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Summary

On August 18, 2014, Assistant to the President for Homeland Security and Counterterrorism Lisa Monaco and Assistant to the President for Science and Technology John Holdren issued a memorandum, titled “Enhancing Biosafety and Biosecurity in the United States,” which urged all United States Government departments and agencies that work with infectious agents to take immediate and long-term steps to enhance safety and security of research to minimize the potential for future incidents. All United States Government departments and agencies that possess, use, or transfer human, animal, or plant infectious agents or toxins were urged to perform a Safety Stand-Down to include an immediate sweep of their facilities to verify that all Biological Select Agents and Toxins (BSAT) in their possession were appropriately registered, stored, and disposed of in accordance with applicable regulations. Read a summary of the U.S. Government-wide Safety Stand-Down.

In July 2014, the ľ��ֱ�� (NIH) had already initiated a careful and deliberate review of its biosafety and biosecurity protocols and implemented a series of measures to improve laboratory safety practices across the agency, including a comprehensive search of laboratory and associated spaces, to identify BSAT and ensure their proper registration, safe stewardship, and secure storage or disposal, among other measures. In addition, NIH and other HHS agencies continued these efforts by announcing September as National Biosafety Stewardship Month, providing a valuable opportunity to encourage the extramural community to conduct similar efforts. These measures fulfilled the immediate and long-term steps called for in the August 18, 2014, memorandum.

Overview of process

In the first phase of NIH’s review, between July 11-September 30, laboratory principal investigators at all NIH Institutes and Centers searched 3,000 labs, 35 million samples, and entered more than 534,000 record entries into a centralized database. This phase was completed on September 30, 2014.

NIH also has implemented a second phase of this search in an effort to continue to improve the safety and security of all laboratories across NIH. This phase will involve an additional review and monitoring of all inventory, labs and storage areas for verification purposes. This final phase is expected to take several months.

Overall findings

• As a result of the comprehensive review, NIH identified five vials of biological select agents and toxins that were stored safely, but were not in appropriately registered space. All holdings of potentially hazardous biological materials (BSL-2 and above) found during the sweep were entered into a central database. Each finding was reported to the Division of Select Agents and Toxins at the CDC, and the agents were transferred to a select agent-registered laboratory for final destruction.
• In no case was there an indication of human exposure, including staff or the general public, to any of these agents or toxins.

The findings included:

• Burkholderia pseudomallei, a patient microbial isolate. B. pseudomallei causes melioidosis, which is an uncommon bacterial infection usually found in tropical or sub-tropical areas.
• Ricin, bottle of unknown quantity, but labeled 5 grams. Ricin is very poisonous if inhaled, injected, or ingested; it acts as a toxin by inhibiting protein synthesis. This sample was found in a historical collection dating from 1914 and is thought to be 85-100 years old. Ricin has legitimate lab uses in very small quantities.
• Botulinum neurotoxin in individual quantities was below the regulatory limits, but in aggregate was above the allowable limit. This neurotoxin is the cause of botulism, which is a rare, but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum.

Additional NIH Actions

NIH is mindful of the need for constant vigilance in monitoring laboratory materials in compliance with federal regulations on biosafety. The safety of NIH employees and the public is of paramount importance.

Comprehensive Review of Current Biosafety and Biosecurity Protocols

NIH has performed a review of all NIH Policy Manual Chapters that govern the use of biological materials across the NIH. The following items were identified as opportunities for improving research safety and local oversight:

• NIH will finalize a Manual Chapter addressing biosurety/biosecurity policy to strengthen and enhance the oversight of high risk biological hazards.
• NIH will develop a method to maintain inventories and will institute spot checks during annual laboratory inspections.
• NIH will develop a procedure for the transfer of ownership/responsibility for an inventory should a researcher leave the NIH.
• NIH has performed a review of the standard operation procedures, plans and policies that govern the use, transfer and possession of select agents and toxins on all campuses.

Opportunities for improving research safety

As a result of the “Safety Stand-Down” and NIH comprehensive search effort, all laboratory staff have been informed that the principal investigator of the laboratory is required to maintain a central list of the human pathogenic organisms that require Biosafety Level 2 (BL2) containment and above, and biological toxins, venoms, or poisons. The new biological material inventories that have been developed during the comprehensive search that contain a listing of hazardous biological materials that are not select agents and toxins will be spot checked during annual laboratory inspections. Biological Select Agents and Toxins inventories will continue to be checked using the current practice, which is on a quarterly basis.