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

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Page 1: Gabrielle Dotson - Volunteer Scholar Program Final Deliverable

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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.

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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.