This document discusses laboratory commissioning and whether it could serve as a basis for biosafety regulation. It defines commissioning as ensuring facilities are constructed and operating according to design standards. Commissioning involves planning, design, construction, acceptance testing, and warranty phases with various stakeholders. Existing policies like BMBL and FSAP registration already promote some commissioning practices. The document considers options for expanding commissioning requirements and regulating more bioscience institutions to help minimize biosafety risks.

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Laboratory Commissioning – A
Potential Basis for Biosafety
Regulation?
Gabrielle A. Dotson
March 2016

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Table of Contents
ABSTRACT.................................................................................................................................................3
INTRODUCTION.......................................................................................................................................3
History and Existing Policy....................................................................................................................3
Biosafety in Microbiological and Biomedical Laboratories (BMBL) ..................................................3
Executive Order 12902 .........................................................................................................................4
Public Health Security and Bioterrorism Preparedness and Response Act of 2002 .............................5
WHAT DOES IT MEAN FOR A LABORATORY TO BE COMMISSIONED? ................................6
Commissioning Phases............................................................................................................................6
Planning Phase......................................................................................................................................7
Design Phase.........................................................................................................................................7
Construction Phase................................................................................................................................7
Acceptance Phase..................................................................................................................................7
Warranty Phase.....................................................................................................................................8
Retro-commissioning and Re-commissioning ......................................................................................8
Retro-commissioning............................................................................................................................8
Re-commissioning ................................................................................................................................9
Guidelines and Standards ......................................................................................................................9
SHOULD ALL BIOSCIENCE INSTITUTIONS BE COMMISSIONED?.........................................10
Regulatory Goal ....................................................................................................................................10
Regulatory Scope ..................................................................................................................................11
Option 1 - Commissioning with Discretion.........................................................................................11
Option 2 - Commissioning and Retro-Commissioning with Discretion..............................................11
Option 3 - Universal Guideline-Driven Commissioning and Retro-Commissioning..........................11
Regulatory Demand..............................................................................................................................12
CONCLUSION .........................................................................................................................................13

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ABSTRACT
This report addresses the laboratory commissioning process and considers whether it is a practice
that could potentially serve as a basis for biosafety regulation. The contained use of biological
pathogens in laboratories across the nation remains an ongoing safety concern among the public,
scientific communities, and regulatory agencies alike. Proper laboratory conduct and personnel
training play an instrumental role in minimizing the risk of toxic release into the environment.
However, quality design, construction, and engineering standards tailored towards facilities
housing these pathogens are a necessary supplement. Commissioning of high and maximum
containment laboratories (at or above BSL-3) is concerned with ensuring proper physical
infrastructure – that includes electrical, mechanical, and plumbing systems among others – as
well as the training of operation and maintenance staff to create the necessary containment
barrier for working with high-risk pathogens.
INTRODUCTION
Simply put from a safety standpoint, commissioning is “a method of risk reduction.”1
The
Department of Health and Human Services (HHS) has defined commissioning as, “the
systematic process of ensuring facilities are performing properly in accordance with design intent
and the needs of the use.”2
Quality, reliability, functionality, and maintainability are all within
the scope of what laboratory commissioning aims to achieve for biocontainment facilities.
History and Existing Policy
There are policies and guidelines in place that provide varying levels of regulatory authority over
compliance with biosafety measures like laboratory commissioning. Biosafety in Microbiological
and Biomedical Laboratories (BMBL) was jointly published by the CDC and NIH in 1984 and
though it lacks legislative force, it is a widely acknowledged set of biosafety guidelines. A
decade later in 1994, Executive Order 12902 was issued and federal agencies moving forward
were required to establish a commissioning program for their facilities. Subsequently, pursuant
to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the
Federal Select Agents Program (FSAP) was established requiring laboratories to register for use,
possession, or transferring of biological select agents and toxins (BSAT), and registered entities
to undergo commissioning.
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
The BMBL outlines “best practices” for each biosafety level and offers facility design and
engineering recommendations that help provide a secondary containment barrier for laboratories.
These recommendations cover facility features like HVAC ventilation and HEPA filter systems,
1
Commissioning for Federal Facilities: A Practical Guide to Building Commissioning, Recommissioning,
Retrocommisisoning, and Continuous Commissioning. U.S. Department of Energy, Federal Energy. Web.
Management Program, and Enviro-Management & Research, Inc. Publication. Web.
2
"Section 4-12: Facility Commissioning." Vol. 2. HHS Facilities Program Manual. U.S. Department of
Health & Human Services, 2011. Web.

