Substantial Questions of Statutory Authority Confront OSHA’s COVID-19 Vaccination Emergency Temporary Standard

Posted in: Business Law

Note: On November 12, 2021, as this piece was going to print, the U.S. Court of Appeals for the Fifth Circuit affirmed its November 6 order staying enforcement of the Occupational Safety and Health Administration’s COVID-19 Vaccination and Testing Emergency Temporary Standard. The court concluded that the promulgation and enforcement of the emergency temporary standard exceeded the Agency’s statutory authority under the Occupational Safety and Health Act. The Fifth Circuit ordered that the emergency temporary standard remain “STAYED pending adequate judicial review of the petitioners’ underlying motions for a permanent injunction” and “FURTHER ORDERED that OSHA take no steps to implement or enforce [it] until further court order.”*

On November 5, 2021, the U.S. Department of Labor’s Occupational Safety and Health Administration (“OSHA”) issued an emergency temporary standard (the “November ETS”) requiring employers to “develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead adopt a policy requiring employees to either get vaccinated or elect to undergo regular COVID-19 testing and wear a face covering at work in lieu of vaccination.”[1]

On November 6, the U.S. Court of Appeals for the Fifth Circuit granted an emergency motion to stay enforcement of the November ETS pending further action by the court.[2] The court granted the motion “[b]ecause the petitions give cause to believe there are grave statutory and constitutional issues with the [ETS] . . . .”[3] The grave statutory issues alone are likely sufficient for the Court of Appeals to permanently stay enforcement of the ETS, as OSHA has not met the statutory requirements for its promulgation; nor is it clear that the Agency has authority to mandate vaccinations and testing.

First Vaccine Mandate in OSHA’s History

This is the first time in OSHA’s history that it has required employee vaccinations. The November ETS generally “covers all employers with a total of 100 or more employees” and permits employers who do not adopt a mandatory COVID-19 vaccination policy to compel unvaccinated workers to pay for the costs associated with weekly COVID-19 testing and face coverings.[4] The ETS will remain in effect until May 5, 2022.[5]

Section 6(b)(5) of the OSH Act directs OSHA to promulgate occupational safety and health standards (“permanent standards”) “dealing with toxic materials or harmful physical agents” in order to protect employees from “material impairment of health or functional capacity.”[6] The promulgation, modification, or revocation of permanent standards require a notice-and-comment rulemaking, which an ETS does not.[7] Before OSHA can issue an ETS, § 6(c)(1) requires that it make two heightened determinations:

(A) [T]hat employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and (B) that such emergency standard is necessary to protect employees from such danger.[8]

For any standard, OSHA must publish a statement of reasons for the requisite determinations, which are “conclusive if supported by substantial evidence in the record considered as a whole.”[9]

OSHA’s Rare Use of Emergency Temporary Standards

OSHA rarely uses its power to promulgate ETSs–having issued only eleven since its inception in 1970 and nine between 1971 and 1983.[10] Six of those nine ETSs were challenged, which ended with courts vacating two and staying enforcement of three.[11] OSHA issued a tenth ETS on June 21, 2021, (the “June 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.”[12] The June ETS primarily requires the use of personal protective equipment (“PPE”) in “all settings where any employee provides healthcare services or healthcare support services.”[13] Unlike the November ETS, the June ETS does not require vaccination against COVID-19 nor does it require routine testing for screening purposes.[14] Instead, it “encourages vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects.”[15] 

June ETS Does Not Require Vaccinations for Healthcare Workers

Notably, the requirements of the November ETS do not apply to workers covered by the June ETS.[16] In the November ETS, OSHA reasoned that “stronger encouragement of vaccination is needed [for non-healthcare workers] . . . because workers who are protected by the [June] ETS are more likely to be vaccinated and/or subject to a vaccination mandate.”[17]

The November ETS raises substantial questions as to whether OSHA has statutory authority under the OSH Act to mandate employers to require vaccination against COVID-19 or for unvaccinated workers to require weekly COVID-19 test results and to wear face coverings. It also raises questions about OSHA’s authority to impose these requirements through an ETS rather than a permanent standard, allowing it to bypass the requirement of a notice-and-comment rulemaking.

