospitalized COVID-19 patients still remain poor. Even with these improvements in health outcomes, COVID-19 still results in considerable loss of life and significant adverse health outcomes for patients hospitalized with COVID-19. The COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), which conducts population-based surveillance in select U.S. counties, reported a cumulative hospitalization rate of 1 in 255 people between the ages of 18 and 49 as well as 1 in 123 people between the ages of 50 and 64 between March 1, 2020, and May 15, 2021 (CDC, May 24, 2021g).
Patients hospitalized with COVID-19 frequently need supplemental oxygen and supportive management of the disease's most common complications, which are discussed in further detail below and include pneumonia, respiratory failure, acute respiratory distress syndrome (ARDS), acute kidney injury, sepsis, myocardial injury, arrhythmias, and blood clots. Among 35,302 inpatients in a nationwide U.S. study, median length of stay was 6 days overall (Rosenthal, et al., December 10, 2020). When cases required treatment in the ICU, ICU stays were on median 5 days in addition to time spent hospitalized outside of the ICU. The Roth et al., (May 3, 2021) study described above reported that mean length of hospital stays decreased from 10.7 days in April and May 2020 to 7.5 days from September to November 2020, and the respective values for ICU stays over the same time period decreased from 13.9 days to 6.6 days. As discussed
in more detail above, improvements in infection control and treatment interventions might be responsible for the improved outcome, but the specific reason is not known, and the numbers of individuals hospitalized with COVID-19 remains high.
The pneumonia associated with the SARS-CoV-2 virus can become severe, resulting in respiratory failure and ARDS, a life-threatening lung injury. In a U.S. study of 35,302 COVID-19 inpatients, 55.8% suffered respiratory failure with 8.1% experiencing ARDS (Rosenthal, et al., December 10, 2020). Thus, the need for oxygen therapy is a key reason for hospitalization. The specific therapy received during hospitalization often depends on the severity of lung distress and can include supplemental oxygen, noninvasive ventilation, intubation for invasive mechanical ventilation, and extracorporeal membrane oxygenation when mechanical ventilation is insufficient (NIH, April 21, 2021a).
Although COVID-19 was initially considered to be primarily a respiratory disease, adverse effects in numerous organs have now been reported. For example, in a New York City area study of 9,657 COVID-19 patients, 39.9% of patients developed acute kidney injury (AKI), a sudden episode of kidney failure or kidney damage; of the approximately 40% of patients who developed AKI, 17% required dialysis (Ng et al., September 19, 2020). AKI similarly occurred in 33.9% of 35,302 inpatients in a nationwide U.S. study (Rosenthal et al., December 10, 2020). For patients who experience AKI associated with COVID-19, a study of patients in the New York area reported a median length of stay in the hospital of 11.6 days for patients who did not require dialysis, but for those who did, the median length of stay almost tripled to 29.2 days (Ng et al., September 19, 2020). Many critically ill COVID-19 patients require renal replacement therapy (NIH, April 21, 2021a). For example, one study including 67 U.S. hospitals found that 20.6% of critically ill COVID-19 patients developed AKI that requires renal replacement therapy (Gupta et al., 2021).
COVID-19 is also capable of causing viral sepsis, a condition where the immune response dysregulates and causes life-threatening harm to organs (
e.g.,
lungs, brain, kidneys, heart, and liver). In Rosenthal et al.'s, (December 10, 2020) U.S. study through May 31, 2020, 33.7% of COVID-19 inpatients developed sepsis. A study of 18-49 year olds in the COVID-NET surveillance system found that 16.6% of patients in that age range developed sepsis (Owusu et al., December 3, 2020). In a study of VA hospitals, sepsis was found to be the most common complication that resulted in readmission within 60 days of being discharged (Donnelly et al., January 19, 2020).
COVID-19 patients have also been reported to experience a number of adverse cardiac complications, including arrhythmias, myocardial injury with elevated troponin levels, and myocarditis (Caforio, December 2, 2020). Acute ischemic heart disease occurred in 8% of 35,302 inpatients in a nationwide U.S. study (Rosenthal et al., December 10, 2020). Patients hospitalized with COVID-19 may also experience shock, a critical condition caused by a sudden drop in blood pressure that can lead to fatal cardiac complications. Shock occurred in 4,028 of 35,302 (11.4%) inpatients in a nationwide U.S. study (Rosenthal et al., December 10, 2020). And a study of 70 COVID-19 patients in a Freiburg ICU found that shock was a complicating factor in 24% of fatal cases (Rieg et al., November 12, 2020). A New York City area study reported that 21.5% of the study's 9,657 patients experience serious drops in blood pressure that required medical intervention during their hospital stay (Ng et al., September 19, 2020).
In addition to its adverse effects on specific organs, COVID-19 may cause patients to develop a hypercoagulable state, a condition in which blood clots can develop in someone's legs and embolize to their lungs, further worsening oxygenation. Blood clots in COVID-19 patients have also been reported in arteries, resulting in strokes—even in young people—as well as heart attacks and acute ischemia from lack of oxygen in limbs in which arterial clots have occurred (Cuker and Peyvandi, November 19, 2020; Oxley et al., May 14, 2020). Blood clots have been reported even in COVID-19 patients on prophylactic-dose anticoagulation. A systematic review of more than 28,000 COVID-19 patients found that venous thromboembolism (deep vein thrombosis, pulmonary embolism or catheter-related thrombosis) occurred in 14% of hospitalized patients overall and 22.7% of ICU patients (Nopp et al., September 25, 2020). Pulmonary embolism was reported in 3.5% of non-ICU and 13.7% of ICU patients. Embolism and thrombosis can cause death. COVID-19 poses such a threat of blood clots that NIH guidelines now recommend that hospitalized non-pregnant adults with COVID-19 should receive prophylactic dose anticoagulation (NIH, April 21, 2021a).
These health effects are particularly relevant to healthcare workers because there is evidence that healthcare workers are more likely to develop more severe COVID-19 symptoms than workers in non-healthcare settings. While the reason for this is not certain, one cause could be that healthcare workers are exposed to higher viral loads (more viral particles entering the body) because of the nature of their work often involving frequent and sustained close contact with COVID-19 patients. For example, a British study compared healthcare workers to other “essential” and “non-essential” workers and found that healthcare workers were more than 7 times as likely to experience severe COVID-19 disease following infection (
i.e.,
disease requiring hospitalization) than infected non-essential workers (Mutambudzi et al., 2020).
