On September 24, the Safer Federal Workforce Task Force released guidance on workplace safety protocols for federal contractors and subcontractors related to COVID-19 (“the Guidance”).  The Guidance was issued pursuant to President Biden’s Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

As expected, the Guidance covers a broad range of contract types and contractors, and mandates COVID-19 vaccinations for covered contractor employees along with masking and social distancing measures to prevent the spread of the disease.  But it also includes some unanticipated exceptions.  The Guidance sets baseline requirements under the Executive Order that are expected to be updated over time and implemented through a contract clause that will be issued by the Federal Acquisition Regulatory (“FAR”) Council.  Federal contractors should carefully examine the Guidance and ensure that they are prepared to timely comply as well as monitor for and adapt to any updates from the Task Force.

Our prior post on the Executive Order can be found here.

What is Covered?

The Guidance extends to prime contractors and subcontractors at any tier that work on covered contracts and contract-like instruments.  Covered instruments are defined broadly to include bilateral agreements and, without limitation:

awards and  notices of awards; job orders or task letters issued under basic ordering agreements; letter contracts; orders, such as purchase orders, under which the contract becomes effective by written acceptance or performance; exercised contract options; and bilateral contract modifications.

The Guidance makes a point to emphasize that covered instruments include, but are not limited to, contracts covered by the Service Contract or Davis-Bacon Acts; concessions contracts not otherwise subject to the Service Contract Act; and contracts in connection with Federal property or land and related to offering services for federal employees, their dependents, or the general public.

The FAR Council is also expected to confirm that the Guidance extends to agreements for commercial items.  The Guidance does not include an exemption for small businesses or non-traditional contractors.

The Guidance exempts covered instruments valued at or below the Simplified Acquisition Threshold (currently $250,000).  In addition, the Guidance indicates that prime contracts and subcontracts “for the manufacturing of products” are exempt.  The Executive Order, in contrast, only includes an express exemption for subcontracts “solely” for the provision of products.  It is not clear whether the Guidance intends for there to be a substantive difference between agreements for “manufacturing” as opposed to “provision” of products.  In addition, it is not clear whether agreements need to primarily or solely involve products to benefit from an exemption.  For example, if the contract primarily is for the manufacture and delivery of products, but includes separate line items for testing or maintenance, it is not clear that the contract is covered.  The FAR Council will hopefully address these issues when issuing a new clause by October 8.

Although not stated in the Guidance, the Executive Order also expressly exempts grants and certain agreements with Indian tribes.  The FAR Council will hopefully confirm whether cooperative agreements are also excluded based on their similarity to grants.

Notwithstanding these exemptions, the Guidance “strongly encourage[s]” agencies to include the new contract clause in agreements that otherwise would be exempt once the clause is available, to the extent consistent with applicable law.  In doing so, the Guidance specifically mentions contracts that are exempt because they fall under the Simplified Acquisition Threshold and contracts and subcontracts for the manufacturing of products.  As a result, the Guidance could still be relevant for contractors and subcontractors that provide products or generally engage in low-value transactions with the U.S. Government if contracting officers insist that prime contractors accept the new clause.

Who is Covered?

The Guidance applies to any full- or part-time contractor or subcontractor employee who works on or “in connection with” a covered agreement.  Importantly, the Guidance notes that the “in connection with” language extends to employees who are not directly performing contract requirements, but provide other support services necessary for the performance of the contract(s), including human resources, billing, and legal support.  As a result, many employees working out of a corporate office or headquarters in general support of government contracts work may be covered.  It is not yet clear whether all indirect cost employees would be covered based on limited connections to covered agreements.  For example, it seems like it would be a stretch for the Guidance to cover executive teams or even heads of divisions merely because they oversee employees supporting a federal agreement.

The vaccination portion of the Guidance also applies to employees who are performing contract work completely remotely.  Remote workers, however, need not comply with the masking or physical distancing rules discussed below.  In addition, employees are not covered if they “only” perform work outside the United States and its outlying areas.

