Some Overlap and Duplication Exist in Inspections of Select Agent Laboratories

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. Inspections conducted by DOT, however, were generally not  duplicative of CDC and APHIS inspections because specific inspection  activities tended to differ. DHS and DOD’s DAIG inspections tended to be more duplicative with  those of CDC and APHIS, in that numerous activities were the same  across these inspections, according to survey results. While Difficult to Quantify, Overlap Adds to the Cost of Inspections and Can Negatively Impact Laboratory Operations

The costs of overlapping federal inspections and effects on lab operations  are difficult to quantify because (1) agencies and entities generally do not  track the costs or effects of inspections and (2) some costs are not  quantifiable. Although we could not quantify  the portion of federal and entity costs directly attributable to overlap, we  could quantify the costs of inspections in general. The approximate overall federal cost for fiscal year  2010 and 2011 inspections was over $2.1 million dollars. On average, the  entity costs per inspection were nearly $15,000 and 380 hours in staff  time, according to our survey. Entities also reported moderate to significant  nonquantifiable costs of inspections when it comes to loss of productivity  and delays in research. According to surveyed entities, overlapping inspections  negatively affected lab productivity, staff morale, available time to  complete research, and the research schedule. Because many of these entities are federal laboratories  or are funded through federal grants, these quantifiable and  nonquantifiable costs are passed on to the federal government. A Coordinated Approach with Consistently Applied Standards is Recommended by Earlier Reports and Surveyed Entities

Actions to reduce the costs and negative effects of overlapping and  duplicative inspections include better coordination and greater  consistency in the application of standards, according to various experts  and surveyed entities. Well-trained inspectors, who are able to apply  consistent standards, would reduce the negative effects of overlapping  inspections. For example, according to DAIG  officials, they have taken steps to address these issues in joint  inspections with CDC and APHIS. Conclusions

Inspections are important for safety and compliance and can help  improve laboratory procedures, infrastructure, and security. While one  could argue that more-frequent inspections might be necessary to better  ensure safety—in particular for larger entities—there is no apparent  value-added when specific inspection activities are duplicative and occur,  in some cases, before entities have had time to respond to findings from  a previous inspection. Recommendations for Executive Action

In order to eliminate overlapping and potentially duplicative inspections,  as well as reduce the burden of such overlap and duplication on select  agent entities, we recommend that CDC and APHIS, as the primary  agencies with regulatory authority, work with DHS and DOD to (1)  coordinate inspections of select agent entities and (2) where possible,  use mechanisms such as (a) joint inspections with a single report of  findings, (b) acceptance of each other’s inspection results rather than  independent inspections, and (c) cross-agency training opportunities to  ensure consistent application of biosafety, biosecurity, and  biocontainment inspection standards. DOT did not provide any comments. Appendix I: Scope and Methodology

To assess (1) the extent of overlap and potential duplication in federal  agencies’ inspections of entities that work with select agents, (2) the costs  of overlapping federal inspections and effects on laboratory operations,  and (3) actions to reduce the costs and negative effects of overlapping  inspections, we interviewed agency officials, reviewed pertinent  legislation, regulations, and agency documents. Specifically, we spoke  with officials from the Center for Disease Control and Prevention (CDC)  Division of Select Agents and Toxins, the Department of Agriculture’s  Animal and Plant Health Inspection Service (APHIS), the Department of  Transportation’s (DOT) Pipeline and Hazardous Materials Safety  Administration (PHMSA), the Department of Defense (DOD) military  service Inspector General’s offices, including the Department of the Army  Inspector General (DAIG), Navy Inspector General, and Air Force  Inspector General offices. Is this correct? Actions to correct deficiencies   9k. Justification for additional resources to  9l.
Why GAO Did This Study

Between 2009 and 2011, there were roughly 374 entities across the United States conducting research with select agents such as anthrax, which have the potential to threaten health and safety. Inspections are one means of ensuring safety and compliance with regulations. However, several federal agencies--CDC, APHIS, DOT, DHS, and DOD--conduct such inspections, creating significant potential for overlap and duplication of effort. In this context, GAO was asked to assess (1) the extent of overlap and potential duplication in federal inspections of select agent entities, (2) the costs of such overlap and effects on laboratory operations, and (3) actions to reduce the costs and negative effects of any overlap. To answer these objectives, GAO analyzed agency data, surveyed entities, held focus groups with lab staff, and interviewed agency officials.

What GAO Found

About 15 percent of entities registered to work with select agents were subject to inspection overlap (multiple federal agencies inspecting within a 2-year period). Entities experiencing overlap tended to be larger ones, with more laboratories, principal investigators, and staff. Although there was overlap between Department of Transportation (DOT) inspections and those of the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS), they were generally not duplicative because specific inspection activities tended to differ, according to GAO's survey of entities experiencing overlap. For example, DOT inspections tended to focus on transportation issues, such as checking hazardous materials and transportation security plans, rather than general biosafety issues. The Department of Homeland Security (DHS) and Department of Defense (DOD) inspections, however, tended to be more duplicative with those of CDC and APHIS. For example, both review the same documents, require safety and security demonstrations, conduct inventory inspections and personnel interviews, and provide corrective action plans. While inspections are important for safety and compliance, there is no value added when federal agencies are expending resources to conduct the same work and, in some cases, reinspecting before entities have had time to respond to findings from a previous inspection.
The costs of overlapping federal inspections and effects on lab operations are difficult to quantify because agencies and entities generally do not track them and some costs are not quantifiable. Although GAO could not quantify the portion of federal and entity costs directly attributable to overlap, it could quantify the costs of inspections in general. According to agency data, the approximate overall federal cost for fiscal years 2010 and 2011 inspections was $2.1 million dollars. On average, the entity costs per inspection were nearly $15,000, and staff time per inspection was 380 hours, according to the GAO survey. While surveyed entities reported that inspections can help correct deficiencies and improve accountability, most reported moderate to significant nonquantifiable costs of inspections due to loss of productivity and delays in research. In addition, according to surveyed entities, overlapping inspections negatively affected lab productivity, staff morale, available time to complete research, and the research schedule. Because many of these entities are federal laboratories or are funded through federal grants, these costs are passed on to the federal government.
Actions to reduce the costs of overlapping and duplicative inspections include better coordination among federal agencies and greater consistency in the application of standards, according to various experts and surveyed entities. CDC has taken actions to better coordinate inspections with other agencies, for example, by increasing the use of joint inspections. But such actions, including joint inspections, do not fully address the negative effects of multiple inspections if agencies apply inconsistent standards and develop separate reports of findings. Well-trained inspectors, who apply consistent standards, are also needed. Collectively, these actions would reduce the negative effects of overlap and duplication and could increase agencies' acceptance of each other's inspection results.

What GAO Recommends

GAO recommends that CDC and APHIS work with DHS and DOD to coordinate inspections and ensure consistent application of inspection standards.
HHS, USDA, DHS, and DOD generally agreed with our recommendations and noted various actions they have already taken, or plan to take, to coordinate inspection efforts.