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Occupational Exposure to COVID-19; Emergency Temporary Standard

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Start Preamble Start Printed Page 32376

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 32377people 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.

Start Printed Page 32378

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 Start Printed Page 32379(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 Start Printed Page 32380federal agencies. Chao v. Mallard Bay Drilling, Inc., 534 U.S. 235, 241 (2002).

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 Start Printed Page 32381technique,” 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]

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.

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. Start Printed Page 32382Ass'n/N. Am. v. OSHA, 727 F.2d 415, 425 (5th Cir. 1984)).

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 Start Printed Page 32383evidence 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.

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 Start Printed Page 32384infections) 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 Start Printed Page 32385in 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 Start Printed Page 32386not 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 Start Printed Page 32387hospitalized 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 Start Printed Page 32388virus 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 Start Printed Page 32389suspected 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).

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.

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(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 Start Printed Page 32394lead 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.Start Printed Page 32395

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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 Start Printed Page 32397requiring 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 COVID-19 cases in the household members after the healthcare provider was fully vaccinated (Shah et al., March 21, 2021). In the Israeli general population, the estimated vaccine effectiveness for the asymptomatic infection proxy group (infection without documented symptoms, which could have included undocumented mild symptoms) was 90% at 7 or more days after the second dose (Dagan et al., February 24, 2021). Preliminary data from Israel suggest that people vaccinated with the Pfizer-BioNTech COVID-19 vaccine who develop COVID-19 have a four-fold lower viral load than unvaccinated people (Levine-Tiefenbrun, February 8, 2021). As noted by CDC (April 2, 2021), this observation may indicate reduced transmissibility, because viral load is thought to be a major factor in transmission (Marks et al., February 2, 2021).

The CDC has acknowledged that a “growing body of evidence suggests that fully vaccinated people are less likely to have asymptomatic infection or transmit SARS-CoV-2 to others” (CDC, April 2, 2021). The decreased risk for infection, especially serious infection, combined with decreased risk of transmission to others has allowed the CDC to relax some recommendations for individuals who are in community or public settings and who are fully vaccinated with one of the three FDA authorized vaccines, as follows.

  • Quarantine is no longer required for fully vaccinated individuals who remain asymptomatic following exposure to a COVID-19 infected person (CDC, May 13, 2021).
  • Testing following a known exposure is no longer needed for a fully vaccinated person, as long as the individual remains asymptomatic and is not in specific settings such as healthcare (CDC, April 27, 2021a), non-healthcare congregate facilities (e.g., correctional and detention facilities, homeless shelters) or high-density workplaces (e.g., poultry processing plants) (CDC, May 13, 2021).

In non-healthcare settings, fully vaccinated people no longer need to wear a mask or physically distance, except where required by federal, state, local, tribal, or territorial laws, rules, and regulations, including local business and workplace guidance (CDC, May 13, 2021). In healthcare settings, the picture is more mixed. While the Start Printed Page 32398CDC still recommends source controls for vaccinated healthcare workers to protect unvaccinated people, it has relaxed several NPIs for health care providers (HCP) in some circumstances. CDC has stated that “fully vaccinated HCP could dine and socialize together in break rooms and conduct in-person meetings without source control or physical distancing” (CDC, April 27, 2021a). The CDC also recommends that fully vaccinated HCP no longer need to be restricted from work after a high-risk exposure, as long as they remain symptom-free (CDC, April 27, 2021a). Perhaps more significantly, while acknowledging the growing body of evidence against SARS-CoV-2 transmission from vaccinated people to unvaccinated people, the CDC has not identified evidence of a substantial risk of such transmission even in healthcare settings. Therefore, pending additional evidence of such transmission, the risk of transmission from vaccinated healthcare workers to unvaccinated co-workers does not appear to be high enough to warrant OSHA's imposition of mandatory controls through an ETS to protect unvaccinated workers from exposure to vaccinated workers.

On the other hand, HCP treating suspected and confirmed COVID-19 patients are expected to have higher exposures to the SARS-CoV-2 virus than others in the workforce, because such work involves repeated instances of close contact with infected patients (Howard, May 22, 2021). Exposure can be even higher in aerosol generating activities. Indeed, one study reported higher infection rates among vaccinated HCWs during a regional COVID-19 surge (Keehner et al., Mar. 23, 2021). Thus, the CDC has not relaxed infection control practices or PPE intended to protect HCP, including respirator use. (CDC, April 27, 2021a). NIOSH has stated that the “available evidence shows that healthcare workers are continuing to become infected with SARS-CoV-2 . . . including both vaccinated and unvaccinated workers, and the conditions for the transmission of the virus exist at healthcare workplaces” (Howard, May 22, 2021). The CDC has also indicated that it will continue “to evaluate the impact of vaccination; the duration of protection, including in older adults; and the emergence of novel SARS-CoV-2 variants on healthcare infection prevention and control recommendations” (CDC, April 27, 2021a). OSHA, too, will continue to monitor this issue and revise the ETS as appropriate.

Grave Danger Exists in Healthcare Workplaces Where Unvaccinated Workers Are Present

The evidence shows that the advent of vaccines does not eliminate the grave danger from exposure to SARS-CoV-2 in healthcare workplaces where less than 100% of the workforce is fully vaccinated. Unvaccinated workers can transmit the virus to each other and can become infected as a result of exposure to persons with COVID-19 who enter the healthcare facility. An outbreak of COVID-19 due to an unvaccinated, symptomatic HCP was recently reported in a skilled nursing facility in which 90.4% of residents had been vaccinated (Cavanaugh, April 30, 2021). The outbreak, due to the R.1 variant, caused attack rates that were three to four times higher in unvaccinated residents and HCPs as among those who were vaccinated. Additionally, unvaccinated persons were significantly more likely to experience symptoms or require hospitalization. Therefore, unvaccinated employees at these workplaces remain at grave danger of infection, along with the serious health consequences of COVID-19, as discussed in the remainder of this section.

Although the risk appears to be lower, breakthrough infections of vaccinated individuals do occur, but the potential for secondary transmission remains not fully substantiated. For instance, a small yet significant portion of the population does not respond well to vaccinations (Agha et al., April 7, 2021; Boyarsky et al., May 5, 2021; Deepak et al., April 9, 2021; ACI, April 28, 2021) and may be as vulnerable as unvaccinated individuals. These individuals could potentially transmit the SARS-CoV-2 infection to unvaccinated employees. In a California study, seven out of 4,167 fully vaccinated health care workers experienced breakthrough infections (Keehner et al., May 6, 2021). A similar study from the Mayo Clinic, included 44,011 fully vaccinated individuals with 30 breakthrough infections being recorded (Swift et al., April 26, 2021). Of those breakthrough cases, 73% were symptomatic. Secondary transmission was not evaluated in the study. A nursing facility in Chicago found 22 possible breakthrough cases of SARS-COV-2 infection among fully vaccinated staff and residents (Teran et al., April 30, 2021). Of those cases, 36% were symptomatic. However, no secondary transmission was observed in the facility. The lack of secondary transmission was likely due to the facility's implementation of non-pharmaceutical interventions and high vaccination rates. The authors concluded that to ensure outbreaks do not occur from breakthrough infections in workplaces with vaccinated and unvaccinated workers that the facilities need to maintain high vaccine coverage and non-pharmaceutical interventions. While these breakthrough events appear to be uncommon, it is important to remember how quickly a few cases can result in an outbreak in unvaccinated populations.

Moreover, even though the U.S. is approaching the time where there is sufficient vaccine supply for the entire U.S. population, administering the vaccine throughout the country will still take more time. As of May 24, 2021, CDC statistics show that 43% of the population between 18 and 65 has been fully vaccinated (CDC, May 24, 2021a). To this end, there is still a need to strengthen confidence in the safety and effectiveness of the vaccines for significant portions of the population, including workers, to reduce vaccine hesitancy. Even in the healthcare industry, where distribution has enabled entire worker populations to be completely vaccinated by now, some workers exhibited reluctance to getting vaccinated. On January 4, 2021, a study of 1,398 U.S. emergency department health care personnel found that 95% were offered the vaccine, with 14% declining (Schrading et al., February 19, 2021). In February of 2021, the CDC released a study of initial vaccine efforts at skilled nursing facilities offering long-term care (Gharpure et al., February 5, 2021). The study found that only 37.5% of eligible staff were vaccinated, leaving a potentially significant population vulnerable to SARS-CoV-2 infections and capable of transmission.

An anonymous survey of employees across the Yale Medicine and Yale New Haven Health system was used to estimate the prevalence of and underlying reasons for COVID-19 vaccine hesitancy. The survey was sent to about 33,000 employees and medical staff across the Yale healthcare system and included clinical staff and those who support the critical infrastructure without direct patient contact (e.g., food service staff). Out of 3,523 responses (an 11% response rate), 85% of respondents stated they were “extremely likely” or “somewhat likely” to receive the COVID-19 vaccine. Of that 85%, 12% expressed mild hesitancy by stating they would get it within the next 6 months. But 14.7% of overall respondents expressed reluctance by responding “neither likely nor unlikely,” “somewhat unlikely,” or “extremely unlikely” to receive the COVID-19 vaccine. Overall, 1 in 6 personnel in this health system survey expressed at least Start Printed Page 32399some reluctance to get vaccinated (Roy et al., December 29, 2020).

Findings in more recent surveys of the general working population from 18 to 65 years old show similar rates of people who stated they would not, probably would not, or would only if required get vaccinated (18.2%) (Census Bureau, May 5, 2021); 17-26% (KFF, April 22, 2021). In March 2021, a survey found that healthcare employees reported some of the highest vaccination percentages of any sector (78.3% and 67.7%, respectively; King et al., April 24, 2021). However, future growth of vaccination may be a concern with vaccine hesitation in those sectors reported as 14.1% and 15.9%, respectively.

That unvaccinated healthcare workers remain in grave danger is emphasized by the fact that thousands of new hospital admissions still occur each day (CDC, May 24, 2021b) in the midst of significant distribution of over three hundred million effective vaccine doses. These factors indicate that transmission remains robust and significant portions of the population remain vulnerable to COVID-19. Spread of the disease within the healthcare workforce may start with a worker becoming ill through community transmission or an ill patient seeking treatment. The rate of new cases, hospitalizations, and deaths peaked in January 2021, just before vaccines became more widely available outside of healthcare settings. The January to February decline, however, is likely not attributable in large part to the new vaccines alone, because only a small portion of the population had received them. During this time, variants of concern, such as B.1.1.7, that are more transmissible and may result in worse health outcomes, have become the majority source of infection (CDC, May 24, 2021c). Hundreds of people each day are still dying of COVID-19 in early May 2021, many of them working-age adults (May 24, 2021d).

OSHA will continue to monitor trends as more of the population becomes vaccinated and the post-vaccine evidence base continues to grow. If and when OSHA finds a grave danger from the virus no longer exists for covered healthcare workplaces (or some portion thereof), or new information necessitates a change in measures necessary to address the grave danger, OSHA will update the rule as appropriate.

In summary, the availability and use of safe and effective vaccines for COVID-19 is a critical milestone that has led to a marked decrease in risk for healthcare employees generally, but grave danger still remains for those whose jobs require them to work in settings where patients with suspected or confirmed COVID-19 receive care. CDC has determined that the remaining risk for fully vaccinated persons outside of healthcare settings is low enough to justify foregoing other layers of controls for settings where all persons are fully vaccinated and asymptomatic (CDC, April 27, 2021), but the CDC continues to recommend respirators and PPE for fully vaccinated healthcare employees in settings where patients with suspected or confirmed COVID-19 receive care. Based on CDC guidance and the best available evidence, OSHA finds a grave danger in healthcare for vaccinated and unvaccinated HCP involved in the treatment of COVID-19 patients.

References

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Agency for Clinical Innovation (ACI). (2021, April 28). Evidence check: Immunocompromised patients and COVID-19 vaccines. https://aci.health.nsw.gov.au/​__​data/​assets/​pdf_​file/​0009/​645750/​Evidence-check-Immunocompromised-patients-COVID-19-vaccines.pdf. (ACI, April 28, 2021).

Agha et al., (2021, April 7). Suboptimal response to COVID-19 mRNA vaccines in hematologic malignancies patients. medRxiv 2021.04.06.21254949. https://doi.org/​10.1101/​2021.04.06.21254949. (Agha, et al., April 7, 2021).

Baden, L et al., (2021, December 30). Efficacy and safety of the mRNA-1273 SARS-CoV-2 Vaccine. The New England Journal of Medicine, 384(5), 403-416. https://doi.org/​10.1056/​NEJMoa2035389. (Baden et al., December 30, 2020).

Birhane, M et al., (2021, May 28). COVID-19 Vaccine Breakthrough Infections Reported to CDC—United States, January 1-April 30, 2021. MMWR 70: 792-793. http://dx.doi.org/​10.15585/​mmwr.mm7021e3. (Birhane et al., May 28, 2021).

Boyarsky, BJ et al., (2021, May 5). Antibody Response to 2-Dose SARS-CoV-2 mRNA Vaccine Series in Solid Organ Transplant Recipients. JAMA. 2021 May 5. doi: 10.1001/jama.2021.7489. PMID: 33950155. (Boyarsky et al., May 5, 2021).

Cavanaugh, AM et al., (2021, April 30). COVID-19 outbreak associated with a SARS-CoV-2 R.1 lineage variant in a skilled nursing facility after vaccination program—Kentucky, March 2021. MMWR 70: 639-643. http://dx.doi.org/​10.15585/​mmwr.mm7017e2. (Cavanaugh et al., April 30, 2021).

Census Bureau. (2021, May 5). Household Pulse Survey COVID-19 Vaccination Tracker. https://www.census.gov/​library/​visualizations/​interactive/​household-pulse-survey-covid-19-vaccination-tracker.html. (Census Bureau, May 5, 2021).

Centers for Disease Control and Prevention (CDC). (2021, April 2). Science brief: Background rationale and evidence for public health recommendations for fully vaccinated people. https://www.cdc.gov/​coronavirus/​2019-ncov/​science/​science-briefs/​fully-vaccinated-people.html. (CDC, April 2, 2021).

Centers for Disease Control and Prevention (CDC). (2021a, 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, 2021a).

Centers for Disease Control and Prevention (CDC). (2021b, April 27). Domestic travel during COVID-19. https://www.cdc.gov/​coronavirus/​2019-ncov/​travelers/​travel-during-covid19.html. (CDC, April 27, 2021b).

Centers for Disease Control and Prevention (CDC). (2021, May 13). Interim public health recommendations for fully vaccinated people. https://www.cdc.gov/​coronavirus/​2019-ncov/​vaccines/​fully-vaccinated-guidance.html. (CDC, May 13, 2021).

Centers for Disease Control and Prevention (CDC). (2021a, May 24). Demographic Trends of People Receiving COVID-19 Vaccinations in the United States. https://covid.cdc.gov/​covid-data-tracker/​?CDC_​AA_​refVal=​https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcases-updates%2Fcas%E2%80%A6#vaccination-demographic. (CDC, May 24, 2021a).

Centers for Disease Control and Prevention (CDC). (2021b, May 24). COVID data tracker. New Admissions of Patients with Confirmed COVID-19, United States. https://covid.cdc.gov/​covid-data-tracker/​#new-hospital-admissions. (CDC, May 24, 2021b).

Centers for Disease Control and Prevention (CDC). (2021c, May 24). Variant Proportions. https://covid.cdc.gov/​covid-data-tracker/​#variant-proportions. (CDC, May 24, 2021c).

Centers for Disease Control and Prevention (CDC). (2021d, May 24). COVID-19 Weekly Deaths per 100,000 Population by Age by Age, Race/Ethnicity, and Sex. https://covid.cdc.gov/​covid-data-tracker/​#demographicsovertime. (CDC, May 24, 2021d).

Dagan, N et al., (2021, February 24). BNT162b2 mRNA COVID-19 vaccine in a nationwide mass vaccination setting. N Engl J Med. 384(15): 1412-1423. doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24. PMID: 33626250; PMCID: PMC7944975. (Dagan et al., February 24, 2021).

Deepak, et al., (2021, April 7). Glucocorticoids and B Cell Depleting Agents Substantially Impair Immunogenicity of mRNA Vaccines to SARS-CoV-2. medRxiv 2021.04.05.21254656. https://doi.org/​10.1101/​2021.04.05.21254656. (Deepak et al., April 7, 2021).Start Printed Page 32400

Food and Drug Administration (FDA). (2020, December 11). Emergency use authorization for an unapproved product review memorandum (Pfizer-BioNTech COVID-19 vaccine/BNT 162b2 mRNA-1273). https://www.fda.gov/​emergency-preparedness-and-response/​coronavirus-disease-2019-covid-19/​pfizer-biontech-covid-19-vaccine. (FDA, December 11, 2020).

Food and Drug Administration (FDA). (2020, December 18). Emergency use authorization for an unapproved product review memorandum (Moderna COVID-19 vaccine/mRNA-1273). https://www.fda.gov/​emergency-preparedness-and-response/​coronavirus-disease-2019-covid-19/​moderna-covid-19-vaccine. (FDA, December 18, 2020).

Food and Drug Administration (FDA). (2021, February 26). Janssen COVID-19 vaccine. Vaccines and Related Biological Products Advisory Committee, February 26, 2021 Meeting Briefing Document. https://www.fda.gov/​media/​146219/​download. (FDA, February 26, 2021).

Gharpure, R et al., (2021, February 5). Early COVID-19 first-dose vaccination coverage among residents and staff members of skilled nursing facilities participating in the pharmacy partnership for long-term care program—United States, December 2020-January 2021. MMWR 2021; 70: 178-182. DOI: http://dx.doi.org/​10.15585/​mmwr.mm7005e2. (Gharpure et al., February 5, 2021).

Hall, VJ et al., (2021, April 23). COVID-19 vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): A prospective, multicentre, cohort study. Lancet. 2021 Apr 23: S0140-6736(21)00790-X. doi: 10.1016/S0140-6736(21)00790-X. Online ahead of print. PMID: 33901423. (Hall et al., April 23, 2021).

Howard, J. (2021, May 22). “Response to request for an assessment by the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, of the current hazards facing healthcare workers from Coronavirus Disease-2019 (COVID-19).” (Howard, May 22, 2021).

Keehner et al., (2021, May 6). SARS-CoV-2 infection after vaccination in health care workers in California. New England Journal of Medicine 384(18). (Keehner et al., May 6, 2021).

KFF. (2021, April 22). KFF COVID-19 Vaccine Monitor https://www.kff.org/​coronavirus-covid-19/​dashboard/​kff-covid-19-vaccine-monitor-dashboard/​. (KFF, April 22, 2021).

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).

Levine-Tiefenbrun, M et al., (2021, February 8). Decreased SARS-CoV-2 viral load following vaccination. medRxiv. 2021; https://www.medrxiv.org/​content/​10.1101/​2021.02.06.21251283v1.full.pdf. (Levine-Tiefenbrun, February 8, 2021).

Marks, M et al., (2021, February 2). Transmission of COVID-19 in 282 clusters in Catalonia, Spain: A cohort study. Lancet Infect Dis. 21(5): 629-636. doi: 10.1016/S1473-3099(20)30985-3. Epub 2021 Feb 2. PMID: 33545090; PMCID: PMC7906723. (Marks et al., February 2, 2021).

Pawlowski, C et al., (2021, February 27). FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system. medRxiv [Preprint posted online February 27, 2021]. https://www.medrxiv.org/​content/​10.1101/​2021.02.15.21251623v3. ( Pawlowski et al., February 27, 2021).

Roy, B et al., (2020, December 29). Health care workers' reluctance to take the COVID-19 vaccine: A consumer-marketing approach to identifying and overcoming hesitancy. https://catalyst.nejm.org/​doi/​full/​10.1056/​CAT.20.0676. (Roy et al., December 29, 2020).

Schrading, WA et al., (2021, February 19). Vaccination rates and acceptance of SARS-CoV-2 vaccination among U.S. emergency department health care personnel. Acad Emerg Med 28: 455-458. (Schrading et al., February 19, 2021).

Shah, ASV et al., (2021, March 21). Effect of vaccination on transmission of COVID-19: an observational study in healthcare workers and their households. medRxiv. 2021 https://www.medrxiv.org/​content/​10.1101/​2021.03.11.21253275v1. (Shah et al., March 21, 2021).

Swift, MD et al., (2021, April 26). Effectiveness of mRNA COVID-19 vaccines against SARS-CoV-2 infection in a cohort of healthcare personnel. Clinical Infectious Diseases DOI: https://doi.org/​10.1093/​cid/​ciab361. (Swift et al., April 26, 2021).

Tande, AJ et al., (2021, March 10). Impact of the COVID-19 Vaccine on asymptomatic infection among patients undergoing pre-procedural COVID-19 molecular screening. Clin Infect Dis. 2021 Mar 10: ciab229. doi: 10.1093/cid/ciab229. Epub ahead of print. PMID: 33704435; PMCID: PMC7989519. (Tande et al., March 10, 2021).

Teran, RA et al., (2021, April 30). Postvaccination SARS-CoV-2 infections among skilled nursing facility residents and staff members—Chicago, Illinois, December 2020-March 2021. MMWR 70(17): 632-638. (Teran et al., April 30, 2021).

Thompson, MG et al., (2021, April 2). Interim estimates of vaccine effectiveness of BNT162b2 and mRNA-1273 COVID-19 vaccines in preventing SARS-CoV-2 infection among health care personnel, first responders, and other essential and frontline workers—eight U.S. locations, December 2020-March 2021. MMWR 70: 495-500. DOI: http://dx.doi.org/​10.15585/​mmwr.mm7013e3. (Thompson et al., April 2, 2021).

Xie, X et al., (2021, February 8). Neutralization of SARS-CoV-2 spike 69/70 deletion, E484K and N501Y variants by BNT162b2 vaccine elicited sera. Nature Medicine. DOI: https://doi.org/​10.1038/​s41591-021-01270-4. (Xie et al., February 8, 2021).

III. Impact on Healthcare Employees

Data on SARS-CoV-2 infections, illnesses, and deaths among healthcare employees supports OSHA's finding that COVID-19 poses a grave danger to these employees. Even fairly brief exposure (i.e., 15 minutes during a 24-hour period) can lead to infection, which in turn can cause death or serious impairment of health. Employees in healthcare settings include healthcare employees, who provide direct patient care (e.g., nurses, doctors, and emergency medical technicians (EMTs)), and healthcare support employees, who provide services that support the healthcare industry and may have contact with patients (e.g., janitorial/housekeeping, laundry, and food service employees). Employees who perform autopsies are also considered to work in healthcare. Most employees who work in healthcare perform duties that put them at elevated risk of exposure to SARS-CoV-2.

SARS-CoV-2 is introduced into healthcare settings by infected patients, other members of the public, or employees. Workers in healthcare settings that provide treatment to patients with suspected or confirmed COVID-19 face a particularly elevated risk of contracting SARS-CoV-2 (Howard, May 22, 2021). Once the virus is introduced into the worksite, the virus can be transmitted from person-to-person at close contact through inhalation of respiratory droplets. In limited scenarios, it might also be transmitted through inhalation of aerosols, which consists of small droplets and particles that can linger in the air, especially in enclosed spaces with inadequate ventilation (CDC, May 7, 2021). Less frequently, transmission is also possible when someone touches a contaminated item or surface and then touches their nose, mouth, or eyes (CDC, April 5, 2021).

A 2021 cross-sectional study of 6,510 healthcare employees from the Northwestern HCW SARS-CoV-2 Serology Cohort Study (conducted May 28-June 30, 2020 in Illinois) shows that infections among healthcare workers were not limited to doctors and nurses; healthcare administrators had similar rates of seropositivity compared to physicians, and support services had the highest seroprevalence (this group included healthcare facility workers in Start Printed Page 32401food service, environmental services, security, and patient access/registration) (Wilkins et al., 2021). A meta-analysis published in the American Journal of Epidemiologists compared data from 97 separate studies and found evidence that COVID-19 infections were both common (11% of the tested cohort of healthcare employees) and spread among different healthcare worker occupations. In this study, however, nurses had the highest rate of seroprevalence while most of the COVID-19-positive medical personnel were working in hospital nonemergency wards during screening (Gomez-Ochoa et al., January 2021).

Healthcare employees who provide direct patient care are at high risk of exposure to SARS-CoV-2 because they have close and sometimes prolonged contact with patients who are infected or potentially infected with SARS-CoV-2. This contact occurs when conducting physical examinations and providing treatment and medical support. The risk can be amplified when examining or treating a COVID-19 patient who has symptoms such as coughing and difficulty breathing (leading to more forceful inhalation and exhalation), both of which can result in the release of more droplets that can be propelled further. Healthcare employees who conduct, or provide support during, aerosol-generating procedures on persons with suspected or confirmed COVID-19 also face a greater risk of infection (Heinzerling et al., April 17, 2020). Examples of procedures that can produce aerosols include intubation, suctioning airways, use of high-speed tools during dental work, and use of power saws during autopsies. A complete list of aerosol-generating procedures, as defined by this ETS, is included in 29 CFR 1910.502(b). Employees in healthcare are also at risk of exposure to SARS-CoV-2 if they have close contact with co-workers while providing patient care or performing other duties in enclosed areas such as a nursing station, laundry room, or kitchen. Based on the biological mechanisms of SARS-CoV-2 transmission, there is no doubt that some employees in healthcare are at risk of exposure to SARS-CoV-2. Healthcare employees are performing some job tasks that create an expectation of exposure to people or human remains infected with COVID-19. The nature of caring for a patient known to have COVID-19 or performing on autopsy on someone who had COVID-19 increases the risk to employees performing that task.

This section summarizes recent studies about U.S. employees in healthcare that illustrate the impact of COVID-19 in several types of settings. Because the pandemic is recent and the evidence generated is on the frontiers of science, studies are not available for every type of employee in every type of healthcare setting. The peer-reviewed scientific journal articles, government reports, and journal pre-print articles described below establish the widespread prevalence of COVID-19 among healthcare employees. OSHA's findings are based primarily on the evidence from peer-reviewed scientific journal articles and government reports. However, peer review for scientific journal articles and the assembly of information for government reports and other official sources of information take time, and therefore those sources do not always reflect the most up-to-date information (Chan et al, December 14, 2010). This is critical in the context of the COVID-19 pandemic, where new information is emerging daily. Therefore, OSHA has supplemented peer-reviewed data and government reports with additional information on occupational outbreaks contained in other sources of media (e.g., newspapers). The reported information from newspapers can provide further evidence of the impact of an emerging and changing disease, especially for certain workers in healthcare and associated occupations (e.g., laundry workers, janitors) that are not well represented in the peer-reviewed scientific literature, and assist OSHA in protecting these employees from the grave danger posed by transmission of SARS-CoV-2. OSHA did not make findings based solely on non-peer-reviewed sources such as pre-prints and news articles, but the agency found that those sources sometimes provided useful information when considered in context with more robust sources. Together, these sources of information represent the best available evidence of the impact on employees of the pandemic thus far.

The peer-reviewed literature, government reports and, in a limited number of cases, non-peer-reviewed articles illustrate a significant number of infections among healthcare employees, but the types of workplaces or conditions described are not the only ones in which a grave danger exists. However, the studies add to the evidence that any healthcare employee is at risk of exposure if they have close contact with others who are suspected or confirmed to have COVID-19. The studies also provide evidence that once SARS-CoV-2 is introduced into the healthcare workplace (e.g., through an infected patient, other member of the public, or employee), unvaccinated employees in that workplace are at risk of exposure.

a. General Investigations of Workers or Workplaces

The Washington State Department of Health and the Washington State Department of Labor and Industries collaborated on a report evaluating COVID-19 cases and their occupational history (WSDH and WLNI, November 10, 2020). They identified 30,895 confirmed cases of COVID-19 in Washington State with occupational data, including healthcare settings, through September 13, 2020. They reported infection rates for 22 occupational groups, and reported that healthcare and social assistance were among the industry sectors with the highest incidence of infections (WSDH and WLNI, November 10, 2020). The report states that some occupations increase the risk to workers of exposure to SARS-CoV-2, but the data does not demonstrate that all the cases reported resulted from occupational exposure.

These data were also used to determine how work activities were related to COVID-19. Zhang used information from a previous Washington State report with an earlier cutoff date (through June 11, 2020; 10,850 cases) and cross-referenced it with information available from O*NET (a Department of Labor database that contains detailed occupational information for more than 900 occupations across the U.S.) to determine occupation-specific COVID-19 risks (Zhang, November 18, 2020). Zhang created a model using the O*NET descriptors and correlated it to the case reports from Washington State to develop a predictive model for COVID-19 cases. 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 healthcare professions in general had the highest predicted risk for COVID-19. This finding provides additional evidence that during an active pandemic, healthcare employees can be exposed to a grave danger during sustained periods in workspaces where they are working in proximity to others, including patients with COVID-19.

The Oregon Health Authority (OHA) publishes a weekly report detailing outbreaks directly related to work settings. OHA epidemiologists consider cases to be part of a workplace outbreak when clusters form with respect to space and time unless their Start Printed Page 32402investigation uncovers an alternative source for the outbreak. In their May 19, 2021, COVID-19 Weekly Report, OHA reported 71 active clusters, including at three separate hospitals (OHA, May 19, 2021).

In a May 21, 2021 report, the Tennessee Department of Health reported 238 active clusters (i.e., 2 or more confirmed cases of COVID-19 linked by the same location of exposure or exposure event that is not considered a household exposure), with 6 occurring in assisted care facilities, 37 in nursing homes, and 3 in other healthcare settings (Tennessee Department of Health, May 21, 2021).

A study on SARS-CoV-2 testing in Los Angeles from mid-September through October 2020 evaluated 149,957 symptomatic and asymptomatic positive cases associated with an occupation (Allan-Blitz et al., December 11, 2020). Infection rates were found to be particularly high for healthcare personnel and first responders.

A Morbidity and Mortality Weekly Report (MMWRs) (a weekly epidemiological digest published by the CDC) reported on the occupational status of COVID-19 cases in Colorado. In the Colorado study, 1,738 COVID-19 cases from nine Colorado counties were evaluated; these cases occurred before the state lockdown that began on March 26, 2020 (Marshall et al., June 30, 2020). Half of the individuals were exposed in a workplace setting, with the greatest number of COVID-19-positive employees coming from healthcare (38%).

Chen et al., (January 22, 2021) analyzed records of deaths occurring on or after January 1, 2016 in California and found that mortality rates in working aged adults (18-65 years) increased 22% during the COVID-19 pandemic (March through October 2020) compared to pre-pandemic periods. Relative to pre-pandemic periods, healthcare or emergency workers were one occupational group that experienced excess and statistically significant mortality compared to pre-pandemic periods (19% increase). The study authors concluded that essential work conducted in person is a likely avenue of infection transmission.

Hawkins et al., (January 10, 2021) examined death certificates of individuals who died in Massachusetts between March 1 and July 31, 2020. An age-adjusted mortality rate of 16.4 per 100,000 employees was determined from 555 death certificates that had useable occupation information. Employees in healthcare support, personal care services, and social services had particularly high mortality rates. The study authors noted that occupation groups expected to have frequent contact with sick people, close contact with the public, and jobs that are not practical to do from home had particularly elevated mortality rates.

The impact of COVID-19 across diverse healthcare sectors is not limited to the United States. The European Centre for Disease Prevention and Control investigated clusters in occupational settings throughout Europe (ECDC, August 11, 2020). The Centre reviewed 1,376 occupational clusters from 16 European countries from March through July of 2020. Indoor settings contributed to 95% of reported clusters. Hospitals and long-term care facilities accounted for many of the clusters.

References

Allan-Blitz, L et al., (2020, December 11). High frequency and prevalence of community-based asymptomatic SARS-CoV-2 Infection. medRxix. https://doi.org/​10.1101/​2020.12.09.20246249. (Allan-Blitz et al., December 11, 2020).

Centers for Disease Control and Prevention (CDC). (2021, April 5). Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/​coronavirus/​2019-ncov/​more/​science-and-research/​surface-transmission.html. (CDC, April 5, 2021).

Centers for Disease Control and Prevention (CDC). (2021, May 7). Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/​coronavirus/​2019-ncov/​more/​scientific-brief-sars-cov-2.html. (CDC, May 7, 2021).

Chan, E et al., (2010, December 14). Global capacity for emerging infectious disease detection. Proceedings of the National Academy of Sciences of the United States of America, 107(50), 21701-21706. https://doi.org/​10.1073/​pnas.1006219107. (Chan et al, December 14, 2010).

Chen, Y et al., (2021, January 22). Excess mortality associated with the COVID-19 pandemic among Californians 18-65 years of age, by occupational sector and occupation: March through October 2020. MedRxiv. doi: 10.1101/2021.01.21.21250266. (Chen et al., January 22, 2021).

European Centre for Disease Prevention and Control (ECDC). (2020, August 11). COVID-19 clusters and outbreaks in occupational settings in the EU/EEA and the UK. (ECDC, August 11, 2020).

Gómez-Ochoa, SA et al., (2021, January). COVID-19 in health-care workers: a living systematic review and meta-analysis of prevalence, risk factors, clinical characteristics, and outcomes. American journal of epidemiology. 2021 Jan; 190(1): 161-75. (Gomez-Ochoa et al., January 2021).

Hawkins, D et al., (2020, December 21). COVID-19 deaths by occupation, Massachusetts, March 1-July 31, 2020. American Journal of Industrial Medicine 64(4): 238-244. DOI: 10.1002/ajim.23227. (Hawkins et al., December 21, 2021).

Heinzerling, A et al., (2020, April 17). Transmission of COVID-19 to Health Care Personnel During Exposures to a Hospitalized Patient—Solano County, California, February 2020. MMWR Morb Mortal Wkly Rep 2020; 69: 472-476. DOI: http://dx.doi.org/​10.15585/​mmwr.mm6915e5. (Heinzerling et al., April 17, 2020).

Howard, J. (2021, May 22). “Response to request for an assessment by the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, of the current hazards facing healthcare workers from Coronavirus Disease-2019 (COVID-19).” (Howard, May 22, 2021).

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. MMWR: 69(26): 847-9. (Marshall et al., June 30, 2020).

Oregon Health Authority (OHA). (2021, May 19). COVID-19 weekly outbreak report. https://www.oregon.gov/​oha/​covid19/​Documents/​DataReports/​COVID-19-Weekly-Outbreak-Report-2021-1-13-FINAL.pdf. (OHA, May 19, 2021).

Tennessee Department of Health. (2021, May 21). COVID-19 critical indicators. (Tennessee Department of Health. May 21, 2021).

Washington State Department of Health (WSDH) and Washington State Department of Labor and Industries (WLNI). (2020, November 10). COVID-19 confirmed cases by industry sector. Publication Number 421-002. https://www.doh.wa.gov/​Portals/​1/​Documents/​1600/​coronavirus/​IndustrySectorReport.pdf. (WSDH and WLNI, November 10, 2020).

Wilkins, JT et al., (2021). Seroprevalence and correlates of SARS-CoV-2 antibodies in health care workers in Chicago. Open Forum Infectious Diseases. 8(1): ofaa582. https://doi.org/​10.1093/​ofid/​ofaa582. (Wilkins et al., 2021).

Zhang, M. (2020, November 18). Estimation of differential occupational risk of COVID-19 by comparing risk factors with case data by occupational group. American Journal of Industrial Medicine 64(1):39-47. doi: 10.1002/ajim.23199. (Zhang, November 18, 2020).

b. Studies Focusing on Employees in Healthcare

General Surveillance and Surveys Across the U.S.

Burrer et al., (2020) reported surveillance data on COVID-19 cases and deaths among “healthcare personnel” between February 12 and April 9, 2020. “Healthcare personnel” were defined as “paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or Start Printed Page 32403infectious materials.” [9] Although only 16% of all surveillance forms indicated whether the case was healthcare personnel, 19% of the reported cases occurred in healthcare personnel. Twelve states indicated whether the case was healthcare personnel for at least 80% of all reported cases. An estimated 11% of COVID-19 cases from those 12 states were healthcare personnel. Based on reported known contact with confirmed COVID-19 cases in the 14 days before illness onset, work exposures likely caused 55% of those infections. Between 8% and 10% of infected employees were hospitalized, 2%-5% of the infected employees were admitted to the ICU, and 0.3%-0.6% of those employees died.

CDC continues to provide general updates for COVID-19 cases and deaths among healthcare personnel. However, information on healthcare personnel status was reported for only 18.21% of total cases and death status reported for only 79.57% of healthcare personnel cases as of May 24, 2021 (CDC, May 24, 2021a). CDC reports 491,816 healthcare personnel cases (10% of the 4,856,885 cases that included information on healthcare personnel status) and 1,611 fatalities (0.4% of healthcare employee cases) as of May 24, 2021 (CDC, May 24, 2021a). Independent reporting by Kaiser Health News and the Guardian in their ongoing investigative reporting database found 3,607 fatalities among healthcare personnel in the United States as of April 2021(Kaiser Health News and the Guardian, April 2021; February 23, 2021). The reporters for this effort consider even their own count—which is higher than the official CDC count—to be an undercount due to various reporting issues, such as a lack of reporting requirements for long-term care employees for a significant portion of the initial COVID-19 surge.

Hartmann et al., (2020) analyzed case interview data from February through May 2020 to assess the burden of COVID-19 on healthcare employees in Los Angeles County, CA, where it is mandated that all positive cases be reported to the County Department of Public Health, and all cases are interviewed. Healthcare employees were defined as any person working or volunteering in healthcare settings including hospitals and skilled nursing facilities, medical offices, mental health facilities, and emergency medical services (EMS). The definition also includes healthcare employees providing care in non-healthcare settings such as schools, senior living facilities, and correctional facilities. Healthcare employees included both staff who interacted directly with patients and staff who do not provide direct clinical care to patients. Through May 31, 2020, 5,458 COVID-19 cases among healthcare employees were reported to the County Health Department, representing 9.6% of all cases during this time period. Of those healthcare employees, 46.6% worked in a long-term care setting, 27.7% worked in a hospital, and 6.9% worked in medical offices. Healthcare employees from all other settings represented less than 4% of total healthcare employee cases. Nurses represented 49.4% of all healthcare employee cases; no other group of healthcare employees represented more than 6% of the total reported healthcare employee cases. Of note is that some healthcare associated employees who are expected to have less close contact with patients represented a greater percentage of cases than some healthcare employee that are expected to have close and direct patient contact. For example, employees in administration (4.3%), environmental services (3.2%), and food services (2.9%) represented a higher percentage of infected healthcare employees than physicians (2.7%). When asked about known exposures, 44% of those who tested positive reported exposure to a COVID-19-positive patient or co-worker in their health facility, 11% reported exposure to a COVID-19-positive friend or family member or recent travel, and 45.1% had unknown exposures. At the time of the interviews, 5.3% of COVID-19-positive healthcare employees in Los Angeles County reported requiring hospitalization because of COVID-19, and as of May 31, 2020 there were 40 (0.7%) deaths.

Fell et al., (October 30, 2020) reviewed exposure and infection data for healthcare personnel in Minnesota between March and July of 2020. After the first confirmed case of COVID-19 in Minnesota (on March 6, 2020), the Minnesota Department of Health (MDH) requested that healthcare facilities provide a list of exposed healthcare personnel. Healthcare personnel included EMS personnel, nurses/nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractors, and those who do not provide direct patient care but could be exposed to infectious agents in a healthcare setting (e.g., clerical, food services, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel). Cases in laboratory personnel are also reported. The facilities were asked to determine if each exposure was high-risk, defined as when the healthcare personnel has close, prolonged contact with a confirmed COVID-19 case or their secretions/excretions while not wearing PPE, or close, prolonged contact with persons with COVID-19 in their household or community. MDH and the 1,217 participating healthcare facilities assessed 17,200 healthcare personnel for 21,406 exposures to COVID-19 cases, of which 5,374 (25%) were classified as higher-risk. It was reported that 373 of 5,374 personnel (6.9%) with high-risk exposures tested positive for COVID-19 within 14 days of the exposure. The report stated that only symptomatic personnel were encouraged to get tested for COVID-19, and therefore it is possible that asymptomatic cases occurred and were not detected. Of those 373 personnel who tested positive for COVID-19, 242 were exposed to a patient, resident of a congregate setting, in a congregate setting outbreak, or to another healthcare personnel. Twenty-one percent of exposures to a confirmed COVID-19 case took place in acute or ambulatory care settings, 24% of exposures were to residents in congregate living or long-term care settings, and 25% of exposures were in congregate setting outbreaks. An additional 25% of exposures to confirmed COVID-19 cases were exposures to co-workers, and 5% were exposures to household/social contacts.

The Fell study (October 30, 2020) also demonstrated that high risk exposures can occur to healthcare employees in positions throughout the healthcare facility. Available data for 4,669 (87%) of the higher risk exposures in the Fell et al., study indicated that the highest percentages of high-risk exposures were in nursing assistants or patient care aides (1,857; 40%) and nursing staff (1,416; 30%). The proportion of high-risk exposures represented by personnel such as administrators (247; 5%) and environmental services staff (155; 3%) were similar to those reported by medical providers, such as physicians or nurse practitioners (220; 5%). Healthcare personnel working in congregate living or long-term care settings, including skilled nursing, assisted living, and group home facilities, were more likely to receive a positive COVID-19 test result within 14 days of a higher-risk exposure than were healthcare personnel working in acute care settings. The study authors note the Start Printed Page 32404potential for employee transmission by cautioning that, in contrast to the recognized risk associated with patient care, healthcare employees might have failed to recognize the risk associated with interacting with co-workers in areas such as breakrooms and nursing stations. Physical distancing and PPE may therefore not have been used as consistently in those situations.

The authors of a different study concluded that nurses and EMTs were, respectively, 26% and 33% more likely to contract COVID-19 than attending physicians. Nurses and EMTs' job duties require more intense, close contact with patients compared to physicians, as well as higher frequency and duration of patient contact. Firew et al., (October 21, 2020) conducted a cross-sectional survey of healthcare employees in May of 2020 across 48 states, the District of Columbia, and U.S. territories. The 2,040 respondents who completed at least 80% of the survey were included in the study. Among included participants, 31.1% were attending physicians, 26.8% were nurses, 13% were EMTs, 8.82% were resident physicians or fellows, 3.97% were physician assistants, and 16.32% were other healthcare employees. A total of 598 respondents (29.3%) reported SARS-CoV-2 infections.

In a prospective study of over 2 million community members and 99,795 frontline healthcare workers that was performed in the U.S. and UK from March through April 2020, healthcare workers were 3.4 times as likely to self-report a positive COVID-19 test as the general public, after adjusting for the increased likelihood of healthcare personnel receiving a COVID-19 test (Nguyen et al., 2020). In the U.S. alone, healthcare workers were almost two times more likely to report a positive test after adjusting for greater likelihood of testing.

Detection of SARS-CoV-2 in Healthcare Employees

OSHA reviewed a number of studies that included hospital employees. Many hospitals provide short-term and/or long-term care for COVID-19 patients who have symptoms that are severe enough to require hospitalization. Therefore, close contact with COVID-19 patients is expected in hospital settings, putting hospital employees at risk of developing COVID-19. Examples of employees who work in hospitals include healthcare practitioners, who generally have either licensure or credentialing requirements (e.g., doctors, nurses, pharmacists, physical therapists, massage therapists) for the purpose of promoting, maintaining, monitoring, or restoring health. Individuals who provide healthcare support services also work at hospitals. Examples of employees who provide healthcare support services and may have close contact with COVID-19 patients in some circumstances include patient intake/admission, patient food services, chaplain services, equipment and facility maintenance, housekeeping services, healthcare laundry services, and medical waste handling services. As noted above, hospital employees are at risk from close contact with patients.

Some of the studies reviewed below were done in employees of healthcare systems that included both hospitals and ambulatory care centers such as physician offices, medical clinics (including urgent care and retail-based clinics), outpatient surgical centers, and outpatient cancer treatment centers. Although this ETS does not cover non-hospital ambulatory care settings where all non-employees are screened prior to entry and people with suspected or confirmed COVID-19 are not permitted to enter, it was not possible to separate out results for hospital versus ambulatory care employees. Also it is not known to what extent those ambulatory care centers in the studies reviewed by OSHA performed screening to identify suspected or confirmed COVID-19. Risk of exposure and transmission of SARS-CoV-2 is expected to be lower in ambulatory healthcare settings that perform screening to exclude persons with suspected or confirmed COVID-19. However some types of ambulatory medical facilities (e.g., family practice; pediatrics clinic; urgent care) may choose to test patients for COVID-19 or examine and treat COVID-19 patients on site. Therefore, healthcare employees and healthcare support employees in some ambulatory care centers who do not conduct health screening to identify and exclude suspected or confirmed COVID-19 patients are at risk of infection due to close contact with patients who could potentially have COVID-19.