As a supplement to agreement-based coverage, the Guidance further applies to any employee who works at a contractor workplace location where employees who are working on or in connection with a federal agreement are “likely to be present,” unless the contractor can affirmatively determine that no interaction between covered and non-covered employees will take place.  As a result, employees who are not directly engaged in their employer’s federal contracts, or supporting them indirectly, may end up being covered at the same facility or campus due to their potential contact in common areas, including, for example, parking garages and stairwells.

The Guidance does not indicate when employees would be considered “likely to be present” at a covered facility.  Without additional detail from the FAR Council, employers may be left to exercise their best judgment in evaluating issues like whether an employee who can be expected to periodically visit a covered facility once or twice per year is subject to the vaccine mandate.  Similarly, employers may be left to determine whether employees who are internally designated as working remotely are subject to the vaccine mandate when they are not working on or in connection with a covered agreement, but may be called in for meetings at a facility only once or twice per year.

What Is a Covered Contractor Workplace Location?

A covered contractor workplace is any location controlled by a covered contractor where any employee working on or in connection with a covered contract is likely to be present during the period of performance of the contract, with the exception of employee residences for mask and social-distancing requirements.  The definition has broad application, and includes the entirety of a building or facility even if covered employees work only in a particular wing or specific floor, and all facilities in a multi-building complex or site even if covered employees work solely in a particular building, unless the covered contractor “affirmatively determine[s]” that none of its employees from other wings, floors, or buildings will come into contact with a covered employee during the period of performance, including in common areas such as lobbies, security clearance areas, elevators, stairwells, meeting rooms, kitchens, dining areas, and parking garages.  As indicated above, covered contractor workplace will in many instances also likely include corporate offices or headquarters where indirect cost employees may be working to support covered contract work.

What Does the Guidance Require?

Employees who are covered by the Guidance must be fully vaccinated by December 8, 2021, or by the first day of the period of performance of a newly awarded agreement, exercised option period, or extension or renewal that includes the clause and is issued on or after December 8, 2021.  Based on the broad definition of covered instruments, bilateral modifications to existing agreements and task, delivery, or purchase orders would also likely be subject to the same vaccination deadlines when subject to the new clause.  An employee is considered to be fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine.  The Guidance may be updated in the future to address the extent to which boosters will be required and any increase in the number of doses required for a single-dose vaccine.  Procedures implemented to comply with the Guidance will need to be sufficiently flexible to account for potential changes.

A vaccine counts under the Guidance if it is currently approved or authorized for emergency use by the U.S. Food and Drug Administration, which covers the Pfizer-BioNTech, Moderna, and Johnson & Johnson/Janssen vaccines, or listed for emergency use by the World Health Organization, which covers the AstraZeneca/Oxford vaccine.  Vaccines (not placebo) provided to participants in a clinical trial at a U.S. site also count, which covers the NovaVax vaccine.  Prior exposure to COVID-19 will not be an acceptable substitute for vaccination.

The Guidance requires employers to “review” proof of vaccination through proper documentation.  In particular, employers must review digital or paper copies of medical records documenting the vaccination, a COVID-19 Vaccination Record Card (CDC Form LS-319813_r), immunization records from a public health or state immunization information system, or another form of official documentation that identifies the vaccine name, date(s) of administration, and the name of health care professional or clinic site administering the vaccine.  Retention of employee documentation does not appear to be required.  However, copies of provided documentation or confirmation of review would likely need to be retained for audit purposes.  Employers are not permitted to rely solely on an employee attestation of vaccine status or the results of recent antibody tests showing prior exposure to COVID-19 or a covered vaccine.

In addition to vaccine requirements, the mandate sets out masking and social distancing requirements for covered workplaces.  These requirements supplement the rules already in place for any contract work being performed at federal work sites.

