The Federal Security Advisory Panel (FESAP) Best Practices Checklist for Assessment of Current and Projected Needs for High or Maximum Containment Laboratory Space

S3: Science Safety Security

Biorisk Management

FESAP Function

In July 2010, Executive Order 13546 “Optimizing the Security of Biological Select Agents and Toxins (BSAT),” created and tasked the Federal Experts Security Advisory Panel (FESAP) to address policy issues relevant to the security of biological select agents and toxins.

The duties of the FESAP are solely advisory and shall extend only to the submission of advice or recommendations.

Background

In 2014, a series of incidents involving BSAT raised serious safety and security policy issues. The White House National Security Council (NSC) staff tasked the FESAP, in September 2014, to 1) identify needs and gaps and make recommendations to optimize biosafety, biosecurity, oversight, and inventory management and control for BSAT; 2) identify actions and any regulatory changes to improve biosafety and biosecurity; and 3) identify an approach to determine the appropriate number of high-containment U.S. laboratories required to possess, use, or transfer BSAT.

In response to these taskings, the FESAP delivered the December 2014 Report of the Federal Experts Security Advisory Panel. Among its other recommendations, Part IV of the report addresses the “Identification of an Approach to Determine the Appropriate Number of High-Containment U.S. Laboratories Required to Possess, Use, or Transfer BSAT”. The three-phase approach described in Part IV includes:

Phase I: Federal Assessment
Phase II: External Review Panel Assessment
Phase III: USG Consideration of External Review Panel Assessment

An intended outcome of Phase I is a ‘best practices checklist’ to be used as a guideline by departments and agencies when considering the construction of high or maximum containment laboratories (HCL). The best practices checklist will help ensure that departments and agencies have considered the different potential options to address their containment research needs and could potentially enable a reduction in the time and cost for planning; design; the release of the request for funding; the award; and the construction of HCL.

The checklist should help departments and agencies in operationalizing generalized principles, foster the use of standard methodologies, and assist in developing templates that could be applied to guide assessments of current and projected needs for HCL space, as well as mechanisms to efficiently meet those needs.

Scope

This Best Practices Checklist is advisory in nature; it is intended to assist departments and agencies in determining and evaluating all possible options and variables when considering their HCL needs. This guidance is not exclusive and does not replace existing policy or regulations. Departments and agencies will still be required to abide by all applicable acquisition, procurement, and contracting regulations, policy, and guidelines.

This checklist is intended to be applied only to HCL supported by federal funding within the United States. For federally supported laboratories outside the United States, see the Department of State’s “Guiding Principles and Assessment Process Related to the Provision of Biocontainment Facilities to Foreign Countries.”

General Principles

Departments and agencies who are considering their current and projected needs for HCL space should adhere to the following general principles:

Departments and agencies should be able to show a demonstrated need for HCL space, and should have a process that carefully considers alternatives before constructing new HCL space.
Departments and agencies should demonstrate their commitment and ability to operate, maintain, and sustain the facility in a safe and secure manner upon completion.
High or maximum containment laboratory space should be designed to conform to current U.S. biorisk management standards, as appropriate, and should be sufficient to meet mission requirements in a safe, secure, and efficient manner.
Departments and agencies should ensure that a robust community engagement process is initiated before the construction of any new HCL buildings. Proactive community engagement is important for transparency, trust, and the ongoing operation of HCL facilities.

Best Practices Checklist: Factors for Consideration in Assessing High Containment Space Needs

The following checklist contains questions that departments and agencies should consider in operationalizing the general principles listed above. These questions may not have simple ‘yes’ or ‘no’ answers; departments and agencies should develop detailed responses for each.

This checklist is not intended to serve as a series of boxes that must be checked. Rather, it is intended to provide a comprehensive set of questions that department and agencies should consider throughout their planning process. It is intended as tool to help departments and agencies ensure that they are evaluating all possible options and variables when considering their HCL needs.

1. Departments and agencies should be able to show a demonstrated need for HCL space, and should have a process that carefully considers alternatives before constructing new HCL space.

What is the mission or mandate of the department or agency funding the facility? How will the facility be used to carry out this mission? Which capabilities and capacity needs are being addressed?
What is the existing scientific program, and are there gaps in the existing program that require HCL space?
What are the program’s future direction, priorities, and anticipated expansion?
Are there internal or external partnership opportunities which would mitigate the need to build HCL space? If so, with which organizations?
Is an HCL capability the only means to meet the demonstrated need? Has the department or agency conducted an analysis of alternatives to consider other means of achieving the desired capacity and, if so, what were the alternatives and what were the results for each?
What additional or unique HCL capability has or will be provided by this effort, which goes beyond existing capabilities (e.g., biosafety level, additional facility square footage, and equipment)?
Will the facility provide capacity to handle emergency response surges in processing high-volumes of samples? Should it have the flexibility to support both research and emergency response?
What are the projected utilization rates for the facility?