Barrett et al., (2020) conducted a prospective cohort study of healthcare employees and non-healthcare employees with no known previous SARS-CoV-2 infection who were recruited and tested for SARS-CoV-2 from March 24 through April 7, 2020 at Rutgers University and two of its affiliated university hospitals in New Jersey. As of July 2020, New Jersey was one of the hardest hit areas, with less than 3% of the U.S. population but 8.5% of all known U.S. cases. Healthcare employees were defined as individuals who worked at least 20 hours per week in a hospital, had occupations with regular patient contact, and were expected to have contact with at least three patients per shift over the following three months. Occupations included residents, fellows, attending physicians, dentists, nurse practitioners, physician assistants, registered nurses, technicians, respiratory therapists, and physical therapists. Non-healthcare employees included faculty, staff, trainees, or students working at Rutgers for at least 20 hours a week and who had no patient contact. The study reported that 7.3% of healthcare employees (40 of 546) and 0.4% of non-healthcare employees (1 of 283) tested positive for SARS-CoV-2 infection. Even after the authors conducted sensitivity analyses to exclude individuals with symptoms at baseline and those who had exposure to someone with COVID-19 or COVID-19 symptoms outside of work, differences between infection rates in healthcare employees and non-healthcare employees continued to be observed. OSHA finds this suggests that healthcare employees were more likely than non-healthcare employees to have developed COVID-19 from a workplace exposure during the early months of the pandemic in the United States. The study authors concluded that the potential for workplace exposure is further supported by the fact that only 8% of infected study subjects reported contact with someone having COVID-19 symptoms outside of work. In addition, higher rates of infection were observed in healthcare employees who worked in the hospital that had more COVID-19 patients and was located in the community that had higher rates of SARS-CoV-2 infections. The study authors noted that because that hospital was overwhelmed, it was not always possible to separate COVID-19 vs. non-COVID-19 patients, which may have led to additional exposures among staff. Among healthcare employees, nurses had the highest rate of observed infections (11.1% tested positive), and attending physicians had the lowest rate of observed infection (1.8% positive). Resident and fellow physicians had a 3.1% positivity rate and other groups of healthcare employees had a 9% positivity rate. Increased risk of infection was associated with spending greater proportions of work time in patients' rooms and higher reported exposures to patients with suspected or diagnosed COVID-19.

Mani et al., (November 15, 2020) reported results from SARS-CoV-2 testing of 3,477 symptomatic employees in the University of Washington Start Printed Page 32405Medical system and its affiliated organizations in Seattle, WA, between March 12 and April 23, 2020. During that period, 185 (5.3%) employees tested positive. Prevalence (i.e., proportion) of SARS-CoV-2 in frontline healthcare employees (those with face-to-face contact with patients) was 5.2% and prevalence in non-frontline staff was 5.5%. Some staff who were asymptomatic also underwent screening as part of outbreak investigations, and 9 of 151 (6%) tested positive. When findings from symptomatic and asymptomatic staff were combined, SARS-CoV-2 prevalence was 5.3% in frontline healthcare employees and 5.3% among all employees. Of the 174 employees who tested positive and were followed, six (3.2%) reported COVID-related hospitalization, and one employee was admitted to the ICU. No deaths were reported. The study authors suspected that community transmission likely played a major role in infection among healthcare employees early in the local epidemic and that similar percentages of infections in frontline and non-frontline healthcare employees support the PPE protocols implemented for frontline workers at the institution. In addition, positive cases were likely underestimated due to the focus on testing symptomatic employees.

Vahidy et al., (2020) studied asymptomatic infection rates among staff from a medical center consisting of seven hospitals in Texas and members of the surrounding community in March through April of 2020. Healthcare jobs with possible exposure to COVID-19 patients were classified into five categories, with varying levels of patient exposure: (1) Nursing (e.g., nurses/nurses aids, emergency medical technicians), (2) clinicians (e.g., physicians, nurse practitioners), (3) allied healthcare workers (e.g., therapists, social workers), (4) support staff (e.g., security, housekeeping), and (5) administrative or research staff (e.g., managers, research assistants). A total of 2,872 asymptomatic individuals, including 2,787 healthcare personnel and 85 community residents, were tested for SARS-CoV-2 infection. Among the healthcare personnel tested, the prevalence of SARS-CoV-2 infection was 5.4% among the 1,992 patient-facing staff treating COVID-19 patients and 0.6% among the 625 patient-facing staff not treating COVID-19 patients. No cases were seen among the 170 nonclinical healthcare staff that did not interact with patients or in the 85 community residents (Vahidy et al., 2020). The nonclinical healthcare staff worked in buildings with separate heating, ventilation, and air conditioning systems, and with lower population density because of remote work when compared to clinical healthcare staff. In the different healthcare categories that cared for COVID-19 patients, prevalence of infection ranged from 3.6% to 6.5%, with no significant differences in the different categories of healthcare workers. Therefore, the study indicates that healthcare workers providing both direct and indirect care to COVID-19 patients are at risk.

Nagler et al., (June 28, 2020), reported the results of SARS-CoV-2 testing in employees from the New York Langone Health system, an academic medical center encompassing four hospital campuses and over 250 ambulatory sites, with approximately 43,000 employees. Between March 25 and May 18, 2020, the health system tested employees who were symptomatic (4,150), were asymptomatic but exposed to COVID-19 (4,362), and asymptomatic employees who were returning to work after their services had been suspended during the peak of the epidemic (6,234). Among symptomatic employees, the COVID-19 positivity rate across the duration of the study was 33%. Among asymptomatic employees with self-reported exposure, the COVID-19 positivity rate was 8%. In asymptomatic employees returning to work, COVID-19 positivity rate was 3%. In all groups, the positivity rate in the first week of testing was substantially higher than in the last week of testing, which occurred more than a month after the first week. The study authors noted a temporal correlation of COVID-19 case declines in healthcare employees and the community, despite continued workplace exposure, and suggested that infections in healthcare employees may reflect importance of community transmission and efficacy of stringent infection control and PPE standards that remained largely unchanged since the start of the pandemic in March 2020. OSHA finds that the study demonstrates the potential for COVID-19 to be introduced into the workplace from uncontrolled community spread and that the effective use of infection control practices and PPE most likely prevented transmission to healthcare employees.

Misra-Hebert et al., (September 1, 2020) conducted a retrospective cohort study to obtain data on rates of COVID-19 and risk factors for severe disease in healthcare employees and non-healthcare employees (neither category defined) who were tested for SARS-CoV-2, and listed in a registry at the Cleveland Clinic Health System, between March 8 and June 9, 2020. The data was drawn from healthcare employees from different segments of the country. Ninety percent of the healthcare employees and 75% of non-healthcare employees were from Ohio, and the remainder were from Florida. Although more healthcare employees than non-healthcare employees reported exposures to COVID-19 (72% vs. 17%), similar, and not significantly different, proportions of employees tested positive for COVID-19 in each group: 9% (551/6145) of healthcare employees and 6.5% (4353/66,764) of non-healthcare employees. OSHA finds it difficult to draw conclusions regarding this finding because the nature of the exposure (e.g., whether it was at close contact) was not explained. In fact, patient-facing healthcare employees (those having direct contact with patients) were 1.6 times more likely than non-patient-facing healthcare employees to test positive. The study authors suggested that the finding represents an increased risk of infection with work exposure, however they were not able to confirm if the exposure occurred 14 days prior to testing or if PPE was worn during the exposure. Positive cases peaked in early-to-mid April for both healthcare employees and non-healthcare employees (16% and 12%, respectively, as estimated from figure 2 of the study), and then decreased concurrently with the implementation of preventive measures, such as masking and physical distancing, over the course of the study. Of those who tested positive, 6.9% of healthcare employees and 27.7% of non-healthcare employees were hospitalized, and 1.8% and 10.8% respectively, were admitted to the intensive care unit. The study noted that the lower rates of hospitalization for the healthcare employee group could be explained on the basis that the healthcare employee population was younger and had fewer co-morbidities.

Serology Testing in Employees in Hospitals.

Although most of the studies described in this section relied on polymerase chain reaction (PCR) tests to detect cases of COVID-19, a number of studies conducted serology testing to determine how many individuals had been infected by the SARS-CoV-2 virus in the past. Serology tests determine if antibodies that respond to the SARS-CoV-2 virus are present in samples of blood serum. Seroprevalence is the percentage of individuals in a population who have antibodies. Terms such as seropositive or seroconversion are often used to describe persons who have tested positive for the SARS-CoV-2 antibody. Most of the serology tests Start Printed Page 32406conducted looked at a type of antibody known as Immunoglobulin G (IgG). Seroprevalence studies provide a more complete picture of how many individuals in a population may have been infected because many individuals who were infected were not tested for current infections for reasons such as lack of symptoms and lack of available testing. Indeed, many individuals who were asymptomatic may be unaware that they were exposed to SARS-CoV-2 or had COVID-19 (CDC, July 6, 2020). The studies described below were conducted before vaccination began, and it is therefore unlikely that the studies are detecting antibodies produced as a result of vaccination.

Venugopal et al., (2020) conducted a cross-sectional study of healthcare employees across all hospital services (including physicians, nurses, ancillary services, and “others”) who worked at a level one trauma center in the South Bronx, NY between March 1 and May 1, 2020. The period of analysis included the first few weeks of March, when New York City experienced a surge of infections that resulted in strained resources and supplies such as PPE. This hospital was so highly impacted that it was considered “the epicenter of the epicenter.” Participants were tested for IgG antibodies. They were also tested for SARS-CoV-2. Of the 500 out of 659 healthcare employees who completed serology testing, 137 (27%) were positive for SARS-CoV-2 IgG antibodies. Seroprevalence was similar across the different types of healthcare employees (25% to 28%). The study authors indicated that seroprevalence in healthcare employees was higher than in the community, and that seroprevalence likely reflected healthcare and community exposures.

Sims et al., (November 5, 2020) conducted a prospective cohort serology study at Beaumont Health, which includes eight hospitals across the Detroit, MI metropolitan area. In April of 2020, during the peak of the pandemic's first wave, Michigan had the third highest number of cases in the U.S. and most cases were in the Detroit metropolitan area. All 43,000 hospital employees were invited to participate and seroprevalence was analyzed in 20,614 of them between April 13 and May 28, 2020. A total of 1,818 (8.8%) of participants were seropositive. However, when separated according to employees working at home (n=1,868) versus working in their normal manner, employees working at home were significantly less likely to be seropositive (5.6%) than those going into work (9.1%). The authors speculated that the seropositivity level for employees working at home was representative of the population sheltering at home and only leaving home when necessary. Participants involved with direct patient care had a higher seropositive rate (9.5%) than those who were not (7%). Healthcare employees with frequent patient contact (phlebotomy, respiratory therapy, and nursing) had a significantly higher seropositive rate (11%) than those with intermittent patient contact (physicians or clinical roles such as physical therapists, radiology technicians, etc.), who on average had a seropositive rate of 7.4%. The study authors speculated that the differences in these two groups may have been based on differences in both duration and proximity of exposure to patients. Another notable observation is that support personnel such as facilities/security and administrative support employees had seropositivity rates of approximately 7% to 8%, which were similar to rates in physicians (values estimated from Figure 2B). Participants reporting frequent contact with either 1) non-COVID-19 patients, or 2) physicians or nurses but not patients, had higher rates of seropositivity (7.6%) than those reporting no significant contact with patients, physicians, or nurses (but who handled patient samples) (6.5%).

Moscola et al., (September 1, 2020) reported the prevalence of SARS-CoV-2 antibodies in healthcare employees from the Northwell Health System in the greater New York City area. The healthcare employees were offered free, voluntary testing at each of the system's 52 sites between April 20 and June 23, 2020. The analysis included 40,329 of the system's 70,812 employees and found that 5,523 (13.7%) were seropositive. The prevalence of SARS-CoV-2 antibodies was similar to that found in randomly-tested adults in New York State at that time (14%). Analysis of seropositivity by job type reported the highest levels of seropositivity (20.9%) in service maintenance staff (including housekeepers, groundskeepers, medical assistants, and 21 others), followed by 13.1% in nurses, 12.6% in administrative and clerical staff (including non-clinical professionals such as employees in information technology, human resources, medical records, and billing); 11.6% in allied health professionals (including clinical professionals such as physician assistants, physical therapists/occupational therapists, social workers, mental health professionals, pharmacists, and laboratory technicians), and 8.7% in physicians. Seropositivity rates were highest in employees from the emergency department and non-ICU hospital units (approximately 17% each), followed by “other” non-specified areas (12.1%), and ICUs (9.9%).

Wilkins et al., (2021) conducted a cross-sectional study to examine seropositivity rates in 6,510 healthcare workers from a Chicago healthcare system consisting of hospitals, immediate care centers, and outpatient practices. Blood samples were collected through July 8, 2020. The study authors then compared the seropositivity rate of different occupational groups of workers, using administrators as the referent group to reflect exposure consistent with non-healthcare workers. Overall seropositivity for all study participants was 4.8%. Before adjusting for demographics and self-reported out-of-hospital exposure to COVID-19, the study found that a number of healthcare occupations had a higher crude prevalence rate than the administrator group, including: 10.4% for support service healthcare workers; 10.1% for medical assistants; 9.3% for respiratory technicians; 7.6% for nurses; and 3.8% for administrators. After adjustment for demographics and self-reported out-of-hospital exposure to COVID-19, the only type of healthcare workers that continued to be significantly more likely to be seropositive than administrators were nurses, who were 1.9 times more likely to be seropositive. The study authors concluded that the higher work-related risk in nurses likely occurred as a result of frequent and close contact with patients. The study also compared seropositivity rates for different occupational tasks and found that adjusted seropositivity rates were higher for workers participating in the care of COVID-19 patients when compared with those who did not report participating in the care of COVID-19 patients. Being exposed to patients receiving high-flow oxygen therapy and hemodialysis was significantly associated with 45% and 57% higher odds for seropositive status, respectively.

Comparison of Healthcare Worker Serology and the Surrounding Community

Although some serology studies suggest that infections are more correlated to community transmission than job designation (Jacob et al., March 10, 2021; Carter et al., May 2021), these studies do not undermine the robust evidence that healthcare employees with potential workplace exposure to patients with suspected or confirmed COVID-19 are exposed to an elevated risk of contracting COVID-19 compared Start Printed Page 32407to the general population. Carter et al., (May 2021) found that healthcare worker infection rates varied from region to region, noting the importance of community transmission as a factor in infection rates. In Jacob et al., (March 10, 2021), health care workers' serology results were compared to residence location, job designation, and other characteristics to identify risk factors. The study authors found that community transmission was a significant factor in acquiring infections, but were not able to tie in any specific job designation resulting in increases in infection risk. The authors note, however, that the study did not show that workplace exposures did not increase risk; rather it showed that the levels of community transmission observed may be a greater driver of transmission. It should also be noted that the non-pharmaceutical interventions for each job classification are different, so a direct comparison of non-clinical and clinical personnel may result in conclusions with limited application.

One might expect that a full shift with fully and properly implemented non-pharmaceutical interventions should result in lower infection rates. This appeared evident in a study comparing infection rates between first and second COVID-19 outbreak surges in Norway (Magnusson et al., January 6, 2021). For instance, during the first wave from February 26, 2020 to July 17, 2020, nurses were almost three times more likely to be infected than those in a similar age range (20 to 70 years old). However, during the second wave from July 18, 2020 to December 18, 2020, infection rates for nurses were largely indistinguishable from the population at large of a similar age. The authors suggested that the decrease in the odds ratio was potentially due to the implementation of appropriate infection control practices that were previously lacking.

Studies Examining Risks After Known Exposures

Heinzerling et al., (April 17, 2020) examined the development of COVID-19 in 120 healthcare employees who were unknowingly exposed to a patient with COVID-19. The patient was later identified as one of the first U.S. community cases of COVID-19, and Heinzerling et al., (April 17, 2020) concluded that the “investigation presented a unique opportunity to analyze exposures associated with SARS-CoV-2 transmission in a healthcare setting without recognized community exposures.” Of the 120 healthcare employees who were exposed, 43 developed symptoms within 14 days of exposure and were tested for COVID-19. Three of those employees (7% of those tested) were positive for COVID-19. Although those three employees represent 2.5% of the total exposed, it is possible that more employees might have developed COVID-19 because asymptomatic employees were not tested. The healthcare employees who became infected, when compared to those who were not infected, were more commonly present during two aerosol-generating procedures (nebulizer treatment (67% vs. 9%) and non-invasive ventilation (67% vs. 12%); more commonly performed physical examinations of the patient (100% vs. 24%); and were exposed to the patient for longer durations of time (median 120 minutes vs. 25 minutes). None of the exposed healthcare employees had been wearing the complete set of PPE recommended for contact with COVID-19 patients.

Long-Term Care Facilities

Long-term care facilities include nursing homes, skilled nursing facilities, and assisted living facilities. They provide both medical and personal care services to people unable to live independently. Because long-term care facilities are a congregate living situation, infections such as COVID-19 can spread rapidly between patients or residents and the healthcare staff who care for them. Therefore, employees who work at these facilities have an elevated risk of exposure and infection. Like employees who work at hospitals, employees who work at long-term care facilities include both healthcare practitioners, who may have direct and close contact with patients and residents, as well as healthcare support staff who could also be exposed to patients and residents. See the section on “Detection of SARS-CoV-2 in Healthcare Employees” above for a description of the types of employees who may work at these facilities.

McMichael et al., (March 27, 2020) investigated a COVID-19 outbreak affecting patients, employees, and visitors at a long-term care facility in King County, Washington in February of 2020. SARS-CoV-2 infections were identified in 129 persons, including 81 residents, 34 of 170 staff (20%), and 14 visitors. None of the employees died, but 2 of the 34 infected employees (5.9%) had symptoms severe enough to require hospitalization. The median age of the employees was 42.5 years (range 22-79 years). Job titles reported for the employees that were infected included physical therapist, occupational therapist assistant, environmental care worker, nurse, certified nursing assistant, health information officer, physician, and case manager. The study authors noted that infection prevention procedures at the facility were insufficient, and they concluded that introduction of SARS-CoV-2 into long-term care facilities will result in high attack rates among residents, staff, and visitors.

Weil et al., (September 1, 2020) reported a cross-sectional study of skilled nursing facilities in the Seattle area between March 29 and May 13, 2020. Testing was performed by Public Health of Seattle and King County (testing of both residents and staff) or the Seattle Flu Study (testing of only employees). The authors described the period of the study to be at the peak of the pandemic, but the skilled nursing facilities were not experiencing outbreaks at the time of the study. Testing of employees for SARS-CoV-2 was voluntary, and 1,583 employees at 16 skilled nursing facilities were tested. Eleven of the 16 skilled nursing facilities had at least one resident or employee who tested positive. Forty-six (2.9%) employees had positive or inconclusive testing for SARS-CoV-2. Of 1208 residents tested, 110 (9.1%) were positive. Study authors noted shortages in PPE.

Yi et al., (September 7, 2020) evaluated surveillance data on COVID-19 for assisted living facilities in 39 states (representing 44% of the total long-term care facilities in the U.S.). The states began reporting data at various periods ranging from February 27 to April 30, 2020. As of October 15, 2020, 6,440 of 28,623 (22%) assisted living facilities had at least one COVID-19 case among residents or staff (ranging from 1.3% of assisted living facilities in Iowa to 92.8% of assisted living facilities in Connecticut). In 22 states, 17,799 cases of COVID-19 were reported in staff (total number of staff not specified). In 9 states, 46 of 7,128 (0.6%) employees with COVID-19 died.

Bagchi et al., (2021) reported on the CDC's National Healthcare Safety Network (NHSN) surveillance of nursing homes, which began on April 26, 2020. As of May 25, 2020, the Centers for Medicare & Medicaid Services (CMS) began requiring nursing homes to report COVID-19 cases in residents and staff. The authors analyzed data in residents, nursing home staff, and facility personnel that was reported from May 25 through November 22, 2020 in all 50 states, the District of Columbia, Guam, and Puerto Rico. Staff members and facility personnel were defined as “all persons working or volunteering in the facility, including contractors, Start Printed Page 32408temporary staff members, resident caregivers, and staff members who might work at multiple facilities.” The study authors reported that “case count data were aggregated weekly, and resident-weeks were calculated as the total number of occupied beds on the day data were reported.” Data on number of staff members employed were not collected, and therefore “resident weeks” was used as “a closest best estimate of the at-risk denominator for staff members.” The study authors indicated that “cases per 1,000 resident-week were calculated for residents and staff members using the number of COVID-19 cases reported in a week over the corresponding 1,000 resident-weeks.” COVID-19 cases in staff members increased during June and July (10.9 cases per 1,000 resident-weeks reported in the week of July 26); declined during August and September (6.3 per 1,000 resident-weeks in the week of September 13); and increased again by late November (21.3 cases per 1,000 resident-weeks in the week of November 22). The study authors noted that COVID-19 rates among nursing home staff followed similar trends in nursing home residents and the surrounding communities, thereby indicating a possible association between COVID-19 rates in nursing homes and nearby communities.

Terebuh et al., (September 20, 2020) investigated COVID-19 clusters in 45 congregate living facilities in Ohio, from March 7 to May 15, 2020. Most of the facilities investigated were healthcare worksites. More than half of the clusters occurred at medical facilities (51% at nursing homes, 11% at assisted living facilities, 7% at treatment facilities, and 2% at intermediate care facilities). The remaining clusters occurred at corrections facilities (7%), group homes (20%), and shelters (2%). Of the combined 598 residents and healthcare employees who were either confirmed to have COVID-19 or identified as a probable case based on symptoms and close contact with a confirmed case, healthcare employees represented 167 (28%) of the confirmed and 37 (6%) of the probable cases of COVID-19. None of the healthcare employees died. The study authors were able to identify the index case in 25 of the clusters, and 88% of the index cases were determined to be healthcare employees.

Studies Focusing on Healthcare Support Services

Healthcare support services employees, such as personnel that provide food, laundry, or waste-handling services, are at risk of exposure to patients with SARS-CoV-2 and contracting COVID-19. Employees who provide healthcare support services usually have less direct contact with patients, but they can have close contact with COVID-19 patients or contaminated materials when performing tasks such as cleaning patient rooms, removing waste or dirty laundry from patient rooms, delivering food and picking up used food trays and utensils, or repairing equipment in the patient's room. In addition, healthcare support employees can have close and prolonged contact with their co-workers while performing their duties.

One study discussed above (Sims et al., November 5, 2020), shows an infection rate among healthcare support services employees that is similar to healthcare employees, such as physicians, who have some patient contact. As noted, support personnel such as facilities/security and administrative support employees had seropositivity rates of approximately 7% to 8%, which were similar to rates in physicians (values estimated from Figure 2B). Both healthcare support employees and physicians had seropositivity rates that were higher than the rates among employees working from home.

Hale and Dayot (2020) examined an outbreak of COVID-19 among food service employees that occurred in an academic medical center before masking and physical distancing requirements were implemented. After an employee in the food and nutrition department tested positive, 280 asymptomatic staff were tested. The entire food and nutrition department that was actively working was considered exposed because employees shared a common locker room and break area. Therefore, testing was not limited to employees who worked near the index case as part of their duties. Ten staff members in the department (including the index case) tested positive during the investigation. At least seven of the cases were thought to result from transmission from the index case.

Outbreaks for support services have not been well documented and may be encapsulated with incidents for the entire hospital. Local newspaper reports have identified potential incidents in laundry facilities that handle linens contaminated with SARS-CoV-2. In a New Jersey unionized laundry facility, representatives noted that eight employees had been infected with SARS-CoV-2 and demanded improvements in infectious disease control implementation (Davalos, December 21, 2020). In Canada, a Regina hospital laundry plant was connected with an 18-employee outbreak (Martin, August 10, 2020). The cause of the outbreak was not determined.

Emergency Medical Services (EMS)

A limited number of studies have examined the impact of COVID-19 on employees who provide EMS (e.g., EMTs, paramedics), who are considered healthcare personnel under this standard. The studies that address EMS often address personnel such as EMTs along with other types of emergency responders such as firefighters, who are not considered healthcare personnel under this standard. EMTs and similar occupations, such as paramedics, have close contact with patients who are or could be infected with SARS-CoV-2 when they provide medical care or transport those patients. The medical care they provide includes intubation and cardiopulmonary resuscitation, which could generate aerosols and put them at particularly high risk when performing those procedures on someone with confirmed or suspected COVID-19.

Prezant et al., (2020) reviewed paid medical leave data for EMS providers and firefighters using New York City fire department electronic medical records from October 1, 2017 through May 31, 2020. The study authors found that as of May 31, 2020, 1,792 of 4,408 EMS providers (40.7%) had been on leave for suspected or confirmed COVID-19. When compared with the medical leave data from before the pandemic—including months during influenza periods in prior years—the authors found that medical leave for EMS providers was 6.8% above baseline in March 2020 and peaked at 19.3% above baseline in April 2020. The authors determined that COVID-19 was responsible for this increase. The medical leave levels for EMS providers were above those for firefighters. Among firefighters, the data showed that 34.5% had been on leave for suspected or confirmed COVID-19 as of May 31, 2020, and there was a peak in medical leave at 13.0% above baseline in April 2020. A total of 66 (1.2%) firefighters and EMS providers with COVID-19 were hospitalized and 4 died. Despite EMS providers having been given the same PPE (not further specified) as firefighters, EMS providers had higher rates of COVID-19. The study authors concluded that higher rates in EMS providers were attributable to greater exposure to COVID-19 patients while administering medical care.

Weiden et al., (January 25, 2021) investigated risk factors for SARS-CoV-2 infection and severe disease (hospitalization or death) in New York City first responders (EMS and Start Printed Page 32409firefighters) from March 1 through May 31, 2020, based on medical records. The study had a total of 14,290 participants (3,501 EMS personnel and 10,789 firefighters). From March 1 to May 31, 2020, 9,115 (63.8%) responders had no COVID-19 diagnosis, 5,175 (36.2%) were confirmed or suspected COVID-19 cases, and 62 (0.4%) were hospitalized. Three participants died in a hospital, and one died at home. Researchers found that EMS respondents had more cases of severe COVID-19 than firefighters (42/3501 [1.2%] vs. 21/10,789 [0.19%]). The SARS-CoV-2 infection rate among New York City first responders overall was 15 times the New York City rate. EMS personnel had a 4-fold greater risk of severe disease and 26% increased risk of confirmed COVID-19 cases when compared with firefighters. Both firefighters and EMS personnel responded to the pandemic-related emergency medical calls and followed the same PPE protocols. However, EMS personnel had greater COVID-19 exposure than firefighters due to greater COVID-19-related call volume and being solely responsible for patient transport, nebulization of bronchodilators, and intubation.

Tarabichi et al., (October 30, 2020) recruited first responders (from EMS and fire departments) to participate in a study in the Cleveland, Ohio area. The authors conducted a first serologic survey and virus test in the period between April 20 through May 19, 2020 and a second between May 18 and June 2, 2020. A total of 296 respondents completed a first visit and 260 completed the second visit. Seventy-one percent of respondents reported exposure to SARS-CoV-2 and 16 (5.4%) had positive serological testing. No subject had a positive virus test. Fifty percent (8/16) of those who tested positive were either asymptomatic or mildly symptomatic. Based on responses to questions about suspected contacts (it does not appear that the time period of exposure was considered), the study author concluded that likely sources of transmission in participants who tested positive were patients or co-workers.

In a study examining COVID-19 antibodies in employees from public service agencies in the New York City area from May through July of 2020, 22.5% of participants were found to have COVID-19 antibodies (Sami et al., March 2021). The percentages of EMTs and paramedics found to have antibodies (38.3 and 31.1%) were among the highest levels observed in all the occupations. The study authors noted that risk of exposures may be increased for employees who provide emergency medical services because those services are provided in uncontrolled, unpredictable environments, where space is limited (e.g., ambulances) and quick decisions must often be made. Both emergency technicians and paramedics perform procedures such as airway management that involve a high risk of exposure. In fact, the proportions of employees who had antibodies were found to be increased with increasing frequency of aerosol-generating procedures.

In-Home Healthcare Providers

In-home healthcare workers provide medical or personal care services, similar to those provided in long-term care facilities, inside the homes of people unable to live independently. Patients receiving in-home care could receive services from different types of healthcare providers (e.g., a nurse administering medical care, a physical therapist assisting with exercise, a personal care services provider assisting with daily functions such as bathing). In addition, a number of workers may provide services to the same patient, while working in shifts over the course of the day. In-home healthcare providers have a high risk of infection from working close to patients and possibly their family members or other caregivers in enclosed spaces (e.g., performing a physical examination, helping the patient bathe).

The impact of COVID-19 on in-home healthcare workers is not well studied. In-home healthcare workers might be included in reports of COVID-19 cases and deaths in healthcare workers, but those reports do not indicate if any of the affected healthcare workers provided home care. One report from the UK indicated that an occupational category of “social care” which included “care workers and home carers” experienced significantly increased rates of death involving COVID-19 (50.1 deaths per 100,000 men and 19.1 deaths per 100,000 women) from March through May of 2020 (Windsor-Shellard et al., June 26, 2020). And in a related study from March through December of 2020, it was reported that nearly three in four deaths involving COVID-19 in social care operations were in “care workers and home carers,” with 109.9 deaths per 100,000 men and 47.1 deaths per 100,000 women (Windsor-Shellard et al., January 25, 2021).

Conclusion

The representative studies OSHA described in this section on healthcare provide examples of the pervasive impact that SARS-CoV-2 exposures have had on employees in those industries before vaccines were available. Even since vaccines have become widely available, approximately 20 to 30% of healthcare workers remained unvaccinated as of March 2021 (King et al., April 24, 2021), and breakthrough cases among vaccinated healthcare employees are evident. The evidence is consistent with OSHA's determination that SARS-CoV-2 poses a grave danger to healthcare employees. Cases or outbreaks in settings such as hospitals, long-term care facilities, and emergency services departments have had a clear impact on employees in those types of workplaces. The evidence establishes that employees in those settings, whether they provide direct patient care or supporting services, have been infected with SARS-CoV-2 and have developed COVID-19. Some of these employees have died and others have become seriously ill. Employees in healthcare are at elevated risk for transmission in the workplace. Employees in these industry settings are exposed to these forms of transmission through in-person interaction with patients and co-workers in settings where individuals with suspected or confirmed COVID-19 receive care. In many cases, close contact with people who are suspected or confirmed to have COVID-19 is required of personnel in these types of workplaces, and such close contact usually occurs indoors. These employees, who form the backbone of the nation's medical response to the COVID-19 public health emergency, clearly require protection under this ETS.

References

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Barrett, ES et al., (2020). Prevalence of SARS-CoV-2 infection in previously undiagnosed health care workers in New Jersey, at the onset of the US COVID-19 pandemic. BMC infectious diseases 20(1): 1-0. doi: 10.1101/2020.04.20.20072470. (Barrett et al., 2020).

Burrer, SL et al., (2020). Characteristics of health care personnel with COVID-19—United States, February 12-April 9, 2020. MMWR 69(15): 477-481. https://www.cdc.gov/​mmwr/​volumes/​69/​wr/​mm6915e6.htm. (Burrer et al., 2020).

Carter, RE et al., (2021, March 26). Prevalence of SARS-CoV-2 Antibodies in a Multistate Academic Medical Center. Mayo Clin Proc. 2021 May; 96(5): 1165-1174. doi: 10.1016/j.mayocp.2021.03.015. PMID: 33958053; PMCID: Start Printed Page 32410PMC7997730. (Carter et al., March 26, 2021).

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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).

Davalos, J. (2020, December 21). Hospital laundry workers fear their infection risk is rising. Bloomberg. https://www.bloomberg.com/​news/​articles/​2020-12-21/​hospital-laundry-workers-say-every-day-at-work-risks-covid-infection. (Davalos, December 21, 2020).

Fell, A et al., (2020, October 30). SARS-CoV-2 exposure and infection among health care personnel—Minnesota, March 6-July 11, 2020. MMWR 69(43): 1605-1610. https://www.cdc.gov/​mmwr/​volumes/​69/​wr/​mm6943a5.htm?​s_​cid=​mm6943a5_​x. (Fell et al., October 30, 2020).

Firew, TS et al., (2020). Protecting the front line: A cross-sectional survey analysis of the occupational factors contributing to healthcare workers' infection and psychological distress during the COVID-19 pandemic in the USA. BMJ Open 10(10). doi: 10.1136/bmjopen-2020-042752. (Firew et al., 2020).

Hale, M and Dayot, A. (2020). Outbreak investigation of COVID-19 in hospital food service workers. American Journal of Infection Control 49(3): 396-397. https://doi.org/​10.1016/​j.ajic.2020.08.011. (Hale and Dayot, 2020).

Hartmann, S et al., (2020). Coronavirus 2019 (COVID-19) Infections among healthcare workers, Los Angeles County, February-May 2020. Clinical Infectious Diseases. doi: 10.1093/cid/ciaa1200. (Hartmann et al., 2020).

Heinzerling, A et al., (2020, April 17). Transmission of COVID-19 to health care personnel during exposures to a hospitalized patient—Solano County, California, February 2020. MMWR 69(15): 472-476. https://www.cdc.gov/​mmwr/​volumes/​69/​wr/​mm6915e5.htm. (Heinzerling, et al., April 17, 2020).

Jacob, JT et al., (2021, March 10). Risk Factors Associated With SARS-CoV-2 Seropositivity Among US Health Care Personnel. JAMA Netw Open. 2021; 4(3): e211283. doi: 10.1001/jamanetworkopen.2021.1283. (Jacob et al., March 10, 2021).

Kaiser Health News and the Guardian. (2021, February 23). Lost on the Frontline. The Guardian. https://www.theguardian.com/​us-news/​ng-interactive/​2020/​aug/​11/​lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database. (Kaiser Health News and the Guardian, February 23, 2021).

Kaiser Health News and the Guardian. (2021, April). Lost on the Frontline. The Guardian. https://www.theguardian.com/​us-news/​ng-interactive/​2020/​aug/​11/​lost-on-the-frontline-covid-19-coronavirus-us-healthcare-workers-deaths-database. (Kaiser Health News and the Guardian, April 2021).

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).

Magnusson, K et al., (2021, January 6). Occupational risk of COVID-19 in the 1st and 2nd wave of infection. medRxiv https://doi.org/​10.1101/​2020.10.29.20220426. (Magnussen et al., January 6, 2021).

Mani, NS et al., (2020, November 15). Prevalence of COVID-19 infection and outcomes among symptomatic healthcare workers in Seattle, Washington. Clin Infectious Disease 71(10): 2702-2707. doi: 10.1093/cid/ciaa761. (Mani et al., November 15, 2020).

Martin, A. (2020, August 10). Outbreak at Regina's K-Bro Linens: 18 employees test positive. Regina Leader-Post. https://leaderpost.com/​news/​local-news/​outbreak-at-reginas-k-bro-linens-18-employees-test-positive. (Martin, August 10, 2020).

McMichael, TM et al., (2020, March 27). Epidemiology of Covid-19 in a long-term care facility in King County, Washington. New England Journal of Medicine 382(21): 2005-2011. doi: 10.1056/NEJMoa2005412. (McMichael et al., March 27, 2020).

Misra-Hebert, AD et al., (2020, September 1). Impact of the COVID-19 pandemic on healthcare workers' risk of infection and outcomes in a large, integrated health system. Journal of General Internal Medicine 35: 3293-3301. https://doi.org/​10.1007/​s11606-020-06171-9. (Misra-Hebert et al., September 1, 2020).

Moscola, J et al., (2020, September 1). Prevalence of SARS-CoV-2 antibodies in health care personnel in the New York City Area. JAMA 324(9): 893-895. doi: 10.1001/jama.2020.14765. (Moscola et al., September 1, 2020).

Nagler, AR et al., (2020, June 28). Early results from SARS-CoV-2 PCR testing of healthcare workers at an academic medical center in New York City. Clinical Infectious Diseases 72(7): 1241-1243. doi: 10.1093/cid/ciaa867. (Nagler et al., June 28, 2020).

Nguyen, LH et al., (2020). Risk of COVID-19 among front-line health-care workers and the general community: a prospective cohort study. The Lancet Public Health 5(9): e475-e483. https://doi.org/​10.1016/​S2468-2667(20)30164-X. (Nguyen et al., 2020).

Prezant, DJ et al., (2020). Medical leave associated with COVID-19 among emergency medical system responders and firefighters in New York City. JAMA Netw Open 3(7). https://doi.org/​10.1001/​jamanetworkopen.2020.16094. (Prezant et al., 2020).

Sami, S et al., (2021, March). Prevalence of SARS-CoV-2 antibodies in first responders and public safety personnel, New York City, New York, USA, May-July 2020. Emerging Infectious Diseases 27(3). https://doi.org/​10.3201/​eid2703.204340. (Sami et al., March 2021).

Sims, MD et al., (2020). COVID-19 seropositivity and asymptomatic rates in healthcare workers are associated with job function and masking. Clinical Infectious Diseases. doi: 10.1093/cid/ciaa1684. (Sims et al., November 5, 2020).

Tarabichi, Y et al., (2020, October 30). SARS-CoV-2 infection among serially tested emergency medical services workers. Prehospital Emergency Care 25(1): 39-45. https://doi.org/​10.1080/​10903127.2020.1831668. (Tarabichi et al., October 30, 2020).

Terebuh et al., (2020, September 20). Characterization of community-wide transmission of SARS-CoV-2 in congregate living settings and local public health-coordinated response during the initial phase of the COVID-19 pandemic. Influenza Other Respir Viruses. doi: 10.1111/irv.12819. (Terebuh et al., September 20, 2020).

Vahidy, FS et al., (2020) Prevalence of SARS-CoV-2 infection among asymptomatic health care workers in the greater Houston, Texas, area. JAMA Network Open 3(7): e2016451. https://doi.org/​10.1001/​jamanetworkopen.2020.16451. (Vahidy et al., 2020).

Venugopal, U et al., (2020, January). SARS-CoV-2 seroprevalence among health care workers in a New York City hospital: A cross-sectional analysis during the COVID-19 pandemic. International Journal of Infectious Diseases 102: 63-69. https://doi.org/​10.1016/​j.ijid.2020.10.036. (Venugopal et al., January 2020).

Weiden, M et al., (2021, January 25). Pre-COVID-19 lung function and other risk factors for severe COVID-19 in first responders. ERJ open research 7(1): 00610-2020. https://doi.org/​10.1183/​23120541.00610-2020. (Weiden et al., January 25, 2021).

Weil, A et al., (2020, September 1). Cross-sectional prevalence of SARS-CoV-2 among skilled nursing facility employees and residents across facilities in Seattle. J Gen Intern Med 35: 11. doi: 10.1007/s11606-020-06165-7. (Weil et al., September 1, 2020).

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Windsor-Shellard, B and Butt, A. (2020, June 26). Coronavirus (COVID-19) related deaths by occupation, England and Wales: deaths registered between 9 March and 25 May 2020. https://www.ons.gov.uk/​peoplepopulationandcommunity/​healthandsocialcare/​causesofdeath/​bulletins/​coronaviruscovid19relateddeathsbyoccupationenglandandwales/​deathsregisteredbetween9marchand25may2020. Start Printed Page 32411(Windsor-Shellard and Butt, June 26, 2020).

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IV. Conclusion

OSHA finds that healthcare employees face a grave danger from exposure to SARS-CoV-2 in the United States.[10] OSHA's determination is based on three separate manifestations of incurable, permanent, or non-fleeting health consequences of exposure to the virus, each of which is independently supported by substantial evidence in the record. The danger to healthcare employees is further supported by powerful lines of evidence demonstrating the transmissibility of the virus in the workplace and the prevalence of infections in employee populations where individuals with suspected or confirmed COVID-19 receive care.

First, with respect to the grave health consequences of exposure to SARS-CoV-2, OSHA has found that regardless of where and how exposure occurs, COVID-19 can result in death. The risk of death from COVID-19 is especially high for employees who have underlying health conditions, older employees, and employees who are members of racial and ethnic minority groups, who together make up a significant proportion of the working population. Second, even for those who survive a SARS-CoV-2 infection, the virus often causes serious, long-lasting, and potentially permanent health effects. Serious cases of COVID-19 require hospitalization and dramatic medical interventions, and might leave employees with permanent and disabling health effects. Third, even mild or moderate cases of COVID-19 that do not require hospitalization can be debilitating and require medical care and significant time off from work for recovery and quarantine. People who initially appear to have mild cases can suffer health effects that continue months after the initial infection. Furthermore, racial and ethnic minority groups are at increased risk of SARS-CoV-2 infection, as well as hospitalization and death from COVID-19.

Each of these categories of health consequences independently poses a grave danger to individuals exposed to the virus. That danger is amplified for healthcare employees because of the high potential for transmission of the virus in healthcare settings where individuals with suspected or confirmed COVID-19 receive care. The best available evidence on the science of transmission of the virus makes clear that SARS-CoV-2 is transmissible from person to person in these settings, which can result in large-scale clusters of infections. Transmission is most prevalent in healthcare settings where individuals with suspected or confirmed COVID-19 receive care, and can be exacerbated by, for example, poor ventilation, close contact with potentially infectious individuals, and situations where aerosols containing SARS-CoV-2 particles are likely to be generated. Importantly, while older employees and those with underlying health conditions face a higher risk of dying from COVID-19 once infected, fatalities are certainly not limited to that group. Every healthcare workplace exposure or transmission has the potential to cause severe illness or even death, particularly in unvaccinated healthcare workers in settings where patients with suspected or confirmed COVID-19 receive care. Taken together, the multiple, severe health consequences of COVID-19 and the evidence of its transmission in environments characteristic of the healthcare workplaces where this ETS requires worker protections demonstrate that exposure to SARS-CoV-2 represents a grave danger to employees in these workplaces throughout the country.[11]

The existence of a grave danger to employees from SARS-CoV-2 is further supported by the toll the pandemic has already taken on the nation as a whole. Although OSHA cannot estimate the total number of healthcare workers in our nation who contracted COVID-19 at work and became sick or died, COVID-19 has killed 587,342 people in the United States as of May 24, 2021 (CDC, May 24, 2021a). That death toll includes 91,351 people who were 18 to 64 years old (CDC, May 24, 2021b). Current mortality data shows that unvaccinated people of working age have a 1 in 217 chance of dying when they contract COVID-19. As of May 24, 2021, more than 32 million people in the United States have been reported to have infections, and thousands of new cases were being identified daily (CDC, May 24, 2021c). One in ten reported cases of COVID-19 becomes severe and requires hospitalization. Moreover, public health officials agree that these numbers fail to show the full extent of the deaths and illnesses from this disease, and racial and ethnic minority groups are disproportionately represented among COVID-19 cases, hospitalizations, and deaths (CDC, December 10, 2021; CDC, May 26, 2021; Escobar et al., 2021; Gross et al., 2020; McLaren, 2020). Given this context, OSHA is confident in its finding that exposure to SARS-CoV-2 poses a grave danger to the healthcare employees covered by the protections in this ETS.

The above analysis fully satisfies the OSH Act's requirements for finding a grave danger. Although OSHA usually performs a quantitative risk assessment before promulgating a health standard under section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b)(5), that type of analysis is not necessary in this situation. OSHA has most often invoked section 6(b)(5) authority to regulate exposures to chemical hazards involving much smaller populations, many fewer cases, extrapolations from animal evidence, long-term exposure, and delayed effects. In those situations, mathematical modelling is necessary to evaluate the extent of the risk at different exposure levels. The gravity of the danger presented by a disease with acute effects like COVID-19, on the other hand, is made obvious by a straightforward count of deaths and illnesses caused by the disease, which reach sums not seen in a century. The evidence compiled above amply support OSHA's finding that SARS-CoV-2 presents a grave danger in to the healthcare employees covered by the protections in this ETS. In the context of ordinary 6(b) rulemaking, the Supreme Court has said Start Printed Page 32412that 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). This is true a fortiori here in the current national crisis where OSHA must act to ensure employees are adequately protected from the new hazard presented by the COVID-19 pandemic (see 29 U.S.C 655(c)(1)).

Having made the determination of grave danger, as well as the determination that an ETS is necessary to protect these employees from exposure to SARS-CoV-2 (see Need for the ETS, in Section IV.B. of this preamble), OSHA is required to issue this standard to protect these employees from getting sick and dying from COVID-19 acquired at work. See 29 U.S.C. 655(c)(1).

References

Centers for Disease Control and Prevention (CDC). (2020, December 10). COVID-19 racial and ethnic health disparities. https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​health-equity/​racial-ethnic-disparities/​index.html. (CDC, December 10, 2020).

Centers for Disease Control and Prevention (CDC). (2021, May 26). Health disparities: race and Hispanic origin. https://www.cdc.gov/​nchs/​nvss/​vsrr/​covid19/​health_​disparities.htm. (CDC, May 26, 2021).

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). 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, 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).

Escobar, GJ et al., (2021, February 9). Racial disparities in COVID-19 testing and outcomes. Annals of Internal Medicine. doi: 10.7326/M20-6979. (Escobar et al., February 9, 2021).

Gross, CP et al., (2020, October). Racial and ethnic disparities in population-level COVID-19 mortality. Journal of General Internal Medicine 35(10): 3097-3099. doi: 10.1007/s11606-020-06081-w. (Gross et al., October 2020).

McLaren, J. (2020, June). Racial disparity in COVID-19 deaths: Seeking economic roots with Census data. NBER Working Paper Series. Working Paper 27407. doi: 10.3386/w27407. (McLaren, June 2020).

B. Need for the ETS

This ETS is necessary to protect the healthcare workers with the highest risk of contracting COVID-19 at work. Healthcare workers face a particularly elevated risk of contracting COVID-19 in settings where patients with suspected or confirmed COVID-19 receive treatment, especially those healthcare workers providing direct care to patients. The ETS is necessary to protect these workers through requirements including patient screening and management, respirators and other personal protective equipment (PPE), limiting exposure to aerosol-generating procedures, physical distancing, physical barriers, cleaning, disinfection, ventilation, health screening and medical management, access to vaccination, and anti-retaliation provisions and medical removal protection.

