On December 16, the Equal Employment Opportunity Commission (“EEOC”) updated existing guidance in order to address COVID-19 vaccinations.[1] In addition to discussing vaccinations in the context of equal employment opportunity (“EEO”) laws, the guidance also discusses the Food, Drug and Cosmetic Act (“FD&C Act”), a law outside of the EEOC’s jurisdiction that nevertheless provides a statutory basis to decline vaccination. While this law provides an additional basis by which an individual may decline a COVID-19 vaccination, it should not affect our prior analysis[2] concluding that it is permissible for an employer to require that employees be vaccinated for COVID-19 as a condition of employment.
The EEOC guidance refers to the FD&C Act, which provides individuals a right to refuse to be vaccinated when the Food and Drug Administration (“FDA”) approves a drug or vaccine for emergency use, rather than general use. This should not change our analysis or conclusion concerning the permissibility of a COVID-19 vaccine requirement. In that analysis, we assumed that certain employees would be exempt from a COVID-19 vaccine requirement because of either a qualified disability under the Americans with Disabilities Act (“ADA”) or a sincerely held religious belief under Title VII of the Civil Rights Act of 1964 (“Title VII”)[3]. The FD&C Act expands the scope of employees who may decline a COVID-19 vaccine by providing individuals who do not have a qualified disability or a sincerely held religious belief a statutory basis to refuse vaccination, but it does not change any underlying analysis.
The purpose of this bulletin is to explain an individual’s entitlement to refuse a COVID-19 vaccination under the FD&C Act and how this entitlement interacts with an employer’s authority to require that employees be vaccinated. While the FD&C Act provides no entitlement to an accommodations process, this bulletin provides employers a framework by which to manage employees who elect to exercise their statutory right under the FD&C Act not to be vaccinated.
EEOC Guidance regarding the FDA’s Emergency Use Authorizations of COVID-19 Vaccines
While not a workplace EEO law or even a matter within the EEOC’s jurisdiction, the EEOC guidance refers to the FD&C Act and its statutory entitlement in the following manner:
Some COVID-19 vaccines may only be available to the public for the foreseeable future under [Emergency Use Authorization (“EUA”] granted by the FDA[4], which is different than approval under FDA vaccine licensure. The FDA has an obligation to:
[E]nsure that recipients of the vaccine under an EUA are informed, to the extent practicable under the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product.
The FDA says that this information is typically conveyed in a patient fact sheet that is provided at the time of the vaccine administration…[5]
As the EEOC guidance mentioned, one of the statutory requirements for drugs approved under the EUA process is that the Secretary of Health and Human Services (“HHS”) ensure that recipients of the vaccine are informed “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product…”[6] In order to comply with this requirement, both Pfizer-BioNTech and Moderna provide the following language for their COVID-19 vaccines: “It is [the recipient’s] choice to receive or not receive the COVID-19 Vaccine. Should [the recipient] decide not to receive [the COVID-19 Vaccine], it will not change [the recipient’s] standard medical care.”
While there is a paucity of guidance concerning the operation of the specific statutory section in question, there is no evidence that the FD&C Act is intended to abridge either employers’ authority to establish the terms and conditions of their employees’ employment or their obligation to provide for the health and safety of its workplaces. Therefore, employers are more likely than not entitled to change the terms and conditions of employment in ways that may have consequences for individuals who elect not to be vaccinated, even if the individuals retain the right to decline vaccination.
Practical Implication for Refusing Vaccination and Potential Work-Related Consequences for Such Refusal
While the FD&C Act provides an additional basis upon which an individual may refuse a COVID-19 vaccine[7], it does not provide a process by which employers must accommodate employees who elect not to be vaccinated. Employers may still require that their employees be vaccinated for COVID-19, but should develop a process to account and provide for employees who exercise their rights under the FD&C Act. To avoid potential exposure to discrimination and/or retaliation claims by employees who have exercised their rights not to be vaccinated, employers should not terminate or take other adverse employment actions against employees who exercise their rights under the statute.
In order to reduce the likelihood of employees claims alleging that their employer took adverse employment actions against them for exercising their rights not to be vaccinated under the FD&C Act, employers should consider adopting and implementing an accommodations processes. . Under such a process, an employer should determine whether the unvaccinated employee constitutes a “direct threat” to the health and safety of the workplace. While the “direct threat” standard is an ADA concept, employers may nevertheless employ it in order to determine whether individuals who exercised their rights not to be vaccinated under either Title VII or the FD&C Act can be safely accommodated at work.