Mild to Moderate Cases of COVID-19
Even the less severe health effects of COVID-19 cover a wide range of symptoms and severity, from serious illness to milder symptomatic illness to asymptomatic cases. The most common symptoms include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, developing a loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, and/or diarrhea (CDC, February 22, 2021).
Approximately 80% of symptomatic COVID-19 cases are mild to moderate (Wu and McGoogan, April 7, 2020), which is defined as having any symptom of COVID-19 but without substantially decreased oxygen levels, shortness of breath, or difficulty breathing (NIH, April 21, 2021b). Moderate cases, however, also show evidence of lower respiratory disease, although these cases largely do not require admission into hospitals (CDC, February 16, 2021). While deaths and severe health consequences of COVID-19 are sufficiently robust in support of OSHA's finding that COVID-19 presents a grave danger, even many of the typical mild or moderate cases surpass the
Florida Peach Growers
threshold of “fleeting effects . . . so minor that they often went unreported” (supra). Mild and moderate cases can be treated at home but may still require medical intervention (typically through telehealth visits) (Wu and McGoogan, April 7, 2020). Individuals with mild cases often need at least one to two weeks to recover enough to resume work, but effects can potentially last for months. Fatigue, headache, and muscle aches are among the most commonly-reported symptoms in people who are
not hospitalized (CDC, February 16, 2021), and their effects are not fleeting and often linger. In a multistate telephone survey of 292 adults with COVID-19, the majority of whom did not eventually require hospitalization, 274 (94%) of the survey respondents were symptomatic at the time of their SARS-CoV-2 test, reporting illness for a median of three days prior to the positive test (Tenforde et al., July 24, 2020). Around one third of symptomatic respondents (95 of 274) reported that they still had not returned to their usual state of health 2-3 weeks after testing positive. Even among the young adults (aged 18-34 years) with no chronic medical conditions, nearly one in five had not returned to their usual state of health 2-3 weeks after testing.
Even though these cases rarely result in hospitalization, individuals with mild to moderate cases of COVID-19 are also significantly impacted by their illness as a result of CDC isolation recommendations. According to the current CDC criteria, a person with symptomatic COVID-19 should generally discontinue isolation only when all three of the following conditions have been met: (1) At least 10 days have passed since symptom onset; (2) at least 24 hours have passed since experiencing a fever without the use of fever-reducing medications; and (3) other symptoms have improved (other than loss of taste or smell) (CDC, February 18, 2021). And the CDC notes with respect to the first criteria that individuals with severe illness or with compromised immunity might require up to 20 days of isolation. Even those with mild or moderate cases of COVID-19 may be prevented by their illness from working from home during the period of isolation.
Longer-Term Health Effects
Recovery from acute infection with the SARS-CoV-2 virus can be prolonged. Three categories of patients in particular are known to require ongoing care after resolution of their acute viral infection: Those with a severe illness requiring hospitalization (especially ICU care); those with a specific medical complication from the infection, such as a stroke; and those with milder acute illnesses who experience persistent symptoms such as fatigue and breathlessness. The lingering of, or development of, related health effects after a SARS-CoV-2 infection is known as post-acute sequelae. Dr. Francis Collins, Director of the National Institutes of Health, testified that recovery can be prolonged even in previously healthy young adults with milder infections. Some people experience persistent symptoms for weeks or even months after the acute infection (Collins, April 28, 2021). Post-Acute COVID-19 syndrome has been proposed as a diagnostic term for these patients, although the term “long COVID” is more common outside the medical community. According to the CDC, the most common symptoms of Post-Acute COVID-19 syndrome are fatigue, shortness of breath, cough, and joint and chest pain (CDC, April 8, 2020). Other symptoms reported by these patients include decreased memory and concentration, depression, muscle pain, headache, intermittent fever, and racing heart (CDC, April 8, 2021). Additional common symptoms, as reported by Dr. Collins, are abnormal sleep patterns and persistent loss of taste or smell (Collins, April 28, 2021). The cause of these long-term effects and effective treatments have yet to be established. The report from the Pulmonary Breakout Session of the National Institute of Allergy and Infectious Diseases (NIAID) Workshop on Post-Acute Sequelae of COVID-19 stated that the “burden of post-acute sequelae overall could be enormous” (NIAID, December 4, 2020). Dr. John Brooks, the chief medical officer for the CDC's COVID-19 response, said he expected long-term symptoms would affect “on the order of tens of thousands in the United States and possibly hundreds of thousands” (Belluck, December 5, 2020). Dr. Collins testified that longer-term health impairments may occur in up to 30% of recovered COVID-19 patients (Collins, April 28, 2021).
Prolonged illness is common in patients who required hospitalization because of COVID-19, and particularly in those who required ICU admission. In a large nationwide U.S. study, 18.5% of hospitalized patients were discharged to a long-term care or rehabilitation facility (Rosenthal et al., December 10, 2020). Of 1,250 patients in a Michigan study, 12.6% were discharged to a skilled nursing or rehabilitation facility and 15.1% of hospital survivors were re-hospitalized within 60 days of discharge (Chopra et al., November 11, 2020). Of the 195 who were employed prior to hospitalization, 23% were unable to return to work due to health reasons and 26% of those who returned to work required reduced hours or modified duties (Chopra et al., November 11, 2020). Those who returned to work did so a median of 27 days after hospital discharge (Chopra et al., November 11, 2020). Existing evidence indicates that COVID-19 patients requiring ICU care and mechanical ventilation may experience Post Intensive Care Syndrome (PICS), which is a constellation of cognitive dysfunction, psychiatric conditions, and/or physical disability that persists after patients leave the ICU (Society of Critical Care Medicine, 2013). In a study at 3 months post-discharge of 19 COVID-19 patients who required mechanical ventilation while hospitalized, 89% reported pain or discomfort, 47% experienced decreased mobility, and 42% experienced anxiety/depression (Valent, October 10, 2020). The authors noted that these results are similar to those reported in follow-up studies of patients who survived ARDS due to other viral infections. Many employees hospitalized with COVID-19 may require a long period of recovery should this trajectory continue to hold. In a 5-year follow-up of 67 previously-employed ARDS survivors, 34 had not returned to work within one year of discharge and 21 had not returned at five years (Kamdar, February 1, 2018). ARDS is a serious complication that may have an impact on employees' ability to return to work after a COVID-19 diagnosis.
