By Conn Maciel Carey LLP’s COVID-19 Task Force

After OSHA just recently initiated a three-month COVID-19 focused enforcement blitz targeting the healthcare industry, earlier this week, on March 22^nd, OSHA announced that it has officially reopened the rulemaking record for a “permanent” COVID-19 standard applicable to the healthcare industry, and perhaps now some industries tangentially related to healthcare.

OSHA will accept comments on the proposed permanent standard through April 22, 2022, and has scheduled a public hearing on the rulemaking for April 27^th.

Below we provide some important background and recommendations on next steps to ensure the healthcare industry and other potentially impacted employers maximize this opportunity to influence the direction and outcome of the permanent COVID-19 rulemaking.

Importantly, we also identify below a potential major expansion of the scope of coverage of the standard that OSHA is contemplating.  OSHA is explicitly considering eliminating the coverage exemption that had been included in the COVID-19 Emergency Temporary Standard for Healthcare (the ETS) for those ambulatory care, non-hospital settings where some healthcare services are provided, but that screen individuals for COVID-19 before entry and prevent COVID-19 infected individuals from entering. If that exemption is not carried forward from the ETS into the permanent standard, then general industry manufacturers that have medical clinics onsite; dental and other doctors’ offices; retail pharmacies; etc. will be pulled into coverage under the permanent standard; i.e., any employer that operates any type of facility where any form of healthcare services are provided could be regulated by the permanent standard.  It is imperative, therefore, that potentially impacted employers participate in this rulemaking.

Why is OSHA Partially Reopening the Rulemaking?

As you likely recall, on June 21, 2021, OSHA issued an emergency temporary standard (“ETS”) to protect workers in healthcare settings from occupational exposure to COVID-19 (“Healthcare ETS”).  By operation of law, an ETS automatically serves as a proposed permanent standard, so OSHA also simultaneously solicited comments on the Healthcare ETS as a final standard when it was issued last summer.

OSHA received 481 comments concerning the Healthcare ETS during that comment period, which was originally set to close on July 21, 2021, but was extended to August 20, 2021 in response to requests from the public.

Fast-forward to December 27, 2021 – a few days after the six-month anniversary of the Healthcare ETS – OSHA announced that it was withdrawing the Healthcare ETS (sans the recordkeeping portion of the standard, which has remained in effect under separate legislative authority) while making clear its intention “to continue to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards[.]”  The agency is now preparing to promulgate a final standard, and has officially reopened the rulemaking record to allow for new data and comments, at least on select topics identified in a Notice that OSHA published in the Federal Register yesterday.

Which Parts of the Rulemaking Record Have Been Reopened?

OSHA is seeking public comment on the specific topics and questions listed below.  OSHA is encouraging commenters to explain why they prefer or disfavor particular policy choices, and include any relevant studies, experiences, anecdotes, or other information that may help support the comments.

