The Occupational Safety and Health Administration (“OSHA”) has reopened the comment period on its June 2021 interim final rule establishing an Emergency Temporary Standard governing occupational exposure to COVID-19 in healthcare settings, codified at 29 C.F.R. § 1910 Subpart U (“Healthcare ETS”).
While this reopening reaches certain questions and issues presented by OSHA and not the entire rule, the reopening of the comment period signals the beginning of the effort to finalize a permanent standard by OSHA only three months after the agency withdrew the Healthcare ETS. The Healthcare ETS required healthcare organizations to develop a COVID-19 plan for its workplace that included health screening and management, masking, distancing, and support for vaccination. The Healthcare ETS was withdrawn in December 2021 because OSHA determined that its efforts to establish a permanent standard would exceed the six-month time period allowed under the Occupational Safety and Health Act.
The notice reopening the comment period gives stakeholders both an early view into potential regulatory outcomes of the final rule as well as a series of information requests.
Potential regulatory outcomes
OSHA has identified a list of ten categories of potential ways in which its final rule might differ from the June 2021 Healthcare ETS, and is seeking public comment on each of these items. OSHA encourages commenters to explain why they prefer or disfavor particular policy choices and to include supporting information/documentation.
- Alignment with the Centers for Disease Control and Prevention (“CDC”) recommendations for healthcare infection control practices
OSHA is considering altering portions of the Healthcare ETS to align the final rule with some or all of the CDC’s recommendations as of the time the current comment period closes, e.g., in regard to isolation and return-to-work guidance. OSHA seeks comments on whether it is appropriate to align its final rule with some or all of the CDC recommendations that have changed.
- Additional flexibility for employers
The Healthcare ETS specified how employers were required to implement particular policies and procedures, such as criteria for medical removal, return-to-work, and cleaning, among others. OSHA is considering restating various provisions in its final rule as broader requirements without the level of detail included in the Healthcare ETS and even providing a “safe harbor” enforcement policy for employers who were in compliance with CDC guidance applicable during the period at issue even if that guidance has since changed.
- Removal of scope exemptions
The Healthcare ETS generally applied in settings where any employee provides healthcare services or healthcare support services, with some exceptions. The Healthcare ETS did not apply, for example, to ambulatory care settings where patients and other visitors were screened prior to entry for confirmed or suspected COVID-19 infection. OSHA is considering whether the scope of the final standard should include employers in healthcare or healthcare support settings regardless of screening procedures for non-employees and/or vaccination status of employees to ensure that all workers are protected to the extent there is a significant risk. This expansion would significantly expand its reach into the healthcare provider and supplier communities.
- Tailoring controls to address interactions with people with suspected or confirmed COVID-19
In areas within a healthcare facility where healthcare employees are not reasonably expected to encounter people with suspected or confirmed COVID-19, OSHA is considering eliminating certain requirements that were included in the Healthcare ETS, such as cleaning, facemask, and medical removal provisions. However, such narrowing of scope would likely be balanced with a new outbreak provision that could allow the facility to quickly scale up its protection efforts in case of an outbreak.
- Booster doses
The Healthcare ETS defines “fully vaccinated” as “2 weeks or more following the final dose of the COVID-19 vaccine.” Since the publication of the Healthcare ETS, the Advisory Committee on Immunization Practices (“ACIP”) has recommended booster doses and the CDC adopted the concept of “up to date” to include vaccination recommendations beyond the initial vaccination series. OSHA is considering how and whether its final rule should reflect these latest recommendations.
- Employer support of employee vaccination
OSHA has stated that, at this time, it is not planning to mandate vaccination for employees covered by its final rule. However, it is considering revising and bolstering the Healthcare ETS provisions regarding employers’ support for employee vaccination, including requiring employers to:
- Provide paid time off up to 4 hours for employees to receive a vaccine;
- Paid sick leave to recover from side effects; and
- Provide support for employees who wish to stay up to date with vaccination and boosters in accordance with ACIP and CDC recommendations.
OSHA is also considering whether to limit explicitly the provisions that provide support for vaccination to employees not covered by the Centers for Medicare & Medicaid Services vaccination rule.
- Limited coverage of construction activities in healthcare settings
The Healthcare ETS did not expressly include employers that engage in construction work in healthcare settings. OSHA is considering clarifying the final rule’s applicability to this category of employers.
- COVID-19 recordkeeping and reporting provisions
The only portions of the Healthcare ETS that remained in effect after its withdrawal in December 2021 were the recordkeeping and reporting requirements. OSHA is seeking comment on whether any adjustments should be made to these requirements in the final rule, and is specifically proposing to cap the record retention period for the COVID-19 log at one year from the date of the last entry in the log.
- Triggering requirements based on community transmission levels
When healthcare workers treat individuals with suspected or confirmed COVID-19, the Healthcare ETS requires certain control strategies to be put in place. OSHA is considering eliminating specific control strategies from its final rule and instead linking regulatory requirements to measures of local risk, such as the levels of community transmission used in CDC’s guidance for healthcare settings.
- The potential evolution of SARS-CoV-2 into a second novel strain
Due to the possibility of another novel coronavirus strain, OSHA is considering specifying that the final standard would apply not only to COVID-19, but also to subsequent related strains of the virus transmitted in the same way as COVID-19.
Other information requests
OSHA is also seeking public comment on several other topics as it prepares to develop a final standard. In light of the emergence of the Delta and Omicron variants after the original comment period for the Healthcare ETS closed, OSHA requests the public to submit new studies or data related to these variants. OSHA is also requesting specific additional information regarding:
- The average number of days healthcare workers have taken off work because of a COVID-19 infection or quarantine and the percentage of workers who have taken days off for the same reasons;
- The health effects on fully-vaccinated employees who test positive for COVID-19;
- The percentage of healthcare workers at an elevated risk of severe COVID-19 infections;
- The rate of infection, long COVID, hospitalization, and death among healthcare workers as compared to that of the general population; and
- Health effects and transmission rates of emerging variants.
Moreover, OSHA requests data and information on the vaccination rate among healthcare workers, clinical indicators to predict the degree of protection afforded by prior infection, vaccine efficacy, and unintended consequences, among others.
Written comments with optional supporting attachments can be submitted by stakeholders online until 11:59 PM on April 22, 2022.
There will also be an opportunity to testify at a virtual hearing on April 27, 2022. Those who wish to attend and testify or produce documentary evidence at the hearing must file a notice of intention to appear by April 6, 2022. Following the close of the hearing and the post-hearing comment period, OSHA will review all of the evidence and is expected to issue a final rule based on the record as a whole.
Reed Smith will continue to track developments related to OSHA’s Healthcare ETS and eventual implementation of the final rule. Please reach out to the authors or the healthcare attorneys at Reed Smith if you have any questions about how this ruling might affect your organization or if your organization would like assistance in preparing comments on the proposed standard.