About Us

Safety FAQs

These FAQs provide answers to basic questions about NBACC.
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The National Biodefense Analysis and Countermeasures Center (NBACC) is a Federally Funded Research and Development Center (FFRDC) managed and operated by Battelle National Biodefense Institute, LLC (BNBI) for the Department of Homeland Security (DHS). As captured in the Strategic Plan, accomplishing the NBACC mission requires robust, special facility functions and safe, secure, compliant, and sustainable infrastructure operations. As described in the Governance section of the website, both DHS and the BNBI Board of Directors provide oversight for NBACC/BNBI. Specific oversight roles in safety, security, and compliance are summarized in Figure 1. Safety, security and compliance are an integrated part of project planning and execution, organizational structure (e.g., utilizing a tenant-landlord model for lease agreements between project and institutional staff), and oversight by regulators, DHS and the BNBI Board of Directors.

The NBACC emphasizes a culture of responsibility that begins with safety and extends expectations for rule following and human reliability (e.g., identification and remediation of error precursors) to all areas—science, operations, and outreach (Figure 2).

Inspections, Audits, Certifications and Registration

As shown in Tables 1, 2, and 3, compliant operations at NBACC are verified through inspections, audits, certifications and registrations. In addition, the NBACC utilizes communities of practice (e.g., professional societies, DHS S&T Laboratories, Battelle affiliates) to benchmark best practices.

Agency Providing Oversight Frequency of Inspection Purpose of Inspection
Centers for Disease Control and Prevention and United States Department of Agriculture (CDC/USDA) Biosafety Level 4 (BSL-4) Annually Ensure compliance with Biosafety in Microbiological and Biomedical Laboratories (BMBL) and Biological Select Agents and Toxins (BSAT) regulations
CDC/USDA BSL-3/BSL-2 At least every three years with unannounced inspections in-between Ensure compliance with BMBL and BSAT regulations
Nuclear Regulatory Commission  (NRC) Annually Ensure compliance with 10 Code of Federal Regulations (CFR) required for all organizations that operate a sealed source irradiator for sterilizing biological material (see http://www.nrc.gov/reading-rm/doc-collections/cfr/)
Department of Transportation (DOT) Random Ensure compliance with 49 CFR
Occupational Safety and Health Administration (OSHA) Random Ensure compliance with 29 CFR
Defense Security Service (DSS) Annually Ensure compliance with the National Industrial Security Program (NISP)
Fort Detrick Fire Department Quarterly Ensure compliance with life safety codes and fire protection standards
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) Every three years Ensure compliance with animal welfare standards
The American Association for Laboratory Accreditation (A2LA) Every two years Ensure compliance with ISO 17025 standards for the management of quality, administrative and technical operations of tests and calibrations. ISO is an important component of bioforensics.
US Environmental Protection Agency (EPA) Random Ensure compliance with 40 CFR regulations for hazardous waste generators
Department of Homeland Security (DHS) Regulatory Compliance Office Random Ensure compliance with various regulatory requirements
DHS Office of Security Annually Ensure compliance with DHS Security Directives
Type of Inspection Frequency of Inspection
BSL-4 Inspection Monthly
BSL-3 Inspection Monthly
BSL-2 Inspection Quarterly
General Facility Inspection Monthly
Environmental Surveillance Sampling Monthly
Decontamination Operations Validated by Biological Indicators (BIs)
Certification of HEPA filters Annually
Autoclaves Validated with Chemical Indicators every run and BI’s quarterly. Temperature records maintained for all runs.
Engineering controls and building systems validated Prior to operation of new and renovated laboratories, and annually for all laboratories
Biological Personnel Reliability Program Ongoing for all employees with laboratory access
Department of Justice Security Risk Assessment for all employees with access to BSAT
Background Investigation, applicable security clearance, and DHS Suitability for all NBACC employees
Maryland’s Biological Agents Registry Program Registration
CDC/USDA Biological Select Agent and Toxins Registration at BSL-2, 3 and 4
Nuclear Regulatory Commission (NRC) License
Institutional Biosafety Committee (IBC) Registration with National Institutes of Health’s Office of Biotechnology Activities (NIH/OBA)
DHS Assessments (Risk, Vulnerability, and Threat)
Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) , Alcohol and Tobacco Tax and Trade Bureau Industrial Alcohol User Permit
Drug Enforcement Agency (DEA) Controlled Substance Registration
CDC Laboratory Response Network (LRN) member

Personnel Reliability

An important component of NBACC safety, security, and quality processes is the Personnel Reliability Program (PRP), which is described in the peer reviewed publication “Implementation of a personnel reliability program as a facilitator of biosafety and biosecurity culture in BSL-3 and BSL-4 laboratories” in Biosecurity and Bioterrorism: Biodefense strategy, practice, and science, vol. 11, No. 2, 2013. Significant prior approvals, as well as on-going monitoring are required (see Figure 3) in order for an employee to have laboratory access to biological select agents and toxins.

Figure 3. NBACC’s Personnel Reliability Program (PRP)

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How you can get involved with us, from working with us to meeting our scientists at events.