OSHA’s Prior Uncertainty Over Its Authority to Mandate Vaccinations

The OSH Act does not clearly authorize OSHA to mandate vaccinations or testing. In the November ETS, OSHA cites the broad language of § 6(b)(5) and its previous regulation of workplace exposure to HIV and hepatitis B through the 1991 Occupational Exposure to Bloodborne Pathogens Final Rule (the “1991 Standard”) as evidence of its authority to regulate “biological hazards like [COVID-19] as health hazards under section 6(b)(5).”[18]

OSHA itself previously expressed uncertainty over its authority to mandate vaccinations and testing in the 1991 Standard that it now relies upon.[19] OSHA rejected an approach in the 1991 Standard that would have mandated covered employees to be vaccinated against hepatitis B and instead “requir[ed] employers to make the vaccine available after providing information about its benefits.”[20] OSHA in the 1991 Standard relied on its reasoning from the 1978 Occupational Exposure to Lead Final Standard (the “1978 Standard”) where it rejected biological testing of workers as a means of monitoring employer compliance with occupational lead exposure limits.[21] In the 1978 Standard, OSHA concluded that “[a]ttempting to compel workers to subject themselves to detailed medical examinations presents the possibility of clashes with legitimate privacy and religious concerns” and that “[h]ealth in general is an intensely personal matter.”[22]

“Grave Danger” Finding in November ETS Is Flawed and Inconclusive

As one court explained, “[g]ravity of danger is a policy decision committed to OSHA, not to the courts.”[23] However, the basis of the grave danger that OSHA articulates in the November ETS–6,500 worker lives and 250,000 hospitalizations over six months–must find support in the record.[24] OSHA arrives at these quantitative estimates by using “infections and fatalities occurring between April 1, 2021 and August 31, 2021 to generate infection and fatality rates.”[25] It assumes that these rates “will remain constant over the 6 months for which impacts [of the ETS] are taken.”[26] Critically, OSHA admits that, because of “the emergency conditions created by the pandemic,” it “was not able to adjust its quantitative estimates to account for . . . [p]otential reductions in fatalities from improvements in medical treatment for COVID-19 in the coming months.”[27]

By nature of the selected timeframe, OSHA’s estimates also fail to capture the effects of improvements in medical treatment between September 1 and November 5; nor do they appear to fully capture the effects of improvements in medical treatment after May 1 but before August 31.[28] Additionally, the Agency “does not take into account the cyclical nature of the course of the pandemic” and acknowledges that, “given these analytical limitations, aspects of [its] quantitative estimate of health impacts either may be over- or under-estimated.”[29] Therefore, the assumptions in this analysis call into question the sufficiency of the grave-danger determination because they produce an estimate in which “the actual number of lives saved is uncertain, and is likely to be substantially less than [the stated basis for the grave-danger determination].[30]

OSHA’s Cost-Benefit and Feasibility Analysis Is Incomplete and Underinclusive

A further problem with the November ETS is that OSHA did not adequately compare the costs and benefits of the proposed ETS and conducted an underinclusive economic feasibility analysis.[31] Reviewing courts have stated that, “even if adequately explained, an ETS must, on balance, produce a benefit the costs of which are not unreasonable.”[32] Specifically, “[t]he protection afforded to workers should outweigh the economic consequences to the regulated industry.”[33] To support its position that the balancing requirement does not apply to ETSs, OSHA relies on the Supreme Court’s reasoning in the 1981 Cotton Dust ruling.[34] However, while the Court in that case did hold that a cost-benefit analysis is not required with respect to § 6(b)(5) permanent standards, it did not address whether such an analysis is required with respect to § 6(c) ETSs.[35]