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self-closing doors and sealed windows, eye-wash and shower stations, and audible alarms. Some
of these recommendations are as follows,3
BSL-3 Recommendation 9: “A ducted air ventilation system is required. This system must
provide sustained directional airflow by drawing air into the laboratory from “clean”
areas toward “potentially contaminated” areas. The laboratory shall be designed such
that under failure conditions the airflow will not be reversed. Laboratory personnel must
be able to verify directional airflow. A visual monitoring device, which confirms
directional airflow, must be provided at the laboratory entry. Audible alarms should be
considered to notify personnel of air flow disruption.”
BSL-4 Recommendation 9: “All HEPA filters should be located as near as practicable to
the cabinet and laboratory in order to minimize the length of potentially contaminated
ductwork. All HEPA filters must be tested and certified annually. The HEPA filter
housings should be designed to allow for in situ decontamination and validation of the
filter prior to removal. The design of the HEPA filter housing must have gas-tight
isolation dampers, decontamination ports, and ability to scan each filter assembly for
leaks.”
Executive Order 12902
Mandated facility commissioning initially began not as a safety effort but rather as an effort to
optimize facility energy systems and reduce overall energy consumption. Part 3, Section 306 of
Executive Order 12902 calls for all federal agencies involved in the construction of a new
facility to,
“Ensure that the design and construction of facilities meet or exceed the energy
performance standards applicable to Federal residential or commercial buildings as set
forth in 10 CFR 435… and establish and implement a facility commissioning program
that will ensure that the construction of such facilities meets the requirements outlined in
this section before the facility is accepted into the Federal facility inventory.” 4
EO 12902 also calls for the Secretary of Energy and Administrator of General Services to
develop a model building commissioning program. Pursuant to this request, the Department of
Energy (DOE) published the Model Commissioning Plan and Guide Specifications.5
This guide,
however, is not specific to biological research facilities.
3
Chosewood, L. Casey., and Deborah E. Wilson. Biosafety in Microbiological and Biomedical
Laboratories. U.S. Dept. of Health and Human Services, Public Health Service, Centers for Disease
Control and Prevention, National Institutes of Health, 2009. Web.
4
Exec. Order No. 12902, 3 C.F.R. (1994). Print.
5
Stum, Karl, and Arun Jhaveri. Model Commissioning Plan and Guide Specifications. Version 2.02. US
Department of Energy, 1997.

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Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The passing of the Public Health Security and Bioterrorism Preparedness and Response Act of
2002 instituted the Federal Select Agents Program (FSAP) which required the U.S. Department
of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) to
establish regulation concerning the possession, use, and transfer of select agents – a set of
regulations now known as the Select Agents Regulations (SAR).
SAR requires laboratories seeking BSAT certification, also referred to as FSAP registration, to
undergo commissioning. Laboratories must prove that their commissioned facilities are
operationally ready and must pass the FSAP-conducted inspection prior to receiving
certification. Pre-registration inspections occur once a laboratory facility has completed the
commissioning process. FSAP has a set of standardized checklists used for inspection purposes
that verify the presence of systems installed during commissioning as well as overall compliance
with SAR.6
The following regulations address the respective FSAP registration and biosafety
requirements.7
42 C.F.R Part 73.7 – FSAP Registration
73.7(f) “The issuance of a certificate of registration may be contingent upon inspection or
submission of additional information, such as the security plan, biosafety plan, incident
response plan, or any other documents required to be prepared under this part.”
42 CFR Part 73.12 – Biosafety,
73.12(a) “An individual or entity required to register under this part must develop and
implement a written biosafety plan that is commensurate with the risk of the select agent or
toxin, given its intended use. The biosafety plan must contain sufficient information and
documentation to describe the biosafety and containment procedures for the select agent or
toxin, including any animals (including arthropods) or plants intentionally or accidentally
exposed to or infected with a select agent.”
73.12(b) “The biosafety and containment procedures must be sufficient to contain the select
agent or toxin (e.g., physical structure and features of the entity, and operational and
procedural safeguards).”
73.12(c) “In developing a biosafety plan, an individual or entity should consider:
(1) The CDC/NIH publication, “Biosafety in Microbiological and Biomedical
Laboratories.”
6
FSAP Inspection Checklists can be retrieved from: http://www.selectagents.gov/checklists.html
7
42 C.F.R. § 73

