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Developing a Biosafety Program
Kathryn Nobrega - Amherst, MA
Imagine a health and safety discipline that, in the absence of extensive formal regulation is governed largely by voluntary standards and guidelines. Many regulators, especially OSHA, are considering the need for formal regulation and oversight. It is a discipline in which senior management supported by EHS professionals and others selects exposure controls that may be life-saving.
The discipline is biosafety, also known as biocontainment, and sometimes associated with biosecurity. Biosafety strives to prevent the unintended exposure and spread of pathogenic organisms and biological materials used in research and manufacturing to workers, the community, and the environment. Originally practiced in laboratories and related to the field of infection control in healthcare, the discipline of biosafety now extends beyond research and clinical settings to large-scale manufacturing operations in the biopharmaceutical industry, and covers the hundreds of biohazardous materials. Much of biosafety focuses on the prevention of laboratory-acquired infections (LAIs).
From the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules, to the US Public Health Service regulations on importation of etiologic agents, the field of biosafety presents a patchwork of possible resources that organizations can use to develop and implement a succesfful "compliance" strategy. Interpreting and applying the appropriate standards, guidelines, best practices, and federal and international regulations can be challenging, but is essential to an effective program. The strategy should necessarily evolve over time, to reflect updates in the standards, new scientific information, and operational changes.
Within the body of OSHA regulations, the bloodborne pathogens standard found at 29 CFR 1910.1030 and regulating work with human blood and other potentially infectious materials (OPIM) is a specific example of a biosafety-related standard. First promulgated in 1992 to protect healthcare workers in response to the AIDS epidemic, these regulatory requirements combine aspects of infection control (universal precautions) with traditional laboratory biosafety practices (biosafety manual for HIV research labs). The standard requires employers to establish a written exposure control plan (ECP) that identifies the employee classifications covered by the program and the appropriate exposure controls. The bloodborne pathogens standard also applies to workplaces in which emergency medical responders, first aiders, etc. may be exposed to blood and OPIM during the course of their assigned or voluntary duties. Other OSHA standards that may apply to biosafety programs include personal protective equipment, respiratory protection, and recordkeeping. In California, the Aerosol Transmissible Diseases Standard may also apply.
Risk assessment is another particular challenge for biosafety programs. The Centers for Disease Control (CDC) and World Health Organization (WHO) deem risk assessment a critical component of biosafety management. Risk assessment considers the hazards of the agent (e.g., human / animal pathogenicity, virulence, associated disease(s)), in conjunction with the hazards of the work (e.g., aerosol-producing tasks such as centrifugation; work with sharps). CDC has established a scheme to facilitate classification and risk assessment of agents. A risk group (RG) 1 organism demonstrates low potential for pathogenicity, while a RG 4 organism is very dangerous and has the potential to produce life-threatening disease. Risk assessment also considers the susceptibility of workers to infection should an exposure occur; the availability of vaccines and post-exposure treatments; the effectiveness of decontaminating methods; and numerous other variables.
In biosafety, adequate employee protection relies on completing a specific risk assessment for each discrete research protocol, scale-up activity, and/or manufacturing process, and then specifying the proper level of containment. In laboratory environments, biohazardous materials are handled at one of four biosafety levels, with biosafety level 4 (BSL 4 or BL 4) reserved for the most hazardous work, typically using RG 3 or 4 agents. Large-scale work can also be classified into the appropriate large-scale containment designations. The biosafety levels specify a set of standard and special practices, and facilities designed to protect workers and the environment.
Despite the importance of biosafety risk assessment, a single approach or methodology has not been clearly established. Organizations typically identify a biosafety officer (BSO) and/or a committee, often called an Institutional Biosafety Safety Committee (IBC), to ensure that risk assessments are completed. Originally conceived by the National Institutes for Health (NIH) as a requirement for work with recombinant DNA conducted under agency grant programs, the IBC serves in a self-policing or oversight role, particularly in the absence of specific occupational health and safety regulatory requirements. The IBC is charged with facilitating risk assessment, reviewing and approving research protocols, and working with scientific and operations staff to ensure that exposure controls are matched appropriately to the risks. The BSO and/or IBC also evaluate the risks of the work activities and assure that the proposed containment is adequate.
In well-functioning biosafety programs, the senior scientific staff and operations line management take a leadership role in assessing risks, ensuring the adequacy of containment, fostering employee involvement, and advancing continuous improvement. Herein lie yet additional challenges and opportunities in biosafety management, particularly for EHS professionals. Proactive and effective programs require close cross-functional collaboration, trust and transparency among all parties, and an ongoing dialog, especially about the scientific and microbiological aspects of the work, to inform sound collective decision-making.
Kathryn Nobrega is an STC Senior Program Director located in Amherst, MA. She has over 20 years of experience, specializing in lab safety, management systems, and auditing. Consulting and management in corporate, nonprofit, and government sectors. Life sciences background STC provides numerous services in biosafety management, including requirements analysis and risk assessment, program evaluation and auditing, participation on biosafety committees, training, and development of written program materials. For more information about STC's biosafety services, contact Kathryn Nobrega at (413) 325-4955 or email: knobrega@stcenv.com.
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