Several studies conducted outside the U.S. have also noted the persistence of COVID-19 symptoms after hospital discharge. In a study of 1,733 discharged patients in China, 76% reported at least one symptom of COVID-19 six months after hospital discharge with 63% experiencing persistent fatigue or muscle weakness (Huang et al., January 8, 2021). Similarly, an Irish study found 52% of 128 patients reported persistent fatigue a median of 10 weeks after initial symptoms first appeared (Townsend et al., November 9, 2020). A study of 991 pregnant women (5% hospitalized) in the U.S. found that the median time for symptoms to resolve was 37 days and that 25% had persistent symptoms (mainly cough, fatigue, headache, and shortness of breath) eight weeks after onset (Afshar et al., December, 2020). A study of 86 previously-hospitalized Austrian patients observed that 88% had CT scans still indicating lung damage at 6 weeks after their hospital discharge; at 12 weeks, 56% of CT scans still revealed damage (European Respiratory Society, September 7, 2020). A study of 152 previously-hospitalized patients with laboratory-confirmed COVID-19 disease who required at least 6 liters of oxygen during admission found that 30 to 40 days after discharge, 74% reported shortness of breath and 13.5% still required oxygen at home (Weerahandi et al., August 14, 2020). A UK study found that among 100
hospitalized patients (32% required ICU care), 72% of the ICU patients and 60% of the non-ICU patients reported fatigue a mean of 48 days after discharge (Halpin et al., July 27, 2020). Breathlessness was also common, affecting 65.6% of ICU patients and 42.6% of non-ICU patients.
In a New York City study, of the 638 COVID-19 patients who required dialysis for AKI while hospitalized, only 108 survived. Of those 108, 33 still needed dialysis at discharge (Ng et al., September 19, 2020). A study of Chinese patients reported that 11% of 333 hospitalized patients with COVID-19 pneumonia developed AKI (Pei et al., June, 2020). Only half (45.7%) experienced complete recovery of kidney function with a median follow up of 12 days. A similar study in Spain also found only half (45.72%) experienced complete recovery with a median follow up of 11 days (Procaccini et al., February 14, 2021). A Hong Kong study provided a longer follow-up period including 30 and 90 days after the initial AKI event. At 7, 30, and 90 days after the initial AKI event, recovery was observed in 84.6, 87.3% and 92.1%, respectively (Teoh et al., 2021). A study in New York City found that 77.1% of patients with AKI experienced complete recovery during the follow up period, excluding those who died or were sent to hospice (Charytan et al., January 25, 2021). While 88% of these AKI cases were in March and April with a final follow-up date of August 25, it is uncertain how long it took for recovery to occur.
Long-term cardiovascular effects also appear to be common after SARS-CoV-2 infections, even among those who did not require hospital care. A German study evaluated the presence of myocardial injury in 100 patients a median of 71 days after COVID-19 diagnosis (Puntmann et al., July 27, 2020). While only a third (33%) of study participants required hospitalization, cardiovascular magnetic resonance (CMR) imaging was abnormal in 78%. In the U.S., a study of COVID-19 cases in college athletes, of whom 16 of 54 (30%) were asymptomatic, identified abnormal findings in 27 (56.3%) of the 48 athletes who completed both imaging studies, with 39.5% consistent with resolving pericardial inflammation (Brito et al., November 4, 2020). A small number remained symptomatic with fatigue and shortness of breath at 5 weeks and were referred to cardiac rehabilitation (Lowry, November 12, 2020).
A database for clinicians in the UK to report COVID-19 patients with neurological complications revealed that 62% of the initial 125 patients enrolled presented with a cerebrovascular event including ischemic strokes and intracerebral hemorrhages (Varatharaj et al., June 25, 2020). A UK study comparing COVID-19 ischemic stroke and intracerebral cases with similar non-COVID-19 cases found a fatality rate of 19.8% for COVID-19 patients in comparison to a fatality rate of 6.9% for non-COVID-19 patients (Perry et al., 2021). As discussed above, PICS, involving prolonged impairments in cognition, physical health, and/or mental health, may also occur. Other neurologic diagnoses, including encephalopathy, Guillain-Barre syndrome, and a range of other less-common diagnoses, may cause morbidity that persists during recovery (Elkind et al., April 9, 2021; Sharifian-Dorche et al., August 7, 2020). A recent autopsy study of brain tissue from 18 COVID-19 patients reported the presence of small blood vessel inflammation and damage in multiple different brain areas (Lee et al., February 4, 2021). Persistent abnormalities in brain imaging have also been reported in patients after discharge (Lu et al., August 3, 2020). A study of 509 hospitalized patients in the Chicago area early in the pandemic reported that a third had encephalopathy, resulting in symptoms such as confusion or decreased levels of consciousness (Liotta et al., October 5, 2020). Encephalopathy was associated with worse functional outcomes at discharge (only 32% were able to handle their own affairs without assistance) and higher deaths in the 30 days post-discharge.
COVID-19 also impacts mental health, both as a result of the toll of living and working through such a disruptive pandemic, but also because of actual medical impacts the virus might have on the brain itself. As de Erausquin et al., (January 5, 2021) notes, SARS-CoV-2 is a suspected neurotropic virus and “neurotropic respiratory viruses have long been known to result in chronic brain pathology including emerging cognitive decline and dementia, movement disorders, and psychotic illness. Because brain inflammation accompanies the most common neurodegenerative disorders and may contribute to major psychiatric disorders, the neurological and psychiatric sequelae of COVID‐19 need to be carefully tracked.” An international consortium guided by WHO is attempting to determine these long-term neurodegenerative consequences more definitively, with follow up studies ending in 2022 (de Erausquin et al., January 5, 2021).
In the short term, a number of studies have already demonstrated the potential mental health effects caused by COVID-19. In the UK database mentioned above, 21 of 125 COVID-19 patients had new psychiatric diagnoses, including 10 who became psychotic and others with dementia-like symptoms or depression (Varatharaj et al., June 25, 2020). An Italian study screened 402 adults with COVID-19 for psychiatric symptoms with clinical interviews and self-report questionnaires at one month follow-up after hospital treatment for COVID-19. Patients rated in the psychopathological range as follows: 28% for post-traumatic stress disorder (PTSD), 31% for depression, 42% for anxiety, 20% for obsessive-compulsive symptoms, and 40% for insomnia. Overall, 56% scored in the pathological range in at least one clinical dimension (Mazza et al., July 30, 2020). The TriNetX analytics network was used to capture de-identified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States (Taquet et al., November 9, 2020). Of those patients, 62,354 adults were diagnosed with COVID-19 between January 20 and August 1, 2020. Within 14 to 90 days after being diagnosed with COVID-19, 5.8% of those patients received a first recorded diagnosis of psychiatric illness, which was measured as significantly greater than psychiatric onset incidence during the same time period after diagnoses of other medical issues including influenza (2.8%), other respiratory diseases (3.4%), skin infections (3.3%), cholelithiasis (3.2%), urolithiasis (2.5%), and fractures (2.5%). At the NIAID Workshop on Post-Acute Sequelae of COVID-19, medical personnel discussed their experiences treating COVID-19 patients in the Johns Hopkins Post-Acute COVID-19 Team (PACT) Clinic. Among 49 patients in the Clinic, more than 50% had some form of cognitive impairment 3 months after acute illness (Parker, December 3, 2020). Both ICU and non-ICU patients were affected, but impairment was more pronounced in ICU survivors (Parker, December 3, 2020). The medical personnel also reported mental health impairments among patients treated at the PACT Clinic.