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While SAR might suggest that a certified laboratory is a commissioned laboratory and
conversely that a commissioned laboratory is a certified laboratory, there are some exceptions
that prevent these terms from being completely interchangeable. BSAT laboratories that existed
prior to the implementation of this statute, for example, are able to obtain certification without
undergoing the commissioning process, although there is a set of minimum facility verification
requirements that must be performed.8
Additionally, a commissioned laboratory may not be
certified if it does not satisfy the appropriate standards required by FSAP, although this status is
typically only temporary.
WHAT DOES IT MEAN FOR A LABORATORY TO BE COMMISSIONED?
Laboratory commissioning is a team effort. Individuals with varying functional expertise
collaborate to make sure laboratory facilities are constructed in accordance with their intended
use and to make sure that there is a smooth transition from phase to phase of the commissioning
process. The critical individuals involved include the laboratory owner, architects and engineers
(A/E), operations and maintenance personnel (O&M), commissioning agent or authority,
construction manager, construction contractors, and the biosafety officer and staff. These
individuals are typically hired from specialized firms to participate in building commissioning,
referred to as third-party commissioning. Some entities, like the CDC however, are already
equipped with their own interagency commissioning teams and solely use their own manpower
instead of third party services, referred to as self-commissioning.9
It is not clear whether there is
a significant outcome disparity between third-party commissioning teams and those
characterized as self-commissioning, however, tradeoffs do exist. Third-party commissioning
teams are said to be more cost-effective while self-commissioning requires a large internal
capacity and use of personal resources. On the other hand, self-commissioning teams are said to
be more efficient because the entire commissioning team is involved from the beginning --
resulting in a more cohesive unit -- rather than members being brought in at different phases of
the process on an ad hoc basis, as is typically the case with third-party commissioning teams.
Regardless, the step-by-step process of commissioning is essentially the same. Each member of
the commissioning team plays a key role in one or more of the roughly five commissioning
phases: Planning (or Pre-Design), Design, Construction (or Installation), Acceptance, and
Warranty.
Commissioning Phases
The following descriptions are not formally established commissioning procedures but are the
common steps taken during the commissioning process, as identified by the Department of
Energy (DOE).10
When approaching the acceptance phase, functional performance testing and
training procedures may vary depending on laboratory type. Typically, facilities operating at
BSL-3 or ABSL-3 are subject to the same testing standards while BSL-3-Ag, BSL-4, and ABSL-
8
2014 FSAP Policy Statement: http://www.selectagents.gov/regBSL3ABSL3policy.html
9
The CDC’s commissioning team is independent of the CDC group involved with the Federal Select
Agents Program (FSAP).
10
Commissioning for Federal Facilities available at:
http://cms.doe.gov/sites/prod/files/2014/07/f17/commissioning_fed_facilities.pdf

