Assuring Laboratory Biosecurity

Transcription

1 Assuring Laboratory Biosecurity Presentation to The Working Group (WG) on Strengthening the Biosecurity of the United States, Established by Executive Order (EO) 13486, January 9, 2009 Ronald Atlas and Janet Shoemaker American Society for Microbiology March 18, 2009

2 American Society for Microbiology The American Society for Microbiology (ASM) is the oldest and largest single life science membership organization in the world, with more than 43,000 members today. The members represent 26 disciplines of microbiological specialization including infectious disease research, clinical laboratory testing and public health.

3 Questions from the Working Group Are current regulations (e.g., Select Agent regulations, transportation regulations) and guidance effective? Do you have recommendations to improve regulations and guidance? Do you have any recommendations regarding personnel reliability programs? Are there specific changes that you would make to improve laboratory biosecurity?

4 Biosecurity Requires Working with Dangerous Pathogens Work with pathogenic microorganisms, including select agents, is essential for the security of the United States Research is needed to find protective vaccines and therapeutic drugs Diagnostic activities are critical for protecting public health and safety

5 High Containment Labs are Needed To meet the challenges of emerging and reemerging infectious diseases microbiologists must have laboratories in which pathogens may be stored and studied in a manner that is safe to microbiologists and to the public High containment labs should not be equated with high risk to the public or considered weapons labs

6 Enhanced Biosafety and Assuring Biosecurity are Needed There is need to enhance biosafety Guidance and oversight are essential to improve biosecurity Adequate training and compliance with protective measures must be ensured to minimize the risk of laboratory acquired infections, to protect laboratory workers and the wider public, and to ensure the security of dangerous pathogens that could be misused as bioweapons there is a need for training standards and assesments

7 Biosafety/Biosecuirty Protocols The BMBL The Biosafety in Microbiological and Biomedical Laboratories Manual (BMBL) provides critical standards for laboratory biosafety now includes sections on biosecurity Biosecurity is an extension of biosafety good laboratory practice is key Compliance with BMBL biosafety and biosecurity standards should be a term of award by federal agencies there should be assurance that institutions are adhering to the BMBL The BMBL does not always provide the detail needed to assure adequate implementation

8 Biosafety/Biosecurity Protocols The BMBL The BMBL should be subject to regular biennial review and update as needed The BMBL does not provide specific competencies for biosafety training or recommended procedures for incident reporting more guidance is needed The CDC, NIH and USDA should take the lead for BMBL revisions and for maintaining the currency of the list of organisms requiring containment There should be an advisory committee that includes representation from the relevant scientific and biosafety organizations

9 Regulations and the BMBL Regulatory issues are not as clearly understood as they need to be: The BMBL (Biosafety in Microbiological and Biomedical Laboratories document) guidelines are best practices. BMBL is partly biosafety, partly biosecurity How much of the BMBL is guidance? standards? BMBL is partly mandatory. Federally funded labs must adhere to the BMBL biosafety guidelines as a condition of award is this clearly understood by institutions? Select Agent registered facilities are required to consider the BMBL for biosafety plans BMBL guidelines are used for building design standards, grant and contract requirements

10 BMBL The BMBL manual (currently only available on-line) should be published as hard copies and made widely available, aggressively advertised and circulated to all involved parties for use as a reference. The current BMBL is seen as an open-ended draft. Users now feel that the rules can change at any time and without due process for discussion. We need to set the rules and then accumulate suggested modifications for consideration for the next revision.

11 Select Agent Regulations The current exemption for clinical and diagnostic laboratories that come into possession of select agents because of specimen diagnosis, verification or proficiency testing and report but do not retain select agents, should continue. The language in Executive Order is confusing and should be clarified, given that the law exempts clinical labs and diagnostic labs that destroy or promptly transfer select agents. The current exemption for clinical diagnostic laboratories is important to the diagnosis of disease and clinical care.

12 Select Agent Regulations The legislation PL that led to the select agent regulations recognized that some select agents may pose a greater threat to the public health and safety than others and specifically stated that security requirements be commensurate with the risk of the agent (physical and personnel) and toxin, including the risk of use in terrorism. The legislation gave the Secretary of HHS flexibility to impose different levels of security requirements on different select agents based on an evaluation of the level of threat to the public as is done for laboratory biosafety levels.

13 Select Agent Regulations The select agent list should be tiered so that biosecurity requirements are commensurate with the risk that a particular agent could be misused to do significant harm

14 Lists Lists of pathogens designated as select agents and those requiring BSL 3 and BSL 4 containment should be regularly updated Legislation requires that the select agent list be reviewed biennially or as necessary the list should be reviewed by experts and tiered commensurate with risk to the public health and safety. CDC, NIH and USDA should review and update the BMBL list of agents, biennially or more often as needed Establish scientific advisory committee to help guide which organisms are included on the BMBL list Communicate lists to research institutions, scientists, laboratory directors, biosafety officers, and the public There is a need for international harmonization

15 Requirement to Inventory Vials of Select Agents is Inappropriate There is a difference between accounting and accountability Should not require actual counting of all vials Inventory of vials of live agents is ineffective Need to focus on security in general Except for the most dangerous select agents (e.g. smallpox), need to focus on the human behavior aspect not the bean-counter aspect

16 International Exchange In its review of biosecurity issues, the federal government should keep in mind the importance of foreign researchers to the advancement of science and public health. We need to keep open the flow of biosamples into the United States We need to be able to ship samples out of the United States We recommend review of the effect on research progress of the NIH award terms for international infectious disease work with select agents the NIH requirements that foreign institutions must have comparable facilities and standards to their U. S. collaborators has curtailed some longstanding collaborations, making it difficult to share regents, antigens and to obtain biosamples

17 Transportation of Microorganisms Distribution of microorganisms for identification, research, reference, production, diagnostic purposes is essential to public health and scientific progress Safe handling that minimizes risk is essential Effective communication from regulators DOT, IATA, ICAO, UN, EU, Commerce, CDC, USDA, Postal Service will aid compliance. Institutions must take a proactive role to assure materials are shipped in compliance with applicable regulations A single web site with up-to-date information about regulations would be valuable.