The studies and evidence discussed above give some indication of the many serious long-term health effects COVID-19 patients might experience, including respiratory, cardiovascular, neurological, and psychiatric complications. However, the full extent of the long-term health consequences of COVID-19 is unknown because the
virus has only been transmitted between humans since the end of 2019. Therefore, to fully appreciate the likely long-term risks to individuals with COVID-19, it is important to consider the long-term impacts of similar coronaviruses found among human populations where there has been more time to gather data.
The previous SARS outbreak in 2002 to 2003, caused by the SARS-CoV-1 virus, is one such example, and it indicates long-term impacts to infection survivors, which might result from the viral infection, medications used, or a combination of those factors. Patients who survived a SARS-CoV-1 infection report that they have a reduced quality of life at least 6 months after illness (Hui et al., October 1, 2005). These patients were found to have reduced exercise capacity; some had abnormal chest radiographs and lung function, and weak respiratory muscles at least 6 months after illness (Hui et al., October 1, 2005). Survivors reported experiencing depression, insomnia, anxiety, PTSD, chronic fatigue, and decreased lung capacity with patient follow up as long as four years after infection (Lam et al., December 14, 2009; Lee et al., April 1, 2007; Hui et al., October 1, 2005). Long term studies have revealed that some survivors of SARS-CoV-1 infections have chronic pulmonary and skeletal damage after a 15 year follow up (Zhang et al., February 14, 2020). Zhang et al., found that approximately half of the area of ground glass opacities present after infection in a 2003 CT scan (9.4%) remained after 15 years (4.6%). The study also found significant femoral head loss (25.52%) remained in 2018. Bone loss was likely an indirect effect caused by the high pulse steroid therapies used to treat the infection in many patients with severe disease. Survivors also suffer long-term neurologic complications, deficits in cognitive function, musculoskeletal pain, fatigue, depression, and disordered sleep up to at least three years after infection (Moldofsky and Patcai, March 24, 2011).
Individuals at Increased Risk From COVID-19
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. Comorbidities are fairly 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). Furthermore, over a quarter of those between 65 and 74 years old remain in the workforce, as well as almost 10% of those 75 and older (BLS, May 29, 2019). In hospitals and other health services (
e.g.,
physician offices, residential care facilities), 1,078,000 workers are employed who are 65 years old and older (BLS, January 22, 2021). Individuals who are at increased risk of severe infection (hospitalization, admission to the ICU, or death) include: Individuals who have cancer, chronic kidney disease, chronic lung disease (
e.g.,
chronic obstructive pulmonary disease (COPD), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension), serious heart conditions, obesity, pregnancy, sickle cell disease, type 2 diabetes, and individuals who are over 65 years of age, immunocompromised and/or smokers (CDC, May 13, 2021). Of 5,700 COVID-19 patients hospitalized from March 1 to April 4, 2020 in the New York City area, the most common comorbidities were hypertension (56.6%), obesity (41.7%), and diabetes (33.8%), excluding age (Richardson et al., April 22, 2020).
Observed Disparities in Risk Based on Race and Ethnicity
During the COVID-19 pandemic, research has found that employees in racial and ethnic minority groups, and especially Black and Latinx employees, have often faced substantially higher risks of SARS-CoV-2 exposure and infection through the workplace than have non-Hispanic White employees (Hawkins, June 15, 2020; Hertel-Fernandez et al., June 2020; Roberts et al., November 26, 2020). Among the general U.S. population, American Indian, Alaskan Native, Latinx, and Black populations are more likely than White populations to be infected with SARS-CoV-2 (CDC, April 23, 2021). Once infected, people in these demographics are also more likely than their White counterparts to be hospitalized for and/or die from COVID-19 (CDC, April 23, 2021). These observed disparities in risk of infection, risk of adverse health consequences, and risk of death may be attributable to a number of factors, including that people from racial and ethnic minority groups are often disproportionately represented in essential frontline occupations that require close contact with the public and that offer limited ability to work from home or take paid sick days. Disease severity is also likely exacerbated by long-standing healthcare inequities (CDC, April 19, 2021).
Hawkins (June 15, 2020) compared data on worker demographics from the Bureau of Labor Statistics' 2019 Current Population Survey and O*NET (a Department of Labor database that contains detailed occupational information on the nature of work for more than 900 occupations across the U.S.) to determine occupation-specific COVID-19 risks. The model found that among O*NET's 57 physical and social factors related to work, the two predictive variables of COVID-19 risk were frequency of exposure to diseases and physical proximity to other people. The author found that Black individuals were overwhelmingly employed in essential industries and that people of color—which in this study included Black, Asian, and Hispanic populations—were more likely than White individuals to work in essential occupations (
e.g.,
healthcare and social assistance, personal care aids) that were identified as having greater disease exposure risk characteristics. A similar evaluation of workers employed in frontline industries (
e.g.,
healthcare) found that people of color—defined in this study to include individuals who are Black, Hispanic, Asian-American/Pacific Islander, or some category other than White—are well represented in these types of work (Rho et al., April 7, 2020). These studies suggest that people in racial and ethnic minority groups are greatly represented among the American workforce in jobs associated with greater risk of exposure to SARS-CoV-2, including those in healthcare and related industries.
Through April 2021, infection rates compared to White, Non-Hispanic persons in the United States are 60% greater for American Indian or Alaskan Native persons, 100% greater for Latinx persons, and 10% greater for Black persons (CDC, April 23, 2021). This disparity is also reflected in studies addressing infections by occupation, race, and ethnicity. In a large study of healthcare employees in Los Angeles, researchers found that increased risk of infection was significantly related to whether an employee was Latinx or Black (Ebinger et al., February 12, 2021). Another study of frontline healthcare workers in the U.S. and UK found that Black, Asian, and minority ethnic workers were more likely to report a positive COVID-19 test than non-Hispanic, White workers (Nguyen et al., September 1, 2020). The study also found that Black, Asian, and minority ethnic healthcare workers were more likely to report reuse of or inadequate PPE, were more likely to work in higher-risk clinical settings (
e.g.,
in-patient hospitals or nursing homes), and were more likely to care for patients with
suspected or documented COVID-19. These studies illustrate that racial and ethnic minorities are likely to be at increased risk of occupational SARS-CoV-2 exposures and related infections.