I. Events Leading to the ETS

Since January 2020, OSHA has received numerous petitions and supporting letters from members of Congress, unions, advocacy groups, and one group of large employers urging the agency to take immediate action by issuing an ETS to protect healthcare employees from exposure to the virus that causes COVID-19 (Scott and Adams, January 30, 2020; NNU, March 4, 2020; AFL-CIO, March 6, 2020; Wellington, March 12, 2020; DeVito, March 12, 2020; Carome, March 13, 2020; Murray et al., April 29, 2020; Solt, April 28, 2020; Public Citizen, March 13, 2020; Pellerin, March 19, 2020; Yborra, March 19, 2020; Owen, March 19, 2020; ORCHSE, October 9, 2020). These petitions and supporting letters asserted that many employees have been infected because of workplace exposures to the virus that causes COVID-19 and immediate, legally enforceable action is necessary for protection. OSHA quickly began issuing detailed guidance documents and alerts beginning in March 2020 that helped employers determine employee risk levels of COVID-19 exposure and made recommendations for appropriate controls.

On March 18, 2020, then-OSHA Principal Deputy Assistant Secretary Loren Sweatt responded to an inquiry from Congressman Robert C. “Bobby” Scott, Chairman of the House Committee on Education and Labor, regarding OSHA's response to the COVID-19 outbreak (OSHA, March 18, 2020). In the letter, she stated that OSHA had “a number of existing enforcement tools” it was using to address COVID-19, including existing standards such as Personal Protective Equipment (PPE), Respiratory Protection, and Bloodborne Pathogens, as well as the General Duty Clause, 29 U.S.C. 654(a)(1). She also stated that OSHA was working proactively to assist employers by developing guidance documents. And, given the existing enforcement tools, “we currently see no additional benefit from an ETS in the current circumstances relating to COVID-19,” and “OSHA can best meet the needs of America's workers by being able to rapidly respond in a flexible environment.” However, she noted that OSHA would continue to monitor “this quickly evolving situation and will take appropriate steps to protect workers from COVID-19 in coordination with the overall U.S. government response effort.”

Shortly after OSHA's announcement that it did not intend to pursue an ETS at that time, the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO), the country's largest federation of labor unions, filed an emergency petition with the U.S. Court of Appeals for the D.C. Circuit, for a writ of mandamus to compel OSHA to issue an ETS for COVID-19, arguing that OSHA's failure to issue legally enforceable COVID-19-specific rules endangered workers (AFL-CIO, May 18, 2020). On May 29, 2020, OSHA denied the AFL-CIO's pending March 6 petition to OSHA for an ETS [12] and simultaneously filed a response brief with the D.C. Circuit, arguing the AFL-CIO was not entitled to a writ of mandamus (DOL, May 29, 2020). The agency stated that the union had not clearly and indisputably demonstrated that an ETS was necessary and expressed its view that an ETS was not necessary at that time because of the agency's two-pronged strategy for addressing COVID-19 in the workplace: Start Printed Page 32413Enforcement of existing standards and section 5(a)(1) of the OSH Act (the General Duty Clause), as well as development of rapid guidance to provide a flexible response to new and evolving information about the virus. On June 11, 2020, the U.S. Court of Appeals for the D.C. Circuit issued a one paragraph per curiam order denying the AFL-CIO's petition, finding that OSHA's “decision not to issue an ETS is entitled to considerable deference,” and “[i]n light of the unprecedented nature of the COVID-19 pandemic, as well as the regulatory tools that the OSHA has at its disposal to ensure that employers are maintaining hazard-free work environments, . . . OSHA reasonably determined that an ETS is not necessary at this time.” In re Am. Fed'n of Labor & Cong. of Indus. Orgs., No. 20-1158, 2020 WL 3125324 (AFL-CIO, June 11, 2020), rehearing en banc denied (AFL-CIO, July 28, 2020).[13]

Following OSHA's decision in May 2020 not to issue an ETS, some states and local health departments determined enforceable regulation was necessary, leading to the adoption of a variety of state and local executive orders and emergency regulations with specific worker protection requirements. Virginia, Oregon, California, Michigan, and Washington have issued their own ETSs, (see Section VII, Additional Requirements, for a full discussion of OSHA-approved State Plans), and many additional states and localities have issued other kinds of requirements, guidelines, and protective ordinances for workers. Other states and localities have not. The resulting patchwork of state and local regulations led to inadequate and varying levels of protection for workers across the country, and has caused problems for many employees and businesses. As a result, on October 9, 2020, ORCHSE Strategies, LLC (since acquired by the National Safety Council (NSC))—a group of more than 100 large (mostly Fortune 500) companies in over 28 industries—petitioned OSHA to issue an ETS, recognizing that OSHA had provided “very well prepared and thoughtful” guidance, but concluding an ETS is still needed and that the lack of a uniform response has caused confusion and unnecessary burden on already struggling workplaces (ORCHSE, October 9, 2020).

Notwithstanding the patchwork efforts at the state and local level, the country experienced a significant increase in COVID-19 deaths and infections. When OSHA decided not to promulgate an ETS in May 2020, the COVID-19 death toll in the United States was reaching 100,000 (CDC, May 28, 2020). Since then, an additional 500,000 Americans have died from COVID-19 (CDC, May 24, 2021a). 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, 2021b), and thousands of Americans are hospitalized with COVID-19 every day (CDC, May 24, 2021c).

As of May 23, 2021, the agency had issued 689 citations for COVID-19-related violations of existing OSHA requirements, primarily of healthcare facilities including nursing homes. Violations have included, among other things, failure to properly develop written respiratory protection programs; failure to provide a medical evaluation, respirator fit test, training on the proper use of a respirator, and personal protective equipment; failure to report an injury, illness, or fatality; failure to record an injury or illness on OSHA recordkeeping forms; and failure to comply with the General Duty Clause of the OSH Act. In addition, OSHA issued over 230 Hazard Alert Letters (HALs), including over 100 HALs to employers in healthcare settings (e.g., hospitals, ambulatory care, and nursing and residential care facilities), where it found COVID-19-related hazards during workplace inspections, but did not believe it had sufficient basis to cite the employer for violating an existing OSHA standard or the General Duty Clause.

On January 21, 2021, President Biden issued Executive Order 13999, entitled “Protecting Worker Health and Safety” (86 FR 7211). In it, he declared that:

Ensuring the health and safety of workers is a national priority and a moral imperative. Healthcare workers and other essential workers, many of whom are people of color and immigrants, have put their lives on the line during the coronavirus disease 2019 (COVID-19) pandemic. It is the policy of my Administration to protect the health and safety of workers from COVID-19. The Federal Government must take swift action to reduce the risk that workers may contract COVID-19 in the workplace.

He further directed OSHA to take a number of steps to better protect workers from the COVID-19 hazard, including issuing revised guidance on workplace safety, launching a national emphasis program to focus OSHA enforcement efforts on COVID-19, conduct a multilingual outreach program, and evaluate its COVID-19 enforcement policies (id.). In addition, the President directed OSHA to “consider whether any emergency temporary standards on COVID-19, including with respect to masks in the workplace, are necessary, and if such standards are determined to be necessary, issue them by March 15, 2021” (id.). OSHA began working on the issue at once, and shortly after Secretary Walsh took office on March 23, he ordered OSHA to ensure its analysis addressed the latest information regarding the state of vaccinations and virus variants (Rolfson and Rozen, April 6, 2021). In accordance with the executive order and Secretary Walsh's directive, OSHA has reviewed its May 2020 decision not to issue an ETS. For the reasons explained below, OSHA does not believe its prior approach—enforcement of existing standards and the General Duty Clause coupled with the issuance of nonbinding guidance—has proven over time to be adequate to “reduce the risk that workers may contract COVID-19” in healthcare settings. Given the grave danger presented by the hazard, OSHA now finds that this standard is necessary to protect the healthcare employees who face the highest risk of contracting COVID-19 at work. See Nat'l Cable & Telecomm. Ass'n v. Brand X internet Svcs, 545 U.S. 967, 981 (2005) (noting that an agency must “consider the wisdom of its policy on a continuing basis . . . for example, in response to changed factual circumstances, or a change in administrations”); Asbestos Info. Ass'n, 727 F.2d at 423 (5th Cir. 1984) (“failure to act does not conclusively establish that a situation is not an emergency . . . [when there is a grave danger to workers,] to hold that because OSHA did not act previously it cannot do so now only compounds the consequences of the Agency's failure to act.”).

References

American Federation of Labor and Congress of Industrial Organizations. (2020, March 6). “To Address the Outbreak of COVID-Start Printed Page 3241419: A Petition for an OSHA Emergency Temporary Standard for Infectious Disease.” (AFL-CIO, March 6, 2020).

American Federation of Labor and Congress of Industrial Organizations. (2020, May 18). Emergency Petition For A Writ Of Mandamus, and Request For Expedited Briefing And Disposition, No. 19-1158. (AFL-CIO, May 18, 2020).

American Federation of Labor and Congress of Industrial Organizations, USCA Case #20-1158, Document #1846700. (2020, June 11). (AFL-CIO, June 11, 2020).

American Federation of Labor and Congress of Industrial Organizations. Denial of Petition for Rehearing En Banc on Behalf Of American Federation of Labor and Congress of Industrial Organizations. USCA Case #20-1158, Document #1853761. (2020, July 28). (AFL-CIO, July 28, 2020).

American Federation of Teachers, et al., Petition For A Writ Of Mandamus, No. 20-73203 (9th Cir., October 29, 2020). (2020, October 29). (AFT, October 29, 2020).

Carome, M. (2020, March 13). “Letter requesting an immediate OSHA emergency temporary standard for infectious disease.” (Carome, March 13, 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). 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 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). COVID data tracker. New Admissions of Patients with Confirmed COVID-19, United States. https://covid.cdc.gov/​covid-data-tracker/​#new-hospital-admissions. (CDC, May 24, 2021c).

Centers for Disease Control and Prevention (CDC). (2020, May 28). United States Coronavirus (COVID-19) Death Toll Surpasses 100,000. https://www.cdc.gov/​media/​releases/​2020/​s0528-coronavirus-death-toll.html. (CDC, May 28, 2020).

DeVito, J. (2020, March 12). “Grant OSHA emergency standard for COVID-19 to protect frontline workers.” (DeVito, March 12, 2020).

Murray, P, Brown, S, Heinrich, M, Brown, S, Blumenthal, R, Markey, EJ, Van Hollen, C, Durbin, RJ, Smith, T, Whitehouse, S, Wyden, R, King Jr., AS, Kaine, T, Reed, J, Menedez, R, Gillibrand, K, Duckworth, T, Warren, E, Hassan, MW, Casey Jr., RP, Sanders, B, Udall, T, Hirono, MK, Harris, KD, Feinstein, D, Klobuchar, A, Booker, CA, Shaheen, J, Cardin, B. (2020, April 29). “COVID-19 ETS Petition.”(Murray et al., April 29, 2020).

National Nurses United (NNU). (2020, March 4). “National Nurses United Petitions OSHA for an Emergency Temporary Standard on Emerging Infectious Diseases in Response to COVID-19.” (NNU, March 4, 2020).

Occupational Safety and Health Administration (OSHA). (2020, March 18). Letter from Loren Sweatt to Congressman Robert C. “Bobby” Scott. (OSHA, March 18, 2020).

Occupational Safety and Health Administration (OSHA). (2020, May 29). Letter from Loren Sweatt to AFL-CIO President Richard Trumka. (OSHA, May 29, 2020).

Owen, M. (2020, March 19). “Grant OSHA emergency standard to protect frontline workers from COVID-19.” (Owen, March 19, 2020) .

ORCHSE Strategies. (2020, October 9). “Petition to the U.S. Department of Labor—Occupational Safety and Health Administration (OSHA) for an Emergency Temporary Standard (ETS) for Infectious Disease.” (ORCHSE, October 9, 2020).

Pellerin, C. (2020). “Grant OSHA emergency standard to protect frontline workers from COVID-19.” (Pellerin, March 19, 2020).

Public Citizen. (2020, March 13). “Support for AFL-CIO's Petition for an OSHA Emergency Temporary Standard for Infectious Disease to Address the Epidemic of Novel Coronavirus Disease.” (Public Citizen, March 13, 2020).

Rolfson, B, Rozen, C. (2021, April 6). Labor Chief Walsh Puts Hold on OSHA Virus Rule for More Analysis. Bloomberg Law. https://news.bloomberglaw.com/​safety/​labor-chief-walsh-puts-hold-on-osha-virus-rule-for-more-analysis. (Rolfson and Rozen, April 6, 2021).

Scott, RC and Adams, AS. (2020, January 30). “Prioritize OSHA's Work on Infectious Diseases Standard/Immediate Issue of Temporary Standard.” (Scott and Adams, January 30, 2020).

Solt, BE. (2020). “COVID-19 ETS Petition.” (Solt, April 28, 2020).

United States Department of Labor (DOL). (2020, May 29). In Re: American Federation Of Labor And Congress Of Industrial Organizations. Department Of Labor's Response to the Emergency Petition for a Writ of Mandamus, No. 20-1158 (D.C. Cir., May 29, 2020). (DOL, May 29, 2020).

United States Department of Labor (DOL). (2020, December 31). American Federation of Teachers, et al., Department of Labor's Opposition to the Petition for a Writ of Mandamus, No. 20-73203 (9th Cir., December 31, 2020). (DOL, December 31, 2020).

Wellington, M. (2020, March 12). “Grant OSHA emergency standard for COVID-19 to protect front-line workers”. (Wellington, March 12, 2020).

Yborra, G. (2020, March 19). “Grant OSHA emergency standard to protect frontline workers from COVID-19.” (Yborra, March 19, 2020).

II. No Other Agency Action Is Adequate To Protect Employees Against Grave Danger

For the first time in its 50-year history, OSHA faces a “new hazard” so grave that it has killed almost 600,000 people in the United States in barely over a year, and infected millions more. COVID-19 can be spread to employees whenever an infected person exhales. Those employees, once infected, could end up unable to breathe without ventilators or suffer from failure of multiple body organs, and are at risk of death or long-term debilitation. The COVID-19 pandemic has taken a particularly heavy toll on workers in healthcare providing frontline care to patients with suspected or confirmed COVID-19, creating the precise situation that section 6(c)(1) of the OSH Act was enacted to address. This ETS is necessary to protect these employees from the grave danger posed by COVID-19.

When OSHA decided not to issue an ETS last spring, the agency had preliminarily determined that sufficient employee protection against COVID-19 could be provided through enforcement of existing workplace standards and the General Duty Clause of the OSH Act, coupled with the issuance of industry-specific, non-mandatory guidance. However, in doing so OSHA indicated that its conclusion that an ETS was not necessary was specific to the information available to the agency at that time, and that the agency would continue to monitor the situation and take additional steps as appropriate (see, e.g., OSHA, March 18, 2020, Letter to Congressman Scott (stating “[W]e currently see no additional benefit from an ETS in the current circumstances relating to COVID-19. OSHA is continuing to monitor this quickly evolving situation and will take the appropriate steps to protect workers from COVID-19 in coordination with the overall U.S. government response effort.” (emphasis supplied); DOL May 29, 2020 at 20 (stating “OSHA has determined this steep threshold [of necessity] is not met here, at least not at this time.” (emphasis supplied))). OSHA's subsequent experience has shown that a new approach is needed to protect healthcare workers from the grave danger posed by the COVID-19 pandemic.

At the outset, employers do not have a reliance interest in OSHA's prior decision not to issue an ETS on May 29, 2020, which did not alter the status quo or require employers to change their behavior. See Dep't of Homeland Security v. Regents of the Univ. of Start Printed Page 32415California, 140 S. Ct. 1891, 1913-14 (2020). As OSHA indicated when it made the decision, the determination was based on the conditions and information available to the agency at that time and was subject to change as additional information indicated the need for an ETS. In light of the agency's express qualifications and the surrounding context, any employer reliance would have been unjustified and cannot outweigh the countervailing urgent need to protect healthcare workers from the grave danger posed by COVID-19.

Multiple developments support a change in approach. First, as noted above, although the rates of death and hospitalization from COVID-19 have decreased in recent weeks as vaccines have become more widely available, COVID-19 continues to pose a grave danger to healthcare employees in settings where the risk of exposure to an infected person is elevated because of the nature of the work performed. In addition, some variability in infection rates in a pandemic is to be expected. While the curves of new infections and deaths can bend down after peaks, they often reverse course only to reach additional peaks in the future (Moore et al., April 30, 2020). Several new mutations—or variants—of the virus, preliminarily understood to be more contagious than the original, are now spreading in this country.

Second, as discussed in more detail in Grave Danger (Section IV.A of this preamble), while vaccines have been authorized for use for several months, and the nationwide effort to fully vaccinate all Americans is ongoing, more work is needed to build confidence among Americans in the vaccines so that enough people are protected to bring the virus under control, and to ensure that employees can get vaccinated without the risk of losing their jobs or losing pay. The standard is therefore necessary to facilitate vaccination among healthcare workers by requiring employers to “provid[e] reasonable time and paid leave . . . to each employee for vaccination and any side effects experienced following vaccination” (paragraph (m)).

The standard also further encourages vaccination by fully exempting “well-defined hospital ambulatory care settings where all employees are fully vaccinated” and all non-employees are screened and denied entry if they are suspected or confirmed to have COVID-19 (paragraph (a)(2)(iv)) and “home healthcare settings where all employees are fully vaccinated” and all non-employees at that location are screened prior to employee entry so that people with suspected or confirmed COVID-19 are not present (paragraph (a)(2)(v)). In addition, the standard encourages vaccination by exempting fully vaccinated employees from the requirements for facemasks, physical distancing, and barriers “in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present” (paragraph (a)(4)).

Further, OSHA's actual enforcement experience over the past year—which had only just begun when OSHA announced its previous views on the need for an ETS—has demonstrated that existing enforcement options do not adequately protect healthcare employees from the grave danger posed by COVID-19. As of May 23, 2021, OSHA and its State Plan partners have received more than 67,000 COVID-related complaints since March of 2020 (OSHA, May 23, 2021). OSHA has received more complaints about healthcare settings than any other industry.[14] Although the number of employee complaints has gone down in recent months since COVID-19 vaccines have become more widely available, OSHA continues to receive hundreds of employee complaints every month, including many that concern healthcare settings, asking for investigations of workplaces where employees do not believe they are being adequately protected from COVID-19 and indicating that their employers do not follow the guidance issued by the agency and the CDC.

The following narratives are just a few recent examples of the kinds of complaints OSHA continues to receive from healthcare employees on a regular basis:

  • 5/21/21 Doctor's office failed to remove employee with COVID-19 symptoms.
  • 5/21/21 Assisted living facility for the elderly failed to notify employees that they were exposed to residents with COVID-19.
  • 5/19/21 Doctor's office did not maintain distancing for employees, did not notify employees of exposure to COVID-19, and did not remove employees with COVID-19 symptoms from the workplace.
  • 5/19/21 Doctor's office did not ensure that technician wore gloves during COVID-19 treatment.
  • 5/10/21 Clinic did not follow guidance for patient screening or removal from the workplace of potentially infected employee.
  • 5/7/21 Psychiatric facility did not properly clean rooms of COVID-19 positive patients, did not train employees to properly remove infectious disease PPE when exiting COVID-19 positive areas to other areas of the facility, and allows employees who have tested positive for COVID-19 to continue to work at the workplace.
  • 5/6/21 Hospital failed to promptly remove employee with COVID-19 from the workplace, notify other employees of their exposure to the COVID-19, and did not require employees to wear facemasks.
  • 5/3/21 Doctor's office required employees to reuse isolation gowns to an extent not consistent with CDC guidance.

This ETS addresses numerous issues raised in these complaints, including physical distancing, PPE, cleaning and disinfection, and measures to keep contagious co-workers away from the workplace.

Based on its thorough review of OSHA's existing approach to protecting employees from COVID-19, OSHA finds that existing OSHA standards, the General Duty Clause, and non-mandatory guidance issued by OSHA are not adequate to protect healthcare employees from COVID-19. Similarly, the numerous guidance products published by other entities, such as CDC, are not sufficiently effective at protecting these employees because such guidance is not enforceable and there is no penalty for noncompliance. OSHA has determined that each of these tools, as well any combination of them, is inadequate to address COVID-related hazards in the settings covered by this standard, thereby establishing the need for this ETS.

This inadequacy has also been reflected in the number of states and localities that have issued their own mandatory standards in recognition that existing measures (including non-mandatory guidance, compliance assistance, and enforcement of existing standards) have failed to adequately protect workers from COVID-19. While these state and local requirements may have had positive effects where they have been implemented, they are no replacement for a national standard that would establish definitively that COVID-19 safety measures are no longer Start Printed Page 32416voluntary for the workers covered by this standard. Without a national standard, the patchwork of inconsistent requirements has proven both ineffective at a national level and burdensome to employers operating across jurisdictions, increasing compliance costs and potentially limiting the ability to implement protective measures at scale (See ORCHSE, October 9, 2020). Congress has charged OSHA with protecting America's workforce, and an ETS is the only measure capable of providing adequate protection to the workers covered by this standard from the grave danger posed by COVID-19.

a. The Current Standards and Regulations Are Inadequate

In updated enforcement guidance issued in March 2021 (OSHA, March 12, 2021), OSHA identified a number of current standards and regulations that might apply when workers have occupational exposure to SARS-CoV-2 (Interim Enforcement Response Plan) (OSHA, March 12, 2021).[15] In addition to the standards listed there, OSHA has also cited the Hazard communication standard (29 CFR 1910.1200) during COVID-19 investigations. Accordingly, the complete list of potentially applicable standards and regulations follows:

  • 29 CFR part 1904, Recording and Reporting Occupational Injuries and Illnesses. This regulation requires certain employers to keep records of work-related fatalities, injuries, and illnesses and report them to the government in specific circumstances.
  • 29 CFR 1910.132, General requirements—Personal Protective Equipment (PPE). This standard requires that appropriate PPE, including PPE for eyes, face, head, and extremities, protective clothing, respiratory devices, and protective shields and barriers, be provided, used, and maintained in a sanitary and reliable condition.
  • 29 CFR 1910.134, Respiratory protection. This standard requires that employers provide, and ensure the use of, appropriate respiratory protection when necessary to protect employee health.
  • 29 CFR 1910.141, Sanitation. This standard applies to permanent places of employment and contains, among other requirements, general housekeeping and waste disposal requirements.
  • 29 CFR 1910.145, Specification for accident prevention signs and tags. This standard requires the use of biological hazard signs and tags, in addition to other types of accident prevention signs and tags.
  • 29 CFR 1910.1020, Access to employee exposure and medical records. This standard requires that employers provide employees and their designated representatives access to relevant exposure and medical records.
  • 29 CFR 1910.1200, Hazard communication. This standard requires employers to keep Safety Data Sheets (SDS) for chemical hazards, provide SDSs to employees and their representatives when requested, and train employees about those hazards. The standard does not apply to biological hazards, but hazard communication becomes an issue for the SARS-CoV-2 virus when chemicals are used to disinfect surfaces. OSHA notes that, when such chemicals are used in the workplace, the employer is required to comply with the hazard communication standard. The agency has not incorporated hazard communication requirements in the ETS, but has included related training and notification requirements. Section 1910.1200 compliance is only peripherally related to protection against SARS-CoV-2 hazards, employers are generally aware of those requirements, and the requirements of § 1910.1200 are enforceable without being repeated in the ETS.

Through its enforcement efforts to date, OSHA has encountered significant obstacles demonstrating that existing standards and regulations are inadequate to address the COVID-19 hazard for healthcare workers, and has determined that a COVID-19 ETS is necessary to address these inadequacies. As discussed in further detail below, OSHA has determined that some of the above-listed standards—including Sanitation at § 1910.141—are in practice too difficult to apply to the COVID-19 hazard and have never been cited in COVID enforcement; other standards—such as Respiratory Protection at § 1910.134 and general PPE at § 1910.132—are more clearly applicable to the COVID-19 hazard, but for a variety of reasons have offered little protection to the vast majority of employees who are not directly caring for patients with suspected or confirmed COVID-19. Current CDC guidance does not indicate that respirators are generally needed outside of direct patient care, but CDC does support the protective measures the ETS would require for the workers it covers (Howard, May 22, 2021).

Finally, the remaining listed standards and regulations—for recordkeeping and reporting, accident prevention signs and tags, access to employee records, and hazard communication—while applicable to the COVID-19 hazard and important in the overall scheme of workplace safety, do not require employers to implement specific measures to protect workers from COVID-19. Further, as addressed in more detail below, even applicable regulations like the reporting requirements did not contemplate a hazard like COVID-19, and have proven to be difficult to apply to it. Thus, for the reasons elaborated in further detail below, OSHA has determined that its existing standards and regulations are insufficient to adequately address the grave danger posed by COVID-19 to healthcare workers.

First, most of the safety measures known to reduce the hazard of COVID-19 transmission are not explicitly required by existing standards: none expressly requires measures such as facilitating vaccination, facemasks, physical distancing, physical barriers, cleaning and disinfection (when appropriate), improved ventilation to reduce virus transmission, isolation of sick employees, minimizing exposures in the highest hazard settings such as aerosol-generating procedures on patients with suspected or confirmed COVID-19, patient screening and management, notification to employees potentially exposed to people with COVID-19, or training on these requirements. For example, although OSHA's existing Respiratory Protection and PPE standards require respirators and PPE such as gloves and face shields in some settings covered by the ETS, they do not require all of the other layers of protection required by the ETS that are necessary to mitigate the spread of COVID-19 in the workplace. See Need for Specific Provisions (Section V of the preamble).

Similarly, while the Sanitation standard at § 1910.141(a)(3) requires places of employment “to be kept clean to the extent that the nature of the work allows,” the standard does not require disinfection of potentially contaminated surfaces nor does it speak to the level or frequency with which cleaning is required to protect against an infectious Start Printed Page 32417disease hazard like COVID-19. Accordingly, OSHA has not yet identified any instance in which the Sanitation standard could be applied in the agency's COVID-19 enforcement efforts. Thus, OSHA's efforts to enforce existing standards to address the COVID-19 hazard have been significantly hindered by the absence of any specific requirements in these standards related to some of the most important COVID-19-mitigation measures. The COVID-19 ETS addresses this issue by clearly mandating each of these necessary protections.

Second, because existing standards do not contain provisions specifically targeted at the COVID-19 hazard, it may be difficult for employers and employees to determine what particular COVID-19 safety measures are required by existing standards, or how the separate standards are expected to work together as applied to COVID-19. As explained in more detail in the Need for Specific Provisions (Section V of the preamble), the infection control practices required to address COVID-19 are most effective when used together, layering their protective impact. Because no such layered framework is currently enforced nationally, the existing standards leave large gaps in employee protection from COVID-19. An ETS with a national scope that contains provisions specifically addressing the COVID-19 hazards facing healthcare workers will provide clearer instructions to the average employer than the piecemeal application of existing standards. The ETS bundles all of the relevant requirements, providing a roadmap for employers and employees to use when developing a plan and implementing protections, so that employers and employees in the settings covered by this standard know what is required to protect employees from COVID-19. More certainty will lead to more compliance, and more compliance will lead to improved protection of employees.

Third, requirements in some existing standards may be appropriate for other situations but simply do not contemplate COVID-19 hazards. For example, as noted above, the Sanitation standard at § 1910.141 requires employers to provide warm water, soap, and towels that can be used for hand washing, an important protective action against COVID-19, and generally requires that places of employment be kept “clean,” but it does not specify disinfection as a cleaning procedure, even though disinfection is an important precaution against COVID-19 transmission. Nor does it require the provision of hand sanitizer where hand washing facilities cannot be made readily available. Similarly, existing standards do not address facemasks for a hazard such as COVID-19, which protect other workers (source control) as well as provide some degree of protection to the wearer. The ETS, developed in direct response to the COVID-19 hazard and associated pandemic, provides this needed specificity so the employers covered by the ETS understand exactly what is required during this unprecedented public health emergency.

Fourth, the existing recordkeeping and reporting regulations are not adequate to help the employer or the agency assess the full scope of COVID-19 workplace exposures. The recordkeeping regulations were not written with the nature of COVID-19 transmission or illness in mind. In order to adequately understand and thereby control the spread of COVID-19 in the workplace, it is critical that the employer has a record of all cases of COVID-19 occurring among employees; however, such information is outside of the scope of OSHA's existing recordkeeping requirements, which are limited to injuries or illnesses that the employer knows to be work-related. The existing regulations are premised on the assumption that employers can easily identify injuries or illnesses that are work-related, but COVID-19 transmission can occur in the workplace, the community, or the household, and it can be difficult to identify the point of transmission. In numerous investigations, OSHA has identified employee illnesses or deaths from COVID-19 that were not reflected in the employer's required recordkeeping logs because the employer was not able to determine whether the illness or death was work-related. The COVID-19 log required by the ETS will provide a fuller picture of the prevalence of SARS-CoV-2 in the workplace by requiring employers to record employee cases without a work-relatedness determination.

Furthermore, even where work-relatedness can be determined, the existing reporting regulations are also inadequate in ensuring OSHA has the full picture of the impact of COVID-19 in the settings covered by this standard because the regulations only require employers to report in-patient hospitalizations that occur within 24 hours of the work-related incident and to report fatalities that occur within thirty days of the work-related incident. But many COVID-19 infections will not result in hospitalization or death until well after these limited reporting periods; consequently they are not required to be reported to OSHA, which limits the agency's ability to fully understand the impact of COVID-19 on the workforce. In order to adequately understand and thereby control the spread of COVID-19 in the workforce, it is critical that the employer has a record of all cases of COVID-19 occurring among employees and that OSHA is timely informed of all work-related COVID-19 in-patient hospitalizations and fatalities.

OSHA's existing recordkeeping and reporting requirements are also inadequate for addressing the COVID-19 hazard in the workplaces covered by the ETS because the current reporting structure does not require employers to notify employees of possible exposures in the workplace. While the recordkeeping requirements require employers to make illness and injury records available to employees, 29 CFR 1910.35(b)(2), they do not create an affirmative duty requiring employers to notify employees when they may have been exposed to another employee with the disease. Given the transmissibility of COVID-19, timely notification of an exposure is critical to curbing further spread of COVID-19 and protecting employees from the COVID-19 hazard.

Thus, OSHA's existing recordkeeping and reporting requirements are not tailored to address hazards associated with COVID-19 in the workplaces covered by the ETS. As a result, they do not enable OSHA, employers, or employees to accurately identify and address such hazards. The ETS addresses that issue by requiring employers to record each instance identified by the employer in which an employee is COVID-19 positive, regardless of whether the instance is connected to exposure to COVID-19 at work; requiring employers to report work-related, COVID-19 in-patient hospitalizations and fatalities, regardless of when the exposure in the work environment occurred; and imposing an affirmative duty requiring employers to notify employees of COVID-19 exposure.

In conclusion, OSHA's experience has demonstrated that existing standards alone are inadequate to address the COVID-19 hazard. The limitations and inadequacies explained above prevent OSHA from requiring all of the layers of controls necessary to protect employees from COVID-19 under these existing standards, even in situations that are clearly hazardous to employees. Thus, OSHA finds that its existing standards are not sufficient to protect employees from the grave danger posed by COVID-19.Start Printed Page 32418

b. The General Duty Clause Is Inadequate To Meet the Current Crisis

Section 5(a)(1) of the OSH Act, or the General Duty Clause, provides the general mandate that each employer “furnish to each of [its] employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees.” 29 U.S.C. 654(a)(1). While OSHA has attempted to use the General Duty Clause to protect employees from COVID-19-related hazards, OSHA has found that there are significant challenges associated with this approach and therefore this ETS is necessary to protect the workers covered by this standard from the grave danger posed by COVID-19. While the General Duty Clause can be used in many contexts, in OSHA's experience over the past year, the clause falls short of the agency's mandate to protect employees from the hazards of COVID-19 in the settings covered by the standard. As explained more fully below, OSHA finds the ETS will more efficiently and effectively address those hazards. Cf. Bloodborne Pathogens, 56 FR 64004, 64007, 64038 (Dec. 6, 1991) (bloodborne pathogens standard will more efficiently reduce the risk of the hazard than can enforcement under the general duty clause).

As an initial matter, the General Duty Clause does not provide employers with specific requirements to follow or a roadmap for implementing appropriate abatement measures. The ETS, however, provides a clear statement of what OSHA expects employers to do to protect workers, thus facilitating better compliance. The General Duty Clause is so named because it imposes a general duty to keep the workplace free of recognized serious hazards; the ETS, in contrast, lays out clear requirements for COVID-19 plans, facemasks, distancing, barriers, cleaning, personal protective equipment, and training, among other things, and identifies the settings in which they are required. Conveying obligations as clearly and specifically as possible provides employers with enhanced notice of how to comply with their OSH Act obligations to protect workers from COVID-19 hazards. See, e.g., Integra Health Mgmt., Inc., 2019 WL 1142920, at *7 n.10 (OSHRC No. 13-1124, 2019) (noting that standards “give clear notice of what is required of the regulated community”); 56 FR 64007 (“because the standard is much more specific than the current requirements [general standards and the general duty clause], employers and employees are given more guidance in carrying out the goal of reducing the risks of occupational exposure to bloodborne pathogens”).

Moreover, several characteristics of General Duty Clause enforcement actions limit how effectively OSHA can use the clause to address hazards associated with COVID-19. Most important, the General Duty Clause is not a good tool for requiring employers to adopt specific, overlapping, and complementary abatement measures, like those required by the ETS, and some important worker-protective elements of the ETS (such as payment for medical removal) would be virtually impossible for OSHA to require and enforce under the General Duty Clause. Second, OSHA's burden of proof for establishing a General Duty Clause violation is heavier than for standards violations.

Third, the ETS will enable OSHA to issue more meaningful penalties for willful or egregious violations, thus facilitating better enforcement and more effective deterrence against employers who intentionally disregard their obligations under the Act or demonstrate plain indifference to employee safety. Fourth, the General Duty Clause does not provide complete protection to employees at multi-employer worksites, which are common situations in hospitals, where more than one employer controls hazards at the workplace. The ETS will permit more thorough enforcement in these situations. Each of these is discussed in more detail below.

General Duty Clause Citations Impose a Heavy Litigation Burden on OSHA

For contested General Duty Clause citations to be upheld, OSHA must demonstrate elements of proof that are supplementary to, and can be more difficult to show than, the elements of proof required for violations of specific standards, where a hazard is presumed. Specifically, to prove a violation of the General Duty Clause, OSHA needs to establish—in each individual case—that: (1) An activity or condition in the employer's workplace presented a hazard to an employee; (2) the hazard was recognized; (3) the hazard was causing or was likely to cause death or serious physical harm; and (4) feasible means to eliminate or materially reduce the hazard existed. BHC Nw. Psychiatric Hosp., LLC v. Sec'y of Labor, 951 F.3d 558, 563 (D.C. Cir. 2020).

For the first element of a General Duty Clause case, OSHA must prove that there is a hazard, i.e., a workplace condition or practice to which employees are exposed, creating the potential for death or serious physical harm to employees. See SeaWorld of Florida LLC v. Perez, 748 F.3d 1202, 1207 (D.C. Cir. 2014); Integra Health Management, 2019 WL 1142920, at *5. In the case of COVID-19, this means showing not just that the virus is a hazard as a general matter—a fairly indisputable point—but also that the specific conditions in the cited workplace, such as performing administrative tasks in a waiting room setting where patients are seeking treatment for suspected or confirmed COVID-19, create a hazard. In contrast, an OSHA standard that requires or prohibits specific conditions or practices establishes the existence of a hazard. See Harry C. Crooker & Sons, Inc. v. Occupational Safety & Health Rev. Comm'n, 537 F.3d 79, 85 (1st Cir. 2008); Bunge Corp. v. Sec'y of Labor, 638 F.2d 831, 834 (5th Cir. 1981). Thus, in enforcement proceedings under OSHA standards, as opposed to the General Duty Clause, “the Secretary need not prove that the violative conditions are actually hazardous.” Modern Drop Forge Co. v. Sec'y of Labor, 683 F.2d 1105, 1114 (7th Cir. 1982). With OSHA's finding that the hazard of exposure to COVID-19 can exist in the workplaces covered by this standard (see Grave Danger, above), the ETS will eliminate the burden to repeatedly prove the existence of a COVID-19 hazard in each individual case under the General Duty Clause.

One of the most significant advantages to standards like the ETS that establish the existence of the hazard at the rulemaking stage is that the Secretary can require specific abatement measures without having to prove that the cited workplace is hazardous.[16] In contrast, under the General Duty Clause, the Secretary cannot require abatement before proving in the enforcement proceeding that an existing condition at the workplace is hazardous. For example, in a facial challenge to OSHA's Grain Handling Standard, which was promulgated in part to protect employees from the risk of fire and explosion from accumulations of grain dust, the Fifth Circuit acknowledged OSHA's inability to effectively protect employees from these hazards under the General Duty Clause in upholding, in large part, the standard. Start Printed Page 32419See Nat'l Grain & Feed Ass'n v. Occupational Safety & Health Admin., 866 F.2d 717, 721 (5th Cir. 1988) (noting Secretary's difficulty in proving explosion hazards of grain handling under General Duty Clause). Although OSHA had attempted to address fire and explosion hazards in the grain handling industry under the General Duty Clause, “employers generally were successful in arguing that OSHA had not proved that the specific condition cited could cause a fire or explosion.” Id. at 721 & n.6 (citing cases holding that OSHA failed to establish a fire or explosion hazard under the General Duty Clause). In other words, the General Duty Clause was not an effective tool because OSHA could not prove that existing conditions at the cited workplace were hazardous. The Grain Handling Standard, in contrast, established specific limits on accumulations of grain dust based on its combustible and explosive nature, and the standard allowed OSHA to cite employers for exceeding those limits without the need to prove at the enforcement stage that each cited accumulation was likely to cause a fire or explosion. See id. at 725-26. The same logic applies to COVID-19 hazards. Given OSHA's burden under the General Duty Clause to prove that conditions at the cited workplace are hazardous, it is difficult for OSHA to ensure necessary abatement before employee lives and health are unnecessarily endangered by exposure to COVID-19. The ETS, on the other hand, allows OSHA to cite employers for each protective requirement they fail to implement without the need to prove in an enforcement proceeding that the particular cited workplace was hazardous at the time of citation without that particular measure in place.

An additional limitation of the General Duty Clause is that it requires OSHA to show that there was a feasible and effective means of abating the hazard. To satisfy this element, OSHA is required to prove that there are abatement measures that will be effective in materially reducing the hazard. See Integra Health Management, 2019 WL 1142920, at *12. Proving the existence of feasible abatement measures that will be effective in materially reducing the hazard usually requires testimony from an expert witness, which limits OSHA's ability to prosecute these cases as broadly as needed to protect more workers. See, e.g., id. at *13 (requiring expert witness to prove proposed abatement measures would materially reduce hazard). In contrast, where an OSHA standard specifies the means of compliance, the agency has already made the necessary technical determinations in the rulemaking and therefore does not need to establish feasibility of compliance as part of its prima facie case in an enforcement proceeding; instead, the employer bears the burden of proving infeasibility as an affirmative defense. See, e.g., A.J. McNulty & Co. v. Sec'y of Labor, 283 F.3d 328, 334 (D.C. Cir. 2002); S. Colorado Prestress Co. v. Occupational Safety & Health Rev. Comm'n, 586 F.2d 1342, 1351 (10th Cir. 1978). Protecting as many workers as quickly as possible is especially critical in the context of COVID-19 because, as explained in Section IV.A, Grave Danger, it can spread so easily in the workplaces covered by this ETS.

The General Duty Clause Is Ill-Suited to Requiring Employers To Adopt a Comprehensive Set of Complementary Abatement Measures, Like Those Required by the ETS

As explained in Section V. Need for the Specific Provisions of the ETS, effective infection control programs use a suite of overlapping controls in a layered approach to ensure that no inherent weakness in any one approach results in an infection incident. Each of the practices required by the ETS provides some protection from COVID-19 on its own, but the practices must be used together to ensure adequate worker protection. However, General Duty Clause enforcement poses key obstacles that prevent OSHA from requiring the types of overlapping controls necessary to address COVID-19 hazards. Because the General Duty Clause requires OSHA to establish the existence and feasibility of abatement measures that can materially reduce a hazard, it can be difficult for OSHA to use 5(a)(1) to require a full suite of overlapping or complementary control measures, or, in other words, to require additional abatement measures in situations where an employer is doing something, but not everything the ETS will require, to address COVID-19 hazards.

In many cases over the past year where OSHA investigated COVID-19-related complaints, the agency discovered that employers were following some minimal mitigation strategy while ignoring other crucial components of employee protection. In such instances, because the employer had taken some steps to protect workers, successfully proving a General Duty Clause citation would have required OSHA to show that additional missing measures would have further materially reduced the COVID-19 hazard. Although OSHA believes each measure required by this ETS materially reduces the COVID-19 hazard, there are key challenges inherent in trying to make such a showing in an individual case, such as the difficulty of pinpointing exactly when and how employees could become infected with COVID-19 and establishing the magnitude of the effect particular abatement measures would have on reducing infection in the specific conditions present in the employer's workplace. See, e.g., Pepperidge Farm, Inc., 17 OSH Cas. (BNA) 1993, 1997 WL 212599, at *51 (OSHRC No. 89-265, Apr. 26, 1997) (finding that additional feasible abatement measure established by the Secretary to address ergonomic hazard did not materially reduce the hazard in light of the other steps the employer had taken). The ETS cures this problem by imposing separate requirements for, and establishing the general effectiveness of, each necessary mitigation measure, thereby ensuring employers have an enforceable obligation to provide the full suite of workplace protections recommended by the CDC and other expert bodies.

Consider a hospital setting where patients with suspected or confirmed COVID-19 receive treatment. The employer requires respirators for employees providing direct care to those patients but little else to protect those employees or other workers in those settings who are not directly involved in patient care. Under the ETS, OSHA can cite the employer for violating the specific requirements necessary to protect all workers in those settings, such as facemasks for workers who are not directly caring for patients, physical distancing or barriers between administrative employees and patients who have not yet been screened for suspected or confirmed COVID-19, work practice controls for employees performing aerosol-generating procedures on people with suspected or confirmed COVID-19, patient screening and management, paid leave for vaccination, and medical removal protection.

Without the ETS, however, OSHA would have to cite the employer under the General Duty Clause for the much broader violation of failing to eliminate the recognized workplace hazard of COVID-19 infection. This would require OSHA to prove: (1) That the hazard of COVID-19 infection was present and recognized for employees at this particular healthcare workplace, and (2) that additional abatement methods would materially reduce the hazard, over and above the reduction achieved by the use of respirators as already required under 29 CFR 1910.134 for Start Printed Page 32420exposure to people with suspected or confirmed COVID-19. Both of these elements would likely require expert witness testimony specific to conditions in this particular workplace, and it may be difficult to establish that each layer of protection necessary to comprehensively protect employees would have materially reduced the hazard depending on the facts of the specific instance.

Further, even where OSHA establishes a violation of the General Duty Clause, the employer is under no obligation to implement the precise feasible means of abatement proven by OSHA as part of its prima facie case. Cyrus Mines Corp., 11 OSH Cas. (BNA) 1063, 1982 WL 22717, at *4 (OSHRC No. 76-616, Dec. 17, 1983). Thus, even in cases where OSHA prevails, the employer need not necessarily implement the specific abatement measure(s) OSHA established would materially reduce the hazard. The employer could select alternative controls and then it would be up to OSHA, if it wished to cite the employer again, to establish that the recognized hazard continued to exist and that adding physical distancing or barriers, for example, could materially reduce the hazard even further.

Finally, there are some crucial requirements in the ETS that OSHA would have difficulty enforcing under the General Duty Clause. Of particular note, OSHA is adopting provisions in the ETS that require paid time for vaccination and recovery from vaccine side effects, and removal of COVID-19-positive employees and other workers exposed to them from the workplace and payment of salary for employees who are removed (medical removal protection, or “MRP”). These provisions are critical to protecting workers because they facilitate vaccination, which is the preferred means of protecting workers exposed to COVID-19 hazards, and removal of infected employees and their close contacts as soon as the employer knows they have COVID-19. Additional discussion of the importance of these provisions can be found in Section V. Need for the Specific Provisions of the ETS. While it might be possible for OSHA to establish the value of vaccination as a protective measure and the need to remove known infected employees in a General Duty Clause case, it is highly unlikely that OSHA could require payment to those employees, or other measures to encourage employees to get vaccinated or to let their employers know when they test positive for COVID-19. Rather, paid leave for vaccination and MRP are measures better implemented through OSHA's statutory authority to promulgate standards. Standards are forward-looking and can be used to create a comprehensive network of required, and in this case of layered, worker safety protections. The ETS creates just such a network, and vaccination and MRP are important layers of that approach.

The ETS Will Permit OSHA To Achieve Meaningful Deterrence When Necessary To Address Willful or Egregious Failures To Protect Employees Against the COVID-19 Hazard

As described above, in contrast to the broad language of the General Duty Clause, the ETS will clarify what exactly employers are required to do to protect employees from COVID-19-related hazards, making it easier for OSHA to determine whether an employer has intentionally disregarded its obligations or exhibited a plain indifference to employee safety or health. In such instances, OSHA can classify the citations as “willful,” allowing it to propose higher penalties, with increased deterrent effects. Early in the pandemic, shifting guidance on the safety measures employers should take to protect their employees from COVID-19 created ambiguity regarding employers' specific obligations. Thus, OSHA could not readily determine whether a particular employer had “intentionally” disregarded obligations that were not yet clear. And, even as the guidance began to stabilize, OSHA's ability to determine “intentional disregard” or “plain indifference” was difficult, for example, when an employer took some, but not all, of the necessary steps to sufficiently address the COVID-19 hazard. Given the current understanding that multiple layers of protection are necessary to adequately protect workers from COVID-19, an ETS will ensure that employers have clearer notice of their obligations. This will allow the agency to take appropriate steps to redress the situation where an employer has intentionally disregarded the requirements necessary to protect employees from the COVID-19 hazard, or has acted with plain indifference to employee safety.