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4 facilities are subject to more stringent guidelines and held to higher standards because of their
more demanding laboratory environment.
Planning Phase
The laboratory owner is responsible for most of the planning phase responsibilities. During this
time, the owner documents the design objective and intent, defines the project budget, hires the
A/E, and collaborates with others to begin drafting the commissioning plan. The commissioning
plan is an important document and serves as a useful guide for team members throughout the
commissioning process. It includes the project and design overview, scheduling details,
commissioning requirements, testing procedures and requirements, as well as any additional
information logistically relevant to the commissioning process. The commissioning plan
continually undergoes refining and updating as the process progresses. The commissioning agent
may be hired at this time to aid in the development of the commissioning plan, however in some
cases they are not brought in until the design or construction phases. If the commissioning agent
is present, their primary role will be to provide oversight and ensure that the project remains
organized and on track.
Design Phase
During the design phase, the A/E drafts the Basis of Design (BOD) document which specifies
what containment systems are needed and clearly defines the standards for these systems
including their installation, operation, and maintenance requirements. The design parameters that
are specified should be consistent and compliant with existing biosafety regulatory guidelines. At
this time, other members of the commissioning team begin preparing for the subsequent
commissioning phases by developing construction checklists, functional performance test
procedures, and operator training requirements. Additionally, the commissioning agent is
responsible for reviewing the design documents and verifying that everything is consistent with
the design objective and intent laid out in the planning phase documentation.
Construction Phase
Contractors are brought in at this time to begin constructing the laboratory. The construction
checklist and documentation from the previous phases allow the contractor to better understand
and meet the expectations of the project. The commissioning agent documents the construction
by verifying that everything on the checklist is satisfied and is responsible for determining
whether or not the facility equipment and systems are ready for the next phase where they will
undergo functional testing.
Acceptance Phase
The acceptance phase involves functional performance testing as well as training for O&M staff.
Functional testing is a way to verify that all equipment and systems are performing as they
should -- according to their design intent and standards. Tests typically include failure scenario
simulations to ensure that reboot and backup systems are successful. Throughout the testing
period, deficiencies and failures are documented and re-testing occurs until all systems are
working properly. This phase of the process is imperative for laboratory certification. The
installation contractors are responsible for running the tests while the commissioning agent

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documents the results. Additionally, O&M staff are required to complete the necessary training
sessions during this phase. Training serves the purpose of ensuring that occupants are equipped
to operate system controls and are prepared for all contingencies like system failures. Trainees
are made aware of the location and operation of safety equipment like eye washes and showers,
briefed on procedures for rectifying overnight system set-backs, and familiarized with location
and use of alarms as well as with proper emergency evacuation protocols. Manuals addressing
these procedures and more are reviewed and finalized as a future reference for laboratory
occupants. Additionally, earlier documentation is collected to submit into a draft commissioning
report that will later serve as a guideline for inspection purposes.
Warranty Phase
This last phase of the commissioning process is an opportunity for the commissioning agent to
periodically check in with the facility staff and resolve concerns regarding operational issues that
may impact the facility’s intended use – that is, operational issues identified during performance
testing by the installing contractors. Additionally, seasonal testing is performed and feedback on
the commissioning report is welcomed before finalization. The typical warranty period for an
entire laboratory facility is 12 months and begins once construction of the facility is complete.
As a biocontainment lab, annual inspections are required so facility systems and equipment
typically undergo routine re-validation even after the warranty period has expired. Seasonal
testing, also referred to as deferred testing, is when functional performance testing for systems
are intentionally delayed until a different time of year to ensure that they operate under certain
weather conditions. The very last step of commissioning is finalization of the commissioning
report which brings together earlier project documentation in addition to functional testing
reports, O&M training records, the timeline/schedule of significant events that took place
throughout the project, and additional information that may be referred to or requested during
forthcoming inspections.
The laboratory facility is not fully operational and open to laboratory occupants until all phases
of the commissioning process are complete. Though the facility may be fully capable of
operation once the acceptance phase is finished, the warranty phase is reserved only for
operation for functional testing purposes. Once the warranty phase ends, FSAP inspections will
ensue and once the facility has been approved by and officially registered with FSAP, then the
facility is made available for full operation.
Retro-commissioning and Re-commissioning
Not all high and maximum containment laboratories have undergone the commissioning process
and, for those that did, the certification must be renewed every three years. Facilities that were
built prior to the establishment of the FSAP commissioning requirement, are able to undergo a
slightly modified process referred to as retro-commissioning. Those that have been
commissioned but that have subsequently undergone substantial renovation are required by SAR
to be commissioned again, a process called re-commissioning.
Retro-commissioning
Since retro-commissioning applies to facilities that are already constructed, the process has less
to do with the design and intent of the facility and more to do with optimization of individual