In addition to an increased likelihood of exposures and potential infection, Native American, Alaskan Native, Latinx, and Black populations all have increased risk of hospitalization and/or death from COVID-19 in comparison to White populations (CDC, April 23, 2021). Chen et al., (January 22, 2021) studied increased mortality risk between different racial and ethnic minority groups and occupations for working age Californians in pre-pandemic and pandemic time frames. Measured mortality risks increased during the pandemic for all races and ethnicities, but White populations had lower increased risk (6% increase) compared to Asian populations (18%), Black populations (28%) and Latinx populations (36%). A similar disparity in excess mortality was also observed between races and ethnicities within the same occupational sector (Chen et al., January 22, 2021). In the “health or emergency” sector, risk ratios were far greater for Asian (1.40), Black (1.27), and Latinx (1.32) workers in comparison to White workers (1.02).
Health equity is a major concern in assessing the pandemic's effects (CDC, April 19, 2021). Some of the factors that contribute to increased risk of morbidity and mortality from COVID-19 include: Discrimination, healthcare access/utilization, economic issues, and housing (CDC, April 23, 2021). And although racial and ethnic minority groups are more likely to be exposed to and infected with SARS-CoV-2, research indicates that testing for the virus is not markedly higher for these demographic groups (Rubin-Miller et al., September 16, 2020). Rubin-Miller et al., note that there may be barriers to testing that decrease access or delay testing to a greater degree than in White populations. These barriers to testing can delay needed medical care and lead to worse outcomes. And even when able to seek care, other barriers may exist. In discussing widespread health inequities, studies have noted that American Indian communities lacked sufficient facilities to respond to COVID-19 (Hatcher et al., August 28, 2020; van Dorn et al., April 18, 2020).
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b. Transmission of SARS-CoV-2
SARS-CoV-2 is a highly transmissible virus. Since the first case was detected in the U.S., there have been over 32 million reported cases of COVID-19, affecting every state and territory, with thousands more infected each day. 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).
8
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, May, 2021).
8
On May 7, 2021, the CDC updated its guidance regarding airborne transmission (CDC, May 7, 2021;
https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html
). OSHA notes that this change does not alleviate the need for any of the controls in this ETS. Because OSHA has determined that the controls in this ETS are necessary to address a grave danger as quickly as possible, the agency determined that it was appropriate to issue the ETS while it continues to evaluate the new evidence to determine whether additional controls may be necessary at a later date.
The best available current scientific evidence demonstrates that the farther a person is away from the source of the respiratory droplets, the fewer infectious viral particles will reach that person's eyes, nose, or mouth because gravity pulls the droplets to the ground (see the
Need for Specific Provisions,
Section V of the preamble, on Physical Distancing). For example, a systematic review of SARS-CoV-2 (up to early May 2020) and similar coronaviruses (
i.e.,
SARS-CoV-1 (a virus related to SARS-CoV-2) and Middle Eastern Respiratory Syndrome (MERS) (a disease caused by a virus that is similar to SARS-CoV-2 and spreads through droplet transmission)) found 38 studies, containing 18,518 individuals, to use in a meta-analysis that found that the risk of viral infection decreased significantly as distance increased (Chu et al., June 27, 2020). A second COVID-19 study from Thailand reviewed physical distancing information collected from 1,006 individuals who had an exposure to infected individuals (Doung-ngern et al., September 14, 2020). The study revealed that the group with direct physical contact and the group within one meter but without physical contact were equally likely to become infected with SARS-CoV-2. However, the group that remained more than one meter away had an 85% lower infection risk than the other two groups. The studies' findings on physical distancing combined with expert opinion firmly establish the importance of droplet transmission as a driver of SARS-CoV-2 infections and COVID-19 disease.
COVID-19 may also be spread through airborne particles under certain conditions (Schoen, May 2020; CDC, May 7, 2020; Honein et al., December 11, 2020). That airborne transmission can occur during aerosol-generating procedures (AGPs) in healthcare (such as when intubating an infected patient) is a reasonable concern (see CDC, March 12, 2020). CDC provides recommendations for infection prevention and control practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection that include the use of a respirator (CDC, February 23, 2021). There are several studies examining the risks associated with AGPs. For example, a publication detailing one of the first known SARS-CoV-2 occupational transmission events in U.S. healthcare providers reported a statistically significant increased risk from AGPs (Heinzerling et al., April 17, 2020). However, the currently available information specifically related to SARS-CoV-2 exposure during AGPs is limited (Harding et al., June 1, 2020).
Data from the Respiratory Protection Effectiveness Trial (ResPECT), designed to assess effectiveness of PPE to prevent respiratory infections, were analyzed to identify risk factors for endemic coronavirus infections among healthcare personnel (Cummings et al., July 9, 2020). This study found that AGPs may double the risk of infection among healthcare providers. Although the infectious agents studied were surrogate coronaviruses and not the SARS-CoV-2 virus, the study indicates increased risk from such procedures for infections from the coronavirus family, and thus the study is relevant. In addition, a systematic review of research on transmission of acute respiratory infections from patients to healthcare employees focused on publications from the first SARS virus outbreak (Tran et al., April 26, 2012). Risks of SARS-CoV-1 infection in those performing AGPs were several times higher than in healthcare workers not exposed to AGPs. Workers may also be exposed to the SARS-CoV-2 virus during AGPs conducted outside of the hospital setting, including certain dental surgical procedures (Leong et al., December 2020), cardiopulmonary resuscitation (CPR) provided by homecare workers (Payne and Peache, February 4, 2021), and endoscopy (Teng et al., September 16, 2020; Sagami et al., January 2021).
Risk from AGPs during autopsies is evident from reports of staff infections during autopsies on decedents infected with tuberculosis, which is a well-known airborne infectious agent (Nolte et al., December 14, 2020). Additionally, research that measured airborne particles released during the use of an oscillating saw with variable saw blade frequencies and different saw blade contact loads concluded that, even in the best-case scenario tested on dry bone, the number of aerosol particles produced was still high enough to provide a potential health risk to forensic practitioners (Pluim et al., June 6, 2018). Other reports from healthcare settings have raised the possibility of spread of airborne particles from suspected or confirmed COVID-19 patients, absent AGPs. For example, infectious viral particles were collected from in the room of a COVID-19 patient from distances as far as 4.8 meters away in non-AGP hospital settings (Lednicky et al., September 11, 2020), and transmission via aerosol was suspected in a Massachusetts hospital (Klompas et al., February 9, 2021). For more discussion of this subject, see the
Need for Specific Provisions
(Section V of the preamble) on Respirators.
