Lab Security

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Status Brief
History/Origins:

Developmental Milestones/Developments to Date:

Current Assessment/State of the Field:

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Proposals:

2003

Atlas, Ronald. “National Security and the Lab” Medical Laboratory Observer, Volume 35, Issue 9. 52. September 2003.

1. ”The aftermath of anthrax attacks following the horrific 9/11 events increased fear that terrorists could acquire deadly pathogens from legitimate U.S. laboratories, which led to a series of laws and regulations directly impacting clinical microbiology laboratories.” – page 52
2. ”Enhancement of clinical and public health laboratories is key to the nation’s biodefense capabilities, so the American Society for Microbiology (ASM) worked with the Centers for Disease Control and Prevention (CDC) to develop protocols for diagnostic laboratories to recognize and handle major biothreat agents.” – page 52
3. ”Since clinical labs have been the sources of the agents used in prior acts of bioterrorism or biocrimes, (e.g., the 1989 use of salmonella by the Rajneesh cult in Dalles, OR), they must exercise appropriate oversight as to who is given access to any pathogen which can be misused to cause harm.” – page 52
4. ”Clinical labs wishing to retain select agents as clinical specimens or reference standards must meet all of the registration requirements of the Biopreparedness Act, including imposing strict biosecurity procedures and obtaining Department of Justice clearance for all individuals with access to the select agents.” – page 52
5. ”The CDC and USDA must maintain accurate tracking of the acquisition, transfer and possession of these select agents, and must establish safeguards and biosecurity procedures to be followed by institutions possessing select agents.” – page 52
6. ”The FBI is responsible for conducting security risk assessments of individuals seeking access to listed agents and toxins, and individuals or entities seeking to register under the Act.” – page 52
7. ”The Biopreparedness Act, a new regulatory burden, should have minimal impact. The greatest impact is likely to be on the labs in the western United States where plague, tularemia, and coccidioidomycoses occur.” – page 52

Public Health, Lab Security, Anthrax, Salmonella, Tularemia, Plague, CDC, Bioterrorism, Biodefense, Biosecurity

 

Atlas, Ronald, “National Security and the Lab” Medical Laboratory Observer, Volume 35, Issue 9. 52. September 2003.

1. ”The aftermath of anthrax attacks following the horrific 9/11 events increased fear that terrorists could acquire deadly pathogens from legitimate U.S. laboratories, which led to a series of laws and regulations directly impacting clinical microbiology laboratories.” – page 52
2. ”Enhancement of clinical and public health laboratories is key to the nation’s biodefense capabilities, so the American Society for Microbiology (ASM) worked with the Centers for Disease Control and Prevention (CDC) to develop protocols for diagnostic laboratories to recognize and handle major biothreat agents.” – page 52
3. ”Since clinical labs have been the sources of the agents used in prior acts of bioterrorism or biocrimes, (e.g., the 1989 use of salmonella by the Rajneesh cult in Dalles, OR), they must exercise appropriate oversight as to who is given access to any pathogen which can be misused to cause harm.” – page 52
4. ”Clinical labs wishing to retain select agents as clinical specimens or reference standards must meet all of the registration requirements of the Biopreparedness Act, including imposing strict biosecurity procedures and obtaining Department of Justice clearance for all individuals with access to the select agents.” – page 52
5. ”The CDC and USDA must maintain accurate tracking of the acquisition, transfer and possession of these select agents, and must establish safeguards and biosecurity procedures to be followed by institutions possessing select agents.” – page 52
6. ”The FBI is responsible for conducting security risk assessments of individuals seeking access to listed agents and toxins, and individuals or entities seeking to register under the Act.” – page 52
7. ”The Biopreparedness Act, a new regulatory burden, should have minimal impact. The greatest impact is likely to be on the labs in the western United States where plague, tularemia, and coccidioidomycoses occur.” – page 52

Public Health, Lab Security, Anthrax, Salmonella, Tularemia, Plague, CDC, Bioterrorism, Biodefense, Biosecurity