2. Departments and agencies should demonstrate their commitment and ability to operate, maintain, and sustain the facility in a safe and secure manner upon completion.

What organization does or will own, operate, and oversee the functions of the proposed HCL? Has this organization committed to long-term funding, oversight and leadership of the facility? How has the organization demonstrated this commitment?
What experience does the organization have in operating HCL? Do the management and laboratory staff have high or maximum containment experience? Has a training and education plan been envisioned for the staff prior to, or as part of, the facility commissioning?
What resources are available to management and laboratory personnel? Have budget requests for modification or new construction been factored into long term maintenance and improvement costs? Have these projected costs been properly assessed and vetted with experts?
What organizations will partner on, collaborate with, or fund activities at the proposed HCL? Specify the role of each organization.
Have plans for long-term sustainability of the facility been developed and evaluated? What are they?
What guidance, plans, procedures, and training programs are available to operate safely and securely? Do they include:

Biosafety
Biosecurity
Biorisk Management
Incident Response Plans for breaches of containment or releases of biological agents or other hazardous materials
Occupational Safety and Health
Security

Has the organization or its partners lost control or accountability of select agent material in the past five years, had significant accidents or laboratory-acquired infections, or suffered breaches in security? Consider the specifics for each significant episode, if any, as well as the corrective actions taken.

3. HCL space should be designed to conform with current U.S. biorisk management standards, as appropriate, and should be sufficient to meet mission requirements in a safe, secure, and efficient manner.

Will the planned HCL space replace existing containment space that is outdated, not in conformance with current safety or security standards, or exceedingly costly to maintain? If so, describe the facility to be replaced.
Have comprehensive risk assessments, based on the types of agents and operations that are planned, been conducted to determine necessary biosafety and security features to include in the HCL? If so, describe the results.
Has a threat assessment been conducted for the facility to determine security design features?
What standards will be used for:

Physical security
Information security
Personnel reliability
An inventory tracking system and protocols for access to and accountability for pathogens located at the facility
An occupational health and safety program that complies with applicable federal, state, and local requirements. Such a program should include training procedures for personnel to ensure safe and secure handling of pathogens. Has the facility considered a system to document training and proficiency of staff?
Accreditation for clinical testing (if applicable)

Is there a comprehensive Incident Response Plan? What scenarios does it cover? Will personnel be trained to implement the Incident Response Plan?
Have training procedures for personnel been developed and evaluated to ensure safe and secure handling of pathogens at the HCL, or are there plans for such training? Describe those procedures developed and/or those procedures being planned and describe the results of the evaluations, if any.

4. Departments and agencies should ensure that a robust community engagement process is initiated before the construction of any new HCL buildings. Proactive community engagement is important for transparency, trust, and the ongoing operation of high or maximum containment facilities.

Has there been a process of community engagement regarding the proposed siting (or significant expansion) of the HCL, perhaps as part of the Environmental Impact Assessment process? If so, describe the community engagement activities.
How have the risks and benefits of the proposed HCL been communicated to the community?
Are there any community concerns? If so how have they been addressed, or is there a plan to address them? Are there any ongoing protests or legal actions?
Is there a plan for ongoing engagement and transparency between the HCL and the community? How will the community be kept informed of safety or security incidents, as appropriate? Review or implement engagement and communication plans.

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The Federal Security Advisory Panel (FESAP) Best Practices Checklist for Assessment of Current and Projected Needs for High or Maximum Containment Laboratory Space

S3: Science Safety Security

FESAP Function

Background

Scope

General Principles

Best Practices Checklist: Factors for Consideration in Assessing High Containment Space Needs

1. Departments and agencies should be able to show a demonstrated need for HCL space, and should have a process that carefully considers alternatives before constructing new HCL space.

2. Departments and agencies should demonstrate their commitment and ability to operate, maintain, and sustain the facility in a safe and secure manner upon completion.

3. HCL space should be designed to conform with current U.S. biorisk management standards, as appropriate, and should be sufficient to meet mission requirements in a safe, secure, and efficient manner.

4. Departments and agencies should ensure that a robust community engagement process is initiated before the construction of any new HCL buildings. Proactive community engagement is important for transparency, trust, and the ongoing operation of high or maximum containment facilities.

Biosafety

Biosecurity

High Consequence Research Oversight

Law and Policy

Synthetic Nucleic Acid Screening

Frequently Asked Questions