The extent to which COVID-19 may spread through airborne particles in other contexts is less clear. CDC has noted that in some circumstances airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes) in situations that would not be defined as involving close contact:
With increasing distance from the source, the role of inhalation likewise increases. Although infections through inhalation at distances greater than six feet from an infectious source are less likely than at closer distances, the phenomenon has been repeatedly documented under certain preventable circumstances. These transmission events have involved the presence of an infectious person exhaling virus indoors for an extended time (more than 15 minutes and in some cases hours) leading to virus concentrations in the air space sufficient to transmit infections to people more than 6 feet away, and in some cases to people who have passed through that space soon after the infectious person left.
(CDC, May 7, 2021).
In general, enclosed environments, particularly those without good ventilation, increase the risk of airborne transmission (CDC, May 7, 2021; Tang et al., August 7, 2020; Fennelly, July 24, 2020). In one scientific brief, CDC provides a basic overview of how airborne transmission occurs in indoor spaces. Once respiratory droplets are exhaled, CDC explains, they move outward from the source and their concentration decreases through fallout from the air (largest droplets first, smaller later) combined with dilution of the remaining smaller droplets and particles into the growing volume of air they encounter (CDC, May 7, 2020). Without adequate ventilation, continued exhalation can cause the amount of infectious smaller droplets and particles produced by people with COVID-19 to become concentrated enough in the air to spread the virus to other people (CDC, May 7, 2020). For example, an investigation of a cluster of cases among meat processing employees in Germany found that inadequate ventilation within the facility, including low air exchange rates and constant air recirculation, was one key factor that led to transmission of SARS-CoV-2 within the workplace (Gunther et al., October 27, 2020). An epidemiological investigation of a cluster of COVID-19 cases in an indoor athletic court in Slovenia demonstrated that the humid and warm environment of the setting, combined with the turbulent air flow that resulted from the physical activity of the players, allowed COVID-19 particles to remain suspended in the air for hours (Brlek et al., June 16, 2020). A cluster of cases in a restaurant in China also suggested transmission of SARS-CoV-2 via airborne particles because of little mixing of air throughout the restaurant (Li et al., November 3, 2020). Infections have been observed with as little as five minutes of exposure in an enclosed room (Kwon et al., November 23, 2020). Outdoor settings (
i.e.,
open air or structures with one wall) typically have a lower risk of transmission (Bulfone et al., November 29, 2020), which is likely due to increased ventilation with fresh air and a greater ability to maintain physical distancing. For more discussion of this subject, see the
Need for Specific Provisions
(Section V of the preamble) on Ventilation.
Transmission of SARS-CoV-2 is also possible via contact transmission (both direct contact as well as surface contact), though this risk is generally considered to be low compared to other forms of transmission (CDC, April 5, 2021). Infectious droplets produced by an infected person can land on and contaminate surfaces. Surface, or indirect, transmission can then occur if another person touches the contaminated surface and then touches their own mouth, nose, or eyes (CDC, April 5, 2021). Contact transmission can also occur through direct contact with someone who is infectious. In direct contact transmission, the hands of a person who has COVID-19 can become contaminated with the virus when the person touches their face, blows their nose, coughs, or sneezes. The virus can then spread to another person through direct contact such as a handshake or a hug.
The risk posed by contact transmission depends on a number of factors, including airflow and ventilation, as well as environmental factors (
e.g.,
heat, humidity), time between surface contamination and a person touching those surfaces, the efficiency of transference of virus particles, and the dose of virus needed to cause infection. Studies show that the virus can remain viable on surfaces in experimental conditions for hours to days, but that under typical environment conditions 99% of the virus is no longer viable after three days (Riddell et al., October 7, 2020; van Doremalen, April 16, 2020; CDC, April 5, 2021). At this time, it is not clear what proportion of SARS-CoV-2 infection are acquired through contact transmission and infections can often be attributed to multiple transmission pathways.
In recognition of the potential for contact transmission, CDC recommends cleaning, hand hygiene, and, under certain circumstances, disinfection for helping to prevent transmission of SARS-CoV-2 (CDC, May 17, 2020; CDC, April 5, 2021). These are long established recommendations to prevent the transmission of viruses that cause respiratory illnesses (Siegel et al., 2007). The potential for contact transmission was demonstrated in one study that reviewed cleaning and disinfection in households (Wang et al., May 11, 2020). The study found that the transmission of SARS-CoV-2 to family members was 77% lower when chlorine- or ethanol-based disinfectants were used on a daily basis compared to use only once in two or more days, irrespective of other protective measures taken such as mask wearing and physical distancing. For more discussion of this subject, see the
Need for Specific Provisions
(Section V of the preamble) on Cleaning and Disinfection.
These methods of transmission are not mutually exclusive, and each can present a risk to employees in healthcare settings. Based on these methods of transmission, there are a number of factors—often present in healthcare settings—that can increase the risk of transmission: Indoor settings, prolonged exposure to respiratory particles, and lack of proper ventilation (CDC, May 7, 2020). First, and most significantly, healthcare employees in settings where patients with suspected or confirmed COVID-19 receive treatment may be required to have frequent close contact with infectious individuals, these settings are typically not designed for physical distancing, and many areas in these facilities are not ventilated for the purpose of minimizing infectious diseases capable of droplet or airborne transmission. Employees frequently touch shared surfaces and use shared items. Even in healthcare settings where employees have their own offices or equipment, they often share a number of common spaces with other workers, including bathrooms, break rooms, and elevators. Based on these characteristics, SARS-CoV-2 appears to be transmissible in healthcare environments, a conclusion supported by existing data (Howard, May 22, 2021). COVID-19 incidence rates have increased significantly for adults of working age as the pandemic has progressed in comparison with other age groups, with researchers noting that occupational status might be a driver (Boehmer et al., September 23, 2020). Currently, case rates continue to be predominantly higher in working age groups in comparison to children and those over the age of 65 (CDC, May 24, 2021).
Given the high transmissibility expected in healthcare environments, the exposure risk that employees face is high. This risk is related to some extent to viral prevalence, which refers to the number of individuals in healthcare settings who may be infectious at any moment. As explained below, current data indicates that viral prevalence in the population is based on a number of factors, including the virus's existing reproductive number, the prevalence of pre-symptomatic and asymptomatic transmission, and the recent documentation of mutations of the virus that appear to be more infectious.
