LLNL is one of three nuclear weapons design facilities that are managed by the National Nuclear Security Administration (NNSA). The Lab employs approximately 8,200 people and has an annual budget of $1.7 billion. Two major facilities at the Lab include the National Ignition Facility, which houses the largest laser in the world, and the Terascale Simulation Facility, which houses the world’s fastest computer.

Three of the Lab’s programs for safety and security have been implemented at the BSL-3 Facility: a safety basis program, a security program, and the Department of Energy (DOE) authorization process.

Non-Nuclear Safety Basis Program

“Hazard classification is based on an unmitigated risk,” says Bruce McDowell, the BSL-3 facility program manager at LLNL. “With high impact from an unmitigated risk, a high-hazard facility has a strict set of controls. This facility is classified as a low-hazard facility, with standard operating procedures and engineering controls.”

The safety basis envelope is the combination of features that controls the safety of a facility. The safety assessment identified nine items including equipment and inventory limits that are important to safety. These safety systems include heating, ventilation, air conditioning and negative ventilation systems, HEPA filters, respirators, packaging and shipping requirements, biosafety cabinets, sample double containment, rodent caging system, containment centrifuge, and inventory limits.

The safety basis documentation begins with facility design specifications, followed by a facility safety plan. As work is authorized, controls are brought forward into integration worksheets or a work approval process. Lastly, controls are implemented at the work level through standard operating procedures.

Security Program

“A design basis threat is a combination of threats to which a facility may be subjected,” says McDowell. “It depends on the person and the type of act he or she may perpetrate. Because of the Lab’s work with nuclear weapons, there is a robust methodology in countering security threats. Those methodologies needed to be adapted to the bio field, which poses a different type of threat.”

The biological risk and threat assessment used a methodology designed by the University of California, the DOE, Sandia National Laboratory, and the NNSA to guide the security risk and threat assessments process. The biological risk and threat assessment developed for the BSL-3 facility uses the DOE Design Basis Threat to examine the potential vulnerabilities of the facility and planned operations, and assess risk mitigation.

The Select Agents and toxins security plan provides integrated safeguards and a security management approach to implementing a protection program for LLNL’s toxin use and storage areas. The final, as-built configuration of the building, and the threat assessment, were integral in developing the building’s security plan. The assessment resulted in the final authorization basis document.

In addition to a personnel security program, all workers at the Lab must have Department of Justice and Centers for Disease Control (CDC) clearance, and be enrolled in the Select Agent human reliability program which screens for physical or mental/personality disorders, alcohol abuse, illegal drug use, and other security concerns. Everyone who enters the facility must be in that program and approved by the Select Agent facility manager. The University of California imposes a Select Agent Human Reliability Program (SAHRP) for workers that handle Select Agents that exceed the CDC requirements. The SAHRP also has screening for physical or mental/personality disorders, alcohol abuse, use of illegal drugs or the abuse of legal drugs, and other circumstances that may be a security concern.

“The Lab employs the Three G Method—guards, gates, and guns, including a 50-caliber machine gun,” says McDowell. “Because the BSL-3 is a stand-alone building, it is much easier to control with an onsite security staff.”

The security staff was consulted early on and throughout the process on issues such as design and access control, motion sensors, and controlling any crawl spaces above the rooms. This interaction ensured the facility met security requirements without costly, last-minute construction additions.

Foundation access points and ventilation systems are locked and screened, and all perimeter access/entry points are controlled with card access via the facility manager. Inside the laboratories, each door has a reader with a token provided by the facility manager that is good for a specified time for each person. There are access restrictions on the freezer units housing the Select Agents. All unescorted workers must have approval from CDC to access Select Agents.  Finally, facility training and emergency drills are conducted, both intentional and random, says McDowell.

DOE Authorization Process

The site office of the NNSA conducted a readiness review prior to authorizing operations in the Livermore BSL-3 facility. This review is conducted following DOE Standard DOE-STD-3006-95, the Planning and Conduct of Operational Readiness Review (ORR) and the DOE/NNSA/LSO Procedures for Startup and Restart of Facilities (LSO/LSOD-SOP-000162.02) using a graded approach. Although the standard is for nuclear facilities, the core requirements given in the standard are appropriate to the review of a pathogens research facility when tailored by utilizing a graded approach.

The review consists of three steps. In the initial step, management completes construction of the facility, installs and tests all equipment, and establishes controls to maintain the safety envelope of the building. Second, an independent team reviews all aspects of the facility and operations to verify that the building has achieved readiness. Lastly, the site office team reviews all aspects of the facility and operations to confirm that the facility is ready to operate. Both the independent and site office teams have expertise in management/operations, facility commissioning, safety basis/AB, regulatory compliance, electrical, structural and mechanical engineering, security,  environmental, waste management, industrial hygiene, and biosafety/medical areas.

The two teams also included subject matter experts from LLNL who were not part of the project, a biosafety officer from another DOE facility, a security specialist from the University of California Office of the President, and a private biosafety specialist.

The site office team reviewed the report written by the independent team and verified its findings. Following these three reviews and completion of any corrective actions, the site office authorizes operations.

Configuration Management Ensures Consistency

The configuration management plan defines the roles and responsibilities of the facility manager, and the people who work in and maintain the building. It also defines items including equipment, packaging requirements, and inventory limits.

Configuration management establishes mechanisms for maintaining consistency between the safety basis envelope, as defined by the initial design requirements, and the physical configuration and documentation. It is important to determine that a change does not exceed the safety envelope of the facility before the change occurs. The DOE developed this program to ensure consistency between the initial project design, the documentation, and the equipment.

“For changing out a type of equipment, an evaluation would be performed to determine if it maintains the safety basis envelope,” says McDowell.

There are four procedures used to ensure that changes fall within the same safety basis envelope: document change control, work process change control, configured item change control, and quality significant procurements.

There is an initial evaluation by the facility manager, followed by the authorization basis group, if necessary, to determine if the change is warranted. For changes that may affect the safety basis, the site office approves the change. Lastly, new procurements follow a quality significant procedure to ensure the right equipment is used and that all procedures are within the envelope.

“These programs result in a process structure, and team and confidence building,” says McDowell. “It also is an education for our oversight agency, the NNSA. As we go through the readiness process, we are not only demonstrating to the NNSA that we know what we are doing, but also educating them on what the process is and what items they should and should not be concerned about.”

By Lisa Brown

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