Notably, in an ETS challenge decided after the Supreme Court’s Cotton Dust decision, the Fifth Circuit continued to require a cost-benefit analysis.[36] OSHA need not provide a formal cost-benefit analysis in support of an ETS, but the cost-benefit balancing requirement still applies.[37] In a footnote to its November ETS, OSHA merely states that “even under [a cost-benefit analysis] approach this ETS easily passes muster.”[38] Without specifying how the protection afforded to workers by the November ETS outweighs the consequences to the regulated industries or the employees themselves, the Court of Appeals may well reject such a conclusory statement as not satisfying the cost-benefit balancing requirement.[39] Rather than weigh the costs and benefits of the ETS, OSHA’s economic analysis focuses on whether employers could remain economically viable.[40] The Agency does not weigh the costs and benefits to the individual industries affected by the ETS and generally states that “OSHA estimates that all employers in all private sector industries are affected by this ETS to some extent.”[41]

OSHA undermined its ability to secure adequate data on potential negative side effects to the COVID-19 vaccine. In May 2021, OSHA suspended enforcement of “29 C.F.R. 1904’s recording requirements to require any employers to record worker side effects from COVID-19 vaccination at least through May 2022,” including when vaccination is a required condition of employment.[42] This suspension remains in effect, despite the inclusion of comprehensive reporting requirements for COVID-19 fatalities and hospitalizations in the November ETS.[43]

Relatedly, OSHA dismissed the impact of employers requiring unvaccinated workers to pay for the costs associated with face coverings and testing in its underinclusive economic feasibility analysis.[44] The Agency reasoned that “these costs are not mandatory because any employee who does not wish to pay them may choose to become vaccinated or leave employment, . . . after which the costs would not be incurred.”[45] Given OSHA’s stated position that the November ETS provides an option for weekly testing and masking in lieu of vaccination, the costs associated with such an option should be included in a cost-benefit analysis.

Failure to Specify Religious Exemption Process Is Problematic Under § 20(a)(5)

OSHA’s statutory authority to enforce the November ETS faces further questions in light of § 20(a)(5) of the OSH Act, which provides, “Nothing in this or any other provision of this Act shall be deemed to authorize or require medical examination, immunization, or treatment for those who object thereto on religious grounds, except where such is necessary for the protection of the health or safety of others.”[46] The November ETS notes that the Americans with Disabilities Act and Title VII of the Civil Rights Act of 1964 require medical and religious exemptions from the vaccination, testing, and face covering requirements, but it does not include clear guidance for evaluating requests for reasonable accommodations under its ETS.[47] Instead, it refers employers to “the Equal Employment Opportunity Commission’s regulations, guidance, and technical assistance.”[48] The lack of clear guidance in the November ETS itself jeopardizes the provision of accommodations required by § 20(a)(5) because it creates uncertainty for employers as to whether a particular accommodation is reasonable, as well as for employees with religious objections to the COVID-19 vaccine.

Blanket Application to All Industries and Circumstances Is Unjustified

There is a compounding issue of whether the scope of the November ETS is beyond the level of generality permitted by reviewing courts. As the Dry Color court explained, “[T]o provide immediate protection to employees exposed to a grave danger, emergency temporary regulations may necessarily be somewhat general,” but “it is expected that even an [ETS] not overlook those obvious distinctions among the chemicals to be regulated, uses and plant practices that make certain regulations that are appropriate in one category of cases entirely unnecessary in another.”[49] The November ETS has a blanket application based on a relatively low threshold of 100 employees and does not consider industry-specific factors that could affect the risks posed by COVID-19.[50]

OSHA attempts to justify this blanket application by positing that COVID-19 “is readily transmissible in workplaces because they are areas where multiple people come into contact with one another, often for extended periods of time” and that the Agency has the authority to regulate hazards that are not “uniquely work-related.”[51] This logic describes any public place and any hazard while discounting the importance of industry-specific determinations.