The transmissibility of viruses is measured in part by their reproductive number or “R0.” This number represents the average number of subsequently-infected people (or secondary cases) that are expected to occur from each existing case, which includes low transmission events as well as super-spreading phenomenon. Thus, an R0 of “1” indicates that on average every one case of infection will
lead to one additional case. As long as a virus has an R0 of more than 1, it is expected to continue to spread throughout the population. The observed R0 (also known as simply R) must be below 1 to prevent sustained spread; such a reduction can be achieved through infection control interventions (
e.g.,
vaccination, non-pharmaceutical interventions) that either reduce the susceptibility of the population to the virus or reduce the likelihood of transmission within the population (Delamater et al., 2019). During the early part of the COVID-19 outbreak in China, before consistent protective measures were put into place, the R0 for SARS-CoV-2 was estimated as 2.2 (Riou and Althaus, January 30, 2020). Higher estimates of the R0 early in China (5.7) have also been published (Sanche et al., April 7, 2020). R0 ranges from 2 to 5 have been published for earlier MERS and SARS-CoV-1 coronavirus outbreaks (WHO, May 2003; Choi et al., September 25, 2017). Since the start of the COVID-19 pandemic, the R0 has varied depending on the natural ebb and flow of rolling infection surges as well as the fluctuating non-pharmaceutical interventions (NPIs) put in place, such as face coverings, nonessential business shutdowns, and testing with follow-up isolation and quarantining. The R0 value in the U.S. early in the pandemic was estimated to be approximately 2 (Li et al., October 22, 2020), and this value has generally remained above 1 for the country as a whole throughout the pandemic, with various states well above and below this value at various times (Harvard Chan School of Public Health, February 26, 2021; Shi et al., May 18, 2021).
Pre-symptomatic and asymptomatic transmission are significant drivers of the continued spread of COVID-19 (Johansson et al., January 7, 2021). Individuals are considered most infectious in the 48 hours before experiencing symptoms and during the first few symptomatic days (Cevik et al., October 23, 2020). The time it takes for a person to be infected and then transmit the virus to another individual is called the serial interval. Several studies have indicated that the serial interval for COVID-19 is shorter than the time for symptoms to develop, meaning that many individuals can transmit SARS-CoV-2 before they begin to feel ill (Nishiura et al., March 4, 2020; Tindale et al., June 22, 2020). It is also possible for individuals to be infected and subsequently transmit the virus without ever exhibiting symptoms. This is called asymptomatic transmission. As noted earlier, a recent meta-analysis reviewed 13 studies in which the asymptomatic prevalence ranged from 4% to up to 41% (Byambasuren et al., December 11, 2020).
The existence of both pre-symptomatic transmission and asymptomatic infection and transmission pose serious challenges to containing the spread of the virus. Although the risk of asymptomatic transmission is 42% lower than from symptomatic COVID-19 patients (Byambasuren et al., December 11, 2020), asymptomatic transmission may result in more transmissions than symptomatic cases, perhaps because asymptomatic persons are less likely to be aware of their infection and can unknowingly continue to spread the disease to others. Similarly, pre-symptomatic individuals can transmit the virus to others before they know they are sick and should isolate, assuming they are aware of their exposure. Existing evidence demonstrates that asymptomatic transmission is a significant contributor to the spread of COVID-19 in the United States. Johansson et al., (January 7, 2021) conducted a study to assess the proportion of SARS-CoV-2 transmission from pre-symptomatic, never symptomatic, and symptomatic individuals in the community. Based on their modeling, they found 59% of transmission came from asymptomatic transmission, including 35% from pre-symptomatic individuals and 24% from individuals who never develop symptoms (Johansson et al., January 7, 2021).
The SARS-CoV-2 virus also regularly mutates over time into different genetic variants. Many of these variants results in no increase in transmission or disease severity. However, the CDC monitors for variants of interest, variants of concern, and variants of high consequence (CDC, May 5, 2021). A variant of interest is one “with specific genetic markers that have been associated with changes to receptor binding, reduced neutralization by antibodies generated against previous infection or vaccination, reduced efficacy of treatments, potential diagnostic impact, or predicted increase in transmissibility or disease severity” (CDC, May 5, 2021). CDC-listed variants of interest include strains first identified in the United States (
e.g.,
B.1.526, B.1.526.1), the United Kingdom (
e.g.,
B.1.525), and Brazil (
e.g.,
P.2). A variant of concern is one 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, May 5, 2021). CDC-listed variants of concern include strains first identified in the United States (
e.g.,
B.1.427, B.1.429), United Kingdom (
e.g.,
B.1.17), Brazil (
e.g.,
P.1), and South Africa (
e.g.,
B.1.351). As of April 24, B.1.1.7 made up 60% of infections in the United States (CDC, May 11, 2021). CDC notes that B.1.1.7 is associated with a 50% increase in transmission, as well as potentially increased incidence of hospitalizations and fatalities (CDC, May 5, 2021). As new strains with increased transmissibility or more severe effects enter the U.S. population, healthcare workers may be among the first to be exposed to them when those who are infected seek medical care (Howard, May 22, 2021).
OSHA also recognizes that reported cases of SARS-CoV-2 likely undercount actual infections in the U.S. population. This finding is based on seroprevalence data, which measure the presence of specific antibodies in the blood that are typically developed when an individual is infected with SARS-CoV-2. Reported cases, in contrast, are based on COVID-19 tests that measure active infections. Recent reported case numbers suggest that approximately 10% of the US population has been infected. However, only seven states reported seroprevalence below 10% (
i.e.,
Alaska, Hawaii, Maine, New Hampshire, Oregon, Vermont, Washington) and 23 states plus Washington DC and Puerto Rico exceeded 20% (CDC, May 14, 2021). The likely reason for this difference is that serological tests measure antibodies in the blood that can be detected for a longer period of time than can an active COVID-19 infection. As such, serological testing may be able to detect past COVID-19 infections in individuals who never sought out a viral test. A sampling of states from the Nationwide Commercial Laboratory Seroprevalence Survey illustrates this (CDC, May 14, 2021). On March 30, 2021, California had reported 3,564,431 cases, but seroprevalence estimates indicate that there have been 7,986,000 cases in the state (95% CI: 7,023,000-8,965,000). Similarly, Texas has reported 2,780,903 cases, but seroprevalence data indicate 6,692,000 cases (95% CI: 5,624,000-7,819,000). Given the very real possibility of higher numbers of cases than are reported in national case counts, the disease burden discussed in this document may well be underestimated.