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systems and equipment. The purpose of retro-commissioning is to improve system efficiency,
reduce risk, relieve the burden on maintenance and engineering staff, and bring all facility
standards into full compliance. The process consists of a planning phase where problems are
identified, a discovery phase where system and equipment are analyzed and diagnosed, a
correction phase where optimization and functional testing takes place, and finally a hand-off
phase where documentation is finalized and operational and maintenance training occurs. While
retro-commissioning is not an FSAP requirement, it is encouraged because it is the easiest way to
ensure compliance with containment criteria and because it is considered a laboratory “best
practice”.
Re-commissioning
Re-commissioning is performed typically to address any increase in occupant complaints, energy
use, and maintenance calls. Though re-commissioning is only required if a commissioned
existing building is planning to, or has undergone substantial renovation, other commissioned
facilities will typically undergo this abbreviated commissioning process to ensure they continue
to comply with FSAP inspection standards. Re-validation occurs annually and if inspectors find
that issues uncovered are not being subsequently addressed, the facility’s registration can be
revoked. It is suggested that laboratory facilities undergo re-commissioning every three to five
years, focusing on different systems and equipment on a rotating basis. During the process,
functional testing may be performed and results compared against baselines from initial
commissioning testing. Additionally, this is the time for documentation and testing procedures to
be updated
There are project planning, design review, implementation and verification, and periodic review
phases. If the facility is being recommissioned for renovation purposes, components like the
design intent are redrafted and any other necessary redesign parameters are applied. If a facility
is being recommissioned for optimization purposes, then the primary goal of each phase is to
verify that systems are operating according to the original intended specifications and ensure
optimal functionality of the equipment and systems in question.
Guidelines and Standards
For the purpose of this discussion, guidelines refer to the specific procedures undertaken during
the commissioning process - like those presented earlier. Often, these procedures are not
consistent from lab to lab, as there is plenty of room for variation and personal discretion. What
keeps these guidelines from being completely heterogeneous and lab-dependent, however, are
the standards that all laboratories have to meet as biocontainment facilities. In 2008, the National
Institutes of Health (NIH) published their most recent edition of Design Requirements Manual
for Biomedical Laboratories and Animal Research Facilities which outlines design policies and
guidelines for BSL-3 and ABSL-3 biocontainment facilities.11
In this manual, the NIH defines a
11
According to the NIH, the Design Requirements Manual is the only manual of its kind for biomedical
research laboratory and animal research facilities in the United States. Compliance with guidelines in this
manual are only enforced for NIH owned and leased new buildings and renovated facilities.

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“containment laboratory” as a laboratory that, “employs engineering controls for managing
infectious materials in the laboratory environment where they are being handled or maintained.”
Federal agencies, like the CDC and DHS who do not have commissioning guidelines of their
own, have used these NIH guidelines when commissioning their facilities in the past. Provisions
outlined in the BMBL, SAR, and FSAP Inspection Checklists are considered to be standards.
Due to the legislative force of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, commissioning standards tend to have more leverage than commissioning
guidelines and are consequently more enforceable.
SHOULD ALL BIOSCIENCE INSTITUTIONS BE COMMISSIONED?
It is evident that laboratory commissioning is a precautionary practice, and perhaps one that
could adequately serve as a basis for federal biosafety regulation. Commissioning a laboratory is
already a useful way of distinguishing BSAT labs from non-BSAT labs and, by way of that
distinction, delegating what kind of work can and cannot be done in each. Is it enough that only
high-containment laboratories be required to undergo this practice? Should all laboratories be
required to undergo commissioning? While this is not an endorsement for adopting a mandate
requiring non-BSAT labs to be commissioned, it is a proposal to consider the implications of
such a mandate. With or without all labs undergoing commissioning, the commissioning process
would not only serve as a means of risk reduction as stated earlier, but could also give a useful
indication of the number of high and maximum containment facilities in use by requiring
commissioning reports to include the biosafety level that the facility operates at. In considering
what a regulation requiring all bioscience laboratory facilities to be commissioned might look
like, it is important to understand the goal it would aim to achieve, identify the scope of the
requirement, and determine whether there is a demand for the regulation.
Regulatory Goal
The goal of the proposed regulatory practice would first and foremost be to ensure the safety of
the community writ large from the release of toxic biological agents as well as ensure public
confidence in the safe operation and maintenance of biocontainment labs. Though it has been
acknowledged that biological risk expands beyond research involving BSAT, non-BSAT
laboratories are currently not subjected to a similar sense of urgency to establish more stringent
secondary containment barriers. Incidentally, most laboratory-acquired infections (LAIs) occur
at BSL-2 laboratories.
While the BMBL does not insist that BSL-2 laboratories be annually re-verified and documented
as it does for laboratories operating at BSL-3 or above, it does offer some secondary containment
barrier recommendations:
The manual is available at the NIH Policies and Guidelines Webpage:
http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoliciesandG
uidelines/Pages/DesignRequirementsManualPDF.aspx

