In 2007, GAO reported on issues associated with the proliferation of biosafety laboratories in the United States. In 2009, we noted that while proliferation of these laboratories was taking place in the federal, academic, and private sectors across the United States, the federal oversight of these laboratories was fragmented—there was not a single federal agency to provide oversight. As a result, numerous federal agencies could be involved in separate and independent inspections of these entities and their associated laboratories. The various agencies that have a role in the oversight of select agent entities and can conduct inspections are shown in figure 1. CDC and APHIS have regulatory authority to assess compliance with biosafety, biosecurity, and biocontainment requirements. Under the current SAR, entity registration must be renewed every 3 years, and CDC or APHIS may conduct an on-site inspection before the award of a new certificate of registration or the renewal of an existing registration. These inspections generally cover all aspects of the SAR. As a matter of policy, to ensure that the entity is compliant with the SAR, CDC or APHIS inspects the premises and records of applicants, including a review of all required plans, before issuing the initial certificate of registration. In addition, CDC or APHIS may conduct inspections to (1) respond to concerns about an entity’s compliance, (2) verify corrections of deficiencies identified through inspections or accomplishment of Performance Improvement Plan goals; or when (3) modifications are made to the entity’s registration, (4) a new building or laboratory is added, (5) a higher-risk agent or toxin is added, (6) a change is made in security infrastructure or policy and procedures, (7) a theft, loss, or release incident occurs, or (8) a violation is reported. Any entity where select agents are possessed, used, or transferred must allow CDC and APHIS to inspect, with or without prior notification. In addition to CDC or APHIS inspections, the SAR requires each registered entity to conduct annual self-inspections under the direction of the entity’s RO. DOT has the primary authority to regulate the safe and secure transport of all hazardous materials shipped intrastate, interstate, and in foreign commerce. Infectious substances, which include select agents, are regulated as hazardous materials by DOT. DOT regulates select agents in commercial transportation to, from, and within the United States, and its oversight extends to all parts of the hazardous materials transportation system, including classification of materials, packaging, handling, moving, loading, and unloading of hazardous materials shipments in commerce. PHMSA is the component of DOT responsible for this oversight. As its authority is limited to transportation, its focus is on the shipping and packaging aspects of biosafety and biosecurity requirements. Consequently, entities that are active in the transfer of select agents may have their shipping and handling facilities inspected by PHMSA. DHS and DOD own or fund research at select agent entities, and these entities may undergo additional inspections from these agencies as part of the conditions of funding or based on the safety and security policies of the parent agency. For example, entities that receive funds from DHS to conduct laboratory work involving select agents are subject to on-site compliance reviews and inspections by the DHS Regulatory Compliance Office. In addition, select agent laboratories operated by DOD are subject to inspections by the service IGs and other commands. DHS established a regulatory compliance program to facilitate department-wide implementation of and compliance with DHS policies for biosafety, select agent security, and the care and use of animals in research. DHS’s select agent research is subject to regulatory oversight by CDC and APHIS. In addition, entities that receive funding from DHS to conduct laboratory work involving select agents are subject to on-site compliance reviews and inspections based on DHS Management Directives. According to DHS, it “conducts significant additional oversight because of unique sensitivities related to biodefense research, as distinct from conventional public health research, and a desire to ensure complete transparency for senior management of the department about all ongoing biodefense efforts.” DHS also has responsibility for ensuring biosecurity compliance of DHS funded research under biodefense weapon treaties. Through its long-standing Chemical and Biological Defense Program, the DOD supports research on detection, identification, and characterization of biological threats and the development of countermeasures against those threats. DOD research activities take place at numerous facilities, including military-owned entities as well as entities in academia and private industry supported by contracts. DOD entities that are registered with CDC or APHIS are required to follow SAR requirements as well as service-specific requirements derived from DOD requirements. DOD- related select agent entities can therefore be subject to inspections from CDC, APHIS, the service IGs, and other commands. Specifically, the Department of the Army Inspector General (DAIG) conducts inspections