COVID-19

How Can OSHA Even Require Vaccines?

How is it that President Joe Biden can order the Occupational Safety and Health Administration (OSHA) to establish an emergency rule that requires employers to vaccinate all their employees or test them for COVID-19?

Is this normal? How does OSHA even have that kind of authority?

Like much since the COVID-19 pandemic was first declared on March 11, 2020, none of this is normal. The president’s private-employer vaccine mandate relies on OSHA’s emergency authority created by a provision of the Occupational Safety and Health Act (OSH Act) of 1970 (29 USC §655(c)). Before an emergency healthcare COVID-19 rule in June, however, OSHA hadn’t issued an emergency temporary standard (ETS) since an asbestos ETS in 1983 that was struck down in federal court.

The OSH Act authorizes OSHA to issue an ETS when “employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and such emergency standard is necessary to protect employees from such danger.” Once an ETS is published in the Federal Register and becomes effective, OSHA has six months to establish a permanent standard.

An ETS must meet that two-part test—evidence of a grave workplace danger and the need for a temporary rule—to survive judicial challenge. Given the agency’s experiences in the 1970s and ’80s, it rarely uses its ETS-setting authority.

Right after taking office, Biden issued an Executive Order (EO) on January 21 directing OSHA to issue a COVID-19 ETS. The EO gave the agency a March 15 deadline to issue an ETS. OSHA released text of the pared-down rule on June 10, covering only the healthcare sector. Its was published June 21 in the Federal Register—months after the president’s deadline. The June 21 ETS applies to health care and healthcare support services, as well as emergency medical services, home health care, and skilled nursing homes.

The rule becomes effective immediately with its June 21 publication in the Federal Register, but the agency set July 6 and July 21 compliance deadlines for the provisions of the emergency rule. The healthcare ETS required employers to provide workers with paid time off to get vaccinated and to recover from any side effects. It also required them to conduct a hazard assessment and develop a written plan to mitigate virus spread, including the use of respirators and other personal protective equipment.

To satisfy the OSH Act’s two-pronged test, OSHA justified the healthcare COVID-19 ETS by citing the health consequences of COVID-19, elevated risks of transmission in the shared spaces of healthcare facilities, and risk of transmission where patients with known or suspected infections receive treatment. The agency also argued that the inadequacies of protections under existing guidance and standards and the OSH Act’s General Duty Clause necessitated the creation of an ETS.

OSHA assesses the ongoing need for the ETS, reviewing the latest data and guidance for and scientific understanding of COVID-19 and the SARS-CoV-2 virus that causes the disease. In consultation with the National Institute for Occupational Safety and Health (NIOSH), the agency determined in August that the ETS remains necessary to address the grave danger of COVID-19 in healthcare.

September 9 announcement

The Biden administration now intends to add a second ETS compelling employers to require employee vaccination or conduct weekly testing for infections. When Biden unveiled the new federal COVID-19 response plan on September 9, he also announced vaccination orders for federal employees and contractors and that the Centers for Medicare and Medicaid Services (CMS) would require COVID-19 vaccinations for workers in healthcare settings that receive Medicare or Medicaid reimbursement.

Other elements of the White House strategy include a vaccination requirement for teachers and staff in Bureau of Indian Education-operated schools, Department of Defense schools, and Head Start programs; booster shots of authorized vaccines for those already vaccinated; the doubling of Transportation Security Administration (TSA) fines for passengers who refuse to wear face coverings; a small business loan program; additional shipments of monoclonal antibody treatments; and the deployment of additional federal COVID-19 Surge Response Teams.

The bulk of the plan’s intent to increase the number of vaccinated Americans hinges on OSHA’s use of its emergency rulemaking authority. The agency has had that authority from the beginning but rarely uses it. Did Congress intend for the agency’s workplace safety and health mission to include addressing public health crises?

The regular process for setting permanent standards is very different. Establishing an OSHA rule takes an average of 7 years, and the process has ranged from 15 months to 19 years between 1981 and 2010, the Government Accountability Office (GAO) reported to Congress in 2012. At the time, OSHA had not issued an ETS in nearly 30 years, according to the GAO. Between 1971, when the agency was established, and 1983, OSHA had issued nine ETSs. The agency has struggled to gather sufficient evidence of grave danger and the need for a temporary rule to withstand court challenges. 

For example, OSHA issued an ETS in 1983 lowering the permissible exposure limit for asbestos. In a challenge in federal court, the court found that OSHA had failed to show sufficient evidence that workers faced grave danger from exposure under existing limits for the six months the ETS would be in effect. The agency also failed to meet the statute’s bar that an ETS was necessary to protect workers from grave danger.