In support of the claim that it has the authority to promulgate a standard not limited to a workplace hazard, OSHA states that “COVID-19 is not the first hazard that OSHA has regulated that occurs both inside and outside the workplace.”[52] OSHA cites three permanent standards–the Occupational Noise Exposure Standard (the “Noise Standard”), the Sanitation Standard, and the aforementioned 1991 Standard–but comparison of these standards to the November ETS as regulating non-occupational hazards is problematic.[53] The regulated hazard at issue in the Noise Standard concerned sustained exposure to noise of great intensity that the reviewing court found “hard to imagine” in a non-occupational setting.[54] Similarly, the 1991 Standard dealt with healthcare worker exposure to bloodborne pathogens arising out of unique occupational risks, such as blood splatter, accidental injuries from used scalpels, and treatment of infected patients.[55] Thus, the Noise Standard and the 1991 Standard actually regulate hazards unique to the workplace in targeted industries. The Sanitation Standard is also a poor reference point because it controls the physical conditions of the workplace and does not place compliance burdens on workers.[56] Not only does the level of generality place the November ETS beyond the limits of OSHA’s statutory authority, but it also provides the Agency with tremendous power to regulate aspects of individual health that are the domain of state governments or other federal agencies.

OSHA’s exemption of healthcare workers, who are presumably the class of workers most likely to be exposed to individuals infected with COVID-19, from the vaccination and testing mandates of the November ETS presents further inconsistencies that undermine the validity of the ETS.[57] OSHA acknowledges that it engaged in an industry-specific analysis of the healthcare industry, weighing factors like the vaccination rate among healthcare workers, but declined to apply such a tailored analysis in evaluating other industries subject to the blanket coverage of the November ETS.[58] As a result, the Court of Appeals may well find that the November ETS overlooks obvious distinctions among industries that bear on the necessity of the ETS.

OSHA’s Delay in Issuing November ETS Undermines “Necessity” Requirement

The reviewing court is also likely to question OSHA’s timing for promulgating the November ETS, especially since the serious health risks posed by COVID-19 and the data forming the basis for the ETS have been known for some time.[59] OSHA will struggle to explain the timing for the November ETS given the current stage of the recovery from the COVID-19 pandemic, current rates of vaccination, and the Agency’s decision to decline the adoption of a mandatory vaccination and testing approach just four months ago when it promulgated the June ETS.[60]

OSHA could have initiated a rulemaking proceeding for a permanent standard with the effect of the November ETS nearly one year ago, when it began developing the June ETS.[61] This approach would have allowed OSHA to proceed on a timeline similar to a November publication date while allowing the novel regulatory framework and related concerns of the ETS to be fleshed out through notice-and-comment rulemaking.

The absence of a rulemaking proceeding is especially relevant because of the unique permanence of the November ETS’s effect. Unlike the respiratory equipment required by the June ETS, the COVID-19 vaccine will remain with workers when they are away from the workplace and after the ETS expires, regardless of whether a permanent standard supersedes it. In other words, workers cannot don and doff the COVID-19 vaccine. The inclusion of nontrivial financial incentives to “strongly encourage” employers to adopt a mandatory COVID-19 vaccination policy furthers the likelihood that workers will feel compelled to receive the COVID-19 vaccine rather than lose their jobs or absorb the costs associated with weekly testing and masking.[62]

In addition to problematic assumptions underlying the grave-danger determination, the November ETS’s lack of an adequate cost-benefit analysis, its broad coverage, and the timing discrepancies weigh against the required necessity determination for the ETS. The combination of these factors with the uncertainty regarding the availability of religious or other exemptions and OSHA’s authority to require vaccination and testing all cast serious doubt on the validity of the November ETS.

* BTS Holdings, L.L.C. v. OSHA, No. 21-60845, 2021 U.S. App. LEXIS 33698, at *20-21 (5th Cir. Nov. 12, 2021).