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c. The Effect of Vaccines on the Grave Danger Presented by SARS-CoV-2
The development of safe and highly effective vaccines and the on-going nation-wide distribution of these vaccines are encouraging milestones in the nation's response to COVID-19. Although there was initial uncertainty attached to the performance of authorized vaccines outside of clinical trials, vaccines have been in use for several months and they have proven effective in reducing transmission as well as the severity of COVID-19 cases. Data now available clearly establish that fully-vaccinated persons (defined as two weeks after the second dose of the mRNA vaccines or two weeks after the single dose vaccine) have a greatly reduced risk compared to unvaccinated individuals. This includes reductions in deaths, severe infections requiring hospitalization, and less severe symptomatic infections. The combination of data from clinical trials and data from mass vaccination efforts points increasingly to a significantly lower risk in settings where all workers are fully vaccinated and are not providing direct care for individuals with suspected or confirmed COVID-19. OSHA has therefore determined that there is insufficient evidence in the record to support a grave danger finding for employees in non-healthcare workplaces (or discrete segments of workplaces) where all employees are vaccinated. However, in healthcare settings where workers are vaccinated, as discussed below, the best available evidence establishes a grave danger still exists, given the greater potential for breakthrough cases in light of the greater frequency of exposure to suspected and confirmed COVID-19 patients in those settings (Birhane et al., May 28, 2021). In addition, the best available evidence shows that vaccination has not eliminated the grave danger in mixed healthcare workplaces (
i.e.,
those where some workers are fully vaccinated and some are unvaccinated) or in those healthcare workplaces where no one has yet been vaccinated.
The Effectiveness of Authorized Vaccines
There are currently three vaccines for the prevention of COVID-19 that have received EUAs from the FDA, allowing for their distribution in the U.S.: The Pfizer-BioNTech COVID-19 vaccine, the Moderna COVID-19 vaccine, and the Janssen COVID-19 vaccine. Pfizer-BioNTech and Moderna are mRNA vaccines that require two doses administered three weeks and one month apart, respectively. Janssen is a viral vector vaccine that requires a single dose (CDC, April 2, 2021). The vaccines were shown to greatly exceed minimum efficacy standards 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, as well as less severe symptomatic infections.
As stated above, the three authorized vaccine were shown to be highly efficacious in clinical trials. Clinical trial results are commonly considered a best case scenario (
e.g.,
conducted in relatively young and healthy populations), while evidence from follow-up observational studies provides insight on a more diverse population. This essential data from observational studies in populations who were vaccinated outside of clinical trials is emerging and shows that the mRNA vaccines are highly effective. At this time, observational studies for the single dose, viral vector vaccine are not available. Some of the studies for mRNA vaccines examined high-risk populations, such as healthcare workers. Thus, the degree of protection in these studies can be extrapolated to a wide range of workplace settings in healthcare. The results from these studies are very encouraging.
A study of 3,950 health care personnel, first responders, and other essential workers who completed weekly SARS-CoV-2 testing for 13 consecutive weeks reported 90% effectiveness (95% confidence interval [CI] = 68%-97%) after full vaccination with either mRNA vaccine (Thompson et al., April 2, 2021). Still, 22.9% of PCR-confirmed infections required medical care; these included two hospitalizations but no deaths. A study of more than 8,000 individuals in the U.S. general population found that two doses of either mRNA vaccine were 88.7% effective in preventing SARS-CoV-2 infection (Pawlowski et al., February 27, 2021). Similar to the above results in essential workers, although breakthrough infection occurred, vaccinated patients in this study who were subsequently diagnosed with COVID-19 had significantly lower 14-day hospital admission rates than matched unvaccinated participants (3.7% vs. 9.2%). Hall et al., (April 23, 2021), in a study of U.K. healthcare workers with bi-weekly testing, documented an 85% effectiveness of the Pfizer-BioNTech vaccine, though those authors required only one week after dose two for classification as fully vaccinated. Research from Israel provides additional evidence of high effectiveness for the Pfizer-BioNTech vaccine (Dagan et al., February 24, 2021).
Data available regarding vaccine efficacy against some SARS-CoV-2 variants of concern illustrate that the vaccines remain effective at reducing symptomatic infections. Two doses of the Pfizer-BioNTech COVID-19 vaccine was highly effective (85-86%) against SARS-CoV-2 infection and symptomatic COVID-19 during a period when B.1.1.7 was the predominant circulating strain in the UK (Hall et al., April 23, 2021). In Israel, the Pfizer-BioNTech vaccine was 92% effective even with the proportion of cases due to the B.1.1.7 becoming the dominant virus in circulation towards the end of the evaluation period (Dagan et al., February 24, 2021). Another study testing the Pfizer-BioNTech COVID-19 vaccine found that it was equally capable of neutralizing the notable variants from the United Kingdom and South Africa (Xie et al., February 8, 2021). This finding was then reflected in a Qatari study that found that the Pfizer-BioNTech vaccine was not only effective at preventing disease in people infected by those variants, but was observed as 100% effective in preventing fatalities from COVID-19 (Abu-Raddad et al., May 5, 2021). The Janssen vaccine clinical trial was conducted during a time in which SARS-CoV-2 variants were circulating in South Africa (B.1.351 variant) and Brazil (P.2 variant). At 28 or more days past vaccination, efficacy against moderate to severe/critical disease was 72% in the United States; 68% in Brazil; 64% in South Africa (FDA, February 26, 2021). Although some studies have reported antibodies to be less effective against the B.1.351 variant, antibody activity in serum from vaccinated persons was generally higher than activity from serum of persons who recovered from COVID-19 (CDC, April 2, 2021).
A major question not fully addressed in the original clinical trials is whether vaccinated individuals can become infected and shed virus, even if they are asymptomatic. Thompson et al., (April 2, 2021), reported that 11% of the PCR-confirmed breakthrough infections in their essential worker population were asymptomatic, indicating a concern for asymptomatic transmission. However, this concern is based on studies indicating asymptomatic transmission among unvaccinated individuals and it is not known if this phenomena occurs in infected vaccinated individuals. In the Moderna clinical trial, reverse transcription polymerase chain reaction (RT-PCR) testing was performed on participants at their second vaccination visit; asymptomatic positives in the vaccinated group were less than half those in the placebo group (Baden et al., December 30, 2020, supplemental files Table s18). In a Mayo clinic study, an 80% reduction in risk of positive pre-procedural screening tests was observed in patients tested after their second vaccine dose (Tande et al., March 10, 2021). A study of more than 140,000 healthcare workers and their almost 200,000 household members reported a 30% reduction in risk of documented
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