The new regulations, which are part of the Bioterrorism Preparedness Act of 2002, significantly change the way an institution can conduct research with toxic substances. Changes include mandatory registration of all facilities and materials, filing of formal security plans, federal background checks of anyone with access to Select Agents, and mandatory training of all individuals who enter Select Agent facilities

Battelle operates several BSL-3 and BSL-2 labs at its 83,000-sf Medical Research and Evaluation Facility (MREF) in West Jefferson, Ohio, 15 miles from the organization's headquarters in Columbus. Research at the MREF focuses on developing medical countermeasures against pathogens, decontamination of toxic materials, and threat assessment. The facility houses more than 130 scientific and support personnel, and is one of only a couple of BSL-3 labs in the country capable of studying aerosolized biological agents in living organisms.

"We have an established history working with pathogens, which gives us an advantage over newer companies and universities. Our BSL-3 laboratory has been operating since 1995, and has been compliant with federal requirements since the first rules were issued in 1997," says Jim Estep, Ph.D., director and technical manager of Battelle's MREF.

Though 42 CFR 73 officially went into effect February 2003, organizations were given until November of that year to implement the new security requirements.

Preparation and Documentation

Due to Battelle's experience in the field, many of the federal requirements were already being met at the MREF prior to the new regulations. The entire facility is inside a fenced compound with armed guards and camera surveillance. Internal access is strictly controlled with keypads, card readers, and airlocks. Though a security plan has been in place for chemical operations since 1983, the biology security plan was ramped up in direct response to the Bioterrorism Act.

While 42 CFR was the primary guidance document in preparing for the CDC audit, Battelle also focused on the Biosafety in Microbiological and Biomedical Laboratories (BMBL) recommendations, which have been revised to include stricter security controls. New regulations stipulate that organizations handling Select Agents maintain extensive documentation of inventory, agent access, staff training, and emergency protocol.

Some of Battelle's internal guidance documents include security training materials, occupational health policies, and numerous standard operating procedures (SOPs) for vaccinations, spills, and toxin exposures.

"Many of these documents have been in place internally for years, but we upgraded a number of them to meet the November deadline," says Estep.

Findings and Responses

In November 2003, a five person CDC audit team—which included security experts, a containment lab specialist, a microbiologist, and a physician—spent three days reviewing the MREF's documents and operations. The process began with a briefing where the team laid out specific objectives for the visit. This allowed the MREF management to create a focused agenda for meeting the review team's needs, thereby reducing the impact on overall lab operations.

"The quality of the review team was excellent. They did a tremendous amount of on-site activity to ensure that all federal regulations are being met. They walked through every square inch of the facility. When they saw someone working, they stopped and asked what they were doing and how they were trained," Estep says.

In addition to thorough site inspections and staff interviews, the team reviewed all relevant safety documentation including security plans, SOPs, and training records.

The team was not allowed to disclose its findings immediately following the review. However, an out-briefing was held where Battelle officials were allowed to discuss their interpretation of the various requirements. The CDC officially released its findings a month later.

Given Battelle's experience, it is not surprising that the required changes were relatively low-level. Probably one of the most significant was a need for better signage.

"We have around 60 rooms with potential for some sort of Select Agent use, and there were a couple of low-use rooms where spill procedures were not posted. The team said that every room should be posted individually. We have corrected the signage," says Estep.

The MREF also has four flexible-use animal rooms where personal protective equipment (PPE) requirements are posted based on the animal model involved, but CDC regulations dictate that PPE guidelines must be posted in every room.

"Now we have minimum requirements posted in those rooms with the caveat that certain models will require additional equipment," says Estep.

Another concern the team cited was a fabric chair situated in a forward computer area. Though it was not in a lab where toxins are used, the team pointed out that if a contaminated person were to contact the chair, it could not be decontaminated.

There were also a few staff members who were trained to the point of facility access, but not Select Agent access. The CDC deems facility access equivalent to agent access, even if the agents are locked in a secure environment and the worker is accompanied.

"That finding was resolved by finishing the training of those individuals, which was planned anyway, but maintaining a rigorous training program is definitely among our new challenges," Estep says.

Interpretations and Solutions

While most of the rules are highly specific, some operational elements are open to degrees of interpretation. Battelle's experience gave them the ability to contest some of the CDC rulings based on safety interpretations and conflicts with prior regulations.

Probably the most notable issue Battelle contested was the CDC requirement of using wrap-around suits and aprons. Researchers in Battelle's BSL-3 labs work with button-up scrub suits under a hood and splash-guard, in addition to goggles and gloves. When researchers work with animal models, they wear button-up scrub suits under Tyvec suits.

"The CDC team recommended full wrap-around suits and aprons, but wrap-around suits are not functional in a production room because of the required movement. They also do not work in rooms with primates, because primates will pull on anything that is loose, increasing the risk of researcher injury," says Estep.

Battelle also argued against wrap-around suits because their use was in conflict to prior BMBL regulations. For now, the CDC has accepted Battelle's appeal on the issue.

Tracking and Training

Though Battelle was well prepared for the review, recent bioterrorism legislation has brought new challenges to the organization. Principal among these are the increased need for rigorous training, better inventory tracking, and specific procedures for transferring materials between departments within the MREF.

Upgrades include installing constant-capture video surveillance and more cameras. Battelle has also developed sign-in/out sheets and inventory controls. Another significant challenge is getting people into the facility who haven't received all the training necessary to work alone. Battelle has dealt with this by creating a tiered escort system with strict criteria for who can enter the facility and who can act as escort.

"We have always had a strong training program, but the intensity of it has gone up considerably since 2001. Making sure everyone is trained properly, and that you know exactly who is working with what materials, is an ongoing challenge. These issues are still evolving for us, and for the entire research community," says Estep.

By Johnathon Allen

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