Further, OSHA has adopted its “egregious” policy to impose sufficiently large penalties to achieve appropriate deterrence against bad actor employers who willfully disregard their obligation to protect their employees when certain aggravating circumstances are present, such as a large number of injuries or illnesses, bad faith, or an extensive history of noncompliance. (OSHA Directive CPL 02-00-080 (October 21, 1990.)) Its purpose is to increase the impact of OSHA's enforcement ability. This policy uses OSHA's authority to issue a separate penalty for each instance of willful noncompliance with an OSHA standard, such as each employee lacking the same required protections, or each workstation lacking the same required controls. It can be more difficult to use this policy under the General Duty Clause because the Fifth Circuit and the Occupational Safety and Health Review Commission have held that OSHA may only cite a hazardous condition once under the General Duty Clause, regardless of its scope. Reich v. Arcadian Corp., 110 F.3d 1192, 1199 (5th Cir. 1997). Thus, even where OSHA finds that an employer willfully failed to protect a large number of employees from a COVID-19 hazard, OSHA likely could not cite the employer on a per-instance basis for failing to protect each of its employees. A COVID-19-specific ETS will clarify the permissible units of prosecution and thereby make clear OSHA's authority to separately cite employers for each instance of the employer's failure to protect employees and for each affected employee, where appropriate.

By providing needed clarity, the ETS will facilitate “willful” and “egregious” determinations that are critical enforcement tools OSHA can use to adequately address violations by employers who have shown a conscious disregard for the health and safety of their workers in response to the pandemic. Without the necessary clarity, OSHA has been limited in its ability to impose penalties high enough to motivate the very large employers who are unlikely to be deterred by penalty assessments of tens of thousands of dollars, but whose noncompliance can endanger thousands of workers. Without a willful classification (or a substantially similar prior violation), the maximum penalty for a serious General Duty Clause violation is $13,653, regardless of the scope of the hazard.

The General Duty Clause Provides Incomplete Protection at Multi-Employer Worksites

Finally, the General Duty Clause has limited application to multi-employer worksites like hospitals, as it cannot be used to cite an employer whose own employees were not exposed to a hazard even if that employer may have created, contributed to, or controlled the hazard. See Solis v. Summit Contractors, Inc., 558 F.3d 815, 818 (8th Cir. 2009) (“Subsection (a)(1) [the General Duty Clause] creates a general duty running only to an employer's own employees, Start Printed Page 32421while subsection (a)(2) creates a specific duty to comply with standards for the good of all employees on a multi-employer worksite.”). For example, if a janitorial services contractor were to send one employee who is COVID-19 positive into a healthcare setting and knowingly allow that employee to work around employees of other employers, the janitorial services contractor who created the hazard could not be issued a General Duty Clause citation because none of that employer's own employees would have been exposed to the hazard. This limitation of the General Duty Clause can prevent OSHA from citing the employer on a multi-employer worksite who may be the most responsible for an existing COVID-19 hazard or best positioned to mitigate that hazard.

For all of the reasons described above, OSHA finds that the General Duty Clause is not an adequate enforcement tool to protect the employees covered by this standard from the grave danger posed by COVID-19.

c. OSHA and Other Entity Guidance Is Insufficient

OSHA has issued numerous non-mandatory guidance products to advise employers on how to protect workers from SARS-CoV-2 infection. (See https://www.osha.gov/​coronavirus) Even the most comprehensive guidance makes clear, as it must, that the guidance itself imposes no new legal obligations, and that its recommendations are “advisory in nature.” (See OSHA's online guidance, Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace (January 29, 2021); and OSHA's earlier 35-page booklet, Guidance on Preparing Workplaces for Covid-19 (March 9, 2020)). This guidance, as well as guidance materials issued by other government agencies and organizations, including the CDC, the Centers for Medicare & Medicaid Services (CMS), the Institute of Medicine (IOM), and the World Health Organization (WHO), help protect employees to the extent that employers voluntarily choose to implement the practices they recommend.[17] Unfortunately, OSHA's experience shows that does not happen consistently or rigorously enough, resulting in inadequate protection for employees.

As documented in numerous peer-reviewed scientific publications, CDC, IOM, and WHO have recognized a lack of compliance with non-mandatory recommended infection-control practices (Siegel et al., 2007; IOM, 2009; WHO, 2009). OSHA was aware of these findings when it previously concluded that an ETS was not necessary, but at the time of that conclusion, the agency erroneously believed that it would be able to effectively use the non-mandatory guidance as a basis for establishing the mandatory requirements of the General Duty Clause, and informing employers of their compliance obligations under existing standards. As explained above, that has not proven to be an effective strategy. Moreover, when OSHA made its initial necessity determination at the beginning of the pandemic, it made an assumption that given the unprecedented nature of the COVID-19 pandemic, there would be an unusual level of widespread voluntary compliance by the regulated community with COVID-19-related safety guidelines (see, e.g., DOL, May 29, 2020 at 20 (observing that “[n]ever in the last century have the American people been as mindful, wary, and cautious about a health risk as they are now with respect to COVID-19,” and that many “protective measures are being implemented voluntarily, as reflected in a plethora of industry guidelines, company-specific plans, and other sources”)).

Since that time, however, developments have led OSHA to conclude that the same uneven compliance documented by CDC, IOM, and WHO is also occurring for the COVID-19 guidance issued by OSHA and other agencies. This was evidenced by a cross-sectional study performed from late summer to early fall of 2020 in New York and New Jersey that found non-compliance and widespread inconsistencies in COVID-19 response programs (Koshy et al., February 4, 2021). Several other factors have also been found to contribute to uneven implementation of controls to prevent the spread of COVID-19. For example, there has been a reported rise of “COVID fatigue” or “pandemic fatigue”—i.e., a decrease in voluntary use of COVID-19 mitigation measures over time (Silva and Martin, November 14, 2020; Meichtry et al., October 26, 2020; Belanger and Leander, December 9, 2020). In addition, the fear of financial loss; skepticism about the danger posed by COVID-19; and even a simple human tendency, called “psychological reactance,” to resist curbs on personal freedoms, i.e., an urge to do the opposite of what somebody tells you to do, may also play a role in the uneven implementation of COVID-19 mitigation measures (Belanger and Leander, December 9, 2020; Markman, April 20, 2020).

The high number of COVID-19-related complaints and reports also suggests a lack of widespread compliance with existing voluntary guidance. Although the number of employee complaints is declining, OSHA continues to receive hundreds of complaints every month, including complaints alleging that healthcare employers are not consistently following non-mandatory CDC guidance to protect employees. If guidance were followed more strictly, or if there were enough voluntary compliance with steps to prevent illness, OSHA would expect to see a significant reduction in COVID-19-related complaints from employees.

The dramatic increases in the percentage of the population that contracted the virus toward the end of 2020 and in early 2021 indicated a continued risk of COVID-19 spread in workplace settings (for more information on the prevalence of COVID-19 see Grave Danger (Section IV.A of the preamble)) despite OSHA's publication of numerous specific and comprehensive guidance documents. OSHA has found that neither reliance on voluntary action by employers nor OSHA non-mandatory guidance is an adequate substitute for specific, mandatory workplace standards at the federal level. Public Citizen v. Auchter, 702 F.2d 1150 at 1153 (voluntary action by employers “alerted and responsive” to new health data is not an adequate substitute for government action). The ETS is one aspect of the national response to the pandemic that is needed to improve compliance with infection control measures by establishing clear, enforceable measures that put covered employers on notice that they must, Start Printed Page 32422rather than should, take action to protect their employees. For these reasons, OSHA finds that non-mandatory guidance efforts are not sufficient, by themselves or in conjunction with General Duty Clause enforcement, to protect employees covered by this ETS from being infected by, and suffering death or serious health consequences from, COVID-19.

d. A Uniform Nationwide Response to the Pandemic Is Necessary To Protect Workers

OSHA is charged by Congress with protecting the health and safety of American workers. Yet OSHA's previous approach proved ineffective in meeting that charge. While some states and localities stepped in to fill the gaps in employee protection, these approaches do not provide consistent protection to workers and have, in some cases, been relaxed prematurely, leading to additional outbreaks (Hatef et al., April 2021). In some states there are no workplace requirements at all. OSHA has determined that a Federal standard is needed to ensure sufficient protection for employees in all states in the settings covered by this ETS; clarity and consistency about the obligations employers have to protect their employees in these settings; and a level playing field among employers.

As the pandemic has continued in the United States, there has been increasing recognition of the need for a more consistent national approach (GAO, September 2020; Budryk, November 17, 2020; Horsley, May 1, 2020). One of the justifications for OSHA standards has always been to “level the playing field” so that employers who proactively protect their workforces are not placed at a competitive disadvantage (Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 521 n.38 (1981)). Many employers have advised OSHA that they would welcome a nationwide ETS for that reason. For example, in its October 9, 2020 petition for a COVID-19 ETS, ORCHSE Strategies, LLC explained that it is “imperative” that OSHA issue an ETS to provide employers one standardized set of requirements to address safety and health for their workers (ORCHSE, October 9, 2020). This group of prominent business representatives explained that an ETS would eliminate confusion and unnecessary burden on workplaces that are struggling to understand how best to protect their employees in the face of confusing and differing requirements across states and localities. While noting that “OSHA could not pre-empt a State from keeping its own rule (assuming it is `at least as effective' as OSHA's standard),” they also observed that “historically, the impact of federal rulemaking in similar situations (e.g., HazCom) has been that most, if not all, of the States ultimately adhere to the federal requirements . . . . That can only be accomplished if OSHA takes the lead” (id.). “Without an ETS,” they continue, “employers are left on their own to determine the preventive measures that need to be undertaken” (id.).

Given that thousands of healthcare employees each week continue to be infected with COVID-19, many of whom will become hospitalized or die, OSHA recognizes that a patchwork approach to worker safety has not been successful in mitigating this infectious disease outbreak, and that an ETS is necessary to provide clear and consistent protection to covered employees across the country.

e. OSHA's Other Previous Rationales for Not Promulgating an ETS No Longer Apply

In addition to asserting that existing standards, guidance, and the General Duty Clause would provide sufficient tools to address COVID-19 hazards to employees, OSHA had previously cited the need to respond to evolving scientific knowledge about the virus as part of its rationale for not issuing an ETS during the late spring of 2020. Knowledge of the nature of COVID-19 was undoubtedly less certain at the beginning of the pandemic when OSHA made its initial determination that an ETS was not necessary. There have been recent changes in CDC recommendations for vaccinated people outside the healthcare context. However, for unvaccinated workers, since the summer of 2020 there has been considerable stability in the guidance from the CDC and other health organizations regarding the basic precautions that are essential to protect unvaccinated people from exposure to COVID-19 while indoors. And the CDC still recommends these precautions to protect vaccinated workers in healthcare settings. For example, the CDC's COVID-19 guidance on How to Protect Yourself & Others (CDC, March 8, 2021) includes the same guidance it issued in July 2020 regarding the basic protections of face coverings, distancing, barriers, and hand hygiene. Moreover, OSHA's previous concern—that an ETS would unintentionally enshrine requirements that are subsequently proven ineffective in reducing transmission—has proven to be overstated. Moreover, even after issuing an ETS OSHA retains the flexibility to update the ETS to adjust to the subsequent evolution of CDC workplace guidance. The major development in infection control over the last year—the development, authorization, and growing distribution and use of COVID-19 vaccines—is addressed in the ETS. Going forward, further developments can be addressed through OSHA's authority to modify the ETS if needed, or to withdraw it entirely if vaccination and other efforts end the current emergency. Nothing in the D.C. Circuit's decision in In re Am. Fed'n of Labor & Cong. of Indus. Orgs., No. 20-1158, 2020 WL 3125324 (AFL-CIO, June 11, 2020); rehearing en banc denied (July 28, 2020) precludes OSHA's decision to promulgate an ETS now. To the contrary, at an early phase of the pandemic, when its most severe effects had not yet been experienced, the court decided not to second-guess OSHA's decision to hold off on regulation in order to see if its non-regulatory enforcement tools could be used to provide adequate protection against the virus. “OSHA's decision not to issue an ETS is entitled to considerable deference,” the court explained, noting the “the unprecedented nature of the COVID-19 pandemic” and concluding merely that “OSHA reasonably determined that an ETS is not necessary at this time.” (Id., with emphasis added).

Finally, it is worth noting that OSHA's conclusion as to the ineffectiveness of the current approach—i.e., relying on existing enforcement tools and voluntary guidance—is supported by a report issued by the DOL Office of Inspector General, dated February 25, 2021, which concluded after an investigation that OSHA's prior approach to addressing the hazards of COVID-19 leaves employees across the country at increased risk of COVID-19 infection (DOL OIG, February 25, 2021). The DOL OIG report specifically recommended that OSHA reconsider its prior decision not to issue an ETS to provide the necessary protection to employees from the hazards of COVID-19.

f. Even in Combination, the Guidance and General Duty Clause Are Still Inadequate

Early in the pandemic, OSHA took the position that existing standards, together with the combination of non-mandatory guidance and General Duty Clause citations, would be sufficient to protect employees so that specific mandatory requirements would not be necessary. In theory, where existing standards did not address an issue directly, the remaining regulatory gap could be filled by guidance from OSHA, Start Printed Page 32423which would provide notice of COVID-19 hazards and describe feasible means of abating them, enabling OSHA to later issue a General Duty Clause citation to an employer who had failed to follow that guidance. OSHA's enforcement experience has now disproven that theory. As explained above, existing standards leave an enormous regulatory gap that OSHA's guidance, together with the General Duty Clause, cannot cover for the settings covered by this ETS.

In practice, the combination of guidance and General Duty Clause authority has done little to protect employees in settings covered by the standard where employers were not focused on that goal. The limitations identified above, including the heavy litigation burden for General Duty Clause citations, remain. Instead of being able to rely on clear requirements in a standard, employers were left to wade through guidance not only from OSHA but also from multiple other agencies, states, media, and other sources without any clarity as to how the different guidance materials should work together or what to do when alternative guidance did not square with OSHA's guidance. Perhaps because OSHA's guidance was not mandatory, it was frequently ignored or followed only in part. As explained above, the General Duty Clause's shortcomings as an enforcement tool left OSHA, in most cases, ultimately unable to impose all of the layers of protection necessary to protect employees from COVID-19.

In sum, based on its enforcement experience during the pandemic to date, OSHA concludes that continued reliance on existing standards, together with the combination of guidance and General Duty Clause obligations, in lieu of an ETS, will not protect employees covered by this ETS against the grave danger posed by COVID-19.

g. Recent Vaccine Developments Demonstrate the Importance of the ETS; They Do Not Obviate the Current Need for an ETS

The development and availability of safe and highly effective vaccines is an important development in the nation's response to COVID-19. The very low percentage of breakthrough cases (illness among vaccinated people) have led to recent updates to CDC guidance acknowledging vaccination as an effective control to prevent hospitalization and death from COVID-19 to such an extent that the CDC has concluded that most other controls are not necessary to protect vaccinated people outside healthcare settings. In the United States, all people ages 12 and older are eligible to be vaccinated, and vaccines are readily available in most parts of the country.

However, despite the remarkable success of our nation's vaccine program and the substantial promise that vaccines hold, as explained below, OSHA does not believe they eliminate the need for this standard. OSHA embraces the value of vaccination and views the ETS as essential to facilitating access to this critical control for those workers who wish to receive it while still protecting those who cannot be, or will not be, vaccinated. And by excluding certain workplaces and well-defined work areas where all employees are fully vaccinated from all requirements of the standard (paragraphs (a)(2)(iv) and (v)), and exempting fully vaccinated workers in certain settings where not all employees are vaccinated from several requirements of the standard (paragraph (a)(4)), the ETS encourages vaccination for employers and employees who do not want to follow those requirements.

In addition, for vaccines to be effective, workers need first to actually receive them. While the supply of vaccines and their distribution continues to increase, as of the date of the promulgation of this standard, approximately a quarter of healthcare workers have not yet completed COVID-19 vaccination with many of those expressing vaccine hesitation (King et al., April 24, 2021). Although a majority of Americans over 65 are vaccinated, the percentage among the working-age population is much lower (44%) (CDC, May 24, 2021a). There are several barriers to vaccination for the working-age population. Many employees who want to be vaccinated may be unable to do so unless the employer authorizes time off work, or may be financially unable to absorb a reduced paycheck for taking unpaid leave to be vaccinated or potentially missing a significantly larger period of time from work (and a larger financial hit) because of the potential side effects of the vaccination (SEIU Healthcare, February 8, 2021). A recent Kaiser Foundation survey of people who expressed reluctance to be vaccinated indicates that 70% of those respondents (76% and 77% among Black and Latinx respondents, respectively) were concerned about side effects, and 45% (57% Black and 54% Latinx) cited fears that they might miss work if the side effects made them sick (KFF, May 6, 2021). Another recent study, which surveyed 500 businesses, found that paid time off for vaccination and recovery was the highest overall motivator for employees to get vaccinated (51%), which was even higher than employers offering the vaccine on site (49%) (Azimi et al., April 9, 2021). Yet a different report indicates that before the pandemic, about 70% of the lowest-wage workers had no access to paid sick leave, meaning that any time off for vaccination or recovery would result in lost wages for those who can least afford those losses (Gould, February 28, 2020). Despite the American Rescue Plan (ARP) extending tax credits for some employers to allow this sort of sick leave, such leave is not mandated. Those surveys are consistent with the experience among healthcare workers at Yale University and Yale New Haven Hospital. When workers were surveyed at the time the FDA granted Emergency Use Authorization of the Pfizer-BioNTech vaccine, the lack of incentives or mitigation of risk (e.g., not using sick days or pay loss for side effects) was a key reason stated by people who identified themselves as unlikely to get the vaccine. (Roy et al., December 29, 2020). Following four months of vaccination efforts, researchers found that although 75% had been vaccinated, roughly half of low wage, hourly employees, had not yet been vaccinated, and based on their previous research, identified the provision of additional paid sick leave days as a critical barrier for this population of workers (Roy and Forman, April 7, 2021). Even when employees can arrange for time off for the first dose, some of the same difficulties may prevent workers from returning during the designated time window for the second dose of two-dose vaccines. The ETS addresses these obstacles with a requirement that employers must authorize paid leave to cover the time for vaccination and for recovery from side effects.

Further, there is a need to continue building vaccine confidence in some parts of the population, making the ETS even more important to assure safe working conditions during the period before these workers are vaccinated. Moreover, as discussed in more depth in Grave Danger (Section IV.A. of the preamble), even though vaccines are now more readily available, they do not protect all workers. Some workers are unable to be vaccinated for medical or other reasons, even if they are willing to be. And in immunocompromised workers, vaccines can be considerably less effective than in immunocompetent individuals.[18] And while some Start Printed Page 32424employees may simply elect not to be vaccinated for personal reasons, OSHA has a statutory duty to ensure that employers protect those employees from the grave danger of COVID-19 regardless of their basis for refusing vaccination.

These factors, along with the uneven vaccination rates among some sub-populations, make the need for this ETS especially acute. For example, the Latinx and Black populations who have been disproportionately harmed by the virus also have the lowest vaccination rates (Ndugga et al., February 18, 2021; CDC, May 24, 2021a). This ETS can help facilitate vaccination among those groups, protect those who cannot or will not be vaccinated, and thereby mitigate the disproportionate impacts of the virus for workers in these groups.

Even when the ETS helps currently unvaccinated workers overcome the obstacles to becoming vaccinated, they must still be protected by the other measures of this standard until they are fully protected by the vaccine. With the two-dose vaccines in particular, the time from a first shot to fully effective vaccination is 5 to 6 weeks.

Furthermore, also increasing are new virus variants, the most prevalent of which, the B.1.1.7 variant first identified in the U.K., now appears responsible for almost 66% of the cases in the U.S (CDC, May 24, 2021b). While the currently authorized vaccines appear effective against all of the variants now circulating, promoting vaccination as quickly as possible becomes even more critical because the variant is not only more transmissible, it also appears to cause more severe disease.

Finally, while the science continues to develop, the full extent and duration of the immune response remains unknown. Additional evidence is also needed to determine the extent to which people who are vaccinated could still be infected and transmit the disease to others, even if they themselves are protected from the worst health effects. Although such cases do not appear to be common, the ETS would help protect these employees and their co-workers in mixed groups of vaccinated and unvaccinated people.

These issues, as elaborated further in the discussion of Grave Danger, demonstrate that the various protections required in this ETS are still necessary, even for workplaces in which many but not all members of the workforce have been vaccinated.

This pandemic has taken a devastating toll on all of American society, and addressing it requires a whole-of-government response (White House, April 2, 2021). This ETS is part of that response. OSHA shares the nation's hope for the promise of recovery created by the vaccines. But in the meantime, it also recognizes that measures to mitigate the spread of COVID-19, including encouraging and facilitating vaccination, are still necessary in the settings covered by this standard. However, although OSHA finds it necessary to continue these mitigation measures for the immediate future, the agency will adjust as conditions change. As more of the workforce becomes vaccinated and the post-vaccination evidence base continues to grow, and the CDC updates its guidance, OSHA will withdraw or modify the ETS to the extent the workplace hazard is substantially diminished in the settings covered by this ETS. However, at this point in time, the available evidence indicates that the ETS is still necessary to protect employees in the settings covered by this ETS, and the potential for higher immunity rates later on does not obviate the need to implement the ETS now.

References

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V. Need for Specific Provisions of the ETS

Grave Danger (Section IV.A. of the preamble) identifies the danger of exposure to SARS-CoV-2 for healthcare workers and explains how the SARS-CoV-2 virus is transmitted. This section, on Need for Specific Provisions, examines the scientific underpinnings for the controls that OSHA has identified to stop that transmission in workplaces. In Section VIII, the Summary and Explanation for the various provisions of the ETS, OSHA Start Printed Page 32426explains how those controls must be implemented in the workplace. Not all of the requirements of the ETS are examined in this Need for Specific Provisions section. Some are addressed fully in the Summary and Explanation sections.

A. Introduction—Effective Infection Prevention Utilizes Overlapping Controls

An effective infection prevention program utilizing a suite of overlapping controls in a layered approach better ensures that no inherent weakness in any one approach results in an infection incident. OSHA emphasizes that each of the infection prevention practices required by the ETS provide some protection from COVID-19 by themselves, but work best when used together, layering their protective impact to boost overall effectiveness. A common depiction of this approach in use is Reason's model of accident causation dynamics, more commonly referred to as the “Swiss Cheese Model of Accident Causation” (Reason, April 12, 1990). Reason combined concepts of pathogen transmission and airplane accidents to present a model that illustrated that accidents are the result of the interrelatedness of imperfect defenses and unsafe actions that are largely unobservable until an adverse outcome becomes apparent. Using the Swiss cheese analogy, each control has certain weaknesses or “holes.” The “holes” differ between different controls. By stacking several controls together with different weaknesses, the “holes” are blocked by the strengths of the other controls. In other words, if controls with different weaknesses are layered, then any unexpected failure of a single control is protected against by the strengths of other controls. The model provides a guiding approach to reduce incidents across many sectors (Reason et al., October 30, 2006) and that perspective is reflected in widely accepted approaches to controlling infectious diseases (HICPAC, January 1, 1996; Rusnak et al., July 31, 2004; CDC, 2012; WHO, 2016).

The CDC Healthcare Infection Control Practices Advisory Committee's (HICPAC) Isolation Guidelines, which apply to healthcare settings, are an example of established national guidelines that illustrate layered controls to prevent the transmission of infectious diseases (Siegel et al., 2007). The Isolation Guidelines recommend two tiers of precautions: Standard Precautions and Transmission-Based Precautions (e.g., airborne, droplet, contact). Standard Precautions, under the Isolation Guidelines, are the minimum infection prevention practices that apply to patient care, regardless of the suspected or confirmed infection status of the patient, in any setting where health care is practiced. They are based on the principle that there is a possible risk of disease transmission from any patient, patient sample, or interaction with infectious material. For Standard Precautions, guidance follows that a certain set of controls should be implemented to reduce infectious disease transmission regardless of the diagnosis of the patient, in part because there is always baseline risk that is not necessarily either obvious or detectable. These precautions include controls such as improved hand hygiene, use of personal protective equipment, cleaning of equipment, environmental controls, handling of bed linens, changing work practices, and patient placement. When used in concert, these approaches protect workers from potential exposure to infectious agents.

The Isolation Guidelines' second tier of precautions, Transmission-Based Precautions, takes into consideration the transmission mechanism of specific diseases and complements Standard Precautions to better protect workers from the presence of known or suspected infectious agents. For instance, SARS-CoV-2, the infectious agent that causes COVID-19, is considered to be mainly transmissible through the droplet route in most settings (though there is evidence for airborne transmission as noted throughout this preamble). Droplet transmission occurs by the direct spray of large droplets onto conjunctiva or mucous membranes (e.g., the lining of the nose or mouth) of a susceptible host when an infected person sneezes, talks, or coughs. Droplet precautions are a suite of layered controls that are designed to prevent the direct spray of infectious material and supplement the suite of layered controls used for Standard Precautions. They are designed to protect workers from infectious agents that can be expelled in large respiratory droplets from infected individuals. These added interventions are implemented when infection is known or suspected and include placing patients in single rooms or physically distant within the same room, increased mask usage, and limiting patient movement. COVID-19 is considered capable of spreading through multiple routes of transmission, including airborne. Thus, the CDC recommends respiratory protection, isolation gowns, and gloves in healthcare settings to protect workers in those settings.

While a suite of layered controls is appropriate for controlling infectious diseases, it is important to use the hierarchy of controls when choosing which controls to include and the order in which to implement them. Briefly, the hierarchy of controls refers to the concept that the best way to control for hazards is to preferentially utilize the most effective before complementing with less effective controls.[19] Ideally, the hazard is eliminated, which would likely mean using an option such as conducting a telehealth visit outside of a patient care setting with respect to COVID-19 to ensure that there is no shared workspace and thus no potential for employee exposure to COVID-19. When a telehealth visit is not possible, workers must be protected through the implementation of controls. Outside the realm of infection control, the utilization of an engineering control or a change in on-site work practices could alone effectively minimize a hazard in many cases. However, infection prevention failures often are not apparent until an outbreak occurs, resulting in many infected workers. Therefore, it is important for employers to not only adhere to the hierarchy of controls when identifying controls to implement, but also to augment layers of feasible engineering controls (e.g., adequate ventilation, barriers) with administrative and work practice controls (e.g., physical distancing, cleaning, disinfection, telework, schedule modification, health screening). Personal protective equipment (e.g., gloves, respirators, and facemasks) can provide the final layer of control. This approach is consistent with both OSHA and CDC guidance for protecting workers and the public from COVID-19.

In addition to the broad recognition and implementation of layered controls to protect against infectious diseases, a recent study elucidated the effectiveness of isolated and layered controls, with respect to close contacts amidst several community COVID-19 outbreaks in Thailand (Doung-ngern et al., September 14, 2020). While individual controls, such as wearing a face covering or maintaining at least a minimum distance from others, significantly reduced cases (28% and 40%, respectively), the researchers concluded Start Printed Page 32427that a layered approach would be expected to reduce infections by 84%.

Several similar studies evaluated the importance of layering controls during the 2002/2003 SARS outbreak caused by SARS-CoV-1, which is a different strain of the same species of virus as the virus that causes COVID-19 (SARS-CoV-2) and has some similar characteristics; importantly, both viruses are strains of the same viral species and exhibit the same modes of transmission. Researchers assessed five Hong Kong hospitals on how the utilization of interventions affected SARS transmission (Seto et al., May 3, 2003). In total, the study evaluated 244 workers on their compliance with wearing masks, gowns, and gloves as well as adhering to hand hygiene protocols. Among the 69 workers who fully complied with the layered controls, there were no infections. However, 13 of 185 workers who used only some of the interventions were infected. The researchers concluded that the combined practice of droplet and contact precautions together significantly reduced the risk of infection from exposures to SARS-infected individuals.

Another study investigated the approaches taken to reduce SARS-CoV-1 transmission in hospitals in Taiwan during the 2003 portion of the outbreak (Yen et al., February 12, 2010). Researchers surveyed forty-eight Taiwanese hospitals that provided care for 664 SARS-CoV-1 patients, including 119 healthcare workers, to determine which controls each hospital implemented. Control measures included isolation of fever patients in the Emergency Department (ED), installation of handwashing stations in the ED, routing patients from the ED to an isolation ward, installation of fever screen stations in the ED, and installation of handwashing stations throughout the hospital. Analysis showed that while early SARS-CoV-1 case identification at fever screening stations outside the hospital could reduce transmission inside the hospital by half, combining that intervention with other interventions could almost double that reduction.

A modeling effort to simulate an epidemic of seasonal influenza at a hypothetical hospital in Ann Arbor, Michigan, found that different interventions used in a layered approach would result in a greater predicted reduction in nosocomial cases (i.e., healthcare-associated infections) (Blanco et al., June 1, 2016). The study evaluated six different intervention techniques thought to be effective against influenza, including hand hygiene, employee vaccination, patient pre-vaccination, patient isolation, therapies (e.g., antibody treatments, steroids), and face coverings. The researchers found, based on the model, that while no individual intervention exceeded a 27% percent reduction in cases, utilizing all controls would prevent half of all cases. While this model employed influenza as the vehicle to examine the effectiveness of layered protections, it gives no reason to believe that this approach would not be equally effective for other viruses such as SARS-CoV-2.

In 2016, the World Health Organization, a specialized agency of the United Nations that is focused on international public health (WHO, 2016), addressed the use of layering interventions to reduce infections in performed systematic reviews in its “Guidelines on Core Components of Infection Prevention and Control Programmes at the National and Acute Health Care Facility Level.” OSHA's perspective of layered interventions (e.g., engineering controls, work practice controls, personal protective equipment, training) is consistent with what the WHO Guidelines define as “multimodality.” WHO defines multimodality as follows:

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

The WHO guidelines strongly recommend practicing multimodality/layered interventions to reduce infections based on WHO's systematic review of implementation efforts at facility-level and national scales. Based on a systematic review of 44 studies on implementing infection control practices at the facility level, and another systematic review of 14 studies on the success of National rollout programs using layered strategies, WHO concluded that using layered strategies was effective in improving infection prevention and control practices and reducing hospital-acquired illnesses (WHO, 2016).

Vaccination does not eliminate the need for layered controls for healthcare workers exposed to COVID-19 patients, which can result in exposures that are more frequent and potentially carrying higher viral loads than those faced in workplaces not engaged in COVID-19 patient care. The Director of the CDC's National Institute for Occupational Health (NIOSH) recently wrote to OSHA that layers of control are still needed for vaccinated healthcare workers who remain at “particularly elevated risk of being infected” while treating COVID-19 patients: “The available evidence shows that healthcare workers are continuing to become infected with SARS-CoV-2, the virus that causes COVID-19, including both vaccinated and unvaccinated workers . . . Regardless of vaccination status, healthcare workers need additional protections such as respirators and other personal protective equipment (PPE) during care of patients with suspected or confirmed COVID-19.” (Howard, May 22, 2021). Further, a recent CDC study found that despite the positive impact on the roll-out of large-scale vaccination programs on reducing the transmission of COVID-19, a decline in non-pharmaceutical interventions (NPIs; e.g., physical distancing, face covering use) may result in a resurgence of cases (Borchering, May 5, 2021). The authors concluded that vaccination coverage in addition to compliance with mitigation strategies are essential to minimize COVID-19 transmission and prevent surges in hospitalizations and deaths. Thus, to effectively control COVID-19 transmission to those who are not vaccinated or immune, an increase in vaccination coverage in addition to NPIs, such as physical distancing, are crucial.

Based on the above evidence, OSHA is requiring in the ETS that healthcare employers must not only implement the individual infection prevention measures discussed in the following sections, but also layer their controls to protect workers from the COVID-19 hazard due to the additional protection provided to workers when multiple control measures are combined.

References

Blanco, N et al., (2016, June 1). What Transmission Precautions Best Control Influenza Spread in a Hospital. American Journal of Epidemiology 183 (11): 1045-1054. https://doi.org/​10.1093/​aje/​kwv293. (Blanco et al., June 1, 2016).

Borchering, RK et al., (2021, May 5). Modeling of Future COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Rates and Start Printed Page 32428Nonpharmaceutical Intervention Scenarios—United States, April-September 2021. MMWR Morb Mortal Wkly Rep. ePub: 5 May 2021. doi: http://dx.doi.org/​10.15585/​mmwr.mm7019e3. (Borchering, May 5, 2021).

Centers for Disease Control and Prevention (CDC). (2012). An Introduction to Applied Epidemiology and Biostatistics, Lesson 1: Introduction to Epidemiology, Section 10: Chain of Infection. In: Principles of Epidemiology in Public Health Practice, Third Edition: http://www.cdc.gov/​ophss/​csels/​dsepd/​SS1978/​Lesson1/​Section10.html. (CDC, 2012).

Doung-ngern, P et al., (2020, September 14). Case-control Study of Use of Personal Protective Measures and Risk for SARS Coronavirus 2 Infection, Thailand. Emerg In Dis 26, 11: 2607-2616. https://doi.org/​10.3201/​eid2611.203003. (Doung-ngern et al., September 14, 2020) .

Hospital Infection Control Practices Advisory Committee (HICPAC). (1996, January 1). Guideline for isolation precautions in hospitals. Infection Control and Hospital Epidemiology 17(1): 53-80. (HICPAC, January 1, 1996).

Howard, J. (2021, May 22). “Response to request for an assessment by the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, of the current hazards facing healthcare workers from Coronavirus Disease-2019 (COVID-19).” (Howard, May 22, 2021).

Reason, J. (1990, April 12). The Contribution of Latent Human Failures to the Breakdown of Complex Systems. Philosophical Transactions of the Royal Society London B327475 B327484. https://dol.org/​10.1098/​rstb.1990.0090. (Reason et al., April 12, 1990).

Reason, J et al., (2006, October 30). Revisiting the Swiss Cheese Model of Accidents. EUROCONTROL Experimental Centre, Note No. 13/06. (Reason et al., October 30, 2006).

Rusnak, JM et al., (2004, July 31). Management guidelines for laboratory exposures to agents of bioterrorism. Journal of Occupational and Environmental Medicine 46(8): 791-800. doi: 10.1097/01.jom.0000135536.13097.8a. (Rusnak et al., July 31, 2004).

Seto, WH et al., (2003, May 3). Effectiveness of precautions against droplets and contact in prevention of nosocomial transmission of severe acute respiratory syndrome (SARS). The Lancet 361(9368): 1519-1520. https://doi.org/​10.1016/​s0140-6736(03)13168-6. (Seto et al., May 3, 2003).

Siegel, J, Rhinehart, E, Jackson M, Chiarello, L, and the Healthcare Infection Control Practices Advisory Committee. (2007). 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings. https://www.cdc.gov/​infectioncontrol/​pdf/​guidelines/​isolation-guidelines-H.pdf. (Siegel et al., 2007).

World Health Organization (WHO). (2016). Guidelines on Core Components of Infection Prevention and Control Programmes at the National and Acute Health Care Facility Level. https://www.who.int/​gpsc/​ipc-components-guidelines/​en/​. (WHO, 2016).

Yen, MY et al., (2010, February 12). Quantitative evaluation of infection control models in the prevention of nosocomial transmission of SARS virus to healthcare workers: implication to nosocomial viral infection control for healthcare workers. Scandinavian Journal of Infectious Diseases 42: 510-515. https://10.3109/​00365540903582400. (Yen et al., February 12, 2010).

B. COVID-19 Plan

An effective COVID-19 plan is modeled on the core components of safety and health programs, which utilize a systematic approach to reduce injuries and illnesses in the workplace. The occupational safety and health community uses various names to describe this type of systematic approach (e.g., safety and health programs, safety and health management systems, and injury and illness prevention programs) and uses the terms “plans” and “programs” interchangeably. An effective safety and health program involves proactively and continuously identifying and mitigating hazards, before employees are injured or develop disease. The approach involves trained employees and managers working together to identify and address issues before the issues become a problem. Such an approach helps employers meet their obligation under the OSH Act to provide employees a place of employment free from recognized hazards (OSHA, January 2012; OSHA, October 18, 2016). The COVID-19 plan required by this ETS encompasses the core components of this type of safety and health programs. Developing and implementing a COVID-19 plan is an essential part of an effective response to the COVID-19 hazards present in the workplace because the process involves identifying employees who are at risk of exposure to the virus and determining how they can be effectively protected from developing COVID-19 using a multi-layered approach.

Many companies that have received awards for their safety and health accomplishments have credited safety and health programs for their success. Because of the value, effectiveness, and feasibility of such programs, many countries throughout North America, Asia, and Europe require employers to implement programs to prevent injury and illness. Numerous studies and data sources provide evidence of such programs improving safety and health management practices and performance which leads to reductions in injury, illness, and fatalities. For example, a review of the impact of implementation of safety and health programs in eight states showed a reduction of injury and illness rates ranging from 9% to more than 60% (OSHA, January 2012). In three of these states with mandatory injury and illness prevention programs, workplace fatality rates were up to 31% lower than the national average (OSHA, January 2012).

OSHA has traditionally identified seven core elements of successful safety and health programs including (1) management leadership, (2) worker participation, (3) hazard identification and assessment, (4) hazard prevention and controls, (5) evaluation and improvement, (6) coordination and communication at multi-employer sites, and (7) education and training (OSHA, January 2012; OSHA, October 18, 2016). The COVID-19 plan required by this ETS was developed with these elements in mind. The first core element, management leadership, involves a demonstrated commitment to establishing a safety and health culture and continuously improving safety and health in the workplace. A commitment to health and safety is demonstrated by implementing a clear plan for preventing illness and injury, and communicating the plan to all employees (including contractors and temporary staff). Designating a coordinator to track progress of the plan and ensure that all aspects of the plan are implemented further demonstrates management's commitment to employee safety and health (OSHA, 2005; OSHA, January 2012; OSHA, October 18, 2016).

The second, and one of the most important components of a safety and health program, is the participation of trained and knowledgeable employees, including those employed by other employers (e.g., contractors, temporary staff). Employees provide unique perspective and expertise because they are often the most knowledgeable people about the hazards associated with their jobs and how those hazards can be controlled. Employees who are trained to recognize hazards and appropriate controls to address those hazards and know that they can speak freely to employers, can provide valuable input on hazards that need to be addressed, which can lead to a reduction in hazards or exposure to hazards. They can also provide input on improvements that are needed to protections that have already been implemented. An emphasis on employee participation is consistent with the OSH Act, OSHA standards, and Start Printed Page 32429OSHA enforcement policies and procedures, which recognize the rights and roles of workers and their representatives in matters of workplace safety and health (OSHA, 2005; OSHA, January 2012; OSHA, October 18, 2016).

The third core element of a safety and health program approach is hazard identification and assessment. To be most effective, hazard assessments must be conducted as a team approach with management, coordinators, and employees involved in the hazard assessment process (e.g., identifying potential hazards) and the development and implementation of the COVID-19 plan. An assessment to identify safety and health hazards can include surveying the facility to observe employee work habits and evaluating employee input from surveys or meeting minutes. Specifically, the risk of exposure to biological hazards, such as the COVID-19 virus, can be assessed by determining if workers could be exposed (e.g., through close contact with patients, co-workers, or members of the public; contact with contaminated surfaces, objects, or waste) and if controls are present to mitigate those risks (OSHA, 2005; OSHA, October 18, 2016). While a standard can specify controls applicable to particular hazards, the hazard assessment can help identify where controls are needed in specific areas of a particular worksite.

The fourth core element of an effective workplace safety and health program approach is hazard prevention and control, which involves teams of managers, coordinators, and employees assessing if a hazard can be eliminated (e.g., by working at home to eliminate potential virus exposure in the workplace). When hazards cannot be eliminated, the hazard prevention process considers which hazards can be controlled by implementing work practices (e.g., regular cleaning, disinfecting, physical distancing) or controls (e.g., physical barriers, improvements to the ventilation system). Additionally, the process of hazard prevention and control determines if PPE is required as part of a multi-layered strategy to protect workers from infectious biological agents (OSHA, 2005; OSHA, October 18, 2016). The controls may function more effectively when implemented in the most targeted manner following a hazard assessment and team-based evaluation.

The fifth core element of an effective safety and health program approach is evaluation and improvement. Safety and health programs require periodic evaluation to ensure they are implemented as intended and continue to achieve the goal of preventing injury and illness. This re-evaluation can reduce hazards, or result in improvements in controls to help reduce hazards. Managers have the prime responsibility for ensuring the effectiveness of the program but managers should work as a team with coordinators and employees to continually monitor the worksite to identify what is and is not working and make adjustments to improve worker safety and health measures (OSHA, January 2012; OSHA, October 18, 2016).

The sixth core element of an effective safety and health program approach is communication and coordination between host employers, contractors, and staffing agencies. Because the employees of one employer may expose employees of a different employer to a hazard, this communication is essential to protecting all employees. An effective program ensures that before employees go to a host worksite, both the host employer and staffing agencies communicate about hazards on the worksite, procedures for controlling hazards, and how to resolve any conflicts that could affect employee safety and health (e.g., who will provide PPE). The exchange of information about each employer's plans can help reduce exposures by identifying areas where one employer may need to provide additional protections (barriers, timing of workshifts, etc.) to its employees. Additionally, exchanging contact information between employers can facilitate worker protection in case they need to report hazards or illnesses that may occur (OSHA, October 18, 2016). In order to reduce COVID-19 transmission in the workplace, it will be particularly important for employers to have clear plans about how they can quickly alert other employers if a worker at a multi-employer site subsequently tests positive for COVID-19 and was in close contact with workers of other employers.

The seventh core element of an effective safety and health program is education and training. Education and training ensures that employees, supervisors, and managers are able to recognize and control hazards, allowing them to work more safely and contribute to the development and implementation of the safety and health program (OSHA, 2005; OSHA, January 2012; OSHA, October 18, 2016). Later in this Need for Specific Provisions section there is a detailed explanation about the need for training as a separate control to minimize COVID-19 transmission.

The effectiveness of a safety and health program approach in preventing injury and illnesses is recognized by a number of authoritative bodies. In its Total Worker Health program, the National Institute for Occupational Safety and Health (NIOSH) lists a number of core elements that are consistent with OSHA's safety and health program approaches, including demonstrating leadership commitment to safety and health, eliminating or reducing safety and health hazards, and promoting and supporting employee involvement (NIOSH, December 2016).

The International Organization for Standardization (ISO) developed ISO 45001, a consensus standard to help organizations implement a safety and health management system (ISO, 2018). ISO notes that key potential benefits of the system include reduced workplace incidents, establishment of a health and safety culture by encouraging active involvement of employees in ensuring their health and safety, reinforcement of leadership commitment to health and safety, and improved ability to comply with regulatory requirements.

The American National Standards Institute (ANSI) and American Society of Safety Professionals (ASSP) also developed a health and safety management systems standard for the purpose of reducing hazards and risk in a systematic manner, based on a team approach that includes management commitment and employee involvement, with an emphasis on continual improvement (ANSI/ASSP, 2019). ANSI/ASSP note the widespread acceptance that safety and health management systems can improve occupational safety and health performance. (Id.) They further highlight OSHA reports of improved safety and health performance by companies who implement programs that rely on management system principles (e.g., the Voluntary Protection Program), and that major professional safety and health organizations support management systems as effective in improving safety and health. As further proof that safety and health management systems are valuable, they note that many large and small organizations within the U.S. and internationally are implementing these systems.

Based on the best available evidence, OSHA concludes that a COVID-19 plan that is modeled on the safety and health program principles discussed above, implemented by a COVID-19 coordinator, influenced by employee input, and continuously evaluated, is an effective tool to ensure comprehensive identification and mitigation of COVID-19 hazards. As a result, OSHA concludes that a COVID-19 plan will reduce the incidence of COVID-19 in Start Printed Page 32430the workplace by helping to ensure that all effective measures are implemented as part of a multi-layered strategy to minimize employee exposure to COVID-19.

References

American National Standards Institute (ANSI)/American Society of Safety Professionals (ASSP). (2019). ANSI/ASSP Z10.0-2019. Occupational Health and Safety Management Systems. (ANSI/ASSP, 2019).

International Organization for Standardization (ISO). (2018). Occupational health and safety. ISO 45001. (ISO, 2018).

National Institute for Occupational Safety and Health (NIOSH). (2016, December). Fundamentals of total worker health approaches: essential elements for advancing worker safety, health, and well-being. Publication no. 2017-112. https://www.cdc.gov/​niosh/​docs/​2017-112/​pdfs/​2017_​112.pdf. (NIOSH, December 2016).

Occupational Safety and Health Administration (OSHA). (2005). Small Business Handbook. Small Business Safety and Health Management Series. OSHA 2209 02R 2005. https://www.osha.gov/​sites/​default/​files/​publications/​small-business.pdf. (OSHA, 2005).

Occupational Safety and Health Administration (OSHA). (2012, January). Injury and Illness Prevention Programs. White Paper. https://www.osha.gov/​dsg/​InjuryIllnessPreventionProgramsWhitePaper.html. (OSHA, January 2012).

Occupational Safety and Health Administration (OSHA). (2016, October 18). Recommended Practices for Safety and Health Programs. OSHA 3885. https://www.osha.gov/​sites/​default/​files/​publications/​OSHA3885.pdf. (OSHA, October 18, 2016).