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BSL-2 Recommendation 9: There are no specific requirements for ventilation systems.
However, planning of new facilities should consider mechanical ventilation systems that
provide an inward flow of air without recirculation to spaces outside of the laboratory.
BSL-2 Recommendation 10: HEPA filtered exhaust air from a Class II BSC can be safely
recirculation [sic] back into the laboratory environment if the cabinet is tested and
certified at least annually and operated according to manufacturer’s recommendations.
Even though these standards are not as strict as those for high and maximum containment
laboratories, BSL-2 labs could still undergo the same commissioning process. Similar to the
reduced parameters between BSL-3 and BSL-4 laboratories, BSL-2 laboratories would simply
have a lower number of controls to monitor. Nevertheless, there is still a need for confirming that
the systems and equipment that these laboratories do have, are performing and functioning as
designed.
Regulatory Scope
If both BSAT and non-BSAT laboratories were required to undergo commissioning, the
regulation for that requirement could be implemented in a number of ways.
Option 1 - Commissioning with Discretion. Require all laboratory facilities yet-to-be built to
undergo commissioning prior to occupancy and operation, without further stipulation.
This option would be a “bare minimum” approach, so to speak. While it would effectively serve
to provide a level of safety for all new laboratory facilities to come, it would do so without
burdening existing laboratories that were never commissioned. Restraint in imposing this
requirement on un-commissioned laboratories, however, would defeat the intent of the
regulation. Solely commissioning new laboratories would only partially achieve the secondary
containment barrier that is needed to extensively attain appropriate biocontainment.
Option 2 - Commissioning and Retro-Commissioning with Discretion. Option 1 plus requiring
that existing un-commissioned laboratories undergo retro-commissioning.
This broader-scoped option would rectify the issue mentioned under option 1. Additionally, it
would mitigate the burden on operation and maintenance staff at un-commissioned
biocontainment labs who likely deal with a high frequency of system deficiencies and failures
because the equipment and systems may not be optimized for a laboratory setting or the intended
use. The retro-commissioning process as discussed earlier is not as extensive as the
commissioning process for new facilities. There is little that can be done to revamp the facility
systems and construction. However, the benefit of being able to optimize operating and
maintenance procedures can still have an invaluable effect on biosafety.
Option 3 - Universal Guideline-Driven Commissioning and Retro-Commissioning. Option 2 plus
establishing a set of commissioning guidelines and standards that all laboratories henceforth have
to comply with.