[1] COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. 61,402, 61,402 (Nov. 5, 2021) (to be codified at 29 C.F.R. pts. 1910, 1915, 1917, 1918, 1926, and 1928). OSHA promulgated this ETS in response to a directive announced by President Joe Biden on September 9, 2021. Remarks By President Biden On Fighting the Covid-19 Pandemic, 2021 WL 4099974, at *3 (Sep. 9, 2021).

[2] BTS Holdings, L.L.C. v. OSHA, No. 21-60845, 2021 U.S. App. LEXIS 33117, at *3-4 (5th Cir. Nov. 6, 2021).

[3] Id.

[4] 29 C.F.R. §§ 1910.501(b), (g)(1), (i) (2021).

[5] Sections 6(c)(2) and (3) of the Occupational Safety and Health Act (the “OSH Act”) limit the effective period of an ETS to six months from the date of publication. 29 U.S.C. §§ 655(c)(2)-(3). See also COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,406.

[6] 29 U.S.C. § 655(b)(5). The OSH Act does not provide a definition for “toxic materials” or “harmful physical agents.” Section 652(8) broadly defines an “occupational safety and health standard” to mean “a standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment.”

[7] 29 U.S.C. §§ 655(b)-(c)(1).

[8] Id. (emphasis added).

[9] 29 U.S.C. §§ 655(e)-(f).

[10] Scott D. Szymendera, Cong. Rsch. Serv., R46288, Occupational Safety and Health Administration (OSHA): Emergency Temporary Standards (ETS) and COVID-19, 27 (2021).

[11] Id.

[12] Occupational Exposure to COVID-19 Emergency Temporary Standard, 86 Fed. Reg. 32,376, 32,376 (June 21, 2021) (to be codified at 29 C.F.R. pt. 1910).

[13] 29 C.F.R. § 1910.502(a)(1) (2021).

[14] Occupational Exposure to COVID-19 Emergency Temporary Standard, 86 Fed. Reg. at 32,599, 32,606. The June ETS allows employers to decide how to screen workers and choose from methods other than COVID-19 testing. Id. at 32,606.

[15] Id. at 32,376.

[16] 29 C.F.R. §1910.501(b)(2)(ii).

[17] COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,438. OSHA cited higher vaccination rates among healthcare workers compared to non-healthcare workers in support of this determination. Id.

[18] Id. at 61,406 (citing Occupational Exposure to Bloodborne Pathogens Final Rule, 56 Fed. Reg. 64,003 (Dec. 6, 1991)).

[19] Occupational Exposure to Bloodborne Pathogens Final Rule, 56 Fed. Reg. at 64,156 (“While the Agency may have the legal authority to require vaccinations as part of the standard, it recognizes that voluntary participation by employees enhances compliance while respecting individuals’ beliefs and rights to privacy.” (emphasis added)).

[20] Id. at 64,154.

[21] Id. (citing Occupational Exposure to Lead Final Standard, 43 Fed. Reg. 54,354, 54,450-51 (Nov. 21, 1978)).

[22] Occupational Exposure to Lead Final Standard, 43 Fed. Reg. at 54,450.

[23] Asbestos Information Ass’n/N. Am. v. OSHA, 727 F.2d 415, 427 (5th Cir. 1984).

[24] Id. (“[A]n ETS that lacks support in the record for the basis OSHA has articulated must be declared invalid.”); COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,408.

[25] Occupational Safety and Health Admin., Attachment 1: Analysis–Health Impacts of the COVID-19 Vaccination and Testing ETS 4 (2021), _1.pdf []. OSHA filed this analysis as an attachment to the COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. 61,402. Id.

[26] Id.

[27] Id. at 2, 5.

[28] See id. at 4.

[29] Id. at 6 (emphasis added).

[30] Asbestos Information Ass’n, 727 F.2d at 425 (emphasis added).

[31] COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,459.

[32] Asbestos Information Ass’n, 727 F.2d at 423.

[33] Id.