Under the ADA, the “direct threat” standard applies where an employee presents a “significant risk of substantial harm to the health or safety of the individual or others.”[8] In order to assess whether an unvaccinated employee constitutes such a threat to employees in the workplace, the employer would need to conduct an individualized assessment of that threat by examining each of the following four (4) factors as they relate to the unvaccinated employee:
The EEOC guidance provides that if an employer determines that an unvaccinated employee poses a direct threat at the worksite, the employer may only exclude that employee from the workplace if the employer determines that there is no way to reasonably accommodate the employee at the workplace. An employer may be able to meet the burden by demonstrating that each of the risk factors establish that the threat of COVID-19 is greater now than ever before. However, an employer should not assume that the employee cannot be accommodated at the workplace. An employer should prepare to respond to requests by unvaccinated employees for employer-provided safety measures and equipment that will allow them to work safely at or from the employer’s workplace, including, but not limited to, personal protective equipment (“PPE”), including, for example, respirators[9]. Regardless, employers should be prepared to undertake an individualized threat assessment of each employee who elects not to be vaccinated under the FD&C Act and to defend their actions by demonstrating that they conducted such assessment for each employee.
However, if a direct threat cannot be reduced to an acceptable level through a workplace accommodation, the EEOC provides that employers may exclude employees from physically entering the workplace. In such circumstances, we recommend that employers adopt and implement a process under which they engage in a good faith attempt to accommodate such employees. This will reduce the employer’s potential exposure to claims arising from or related to the FD&C Act and provide a uniform and standard process by which employers can evaluate the accommodation requests of comparably situated employees.
For individuals who exercised their rights not to be vaccinated under the FD&C Act, employers may expressly provide that employees are not entitled to an ADA-compliant interactive process, but that the employer will nevertheless engage in a good faith process in order to attempt to accommodate such employees. Under such a framework, the employer need not provide accommodations that would impose an undue hardship on the employer or their operations, but should attempt to identify accommodations that will allow employees to continue to perform their essential job duties.
While telework may be a potential option for those employees whose job duties permit such remote work, it is not likely a reasonable option for the frontline service providers, including health care workers and safety employees, who will be among the first to qualify for receipt of a COVID-19 vaccination. For unvaccinated employees in these types of positions, the employer must consider the reasonableness of other accommodations, such as providing and requiring the use of PPE and/or respirators, if necessary[10] that may allow an employee to continue working at the employer’s workplace[11]. Employers may also consider other non-workplace accommodations including allowing the employee to use paid leave or potentially placing the employee on unpaid leave.
Conclusion
For employers who want to require that their employees receive a COVID-19 vaccination, Liebert Cassidy Whitmore recommends that they proceed accordingly and make only small adjustments to account for individuals who elect to exercise their right not to be vaccinated under the FD&C Act.
Employers may still require COVID-19 vaccinations, but must recognize that employees who are not protected under the ADA or Title VII also possess an additional statutory basis upon which to refuse to be vaccinated. If employees exercise this right, employers should consider the advice set forth in this bulletin in determining if and how such unvaccinated employees can safely continue to work in their particular workplace.
Mandatory vaccinations are a complicated and controversial topic and Liebert Cassidy Whitmore attorneys are available to assist employers that have any questions about this guidance.
[1] EEOC “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws” (“EEOC Guidance”), K.1.-9., https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws?utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term= (Last updated on December 16, 2020.)
[2] LCW created client-specific guidance concerning the permissibility of employer-mandated vaccinations. Please review the applicable guidance: (1) public agencies; (2) public schools; (3) community colleges; (4) independent schools; and (5) non-profits.
[3] The Fair Employment and Housing Act (“FEHA”) is the state law that provides protections for individuals with qualified disabilities and individuals with sincerely held religious beliefs. Analysis of accommodations requirements under the FEHA largely mirrors that under the federal laws, including the ADA and Title VII, upon which the FEHA is modeled.
[4] Under the FD&C Act, the FDA may approve drugs under either a full and comprehensive licensure process, known as the Biologics License Application (“BLA”), or a more limited emergency process, known as the Emergency Use Authorization (“EUA”). In order to address both the immediacy of the present public health emergency caused by COVID-19 and the public’s concerns about the safety and efficacy of COVID-19 vaccines, the FDA developed a modified EUA process that incorporates some of the rigors of the BLA process. (See FDA “Emergency Use Authorization for Vaccines to Prevent COVID-19 – Guidance for Industry”, p. 4 https://www.fda.gov/media/142749/download (Last updated in October 2020) [requiring “at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling way.”]) Nevertheless, COVID-19 vaccines approved under this process remain subject to the statutory requirements of the FD&C Act.
[5] EEOC “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws” (“EEOC Guidance”), K.4., https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws?utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term= (Last updated on December 16, 2020)(emphasis added.)
[6] 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III), emphasis added.
[7] The statutory basis under the FD&C Act supplements those provided under the ADA for individuals with qualified disabilities and under Title VII for individuals with sincerely held religious beliefs.
[8] 29 C.F.R. § 1630(r).
[9] A respirator is a device which has met the requirements of 42 C.F.R. Part 84, has been designed to protect the wearer from inhalation of harmful atmospheres, and has been approved by National Institute of Occupational Safety and Health (“NIOSH”) for the purpose for which it is used.
[10] See fn. 7.
[11] An employer should only provide these workplace accommodations if it determines that the employee would not pose a direct threat to the health and safety of the workplace with such accommodation and that the provision of such accommodations would not impose an undue hardship on the employer.