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Evidently, this option is the most stringent and developmentally complex of the three provided. It
may be necessary to supplement the proposed commissioning mandate with a set of
commissioning guidelines to prevent laboratories from engaging in a commissioning project that
may be sub-par to the caliber expected. Previously un-commissioned laboratories that have been
able to operate their facilities for years may consider mandatory commissioning unnecessary. As
expensive, lengthy, and resource-guzzling as the commissioning process is, those same
laboratories may want to take the path of least resistance to circumvent regulatory guidelines that
they view as more of an obstacle than a safety investment. Circumvention could include hiring a
commissioning team that offers general building commissioning service, as opposed to
laboratory-specific services - typically general building standards and guidelines are less
stringent than those for containment facilities. Establishing commissioning guidelines would be a
way to ensure that there are no loopholes in the execution of this regulation.
Additionally, in 2009, the U.S. Government Accountability Office (GAO) published a report on
high-containment laboratories in which they addressed a series of incidents that had occurred in
high-containment laboratories.12
One such incident was a power failure at one of the CDC BSL-4
facilities in 2007. The CDC concluded that the power failure was a result of an unreliable backup
power system that was installed and tested in compliance with “standard building codes”. At the
time the incident occurred, the laboratory was not registered under FSAP so it remains unclear
what specific commissioning or re-validation guidelines the laboratory was complying with. The
incident highlighted the absence of standardized testing procedures for high-containment labs
and the discrepancy in using “standard building codes” for laboratories. The risks associated with
biological research facilities are inherently different from those associated with facilities serving
a different purpose. Though the NIH has since established their own laboratory commissioning
guidelines and several governmental agencies comply with them, those guidelines are certainly
not enforced or universal. As such, it is only reasonable that biosafety-specific and regimented
guidelines, whether informed by existing ones like the NIH commissioning guidelines, be
established and mandated for all laboratory commissioning projects.
Additionally, varying sets of guidelines that correspond to laboratory type (biosafety level) and
facility status (newly constructed, undergoing renovations, or un-commissioned) could be
implemented to add some flexibility to the regulation. Furthermore, so as not to impose a
compounded burden, this option might exempt previously commissioned laboratories -- those
that used commissioning guidelines that may not align with newly proposed ones – unless they
are undergoing renovation.
Regulatory Demand
Taking a step back, the effect of the proposed mandate on the regulated community must be
considered. Is there a demand for the proposed mandate? Who or what will be impacted most by
this regulation? The regulated community would include laboratory owners, agencies that have
their own commissioning teams and guidelines, as well as commissioning firms/industries that
offer third-party commissioning services. Federal agencies like DHS, CDC, and NIH who have
12
United States Government Accountability Office. 2009. High-Containment Laboratories: National
Strategy for Oversight Is Needed. Report to Congressional Requesters. GAO-09-574. Web.

13. 13
their own laboratory facilities and personnel involved in the commissioning process typically
adhere to standards and guidelines laid out in the BMBL and/or NIH Commissioning Policy,
respectively. These agencies will likely view expanded commissioning regulation, especially
regulation imposing new guidelines, as an infringement upon the refined commissioning
practices that they already have in place. Further, it may be difficult to impose guidelines that are
not inherently nebulous and open to varied interpretations.
Users and occupants of the laboratory, on the other hand, may appreciate a regulation requiring
that all laboratories be commissioned. An optimally functioning laboratory that is less prone to
system failures would not only ensure worker and community safety, but would also protect the
researchers’ prized laboratory possession – their experiments. Power failures could compromise
experimental results. Poor air filtration could contaminate reagents. Laboratory occupants may
feel that commissioning has a considerable stake in the outcome of their work.
CONCLUSION
When considering what would make an effective basis for biosafety regulation, several
approaches and strategies may come to mind – typically ones that focus on the threat itself or
that focus on the individuals working with the threat. Laboratory commissioning is a unique
strategy for regulating all bioscience institutions in that respect. It certainly has the depth and
rigor to be a viable option and FSAP has already proven that it is feasible to regulate use,
possession, and transfer of high-risk pathogens through commissioning. The question that
remains is whether this regulation should be expanded and applied to all biological research
facilities. Does it make sense to impose a process so extensive upon non-BSAT labs, especially
those operating at or below BSL-2? Perhaps it would make more sense to have multiple bases of
regulation working together to ensure biosafety for all bioscience institutions – one specific to
the agent, one specific to the individual, and one specific to the facility.