[34] American Textile Mfrs. Institute, Inc. v. Donovan, 452 U.S. 490, 509 (1981) (“Any standard based on balancing costs and benefits by [OSHA] that strikes a different balance than that struck by Congress would be inconsistent with the command set forth in § 6(b)(5). Thus, cost-benefit analysis by OSHA is not required by the statute because feasibility analysis is.”).

[35] Id.

[36] Asbestos Information Ass’n, 727 F.2d at 423.

[37] See id. at 423 n.18.

[38] COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,460 n.22.

[39] Dry Color Mfrs. Ass’n, Inc. v. Department of Labor, 486 F.2d 98, 106 (3d Cir. 1973) (“In the context of a voluminous factual record, . . . a conclusory statement of reasons places too great a burden on interested persons to determine and challenge the basis for the [ETS], and makes possible in any subsequent judicial review the use of posthoc rationalizations that do not necessarily reflect the reasoning of the agency at the time the [ETS] was issued.”).

[40] See COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,460-61,504.

[41] Id. at 61,460 (emphasis added).

[42] Occupational Safety and Health Administration, COVID-19 Frequently Asked Questions (last visited Nov. 5, 2021), []. OSHA suspended this requirement because it “does not wish to have any appearance of discouraging workers from receiving COVID-19 vaccination, and also does not wish to disincentivize employers’ vaccination efforts.” Id. However, the suspension surrendered OSHA’s ability to collect key data on the same population it now seeks to regulate with the November ETS.

[43] 29 C.F.R. § 1910.501(k). The November ETS does not discuss OSHA’s decision to decline the adoption of a reporting requirement for adverse reactions to the COVID-19 vaccine. See COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. 61,402.

[44] COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,459.

[45] Id.

[46] Id. at 61,406; 29 U.S.C. § 669(a)(5).

[47] 29 C.F.R. § 1910.501(d).

[48] Id.

[49] 486 F.2d at 105 (emphasis added).

[50] The November ETS limits its exemption of covered employees to those “[w]ho do not report to a workplace where other individuals such as coworkers or customers are present;” those “working from home;” and those “who work exclusively outdoors.” 29 C.F.R. § 1910.501(b)(3).

[51] COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,407, 61,411.

[52] Id. at 61,407.

[53] Id. at 61,407-08. See 29 C.F.R. § 1910.95 (1984); 29 C.F.R. § 1910.141 (2011); 29. C.F.R. § 1910.1030 (1991).

[54] Forging Indus. Ass’n v. Sec’y of Lab., 773 F.2d 1436, 1444 (4th Cir. 1985).

[55] Am. Dental Ass’n v. Martin, 984 F.2d 823, 824-25 (7th Cir. 1993).

[56] See 29 C.F.R. § 1910.141.

[57] Occupational Exposure to COVID-19 Emergency Temporary Standard, 86 Fed. Reg. at 32,599, 32,606.

[58] Id. at 61,438.

[59] Asbestos Information Ass’n, 727 F.2d at 423 (“OSHA should . . . offer some explanation of its timing in promulgating an ETS, especially when . . . for years it has known of the serious health risk the regulated substance poses, and has possessed, albeit in unrefined form, the substantive data forming the basis for the ETS.”).

[60] Occupational Exposure to COVID-19 Emergency Temporary Standard, 86 Fed. Reg. at 32,376.

[61] See Exec. Order No. 13,999, 86 Fed. Reg. 7,211 (Jan. 26, 2021). Executive Order 13,999, signed by President Joe Biden on January 21, 2021, directed OSHA to consider the need for any COVID-19-related ETSs.

[62] COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. at 61,402, 61,433-39, 61,505, 61,520, 61,525, 61,532, 61,539. In the November ETS, OSHA states twenty-one times that the ETS is designed to “strongly encourage” vaccination as opposed to testing and masking. Id.

Reprinted with permission from the November 15 issue date of the “New York Law Journal” © 2021 ALM Media Properties, LLC. All rights reserved. Further duplication without permission is prohibited, contact 877-257-3382 or

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