18 Select Agent Personnel Security and Personnel Reliability The 2002 law expanding the Select Agent regulations mandates that access to select agents be denied to restricted persons (convicted of a crime, fugitive from justice, user of unlawful drugs, illegal alien, adjudicated mental defective, from a country supporting terrorism, or dishonorable discharge) because of the criminal prohibition on possession by such persons

19 Select Agent Regulations Personnel Reliability The legislation specifically addressed concerns by the scientific community about the timeliness and accuracy of the background screening process and required prompt action by the Attorney General and the Secretary with respect to screening and notification to affected individuals and by providing an expedited review process for good cause. Congress intended that the screening process be conducted in a timely and fair manner to avoid undue interference with research progress.

20 Personnel Reliability Any new policies involving personnel reliability that go beyond the SAP procedures must be timely and fair so as not to delay or impede important research

21 Personnel Reliability Full security checks of lab personnel would have a severe negative impact on biomedical research that would harm the nation s security Look at other industries, e.g., airline pilots, for models of screening for personnel reliability

22 Federal Government Guidance Needed The Federal government has to provide the scientific community with guidance What should I consider as things that raise alarm? How do I identify potential problems? What do I do about personnel concerns? Who do I notify?

23 Personnel Reliability Personnel reliability policies should be commensurate with risk. Honest, reliable and conscientious workers represent the foundation of an effective security program. Facility administrators and laboratory directors are most familiar with laboratory workers. Provide guidance to institutions and lab directors about potential things that raise alarm and where to go for assistance. Build a culture of responsibility, built on the premise that the misuse of science is taboo.

24 Physical Security Pathogens should be secure to the extent possible without undue interference with critical research and diagnostic activities. Physical security should be commensurate with risk. Theft and vandalism in a life science laboratory should be reported to the biosafety professionals as well as security officials and steps taken to prevent recurrence.

25 Oversight Congress has repeatedly endorsed keeping biosecurity and biosafety programs within DHHS and USDA because of public health and technical knowledge of these agencies and their relationship with the research and clinical communities. DHHS (CDC) and USDA should continue to regulate biosecurity and biosafety. We do not support DHS as an appropriate agency for biosecurity and biosafety of research labs.

26 Resources/Select Agent Changes If the scope of biosecurity and biosafety is expanded, even if voluntary, greater federal resources will be needed. Any modifications of the Select Agent regulations or biosafety requirements should be made without additional legislation. Any requests for additional legislative authorities should be made very carefully.

27 Training Lab personnel should be trained to a level of competence that maximizes their own safety and that of the community including biosecurity Learning competencies, formal training programs, and online training information should be established, documented and required There should be a checklist of minimum competencies to be addressed in training

28 Training There should be mandatory, periodic training with annual refreshers for all personnel in BSL 3 and 4 laboratories, including individuals responsible for facility operations, equipment and management and those responsible for responding to emergencies at high containment laboratories Training standards should be established Adequate resources should be provided to ensure adequate training

29 Biocontainment Laboratories The design and building of biocontainment facilities requires careful guidance, e.g. from funding agencies with extensive experience and biosafety experts. There should be public education outreach programs for the community.

30 Laboratory Accreditation Accreditation of high containment laboratories may be desirable But we need to avoid unintended consequences the devil is in the detail Accreditation needs to be well-defined Standards need to be established first Select agent regulations already represent a pseudo accreditation process--requires a facility be registered, facility has to be inspected, undergo security risk assessments, and personnel must be cleared to work in the laboratory

31 Laboratory Accreditation The scientific community is concerned about issues surrounding lab accreditation and expanded personnel screening as part of any revised federal oversight effort, and therefore should be consulted during federal decision-making on standards, guidelines, etc. Need standards first

32 High Containment Laboratory Certification A study should be undertaken to evaluate the costs, benefits and efficacy of registering and/or accrediting high containment laboratories. The study should address: Which high containment laboratories, if any, should be registered and/or accredited Who should be responsible for registration and/or accreditation What would be the budgetary considerations and who would cover the costs

33 High Containment Laboratory Certification Consider certification system for high containment laboratories that ensures biosafety and biosecurity Facility itself (physical) operation with regular inspections Laboratory Director Biosafety Officer Personnel Laboratory operations

34 Concluding Remarks We should take steps to enhance biosafety and assure biosecurity of high containment labs These steps should include: Increased awareness within the scientific community Improved guidance from the Federal Government Establishing standards for biosafety and biosecurity that would form the basis for training Evaluation of a carefully defined accreditation system

35 Approach to Personnel Reliability Addressing the issues of biosafety, biosecurity, and personnel reliability should be a bottom-up process, not a top-down mandate from the federal government.

36 Responsible Conduct To enhance biosecurity we should build a culture of responsibility across the entire scientific community, one that embraces the premise that the misuse of the life sciences is an absolute taboo and that good lab practices should be required routine procedures. Awareness and education are critical for building a culture of responsibility