Potential Changes from the Healthcare ETS

1. 1. Major expansion of coverage of the standard; Removal of scope exemptions (e.g., ambulatory care facilities where COVID-19 patients are screened out; home healthcare).
      • OSHA is contemplating a major expansion of the facilities covered by the permanent COVID-19 standard compared to the ETS.  OSHA explains that a final standard will be adopted under Section 6(b) of the OSH Act, which establishes a lower risk threshold than an ETS (a permanent standard requires a finding of “significant risk” rather than a finding of “grave danger.”)  Section 6(b) requires only that the standard substantially reduce or eliminate significant risk of material impairment of health to the extent feasible.  In view of this different risk finding, OSHA is considering whether the scope of the final standard should cover employers and facilities 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. Elimination of this exemption would significantly expand the coverage of the standard, reaching all on-site medical clinics in manufacturing facilities, dental and other ambulatory care doctors offices, administrative portions of hospitals, etc.
   2. Alignment with the CDC’s infection control procedures.
      • OSHA recognizes that evolving CDC infection control recommendations for the healthcare industry have resulted in inconsistencies between those CDC recommendations and certain requirements included in the Healthcare ETS (e.g., isolation and return-to-work guidance).  OSHA is considering whether it is appropriate to align its final standard with some or all of the current CDC recommendations.
   3. Additional flexibility for employers.
      • OSHA states that the Healthcare ETS, “while rooted in a programmatic approach (e.g., COVID-19 plan, hazard assessment, policies and procedures to minimize the risk of transmission of COVID-19), also specified how employers were required to implement particular policies and procedures (e.g., criteria for medical removal and return to work, cleaning, ventilation, barriers, aerosol-generating procedures).”  OSHA is considering restating various provisions as broader requirements without the level of detail included in the Healthcare ETS and providing a “safe harbor” enforcement policy for employers who are in compliance with CDC guidance applicable during the period at issue.
   4. Tailoring controls to address interactions with people with suspected or confirmed COVID-19.
      • OSHA is considering whether there is a need for COVID-19-specific infection control measures in areas where healthcare employees are not reasonably expected to encounter people with suspected or confirmed COVID-19.  For example, limiting the cleaning requirements or medical removal provisions to only those areas where staff are exposed to COVID-19 patients, or eliminating facemask requirements for staff not exposed to COVID-19 patients.  However, OSHA states that, if it were to restrict infection control requirements to particular areas of a facility or particular staff, it could consider balancing that narrower scope with a new “outbreak provision” to ensure that healthcare employers would still have a duty to address an outbreak quickly if an outbreak occurs among staff in the areas subject to no or fewer requirements.  For example, an outbreak could trigger a broad performance requirement for the employer to implement additional infection control measures to stop the outbreak, or it could trigger more specific requirements, such as employer-provided testing and/or medical removal of staff with COVID-19 even if they do not interact with COVID-19 patients.  OSHA seeks comments on this approach, including comment on how OSHA should define an “outbreak” if it were to implement that approach.  In particular, OSHA points to a CDC discussion of “outbreaks,” which provides in part:
        • Definitions for COVID-19 outbreaks are relative to the local context.  A working definition of “outbreak” is recommended for planning investigations. A recommended definition is a situation that is consistent with either of two sets of criteria:
          • During (and because of) a case investigation and contact tracing, two or more contacts are identified as having active COVID-19, regardless of their assigned priority; OR
          • Two or more patients with COVID-19 are discovered to be linked, and the linkage is established outside of a case investigation and contact tracing (e.g., two patients who received a diagnosis of COVID-19 are found to work in the same office, and only one or neither of [sic] them was listed as a contact to the other).
   5. Employer support for employees who wish to be vaccinated.
      • To be clear, OSHA emphasizes that it is not considering requiring mandatory vaccination for employees covered by this standard.  However, OSHA is considering inclusion of a requirement that employers inform employees about the safety, efficacy, and benefits of vaccination and provide reasonable time and paid leave to each employee for vaccination and side effects experienced following vaccination.  In particular, the adjustment would include paid time up to 4 hours, including travel time, for employees to receive a vaccine and paid sick leave to recover from side effects, similar to requirements promulgated under the now-withdrawn Vaccination and Testing ETS.
      • OSHA recognizes that, subsequent to the publication of the Healthcare ETS, the Advisory Committee on Immunization Practices (“ACIP”) has recommended additional doses and booster doses, and that CDC has also adopted the “up to date” concept to describe vaccination recommendations beyond the primary vaccination series.  Thus, OSHA is considering how these ACIP and CDC recommendations should be addressed in a permanent OSHA standard in taking into account an employee’s vaccination status (e.g., fully vaccinated, up to date) and seeks comment on this issue.  OSHA is also considering requiring employer support for employees who wish to stay up to date on vaccination and boosters in accordance with ACIP and CDC recommendations.
      • OSHA is considering whether the standard should limit the provisions that provide support for vaccination to employees to only those not covered by the Centers for Medicare & Medicaid Services (“CMS”) vaccination rule since the CMS vaccination rule requires healthcare staff in facilities regulated by CMS to be vaccinated.  OSHA notes that the majority of healthcare employees covered by this final rule work in facilities covered by the CMS vaccination rule and are subject to the CMS requirements.
      • OSHA is considering whether certain requirements of the standard should be relaxed based on vaccination status:
        • for masking, barriers, or physical distancing for vaccinated workers
        • in healthcare settings where a high percentage of staff is vaccinated (OSHA also is accepting comment on what that percentage should be)
        • for exposure notification for vaccinated employees
   6. Limited coverage of construction activities in healthcare settings.
      • OSHA states that it had not expressly included employers that engage in construction work in hospitals, long-term care facilities and other settings that are covered by the Healthcare ETS, mentioning that the construction industry was not included in OSHA’s industrial profile for the ETS.  OSHA is considering clarifying that these employers would be covered by the permanent standard, but would consider providing exceptions for construction work in isolated wings or other spaces where construction employees would not be exposed to patients or other staff.
   7. COVID-19 recordkeeping and reporting provisions.
      • While making clear that the COVID-19 log and reporting provisions (29 CFR Section 1910.502(q)(2)(ii), (q)(3)(ii)-(iv), and (r)) have remained in effect, OSHA seeks additional comment on these requirements and on the requirements for reporting COVID-19 fatalities and hospitalizations to OSHA (29 CFR Section 1910.502(r)), and in particular, whether any adjustments to those recordkeeping/reporting paragraphs should be made in light of experiences involving the Delta or  Omicron variants.  Additionally, the agency is 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, rather than the current approach in which that retention period is tied to the duration of the standard.
   8. Triggering requirements based on community transmission levels.
      • OSHA acknowledges that, under the CDC’s current guidance for healthcare workers, many requirements for those workers are triggered based on the level of community transmission of COVID-19 (e.g., controls needed in areas of substantial or high transmission, controls not needed in areas of low or moderate transmission).  OSHA is considering linking regulatory requirements to measures of local risk, such as community transmission used in CDC’s guidance for healthcare settings or the CDC’s COVID-19 Community Levels used in CDC’s guidance for prevention measures in community settings.  OSHA is seeking comment on that approach, including impacts of such an approach on compliance and enforcement.