The healthcare COVID-19 ETS was OSHA’s first emergency rule since the asbestos ETS was struck down in 1983, according to the Congressional Research Service.

The OSH Act’s requirement to replace an ETS with a permanent standard within six months also creates a logistical challenge for the agency: The research, analysis, public consultation, and Small Business Regulatory Enforcement Fairness Act (SBREFA) review cannot practically be completed within six months. Agency officials admitted to the GAO that Congress intended for OSHA’s ETS-setting authority to be used only in very limited circumstances.

Despite the rare use of the ETS-setting authority, labor unions and public health and other advocacy groups continually petition OSHA to issue ETSs for a variety of hazards, including formaldehyde and heat exposure. A coalition led by Public Citizen has repeatedly petitioned OSHA for an emergency or a permanent standard for heat exposure and the prevention of heat-related illnesses.

Regular rulemaking process

OSHA’s usual process for developing permanent workplace safety and health standards is a complex one full of economic, feasibility, and technical research, along with seeking public input, which can often last years. The process includes:

  • Preliminary rulemaking activities, a 12- to 36-month process that involves health effects analysis, risk assessment, technological feasibility analysis, and economic analysis; listing agency regulatory activity on the Unified Agenda/Regulatory Plan (regulatory agenda); and opening a public rulemaking docket;
  • Developing a proposed rule, a 12- to 36-month process that includes drafting regulatory text, conducting a review under SBREFA and consulting agency advisory committees, and continuing discussions with stakeholders;
  • Publishing a proposed rule and planning for public hearings on the proposal, as well as accepting public comment in a rulemaking docket;
  • Developing and analyzing the rulemaking record, a six- to 24-month process involving a review of public comments submitted to the docket and exhibits and testimony presented at public hearings;
  • Developing a final rule, an 18- t0 36-month process, which requires updating agency analysis, considering public comment and testimony, drafting final regulatory text, and submitting it to the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA); and
  • Publishing a final rule, conducting compliance assistance and outreach activities, and responding to any legal challenges to the rule.

Many OSHA standards, especially its earliest standards, are adapted from or based on industry consensus standards. NIOSH also plays a role in standard-setting. Along with creating OSHA within the Department of Labor, the OSH Act created NIOSH within the Department of Health and Human Services as a workplace safety and health research center. In addition to conducting, directing, and funding research, NIOSH also tests and approves respirators at its National Personal Protective Technology Laboratory (NPPTL) and responds to requests for Fatality Assessment and Control Evaluation, Fire Fighter Fatality Investigations, and Health Hazard Evaluations. NIOSH’s standard-setting role involves developing criteria documents to serve as the basis for occupational safety and health standards.

Even OSHA’s permanent standard-setting authority is sometimes regarded with suspicion. At most other agencies, regulations are authorized by specific statute. OSHA has the authority to regulate any demonstrated workplace hazard. Before becoming director of the OIRA under President Barack Obama, economist Cass R. Sunstein argued in an article entitled “Is OSHA Constitutional?” that Congress delegated its authority to legislate to OSHA through the OSH Act. Given Congress’s delegation, OSHA must be accountable and transparent, according to Sunstein.

No permanent administrator

OSHA currently lacks a political leader. The agency is led by Acting Assistant Secretary James Frederick. The White House announced the nomination of Doug Parker, chief of California’s Division of Occupational Safety and Health (Cal/OSHA), to lead OSHA in April. The U.S. Senate has yet to confirm Parker’s nomination.

Last year, labor unions and professional safety organizations urged OSHA to develop an emergency COVID-19 standard, insisting that voluntary employer guidance was too weak to ensure employer compliance.

In the absence of federal action, several states established their own standards. California, Michigan, Oregon, and Virginia created emergency COVID-19 rules in 2020. California’s Occupational Safety and Health Standards Board extended the state’s ETS and can renew it one more time. Michigan’s emergency COVID-19 rules remain in effect until December 22. Oregon and Virginia promulgated permanent standards this year. 

New York, which operates an OSHA-approved state plan covering only state and local government workers (private sector employers and their workers are covered by federal OSHA), passed the New York Health and Essential Rights Act (NY HERO Act), and the New York State Department of Labor issued requirements for private sector employers to have infectious disease exposure prevention plans in place. The plans go into effect when state public health authorities make a “highly contagious communicable disease” declaration.

Will OSHA succeed in creating an ETS that extends beyond healthcare facilities and services, requiring employee vaccination or testing? The OSH Act does grant the agency that authority, but it must pass the two-pronged test, proving a grave danger exists and that an emergency temporary rule is necessary to address it.