C. Patient Screening and Management

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

Symptoms-based screening is a standard component of infection control. This approach was recommended during the 2003 SARS epidemic (caused by SARS-CoV-1, a different strain of SARS) and is routinely recommended for airborne infections such as M. tuberculosis and measles, and as a general practice in infection control programs (Siegel et al., 2007). Because SARS-CoV-2 can be transmitted by individuals who are infected but do not have symptoms (asymptomatic and presymptomatic transmission), symptom-based screening will not identify all infectious individuals (Viswanathan et al., September 15, 2020). However, persons with symptoms early in their SARS-CoV-2 infection are among the most infectious (Cevik et al., November 19, 2020). Therefore, symptom-based screening will identify some of the highest-risk individuals for SARS-CoV-2 transmission and thereby reduce the risk to workers.

References

Centers for Disease Control and Prevention (CDC). (2021, February 23). Interim infection prevention and control recommendations for healthcare personnel during the Coronavirus Disease 2019 (COVID-19) pandemic. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​infection-control-recommendations.html. (CDC, February 23, 2021).

Cevik, M. et al., (2020, November). SARS-CoV-2, SARS-CoV, and MERS-CoV viral load dynamics, duration of viral shedding, and infectiousness: A systematic review and meta-analysis. Lancet Microbe 2021; 2: e13-22. https://doi.org/​10.1016/​S2666-5247(20)30172-5. (Cevik et al., November 19, 2020).

Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L. (2007). Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. https://www.cdc.gov/​infectioncontrol/​pdf/​guidelines/​isolation-guidelines-H.pdf. (Siegel et al., 2007).

Viswanathan, M. et al., (2020, September 15). Universal screening for SARS-CoV-2 infection: A rapid review. Cochrane Database of Systematic Reviews, Issue 9. Art. No.: CD013718. DOI: 10.1002/14651858.CD013718. (Viswanathan et al., September 15, 2020).

D. Standard and Transmission-Based Precautions

Standard and Transmission-Based Precautions are well-accepted as important to controlling disease transmission (HICPAC, December 27, 2018; CDC, January 7, 2016). It should be noted that during times of significant transmission, such as during this pandemic, additional protections are needed to supplement the basic level of recommended precautions and practices in these guidelines. For instance, wearing at least a facemask regardless of interaction with known or suspected infectious patients is needed during the pandemic (CDC, February 23, 2021).

Standard Precautions refers to infection prevention practices, implemented in healthcare settings, where the presence of an infectious agent is assumed (i.e., without the suspicion or confirmation of exposure). The use of Standard Precautions thus relies on the assumption that all patients, patient samples, potentially contaminated materials (e.g., patient laundry, medical waste), and human remains in healthcare settings are potentially infected or colonized with an infectious agent(s). For example, Standard Precautions would include appropriate hand hygiene and use of personal protective equipment as well as practices to ensure respiratory hygiene, sharps safety, safe injection practices, and sterilization and disinfection of equipment and surfaces (CDC, February 23, 2021).

Transmission-Based Precautions add an additional layer of protection to Standard Precautions. Transmission-Based Precautions refers to those good infection prevention practices, used in tandem with Standard Precautions that are based on the way an infectious agent(s) may be transmitted. These precautions are needed, for example, when treating a patient where it is suspected or confirmed that the patient may be infected or colonized with agents that are infectious through specific routes of exposure (Siegel et al., 2007). For example, handwashing and safe handling of sharps (needles, etc.) are routine Standard Precautions. An infectious agent capable of airborne transmission through aerosols would require patient care in an airborne infection isolation room (AIIR), if available, under Transmission-Based Precautions.

Even before a patient is treated, certain Transmission-Based Precautions Start Printed Page 32431can be critical to protecting healthcare workers. For example, one typical precaution is that patients and visitors who enter a waiting room before being seen or triaged must wear facemasks, or face coverings, as a source control device to prevent them from spreading airborne droplets near the employees. These source control devices may also be critical to reducing the likelihood that COVID-19 is spread as the patients are transported from the admission area to a treatment area.

The critical need for implementing Standard and Transmission-Based Precautions in healthcare settings is evident in the Healthcare Infection Control Practices Advisory Committee's (HICPAC's) 2017 Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings.[21] The core practices included in that document include Standard and Transmission-Based Precautions, which, HICPAC recommended, need to be implemented in all settings where healthcare is delivered.

That Standard and Transmission-Based Precautions are a long-standing and essential element of infection control in healthcare industries is also evidenced by the CDC's 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, which incorporate Standard and Transmission-Based Precautions into their recommendations. This 2007 Guideline updated 1996 guidelines, which introduced the concept of Standard Precautions and also noted the existence of infection control recommendations dating back to 1970 (Siegel et al., 2007).

Both Standard and Transmission-Based Precautions are recommended by the CDC for healthcare personnel during the COVID-19 pandemic (CDC, February 23, 2021). The CDC considers healthcare personnel (HCP) to include all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, home healthcare personnel, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).

The CDC also has recommendations for protection of workers in industries associated with healthcare. According to the CDC's Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic (incorporated by reference, § 1910.509), on-site management of laundry, food service utensils, and medical waste should also be performed in accordance with routine procedures (CDC, February 23, 2021).

The work of the College of American Pathologists (CAP) illustrates the importance of taking core precautionary measures in healthcare industries during the pandemic. CAP has provided recommendations for staff protection during the COVID-19 pandemic. For example, CAP has provided COVID-19-specific autopsy recommendations which include biosafety considerations such as performing autopsies on COVID-19-positive cases in an airborne infection isolation room (College of American Pathologists, February 2, 2021).[22]

The Standard and Transmission-Based Precautions required by the ETS only extend to exposure to SARS-CoV-2 and COVID-19 protection. The agency does not intend the ETS to apply to other workplace hazards.

References

Centers for Disease Control and Prevention (CDC). (2016, January 7). Transmission-based precautions. https://www.cdc.gov/​infectioncontrol/​basics/​transmission-based-precautions.html. (CDC, January 7, 2016).

Centers for Disease Control and Prevention (CDC). (2021, February 23). Interim infection prevention and control recommendations for healthcare personnel during the Coronavirus Disease 2019 (COVID-19) pandemic. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​infection-control-recommendations.html. (CDC, February 23, 2021).

College of American Pathologists. (2021, February 2). Amended COVID-19 autopsy guideline statement from the CAP Autopsy Committee. https://documents.cap.org/​documents/​COVID-Autopsy-Statement.pdf. (College of American Pathologists, February 2, 2021).

Healthcare Infection Control Practices Advisory Committee (HICPAC). (2018, December 27). Core infection prevention and control practices for safe healthcare delivery in all settings. https://www.cdc.gov/​hicpac/​recommendations/​core-practices.html. (HICPAC, December 27, 2018).

Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L. (2007). Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. https://www.cdc.gov/​infectioncontrol/​pdf/​guidelines/​isolation-guidelines-H.pdf. (Siegel et al., 2007).

E. Personal Protective Equipment (PPE)

As previously discussed in Grave Danger (Section IV.A. of the preamble), COVID-19 infections occur mainly through exposure to respiratory droplets (referred to as droplet transmission) when a person is in close contact with someone who has COVID-19. COVID-19 can sometimes also be spread by airborne transmission (CDC, May 13, 2021). As the CDC explains, when people with COVID-19 cough, sneeze, sing, talk, or breathe, they produce respiratory droplets, which can travel a limited distance—thereby potentially infecting people within close physical proximity—before falling out of the air due to gravity. Facemasks, face coverings, and face shields are all devices used for their role in reducing the risk of droplet, and potentially airborne, transmission of COVID-19 primarily at the source. Additional discussion on the efficacy of each device, and the need for facemasks and face shields specifically, is explained below. (Respirator use is also included in the ETS and more information on the Start Printed Page 32432need for respirators to prevent the spread of COVID-19 is discussed in the Need for Specific Provisions for Respirators, further below.)

Well-fitting facemasks, not face coverings, are the baseline requirement in healthcare settings because of their fluid resistant qualities (discussed in detail below). However, the role of facemasks and face coverings are otherwise similar in source control and personal protection for the wearer. OSHA's position on the importance of face coverings and facemasks is supported by a substantial body of evidence. Consistent and correct use of face coverings and facemasks is widely recognized and scientifically supported as an important evidence-based strategy for COVID-19 control. Accordingly, with specific exceptions relevant to outdoor areas and vaccinated persons, the CDC recommends everyone two years of age and older wear a face covering in public settings and when around people outside of their household (CDC, April 19, 2021). And, on January 21, 2021, President Biden issued Executive Order 13998, which recognizes the use of face coverings or facemasks as a necessary, science-based public health measure to prevent the spread of COVID-19, and therefore directed regulatory action to require that they be worn in compliance with CDC guidance while traveling on public transportation (e.g., buses, trains, subway) and while at airports (Executive Order 13998, 86 FR 7205, 7205 (Jan. 21, 2021); CDC, February 2, 2021). Similarly, the World Health Organization (WHO) has recognized face coverings as a key measure in suppressing COVID-19 transmission, and thus, saving lives. The WHO observes that face coverings (and facemasks) serve two purposes, to both protect healthy people from acquiring COVID-19 and to prevent sick people from further spreading it (WHO, December 1, 2020).

I. Need for Facemasks

Facemasks are simple bi-directional barriers that tend to keep droplets, and to a lesser extent airborne particulates, on the side of the filter from which they originate. The term “facemask,” as used in this ETS, is defined as a surgical, medical procedure, dental, or isolation mask that is FDA-cleared, FDA-authorized, or offered or distributed as described in an FDA enforcement policy. These are most commonly referred to as “surgical masks” or “medical procedure masks.” As previously mentioned, facemasks reduce the risk of droplet transmission through their dual function as both source control and personal protection (OSHA, January 28, 2021; Siegel et al., 2007). In healthcare settings, facemasks have long been recognized as an important method of source control for preventing the spread of infectious agents transmitted via respiratory droplets (e.g., in the operating room to prevent provider saliva and respiratory secretions from contaminating the surgical field and infecting patients). However, facemasks do not filter out very small airborne particles and do not provide complete protection even from larger particles because the mask seal is not tight (FDA, December 7, 2020).

Facemasks are designed and regulated through various FDA processes to protect the person wearing them. Not all devices that resemble facemasks are FDA-cleared or authorized. To receive FDA clearance, manufacturers are required to submit an FDA premarket notification (also known as a 510(k) notification) for new products. Data in the 510(k) submission must show that the facemask is substantially equivalent to a facemask already on the market in terms of safety and effectiveness. Facemasks are tested for fluid resistance, filtration efficiency (particulate filtration efficiency and bacterial filtration efficiency), differential pressure, flammability and biocompatibility (FDA, July 14, 2004).[23]

Research developed during the current SARS-CoV-2 pandemic provides evidence of the protection afforded by facemasks. First, a universal surgical masking requirement for all healthcare workers and patients was implemented in Spring 2020 in the Mass General Brigham healthcare system, which is the largest in Massachusetts (Wang et al., July 14, 2020). Based on daily infection rates among healthcare workers, the authors found that universal masking was associated with a significantly lower rate of SARS-CoV-2 positivity. Although the authors noted that other interventions, such as restricting visitors, were also put in place, they concluded that their results supported universal masking as part of a multi-pronged infection reduction strategy in healthcare settings.

Second, a systematic review and meta-analysis evaluated research on healthcare workers exposed to SARS-CoV-2, as well as the SARS and Middle East respiratory syndrome (MERS) viruses (Chu et al., June 27, 2020). Six studies compared the odds of infection in those who wore surgical or similar facemasks compared to those who did not wear any facemask; four of the six studies were on healthcare workers and all six were from the 2003 SARS epidemic. Participants who wore surgical or similar facemasks had only a third of the infection risk of those who did not wear any facemask.

Third, a review of respiratory protection for healthcare workers during pandemics noted that surgical mask material has been shown to protect against more than 95% of viral aerosols under laboratory conditions (Garcia-Godoy et al., May 5, 2020). The authors also reviewed research showing that surgical masks reduced aerosolized influenza exposure by an average of six-fold, depending on mask design.[24]

Finally, in one epidemiological study, a specialized team of contact tracers at Duke University Health System in North Carolina categorized recorded COVID-19 cases among their healthcare workers (Seidelman et al., June 25, 2020). Of the cases that were categorized as healthcare-acquired (meaning acquired as a result of either an unmasked exposure for greater than 10 minutes at less than 6 feet to another healthcare worker who was symptomatic and tested positive for the virus, or an exposure to a COVID-19-positive patient while not wearing all CDC-recommended PPE or while there was a breach in PPE), 70% were linked to an unmasked exposure to another healthcare worker.

Although cloth face coverings have gained widespread use outside of healthcare settings during this pandemic, OSHA has determined that cloth face coverings do not offer sufficient protection for covered healthcare workers for multiple reasons. First, cloth face coverings, as defined by the CDC, encompass such a wide variety of coverings that there is no assurance Start Printed Page 32433of any consistent protection to the wearer, and even source protection can vary significantly depending on the construction and fit of the face covering. Second, a number of studies suggest that, properly worn over the nose and mouth, facemasks provide better protection than face coverings, which is an important consideration in healthcare settings where there are regular, known exposures to COVID-19-positive persons. For example, one randomized trial of cloth face coverings compared rates of clinical respiratory illness, influenza-like illness, and laboratory-confirmed respiratory virus infections in 1,607 healthcare workers in 14 hospitals in Vietnam (MacIntyre et al., March 26, 2015). Infection risks were statistically higher in the cloth face covering group compared to the facemask group: The risk of influenza-like illness was 6.6 times higher, and the risk of laboratory-confirmed respiratory virus infection was 1.7 times higher, in those who wore cloth face coverings compared to those who wore facemasks. Another study which reviewed respiratory protection for healthcare workers during pandemics showed greater protection from surgical masks compared to face coverings (Garcia-Godoy et al., May 5, 2020). Finally, Ueki et al., (June 25, 2020) evaluated the effectiveness of cotton face coverings, facemasks, and N95s (a commonly used respirator) in preventing transmission of SARS-CoV-2 using a laboratory experimental setting with manikins. The researchers found that all offerings provided some measure of protection as source control, limiting droplets expelled from both infected and uninfected wearers, but that facemasks and N95s provided better protection than cotton face coverings. Specifically, the researchers found that when spaced roughly 20 inches apart, if both an infected and uninfected individual were wearing a cotton face covering, the uninfected person reduced inhalation of infectious virus by 67%. But if both individuals were wearing facemasks, exposure was reduced by 76% and when an infected individual was wearing an N95, exposure was reduced by 96%.

Third, cloth face coverings do not function as a barrier to protect employees from hazards such as splashes or large droplets of blood or bodily fluids, which is a common hazard in healthcare settings. And finally, OSHA has previously established that medical facemasks are essential PPE for many workers in healthcare, as enforced under both the PPE standard (29 CFR 1910.132) and more specifically, the Bloodborne Pathogens standard (29 CFR 1910.1030).

Given the health outcomes related to COVID-19 and the exposure characteristics found in healthcare settings (e.g., splashes or large droplets of blood or bodily fluids), OSHA has determined that cloth face coverings are not appropriate for workers in these settings. Research clearly indicates that facemasks provide essential protection for workers in covered healthcare settings.

II. Need for Face Shields

The term “face shield,” as used in this ETS, is a device typically made of clear plastic, that covers the wearer's eyes, nose, and mouth, wraps around the sides of the wearer's face, and extends below the wearer's chin. Face shields have long been recognized as effective in preventing splashes, splatters, and sprays of bodily fluids and have a role in preventing the primary route of droplet transmission, although not aerosolized transmission. As explained above, OSHA has determined based on the best available evidence that facemask usage is a necessary protective measure to prevent the spread of COVID-19 for any covered employee. However, the use of face shields, a less protective barrier, is permitted to either supplement facemasks where there is a particular risk of droplet exposure, or as an alternative option in certain limited circumstances where facemask usage is not feasible.

Face shields are proven to provide some protection to the wearer from exposure to droplets, and OSHA has long considered face shields to be PPE under the general PPE standard (29 CFR 1910.132) and the Eye and Face Protection standard (29 CFR 1910.133) for protection of the face and eyes from splashes and sprays. The potential protective value of face shields against droplet transmission is supported by a 2014 study, in which NIOSH investigated the effectiveness of face shields in preventing the transmission of viral respiratory diseases. The purpose of the study was to quantify exposure of cough aerosol droplets and examine the efficacy of face shields in reducing this exposure. Although face shields were not found to be effective against smaller particles, which can remain airborne for extended periods and can easily flow around a face shield to be inhaled, the face shields were effective in blocking larger aerosol particles (median size of 8.5 µM). Face shields worn over a respirator also reduced surface contamination of the respirator by 97%. The study's final conclusion was that face shields can be a useful complement to respiratory protections; however, they cannot be used as a substitute for respiratory protection, when needed (Lindsley et al., June 27, 2014). A recent update of the Lindsley study (Lindsley et al., January 7, 2021) found that face shields blocked only 2% of aerosol produced by coughing. These findings suggest that face shields might be a relevant form of protection in healthcare settings to protect employees from droplet exposure when they could have close contact with individuals who are potentially infected with COVID-19.

Face shields have proven less effective as a method of source control or a method of personal protection than facemasks. For example, in considering face shields' value as source control, Verma et al., (June 30, 2020) observed the effect of a face shield on respiratory droplets produced by simulating coughs or sneezes with a manikin. The face shield initially blocked the forward motion of the droplet stream, but droplets were then able to flow around the shield and into the surrounding area. The study authors concluded that face shields alone may not be as effective in blocking droplets.

In another study, Stephenson et al., (February 12, 2021) evaluated the effectiveness of face coverings, facemasks, and face shields in reducing droplet transmission. Breathing was simulated in two manikin heads (a transmitter and receiver) that were placed four feet apart. Artificial saliva containing a marker simulating viral genetic material was used to generate droplets from the transmitter head. The researchers found that face coverings, facemasks, and face shields all reduced the amount of surrogate genetic material measured in the environment and the amount that reached the receiver manikin head at four feet. While face shields reduced surrogate genetic material by 98.6% in the environment and 95.2% at the receiver, genetic material was still deposited downward in the immediate area of the transmitter, suggesting that use of face shields without a facemask could result in a contamination of shared surfaces. This limits the effectiveness of face shields alone as a method of source control for shared workspaces. Additionally, face shields used as personal protective devices showed that the face shields protected the wearer from large cough aerosols directed at the face, but were much less effective against smaller aerosols which were able to flow around the edges of the shield and be inhaled (Lindsley et al., June 27, 2014).

Based on this evidence, OSHA has determined that face shields are not Start Printed Page 32434generally appropriate as a substitute for a facemask because they are less effective at reducing the risk of droplet and potential airborne transmission. However, face shields do offer some protection from droplet transmission and are, accordingly, required by the ETS to be used in any circumstance where, for example, an individual may not be able to wear a facemask due to a medical condition or due to other hazards (e.g., heat stress, arc flash fire hazards). In such limited (and often temporary) situations, a face shield may be the most effective measure to add a layer of protection to reduce workers' overall COVID-19 transmission risk, particularly when combined with other protective measures.

Additionally, OSHA recognizes that face shields can provide some additional protection when used in addition to a facemask by protecting the wearer's eyes and preventing their facemask from being contaminated with respiratory droplets from other persons. This additional protection may be particularly useful for employees who cannot avoid close contact with others or are unable to work behind barriers. Accordingly, the ETS allows employers to require face shields in addition to facemasks where employment circumstances might warrant the additional protection.

OSHA has always considered recognized consensus standards, with design and construction specifications, when determining the PPE requirements of the agency's standards, as required by the OSH Act (29 U.S.C. 655(b)(8)) and the National Technology Transfer and Advancement Act (15 U.S.C. 272 note).

The agency has already incorporated by reference the ANSI/ISEA Z87.1, Occupational and Educational Personal Eye and Face Protection Devices consensus standard for face shields in its Eye and Face Protection standard (29 CFR 1910.133). In this ETS the agency will incorporate by reference more recent editions of the ANSI/ISEA standard than are currently provided for in the existing standard. Additionally, for the limited purpose of complying with the ETS, the agency will also allow any face shield that meets the criteria outlined in the definition of “face shield” found in the definition sections of the ETS. That is: (1) Certified to the ANSI/ISEA Z87.1-2010, 2015, or 2020 standard; or (2) covers the wearer's eyes, nose, and mouth to protect from splashes, sprays, and spatter of body fluids, wraps around the sides of the wearer's face (i.e., temple-to-temple), and extends below the wearer's chin. Any face shield that is worn for the purpose of complying with any OSHA standard other than Subpart U must still meet the requirements of 29 CFR 1910.133.

III. Need for Other Types of PPE

Gloves and gowns (overgarments) are the two most common types of PPE used in healthcare settings. A major principle of Standard Precautions is that all blood and body fluids, whether from a patient, patient sample, or infectious material, may contain transmissible infectious agents (Siegel et al., 2007). Therefore, gloves and gowns (overgarments) are required for certain examinations and all procedures. These include everything from venipuncture to removing medical waste to intubation. Similarly, gowns or similar protective clothing are necessary for any activities in which splashes or clothing contamination is possible. This applies as part of Standard Precautions as well as for care of patients on Contact Precautions where unintentional contact with contaminated environmental surfaces must be avoided (Siegel et al., 2007).

Eye protection in the form of goggles or face shields (as discussed above) can be used with facemasks to protect mucous membranes (eyes, nose, and mouth) in situations where, for example, sprays of blood or body fluids are possible. CDC recommends that healthcare workers wear eye protection during patient care encounters to ensure eyes are protected from infectious bodily fluids (CDC, February 23, 2021).

IV. Conclusion

In closing, the best available experimental and epidemiological data support consistent use of facemasks in healthcare work settings to reduce the spread of COVID-19 through droplet transmission. Adopting facemask policies is necessary, as part of a multi-layered strategy combined with other non-pharmaceutical interventions such as physical distancing, hand hygiene, and adequate ventilation, to protect employees from COVID-19. Based on the proven effectiveness of facemask use and the effectiveness of face shields in preventing contamination of facemasks and protecting the eyes when there is a particular risk of droplet exposure, OSHA's COVID-19 ETS includes necessary provisions for required use of facemasks and face shields (e.g., either as a complementary device or in such circumstances where it is not appropriate or possible to wear a facemask). The ETS also requires additional PPE, such as gloves, gowns, and eye protection, in certain limited circumstances where there is likely exposure to persons with COVID-19.

References

Centers for Disease Control and Prevention (CDC). (2021, February 2). Order under Section 361 of the Public Health Service Act (42 U.S.C. 264) and 42 Code of Federal Regulations 70.2, 71.31(b), 71.32(b). Federal Register notice: wearing of face masks while on conveyances and at transportation hubs. https://www.cdc.gov/​quarantine/​masks/​mask-travel-guidance.html. (CDC, February 2, 2021).

Centers for Disease Control and Prevention (CDC). (2021, February 23). Interim infection prevention and control recommendations for healthcare personnel during the Coronavirus Disease 2019 (COVID-19) pandemic. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​infection-control-recommendations.html. (CDC, February 23, 2021).

Centers for Disease Control and Prevention (CDC). (2021, April 19). Guidance for Wearing Masks. https://www.cdc.gov/​coronavirus/​2019-ncov/​prevent-getting-sick/​cloth-face-cover-guidance.html. (CDC, April 19, 2021).

Centers for Disease Control and Prevention (CDC). (2021, May 13). How COVID-19 spreads. https://www.cdc.gov/​coronavirus/​2019-ncov/​prevent-getting-sick/​how-covid-spreads.html. (CDC, May 13, 2021).

Chu, DK et al., (2020, June 27). Physical Distancing, Face Masks, and Eye Protection to Prevent Person-to-Person Transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. The Lancet 395: 1973-1987. https://doi.org/​10.1016/​. (Chu et al., June 27, 2020).

Food and Drug Administration (FDA). (2004, July 14). Guidance for industry and FDA staff. Surgical masks—premarket notification [510(k)] submissions. https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​surgical-masks-premarket-notification-510k-submissions. (FDA, July 14, 2004).

Food and Drug Administration (FDA). (2020, December 7). N95 respirators, surgical masks, and face masks. https://www.fda.gov/​medical-devices/​personal-protective-equipment-infection-control/​n95-respirators-surgical-masks-and-face-masks#s2. (FDA, December 7, 2020).

Garcia-Godoy, L. et al., (2020, May 5). Facial protection for healthcare workers during pandemics: A scoping review. BMJ global health, 5(5), e002553. https://doi.org/​10.1136/​bmjgh-2020-002553. (Garcia-Godoy et al., May 5, 2020).

Lindsley, W. et al., (2014, June 27). Efficacy of face shields against cough aerosol droplets from a cough simulator. Journal of Occupational and Environmental Hygiene, 11(8), 509-518. doi: 10.1080/15459624.2013.877591. (Lindsley et al., June 27, 2014).

Lindsley, W. et al., (2021, January 7). Efficacy of face masks, neck gaiters and face shields for reducing the expulsion of simulated cough-generated aerosols. Aerosol Science and Technology, DOI: Start Printed Page 3243510.1080/02786826.2020.1862409. (Lindsley et al., January 7, 2021).

MacIntyre, C. et al., (2015, March 26). A cluster randomised trial of cloth masks compared with medical masks in healthcare workers. BMJ Open 2015; 5: e006577. doi: 10.1136/bmjopen-2014-006577. (MacIntyre et al., March 26, 2015).

Occupational Safety and Health Administration (OSHA). (2021, January 28). Frequently asked questions COVID-19. https://www.osha.gov/​coronavirus/​faqs. (OSHA, January 28, 2021).

Seidelman, J. et al., (2020, June 25). Universal masking is an effective strategy to flatten the severe acute respiratory coronavirus virus 2 (SARS-CoV-2) healthcare worker epidemiologic curve. Infection Control & Hospital Epidemiology, 41(12), 1466-1467. doi: 10.1017/ice.2020.313. (Seidelman et al., June 25, 2020).

Siegel, J, Rhinehart, E, Jackson, M, Chiarello, L, and the Healthcare Infection Control Practices Advisory Committee. (2007). 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings. https://www.cdc.gov/​infectioncontrol/​pdf/​guidelines/​isolation-guidelines-H.pdf. (Siegel et al., 2007).

Stephenson, T. et al., (2021, February 12). Evaluation of facial protection against close-contact droplet transmission. MedRxiv. doi: 10.1101/2021.02.09.21251443. (Stephenson et al., February 12, 2021).

Ueki, H et al., (2020, June 25). Effectiveness of face masks in preventing airborne transmission of SARS-CoV-2. mSphere 5: e00637-20. https://doi.org/​10.1128/​mSphere.00637-20. (Ueki et al., June 25, 2020).

Verma, S. et al., (2020, June 30). Visualizing the effectiveness of face masks in obstructing respiratory jets. Physics of Fluids, 32(6), 061708. doi: https://doi.org/​10.1063/​5.0016018. (Verma et al., June 30, 2020).

Wang, X. et al., (2020, July 14). Association between universal masking in a health care system and SARS-CoV-2 positivity among health care workers. Journal of the American Medical Association, 324(7), 703-704. doi: 10.1001/jama.2020.12897. (Wang et al., July 14, 2020).

World Health Organization (WHO). (2020, December 1). Mask use in the context of COVID-19. https://www.who.int/​emergencies/​diseases/​novel-coronavirus-2019/​advice-for-public/​when-and-how-to-use-masks. (WHO, December 1, 2020).

F. Respirators

I. Respirator Use in Healthcare

As noted in Grave Danger (Section IV.A. of the preamble), it is well-accepted that COVID-19 might spread through airborne transmission during aerosol-generating procedures (AGPs) such as intubation. Moreover, outside of AGP scenarios, CDC has noted growing evidence that airborne droplets and particles can remain suspended in air, travel distances beyond 6 feet, and be breathed in by others (CDC, May 13, 2021). Grave Danger (Section IV.A. of the preamble) notes studies showing that infectious viral particles have been collected at distances as far as 4.8 meters away from a COVID-19 patient (Lednicky et al., September 11, 2020), and airborne COVID-19 infection has been identified in a Massachusetts hospital (Klompas et al., February 9, 2021). Accordingly, the CDC recommends the use of airborne Transmission Precautions, including the use of respirators, for any healthcare workers caring for patients with suspected or confirmed COVID-19 (CDC, March 12, 2020). This airborne transmission risk is in addition to the risks associated with contact and droplet transmission. Respirators have long been recognized as an effective and mandatory means of controlling airborne transmissible diseases and the use of this personal protective equipment is regulated under OSHA's Respiratory Protection standard (29 CFR 1910.134).

The CDC has issued core guidelines for when “healthcare personnel” should use respiratory protection against COVID-19 infection (see Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic (CDC, February 23, 2021)). These recommendations have been based on the most currently available information about COVID-19, such as how the virus spreads, and are applicable to all healthcare settings in the U.S. In the guidance, the CDC defines “healthcare settings” as places where healthcare is delivered, including but not limited to: acute care facilities, long-term acute care facilities, inpatient rehabilitation facilities, nursing homes, assisted living facilities, home healthcare, vehicles where healthcare is delivered (e.g., mobile clinics), and outpatient facilities (e.g., dialysis centers, physician offices). In addition, the CDC provides examples of “healthcare personnel,” which include emergency medical service personnel, nurses, nursing assistants, home healthcare personnel, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).

The CDC describes who is at greatest risk for COVID-19 infection in a set of FAQs designed for healthcare workers (CDC, March 4, 2021). In the FAQs, the CDC notes that those currently at greatest risk of COVID-19 infection are persons who have had prolonged, unprotected close contact (i.e., within 6 feet for a combined total of 15 minutes or longer in a 24 hour period) with a patient with confirmed COVID-19, regardless of whether the patient has symptoms. Moreover, according to the CDC, persons frequently in congregate healthcare settings (e.g., nursing homes, assisted living facilities) are at increased risk of acquiring infection because of the increased likelihood of close contact. In the FAQs, the CDC also reports that current data suggest that close-range aerosol transmission by droplet and inhalation, and contact followed by self-delivery to the eyes, nose, or mouth are likely routes of transmission for COVID-19, and that long-range aerosol transmission, has not been a feature of the virus. The CDC further explains that potential routes of close-range transmission include splashes and sprays of infectious material onto mucous membranes and inhalation of infectious virions (i.e., the active, infectious form of a virus) exhaled by an infected person, but that the relative contribution of each of these is not known for COVID-19.

As the CDC states in the FAQs (CDC, March 4, 2021), although facemasks are routinely used for the care of patients with common viral respiratory infections, N95 filtering facepiece respirators or equivalent (e.g., elastomeric half-mask respirators) or higher-level (e.g., full facepiece respirators or PAPRs) respirators are routinely recommended to protect healthcare workers from emerging pathogens like the virus that causes COVID-19, which have the potential for transmission via small particles. The CDC further advises that while facemasks will provide barrier protection against droplet sprays contacting mucous membranes of the nose and mouth, they are not designed to protect wearers from inhaling small particles. Because of this, the CDC recommends the use of respirators for close-contact care of patients with suspected or confirmed COVID-19. The CDC recommends that N95 filtering facepiece respirators (FFRs) and higher-level respirators, such as other disposable FFRs, powered air-purifying respirators (PAPRs), and elastomeric respirators, should be used when both barrier and respiratory protection is Start Printed Page 32436needed for healthcare workers because respirators provide better fit and filtration characteristics.

The CDC recommendations in Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic are divided into two separate categories. These include: (1) Recommended infection prevention and control practices when caring for a patient with suspected or confirmed COVID-19; and (2) recommended routine infection prevention and control practices during the COVID-19 pandemic (CDC, February 23, 2021).

A topic of interest related to the selection and use of respirators is their dual role as both personal protective equipment for the wearer and also source control to reduce the potential for transmission of potentially infectious exhaled air to others. While many filtering facepiece respirators do not have an exhalation valve, other filtering facepiece respirators do. The other “higher-level” respirators referenced above, and in CDC guidance (e.g., half or full facepiece elastomeric respirators and PAPRs), do have exhalation valves. An exhalation valve is a portal in the respirator to allow unfiltered air to leave the respirator in order to reduce breathing resistance for the wearer and reduce moisture and heat buildup inside the respirator. While the exhalation valve does allow some particles to escape through the valve, it is important to compare the performance of a respirator with an exhalation valve to other acceptable forms of source control in order to determine if there are actually reduced levels of effectiveness. NIOSH studied this issue and released a technical report entitled “Filtering Facepiece Respirators with an Exhalation Valve: Measurements of Filtration Efficiency to Evaluate Their Potential for Source Control” (NIOSH, December 2020). In the report, NIOSH concluded that respirators with exhalation valves were equally effective as facemasks:

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

The results that NIOSH observed can be explained in two ways. First, the majority of the leakage takes place around the seal by the nose and mouth, and respirators are designed to provide tight seals around the face so that there is only minimal leakage. Facemasks, on the other hand, do not typically seal tightly to the face and thus significant quantities of unfiltered air with small particles will also escape through the gaps on the side and at the nose, as well as potentially through the fabric of less protective filter materials. Second, the level of filtration in facemasks is highly variable, so a wide range of filter efficiencies have been acceptable under CDC guidance. The CDC does not recommend that respirators with exhaust valves be used as source controls, but the CDC's last updated recommendation on this subject was published in August of 2020, four months before the NIOSH study, and cited lack of data as the basis for the warning against relying on such respirators (CDC, April 9, 2021b). Therefore, the NIOSH study with its conclusion that respirators with exhaust valves are not less adequate as source controls than other acceptable source controls, appears to represent the best available evidence. OSHA therefore concludes that at this time there is no basis for OSHA to prohibit any NIOSH-approved filtering facepiece respirator from serving as both personal protective equipment and as source control. The NIOSH report also details methods of covering the filtering facepiece respirator's exhalation valve in various manners to further improve the effectiveness as source control, which OSHA considers a recommended practice, but not strictly necessary. There are also other methods that can be used to cover or filter the exhalation valve of elastomeric respirators (e.g., place a medical mask over the respirator).

II. The CDC's Recommended Infection Prevention and Control Practices When Caring for a Patient With Suspected or Confirmed COVID-19

The CDC recommends that healthcare personnel (including workers that perform healthcare services and those that perform healthcare support services) who enter the room or area of a patient with suspected or confirmed COVID-19 adhere to Standard Precautions plus gown, gloves, and eye protection, and also use a NIOSH-approved N95 filtering facepiece or equivalent or higher-level respirator. The CDC notes in a set of FAQs that its recommendation to use NIOSH-approved N95 disposable filtering facepiece or higher-level respirators when providing care for patients with suspected or known COVID-19 is based on the current understanding of the COVID-19 virus and related respiratory viruses (CDC, March 10, 2021).

As noted above, the CDC recommendations listed in Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic are applicable to all U.S. settings where healthcare is delivered. To this end, the recommendations on respirator use are repeated in a variety of additional CDC guidelines for specific categories of healthcare settings (e.g., nursing homes, dental settings, assisted living facilities, home health care settings). For example, in its guidance for nursing homes, the CDC recommends that residents with known or suspected COVID-19 be cared for while using all recommended PPE, including an N95 or higher-level respirator (CDC, March 29, 2021). In addition, in its guidance for dental settings, the CDC recommends that dental healthcare personnel who enter the room of a patient with suspected or confirmed COVID-19 use a NIOSH-approved N95 or equivalent or higher-level respirator, as well as other PPE (CDC, December 4, 2020). Additionally, in its guidance for assisted living facilities, the CDC recommends an N95 or higher-level respirator for personnel for situations where close contact with any (symptomatic or asymptomatic) resident cannot be avoided, if COVID-19 is suspected or confirmed in a resident of the assisted living facility (i.e., resident reports fever or symptoms consistent with COVID-19) (CDC, May 29, 2020). Also, in its guidance for home healthcare settings, the CDC recommends that when home health agency personnel are involved in the care of people with confirmed or suspected COVID-19 at their homes, the personnel adhere to relevant infection prevention and control practices as described in the core healthcare guidance Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic (i.e., that they use N95 or higher-level respirators) (CDC, October 16, 2020).

In addition to its infection prevention and control guidelines for healthcare personnel in healthcare settings, the CDC has issued infection prevention and control guidelines for conducting postmortem procedures on decedents/Start Printed Page 32437human remains during the COVID-19 pandemic in Collection and Submission of Postmortem Specimens from Deceased Persons with Confirmed or Suspected COVID-19 (CDC, December 2, 2020). In this guidance, the CDC recommends respirators while conducting autopsies on decedents in all cases due to the likelihood of aerosol generation during the performance of autopsies (CDC, December 2, 2020). The WHO has also issued guidelines for COVID-19 infection control for aerosol-generating procedures during autopsies. For example, WHO recommends respirators for procedures such as the use of power saws (WHO, September 4, 2020).

As supported by the above evidence and guidance from authoritative bodies, OSHA has concluded that healthcare employees have a heightened risk of COVID-19 infection when working with patients with known or suspected COVID-19. Accordingly, in any healthcare setting where employees are exposed to patients with known or suspected COVID-19, whether or not AGPs are performed, employers are required to provide N95s or higher-level respirators and follow all requirements under 29 CFR 1910.134, including medical evaluations and fit testing.

III. Applicability of the Respiratory Protection Standard to COVID-19

OSHA's Respiratory Protection standard (29 CFR 1910.134) has general requirements for respiratory protection for workers exposed to respiratory hazards, including the COVID-19 virus. In the context of the pandemic, the agency has applied the Respiratory Protection standard to situations in healthcare settings where workers are exposed to suspected or confirmed sources of COVID-19. OSHA's Respiratory Protection standard has been in effect since 1998 and the purpose of those controls have been established for decades (63 FR 1152, January 8, 1998). The standard contains requirements for the administration of a respiratory protection program, with worksite-specific procedures, respirator selection, employee training, fit testing, medical evaluation, respirator use, respirator cleaning, maintenance, and repair, among other requirements. It is important to note that the standard applies to “biological hazards” (63 FR 1180, January 8, 1998). Accordingly, the agency will continue to apply the Respiratory Protection standard to work tasks and situations in healthcare as covered by 29 CFR 1910.502.

IV. Respirator Provisions Tailored to the COVID-19 Pandemic Will Clarify Employer Responsibilities

Notwithstanding the applicability of the Respiratory Protection standard, as OSHA will explain in this discussion, it is imperative that the ETS contain additional provisions related to the employer's discretion to select respirators beyond what is required by 29 CFR 1910.134. These additional requirements are necessary in order to appropriately protect workers in healthcare industries. In the Need for the ETS (Section IV.B. of the preamble), OSHA has addressed why existing standards in general are inadequate to address the COVID-19 hazard. In this discussion the agency focuses more specifically on how clarifications regarding respirator need and use will help address COVID-19 hazards.

Many employers are confused as to when respiratory protection is required for protection against COVID-19, leaving many unprotected healthcare workers at high risk of becoming infected with COVID-19. This confusion has been exacerbated by two factors. First, many employers that need to provide respirators to protect their workers from COVID-19 have never needed to provide respirators to their workers in the past (e.g., many employers in the home health care or nursing home sector), or have not had to routinely provide respirators to certain workers in their facilities to protect them against infectious disease hazards (e.g., the housekeeping or facilities maintenance staff in some medical facilities). Second, there have been respirator and fit testing supply shortages and a widespread misinterpretation by employers of OSHA's temporary enforcement memoranda on respiratory protection. One issue of great concern to the agency is a misunderstanding by employers about crisis capacity strategies, which were initially suggested by the CDC as a means to optimize supplies of disposable N95 FFRs in healthcare settings when the alternative would be no respiratory protection at all. Many workers report that their employers have employed crisis capacity strategies as the de facto daily practice, even when additional respirators were available for use. To address these issues, the ETS contains clear mandates on when respiratory protection is required for protection against COVID-19 and contains a note encouraging employers to use elastomeric respirators or PAPRs instead of filtering facepiece respirators to prevent shortages and supply chain disruption.

To address initial N95 FFR shortages, the CDC began to create and issue a series of strategies to optimize supplies of disposable N95 FFRs in healthcare settings when there is limited supply (CDC, April 9, 2021a). The strategies are based on the three general strata that have been used to describe surge capacity to prioritize measures to conserve N95 FFR supplies along the continuum of care (Hick et al., June 1, 2009). Contingency measures (temporary measures during expected N95 shortages), and then crisis capacity measures (emergency strategies during known shortages that are not commensurate with U.S. standards of care), augment conventional capacity measures and are meant to be considered and implemented sequentially. However, as the supply of respirators for healthcare personnel has increased, the CDC and FDA have encouraged employers to transition away from the most extreme measures of respirator conservation, crisis and contingency capacity strategies, to conventional use (FDA, April 9, 2021; CDC, April 9, 2021a). The use of crisis capacity strategies is likely to increase the risk of COVID-19 exposure when compared to conventional and contingency capacity strategies.

The CDC's conventional capacity strategies for optimizing the supply of N95 FFRs, which the CDC recommends be incorporated into everyday practices, include a variety of measures, such as training on use and indications for the use of respirators, just-in-time fit testing, limiting respirators during training, qualitative fit testing, and the use of alternatives to FFRs. CDC's conventional capacity strategy recommendation is to use NIOSH-approved alternatives to N95 FFRs where feasible. These include other classes of disposable FFRs, reusable elastomeric half-mask and full facepiece air-purifying respirators, and reusable powered air-purifying respirators (PAPRs). All of these alternatives provide equivalent or higher-level protection than N95 FFRs when properly worn. To assist employers in this effort, NIOSH maintains a searchable, online Certified Equipment List identifying all NIOSH-approved respirators (NIOSH, n.d., retrieved on January 11, 2021). Since they are reusable, elastomeric respirators and PAPRs have the added advantage of being able to be disinfected, cleaned, and reused according to manufacturers' instructions. As such, they can be used by workers after the COVID-19 pandemic and during future pandemics that may again create N95 FFR Start Printed Page 32438shortages. Consistent with this, the ETS provides in a note that, where possible, employers are encouraged to select elastomeric respirators or PAPRs instead of filtering facepiece respirators to prevent shortages and supply chain disruption.

Also consistent with this, the ETS provides in the same note that, when there is a limited supply of filtering facepiece respirators (and only when there is a limited supply of filtering facepiece respirators), employers may follow the CDC's Strategies for Optimizing the Supply of N95 Respirators (April 9, 2021a). This may include the use of respirators beyond the manufacturer-designated shelf life for healthcare delivery; use of respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators; limited re-use of N95 FFRs; and prioritizing the use of N95 respirators and facemasks by activity type. However, again, the FDA and CDC are recommending healthcare personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse, due to the increased domestic supply of new respirators. The FDA and CDC believe there is an increased supply of respirators to transition away from these strategies (FDA, April 9, 2021; CDC, April 9, 2021a).

OSHA notes finally that its enforcement of the Respiratory Protection standard has been complicated by the respirator and fit-testing supply shortages incurred during the pandemic. In response to these shortages, the agency issued numerous temporary enforcement guidance memoranda allowing its Compliance Safety and Health Officers (CSHOs) to exercise enforcement discretion when considering issuing citations under the Respiratory Protection standard and/or the equivalent respiratory protection provisions of other health standards during the pandemic (OSHA, n.d., Retrieved December 22, 2020). OSHA's temporary enforcement memoranda are aligned with CDC's Strategies for Optimizing the Supply of N95 Respirators, which recommend a variety of conventional, contingency, and crisis capacity control strategies, as mentioned above (CDC, April 9, 2021a). Unfortunately, these memoranda have been widely misinterpreted by employers, resulting in additional confusion about OSHA's respiratory protection requirements during the pandemic. OSHA bases this conclusion on staff expertise and experience, as well as on reporting in news media articles (Safety + Health, April 9, 2020; Bailey and Martin, March 19, 2020). (See also Need for the ETS (Section IV.B. of the preamble).) For example, employers have misinterpreted the temporary enforcement guidance memoranda as offering blanket waivers or exemptions for complying with certain provisions of the Respiratory Protection standard (e.g., annual fit-testing requirements). In addition, many employers did not understand that these memoranda allow for enforcement discretion by CSHOs only in circumstances where an employer can demonstrate that it made unsuccessful but objectively reasonable efforts to obtain and conserve supplies of FFRs and fit-testing supplies. While the memoranda were intended as guidelines for CSHOs, employer misinterpretation of these memoranda has resulted in fewer protections for workers, particularly in healthcare industries.

OSHA is therefore clarifying that respirators are required for the protection of workers exposed to suspected or confirmed sources of COVID-19 in healthcare settings, and in all of those cases the respirators must be used in accordance with the Respiratory Protection standard (29 CFR 1910.134). OSHA also encourages employers, where possible, to select elastomeric respirators or PAPRs instead of filtering facepiece respirators to prevent shortages and supply chain disruption. Because the crisis capacity strategy is less protective, the employer should only use crisis capacity strategies for a limited period of time and take immediate steps to purchase and use elastomeric respirators or PAPRs in order to prevent future shortages and further expose their workers to the grave danger of COVID-19.

V. Conclusion

The best available evidence demonstrates that respirator use is an important means of reducing the likelihood of COVID-19 infection of the wearer when used in accordance with § 1910.134. Respirators are necessary controls that provide some protection to healthcare workers and healthcare support service workers when exposed to persons with known or suspected COVID-19.

Based on the above analysis, the agency concludes that it is necessary to add into the ETS respiratory protection requirements tailored specifically to the COVID-19 pandemic. These requirements will assist employers in identifying when respiratory protection is required for healthcare workers and will help address and strengthen worker protection during the pandemic. To this end, the ETS takes a prioritization approach to the conservation of respirators by requiring the use of respirators only where airborne transmission is the most likely (when employees are exposed to persons with suspected or confirmed COVID-19, or in accordance with Standard and Transmission-Based Precautions in healthcare settings).