1. 1. The potential evolution of a second novel strain of SARS-CoV-2.
      • Keeping in mind the future of this rule, OSHA recognizes that it is possible that a future variant of SARS-CoV-2 will have sufficient genetic drift to be designated another novel coronavirus strain but still results in a disease that is similar to the current illness (e.g., a hypothetical “COVID-22”).  Thus, OSHA is considering specifying that this final standard would apply not only to COVID-19, but also to subsequent related strains of the virus that are transmitted through aerosols and pose similar risks and health effects.  OSHA seeks comment on this approach and alternatives to addressing the potential for new strains related to SARS-CoV-2.

Additional Information/Data Requested

Recognizing that the majority of the period that the public and industry had to comment on the proposed standard (aka the Healthcare ETS) occurred prior to when the Delta and Omicron variants became prevalent in the United States, OSHA requests new studies or data related to the two variants, particularly with respect to:

1. 1. The average number of days healthcare workers have taken away from work resulting from a COVID-19 infection or quarantine and the percentage of healthcare workers who have taken days away from work due to a COVID-19 infection or quarantine.
   2. The health effects for fully vaccinated employees, and fully vaccinated and boosted employees, who test positive for COVID-19, including data on days away from work, hospitalizations, long COVID, and fatalities.
   3. The percentage of healthcare workers who are at elevated risk of severe COVID-19 infections (e.g., resulting in hospitalization or extended days away from work), including for age-related or immunocompromised reasons (not based solely on vaccination status).
   4. The rate of infection, long COVID, hospitalization, and death among healthcare workers compared to those rates among the general adult population.
   5. The health effects and transmission rate of new and emerging variants and sublineages of variants, including Omicron BA.2.
   6. The vaccination rate among healthcare workers, including the rate of healthcare workers who are fully vaccinated and boosted.
   7. The clinical indicators that will reliably predict the degree of protection afforded by prior infection (i.e., infection-acquired immunity), and how long such protection lasts.
   8. Vaccine efficacy and how such efficacy decreases over time.
   9. The appropriate periodicity of additional vaccine doses and booster doses.
   10. Unintended consequences, such as decreases in staffing retention, or other impacts, such as increases in staffing retention, due to the potential alternatives raised in this partial reopening of the rulemaking record. The

The Informal Public Hearing and What this Includes

In addition to the opportunity to submit written comments, OSHA will hold a public hearing on the rulemaking.  If requested, the agency virtually always holds public hearings on significant rulemakings. The public hearing provides stakeholders an opportunity to provide oral testimony and documentary evidence on issues raised by the proposal.

