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Safety and Security Requirements for Select Agent Research.

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Presentation on theme: "Safety and Security Requirements for Select Agent Research."— Presentation transcript:

1 Safety and Security Requirements for Select Agent Research

2 BioterrorismBioterrorism

3 Definitions Biological terrorism (BT) – Use of biological agent on a population to deter, hinder, or otherwise slow the productivity of a community. Biological warfare (BW) - Use of biological agent to harm or kill an adversary’s military forces, population, food, and livestock. Select agents (SA): designated subset of biological agents or toxins identified as having the potential to be used in weapons of mass destruction (WMD’s) Biological terrorism (BT) – Use of biological agent on a population to deter, hinder, or otherwise slow the productivity of a community. Biological warfare (BW) - Use of biological agent to harm or kill an adversary’s military forces, population, food, and livestock. Select agents (SA): designated subset of biological agents or toxins identified as having the potential to be used in weapons of mass destruction (WMD’s)

4 Types of Biological Weapons Bacterial agents Viral agents Biological toxins Bacterial agents Viral agents Biological toxins

5 Advantages of BT Killing efficacy Cost effectiveness Vehicle Relative ease of production Interval between dissemination to infection Killing efficacy Cost effectiveness Vehicle Relative ease of production Interval between dissemination to infection

6 HistoryHistory Ancient – 20 th century 20 th century – – today Ancient – 20 th century 20 th century – – today

7 Does the Siege at Caffa Correlate with the Initiation of Black Death?

8 20 th Century to 1972 World War I Glanders and anthrax used on horses Geneva Protocol (1925) -40 violations from of prohibitions of bioweapons used in war World War II - Unit 731, Manchuria, China – weapons tests on Chinese World War I Glanders and anthrax used on horses Geneva Protocol (1925) -40 violations from of prohibitions of bioweapons used in war World War II - Unit 731, Manchuria, China – weapons tests on Chinese

9 20 th Century to th Century to 1972 US military bio-weapon program, Ft. Detrick, Maryland Pine Bluff Arsenal, Arkansas 1966, B. subtilis in NYC subway - Study dissemination patterns 1969, Serratia in San Francisco - Study line-source dissemination Biological Weapons Convention, 1972 Today, 148 signatories - India, North Korea, Pakistan, Iran among those not signed US military bio-weapon program, Ft. Detrick, Maryland Pine Bluff Arsenal, Arkansas 1966, B. subtilis in NYC subway - Study dissemination patterns 1969, Serratia in San Francisco - Study line-source dissemination Biological Weapons Convention, 1972 Today, 148 signatories - India, North Korea, Pakistan, Iran among those not signed

10 Today Today 1979, Sverdlovsk, Russia 66 fatalities from anthrax release For 13 years USSR government tells public it was due to ingestion of contaminated meat. 1992, Boris Yeltsin admits a faulty HEPA exhaust filter as the result of the release from Building 19. Science, 1994, 266(5188): , Sverdlovsk, Russia 66 fatalities from anthrax release For 13 years USSR government tells public it was due to ingestion of contaminated meat. 1992, Boris Yeltsin admits a faulty HEPA exhaust filter as the result of the release from Building 19. Science, 1994, 266(5188):

11 Today Today 1992, Aum Shinrikyo cult Weaponize anthrax - 10 botched attempts (1992) Travel to Zaire to find Ebola Sarin gas attacks in Japan

12 Where in the World is Safety Bob and what is the public health significance of this place?

13 The former Shakey’s Pizza where the Bhagwan Shree Rajneesh cult conducted the first known bio agent attack in the US in September 1984, spraying salmonella on the salad bar to in an attempt to prevent citizens from voting in an upcoming election

14 The 2001 Anthrax Letters 23 reported cases of anthrax New York City (8), New Jersey (7), D.C. (5), Florida (2), and Connecticut (1) 11 inhalation anthrax (5 deaths) 12 cutaneous anthrax 9/11 inhalation anthrax cases are linked to direct exposure to contaminated mail 2 cases had no known exposure (61 y.o. woman in NY, 94 y.o. woman in CT) 23 reported cases of anthrax New York City (8), New Jersey (7), D.C. (5), Florida (2), and Connecticut (1) 11 inhalation anthrax (5 deaths) 12 cutaneous anthrax 9/11 inhalation anthrax cases are linked to direct exposure to contaminated mail 2 cases had no known exposure (61 y.o. woman in NY, 94 y.o. woman in CT)