The increased certainty associated with the respirator requirements in the healthcare section and added flexibility of allowing employers to follow 29 CFR 1910.504 in some limited circumstances will lead to more compliance, and more compliance will lead to improved protection of workers. In addition, a note in the ETS will better inform employers that they can consider selecting from other NIOSH-approved respirator options (i.e., elastomeric respirators and PAPRs) as alternatives to N95 FFRs for protection against COVID-19, as well as other respiratory infections (e.g., tuberculosis, varicella, etc.) both during the pandemic and beyond. Knowledge of alternative respiratory protection options for healthcare employers to consider will help them choose appropriate alternative respirators and help mitigate respirator supply shortages.

References

Bailey, M. and Martin, J. (2020, March 19). OSHA allows healthcare employers to suspend N95 annual fit-testing during Coronavirus “Outbreak.” The National Law Review. https://www.natlawreview.com/​article/​osha-allows-healthcare-employers-to-suspend-n95-annual-fit-testing-during. (Bailey and Martin, March 19, 2020).

Centers for Disease Control and Prevention (CDC). (2020, March 12). What healthcare personnel should know about caring for patients with confirmed or possible COVID-19. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​caring-for-patients-H.pdf. (CDC, March 12, 2020).

Centers for Disease Control and Prevention (CDC). (2020, May 29). Considerations for preventing spread of COVID-19 in assisted living facilities. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​assisted-living.html. (CDC, May 29, 2020).

Centers for Disease Control and Prevention (CDC). (2020, October 16). Interim guidance for implementing home care of people not requiring hospitalization for COVID-19. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​guidance-home-care.html. (CDC, October 16, 2020).

Centers for Disease Control and Prevention (CDC). (2020, December 2). Collection and submission of postmortem specimens from deceased persons with confirmed or suspected COVID-19. Start Printed Page 32439 https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​guidance-postmortem-specimens.html. (CDC, December 2, 2020).

Centers for Disease Control and Prevention (CDC). (2020, December 4). Guidance for dental settings. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​dental-settings.html. (CDC, December 4, 2020).

Centers for Disease Control and Prevention (CDC). (2021, February 23). Interim infection prevention and control recommendations for healthcare personnel during the coronavirus disease 2019 (COVID-19) pandemic. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​infection-control-recommendations.html. (CDC, February 23, 2021).

Centers for Disease Control and Prevention (CDC). (2021, March 4). Clinical questions about COVID-19: Questions and answers. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​faq.html. (CDC, March 4, 2021).

Centers for Disease Control and Prevention (CDC). (2021, March 10). Frequently asked questions about Coronavirus (COVID-19) for laboratories. https://www.cdc.gov/​coronavirus/​2019-ncov/​lab/​faqs.html#Laboratory-Biosafety. (CDC, March 10, 2021).

Centers for Disease Control and Prevention (CDC). (2021, March 29). Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​long-term-care.html. (CDC, March 29, 2021).

Centers for Disease Control and Prevention (CDC). (2021a, April 9). Strategies for optimizing the supply of N95 respirators. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​respirators-strategy/​index.html. (CDC, April 9, 2021a).

Centers for Disease Control and Prevention (CDC). (2021b, April 9). Personal Protective Equipment: Questions and Answers. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​respirator-use-faq.html. (CDC, April 9, 2021b).

Centers for Disease Control and Prevention (CDC). (2021, May 13). How COVID-19 spreads. https://www.cdc.gov/​coronavirus/​2019-ncov/​prevent-getting-sick/​how-covid-spreads.html. (CDC, May 13, 2021).

Food and Drug Administration (FDA). (2021, April 9). FDA Recommends Transition from Use of Decontaminated Disposable Respirators—Letter to Health Care Personnel and Facilities. https://www.fda.gov/​medical-devices/​letters-health-care-providers/​fda-recommends-transition-use-decontaminated-disposable-respirators-letter-health-care-personnel-and. (FDA, April 9, 2021).

Hick, J. et al., (2009, June 1). Refining surge capacity: Conventional, contingency, and crisis capacity. Disaster Medicine and Public Health Preparedness, 3(2 Suppl), S59-S67. https://doi.org/​10.1097/​DMP.0b013e31819f1ae2. (Hick et al., June 1, 2009).

Klompas, M. et al., (2021). A SARS-CoV-2 cluster in an acute care hospital. Annals of Internal Medicine. [Epub ahead of print 9 February 2021] https://doi.org/​10.7326/​M20-7567. (Klompas et al., February 9, 2021).

Lednicky, J. et al., (2020, September 11). Viable SARS-CoV-2 in the air of a hospital room with COVID-19 patients. International Journal of Infectious Diseases, 100, 476-482. doi: 10.1016/j.ijid.2020.09.025. (Lednicky et al., September 11, 2020).

National Institute for Occupational Safety and Health (NIOSH) (2020, December). Filtering facepiece respirators with an exhalation valve: Measurements of filtration efficiency to evaluate their potential for source control. By Portnoff, L., Schall, J., Brannen, J., Suhon, N., Strickland, K., Meyers, J. DHHS (NIOSH) Publication No. 2021-107. https://www.cdc.gov/​niosh/​docs/​2021-107/​pdfs/​2021-107.pdf?​id=​10.26616/​NIOSHPUB2021107. Retrieved January 10, 2021. (NIOSH, December, 2020).

National Institute for Occupational Safety and Health (NIOSH). (n.d.) Certified equipment lists. Retrieved January 11, 2021 from https://www.cdc.gov/​niosh/​npptl/​topics/​respirators/​cel/​default.html. (NIOSH, n.d., Retrieved January 11, 2021).

Occupational Safety and Health Administration (OSHA). (n.d.). COVID-19—regulations—enforcement memoranda. Retrieved December 22, 2020 from https://www.osha.gov/​coronavirus/​standards#temp_​enforcement_​guidance. (OSHA, n.d., Retrieved December 22, 2020).

Safety + Health. (2020, April 9). OSHA allowing all employers to suspend annual respirator fit testing. https://www.safetyandhealthmagazine.com/​articles/​19685-osha-allowing-all-employers-to-suspend-annual-respirator-fit-testing. (Safety + Health, April 9, 2020).

World Health Organization (WHO). (2020, September 4). Infection prevention and control for the safe management of a dead body in the context of COVID-19. https://www.who.int/​publications/​i/​item/​infection-prevention-and-control-for-the-safe-management-of-a-dead-body-in-the-context-of-covid-19-interim-guidance. (WHO, September 4, 2020).

G. Mini Respiratory Protection Program

I. Introduction

OSHA emphasizes that when respirators are required under the ETS to protect employees against exposure to suspected or confirmed sources of COVID-19, they must be used in accordance with the Respiratory Protection standard (29 CFR 1910.134). Moreover, nothing in the ETS changes an employer's obligation to identify hazards or provide a respirator that must be used in accordance with the Respiratory Protection standard for any other workplace hazard that might require respiratory protection (e.g., silica, asbestos, airborne infectious agents such as Mycobacterium tuberculosis).

OSHA's Respiratory Protection standard requires employers to develop and implement a comprehensive written respiratory protection program, required worksite-specific procedures and elements that include, but are not limited to, respirator selection and use, medical evaluation, fit testing, respirator maintenance and care, and training. Establishing such a program can take time to establish and require a level of expertise that some employers do not have, particularly if they are a covered healthcare employer that did not typically have respiratory hazards before COVID-19 (e.g., many employers in the home health care or nursing home sector). In such cases, these regulatory requirements may have unintentionally prevented employers from providing their employees with a higher level of respiratory protection than afforded by a facemask in circumstances where it may have been beneficial to do so.

The “mini respiratory protection program” section of the ETS (29 CFR 1910.504) is designed to strengthen employee protections with a small set of provisions for the safe use of respirators designed to be easier and faster to implement than the more comprehensive respiratory protection program. The ETS is addressing an emergency health crisis, so it is critical for employers to be able to get more employee protection in place quickly. OSHA expects that this approach will facilitate additional employee choice for the additional protection provided by respirators while reducing disincentives that may have discouraged employers from allowing or voluntarily providing respirators. A mini respirator program is therefore an important control to protect employees from the hazard posed by COVID-19.

The mini respiratory protection program section is primarily intended to be used for addressing circumstances where employees are not exposed to suspected or confirmed sources of COVID-19, but where respirator use could offer enhanced protection to employees. Examples include when a respirator could offer enhanced protection in circumstances where a less protective (in terms of filtering and fit) facemask is required under the ETS. (See 29 CFR 1910.502(f)(4).) The decision to use a respirator in place of a facemask could be due to the higher filter efficiency and better sealing characteristics of respirators when compared to facemasks and/or in consideration of an employer's determination during their hazard assessment of constraints on their Start Printed Page 32440ability to implement other ETS provisions (e.g., physical distancing and barriers).

If an employee uses a respirator in place of a facemask, then the employer must ensure that the respirator is used in accordance with the mini respiratory protection program section of the ETS or in accordance with the Respiratory Protection standard. For example, if an employee that is required to wear a facemask instead chooses to wear a respirator when performing an aerosol-generating procedure (AGP) on a patient who is not suspected or confirmed with COVID-19, the ETS only requires the employer to ensure that the respirator is used in accordance with the mini respiratory protection program section, rather than in accordance with the Respiratory Protection standard, because there is no exposure to a suspected or confirmed source of COVID-19 (see 29 CFR 1901.502(f)(4)(ii)). In contrast, employees performing AGPs on patients with suspected or confirmed COVID-19 must be provided with respirators that are used in accordance with the Respiratory Protection standard (see 29 CFR 1901.502(f)(3)(i)). Additionally, employers will still be obligated to provide a respirator that is used in accordance with the Respiratory Protection standard for any AGPs performed on patients suspected or confirmed with an airborne disease, such as tuberculosis or measles.

II. Experience From the Respiratory Protection Standard (29 CFR 1910.134)

In determining the need for a mini respiratory protection program section, the agency considered its experience with the existing Respiratory Protection standard. While the majority of the Respiratory Protection standard pertains to the use of respirators that are required for the protection of employees against airborne hazards, there is one provision allowing, but not requiring, employers to permit employees to wear respirators in situations where respirators are not required for protection against airborne hazards. (See 29 CFR 1910.134(c)(2).) In establishing the requirements of this provision of the Respiratory Protection standard, OSHA also establishes some general concepts to guide respirator use. These concepts include: (1) That the respirator use will not in itself create a hazard; (2) that the employer provides the respirator user with information about the safe use and limitations of respirators; and (3) that the respirator is cleaned, stored, and maintained so that its use does not present a health hazard to the user. (29 CFR 1910.134(c)(2)(i) and (ii)).

OSHA has historically imposed a different set of requirements on employers for when respirators are required to protect employees from airborne hazards as compared to when they are not required for protection against airborne hazards but are instead used voluntarily by employees. More specifically, paragraph (c)(1) of the Respiratory Protection standard requires employers to develop and implement a comprehensive written respiratory protection program with required worksite-specific procedures and elements whenever respirator use is required by the standard. As noted earlier, these elements include, but are not limited to, respirator selection and use, medical evaluation, fit testing, respirator maintenance and care, and training. In contrast, paragraph (c)(2) of the Respiratory Protection standard requires employers to implement only a subset of these elements for the voluntary use of respirators, greatly reducing the obligations of employers who allow their employees to use respirators when such use is not required for employee protection. In the 1998 rulemaking, OSHA determined that paragraph (c)(2) is necessary because the use of respirators may itself present a health hazard to employees who are not medically able to wear them, who do not have adequate information to use and care for respirators properly, and who do not understand the limitations of respirators. Paragraph (c)(2) is intended to allow employers flexibility to permit employees to use respirators in situations where the employees wish to do so, without imposing the burden of implementing an entire respirator program. At the same time, it will help ensure that such use does not create an additional hazard and that employees are provided with enough information to use and care for their respirators properly (63 FR 1190, January 8, 1998).

The vast majority of voluntary respirator use situations under the Respiratory Protection standard have historically involved the use of FFRs, worn merely for an employee's comfort (63 FR 1190, January 8, 1998). Examples include employees who have seasonal allergies requesting a FFR for comfort when working outdoors and employees requesting a FFR for comfort while sweeping a dusty floor (63 FR 1190, January 8, 1998). In contrast, respirator use situations under this section of the ETS will involve employers who provide a respirator or employees who want to wear a respirator, out of an abundance of caution, as enhanced protection against COVID-19. They may also opt to wear respirators other than FFRs (e.g., elastomeric respirators, PAPRs), particularly given the supply shortages of N95 FFRs experienced during the COVID-19 pandemic. Thus, the circumstances of respirator use in the ETS are not merely to accommodate individual conditions or comfort, but rather in recognition of some increased risk due to asymptomatic and pre-symptomatic transmission of COVID-19 that is not expected to rise to the level where respirators are required for exposure to suspected or confirmed sources of COVID-19.

OSHA emphasizes that while the new set of requirements for respirator use under the ETS differ in some aspects from those specified under the Respiratory Protection standard, their intent remains the same; that is, employers who provide respirators at the request of their employees or who allow their employees to bring their own respirators into the workplace must ensure that the respirator used does not present a hazard to the health of the employee.

In the 1998 rulemaking, OSHA concluded in the rare case where an employee is voluntarily using other than a filtering facepiece (dust mask) respirator (paragraph (c)(2)(ii)), the employer must implement some of the elements of a respiratory protection program, e.g., the medical evaluation component of the program and, if the respirator is to be reworn, the cleaning, maintenance, and storage components. An exception to this paragraph makes clear that, where voluntary respirator use involves only filtering facepieces (dust masks), the employer is not required to implement a written program. While medical evaluation is required when employees are voluntarily wearing respirators other than FFRs under the Respiratory Protection standard, there are no requirements under the ETS to provide medical evaluations for employees wearing such respirators. The agency concludes that it would be too onerous and costly for employers to provide medical evaluations to employees wearing elastomeric respirators or PAPRs in place of FFRs used in accordance with crisis capacity strategies during the short period of the ETS. However, OSHA's experience with its Respiratory Protection standard suggests that respiratory protection can still be effective even when subject to particular safety provisions, but not subject to the full range of requirements. In place of medical evaluations, the agency has included a training requirement on how to recognize medical signs and symptoms that may Start Printed Page 32441limit or prevent the effective use of employer-provided respirators and what to do if the employee experiences signs and symptoms (29 CFR 1910.504(d)(1)(v)), as well as a requirement for the discontinuation of employer-provided respirator use (see 29 CFR 1910.504(d)(4)). This requirement mandates that employees who wear employer-provided respirators must discontinue respirator use when the employer or supervisor reports medical signs or symptoms that are related to their ability to use a respirator. In addition, any employee who previously had a medical evaluation and was determined to not be medically fit to wear a respirator should not be provided with an employer-provided respirator under the ETS.

The ETS does not require employers to include any of the use requirements specified under the ETS into a written respiratory protection program. OSHA concludes that it would be too onerous for employers to incorporate these requirements into a written respiratory protection program during the short period of the ETS, particularly for those employers who have no need to have a written respiratory protection program in place for required respirator use. OSHA reemphasizes that the intent of the requirements in the mini respiratory protection program are to ensure that employees are provided with information to safely wear respirators, without imposing the burden of additional requirements for a written respiratory protection program on employers.

OSHA notes that unlike the voluntary use requirements specified under the Respiratory Protection standard, there are different requirements for the use of employee-provided respirators as compared to those for employer-provided respirators under the mini respiratory protection program section. This is because the agency is requiring employers to permit the use of employee-provided respirators. OSHA concludes that it is necessary to permit employees to wear their own respirators in healthcare settings given the risk for asymptomatic and pre-symptomatic transmission and the nature of much of the work that precludes such control measures as physical distancing and barriers. However, the agency concludes that it would be too onerous to mandate as many requirements for such use as are mandated when employers are given the option of whether or not to provide employees with respirators for use.

III. Requirements for Employee-Provided Respirators

In the 1998 rulemaking, OSHA determined that complete training is not required for employees using respirators voluntarily; instead, the final rule required employers to provide the information contained in Appendix D to the Respiratory Protection standard, entitled “Information for Employees Using Respirators When Not Required Under the Standard,” to ensure that employees are informed of proper respirator use and the limitations of respirators (63 FR 1190-1192, January 8, 1998). Under the ETS, there is only one requirement for the use of employee-provided respirators. This requirement is for the employer to provide these employees with a specific notice, as specified under paragraph (c) of the mini respiratory protection program section. This notice is almost identical to the notice contained in Appendix D to the Respiratory Protection standard, with some minor changes intended only to tailor the information to the situational needs of the COVID-19 pandemic.

IV. Requirements for Employer-Provided Respirators

As noted above, under the ETS, the requirements for the use of employer-provided respirators are more expansive under the mini respiratory protection program section than the requirements for employee-provided respirators. However, OSHA notes that employers are not obligated by the ETS to provide employees with respirators for use under the mini respiratory protection program section, so these requirements are only mandated when an employer voluntarily provides employees with respirators for use under the mini program. The requirements include provisions pertaining to training, user seal checks, reuse of respirators, and discontinuing use of respirators. When employers choose to provide respirators to employees, the same rationale applies as it did in the 1998 rulemaking requiring employers to undertake these minimal obligations when they allow voluntary respirator use is consistent with the fact that employers control the working conditions of employees and are therefore responsible for developing procedures designed to protect the health and safety of the employees. Employers routinely develop and enforce rules and requirements for employees to follow based on considerations of safety. For example, although an employer allows employees discretion in the types of clothing that may be worn on site, the employer would prohibit the wearing of loose clothing in areas where clothing could get caught in machinery, or prohibit the use of sleeveless shirts where there is a potential for skin contact with hazardous materials. Similarly, if an employer determines that improper or inappropriate respirator use presents a hazard to the wearer, OSHA finds that the employer must exert control over such respirator use and take steps to see that respirators are safely used under an appropriate program (63 FR 1190-1191, January 8, 1998).

The training requirements for the use of employer-provided respirators expand on the basic respirator awareness notice required for the use of employee-provided respirators. They require the employer to provide training on: (a) How to inspect, put on and remove, and use a respirator; (b) the limitations and capabilities of the respirator, particularly when the respirator has not been fit tested; (c) procedures and schedules for storing, maintaining, and inspecting respirators; (d) how to perform a user seal check as described in paragraph (e) of this section; and (e) how to recognize medical signs and symptoms that may limit or prevent the effective use of respirators and what to do if the employee experiences signs and symptoms. These training requirements for respirator use are similar to the training requirements mandated under the Respiratory Protection standard for required respirator use. (See 29 CFR 1910.134(k)). OSHA concludes that more extensive training provisions are required for the use of employer-supplied respirators under the ETS because such use is likely to be based on other factors related to the risk of COVID-19, including the ability to implement other control measure (e.g., physical distancing and barriers).

The user seal check requirements mandate employers to ensure that employees conduct user seal checks and to ensure the employees correct any problems discovered during the user seal check. This is similar to the user seal check provision for required respirator use under the Respiratory Protection standard. (See 1910.134(g)(1)(iii)). OSHA concludes that ensuring that user seal checks are conducted is necessary because employees who wear respirators are not required to be fit tested under the ETS. OSHA notes that, in the 1998 rulemaking, OSHA concluded that user seal checks are important in assuring that respirators are functioning properly, and that although user seal checks are not as objective a measure of facepiece leakage as a fit test, they do Start Printed Page 32442provide a quick and easy means of determining that a respirator is seated properly (63 FR 1239-40, January 8, 1998). Given that employees who choose to wear employer-provided respirators will likely be doing so out of an abundance of caution to protect against potential airborne transmission of SARS-CoV-2 and will not be fit tested, OSHA concludes that it is necessary for employers to train employees how to conduct a user seal check and to ensure that they are performed properly in order to improve the effectiveness of the respirator.

In the 1998 rulemaking, OSHA determined that “if the respirators being used voluntarily are reused, it is necessary to ensure that they are maintained in proper condition to ensure that the employee is not exposed to any contaminants that may be present in the facepiece, and to prevent skin irritation and dermatitis associated with the use of a respirator that has not been cleaned or disinfected” (63 FR 1190, January 8, 1998). To this end, and given the potential for supply shortages of FFRs necessitating their reuse under certain circumstances during the COVID-19 pandemic, OSHA concludes that it is necessary to add specific requirements for the reuse of respirators used voluntarily. These requirements incorporate some CDC recommendations for the reuse of FFRs used in accordance with crisis capacity strategies (CDC, April 9, 2021).

References

Centers for Disease Control and Prevention (CDC). (2021, April 9). Strategies for Optimizing the Supply of N95 Respirators. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​respirators-strategy/​index.html. (CDC, April 9, 2021).

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

As explained in more detail in Grave Danger (Section IV.A. of the preamble), aerosol-generating procedures (AGP) are well-known to be high-risk activities for exposure to respiratory infections. Workers in a wide range of settings, such as emergency responders, healthcare providers, and medical examiners performing autopsies, are at risk during AGPs. For the purposes of the ETS, only the following procedures are considered AGPs: Open suctioning of airways, sputum induction, cardiopulmonary resuscitation, endotracheal intubation and extubation, non-invasive ventilation (e.g., BiPAP, CPAP), bronchoscopy, manual ventilation, medical/surgical / postmortem procedures using oscillating bone saws, and dental procedures involving ultrasonic scalers, high-speed dental handpieces, air/water syringes, air polishing, and air abrasion. For further information on why these procedures are considered AGPs under the ETS, please see the discussion of aerosol-generating procedures in Section VIII, Summary and Explanation.

The CDC provides extensive guidance for performance of AGPs (CDC, February 23, 2021). First, exposure should be limited where possible. The CDC recommends that the use of procedures or techniques that might produce infectious aerosols should be minimized when feasible, as should the number of people in the room.

CAP has also recognized the risks involved in conducting AGPs by recommending limiting the use of aerosol-generating tools, such as oscillating bone saws, during autopsies on COVID-19-positive cases (College of American Pathologists, February 2, 2021). Post-mortem procedures using oscillating bone saws have specifically been noted as a COVID-19-related exposure concern (Nolte et al., December 14, 2020). The following controls are therefore recommended for autopsies involving the use of oscillating bone saws: Isolation rooms, limiting the number of people in the room who are exposed, negative pressure ventilation, adequate air exchange, double door access, and use of respirators.

As noted in Grave Danger (Section IV.A. of the preamble), it is well-accepted that COVID-19 may spread through infectious aerosols during AGPs. Therefore, where these procedures must be performed, there are two important controls for these situations: Ventilation (for example, in the form of air infection isolation rooms (AIIR), if available) and respiratory protection. Both of these controls are required for AGPs in the ETS. For more information on why there is a need to include in this ETS a requirement for respirators during aerosol-generating procedures, please see Need for Specific Provisions (Section V of this preamble) on Respirators.

It is well-established that insufficient ventilation increases the risk of airborne disease transmission; indeed, this is the foundation for the World Health Organization recommendations on ventilation in healthcare settings (Atkinson et al., 2009). When air is stagnant or poorly ventilated, aerosols may increase in concentration and increase exposure. Both a lack of ventilation and inadequate ventilation are associated with increased infection rates of airborne diseases. Increasing ventilation rates has been shown to decrease transmission risk of airborne disease. Ventilation is able to direct airflow away from uninfected individuals, which reduces risk of transmission.

The American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) is the authoritative organization for ventilation standards in the U.S. The U.S. Army Corps of Engineers (USACE) has been tasked by the U.S. Federal Emergency Management Agency with the design and construction of alternative care sites during surges in the COVID-19 pandemic. USACE requested that ASHRAE provide engineering guidance for ventilation within alternative care sites. The resulting joint ASHRAE/USACE document makes recommendations for removal of aerosols generated by patients during AGPs and other patient care activities in alternative care sites (ASHRAE and USACE. November 20, 2020). Additionally, ASHRAE provides specific guidance on source control and AIIRs related to aerosol-generating procedures during the COVID-19 pandemic (ASHRAE, January 30, 2021).

Airborne infection isolation rooms (AIIR) are specifically designed to control the spread of aerosols and prevent airborne transmission of disease (Sehulster and Chinn, June 6, 2003). An AIIR has negative pressure in comparison to accessible areas outside the room, which causes air to flow into (rather than out of) the room from the room's access points when they are open (e.g., an open door). When the access points (e.g., the door) are closed and ventilation is adequate, contaminated air cannot escape at all into the rest of the facility. Air exhaust can be delivered directly outdoors or passed through a special high-efficiency (HEPA) filter. In this way, AIIRs minimize potentially contaminated air flow outward into the rest of the facility.

Because of the risk of airborne transmission, the CDC recommends the use of AIIRs when AGPs are performed on patients with suspected or confirmed COVID-19. However, increased protection for workers performing AGPs is not a new recommendation solely for the COVID-19 pandemic. The CDC and WHO both routinely recommend higher levels of personal protective equipment for workers performing these procedures on patients with other respiratory infections (CDC, October 30, 2018). The CDC recommendations for AGPs performed on influenza patients specify use of AIIRs when feasible. The Start Printed Page 32443recommendations also specify that the use of portable HEPA filtration units to further reduce the concentration of contaminants in the air should be considered. Similarly, the World Health Organization recommends more protective respirators for AGPs (WHO, April, 2008). Finally, the National Institute for Occupational Safety and Health (NIOSH) has developed a ventilated headboard that can be used to reduce employee exposure to patient-generated aerosols containing respiratory pathogens (NIOSH, May 26, 2020).

References

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). (2021, January 30). Guide to the COVID-19 Pages. https://www.ashrae.org/​technical-resources/​healthcare. (ASHRAE, January 30, 2021).

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) and United States Army Corps of Engineers (USACE). (2020, November 20). Alternate Care Site HVAC Guidebook. https://www.ashrae.org/​about/​news/​2020/​new-alternative-care-site-guidebook-available-to-help-respond-to-the-rising-need-for-hospital-beds-due-to-covid-19. (ASHRAE and USACE, November 20, 2020).

Atkinson, J et al., (2009). Natural Ventilation for Infection Control in Health-Care Setting World Health Organization Guidelines. https://www.who.int/​water_​sanitation_​health/​publications/​natural_​ventilation/​en/​. (Atkinson et al., 2009).

Centers for Disease Control and Prevention (CDC). (2018, October 30). Prevention strategies for seasonal influenza in healthcare settings. https://www.cdc.gov/​flu/​professionals/​infectioncontrol/​healthcaresettings.htm. (CDC, October 30, 2018).

Centers for Disease Control and Prevention (CDC). (2021, February 23). Interim infection prevention and control recommendations for healthcare personnel during the Coronavirus Disease 2019 (COVID-19) pandemic. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​infection-control-recommendations.html. (CDC, February 23, 2021).

College of American Pathologists. (2021, February 2). Amended COVID-19 autopsy guideline statement from the CAP Autopsy Committee. https://documents.cap.org/​documents/​COVID-Autopsy-Statement.pdf. (College of American Pathologists, February 2, 2021).

National Institute for Occupational Safety and Health (NIOSH). (2020, May 26). Worker protective controls—engineering controls to reduce airborne, droplet and contact exposures during epidemic/pandemic response. https://www.cdc.gov/​niosh/​topics/​healthcare/​engcontrolsolutions/​ventilated-headboard.html. (NIOSH, May 26, 2020).

Nolte, K. et al., (2020, December 14). Design and construction of a biosafety level-3 autopsy laboratory. Arch Path Lab Med. doi: 10.5858/arpa.2020-0644-SA. (Nolte et al., December 14, 2020).

Sehulster, L. and Chinn, R. (2003, June 6). Guidelines for Environmental Infection Control in Health-Care Facilities. MMWR 52(RR10); 1-42. https://www.cdc.gov/​mmwr/​preview/​mmwrhtml/​rr5210a1.htm. (Sehulster and Chinn, June 6, 2003).

World Health Organization (WHO). (2008, April). Epidemic- and pandemic-prone acute respiratory diseases—Infection prevention and control in health care. https://www.who.int/​csr/​resources/​publications/​aidememoireepidemicpandemid/​en/​. (WHO, April, 2008).

I. Physical Distancing

The best available current scientific evidence demonstrates that COVID-19 spreads mainly through transmission between people who are physically near each other. The basic concept is that the majority of respiratory droplets expelled from an infected person through talking, coughing, breathing, or sneezing can travel a limited distance before falling to the surface below due to gravity. Therefore, the farther a person is away from the source of the respiratory droplets, the fewer infectious viral particles are likely to reach that person's eyes, nose, or mouth. The fewer infectious viral particles that reach that person, the lower the risk of transmission. Additional explanation of transmission is discussed in Grave Danger (Section IV.A. of the preamble). OSHA recognizes that this is a simplification of the complex issue of how droplets and aerosols moving through space applies to the transmission of SARS-CoV-2. Nonetheless, the broad scientific principles described in this preamble enable OSHA to describe to affected employers and employees why the protective measures required by this ETS are necessary to protect employees from exposure to the virus.

The research described below demonstrates that a significant factor in determining whether a healthy employee will become infected with COVID-19 is how close that employee is to other people (e.g., co-workers, patients, visitors, delivery people). Infected individuals can transmit the virus to others whether or not the infected person is experiencing symptoms, and symptoms may not be immediately noticeable, so it is important to keep all employees distanced from other people whether or not those other people exhibit symptoms. Symptomatic, asymptomatic, and pre-symptomatic transmission is discussed further in Grave Danger (Section IV.A. of the preamble). The role that physical distancing plays in this ETS is thus to ensure that employees are separated from other people as much as possible so as to reduce the risk that virus-containing droplets reach employees.

Consistent with CDC guidance, OSHA defines physical distancing as maintaining a sufficient distance between two people—generally considered to be at least six feet of separation—such that the risk of viral transmission through inhalation of virus-containing particles from an infected individual is significantly reduced. OSHA is aware of emerging scientific literature that suggests even greater distances may be beneficial. OSHA is also aware of some literature from other countries that suggests less than six feet may be appropriate in some circumstances; however, based on the evidence summarized below, OSHA believes that anything less than six feet is not sufficient to address the level of risk established in the studies the agency has reviewed. While it is likely that a distance of greater than six feet will result in some lowered risk and OSHA recommends six feet as a minimum distance, OSHA is not aware of sufficient evidence to justify mandating a distance farther than the six feet recommended by the CDC. Physical distancing is a critical component of infectious disease prevention guidelines and is a key protective measure of the current COVID-19-specific prevention recommendations from the CDC, WHO, and other public health entities, as discussed in greater detail below (CDC and OSHA, March 9, 2020; WHO, June 26, 2020; CalOSHA, 2020; ECDC, March 23, 2020; PHAC, May 25, 2020).

The importance of physical distancing is evident from CDC's guidance for determining who qualifies as close contacts of an individual who is COVID-19 positive. People who have been in close contact with a COVID-19-positive individual are most likely to become infected. To become infected with COVID-19, a healthy individual typically needs to inhale a certain amount of viral particles (i.e., an infectious dose). The closer that healthy individual is to an infected person emitting infectious viral particles, the greater their exposure may be. In practice, a person generally needs to be both close enough to an infectious person and near them long enough to inhale an infectious dose. The CDC acknowledges the potential for inhalation at distances greater than six feet from an infectious source, but notes Start Printed Page 32444that this is less likely than at a closer distance (CDC, May 7, 2021). This continues to support OSHA's recommendation for a minimum distance of six feet. It is also important to note that multiple short exposures over the course of a day can add up to a long enough period of time to receive an infectious dose of COVID-19. Therefore, CDC's definition of close contact is dependent on both proximity to one or more infected people and the time period over which that proximity occurred. The CDC defines close contact as “someone who was within 6 feet of an infected person for a cumulative total of 15 minutes or more over a 24-hour period starting from 2 days before illness onset (or, for asymptomatic patients, 2 days prior to test specimen collection) until the time the patient is isolated” (CDC, March 11, 2021). The CDC uses this close contact designation to help determine contact tracing to minimize transmission spread and to help communicate the risk of transmission to the public.

The CDC close contact definition describes the likely context for transmission events under most circumstances. However, it should be noted that infections can occur from exposures of less than 15 minutes. For example, one infection event was documented that resulted from only roughly five minutes of exposure (Kwon et al., November 23, 2020). Thus, distancing may reduce COVID-19 exposure during even short periods of exposure.

The notion that physical distancing can protect a healthy individual from respiratory droplets is well established for droplet-transmissible diseases and has been a topic of study for well over a hundred years (Flugge, 1897; Jennison, 1942; Duguid, November 1, 1945; Wells, November 1, 1955). Carl Flugge (1897) is credited with originating the concept of droplet transmission. In his study using settling plates to collect large droplets that were emitted from an individual, he found that droplets fell to the plates within two meters (approximately 6.6 feet). Combining this knowledge with the known presence of infectious materials in respiratory droplets, Flugge suggested that remaining two meters from infected individuals would be protective. This understanding of droplet transmission was further expanded a few decades later, when William F. Wells noted that in Flugge's study, Flugge was unable to observe a proportion of small droplets that would evaporate before settling on the plates and that these evaporated droplets traveled differently, suggesting that some measure of transmission may happen beyond the large droplet transmission that Flugge observed (Wells, November 1, 1934). Subsequently, in the 1940s and 1950s, high-speed photography improved to the point where it could capture, upon emission, most of the respiratory droplets—large and small—that formed; this line of study validated much of the groundwork that Flugge and Wells laid (Jennison, 1942; Duguid, November 1, 1945; Hamburger and Robertson, May 1, 1948; Wells, November 1, 1955). These studies illustrated that large droplets can be a major driver of disease transmission, but also that there might be exceptions to the effectiveness of physical distancing when it comes to virus-laden small droplets.

Even though COVID-19 is a recent disease, evidence of the effectiveness of physical distancing in reducing exposures to SARS-CoV-2 has been illustrated through a variety of scientific approaches, including an experimental study by Ueki et al., (October 21, 2020), a modeling study by Li et al., (November 3, 2020), and real world observational studies by Chu et al., (June 27, 2020) and Doung-ngern et al., (September 14, 2020). In a controlled laboratory experiment performed by Ueki et al., (October 21, 2020), researchers developed a scenario where 6 mL of SARS-CoV-2 viral serum was nebulized from a mannequin's mouth to form a mist that simulated a cough. Another mannequin, which was outfitted with an artificial ventilator set to an average adult ventilation rate, collected a proportion of the mist at distances of 0.25 meters (approximately 0.8 feet), 0.5 meters (approximately 1.6 feet), and 1 meter (approximately 3.3 feet). Using the 0.25-meter distance as a baseline, increasing the distance between the mannequins reduced viral particle exposure (measured as the number of viral RNA copies) by 62% at 0.5 meters and 77% at 1 meter. The study clearly illustrates the increased protection from viral exposure that results from increasing distance between individuals.

Modeling studies also provide evidence supporting the effectiveness of physical distancing in preventing exposure to SARS-CoV-2. In Li et al., (November 3, 2020), researchers modeled exposures resulting from respiratory droplets dispersed from a simulated typical cough using simulated saliva with a SARS-CoV-2 viral concentration measured from infected individuals. The simulated cough emitted 30,558 viral copies at distances of one meter (approximately 3.3 feet) and two meters (approximately 6.6 feet) between the infectious person and the person exposed. At one meter, more than 65% of the droplet volume (about 20,000 viral copies) reached the recipient. However, almost all of the exposure was deposited below the head, with only 9 viral copies estimated to land on the area that would normally be covered by a face covering. When the distance was increased to two meters, 63 viral copies landed on the recipient, with only 0.6 copies expected to hit the face covering area. This study illustrates not only the benefit of distance for reducing inhalation exposure, but also for reducing contamination of clothing, which can contribute to overall exposure if a person touches their contaminated clothing and then touches their eyes, nose, or mouth.

Outside of experimental and modeling scenarios, observations in real world situations also substantiate the finding that increasing physical distance protects people from developing infections. A systematic review of 172 studies on SARS-CoV-2 (up to early May 2020), SARS-CoV-1 (a viral strain 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 evaluated the effectiveness of physical distancing (Chu et al., June 27, 2020). The researchers compared the infection rates for individuals who were within one meter (approximately 3.3 feet) of infected people versus the infection rates for those who were greater than one meter away. For individuals who were within one meter, the chance of viral infection was 12.8%. When distance was greater than one meter, the chance of viral infection decreased to 2.6%. Furthermore, researchers projected that with each additional meter of distance the risk would be reduced by an additional 2.02 times.

The importance of physical distancing even when people are not exhibiting symptoms was further demonstrated by a COVID-19 study from Thailand. Researchers reviewed physical distancing information collected from 1,006 individuals who had an exposure to infected individuals (Doung-ngern et al., September 14, 2020). At the time of the exposure, many of the infected individuals were not yet experiencing symptoms, and none of the exposed individuals included in the study were experiencing symptoms. The researchers contacted the individuals 21 days after their exposures to determine if any secondary infections had occurred. Out of 1,006 participants, 197 tested positive and 809 either tested Start Printed Page 32445negative or were considered low risk contacts, did not exhibit symptoms and, therefore, were not tested. The researchers then compared the incidence of secondary infections to data on how close the exposed individuals were to the infected individuals. Exposed individuals were placed into three groups: Those who had direct physical contact with the infected individual, those who were within one meter (approximately 3.3 feet) but without physical contact, and those who remained more than one meter away. 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.

As noted earlier, there is additional nuance to droplet fate beyond just the general effects of gravity on large droplets. Studies evaluating the dispersion of aerosols (i.e., particles that are smaller than typical droplets) and atypical droplets in the air have created a more thorough understanding of disease transmission and the limitations on the effectiveness of physical distancing (Jones et al., August 25, 2020). The distance that droplets may be able to travel depends on their size, expelled velocity, airflow, and other environmental considerations (Xie et al., May 29, 2007; Dbouk and Drikakis, May 1, 2020; Li et al., April 22, 2020). Bahl et al., (April 16, 2020) reviewed ten studies on the horizontal spread of droplets, finding that seven of the studies observed maximum distances traveled by droplets that greatly exceeded two meters (approximately 6.6 feet); one of which suggested the possibility of travel up to eight meters (approximately 26.2 feet). Several case studies have identified incidents where transmission of SARS-CoV-2 occurred over distances of 15.1 feet (Li et al., April 22, 2020), 21.3 feet (Kwon et al., November 23, 2020) and 26.2 feet (Gunther et al., October 27, 2020). These studies suggest that while maintaining a physical distance of two meters reduces transmission significantly, there is still some risk of transmission beyond two meters. Thus, these studies illustrate that physical distancing is an important control, but also why physical distancing alone is insufficient, and a multi-layered strategy that includes additional control measures is necessary to protect employees from contracting COVID-19.

As demonstrated by the studies above, it is widely accepted that physical distancing reduces transmission of infectious diseases generally, and COVID-19 specifically. While the specific distance needed to ensure maximum reduction of COVID-19 transmission can be debated, six feet has long been used in the U.S. as the minimum acceptable distance in most situations to prevent transmission of droplet-transmissible infectious diseases, and the CDC has recommended that distance to combat COVID-19 since the start of the pandemic (CDC and OSHA, March 9, 2020).

Physical distancing strategies can be applied on an individual level (e.g., avoiding coming within six feet of another individual), a group level (e.g., canceling group activities where individuals would be in close contact), and an operational level (e.g., promoting telework, reconfiguring the infrastructure or reducing facility occupancy levels to allow sufficient space for physical distancing). As described in further detail in Summary and Explanation (Section VIII of the preamble), CDC and OSHA have identified various approaches to maintaining physical distance between employees, such as: Reducing the number of employees on-site at one time; reducing facility occupancy levels (both for employees and non-employees); staggering arrival, break, and departure times to maintain distancing during specific times at work when adherence is difficult; and holding on-site training or meeting activities in larger spaces to allow for sufficient distance between attendees (CDC and OSHA, March 9, 2020).

Physical distancing practices and recommendations are also well-accepted internationally as an effective measure to reduce the spread of COVID-19. The World Health Organization (WHO) recommends physical distance of at least one meter (approximately 3.3 feet) in all workplace settings, with a preference for two meters (approximately 6.6 feet) (WHO, June 26, 2020). WHO also recommends providing sufficient work space of at least 10 square meters for each employee where it is feasible based on work tasks. Some foreign governments have implemented physical distancing requirements and recommendations varying in distances of: One meter (e.g., Hong Kong, Singapore, United Kingdom, Norway), 1.5 meters (e.g., Germany, Spain), and 2 meters (e.g., Japan, South Korea, Canada) (Han et al., November 7, 2020; PHAC, May 25, 2020). While the required or recommended amount of distance varies between jurisdictions, it is clear that physical distancing is considered to be a critical tool in preventing the spread of COVID-19 around the world and that, even where six feet of distance cannot be maintained, maintaining as much distance as possible can help minimize the possibility of disease transmission (Chu et al., June 27, 2020; Doung-ngern et al., September 14, 2020; Li et al., November 3, 2020; Ueki et al., 2020).

Based on the best available evidence, the agency concludes that physical distancing of at least six feet is an effective and necessary tool to protect employees from COVID-19 by reducing incidence of COVID-19 illness. This conclusion applies to physical distancing on its own and also when complemented by other measures as part of a multi-layered strategy to minimize employee exposure to COVID-19.

References

Bahl, P. et al., (2020, April 16). Airborne or Droplet Precautions for Health Workers Treating Coronavirus Disease 2019. The Journal of Infectious Diseases jiaa189. https://doi.org/​10.1093/​infdis/​jiaa189. (Bahl et al., April 16, 2020).

California Division of Occupational Safety and Health (CalOSHA). (2020). COVID-19 Prevention Emergency Standard. OSHSB-98(2/98). (CalOSHA, 2020).

Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA). (2020, March 9). Guidance on Preparing Workplaces for COVID-19. https://www.osha.gov/​sites/​default/​files/​publications/​OSHA3990.pdf. (CDC and OSHA, March 9, 2020).

Centers for Disease Control and Prevention (CDC). (2021, March 11). Appendices (Close Contact). https://www.cdc.gov/​coronavirus/​2019-ncov/​php/​contact-tracing/​contact-tracing-plan/​appendix.html#contact. (CDC, March 11, 2021).

Centers for Disease Control and Prevention (CDC). (2021, May 7). Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/​coronavirus/​2019-ncov/​more/​scientific-brief-sars-cov-2.html. (CDC, May 7, 2021).

Chu, DK et al., (2020, June 27). Physical Distancing, Face Masks, and Eye Protection to Prevent Person-to-Person Transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. The Lancet 395: 1973-1987. https://doi.org/​10.1016/​. (Chu et al., June 27, 2020).

Dbouk, T. and Drikakis, D. (2020). On Coughing and Airborne Droplet Transmission to Humans. Physics of Fluids 32, 053310. https://doi.org/​10.1063/​5.0011960. (Dbouk and Drikakis, May 1, 2020).

Doung-ngern, P. et al., (2020, September 14). Case-control Study of Use of Personal Protective Measures and Risk for SARS Coronavirus 2 Infection, Thailand. Emerging Infectious Diseases 26, 11: 2607-2616. https://doi.org/​10.3201/​Start Printed Page 32446eid2611.203003. (Doung-ngern et al., September 14, 2020).

Duguid, JP. (1945). The Numbers and the Sites of Origin of the Droplets Expelled During Expiratory Activities. Edinburgh Medical Journal 52, 11: 385-401. (Duguid, November 1, 1945).

European Centre for Disease Prevention and Control (ECDC). (2020, March 23). Considerations related to social distancing measures in response to COVID-19—second update. https://www.ecdc.europa.eu/​en/​publications-data/​considerations-relating-social-distancing-measures-response-covid-19-second. (ECDC, March 23, 2020).

Flugge, C. (1897). Uber Luftinfection. Zeitschrift fur Hygiene und Infektionskrankheiten 25: 179-224. (Flugge, 1897).

Gunther, T. et al., (2020, October 27). SARS-CoV-2 Outbreak Investigation in a German Meat Processing Plant. EMBO Molecular Medicine. https://doi.org/​10.15252/​emmm.202013296. (Gunther et al., October 27, 2020).

Hamburger, M. and Robertson, OH. (1948, May 1). Expulsion of Group A Hemolytic Streptococci in Droplets and Droplet Nuclei by Sneezing, Coughing, and Talking. American Journal of Medicine 4(5): 690-701. (Hamburger and Robertson, May 1, 1948).

Han, E. et al., (2020, November 7). Lessons Learned from Easing COVID-19 Restrictions: An Analysis of Countries and Regions in Asia Pacific and Europe. The Lancet 396: 1525-1534. https://doi.org/​10.1016/​. (Han et al., November 7, 2020).

Jennison, MW. (1942). Atomising of Mouth and Nose Secretions into the Air as Revealed by High-Speed Photography. Aerobiology 17: 106-128. (Jennison, 1942).

Jones, NR et al., (2020, August 25). Two Metres or One: What is the Evidence for Physical Distancing in COVID-19? BMJ 370: m3223. http://dx.doi.org/​10.1136/​bmj.m3223. (Jones et al., August 25, 2020).

Kwon, KS et al., (2020, November 23). Evidence of Long-Distance Droplet Transmission of SARS-CoV-2 by Direct Air Flow in a Restaurant in Korea. J Korean Med Sci 35(46): e415. https://jkms.org/​DOIx.php?​id=​10.3346/​jkms.2020.35.e415. (Kwon et al., November 23, 2020).

Li, H. et al., (2020, November 3). Dispersion of Evaporating Cough Droplets in Tropical Outdoor Environment. Physics of Fluids 32, 113301. https://doi.org/​10.1063/​5.0026360. (Li et al., November 3, 2020).

Li, Y. et al., (2020, April 22). Aerosol Transmission of SARS-CoV-2: Evidence for Probable Aerosol Transmission of SARS-CoV-2 in a Poorly Ventilated Restaurant. PREPRINT https://doi.org/​10.1101/​2020.04.16.20067728. (Li, April 22, 2020).