For a little background on the process, OSHA’s regulation governing public hearings establishes the purpose and procedures of informal public hearings.  Although an administrative law judge (“ALJ”) presides over each OSHA hearing, the ALJ’s role is fairly limited.  He serves as the presiding officer of the hearing, controls the testimony and questioning of witnesses, and resolves any procedural matters relating to the hearing. The proceeding is largely informal and essentially legislative in purpose.  It is not an adjudicative proceeding subject to the Federal Rules of Evidence.  Instead, it is an informal administrative proceeding convened for the purpose of gathering and clarifying information.  Accordingly, questions of relevance, procedure, and participation generally will be resolved in favor of developing a clear, accurate, and complete record within the available time frame.

Inclusion of a public hearing in the rulemaking process typically adds many months to the rulemaking calendar.  Here, however, OSHA makes clear that, “[t]he available time frame for this rulemaking is short as the agency hopes to complete the rulemaking as quickly as possible[,]” providing that “OSHA remains aware of the dangers to healthcare workers exposed to COVID-19, as well as the potential for new variants and the surges of patients with COVID-19 that could follow in healthcare.”  Perhaps as a warning, OSHA also states that, per applicable law, “the Assistant Secretary may, on reasonable notice, issue additional or alternative procedures to expedite the proceedings.”

At the close of the hearing, there will be a post-hearing comment period during which stakeholders may submit final briefs, arguments, summations, and additional data and information to OSHA.  The ALJ does not make or recommend any decisions as to the content of the final standard.  Rather, OSHA will review all the evidence received into the record and will issue the final rule based on the record as a whole.

What Are the Deadlines?

Although rulemakings typically take years and years, OSHA is acting lightning-fast here, with deadlines quickly approaching (and a very low likelihood of any requests for extension being granted).  Specifically:

• • Although the public Hearing about the rulemaking will take place virtually in late April, individuals interested in testifying at the hearing must submit their notice of intention to appear (“NOITA”) no later than April 6, 2022.
  • Written comments must be submitted in 30 days from the publication of the Notice – by April 22, 2022.
  • The virtual Hearing will take place on April 27, 2022 (and will likely continue on subsequent days as necessary). OSHA emphasizes that although the hearing is open to the public, only individuals who file a NOITA by April 6^th may testify at the hearing.

The backdrop to OSHA’s urgency and speed in pressing forward to finalize a permanent standard is a lawsuit filed by several unions, including National Nurses United and the AFL-CIO.  These petitioners have requested the U.S. Court of Appeals for the District of Columbia Circuit force OSHA to immediately reinstitute the Healthcare ETS that OSHA withdrew, and issue a permanent standard within 30 days of a Court Order.  Oral arguments are set in that case for April 4, 2022.

Why is This Important?

The written comments and public hearing provide the last opportunity industry has to influence the scope, breath and substantive requirements/prohibitions of what will become a permanent COVID-19 standard applicable to the healthcare industry, and potentially to all facilities where any healthcare services are provided, even by non-hospital and non-healthcare employers.  Additionally, although the final rule will be tied to COVID-19 (and possibly subsequent related strains), the final standard also likely will form the foundation for the general infectious disease standard that the Biden Administration has prioritized.  In fact, as you may know, OSHA is in the process of getting the gears moving again on an infectious disease rulemaking.  Heading off concerns in this rulemaking will serve the healthcare industry well in dealing with a general, permanent standard that will exist indefinitely, well beyond this pandemic.

It is critical, therefore, that those industries and employers potentially impacted by this final rule make their voices heard at this final stage.  In particular, given that OSHA’s enforcement blitz is literally pushing covered employers back into compliance with the Healthcare ETS already, it is crucial that we let OSHA know what parts of the standard work and which parts do not, and most importantly, which parts are simply infeasible.

Please let us know if you are interested in our support in the development of written comments, and/or participation in the public hearing, and we can discuss options.