15 Anthrax Anthrax Bacillus anthracis Gram (+) sporulating rod 3 antigens formed (EF), (LF), (PA) Presence of (LF) and (PA) = pathogenic 3 distinct clinical syndromes Cutaneous Inhalational Gastrointestinal Bacillus anthracis Gram (+) sporulating rod 3 antigens formed (EF), (LF), (PA) Presence of (LF) and (PA) = pathogenic 3 distinct clinical syndromes Cutaneous Inhalational Gastrointestinal

16 Inhalational Anthrax Infective Dose = 8, ,000 spores Incubation period = 1-6 days Duration of illness = 3-5 days Diagnostic Hallmark Widened mediastinum Treatment: Ciprofloxacin: 500mg bid x 4 wk Doxycycline: 100mg bid x 4 wk Infective Dose = 8, ,000 spores Incubation period = 1-6 days Duration of illness = 3-5 days Diagnostic Hallmark Widened mediastinum Treatment: Ciprofloxacin: 500mg bid x 4 wk Doxycycline: 100mg bid x 4 wk

17 Anthrax - Clinical Presentations

18 October 2001: Anthrax Mail Attacks: UTHSC-H Experience

19 Ricin Derivative from castor bean plant, Ricinus communis Protein cytotoxin that inhibits protein synthesis through its 2 polypeptide chains Marginal toxicity when compared to other biological toxins LD 50 = 30 μg/kg Recent history 1978 – Bulgarian dissident 1996 – KC Oncologist intent to use 1997 – WI resident possession 2003 – Al Qaeda plot 2004 – Washington DC letter Derivative from castor bean plant, Ricinus communis Protein cytotoxin that inhibits protein synthesis through its 2 polypeptide chains Marginal toxicity when compared to other biological toxins LD 50 = 30 μg/kg Recent history 1978 – Bulgarian dissident 1996 – KC Oncologist intent to use 1997 – WI resident possession 2003 – Al Qaeda plot 2004 – Washington DC letter

20 Ricin, cont’d Major clinical presentations: Inhalation Rapid onset (4-8 h) – fever, chest tightness, cough, dyspnea, nausea Respiratory failure (36-72 h) and pulmonary edema Injection Same onset as inhalation Local lymphoidal and muscle necrosis, GI hemorrhaging Ingestion Less toxic than above Onset of symptoms similar time – abdominal pain, vomiting, diarrhea, progressing to GI hemorrhaging, hepatic, splenic, and renal necrosis Death 3-5 days – cessation of circulatory system Major clinical presentations: Inhalation Rapid onset (4-8 h) – fever, chest tightness, cough, dyspnea, nausea Respiratory failure (36-72 h) and pulmonary edema Injection Same onset as inhalation Local lymphoidal and muscle necrosis, GI hemorrhaging Ingestion Less toxic than above Onset of symptoms similar time – abdominal pain, vomiting, diarrhea, progressing to GI hemorrhaging, hepatic, splenic, and renal necrosis Death 3-5 days – cessation of circulatory system

21

22 SmallpoxSmallpox Variola major virus Orthopox virus BW threat from aerosolization Acute stages often confused with Varicella (chickenpox) Differentiation: Smallpox typically evolves distally Lesions generally all is same stage Febrile illness prodromal stage Eradicated by WHO in 1980 US & UN delay destruction of reserves until 7-02 Delayed longer Treatment No known cure Vaccinia Immune globulin Cidofovir Variola major virus Orthopox virus BW threat from aerosolization Acute stages often confused with Varicella (chickenpox) Differentiation: Smallpox typically evolves distally Lesions generally all is same stage Febrile illness prodromal stage Eradicated by WHO in 1980 US & UN delay destruction of reserves until 7-02 Delayed longer Treatment No known cure Vaccinia Immune globulin Cidofovir

23 Smallpox Presentation

24 Given the Threat – What to Do? Preparedness Needs Detection - Health Surveillance Rapid Laboratory Diagnosis Epidemiological Investigations Implementation of Public Health Control Measures Communication network Research and Development PPE, respirators Triage and decontamination methods Vaccines, prophylaxis Preparedness Needs Detection - Health Surveillance Rapid Laboratory Diagnosis Epidemiological Investigations Implementation of Public Health Control Measures Communication network Research and Development PPE, respirators Triage and decontamination methods Vaccines, prophylaxis