Public Health Agency of Canada (PHAC). (2020, May 25). Physical Distancing: How to Slow the Spread of COVID-19. ID 04-13-01. https://www.canada.ca/​content/​dam/​phac-aspc/​documents/​services/​publications/​diseases-conditions/​coronavirus/​social-distancing/​physical-distancing-eng.pdf. (PHAC, May 25, 2020).

Ueki, H. et al., (2020, October 21). Effectiveness of Face Masks in Preventing Airborne Transmission of SARS-CoV-2. mSphere 5: e00637-20. https://doi.org/​10.1128/​mSphere.00637-20. (Ueki et al., October 21, 2020).

Wells, WF. (1934, November 1). On Airborne Infection: Study II. Droplets and Droplet Nuclei. American Journal of Epidemiology 20(3): 611-618. (Wells, November 1, 1934).

Wells, WF. (1955, November 1). Airborne Contagion and Air Hygiene: An Ecological Study of Droplet Infections. Journal of the American Medical Association 159: 90. (Wells, November 1, 1955).

World Health Organization (WHO). (2020, June 26). Coronavirus disease (COVID-19): Health and Safety in the Workplace. https://www.who.int/​news-room/​q-a-detail/​coronavirus-disease-covid-19-health-and-safety-in-the-workplace. (WHO, June 26, 2020).

Xie, X. et al., (2007, May 29). How far droplets can move in indoor environments—revisiting the Wells evaporation-falling curve. Indoor Air 17: 211-225. doi: 10.1111/j.1600-0668.2006.00469.x. (Xie et al., May 29, 2007).

J. Physical Barriers

When people with COVID-19 cough, sneeze, sing, talk, yell, or breathe, they produce respiratory droplets. Epidemiological research has found that most COVID-19 transmission occurs via respiratory droplets that are spread from an infected individual during close (within 6 feet) person-to-person interactions (CDC, May 7, 2021; CDC, May 13, 2021a; WHO, July 9, 2020). The amount of respiratory droplets and particles released when a person breathes is significant, and the amount increases when someone talks or yells (Asadi et al., February 20, 2019; Alsved et al., September 17, 2020; Abkarian et al., October 13, 2020).

Barriers can be used to minimize occupational exposure to SARS-CoV-2. Barriers work by preventing droplets from traveling from the source (i.e., an infected person) to an employee, thus reducing droplet transmission. When barriers are used properly, they will intercept respiratory droplets that may contain SARS-CoV-2. Barriers are particularly critical when physical distancing of six feet is required but not feasible (AIHA, September 9, 2020; Fischman and Baker, June 4, 2020; CDC, April 7, 2021; CDC, March 8, 2021; WHO, May 10, 2020; University of Washington, October 29, 2020).

When engineering controls, such as physical barriers, are appropriately installed and located, they can reduce exposure to infectious agents, such as SARS-CoV-2, without relying on changes in employee behavior (OSHA, 2009). Therefore, engineering controls are often the most effective type of control and can also be a cost-effective layer of protection (AIHA, September 9, 2020). Physical barriers are not a stand-alone measure and are only one part of a multi-layered approach for infection control. To protect employees from exposure to SARS-CoV-2, engineering controls need to be combined with work practice controls, administrative controls, and PPE to ensure adequate protection (CDC, April 7, 2021; CDC, March 8, 2021).

Physical barriers, such as plastic or acrylic partitions, are well-established and accepted as an infection control approach to containing droplet transmissible diseases. Recommendations for the use of physical barriers are commonly made in connection with pandemic events, such as the 2010 pandemic influenza (see, for example, OSHA, 2009) or avian influenza pandemics (see, for example, CDC, January 23, 2014). However, physical barriers are recognized as effective engineering controls for preventing the transmission of infectious agents and, therefore, have been commonly used in other workplace settings even under non-pandemic conditions. For instance, sneeze guards are included in the FDA's 2017 Food Code, which all 50 states use for their food safety regulations (FDA, 2017). These barriers, typically placed in front of and above food items, intercept contaminants, such as respiratory droplets, that may be expelled from a person's mouth or nose (Todd et al., August 1, 2010).

Impermeable barriers intercept respiratory droplets and prevent them from reaching another individual (Fischman and Baker, June 4, 2020; Ibrahim et al., June 1, 2020; Dehghani et al., December 22, 2020; University of Washington, October 29, 2020). Thus, physical barriers can be a practical solution for decreasing the transmission of infectious viral particles for a wide range of work activities and locations. Only barriers that keep respiratory droplets out of an employee's breathing zone will reduce overall exposure to SARS-CoV-2. The breathing zone is the area immediately around an individual's mouth and nose from which a person draws air when they breathe and extends 9 inches beyond a person's nose and mouth (OSHA, February 11, 2014). Additional considerations for the design and implementation of physical barriers to Start Printed Page 32447properly block face-to-face pathways of breathing zones, including acceptable materials and installation, is discussed in the Summary and Explanation (Section VIII of the preamble).

While COVID-19-related research on barriers is fairly limited due to the recent emergence and ongoing nature of the pandemic, there is some evidence of the effectiveness of physical barriers in healthcare settings during the COVID-19 pandemic. Using a surrogate for SARS-CoV-2, Mousavi et al., (August 13, 2020) designed an experimental study in which general patient rooms in a healthcare facility were converted into isolation rooms constructed out of plastic barriers with zipper doors. The authors found that the use of the barrier alone could stop the particles that contacted the barrier and prevent 80% of the surrogate SARS-CoV-2 particles from spreading to adjacent spaces. In contrast, without the barrier, particles were easily dispersed to other areas of the facility. The barrier was actually more effective at containing particles than a solid door, as the barrier did not create changes in airflow patterns like a door does when it opens and closes.

A simulation study using a double set of plastic drapes as a barrier around a patient's head and neck during patient intubation found that the drapes were effective at minimizing contamination to the healthcare provider and patient (Ibrahim et al., June 1, 2020). Similarly, a simulation study performed in a dental healthcare setting evaluated the use of clear, flexible barriers that were fitted over the patient chair and covered the patient's head, neck, and chest; the barriers had small openings for the employee's hands. The barriers were found to reduce the number of dyed water droplets landing on the provider and in the surrounding work environment during the dental procedure (Teichert-Filho et al., August 18, 2020). A simulation study of peroral endoscopy procedures performed through the mouth found that the use of an acrylic box around a patient's head during the procedure may reduce the number of droplets transmitted to the providers performing the procedure (Gomi et al., October 21, 2020).

A separate group of researchers developed a simulation study in an open work station environment to evaluate how physical barriers may impact disease transmission. They found that physical barriers were able to reduce the transmission of simulated 1um aerosolized particles from a source individual to others who were over 6 feet away by 92% (Abuhegazy et al., October 20, 2020). OSHA notes that it would be expected that large droplets, as opposed to aerosolized particles, would be reduced to a greater extent because they do not remain airborne for extended periods of time unlike aerosolized particles, as noted in the Physical Distancing section of the Need for Specific Provisions analysis.

Researchers found that a COVID-19 outbreak among hospital food service employees was effectively contained with the prompt implementation of physical barriers in the workplace where physical distancing was not implemented (Hale and Dayot, August 13, 2020). This included installing partitions at cashier stations between employees and non-employees, as well as in food preparation areas between workstations (Hale and Dayot, August 13, 2020). While this evidence of the effectiveness of barriers was not drawn from healthcare settings, the same concept would be equally applicable to preventing transmission between people at similarly fixed locations in healthcare facilities, such as barriers separating a receptionist from a patient in intake or barriers separating workers sitting side by side at desks in a hospital's administrative office.

It is not clear, however, that barriers are necessary to separate fully vaccinated employees from employees who are not fully vaccinated and are not suspected or confirmed to have COVID-19. As discussed in the Grave Danger section and in the explanation for the scope exception in § 1910.501(a)(4), the CDC has acknowledged a “growing body” of evidence that vaccination can reduce the potential that a vaccinated person will transmit the SARS-CoV-2 virus to non-vaccinated co-workers (CDC, April 12, 2021; CDC, May 13, 2021b).

Based on the best available evidence, the agency concludes that physical barriers are an effective and necessary means of, and play a vital role in, reducing transmission of SARS-CoV-2 when complemented by other measures as part of a multi-layered strategy to minimize the risks of employee exposure to SARS-CoV-2 by employees who are not fully vaccinated or from non-employees.

References

Abkarian, M. et al., (2020, October 13). Speech can produce jet-like transport relevant to asymptomatic spreading of virus. PNAS 117: 41, 25237-25245. https://www.pnas.org/​cgi/​doi/​10.1073/​pnas.2012156117. (Abkarian et al., October 13, 2020).

Abuhegazy, A. et al., (2020, October). Numerical investigation of aerosol transport in a classroom with relevant to COVID-19. Physics of Fluids 32, 103311. https://doi.org/​10.1063/​5.0029118. (Abuhegazy et al., October 20, 2020).

Alsved, M. et al.,(2020, September 17). Exhaled respiratory particles during singing and talking. Aerosol Science and Technology 54: 1245-1248. https://doi.org/​10.1080/​02786826.2020.1812502. (Alsved et al., September 17, 2020).

American Industrial Hygiene Association (AIHA). (2020, September 9). Reducing the Risk of COVID-19 Using Engineering Controls: Guidance Document. https://aiha-assets.sfo2.digitaloceanspaces.com/​AIHA/​resources/​Guidance-Documents/​Reducing-the-Risk-of-COVID-19-using-Engineering-Controls-Guidance-Document.pdf. (AIHA, September 9, 2020).

Asadi, S et al., (2019, February 20). Aerosol emission and superemission during human speech increase with voice loudness. Scientific Reports 9: 2348. https://doi.org/​10.1038/​s41598-019-38808-z. (Asadi et al., February 20, 2019).

Centers for Disease Control and Prevention (CDC). (2014, January 23). Interim Guidance for Infection Control Within Healthcare Settings When Caring for Confirmed Cases, Probable Cases, and Cases Under Investigation for Infection with Novel Influenza A Viruses Associated with Severe Disease. https://www.cdc.gov/​flu/​avianflu/​novel-flu-infection-control.htm. Accessed January 28, 2021. (CDC, January 23, 2014).

Centers for Disease Control and Prevention (CDC). (2021, April 12). Benefits of getting a COVID-19 vaccine. https://www.cdc.gov/​coronavirus/​2019-ncov/​vaccines/​vaccine-benefits.html. (CDC, April 12, 2021).

Centers for Disease Control and Prevention (CDC). (2021, May 7). Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/​coronavirus/​2019-ncov/​more/​scientific-brief-sars-cov-2.html. (CDC, May 7, 2021).

Centers for Disease Control and Prevention (CDC). (2021a, May 13). How COVID-19 Spreads. https://www.cdc.gov/​coronavirus/​2019-ncov/​prevent-getting-sick/​how-covid-spreads.html. (CDC, May 13, 2021a).

Centers for Disease Control and Prevention (CDC). (2021b, May 13). Interim Public Health Recommendations for Fully Vaccinated People. https://www.cdc.gov/​coronavirus/​2019-ncov/​vaccines/​fully-vaccinated-guidance.html. (CDC, May 13, 2021b).

Centers for Disease Control and Prevention (CDC). (2021, March 8). Guidance for Businesses and Employers Responding to Coronavirus Disease 2019 (COVID-19). https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​guidance-business-response.html. (CDC, March 8, 2021).

Centers for Disease Control and Prevention (CDC). (2021, April 7). COVID-19 Employer Information for Office Buildings. https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​office-buildings.html. (CDC, April 7, 2021).

Dehghani, F. et al., (2020, December 22). The hierarchy of preventive measures to Start Printed Page 32448protect workers against the COVID-19 pandemic: A review. Work 67: 771-777. DOI: 10.3233/WOR-203330. (Dehghani et al., December 22, 2020).

Fischman, ML and Baker, B. (2020, June 4). COVID-19 Resource Center. American College of Occupational and Environmental Medicine [ACOEM]. https://acoem.org/​COVID-19-Resource-Center/​COVID-19-Q-A-Forum/​Could-you-provide-guidance-on-the-use-of-plexiglass-barriers-for-workplaces-for-sneeze-guard%E2%80%9D-dropl. (Fischman and Baker, June 4, 2020).

Food and Drug Administration (FDA). (2017). Food Code: 2017 Recommendations of the United States Public Health Service, Food and Drug Administration. (FDA, 2017).

Gomi, K. et al., (2020, October 21). Peroral endoscopy during the COVID-19 pandemic: Efficacy of the acrylic box (Endo-Splash Protective (ESP) box) for preventing droplet transmission. Journal of Gastroenterology and Hepatology 4: 1224-1228. doi: 10.1002/jgh3.12438. (Gomi et al., October 21, 2020).

Hale, M. and Dayot, A. (2020). Outbreak Investigation of COVID-19 in Hospital Food Service Workers. American Journal of Infection Control. S0196-6553(20)30777-X. https://doi.org/​10.1016/​j.ajic.2020.08.011. (Hale and Dayot, August 13, 2020).

Ibrahim, M. et al., (2020, June 1). Comparison of the effectiveness of different barrier enclosure techniques in protection of healthcare workers during tracheal intubation and extubation. Anesthesia and Analgesia Practice 14: 3. DOI: 10.1213/XAA.0000000000001252. (Ibrahim et al., June 1, 2020).

Mousavi, ES et al., (2020, August 13). Performance analysis of portable HEPA filters and temporary plastic anterooms on the spread of surrogate coronavirus. Building and Environment 183: 107186. https://doi.org/​10.1016/​j.buildenv.2020.107186. (Mousavi et al., August 13, 2020).

Occupational Safety and Health Administration (OSHA). (2009). Guidance on Preparing Workplaces for an Influenza Pandemic. https://www.osha.gov/​Publications/​influenza_​pandemic.html. (OSHA, 2009).

Occupational Safety and Health Administration (OSHA). (2014, February 11). OSHA Technical Manual, Section II: Chapter 1—Personal Sampling for Air Contaminants. https://www.osha.gov/​dts/​osta/​otm/​otm_​ii/​otm_​ii_​1.html. (OSHA, February 11, 2014).

Teichert-Filho, R. et al., (2020, August 18). Protective device to reduce aerosol dispersion in dental clinics during the COVID-19 pandemic. International Endodontic Journal. doi: 10.1111/iej.13373. (Teichert-Filho et al., August 18, 2020).

Todd, ECD et al., (2010, August 1). Outbreaks where food workers have been implicated in the spread of foodborne disease. Part 7. Barriers to reduce contamination of food by workers. J. of Food Protection 73(8): 1552-1565. https://doi.org/​10.4315/​0362-028X-73.8.1552. (Todd et al., August 1, 2010).

University of Washington. (2020, October 29). University of Washington Guidance for Plexiglass Barriers in Support of COVID-19 Prevention Efforts. University of Washington Environmental Health & Safety. https://www.ehs.washington.edu/​system/​files/​resources/​COVID-19-plexiglass-barriers-workplace.pdf. (University of Washington, October 29, 2020).

World Health Organization (WHO). (2020, May 10). Considerations for public health and social measures in the workplace context of COVID-19: Annex to Considerations in adjusting public health and social measures in the context of COVID-19, May 2020. https://www.who.int/​publications-detail-redirect/​considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19. (WHO, May 10, 2020).

World Health Organization (WHO). (2020, July 9). Transmission of SARS-CoV-2: Implications for infection prevention precautions. https://www.who.int/​news-room/​commentaries/​detail/​transmission-of-sars-cov-2-implications-for-infection-prevention-precautions. (WHO, July 9, 2020).

K. Hygiene and Cleaning

COVID-19 can also be spread through contact transmission, which occurs when a person touches another person who has COVID-19 (e.g., during a handshake) or a surface or item contaminated with the virus (e.g., workstations, shared equipment or products) and then touches their own eyes, nose, or mouth (CDC, May 13, 2021; CDC, April 5, 2021d). Contact transmission via inanimate objects is also known as fomite transmission. While contact transmission is less common than droplet transmission, and the risk of infection from touching a surface is low, contracting COVID-19 via contact transmission remains a concern in the workplace. Contact transmission is discussed in greater detail in Grave Danger (Section IV.A. of the preamble).

To protect against COVID-19 transmission, the CDC has recommended cleaning and situational disinfecting of high-touch surfaces, as well as frequent handwashing, as key prevention methods (CDC, April 5, 2021a, and CDC, May 17, 2020, respectively). Cleaning means the removal of dirt and impurities, including germs, from surfaces using soap and water or other cleaning agents (i.e., not Environmental Protection Agency (EPA)-registered disinfectants). Cleaning alone reduces germs on surfaces by removing contaminants and may also weaken or damage some of the virus particles, which decreases risk of infection from surfaces. Disinfection means using an EPA-registered List N disinfectant in accordance with manufacturers' instructions to kill germs on surfaces or objects. Disinfection further lowers the risk of spreading infection and the CDC recommends disinfection in indoor community settings where there has been a suspected or confirmed COVID-19 case in the previous 24 hours (CDC, April 5, 2021d).

I. Cleaning and Hand Hygiene Are Most Effective in Combination

Based on the best available evidence, OSHA has determined that proper hand hygiene, cleaning, and situational disinfection of high-touch surfaces and surfaces touched by someone with COVID-19 are critical provisions of the ETS, both on their own and also when complemented by other measures as part of a multi-layered strategy to minimize employee exposure to this grave COVID-19 danger. Practicing proper hand hygiene combined with routine cleaning of contact surfaces, minimizes the risk of contracting COVID-19 through contact with contaminated surfaces, followed by touching the mouth, nose, or eyes (Honein et al., December 11, 2020). Cleaning surfaces removes harmful contaminants from surfaces, reducing the risk of COVID-19 transmission following hand contact with those surfaces. Disinfection of surfaces and equipment in indoor community settings should be done if a suspected or confirmed COVID-19 case was utilizing those areas within the past 24 hours (CDC, April 5, 2021d). Cleaning, disinfection, and hand hygiene are foundational components of Standard and Transmission-Based Precautions for infection control and prevention (Siegel et al., 2007).

II. Cleaning and Disinfection

Respiratory secretions or droplets expelled by infected individuals can contaminate surfaces and objects (WHO, July 9, 2020). Evidence suggests that the virus that causes COVID-19 may remain viable on surfaces for hours to days (Riddell et al., October 7, 2020; van Doremalen et al., April 16, 2020; CDC, April 5, 2021b), depending on the ambient environment and the type of surface (WHO, July 9, 2020). Although fomites and contaminated surfaces are not a common transmission mode of COVID-19, demonstration of surface contamination and experiences with surface contamination linked to subsequent infection transmission with other coronaviruses, have informed the development of cleaning and situational Start Printed Page 32449disinfection recommendations to mitigate the potential of fomite transmission of COVID-19 (WHO, May 14, 2020; CDC, April 5, 2021d). Cleaning of visibly dirty surfaces is a best practice measure for prevention of COVID-19 and other viral respiratory illnesses in all settings, including healthcare. Disinfection of these surfaces may be appropriate if it is reasonable to assume that individuals with COVID-19 may have been present. Cleaning and disinfection reduces the risk of spreading infection by removing and killing germs on surfaces people frequently touch, and in areas that were occupied or visited by a person confirmed to have COVID-19 (CDC, April 5, 2021a; WHO, May 14, 2020; CDC, April 5, 2021c; CDC, April 5, 2021d).

Scientific evidence and guidelines from the CDC and WHO support cleaning and situational disinfection of surfaces as an effective practice to prevent the transmission of infectious viruses. Human coronaviruses, including MERS coronavirus or endemic human coronaviruses (HCoV), can be efficiently inactivated by surface disinfection procedures (Kampf et al., February 6, 2020). A study of 124 Beijing households with one or more laboratory-confirmed COVID-19 positive family members demonstrated the efficacy of disinfection in preventing the transmission of COVID-19. The study found that disease transmission to family members was 77% less with use of chlorine- or ethanol-based disinfectants every day compared to use of disinfectants once in two or more days, irrespective of other protective measures taken such as mask wearing and physical distancing (Wang et al., May 11, 2020).

The World Health Organization recommends thoroughly cleaning environmental surfaces with water and detergent and applying commonly used hospital-level disinfectants, such as sodium hypochlorite (i.e., the active ingredient in chlorine bleach), for effective cleaning and disinfection (WHO, May 14, 2020). Surface disinfection with 0.1% sodium hypochlorite or 62-71% ethanol significantly reduces coronavirus infectivity on surfaces within 1 minute of exposure time (Kampf et al., February 6, 2020). The Environmental Protection Agency (EPA) has compiled List N, a list of disinfectant products that can be used against the virus that causes COVID-19, including ready-to-use sprays, concentrates, and wipes (EPA, April 9, 2021). EPA includes products on List N if they have demonstrated efficacy against the COVID-19 virus, or a germ that is harder to kill than SARS-CoV-2 virus, or another human coronavirus that is similar to the SARS-CoV-2 virus (EPA, February 17, 2021).

III. Hand Hygiene

In all settings, including settings where regular cleaning may be difficult, frequent hand washing and avoiding touching of the face should be considered the primary prevention approach to mitigate COVID-19 transmission associated with surface contamination (WHO, May 14, 2020). Hand hygiene is generally recognized as an effective intervention at preventing respiratory illnesses and infectious disease transmission (Rabie and Curtis, March 7, 2006; Haque, July 12, 2020; Rundle et al., July 22, 2020). The CDC and the WHO have determined that frequent handwashing, plus sanitization, are essential control measures for COVID-19 prevention within the workplace, and HICPAC identifies hand hygiene as an essential element of Standard Precautions (CDC, May 17, 2020; WHO, July 9, 2020; WHO, May 14, 2020; Siegel et al., 2007).

To prevent virus transmission, the CDC recommends that healthcare workers engage in frequent handwashing with soap and water for at least 20 seconds, or use an alcohol-based hand sanitizer with at least 60% alcohol (CDC, May 17, 2020). Alcohol-based hand sanitizers are the most effective products for reducing the number of germs on the hands of healthcare providers and are the preferred method for cleaning hands in most clinical situations, while handwashing is necessary whenever hands are visibly soiled (CDC, January 8, 2021). Handwashing with soap and water mechanically removes pathogens (Burton et al., January 6, 2011), and laboratory data demonstrates that hand sanitizers that contain at least 60% alcohol are effective at killing the virus that causes COVID-19 (Kratzel et al., July 2020; Siddharta et al., March 15, 2017).

Experience with work settings shows that flexible hand hygiene approaches are effective to address unique scenarios in various work environments. For example, handwashing is usually emphasized over hand sanitizing, but CDC recommends the use of alcohol-based hand sanitizers as the primary method for hand hygiene in most healthcare situations (CDC, October 14, 2020). In healthcare settings, alcohol-based hand sanitizers with 60-95% alcohol effectively reduce the number of pathogens that may be present on the hands of healthcare providers, particularly after interacting with patients (CDC, May 17, 2020). In most clinical settings, unless hands are visibly soiled, an alcohol-based hand rub is preferred over soap and water due to evidence of better compliance compared to soap and water. However, CDC does recommend healthcare workers wash their hands for at least 20 seconds with soap and water when hands are visibly dirty, before eating, and after using the restroom (CDC, May 17, 2020). Alcohol-based hand sanitizers are also important as an alternative to soap and water for workers who do not have ready access to handwashing facilities (e.g., emergency responders).

References

Burton, M. et al., (2011, January 6). The effect of handwashing with water or soap on bacterial contamination of hands. International Journal of Environmental Research and Public Health, 8(1), 97-104. https://doi.org/​10.3390/​ijerph8010097. (Burton et al., January 6, 2011).

Centers for Disease Control and Prevention (CDC). (2020, May 17). Hand hygiene recommendations: Guidance for healthcare providers about hand hygiene and COVID-19. https://www.cdc.gov/​coronavirus/​2019-ncov/​hcp/​hand-hygiene.html. (CDC, May 17, 2020).

Centers for Disease Control and Prevention (CDC). (2020, October 14). Frequent questions about hand hygiene. https://www.cdc.gov/​handwashing/​faqs.html. (CDC, October 14, 2020).

Centers for Disease Control and Prevention (CDC). (2021, January 8). Hand Hygiene in Healthcare Settings. https://www.cdc.gov/​handhygiene/​providers/​index.html. (CDC, January 8, 2021).

Centers for Disease Control and Prevention (CDC) and Environmental Protection Agency (EPA). (2021a, April 5). Reopening guidance for cleaning and disinfecting public spaces, workplaces, businesses, schools, and homes. https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​reopen-guidance.html. (CDC, April 5, 2021a).

Centers for Disease Control and Prevention (CDC). (2021b, April 5). Cleaning and disinfection for households: Interim recommendations for U.S. households with suspected or confirmed COVID-19. https://www.cdc.gov/​coronavirus/​2019-ncov/​prevent-getting-sick/​cleaning-disinfection.html. (CDC, April 5, 2021b).

Centers for Disease Control and Prevention (CDC). (2021c, April 5). Cleaning and disinfecting your facility. https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​disinfecting-building-facility.html. (CDC, April 5, 2021c).

Centers for Disease Control and Prevention (CDC). (2021d, April 5). Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/​coronavirus/​2019-ncov/​more/​science-and-research/​surface-transmission.html. (CDC, April 5, 2021d).Start Printed Page 32450

Centers for Disease Control and Prevention (CDC). (2021, May 13). How COVID-19 spreads. https://www.cdc.gov/​coronavirus/​2019-ncov/​prevent-getting-sick/​how-covid-spreads.html. (CDC, May 13, 2021).

Environmental Protection Agency (EPA). (2021, February 17). How does EPA know that the products on List N work on SARS-CoV-2? https://www.epa.gov/​coronavirus/​how-does-epa-know-products-list-n-work-sars-cov-2. (EPA, February 17, 2021).

Environmental Protection Agency (EPA). (2021, April 9). List N tool: COVID-19 disinfectants. https://cfpub.epa.gov/​giwiz/​disinfectants/​index.cfm. (EPA, April 9, 2021).

Haque, M. (2020). Handwashing in averting infectious diseases: Relevance to COVID-19. Journal of Population Therapeutics and Clinical Pharmacology, 27(S Pt 1), e37-e52. https://doi.org/​10.15586/​jptcp.v27SP1.711. (Haque, July 12, 2020).

Honein, MA et al., (2020, December 11). Summary of Guidance for Public Health Strategies to Address High Levels of Community Transmission of SARS-CoV-2 and Related Deaths, December 2020. MMWR Morb Mortal Wkly Rep 2020; 69: 1860-1867. DOI: http://dx.doi.org/​10.15585/​mmwr.mm6949e2. (Honein et al., December 11, 2020).

Kampf, G. et al., (2020). Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. The Journal of Hospital Infection, 104(3), 246-251. https://doi.org/​10.1016/​j.jhin.2020.01.022. (Kampf et al., February 6, 2020).

Kratzel, A. et al., (2020, July). Inactivation of SARS-CoV-2 by WHO—recommended hand rub formulations and alcohols. Emerging Infectious Diseases, 26(7), 1592-1595. https://doi.org/​10.3201/​eid2607.200915. (Kratzel et al., July 2020).

Rabie, T. and Curtis, V. (2006). Handwashing and risk of respiratory infections: A quantitative systematic review. Tropical Medicine & International Health, 11(3), 258-267. https://doi.org/​10.1111/​j.1365-3156.2006.01568.x. (Rabie and Curtis, March 7, 2006).

Riddell, S. et al., (2020, October 7). The effect of temperature on persistence of SARS-CoV-2 on common surfaces. Virology journal, 17(1), 145. https://doi.org/​10.1186/​s12985-020-01418-7. (Riddell et al., October 7, 2020).

Rundle, C. et al., (2020, July 22). Hand hygiene during COVID-19: Recommendations from the American Contact Dermatitis Society. Journal of the American Academy of Dermatology, 83(6), 1730-1737. https://doi.org/​10.1016/​j.jaad.2020.07.057. (Rundle et al., July 22, 2020).

Siddharta, A. et al., (2017, March 15). Virucidal activity of World Health Organization—recommended formulations against enveloped viruses, including Zika, Ebola, and Emerging Coronaviruses. The Journal of Infectious Diseases, 215(6), 902-906. https://doi.org/​10.1093/​infdis/​jix046. (Siddharta et al., March 15, 2017).

Siegel, J., Rhinehart, E., Jackson, M., Chiarello, L., and the Healthcare Infection Control Practices Advisory Committee. (2007). 2007 Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. https://www.cdc.gov/​infectioncontrol/​pdf/​guidelines/​isolation-guidelines-H.pdf. (Siegel et al., 2007).

van Doremalen, N. et al., (2020, April 16). Aerosol and surface stability of SARS-CoV-2 as compared with SARS-CoV-1. The New England Journal of Medicine, 382(16), 1564-1567. https://doi.org/​10.1056/​NEJMc2004973. (van Doremalen et al., April 16, 2020).

Wang, Y., Tian, H., Zhang, L., Zhang, M., Guo, D., Wu, W. (2020). Reduction of secondary transmission of SAR-CoV-2 in households by face mask use, disinfection and social distancing: A cohort study in Beijing, China. BMJ Global Health, 5, e002794. doi: 10.1136/bmjgh-2020-002794. (Wang et al., May 11, 2020).

World Health Organization (WHO). (2020, May 14). Coronavirus disease 2019 (COVID-19): Situation report, 115. https://apps.who.int/​iris/​handle/​10665/​332090. (WHO, May 14, 2020).

World Health Organization (WHO). (2020, July 9). Transmission of SARS-CoV-2: Implications for infection prevention precautions. https://www.who.int/​news-room/​commentaries/​detail/​transmission-of-sars-cov-2-implications-for-infection-prevention-precautions. (WHO, July 9, 2020).

L. Ventilation

Improving existing ventilation and ensuring optimal performance of ventilation is an effective way to reduce viral transmission in occupational populations. Work sites with existing heating, ventilation, and air conditioning (HVAC) systems can utilize improvements to, and maintenance of, high performance ventilation as part of a layered response for infectious disease control. The effectiveness of ventilation in controlling disease transmission is based on scientific research and the recommendations of well-respected occupational safety and health organizations, including government agencies.

As explained in Grave Danger (Section IV.A. of the preamble), there is evidence of airborne COVID-19 transmission within enclosed spaces with inadequate ventilation. As a result, there is considerable support for ensuring adequate ventilation through maintenance and improvements. Federal agencies, international organizations, industry associations, and scientific researchers agree that ensuring adequate ventilation is important in reducing potential airborne transmission of COVID-19 (ASHRAE, April 14, 2020; Schoen, May 2020; WHO, May 10, 2020; AIHA, September 9, 2020; CDC, May 7, 2021; CDC, April 7, 2021; CDC, March 23, 2021; Tang et al., August 7, 2020; Morawska et al., May 27, 2020).

In one scientific brief, the CDC provides a basic overview of how ventilation can reduce the transmission of COVID-19 in indoor spaces. Once respiratory droplets are exhaled, the 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, 2021). Without adequate ventilation, continued exhalation can lead to 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 13, 2021).

Ventilation controls the transmission of COVID-19 in two ways. First, improving indoor ventilation by appropriately maximizing air exchanges and by maintaining and improving heating, ventilation, and air-conditioning (HVAC) systems can disperse and decrease the concentration of COVID-19-containing small droplets and particles suspended in the air. The lower the concentration, the less likely some of those viral particles can be inhaled into an employee's lungs; contact their eyes, nose, or mouth; or fall out of the air to accumulate on surfaces. Protective ventilation practices and interventions can reduce the airborne concentration, which reduces the overall viral dose to occupants (CDC, March 23, 2021). Improved ventilation can also significantly reduce the airborne time of respiratory droplets (Somsen et al., May 27, 2020; CDC, March 23, 2021). As a result, the risk of transmission of COVID-19 indoors is reduced, which makes workplaces safer (Schoen, May 2020; CDC, April 7, 2021; CDC, March 23, 2021; Honein et al., December 11, 2020). Ventilation systems alone cannot completely prevent airborne transmission (EPA, July 16, 2020; CDC, March 23, 2021), but are particularly effective when implemented in conjunction with additional control measures in a layered approach, including other engineering controls and other protections required in this ETS.

Second, air filters in HVAC systems remove particles, including aerosolized particles containing COVID-19, from Start Printed Page 32451recirculated air streams before returning the air to workspaces. Increased filter efficiency is a component of the HVAC system which can be adjusted to reduce the risk of COVID-19 transmission (Schoen, May 2020; ASHRAE, April 14, 2020; CDC, May 7, 2021; CDC, March 8, 2021; CDC, March 23, 2021; Morawska et al., May 27, 2020). Minimum Efficiency Reporting Values (MERV) report a filter's ability to capture larger particles between 0.3 and 10 microns (µm). MERV ratings range from 1 to 16, and a higher rating indicates a more efficient filter. The virus that causes COVID-19 is approximately 0.125 µm in diameter; however, the virus is contained in infectious particles, droplets, and droplet nuclei (dried respiratory droplets) that are predominantly 1 µm in size and larger.

The CDC recommends increasing filtration to the highest extent possible that is compatible with the design of the HVAC system (CDC, March 23, 2021). The American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE) recommends using filters with a MERV rating of at least 13, where feasible, or the highest level compatible with the specified HVAC system, to help capture the infectious aerosols containing COVID-19 (Schoen, May 2020; ASHRAE, December 8, 2020). The use of filtration has also been supported by others, including Mousavi et al., August 26, 2020. A MERV rating of 13 is at least 85-percent efficient at capturing particles from 1 µm to 3 µm in size (Schoen, May 2020; CDC, March 8, 2021; CDC, March 23, 2021), which is the size of the particles carrying COVID-19. A MERV-14 filter is at least 90% efficient at capturing particles of this same size, and efficiencies for MERV-15 and MERV-16 filters are even greater. As such, filters with MERV ratings of 13 or greater are much more efficient at capturing particles of this size than a MERV 8 filter (CDC, March 23, 2021).

The ability of HVAC systems to reduce the risk of exposure depends on many factors, including design features, operation and maintenance practices, and the quality and quantity of outdoor air supplied to the space. The CDC has emphasized that building owners and operators should ensure that ventilation systems are functioning properly and providing acceptable levels of indoor air quality for the occupancy level of the given space. Consultation with an HVAC professional will help ensure that improvements to ventilation systems are implemented in accordance with the capacity and design of the HVAC system, according to state and local building codes and guidelines, and to avoid imbalances that could negatively alter other indoor air quality parameters (e.g., temperature, humidity, moisture) (EPA, July 16, 2020; CDC, March 23, 2021).

The CDC has also recommended increasing airflow (CDC, March 23, 2021) to occupied spaces, if possible. One way to achieve this is by opening windows and doors (Howard-Reed et al., February 2002; CDC, March 23, 2021), where feasible and as weather conditions permit. However, decisions to open windows and doors should be done after evaluating other safety and health risks for occupants, such as risk of falling or breathing outdoor environmental contaminants (e.g., carbon monoxide, molds, and pollens) (CDC, April 7, 2021; CDC, March 8, 2021; CDC, March 23, 2021). In order for this type of ventilation to serve as an effective COVID-19 control, the air flow must be directed so that contaminated air is not funneled through workspaces toward another person.

Based on the best available evidence, the agency concludes that implementation of improved ventilation and maintaining HVAC system performance is an effective and necessary approach to reduce incidence of COVID-19 both on its own and also when complemented by other measures as part of a multi-layered strategy to minimize employee exposure to the grave COVID-19 danger.

References

American Industrial Hygiene Association (AIHA). (2020, September 9). Reducing the Risk of COVID-19 Using Engineering Controls: Guidance Document. https://aiha-assets.sfo2.digitaloceanspaces.com/​AIHA/​resources/​Guidance-Documents/​Reducing-the-Risk-of-COVID-19-using-Engineering-Controls-Guidance-Document.pdf. (AIHA, September 9, 2020).

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). (2020, April 14). ASHRAE Position Document on Infectious Aerosols. https://www.ashrae.org/​file%20library/​about/​position%20documents/​pd_​infectiousaerosols_​2020.pdf. (ASHRAE, April 14, 2020).

American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). (2020, December 8). Debunking myths about MERV, air filtration. https://www.ashrae.org/​news/​ashraejournal/​debunking-myths-about-merv-air-filtration. (ASHRAE, December 8, 2020).

Centers for Disease Control and Prevention (CDC). (2021, March 8). Guidance for Businesses and Employers Responding to Coronavirus Disease 2019 (COVID-19). https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​guidance-business-response.html. (CDC, March 8, 2021).

Centers for Disease Control and Prevention (CDC). (2021, March 23). Ventilation. https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​ventilation.html. (CDC, March 23, 2021).

Centers for Disease Control and Prevention (CDC). (2021, April 7). COVID-19 Employer Information for Office Buildings. https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​office-buildings.html. (CDC, April 7, 2021).

Centers for Disease Control and Prevention (CDC). (2021, May 7). Scientific Brief: SARS-CoV-2 Transmission. https://www.cdc.gov/​coronavirus/​2019-ncov/​more/​scientific-brief-sars-cov-2.html. (CDC, May 7, 2021).

Centers for Disease Control and Prevention (CDC). (2021, May 13). How COVID-19 Spreads. https://www.cdc.gov/​coronavirus/​2019-ncov/​prevent-getting-sick/​how-covid-spreads.html. (CDC, May 13, 2021).

Environmental Protection Agency (EPA). (2020, July 16). Ventilation and Coronavirus (COVID-19). https://www.epa.gov/​coronavirus/​ventilation-and-coronavirus-covid-19. (EPA, July 16, 2020).

Honein, MA et al., (2020, December 11). Summary of Guidance for Public Health Strategies to Address High Levels of Community Transmission of SARS-CoV-2 and Related Deaths, December 2020. MMWR Morb Mortal Wkly Rep 2020; 69: 1860-1867. DOI: http://dx.doi.org/​10.15585/​mmwr.mm6949e2. (Honein et al., December 11, 2020).

Howard-Reed, C. et al., (2002, February). The effect of opening windows on air change rates in two homes. Journal of Air and Waste Management Association 52: 147-159. (Howard-Reed et al., February 2002).

Morawska, L. et al, (2020, May 27). How can airborne transmission of COVID-19 indoors be minimized? Environmental International 142: 105832. https://doi.org/​10.1016/​j.envint.2020.105832. (Morawska et al., May 27, 2020).

Mousavi, ES et al., (2020, August 26). COVID-19 Outbreak and Hospital Air Quality: A Systematic Review of Evidence on Air Filtration and Recirculation. Environmental Science and Technology. acs.est.0c03247. https://doi.org/​10.1021/​acs.est.0c03247. (Mousavi et al., August 26, 2020).

Schoen, LJ. (2020, May). Guidance for building operations during the COVID-19 pandemic. ASHRAE Journal. (Schoen, May 2020).

Somsen, GA. et al., (2020, May 27). Small droplet aerosols in poorly ventilated spaces and SARS-CoV-2 transmission. The Lancet 8: 658-659. https://doi.org/​10.1016/​. (Somsen et al., May 27, 2020).

Tang, S. et al., (2020, August 7). Aerosol transmission of SARS-CoV-2? Evidence, prevention and control. Environmental International 144: 106039. https://doi.org/​10.1016/​j.envint.2020.106039. (Tang et al., August 7, 2020).Start Printed Page 32452

World Health Organization (WHO). (2020, May 10). Considerations for public health and social measures in the workplace context of COVID-19: Annex to Considerations in adjusting public health and social measures in the context of COVID-19, May 2020. https://www.who.int/​publications-detail-redirect/​considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19. (WHO, May 10, 2020).

M. Health Screening and Medical Management

As discussed in more detail in Grave Danger (Section IV.A. of the preamble), COVID-19 is a disease that is primarily transmitted from person to person through respiratory droplets that are produced when someone breaths, talks, sneezes, or coughs, and the droplets contact the eyes, nose, or mouth of another person. It may also infrequently be transmitted by someone touching a contaminated surface and then touching their eyes, nose, or mouth. Consequently, to effectively reduce the transmission of COVID-19 in the workplace, it is necessary to have a medical management program that identifies and removes infected or likely infected employees from the workplace, and notifies employees about possible exposures to COVID-19 so they can take appropriate steps to further reduce transmission.

I. Employee Screening

Regular health screening for possible indications of COVID-19 is a first step in detecting employees who might be COVID-19-positive so those employees can seek medical care or testing, or inform the employer if they have certain symptoms. While pre-symptomatic and asymptomatic infections and the non-specificity of COVID-19 symptoms make it difficult to quantify the accuracy of symptom screening in predicting COVID-19, health screening is a strategy supported by the CDC and the American College of Occupational and Environmental Medicine (ACOEM). ACOEM recommends that employers implement a medical surveillance program that includes educating and training employees on how to recognize when they may have COVID-19, in order to prevent employees with infections from entering the workplace (ACOEM, August 19, 2020).

The CDC recommends that employers conduct screening at the worksite, or train employees to be aware of and recognize the signs and symptoms of COVID-19 and to follow CDC recommendations to self-screen for symptoms before coming to work (CDC, March 8, 2021). Screening for employee symptoms, particularly when combined with their recent activities (e.g., the likelihood they have had a recent exposure to COVID-19), can help determine if the employee is suspected to have COVID-19 or should be tested. Testing can be useful in guiding the treatment that employees receive for their illness as well as triggering isolation to prevent exposure to others (NASEM, November 9, 2020). The FDA (March 11, 2021) has issued a number of emergency use authorizations for COVID-19 tests that detect infections with the SARS-CoV-2 virus. CDC recommends prompt COVID-19 testing of anyone who has had a known exposure to someone with COVID-19, has had a possible exposure to someone with COVID-19, or has symptoms of COVID-19, as a strategy to reduce SARS-CoV-2 transmission (Honein et al., December 11, 2020). Based on medical advice and information provided by testing, employees can learn if they are suspected or confirmed to have COVID-19. The earlier employees learn whether they are infected, the more likely that workplace exposures can be prevented.

As explained below, it is necessary that employees who are suspected or confirmed to have COVID-19 be removed from the workplace to prevent transmission to other employees. However, because COVID-19 symptoms are non-specific and common with other infectious and non-infectious conditions, not all individuals experiencing these symptoms will necessarily have COVID-19. Thus, Struyf et al., (2021) concluded that using a single sign or symptom of COVID-19 will result in low diagnostic accuracy and that combinations of symptoms increase specificity while decreasing sensitivity (explained in further detail below); however the authors also noted that studies are lacking on diagnostic accuracy of combinations of signs and symptoms.

The success of a screening strategy in identifying whether an employee has COVID-19 is based on two factors: Sensitivity and specificity for identifying COVID-19. Sensitivity refers to the ability of the symptom screening strategy to correctly identify persons who have COVID-19. Specificity refers to the ability of the symptom screening strategy to correctly identify persons who do not have COVID-19. As an example, a systematic review and meta-analysis by Pang et al., (2020) determined a sensitivity of 0.48 and specificity of 0.93 for smell disorders in identifying COVID-19. This means that under the scenarios in which the studies were conducted, screening for smell disorders would correctly identify around 48% of individuals who have COVID-19 (sensitivity), and would correctly identify 93% of individuals who do not have COVID-19 (specificity).

A number of studies have been conducted to determine common symptoms associated with COVID-19, along with their sensitivity and specificity. In addition to the Pang et al., (2020) study, there have been several other studies strongly linking smell and taste disorders as a symptom indicative of COVID-19. In a review of 18 studies of COVID-19 patients, Printza and Constantidis (2020) reported that loss of either smell or smell and taste was reported in most studies, and that that symptom is more prevalent in COVID-19 patients than in patients suffering from other respiratory infections. The report also found that the loss of smell was more prevalent among patients with a less severe case of COVID-19 disease. Four systematic reviews, three of which included meta-analyses, reported that for smell or taste disorders, sensitivity ranged from 0.41 to 0.65 and specificity ranged from 0.90 to 0.93 (Pang et al., 2020; Printza and Constantidis, 2020; Kim et al., 2021; Struyf et al., 2021).

A systematic review found that while loss of taste or smell is the most specific symptom of COVID-19, the most commonly reported symptoms of COVID-19 were fever, cough, fatigue, shortness of breath, and sputum production (Alimohamadi et al., 2020). In another review of a convenience sample (i.e., a non-randomly selected sample based on availability, opportunity, or convenience) of COVID-19 patients in the United States, 96% of patients reported having a fever, a cough, or shortness of breath (Burke et al., 2020). The review also found that 68% of hospitalized patients experienced all three of those symptoms, but only 31% of non-hospitalized patients reported all three symptoms. A systematic review by Kim et al., (2021) determined sensitivity and specificity, respectively, for fever (0.6, 0.55), cough (0.59, 0.39), and difficulty breathing (0.18, 0.84).

Although not intended to identify individuals who could potentially have COVID-19, and the diagnostic accuracy of the approach is not known, the surveillance definition used by the Council of State and Territorial Epidemiologists (CSTE) provides insight on an approach to using symptoms to identify possible cases of COVID-19 in the absence of a more likely determination by a healthcare provider. The CSTE surveillance definition for COVID-19 includes: (1) At least two of Start Printed Page 32453the following symptoms: Fever (measured or subjective), chills, rigors (i.e., shivering), myalgia (i.e., muscle aches), headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion or runny nose; or (2) any one of the following symptoms: Cough, shortness of breath, difficulty breathing, new olfactory (i.e., smell) disorder, new taste disorder; or (3) severe respiratory illness with a least one of the following: Clinical or radiographic evidence of pneumonia, acute respiratory distress syndrome (ARDS) (CSTE, 2020).