Contractors must ensure that in the workplace, all employees and visitors follow U.S. Center for Disease Control and Prevention (“CDC”) guidance for appropriate masking and social distancing.  In addition, in areas of high or substantial community transmission (as defined by the CDC), vaccinated individuals must wear a mask indoors.  The Guidance permits employers to adopt certain exceptions to masking requirements consistent with CDC guidelines, such as with respect to individuals that are alone in a closed office, eating or drinking for a limited time while appropriately distanced, or engaged in activities that may cause a mask to get wet, create difficulty breathing, or create another risk as determined by a workplace risk assessment.  An employer’s obligations may vary depending on local guidance based on data published in a CDC county tracker.

Contractors may need to provide masking accommodations to employees who seek medical or religious exemptions.  Individuals who are not fully vaccinated must wear a mask indoors and in certain outdoor settings, regardless of the community transmission level.  Fully vaccinated people do not need to physically distance, but those who are not fully vaccinated should stay six feet away from others.

The Guidance requires that covered contractors designate at least one person to coordinate implementation of and compliance with the mandate.  Such coordination need not be the person(s) only duties, but the designated individual(s) must ensure that information on required COVID-19 workplace protocols is provided to covered contractor employees and all others likely to be present at covered contractor workplaces, including visitors.  This obligation includes communicating the protocols and related policies, such as via email, websites, memoranda, or flyers, as well as posting signage setting forth the same. The designated person(s) must also ensure that covered contractor employees show or provide vaccination documentation.

Are There Any Exceptions?

As indicated above, contractors may need to provide accommodations to employees who are legally entitled to them for medical purposes or sincerely held religious beliefs. Contractors are responsible for considering and managing these requests for accommodations.

Unlike the Occupational Safety and Health Administration (“OSHA”) requirements for large employers, there is no option for contractor employees to submit to weekly testing as an alternative to vaccination.  Employees who have previously had COVID-19 are also not exempt from the vaccine mandate.  Relatedly, compliance with OSHA workplace safety requirements will not exempt covered contractors from compliance with the mandate, nor will compliance with the mandate excuse noncompliance with state or local laws establishing more stringent workplace safety protocols than required by the Guidance.

The Guidance recognizes that the requirements it imposes may conflict with state law that prohibits a contractor from engaging in covered activities.  For example, it is contrary to Montana’s prohibition on vaccine mandates.  Executive orders and contract clauses can sometimes preempt state law, and the Guidance explicitly provides that it supersedes any contrary State or local law or ordinance. The Montana Department of Labor & Industry has already suggested that there may ultimately be a showdown between Montana and the federal government regarding compliance with OSHA, healthcare, and federal contractor vaccine mandates. There will likely be a number of outstanding questions as to how federal and state law should interact in these circumstances, especially when dealing with situations in which an agency exercises its discretion to include the new clause in agreements that are not covered by the Executive Order.  In the interim, contractors will have to carefully consider how to proceed in the event of such conflicts.

The Guidance sets out a limited exception for contract work to begin in urgent, mission-critical projects before contractor employees have been fully vaccinated.  However, the exception must be approved by the federal agency head, and contractor employees must be fully vaccinated within 60 days of beginning the work.

When Are the Requirements Effective?

The FAR Council is required to release the new clause by October 8, 2021, and agencies responsible for agreements not subject to the FAR, such as concessions contracts, are required to release guidance to incorporate the requirements into their covered instruments by the same date.  For ongoing contracts awarded before October 15, 2021, the requirements must be included when an option is exercised or an extension is made on or after October 15.  Although not expressly addressed by the Guidance, bilateral modifications and task, delivery, and purchase orders appear to be treated like other agreements in terms of determining when they need to include the new contract clause.

For all new agreements, the requirements must be incorporated into agreements awarded on or after November 14 or when solicitation for the agreement was issued on or after October 15.  For agreements awarded between October 15 and November 14 pursuant to a solicitation issued before October 15, agencies are encouraged but not required to include the clause in new Agreements.  As stated above, once the clause is included in an agreement, employees must be fully vaccinated by December 8, 2021 or the first day on which an employer becomes subject to the clause after this date.

