Joining forces are the American Biological Safety Association (ABSA) based in Mundelein, Ill.; the European BioSafety Association (EBSA) in Belgium; the Asia-Pacific Biosafety Association (A-PBA) in Singapore; Det Norske Veritas (DNV) in Norway; and the International Centre for Infectious Diseases (ICID) in Winnipeg, Manitoba. They will follow their vision to fruition by providing a forum for all stakeholders to develop and achieve adoption of a recognized standard regarding the management of biological materials, organisms, and their products primarily within the laboratory environment.

“Similar vision statements are often associated with high-level management system standards because they define where you want to go and what you want to accomplish,” says Dr. Stefan Wagener, Scientific Director for the Office of Biorisk Management at the National Microbiology Laboratory of the Public Health Agency of Canada in Winnipeg. “We want to move biosafety, biosecurity, and biocontainment to the next level by implementing biorisk management.”

Understanding the Need for Biorisk Management

The alliance of biosafety organizations and partners are concerned about improving the overall performance of laboratories through the adoption of practices that have been recognized for their positive outcomes. The practices are intended to address all aspects of performance, including but not limited to operating procedures, administrative controls, engineering, and personal protective equipment.

“It is essential to have facilities, employees, and management teams that perform to the best of their ability,” says Wagener. “In addition to enhancing the performance of each laboratory, we want to facilitate international exchange and collaboration because this standard will bring everybody on the same page throughout the world. There is much more to consider on an international level than just what’s taking place in the United States or Canada.”

At the present time, there is no way to assess the performance of facilities throughout the world. The lack of an international standard makes it difficult for facilities in different countries to effectively collaborate on research. The implementation and acceptance of an overarching international standard would permit the independent assessment of biocontainment facilities to ensure they are properly certified and equipped to conduct research involving infectious microorganisms in a safe environment.

There is also an incredible need to increase awareness and eventual adoption of management system approaches within the sector. Once the management approach has been implemented, organizations will have a means to conduct internal audits and to obtain third-party certification.

“The bottom line is we need a system that allows people to have an internal audit function within their facility so they will know if they meet the metrics,” notes Wagener. “We have to be on a common page by meeting the same requirements. It is very difficult to do this if you do not have an overarching standard.”

Stakeholders must be provided with a standard that can be used as a benchmark in setting the requirements for their facilities. This is especially critical since most countries do not have a single regulatory framework regarding biosafety, biosecurity, and biocontainment facilities. The standard would serve as a tool that allows stakeholders to aspire to a certain level of certification and performance.

The overarching standard will include a code of conduct and independent assessment to determine the qualifications of the people certifying the biocontainment labs. Ensuring the certifiers are qualified to assess the standards and performance of facilities is critical to the future success of the labs and their respective research. Knowing that certain BSL-3 labs around the world are being certified in a few hours makes the biosafety organizations even more determined to create a standard combined with an accreditation system that holds certifiers to a high level of accountability. Currently, “biocontainment certifiers” are not accredited or assessed independently on their qualifications and performance.

Scope of the International Standard

The international standard and guidance document will be based on the World Health Organization’s Laboratory Biosafety Manual (3rd edition). First published in 1983, the manual provides practical guidance on biosafety practices and procedures for use in laboratories at all biosafety levels. Included are guidelines for the commissioning and certification of laboratories, as well as the requirements pertaining to the transport of infectious substances.

The WHO manual is accepted internationally in contrast to the CDC’s Biosafety in Microbiological and Biomedical Laboratories (BMBL) handbook, which is only valid in the United States. The BMBL offers advisory recommendations and describes the combinations of standard and special microbiological practices, safety equipment, and facilities constituting biosafety levels 1 through 4. Because of its international acceptance, the WHO publication is the best common denominator upon which to build a standard and to use as a framework for creating the guidance document.

The main focus of the standard will be on biological agents and materials used primarily in microbiological labs. The recommended management system will call for a holistic approach encompassing people, facilities, and working procedures. Included will be information relevant to engineering controls, administrative controls, standard operating procedures, and personal protective equipment.

The standard will not be prescriptive in nature, but will instead be based upon the philosophy that the operator must understand and manage risk. This performance-based method will allow for a local, customized approach to control measures with evidence-based procedures and recognized effective practices.