Given the non-specificity of COVID-19 symptoms, consultation with a licensed healthcare provider can provide more insight on the likelihood that an employee with certain symptoms has COVID-19. A licensed healthcare provider can elicit key clinical information, such as timing, frequency, intensity, and other factors in diagnosing the patient, after considering different medical explanations. A licensed healthcare provider can also elicit additional clinical information (e.g., pre-existing medical conditions), elicit epidemiologic information (e.g., exposure to COVID-19, travel history, rates of community transmission), and order laboratory testing to assist with the diagnosis of COVID-19 and differentiation from other medical conditions.

In general, the presence of COVID-19 symptoms can alert employees that they may have COVID-19, which will allow them to take appropriate next steps. Thus, by monitoring for COVID-19 symptoms through regular health screening, employees can better address their personal health and avoid potentially infecting other people by seeking medical attention and getting tested for COVID-19 as appropriate; informing their employer if they are suspected or confirmed to have COVID-19, including concerning symptoms; and remaining away from the workplace where appropriate. Therefore, health screening is an effective strategy for preventing the transmission of COVID-19 in the workplace.

II. Employee Notification to Employer of COVID-19 Illness or Symptoms

Employers can reduce workplace exposures by preventing employees who are, or could be, COVID-19 positive from entering the workplace and transmitting the disease to others. But to do so, employers must be aware that an employee is suspected or confirmed to have COVID-19 or is symptomatic. The Summary and Explanation (Section VIII of the preamble) includes more discussion of the precise criteria and rationale for when an employee is required to notify an employer that they are suspected or confirmed to have COVID-19 or are experiencing certain types of symptoms. It is critical that employees make their employers aware promptly after the employee is suspected or confirmed to have COVID-19 through test, medical diagnosis, or the specific symptoms of concern discussed in the Summary and Explanation (Section VIII of the preamble). With this information the employer can act to help prevent transmission in the workplace.

III. Employer Notification to Employees of COVID-19 Exposure in the Workplace

Notifying employees of a possible exposure to someone confirmed to have COVID-19 is an important and effective intervention to reduce transmission. Under the ETS, this includes any employee who was not wearing a respirator and any other required PPE while in close contact with the individual with COVID-19 or while working in the same physical space around the same time as the individual with COVID-19 and consequently may have had contact with that individual or touched a contaminated surface. As the CDC has recognized, notification is important because it allows for an exchange of information with the person exposed to someone with COVID-19 and helps ensure that person can pursue quarantine, timely testing, medical evaluation, and other necessary support services (CDC, February 26, 2021). Notification also acts as a complement to an employer's regular health screening program by informing employees who may have been exposed to COVID-19 in the workplace, so that they can appropriately assess and monitor their health and report any symptoms that may develop to their employer. It is also important for employers to notify other employers whose employees may have had close contact or been in the same area as those infected individuals while not wearing required PPE so those employers can notify their employees.

The impact that notification of possible COVID-19 exposures can have in reducing COVID-19 transmission was demonstrated in a study by Kucharski et al., (2020), which found that when location-specific contact tracing and notification was used to make decisions on isolation and home quarantine, transmission of COVID-19 was reduced by 64% when contact tracing was performed manually and 47% when performed by an app. However, the authors found that while notification is effective in helping to decrease the spread of COVID-19 by making individuals aware of potential infections, it is not a standalone measure. Notification must be used in a layered approach in order to create an effective infection control plan.

IV. Medical Removal From the Workplace

Employers can substantially reduce disease transmission in the workplace by removing employees who are suspected or confirmed to have COVID-19 based on a COVID-19 test or diagnosis by a healthcare provider, or who have developed certain symptoms or combinations of symptoms associated with COVID-19. Employers can also reduce the risk of COVID-19 in the workplace by removing employees who are at risk of developing COVID-19 because they were recently exposed to someone with COVID-19 in the workplace. According to the CDC, a major mitigation effort for COVID-19 is “to reduce the rate at which someone infected comes in contact with someone not infected. . . .” (CDC, February 16, 2021b).

The ETS focuses on removing employees from the workplace, rather than specifying requirements for quarantine or isolation that are typically outside the control of the employer because they would occur away from the workplace, but the concept of separating infected or potentially infected individuals from others is the same. Both the CDC and ACOEM endorse the use of isolation and quarantine as measures needed to reduce this rate of contact and consequently slow the spread of COVID-19. Isolation ensures that persons known or suspected to be infected with the virus stay away from all healthy individuals. Isolating contagious, or potentially contagious, employees from their co-workers can prevent further spread at the workplace and safeguard the health of other employees. Quarantine is used to keep persons at risk of developing COVID-19 away from all other people until it can be determined whether the individual is infected following an exposure to someone with suspected or confirmed COVID-19 (Honein et al., 2020).

The first two categories of employees who should be removed from the workplace are those employees who are suspected to be or are confirmed to have COVID-19 based on a COVID-19 test or diagnosis by a healthcare provider and those employees who develop certain Start Printed Page 32454COVID-19 symptoms.[25] Removal of these two categories of employees is consistent with isolation guidance from the CDC (February 11, 2021). Employers also prevent further transmission of COVID-19 in the workplace by providing employees a place to isolate from other workers until they can go home if they arrive with, or develop, COVID-19 symptoms at work (CDC, February 16, 2021a; CDC, March 8, 2021). ACOEM (August 19, 2020) also recommends that symptomatic employees stay home to protect healthy workers. Several studies have focused on the impact of isolating persons with COVID-19 from others during their likely known infectious period, and those studies show that isolation is a strategy that reduces the transmission of infections. For example, Kucharski et al., (2020) found that transmission of SARS-CoV-2 would decrease by 29% with self-isolation within the household, which would extend to 37% if the entire household quarantined. Similarly, Wells et al., (2021) found that isolation of individuals at symptom onset would decrease the reproductive rate (R0) of COVID-19 from an R0 of 2.5 to an R0 of 1.6. However, the study authors noted that when assuming low levels of asymptomatic transmission the R0 never fell below one, meaning there is a need for isolation to be used in concert with a more robust and layered infection control program, as is required by other provisions in the ETS.

The third category of employees who should be removed from the workplace to further reduce disease transmission are those who are at risk of developing COVID-19 because they have had recent close contact in the workplace with someone who is COVID-19-positive while not wearing a respirator and all required PPE (CDC, March 12, 2021). The need for removal of these employees is based on quarantine guidance from CDC (December 2, 2020) and is consistent with CDC recommendations for quarantine as a means of reducing workplace transmission (CDC, February 16, 2021a). Such removal is important because infected individuals are capable of transmitting the virus before they start experiencing symptoms and are aware that they are ill, and many (estimated to be 17% in one analysis) may never experience symptoms at all (Byambasuren et al., December 11, 2020). Therefore, ensuring that exposed employees are removed from work until it is unlikely that they have developed COVID-19 is critical for preventing the transmission of infections. CDC defines exposure through unprotected close contact as being within 6 feet of an infected person for a cumulative total of at least 15 minutes over a 24-hour period starting at 2 days before illness onset (or 2 days before samples are collected for testing in asymptomatic patients) and until the infected person meets the criteria for ending isolation (CDC, March 1, 2021). The risk level of the exposure depends on factors such as whether the healthcare provider was wearing a facemask or respirator, if an AGP was being performed without all recommended PPE, or if the patient had source control in place.

However, CDC does not recommend quarantine following close contact with someone who is suspected or confirmed to have COVID-19, if the person who had close contact meets all of the following criteria: (1) They have been fully vaccinated for COVID-19; (2) it has been at least 2 weeks since the full vaccination was completed; and (3) they do not develop any symptoms (CDC, May 13, 2021; CDC, March 12, 2021). CDC also has analyzed accumulating evidence indicating that persons who have recovered from laboratory-confirmed COVID-19 and remain symptom-free may not have to quarantine again if exposed within three months of the illness. CDC (March 16, 2021) concluded that although the evidence does not definitively demonstrate the absence of reinfection within a three-month period, the benefits of avoiding unnecessary quarantine likely outweigh the risks of reinfection as long as other precautions such as physical distancing, facemasks, and hygiene continue to be implemented.

CDC's recommendation was based on a review of more than 40 studies examining evidence of re-infection in recovered individuals (complete reference list included in CDC, (March 16, 2021). While many studies demonstrated that reinfection can occur at least 90 days after infection (e.g., Colson et al., 2020; Van Elslande et al., 2021), other studies suggest re-infection is possible as early as 45 days after infection (e.g., Abu-Raddad et al., 2020; Larson et al., 2020; Tillet et. al., 2020). Although antibodies to the virus that causes COVID-19 have not been definitively correlated with protection from reinfection and it is not clear what level of antibodies would be required for protection, increasing numbers of studies are suggesting that the majority of recovered patients develop antibodies specific for the virus that causes COVID-19 (e.g., Deeks et al., 2020; Gudbjartsson et al., 2020). Antibody responses have been reported to last for six months or more in some studies (e.g., Choe et al., 2021; Dan et al., 2021), but other studies suggested lower levels of antibodies or detection of antibodies for shorter periods of time (e.g., Ibarrondo et al., 2020; Seow et al., 2020). In addition to the production of antibodies, immunity can be achieved through virus-specific T- and B-cells (e.g., Kaneko et al., 2020), and some studies show that T- and B-cell immunity can last for 6 months or more (e.g., Dan et al., 2021; Hartley et al., 2020). Some studies suggest that T- and B-cell responses could be higher in symptomatic versus asymptomatic adults (e.g., Zuo et al., 2021). Results from animal challenge studies (e.g., Chandrashekar et al., 2020; Deng et al., 2020), and seropositive adults in outbreak settings (Abu-Raddad et al., 2020; Lumley et al., 2021) provide additional evidence that initial infection might protect against reinfection.

In addition to the uncertainty noted above, CDC notes that risk of reinfection may be increased in the future, with the circulation of variants (e.g., CDC, March 16, 2021; Nonaka et al., 2021; Harrington et al., 2021; Zucman et al., 2021). Because of the uncertainty regarding reinfection and increased possibility of reinfection following exposure to variants, the CDC recommends that employees be removed from the workplace if they develop symptoms after close contact with someone who has COVID-19, even if the employee is fully vaccinated or was confirmed to have COVID-19 in the previous three months (CDC, May 13, 2021; CDC, April 2, 2021).

V. Medical Removal Protection Benefits

Notification and removal will be most effective if the employees responsible for reporting do not face potential financial hardships for accurate reporting of symptoms and illnesses. As noted above, employers must know that an employee is suspected or confirmed to have COVID-19 or has certain symptoms of COVID-19 before they can remove those employees from the workplace. But removing employees from the workplace based on their own reports is likely to prove an effective control for COVID-19 only if the employees are not afraid they will be penalized for making those reports. OSHA's experience demonstrates that employees will self-report at a sufficient level to make removal program effective only when removed employees do not face a significant financial penalty—Start Printed Page 32455such as lost income during the removal period—and when employees may return to work after their removal period without any adverse action or deprivation of rights or benefits because of the removal. Because the employer will often have no other way to learn whether an employee is suspected or confirmed to have COVID-19, or has certain symptoms of COVID-19, medical removal protections are necessary to ensure that employees are not disincentivized to report suspected or confirmed COVID-19 or symptoms of COVID-19. Because infectious employees pose a direct hazard to their co-workers, removing barriers to reporting symptoms or confirmed diagnoses protects not only the reporting employee but also every other employee who would otherwise be exposed to infection.

OSHA's experience shows that the threat of lost earnings, benefits, and/or seniority protection provides a significant disincentive for employees to participate in workplace medical screening and reporting programs (see United Steelworkers of America v. Marshall, 647 F.2d 1189, 1237 (D.C. Cir. 1981) (recognizing the importance of removing financial disincentives for workers exposed to lead)). In the lead rulemaking, OSHA adopted a medical removal protection benefits provision in part due to evidence that employees were using chelating agents to achieve a rapid, short-term reduction in blood lead levels because they were desperate to avoid economic loss, despite the possible hazard to their health from the use of chelating agents (43 FR 54354, 54446 (November 21, 1978)). OSHA's standards for cotton dust and lead contain testimony from numerous employees indicating that workers would be reluctant to report symptoms and participate in medical surveillance if they fear economic consequences (43 FR at 54442-54443; 50 FR at 51154-51155). A major reason that OSHA included medical removal protection benefits in the formaldehyde standard is because the standard does not have a medical examination trigger, such as an action level, but instead relies on annual medical questionnaires and employee reports of signs and symptoms. Thus, the approach is completely dependent on employee cooperation (57 FR at 22293). Literature reviews have similarly reported that lack of compensation is one reason why employees might go into work while sick (Heymann et al., 2020; Kniffen et al., 2021). Based on this evidence, OSHA concludes that protection of benefits for removed employees is necessary to maximize employee reporting of suspected or confirmed COVID-19 and symptoms associated with COVID-19. This in turn maximizes protection for all employees at the workplace.

VI. Return to Work

After employees have been removed from the workplace as required by this standard, the employer must ensure that they do not return to the workplace until there is no longer a risk of disease transmission. Scientific evidence is available to determine the appropriate duration of isolation for COVID-19, which can be used to determine the appropriate duration of removal from the workplace. As general guidance, CDC recommends isolating symptomatic people with COVID-19 for at least 10 to 20 days after symptom onset, dependent on factors such as the severity of infection and health of the immune system. In most cases, the CDC states that a person can end isolation when (i) 10 days have passed since symptom onset; (ii) fever has been resolved (without fever-reducing medications) for at least 24 hours; and (iii) other symptoms (except loss of taste and smell) have improved. In cases of severe illness, the decision to end isolation may require consultation with an infection control expert. For persons who are confirmed positive but never develop symptoms, CDC recommends ending isolation at 10 days after the first positive test (CDC, March 16, 2021). These recommendations are based on scientific evidence reviewed by CDC which suggest that levels of viral RNA in upper respiratory tract samples begin decreasing after the onset of symptoms (CDC, March 16, 2021; CDC, unpublished data, 2020, as cited in CDC, March 16, 2021; Midgley et al., 2020; Young et al., 2020; Zou et al., 2020; Wölfel et al., 2020; van Kampen et al., 2021). Levels of replication-competent viruses (i.e., viruses that are able to infect cells and produce more infectious viral particles) also decrease over time; with only two possible exceptions, no replication-competent virus was detected after 10 days of symptom onset in individuals with mild-to-moderate disease (CDC, unpublished data, 2020, as cited in CDC, March 16, 2021; Wölfel et al., 2020; Arons et al., 2020; Bullard et al., 2020; Liu et al., 2020a; Lu et al., 2020; personal communication with Young et al., 2020, as cited in CDC, March 16, 2021; Korea CDC, May 19, 2020; Quicke et al., 2020). In a study of persons with severe disease (possibly complicated in some individuals by an immunocompromised status), the median duration of shedding infectious virus was 8 days after onset of symptoms, and the probability of shedding virus after 15 days was estimated at 5% or less (van Kampen et al., 2021). In severely immunocompromised patients, “sub-genomic virus RNA” or replication competent virus was detected beyond 20 days and as much as 143 days after a positive virus test (e.g., Avanzato et al., 2020; Choi et al., 2020). A large contact-tracing study found no evidence of infections in individuals who had contact with infectious individuals in a household or hospital when exposure occurred at least 6 days after illness onset (Cheng et al., 2020). Accordingly, these studies support the CDC's recommended isolation guidance (CDC, February 16, 2021a; CDC, February 18, 2021a; CDC, February 18, 2021b). However, as noted, CDC's recommendations for isolation are broad guidance; the appropriate duration for any given individual may differ depending on factors such as disease severity or the health of the employee's immune system.

As a general rule, CDC does not recommend a testing strategy as a means for determining when to end isolation, with the possible exception of severely immunocompromised persons (CDC, March 16, 2021). This is because tests to detect viral genetic material may yield positive results after a person is no longer infectious. Except in a very limited number of cases, studies have demonstrated that although some individuals were observed to persistently shed virus (for up to 12 weeks), replication-competent virus has not been recovered at three weeks past illness (Korea CDC, May 19, 2020; CDC, March 16, 2021; Li et al., 2020; Xiao et al, 2020; Liu et al., 2020a; Quicke et al., 2020). In addition, a study of 285 persons with persistent virus shedding, including 126 who experienced recurrent symptoms, found no evidence that any of the 790 contacts were infected from exposures to the people with persistent virus shedding (Korea CDC, May 19, 2020; CDC, March 16, 2021).

On the other hand, testing conducted after onset of sensitive symptoms associated with COVID-19 can identify individuals who are not infected. Peak virus shedding has been reported to occur just before and as symptoms are developing (Beeching et al., 2020; He et al., 2020). Testing for COVID-19 soon after the onset of symptoms has been estimated to result in a low false-negative rate of 10%, based on the reported Polymerase Chain Reaction test sensitivity (Grassley et al., 2020).Start Printed Page 32456

Return-to-work criteria for employees who are removed from the workplace because they are at risk of developing COVID-19 after exposure to someone with COVID-19 in the workplace, but have not yet developed symptoms or tested positive themselves, are based on the CDC's quarantine guidance. Based on available scientific evidence, the CDC generally recommends a 14-day quarantine period for individuals who have been exposed to a confirmed case of COVID-19 and are therefore at risk of developing COVID-19 (CDC, December 2, 2020; CDC, March 12, 2021). The 14-day quarantine period is based on the conclusion that the upper bound of the incubation period (the period between the point of infection and symptom onset) for COVID-19 is 14 days, and that there is a possibility that an unknowingly infected person can transmit the disease if quarantine is discontinued before 14 days (CDC, December 2, 2020). The scientific community agrees that a 14-day quarantine period is ideal. Linton et al., (2020) recommended a quarantine period of at least 14 days, based on a mean incubation period of 5 days, with a range of 2-14 days, in patients from and outside of Wuhan, China. Lauer et al., (2020) concluded that the CDC recommendation to monitor for symptoms for 14 days is supported by the evidence, including their study of patients outside the Hubei province that reported a mean incubation period of 5.1 days and symptom development within 11.5 days in 97.5% of those who develop symptoms.

Although a 14-day quarantine is ideal and generally recommended, the CDC has recognized that a shorter quarantine period may be less burdensome and result in increased compliance. Therefore, the CDC reviewed emerging scientific evidence to provide shorter quarantine options that employers can consider if allowed by local public health authorities (Oran and Topol, 2020; Johansson et al., 2020; Kucirka et al., 2020; Clifford et al., 2020; Quilty et al., 2021; Wells et al., 2021; Khader et al., 2020, as cited in CDC, December 2, 2020; Liu et al., 2020b; Ng et al., 2021; Grijalva et al., 2020). One of those options is testing for the virus at five days after exposure and ending quarantine at seven days after exposure if results are negative. Importantly, this option is only appropriate for individuals who do not develop symptoms over the quarantine period (as such individuals should instead be managed according to the CDC's isolation strategies). Based on the evidence reviewed, CDC concluded that ending quarantine after a negative test and seven days with no symptoms would result in a residual transmission risk of about 5%, with an upper limit of about 12% (CDC, December 2, 2020).

VII. Conclusion

As demonstrated above, the best available evidence strongly supports OSHA's conclusion that implementation of a comprehensive medical management program which includes health screening; notifications of potential exposures; removing employees who are COVID-19 positive, suspected to be positive, have certain symptoms, or have been exposed to a person with COVID-19 from the workplace until there is no longer a risk of disease transmission; and protection of removed employees' compensation, rights, and benefits are necessary measures to reduce incidence of COVID-19 exposure in the workplace. Because the virus that causes COVID-19 is spread through exposure to infected individuals or surfaces contaminated by infected individuals, quickly identifying and removing employees from the workplace who have developed, likely developed, or are at heightened risk of developing COVID-19 will allow employers to significantly reduce the spread of COVID-19 in the workplace. The prompt identification and removal of these employees can prevent transmission of the virus to others in the workplace. In addition, medical removal protection provisions that ensure compensation and protection of rights and benefits during removal will encourage employees to report diagnoses of suspected or confirmed-positive COVID-19 and symptoms. However, as noted above, some employees with COVID-19 will not have symptoms, and testing to allow employees to return to work after exposures to COVID-19 or experiencing symptoms associated with COVID-19 will likely result in some false negatives. Therefore, a medical management program should be complemented by other measures as part of a multi-layered strategy to minimize employee exposure to the grave danger of COVID-19.

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Printza, A. and Constantinidis, J. (2020). The role of self-reported smell and taste disorders in suspected COVID19. European Archives of Otorhinolaryngol. 2020 Sep; 277(9): 2625-2630. doi: 10.1007/s00405-020-06069-6. Epub 2020 May 23. PMID: 32447496; PMCID: PMC7245504. https://doi.org/​10.1007/​s00405-020-06069-6. Available at https://link.springer.com/​content/​pdf/​10.1007/​s00405-020-06069-6.pdf. (Printza and Constantinidis, 2020).

Quicke, K. et al., (2020). Longitudinal Surveillance for SARS-CoV-2 RNA Among Asymptomatic Staff in Five Colorado Skilled Nursing Facilities: Epidemiologic, Virologic and Sequence Analysis. (Preprint) Medrxiv. 2020. doi: 10.1101/2020.06.08.20125989. (Quicke et al., 2020).

Quilty, BJ. et al., (2021). Quarantine and testing strategies in contact tracing for SARS-CoV-2: A modelling study. The Lancet Public Health. 2021 Mar; 6(3): e175-e183. doi: 10.1016/S2468-2667(20)30308-X. Epub 2021 Jan 21. PMID: 33484644; PMCID: PMC7826085. (Quilty et al., 2021).

Seow, J. et al., (2020). Longitudinal observation and decline of neutralizing antibody responses in the three months following SARS-CoV-2 infection in humans. Nature Microbiology. 2020 Dec; 5(12): 1598-1607. doi: 10.1038/s41564-020-00813-8. Epub 2020 Oct 26. PMID: 33106674. (Seow et al., 2020).

Struyf, T. et al., (2021). Signs and symptoms to determine if a patient presenting in primary care or hospital outpatient settings has COVID-19. Cochrane Database Systematic Reviews. 2021 Feb 23; 2: CD013665. doi: 10.1002/14651858.CD013665.pub2. PMID: 33620086. (Struyf et al., 2021).

Tillett, RL. et al., (2020). Genomic evidence for reinfection with SARS-CoV-2: A case study. The Lancet Infectious Start Printed Page 32459Diseases. 2021 Jan; 21(1): 52-58. doi: 10.1016/S1473-3099(20)30764-7. Epub 2020 Oct 12. PMID: 33058797; PMCID: PMC7550103. (Tillet et al., 2020).

Van Elslande, J. et al., (2021). Symptomatic SARS-CoV-2 reinfection by a phylogenetically distinct strain. Clinical Infectious Diseases ciaa1330. doi: 10.1093/cid/ciaa1330. Epub ahead of print. PMID: 32887979; PMCID: PMC7499557. (Van Elslande et al., 2021).

Van Kampen, JJA et al., (2021) Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19). Nature Communications. 2021 Jan 11; 12(1):267. doi: 10.1038/s41467-020-20568-4. PMID: 33431879; PMCID: PMC7801729. (van Kampen et al., 2021).

Wells, CR. et al., (2021). Optimal COVID-19 quarantine and testing strategies. Nature Communications 2021 Jan 7; 12(1): 356. doi: 10.1038/s41467-020-20742-8. PMID: 33414470; PMCID: PMC7788536. (Wells et al., 2021).

Wölfel, R. et al., (2020). Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May; 581(7809): 465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1. Erratum in: Nature. 2020 Dec; 588(7839): E35. PMID: 32235945. (Wölfel et al., 2020).

Xiao, F. et al., (2020). Infectious SARS-CoV-2 in Feces of Patient with Severe COVID-19. Emerging Infectious Diseases. 2020 Aug; 26(8): 1920-1922. doi: 10.3201/eid2608.200681. Epub 2020 May 18. PMID: 32421494; PMCID: PMC7392466. (Xiao et al., 2020).

Young, BE. et al., (2020). Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. Journal of the American Medical Association. 2020 Apr 21; 323(15): 1488-1494. doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21; 323(15): 1510. PMID: 32125362; PMCID: PMC7054855. (Young et al., 2020).

Zou, L. et al., (2020). SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. New England Journal of Medicine. 2020 Mar 19; 382(12): 1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. PMID: 32074444; PMCID: PMC7121626. (Zou et al., 2020).

Zucman, N. et al., (2021). Severe reinfection with South African SARS-CoV-2 variant 501Y.V2: A case report. Clinical Infectious Diseases. 2021 Feb 10: ciab129. doi: 10.1093/cid/ciab129. Epub ahead of print. PMID: 33566076; PMCID: PMC7929064. (Zucman et al., 2021).

Zuo, J. et al., (2021). Robust SARS-CoV-2-specific T cell immunity is maintained at 6 months following primary infection. Nature Immunology. 2021 Mar 5. doi: 10.1038/s41590-021-00902-8. Epub ahead of print. PMID: 33674800. (Zuo et al., 2021).

N. Vaccination

Vaccines are an important tool to reduce the transmission of COVID-19 in the workplace. A vaccine serves three critical functions: First, it can reduce the likelihood that a vaccinated person will develop COVID-19 after exposure to SARS-CoV-2; second, it can lessen the symptoms and effects in cases where the vaccinated person does contract COVID-19; and third, although the CDC still recommends source controls for vaccinated healthcare workers, it also acknowledges a growing body of evidence that vaccination can reduce the potential that a vaccinated person will transmit the SARS-CoV-2 virus to non-vaccinated co-workers (CDC, April 12, 2021; CDC, April 27, 2021). Vaccination also serves an important role in reducing health disparities in employees of certain demographics, who may be especially vulnerable to severe health effects or death from COVID-19 (Dooling et al., December 22, 2020). Below OSHA provides a general explanation of the need for vaccination measures in the ETS; however, a fuller explanation of the efficacy of existing vaccines and their impact on the risk of COVID-19 infection and transmission is discussed in Grave Danger (Section IV.A. of the preamble).

OSHA has long recognized the importance of vaccinating employees against preventable illnesses to which they may be exposed on the job. The Bloodborne Pathogens standard, for example, requires the hepatitis B vaccine be made available to any employees with occupational exposure to blood and other potentially infectious materials, in order to reduce the risk of hepatitis B infection and subsequent illness and death (56 FR 64004, 64152 (Dec. 6, 1991)). A number of professional health organizations have similarly long recognized the importance of vaccinating employees to prevent illness. This is particularly true in healthcare industries, where employees are more regularly at risk of occupational exposure to transmissible diseases. For example, the Advisory Committee on Immunization Practices (ACIP), which reviews evidence of risk and vaccine effectiveness, recommends vaccinating healthcare employees against numerous diseases, including influenza, another viral disease spread through droplet transmission (Shefer et al., November 25, 2011). Similarly, both HICPAC and the American Hospital Association have encouraged and endorsed vaccination programs or policies for healthcare workers. CDC, WHO, and the National Academies of Science, among others, have all acknowledged that broad vaccination of all people for COVID-19, in combination with other public health measures, is a critical tool that can be used to address the pandemic (CDC, April 29, 2021; WHO, January 8, 2021; NASEM, 2020).

Any vaccines offered to employees must be demonstrated to be safe and effective. Fortunately, over the course of the pandemic, there have been extensive efforts to develop COVID-19 vaccines. As discussed in greater detail in Grave Danger (Section IV.A. of the preamble), there are presently three COVID-19 vaccines authorized for emergency use by the FDA in the United States: the Pfizer-BioNTech COVID-19 vaccine, the Moderna COVID-19 vaccine, and the Janssen Biotech, Inc. Johnson and Johnson COVID-19 vaccine, each recommended for use by ACIP in persons at least 12 years of age and older for the Pfizer-BioNTech vaccines or 18 years of age and older for the Moderna and Johnson and Johnson (Janssen) vaccines (Oliver et al., December 18, 2020; Oliver et al., January 1, 2021; FDA, April 9, 2021; FDA, April 1, 2021; FDA, February 26, 2021; FDA, May 10, 2021). In determining whether to grant EUA for a new COVID-19 vaccine, the FDA considers several statutory criteria provided in section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3). In evaluating an EUA request, FDA considers, among other things, the totality of scientific evidence available to determine if it is reasonable to believe that the vaccine may be effective (i.e., an efficacy of at least 50%) in preventing COVID-19 and that the known and potential benefits of the vaccine, when used to prevent COVID-19, outweigh the known and potential risks of the vaccine (FDA, April 9, 2021; FDA, April 1, 2021; FDA, February 26, 2021). The product manufacturer must also demonstrate quality and consistency in manufacturing. Accordingly, any COVID-19 vaccine that receives an EUA from the FDA—including the Pfizer-BioNTech vaccine, Moderna vaccine, the Johnson and Johnson (Janssen) vaccine, and any future vaccine that receives such an authorization after the issuance of this ETS—has been shown to be sufficiently safe and effective.

All three vaccines that have been authorized to date, including the Pfizer-BioNTech, Moderna, and Johnson & Johnson (Janssen) vaccines, have been found to be highly effective for the appropriate ages (Oliver et al., December 18, 2020; Oliver et al., January 1, 2021; Polack et al., December 31, 2020; FDA, December 17, 2020; FDA, December 10, 2020; FDA, February 26, 2021). The vaccines were also found to be effective in preventing disease that is severe or requires hospitalization. The evidence Start Printed Page 32460available at this time, however, does not yet establish that the vaccines eliminate the potential for asymptomatic COVID-19 development; rather, fully vaccinated people are less likely to have asymptomatic infection or transmit SARS-CoV-2 to others (CDC, May 14, 2021). All three authorized vaccines have met the authorization standard for safety, with the majority of adverse effects observed to be mild or moderate in severity and transient, including: fatigue; headache; chills; muscle pain; joint pain; lymphadenopathy (swelling or enlargement of lymph nodes) on the same side as the injection; and injection site pain, redness, and swelling (CDC, December 13, 2020; CDC, December 20, 2020; CDC, May 14, 2021; Oliver et al., December 18, 2020; Oliver et al., January 1, 2021; Polack et al., December 31, 2020; FDA, December 17, 2020; FDA, December 10, 2020; FDA, February 26, 2021).

Further, as discussed more extensively in the Summary and Explanation (Section VIII of the preamble) requirement for paid time off for vaccination, vaccination can only function as an effective control if workers have access to it. Additional explanation of the importance of removing barriers to controls is also discussed in Summary and Explanation (see discussion of requirements that employees receive protections of the ETS at no cost, as well as requirements for paid time off for vaccination, both in Section VIII of the preamble).

Vaccination References

Centers for Disease Control and Prevention (CDC). (2020, December 13). Local reactions, systemic reactions, adverse events, and serious adverse events: Pfizer-BioNTech COVID-19 vaccine. https://www.cdc.gov/​vaccines/​covid-19/​info-by-product/​pfizer/​reactogenicity.html. (CDC, December 13, 2020).

Centers for Disease Control and Prevention (CDC). (2020, December 20). Local reactions, systemic reactions, adverse events, and serious adverse events: Moderna COVID-19 vaccine. https://www.cdc.gov/​vaccines/​covid-19/​info-by-product/​moderna/​reactogenicity.html. (CDC, December 20, 2020).

Centers for Disease Control and Prevention (CDC). (2021, April 12). Benefits of getting a COVID-19 vaccine. https://www.cdc.gov/​coronavirus/​2019-ncov/​vaccines/​vaccine-benefits.html. (CDC, April 12, 2021).

Centers for Disease Control and Prevention (CDC). (2021, April 27). Updated Healthcare Infection Prevention and Control Recommendations 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, April 29). FAQ “Why would a vaccine be needed when we can do other things . . .?. https://www.cdc.gov/​coronavirus/​2019-ncov/​vaccines/​faq.html. (CDC, April 29, 2021).

Centers for Disease Control and Prevention (CDC). (2021, May 14). Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. https://www.cdc.gov/​vaccines/​covid-19/​info-by-product/​clinical-considerations.html?​CDC_​AA_​refVal=​https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fpfizer%2Fclinical-consideratio%E2%80%A6. (CDC, May 14, 2021).

Dooling, K et al., (2020, December 22). The Advisory Committee on Immunization Practices' updated interim recommendation for allocation of COVID-19 vaccine—United States, December 2020. MMWR Rep 2021; 69: 1657-1660. DOI: http://dx.doi.org/​10.15585/​mmwr.mm695152e2. (Dooling et al., December 22, 2020).

Food and Drug Administration (FDA). (2020, December 10). FDA briefing document. Pfizer-BioNTech COVID-19 Vaccine. https://www.fda.gov/​media/​144245/​download. (FDA, December 10, 2020).

Food and Drug Administration (FDA). (2020, December 17). MRNA-1273 sponsor briefing document (Moderna). https://www.fda.gov/​media/​144453/​download. (FDA, December 17, 2020).

Food and Drug Administration (FDA). (2021, February 26). FDA Briefing Document: Janssen Ad.COV2.S Vaccine for the Prevention of COVID-19. (FDA, February 26, 2021)

Food and Drug Administration (FDA). (2021, April 1). Moderna COVID-19 vaccine. https://www.fda.gov/​emergency-preparedness-and-response/​coronavirus-disease-2019-covid-19/​moderna-covid-19-vaccine. (FDA, April 1, 2021).

Food and Drug Administration (FDA). (2021, April 9). Pfizer-BioNTech COVID-19 vaccine. https://www.fda.gov/​emergency-preparedness-and-response/​coronavirus-disease-2019-covid-19/​pfizer-biontech-covid-19-vaccine. (FDA, April 9, 2021).

Food and Drug Administration (FDA). (2021, May 10). Pfizer-BioNTech COVID-19 vaccine EUA Letter of Authorization Reissued. https://www.fda.gov/​media/​144412/​download. (FDA, May 10, 2021).

National Academy of Sciences, Engineering, and Medicine (NASEM). (2020). Framework for equitable allocation of COVID-19 vaccine. https://www.nap.edu/​download/​25917. (NASEM, 2020).

Oliver, S et al., (2020, December 18). The Advisory Committee on Immunization Practices' interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine—United States, December 2020. MMWR Rep 2020; 69: 1922-1924. DOI: http://dx.doi.org/​10.15585/​mmwr.mm6950e2. (Oliver et al., December 18, 2020).

Oliver, S et al., (2020, December 20). The Advisory Committee on Immunization Practices' interim recommendation for use of Moderna COVID-19 vaccine—United States, December 2020. MMWR Rep 2021; 69: 1653-1656. DOI: http://dx.doi.org/​10.15585/​mmwr.mm695152e1. (Oliver et al., January 1, 2021).

Polack, F et al., (2020). Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine, 383(27), 2603-2615. doi: 10.1056/nejmoa2034577. (Polack et al., December 31, 2020).

Shefer, A. et al., (2011, November 25). Immunization of health-care personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommendations and Reports 60(RR07); 1-45. https://www.cdc.gov/​mmwr/​preview/​mmwrhtml/​rr6007a1.htm. (Shefer et al., November 25, 2011).

World Health Organization (WHO). (2021, January 8). COVID-19 vaccine. https://www.who.int/​emergencies/​diseases/​novel-coronavirus-2019/​covid-19-vaccines. (WHO, January 8, 2021).

O. Training

The CDC has determined that training is a necessary component of a comprehensive control plan for COVID-19. The WHO has also determined that training is an important control strategy for COVID-19 (WHO, May 10, 2020). When providing guidance for employers, the CDC has said that employees need to be educated on steps they can take to protect themselves from potential COVID-19 exposures at work. Employers informing employees of the hazards to which employees may be exposed while working is a cornerstone of occupational health and safety (OSHA, 2017). Employees play a particularly important role in reducing exposures because appropriate application of work practices and controls limit exposure levels. Employees therefore need to be informed of the grave danger of COVID-19, as well as the workplace measures included in their employers' COVID-19 plans because those measures are necessary to reduce risk and provide protection to employees. Employees must know what protective measures are being utilized and be trained in their use so that those measures can be effectively implemented.

Training has been shown to be an effective tool to reduce injury and illness (Burke et al., February 2006), but training is even more critical when the workplace hazard includes the potential transmission of the potentially deadly SARS-CoV-2 virus from one employee to another: One improperly trained employee could increase risk for that employee and for all of that employee's contacts, including coworkers. Start Printed Page 32461Therefore, training is an essential component of a layered approach to minimizing the risk of contracting COVID-19 in the workplace.

Training and education provide employees and managers an increased understanding of existing safety and health programs. A thorough understanding of these programs is necessary so employees can more effectively contribute to their development and implementation. Training provides employers, managers, supervisors, and employees with the knowledge and skills needed to do their work safely and to avoid creating hazards that could place themselves or others at risk, as well as awareness and understanding of workplace hazards and how to identify, report, and control them. Specialized training can address unique hazards.

Because OSHA has long recognized the importance of training in ensuring employee safety and health, many OSHA standards require employers to train employees (e.g., the Bloodborne Pathogen standard at 29 CFR 1910.1030(g)(2)). When required as a part of OSHA standards, such as is required by this ETS, training helps to ensure that employees are able to conduct work in a safe and healthful manner (OSHA, April 28, 2010). Training is essential to ensure that both employers and employees understand the sources of potential exposure to COVID-19 and control measures to reduce exposure to the hazard.

Employee comprehension is critical to ensuring that training is an effective control. If training information is not presented in a way that all employees understand, the training will not be effective. Employers must thus consider language, literacy, and social and cultural appropriateness when designing and implementing training programs for employees (O'Connor et al., 2014). Additionally, if employers do not offer training to employees in a convenient manner, employees may be less likely to participate in the training. Therefore, to be effective, training must be offered during scheduled work times and at no cost to the employee. This will ensure that all employees will have the time and financial resources to receive training. This is also consistent with other OSHA standards. For example, the Bloodborne Pathogen standard requires training be provided at no cost and during working hours (§ 1910.1030(g)(2)(i)) and in a manner employees understand (§ 1910.1030(g)(2)(vi)).

Research dating back to the 1980s has found “overwhelming evidence” of the effectiveness of training programs on employee knowledge (NIOSH, 1998), as well as employee behaviors (NIOSH, January 2010). With enhanced knowledge of safety and health hazards and controls, employees can implement safer work practices. This can result in reductions in workplace-related illnesses (Burke et al., February 2006).

The CDC has stated that information on workplace policies should be communicated clearly, frequently, and via multiple messages (CDC, March 8, 2021). Training and education on safe work practices and controls should be used to raise awareness among employees. Emphasizing the effectiveness of these workplace controls helps to counteract misinformation. Additional training, such as on PPE and infection control policies and procedures, should be given to employees in those workplaces where there is a high risk of exposure to COVID-19 (WHO, May 10, 2020).

Scientific research and case studies have further reinforced the importance of training in responding to the COVID-19 pandemic. Researchers found that a COVID-19 outbreak was effectively contained as a result of prompt implementation of infection control measures, including early in-person education of employees on the signs, symptoms, and transmission of COVID-19 (Hale and Dayot, August 13, 2020). Knowledge of PPE was markedly improved following training on PPE for healthcare employees in China during the COVID-19 pandemic (Tan et al., June, 2020).

Training has been widely recognized as a key component of occupational safety and health. Even though the body of scientific evidence on the importance of training during the COVID-19 pandemic is limited given its ongoing nature, the evidence that does exist only further emphasizes the important role of training in protecting the health and safety of employees. As such, OSHA has concluded that training is necessary to ensure proper implementation of the employer's COVID-19 plan and all other control measures, and that such training will reduce incidence of COVID-19 illness both on its own and when complemented by other measures as part of a multi-layered strategy to minimize employee exposure to the grave COVID-19 danger.

References

Burke, M.J. et al., (2006, February). Relative effectiveness of worker safety and health training methods. American Journal of Public Health 96: 315-324. (Burke et al., February 2006).

Centers for Disease Control and Prevention (CDC). (2021, March 8). Guidance for Businesses and Employers Responding to Coronavirus Disease 2019 (COVID-19). https://www.cdc.gov/​coronavirus/​2019-ncov/​community/​guidance-business-response.html. (CDC, March 8, 2021).

Hale, M. and Dayot, A. (2020). Outbreak Investigation of COVID-19 in Hospital Food Service Workers. American Journal of Infectection Control. S0196-6553(20)30777-X. https://doi.org/​10.1016/​j.ajic.2020.08.011. (Hale and Dayot, August 13,2020).

National Institute for Occupational Safety and Health (NIOSH). (1998, June). Assessing Occupational Safety and Health Training: A literature review, June 1998. https://www.cdc.gov/​niosh/​docs/​98-145/​pdfs/​98-145.pdf?​id=​10.26616/​NIOSHPUB98145. (NIOSH, June 1998).

National Institute for Occupational Safety and Health (NIOSH) (2010, January). A systematic review of the effectiveness of training and education for the protection of workers, January 2010. https://www.cdc.gov/​niosh/​docs/​2010-127/​pdfs/​2010-127.pdf. (NIOSH, January 2010).

O'Connor, T. et al., (2014). Occupational safety and health education and training for underserved populations. New Solutions24(1): 83-106. (O'Connor et al., 2014).

Occupational Safety and Health Administration (OSHA). (2010, April 28). Training Standards Policy Statement. https://www.osha.gov/​dep/​standards-policy-statement-memo-04-28-10.html.(OSHA, April 28, 2010).

Occupational Safety and Health Administration (OSHA). (2017). Workers' Rights. https://www.osha.gov/​sites/​default/​files/​publications/​osha3021.pdf.(OSHA, 2017).

Tan, W. et al., (2020, June). Whole-process emergency training of personal protective equipment helps healthcare workers against COVID-19: Design and effect. Journal of Occupational and Environmental Medicine 62: 420-423. DOI: 10.1097/JOM.0000000000001877. (Tan et al., June, 2020).

World Health Organization(WHO).(2020, May 10). Considerations for public health and social measures in the workplace context of COVID-19: Annex to Considerations in adjusting public health and social measures in the context of COVID-19, May 2020. https://www.who.int/​publications-detail-redirect/​considerations-for-public-health-and-social-measures-in-the-workplace-in-the-context-of-covid-19.(WHO, May 10, 2020).

VI. Feasibility

A. Technological Feasibility

This section presents an overview of the technological feasibility assessment for OSHA's Emergency Temporary Standard (ETS) for COVID-19. The ETS has four sections: Healthcare (29 CFR 1910.502); Mini Respiratory Protection Program (29 CFR 1910.504); Severability (29 CFR 1910.505); and Incorporation by Start Printed Page 32462Reference (29 CFR 1910.509). The ETS applies to all settings where any employee provides healthcare services or performs healthcare support services. The settings covered by the ETS are listed in Table VI.A.-1.

The mini respiratory protection program section supplements the ETS to provide additional protection to workers in appropriate cases. The healthcare and mini respiratory protection program sections of the ETS will be discussed below. It is not necessary to discuss the severability or incorporation by reference sections, as those sections do not by their own terms impose any requirements that raise issues of technological feasibility.

Technological feasibility has been interpreted broadly to mean “capable of being done” (Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 509-510 (1981)). A standard is technologically feasible if the protective measures it requires already exist, can be brought into existence with available technology, or can be created with technology that can reasonably be expected to be developed, i.e., technology that “looms on today's horizon” (United Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1272 (D.C. Cir. 1980) (Lead I); Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991) (Lead II); American Iron and Steel Inst. v. OSHA, 577 F.2d 825 (3rd Cir. 1978)). Courts have also interpreted technological feasibility to mean that a typical firm in each affected industry or application group will reasonably be able to implement the requirements of the standard in most operations most of the time (see Public Citizen v. OSHA, 557 F.3d 165 (3d Cir. 2009); Lead I, 647 F.2d at 1272; Lead II, 939 F.2d at 990).

OSHA's assessment focuses on the controls required by the ETS that stakeholders may believe raise issues of technological feasibility. These controls include the implementation of a COVID-19 plan and healthcare-specific good infection control practices, as well the following controls: Physical distancing; physical barriers; and ventilation.[26] As discussed below, OSHA's finding of technological feasibility is supported by a large number of COVID-19 transmission prevention plans and best practice documents it reviewed, as well as physical distancing scenarios and a job matrix it developed, across the healthcare sector.

While OSHA focuses on certain types of evidence in specific parts of the analysis, much of the evidence supports other discrete findings made by OSHA. Thus, for example, while OSHA focuses on its review of plans and best practice documents in establishing the feasibility of developing and implementing a COVID-19 plan, that evidence also supports the feasibility of implementing healthcare-specific good infection control practices, physical distancing and physical barriers, and ventilation.

In addition, this analysis discusses only a few examples of the plans and best practice documents it reviewed, does not recount every element of the Start Printed Page 32463plans and best practice documents that it reviewed, and does not recount all details of the scenarios and job matrix it developed. OSHA based its technological feasibility assessment on all the evidence in the docket, and not just the select portions discussed here. The discussion below is merely illustrative of the full complement of evidence reviewed to demonstrate that employers have implemented the controls required by the ETS.

Finally, OSHA's finding of technological feasibility should not be read to indicate that individual plans or best practice documents OSHA reviewed are ETS-compliant, that lack of inclusion of a control in a plan or document indicates the control is infeasible, that the use of a barrier by employers in a given situation indicates that physical distancing was not feasible in that situation, or that a particular control used (e.g., a plastic sheet or curtain used as a physical barrier) is compliant with the ETS's requirements. The plans and best practice documents are intended to show two things: (1) That developing plans to address COVID-19 in various workplaces is both common and feasible, and (2) that the controls required by the ETS have been implemented and are feasible in the healthcare settings. The specifics of the plans may vary, but the ETS COVID-19 plan requirements are written as performance requirements that provide sufficient flexibility to ensure that it is feasible for employer