Notwithstanding this timing waterfall, agencies are also “strongly encouraged” to incorporate a clause requiring compliance with the Guidance into existing contracts prior to the date upon which the Executive Order requires its inclusion.

How Will the Mandate be Enforced & What Are the Penalties for Non-Compliance?

It remains unclear what contractors may expect in terms of enforcement or penalties once the new clause is included in an agreement.  Prior experience suggests that monetary fines may be available and that agencies may consider failure to comply with the clause as justification for a termination for default, poor performance evaluations, or even suspension or debarment in some scenarios.  Neither the Order nor the Guidance, however, provides clarification on this point.  It is imperative for future guidance to address this issue.

 

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Photo of Jennifer Plitsch Jennifer Plitsch

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She…

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
  • the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

Photo of Frederic Levy Frederic Levy

Fred Levy is senior counsel in the firm’s Government Contracts and White Collar Defense and Investigations Practice Groups. He is a leading suspension and debarment lawyer, focusing his practice on the resolution of complex compliance and ethics issues. He has successfully represented numerous…

Fred Levy is senior counsel in the firm’s Government Contracts and White Collar Defense and Investigations Practice Groups. He is a leading suspension and debarment lawyer, focusing his practice on the resolution of complex compliance and ethics issues. He has successfully represented numerous high-profile corporations and individuals under investigation by the government in civil and criminal matters, including False Claims Act cases, and in suspension and debarment proceedings to ensure their continued eligibility to participate in federal programs. He has also conducted numerous internal investigations on behalf of corporate clients and advises corporations on voluntary or mandatory disclosures to federal agencies. Fred regularly counsels clients on government contract performance issues, claims and terminations, and litigates matters before the boards of contract appeals and in the Federal Circuit.

Related to his work involving program fraud, Fred counsels clients in the area of contractor “responsibility.” He is involved in the development and implementation of contractor ethics and compliance programs that meet the standards of the Federal Acquisition Regulation, Federal Sentencing Guidelines, and Sarbanes-Oxley, and he regularly conducts ethics and compliance training.

Fred is a principal editor of Guide to the Mandatory Disclosure Rule, and of The Practitioner’s Guide to Suspension and Debarment, 4th Edition. He is a vice-chair of the Debarment and Suspension Committee of the ABA Public Contract Law Section, and a former co-chair of that committee and of the Procurement Fraud Committee. He is a graduate of Columbia College and Columbia Law School.

Photo of A.J. Carvalho A.J. Carvalho

A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance issues. He has assisted clients on myriad matters, including in complying with FDA regulations, responding to FDA enforcement actions and Congressional inquiries, conducting due diligence of FDA-regulated companies…

A.J. Carvalho advises medical device, pharmaceutical, biotechnology, and laboratory companies on FDA regulatory and compliance issues. He has assisted clients on myriad matters, including in complying with FDA regulations, responding to FDA enforcement actions and Congressional inquiries, conducting due diligence of FDA-regulated companies, and resolving issues that arise during product development.

Prior to joining the Food, Drug, and Device practice group, A.J. was a member of the Patent Litigation and White Collar Defense and Investigation Practice Groups. As a member of the Patent Litigation Practice Group, A.J. focused on representing pioneer pharmaceutical and biotechnology companies in Hatch-Waxman patent litigation. As a member of the White Collar Defense and Investigations Practice Group, A.J. focused on helping medical device, pharmaceutical, and biotechnology companies navigate civil and criminal investigations by the Department of Justice and FDA.

Prior to joining Covington, A.J. was a clinical research coordinator at Walter Reed National Military Medical Center focused on exploratory clinical research related to blast injuries (including amputations), advanced prosthetics (including myoelectric prosthetic control), and other concomitant conditions. His research and work has been published in numerous scientific peer-reviewed journals.