25 Web Resources Web Resources 0tips.htm tips.htm

26 The Select Agent Rule

27 Foundation for Select Agents Antiterrorism and Effective Death Penalty Act of 1996 (PL ) Invoke transport requirements, and prohibited possession as weapons USA PATRIOT Act (PL ) Effective 10/16/01 Controlled the possession of 49 Select Agents/Toxins for any use: peaceful, research, or intentional Outlawed use if a “restricted person” Antiterrorism and Effective Death Penalty Act of 1996 (PL ) Invoke transport requirements, and prohibited possession as weapons USA PATRIOT Act (PL ) Effective 10/16/01 Controlled the possession of 49 Select Agents/Toxins for any use: peaceful, research, or intentional Outlawed use if a “restricted person”

28 Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL ) effective 6/12/02 Covers both human and plant/animal select agents; joint program between HHS (CDC) and USDA (APHIS) 9/10/02 - CDC notification of possession or use of SA by facilities required; negative certification also required 12/12/02 – Interim final rule published 02/14/03 – Interim final rule enacted as law 03/18/05 – Final Rule released (PL ) effective 6/12/02 Covers both human and plant/animal select agents; joint program between HHS (CDC) and USDA (APHIS) 9/10/02 - CDC notification of possession or use of SA by facilities required; negative certification also required 12/12/02 – Interim final rule published 02/14/03 – Interim final rule enacted as law 03/18/05 – Final Rule released

29 What is a Select Agent? List of agents can be found on the CDC and APHIS websites Includes infectious agents and biological toxins of WMD concern; often termed “dual use” There are some exemptions for certain strains and amounts of toxin per PI List of agents can be found on the CDC and APHIS websites Includes infectious agents and biological toxins of WMD concern; often termed “dual use” There are some exemptions for certain strains and amounts of toxin per PI

30 42 CFR 73 – Select Agent Regulations 73.7 Registration & related security risk assessment 73.9 Responsible Official Restricting access to Select Agents Security plan Biosafety plan Incident Response Training Inspections Notification for Theft, Loss, or Release 73.7 Registration & related security risk assessment 73.9 Responsible Official Restricting access to Select Agents Security plan Biosafety plan Incident Response Training Inspections Notification for Theft, Loss, or Release

31 CFR Registration You must be registered prior to beginning work Registration good for 3 years Facility must meet CDC/NIH BMBL guidelines in addition to security requirements You must be registered prior to beginning work Registration good for 3 years Facility must meet CDC/NIH BMBL guidelines in addition to security requirements

32 CFR 73.7 – Related Security Risk Assessment Registration information required to be submitted so that Attorney General may perform risk assessment of work at institution with Select Agents

33 CFR 73.9 – Responsible Official Responsible Official (RO) and an Alternate Responsible Official (ARO) must be designated This individual must have resources available to ensure compliance Responsible Official (RO) and an Alternate Responsible Official (ARO) must be designated This individual must have resources available to ensure compliance

34 CFR – Restricting Access Must be an authorized person to have unrestricted, unsupervised access to Select Agents -training & experience required -must be approved by Attorney General Authorization granted for a period of five years Must be an authorized person to have unrestricted, unsupervised access to Select Agents -training & experience required -must be approved by Attorney General Authorization granted for a period of five years

35 Statement of Eligibility Denied SA possession if ‘Yes’ to any of following: Jail >1 year Fugitive from justice Controlled substance use Citizen of one of UN recognized terrorist countries Committed to a mental institution Dishonorably discharged Denied SA possession if ‘Yes’ to any of following: Jail >1 year Fugitive from justice Controlled substance use Citizen of one of UN recognized terrorist countries Committed to a mental institution Dishonorably discharged

36 CFR – Security Inventory Control Measures Physical Security - Looking for at least 3 levels Cyber Security Provisions for visitors, housekeeping, and maintenance Procedures for lost passwords, keys, IDs, personnel leaving, unauthorized personnel Inventory Control Measures Physical Security - Looking for at least 3 levels Cyber Security Provisions for visitors, housekeeping, and maintenance Procedures for lost passwords, keys, IDs, personnel leaving, unauthorized personnel

37 CFR Biosafety Plan Biosafety and containment procedures set forth following BMBL and NIH rDNA Guidelines i.e. entry protocols; PPE; general and special practices and procedures Plan must be tested at least annually using drills to evaluate the effectiveness of plan or after any incident Biosafety and containment procedures set forth following BMBL and NIH rDNA Guidelines i.e. entry protocols; PPE; general and special practices and procedures Plan must be tested at least annually using drills to evaluate the effectiveness of plan or after any incident