of five Army and contractor-owned entities, the Navy Medical IG (MEDIG) conducts inspections of two Navy laboratories located in the United States and three overseas, and the Air Force Materiel Command IG conducts inspections of one Air Force select agent facility. In addition to DAIG inspections, Army facilities are also subject to command/program office (PEO) reviews by (1) Army Material Command Surety Management Review Team, (2) Army Test and Evaluation Command (ATEC) Surety Management Review Team, (3) Army Medical Command (MEDCOM) Surety Management Review Team, and (4) Joint Program Office for Chemical and Biological Defense (JPEO-CBD) Surety Management Review Team. The DAIG and command/PEO teams each have a 2-year inspection cycle and stagger the inspections so that each entity is inspected once per year. Other federal agencies, such as the NIH and USDA’s Agriculture Research Service, have their own internal offices that may perform inspections in addition to those performed by CDC or APHIS as part of the SAP. In many cases, these agencies have internal regulations or policies that are more prescriptive than the CDC or APHIS regulations, according to the Trans-Federal Task Force. In addition, as the agency responsible for the general oversight of workplace safety in the United States, OSHA has oversight authority for the safety and health of workers in all workplaces that fall under its jurisdiction, including individuals who work with hazardous biological agents or toxins in high- and maximum- containment research facilities. This includes jurisdiction over the safety and health of workers employed by privately owned entities and, under certain circumstances, federal high-containment facilities. Inspection activities are generally conducted in three phases: (1) preparation, (2) execution (the actual inspection), and (3) closeout (postinspection activities). In order to prepare for an inspection, entities conduct a variety of activities, such as responding to requests for documents related to the SAR; reviewing and updating guidance, records, and plans; and checking security and medical certifications of inspectors. In the execution phase, inspection activities include, for example, tours of the facility, document reviews, inventory audits, interviews of laboratory staff, equipment tests, and examinations of physical security and shipping and receiving of select agents. The closeout phase includes activities such as discussing the inspection findings and report, developing corrective action plans, and providing verification of corrective actions. (For a detailed list of inspection activities included in the survey, see app. II.) Inspections consist of an extensive review of laboratory safety and security. CDC and APHIS use specific checklists, which they developed from the SAR, OSHA regulations, NIH guidelines for recombinant DNA research, and the Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual, to guide their inspections. The BMBL provides guidance for standards of practice for laboratory principles, practices, and procedures. Other inspecting agencies also use the same or similar checklists for their inspections. DOT inspections, for example, are derived from PHMSA’s regulations for hazardous materials shipping, packaging, testing, certification, safety and security, and record keeping. The scope of a DOD inspection covers a wide range of functional areas, such as security, safety and occupational health, surety management, emergency response, occupational medical requirements, and transportation. The number of federal agencies involved in inspections of select agent entities increases the potential for overlap and duplication. Further adding to the potential for overlap is the increase in the number of inspections. These inspections have increased for a variety of reasons, such as heightened security concern in response to the events of September 2001, as well as an increase in select agent research and the number of agencies funding the research. For example, in addition to announced inspections that generally take place with registration certification and renewal, the number of unannounced CDC inspections substantially increased from fewer than 5 in 2006–07 to nearly 80 in 2012, according to estimates from CDC. And while some federal agencies have increased the use of joint inspections, in which two agencies are on-site for an inspection at the same time, it is unclear whether this will address all of the negative aspects of duplication if compliance is still assessed separately. About 15 percent of the 374 entities that were registered to work with select agents between fiscal years 2009 and 2011 were subject to inspection overlap. This means that in a 2-year period, these entities were inspected by more than one federal agency for biosafety, biosecurity, and biocontainment compliance. In addition, specific inspection activities were often duplicative, according to our survey of the 55 entities that were subject to overlapping inspections. While the percentage of entities affected by inspection overlap was relatively small, the entities affected tended to be larger ones that work with a greater variety of agents and with more laboratories, principal investigators, and laboratory staff.