“I have seen so many risk assessments that are just a checklist. People are just going through the motions in order to have a document, but that is not the right way to do it,” explains Wagener. “Everyone from the management down to the person working in the lab must understand what they are doing. Only then can we have a performance assessment that says everybody works in line with what must be done and the laboratory is a safe entity.”

In addition to the standard, a guidance document will support organizations in determining how adequate measures can be identified and implemented. It will set forth actions that can be taken to address certain circumstances.

The proposed standard, which will be voluntary with no requirement for compliance, will not replace any national or sub-national regulatory requirements that may apply to a particular facility.

The new standard will require a comprehensive management approach from the top down and the bottom up, necessitating a new way of thinking and a cooperation among all parties. The standard might state, for example, that the organization “shall establish and maintain documented methodologies and procedures to ensure that planning, design, redesign, construction, testing, and commissioning of the lab/facility is managed effectively.”

The guidance document would provide specific information to assist management in achieving the recommended standard. For instance, the document might say that features shall be incorporated into the facility design to effectively manage risks and to contain biological materials in a manner that prevents exposure and release.

Questions and Challenges

There are some interesting questions being discussed as part of the development of the new standard. For example, how many containment facility designs actually used a risk assessment-based process for decision making and do we have the quantitative risk assessment tools for a proper containment design?

Although regulatory agencies set forth certain requirements for biocontainment labs, they seldom provide information that is based on risk assessment, nor do they provide the necessary assessment tools to justify and help achieve their requirements. From an engineering and design perspective, information must be obtained to show what tools can be implemented to reduce risks.

One facility in the world that has undergone design based on a quantitative risk assessment process is the CISRO Australian Animal Health Laboratory (AAHL) Facility in Geelong, Australia.

“The construction of biocontainment facilities is driven by a regulatory emphasis,” says Wagener. “Many times, we lack the risk assessment-based metrics for the things that we put into containment facilities and that is something we need to change. We as a community can address this issue.”

Responsibilities

The process of developing an international standard is being facilitated by the ABSA, EBSA, A-PBA, DNV and ICID. The associations and partners are assisting the WHO in the promotion and compliance with the Laboratory Biosafety Manual. Project management is being handled by DNV, which is a recognized facilitator by the European Commission and is accredited by the National Standards Board.

Although the international associations are serving as facilitators for the process, the actual standard will be written based upon input from the biosafety and laboratory community. Stakeholders will be brought together via a workshop of the Comite Europeen de Normalisation, also known as CEN or the European Committee for Standardization, which contributes to the objectives of the European Union with voluntary technical standards, while at the same time providing a standard development mechanism called “CEN Workshop Agreement,” which is accepted worldwide.

The workshop was selected as the appropriate venue because CEN has an internationally recognized standardization platform, is less expensive than a consortia, can facilitate fast agreements, and provide technical specifications, good practice, and guidance. The desired outcome will be a workshop agreement signed by all involved parties.

Project Phases

The international associations began discussing the need for a uniform standard in 2005. The business plan included creating a concept and statement of intent, developing a budget, and determining how to bring the biosafety lab community together. A proposal was submitted earlier this year to the European Commission, which will hopefully fund 75 percent of the project. Additional fundraising will be required to provide the remaining 25 percent of the estimated project cost of $500,000 Euros or approximately $646,000 in U.S. dollars.

Stakeholders are currently being identified and a working document is being created for use at the CEN workshop.

“We might have 150 or 200 people sitting down to discuss the standard. We want to have something on the table that already focuses our thoughts, and we are in the process of developing a working document,” says Wagener.

The workshop will be held at the CEN Premises in Brussels with approval of the agreement, which outlines a solid standard for biosafety, biosecurity, and biocontainment, by all parties expected to occur before the end of 2007. The workshop will be open to any interested party.

An accreditation board or system will then be developed to establish a level of criteria for facility certifiers. The CEN workshop agreement will be distributed and facilities will be certified with the new standard beginning in 2008. The final phase will be a validity check after three years and continuous monitoring.

Members of the biosafety lab community are urged to identify their interests by approaching the appropriate associations, participate in the workshop, financially contribute to the process, and learn about management systems, such as ISO 17025 or OHSAS 18001.

“One of the great educational things that happened to me was having our applied biosafety laboratory undergoing ISO 17025 certification,” says Wagener. “It opened my world to management systems and their importance.”

By Tracy Carbasho