38 CFR Incident Response Do you have an institutional Emergency Situations Response Plan (ESRP)? Where is it located? Planning and coordination with outside parties What are the emergency hazards associated with select agent? Oral, Contact (dermal), Inhalational hazards What are the hazards associated with response that could lead to the spread of select agent? Do you have appropriate site security and control during emergency? Where do you find information about the specific hazards associated with the select agent? Biosafety Plan Do you have an institutional Emergency Situations Response Plan (ESRP)? Where is it located? Planning and coordination with outside parties What are the emergency hazards associated with select agent? Oral, Contact (dermal), Inhalational hazards What are the hazards associated with response that could lead to the spread of select agent? Do you have appropriate site security and control during emergency? Where do you find information about the specific hazards associated with the select agent? Biosafety Plan

39 CFR Records Current, accurate list of individuals approved for access to select agent Current, accurate inventory of select agent Name, characteristics, and source data Quantity acquired and date of acquisition Quantity destroyed and date of destruction Quantity transferred, date of transfer, and to whom it was transferred (EA-101) Records of APHIS/CDC Form 2 (EA-101) transfers Access to area where select agent is used or stored Current, accurate list of individuals approved for access to select agent Current, accurate inventory of select agent Name, characteristics, and source data Quantity acquired and date of acquisition Quantity destroyed and date of destruction Quantity transferred, date of transfer, and to whom it was transferred (EA-101) Records of APHIS/CDC Form 2 (EA-101) transfers Access to area where select agent is used or stored

40 CFR – Notification for Theft, Loss, or Release Must have a procedure for any of the above events Must complete report to USDA or CDC using APHIS/CDC Form 3 Must have a procedure for any of the above events Must complete report to USDA or CDC using APHIS/CDC Form 3

41 Penalties 42 CFR 1003 imposes strict penalties for violations of 42 CFR Part 73 Imprisonment of up to 5 years “….. $250,000 in the case of an individual” “……$500,000 in the case of any other person” Failure to completely comply also carries significant reputational risk 42 CFR 1003 imposes strict penalties for violations of 42 CFR Part 73 Imprisonment of up to 5 years “….. $250,000 in the case of an individual” “……$500,000 in the case of any other person” Failure to completely comply also carries significant reputational risk

42 Foreseeable Trends Increasing regulatory requirements, inspections, scrutiny Opportunities for research The FY03 budget for Department of Homeland Security was $37,450,000,000 Increasing regulatory requirements, inspections, scrutiny Opportunities for research The FY03 budget for Department of Homeland Security was $37,450,000,000

43 Commentary Additional bureaucratic controls for select agents are imminent These rules will not always be based on sound science Incompatibilities with universities: Designed as traditionally open environments Internationally diverse populations Population eschews being told what to do Openly shares information But the work is important –so an infrastructure is needed to support this type of activity Additional bureaucratic controls for select agents are imminent These rules will not always be based on sound science Incompatibilities with universities: Designed as traditionally open environments Internationally diverse populations Population eschews being told what to do Openly shares information But the work is important –so an infrastructure is needed to support this type of activity

44 Commentary (con’t) When looking at positions, suggest asking about the support infrastructure in place - specifically: Who does EH&S report to? Who is the designated “responsible official”? Is “select agent” work currently underway? What facilities exist and are planned? When looking at positions, suggest asking about the support infrastructure in place - specifically: Who does EH&S report to? Who is the designated “responsible official”? Is “select agent” work currently underway? What facilities exist and are planned?

45 Summary Biosafety is much more than just research protocol reviews or bloodborne pathogens Risk assessment process the key to properly classifying and reviewing research with infectious agents or rDNA Safety department must rely on the expertise of the committee for assistance Select agent work is highly regulated and scrutinized Biosafety is much more than just research protocol reviews or bloodborne pathogens Risk assessment process the key to properly classifying and reviewing research with infectious agents or rDNA Safety department must rely on the expertise of the committee for assistance Select agent work is highly regulated and scrutinized

46 References 42 CFR 73 (CDC) 7 CFR 331 and 9 CFR 121 (APHIS) Biosafety in Microbiological and Biomedical Laboratories, 4th ed. CDC/NIH 1999 Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) April 2002 Health Canada MSDS for Biological Agents


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