2006

United States Department Of Defense, “Instruction Number 5210.89- Minimum Security Standards for Safeguarding Biological Select Agents and Toxins“, April 18, 2006 http://www.fas.org/irp/doddir/dod/i5210_89.pdf

1. E3.1.4. A current and favorable personnel security investigation is required for all personnel whose duties require access to Biological Restricted Areas and BSAT. Personnel security investigations will be comprised of the following:
2. E3.1.4.1. A National Agency Check with Local Agency Checks and Credit Checks (NACLC) for military and contractor employees.
3. E3.1.4.2. An Access National Agency Check with Credit Checks and Written Inquiries (ANACI) for civilian employees.
4. E3.1.4.3. A favorably adjudicated security clearance at the SECRET or higher level suffices for the personnel security investigation.
5. E3.2.1. Individuals identified by the Certifying Official as having a legitimate need to access BSAT and Biological Restricted Areas shall be screened for suitability and reliability. They shall be emotionally and mentally stable and trustworthy, physically competent, and adequately trained to perform the assigned duties. They shall complete a current and favorable personnel security investigation adjudicated to national security standards, with periodic reinvestigations according to Reference (h) and described in paragraph E3.1.4. Personnel will pass a urinalysis test for illegal drug/substance use before certification for access to BSAT. They will also be subject to random urinalysis tests.

Biological Personnel Reliability Program (BPRP)

1. “The purpose of the BPRP is to ensure that each individual who is authorized access to BSAT, and to escort and/or supervise personnel with access to Biological Restricted Areas and BSAT, including Responsible and Certifying Officials, meets the highest standards of integrity, trust, and personal reliability. Determination of integrity and reliability shall be accomplished, in part, through the initial and continuing evaluation of individuals assigned duties associated with BSAT. The continuing evaluations will ensure these individuals do not pose a risk to the public health and safety, or national security.”
2. E4.2.2. The Certifying Official shall certify the eligibility of an individual for access to BSAT based on factors including a favorable personnel security investigation, an evaluation of the individual’s physical and mental capability, appropriate personnel and medical records, and a personal interview. The eligible individual will sign an agreement affirming his or her responsibility to abide by the requirements for maintaining BPRP certification.

Qualifying Standards:

1. E4.3.1.1. Emotionally and mentally stable, trustworthy, physically competent, and adequately trained to perform the assigned duties.
2. E4.3.1.2. Dependability in accepting and executing BPRP responsibilities.
3. E4.3.1.3. Flexibility and adaptability in adjusting to a restrictive and demanding work environment with BSAT that must be strictly controlled and secured.
4. individuals are also subject to a Personnel Security Investigation, medical evaluation, personal interview, drug/substance abuse testing

Lab Security, Personnel Reliability

2008

Sands, Derek, “Former DOE counterintelligence official faults security at nuclear laboratories,” Platts Inside Energy, September 29, 2008.

1. “Terry Turchie, a distinguished FBI agent who led the “Unabomber” case and who previously served as the head of counterintelligence at DOE’s Lawrence Livermore National Laboratory, charged in a letter that Congress is being misled by DOE on the “true nature” of the effectiveness of counterintelligence at the laboratories.”
2. “In his letter, Turchie outlined problems at the labs, and said that he left DOE over the “dangerously chaotic state of counterintelligence” within the department. He said DOE’s decision to merge the intelligence and counterintelligence operations at the department and at the National Nuclear Security Administration has meant “the vulnerability of DOE personnel and facilities to hostile intelligence entities has increased exponentially.” Turchie left Livermore in September 2007.”
3. “Gregory Wilshusen, of the Government Accountability Office, unveiled a report that praised some physical and computer security progress at Los Alamos National Laboratory, but also expressed skepticism that the progress could be sustained.”
4. “The DOE nuclear weapons labs — Sandia, Lawrence Livermore, and Los Alamos national laboratories — have been the target of criticism from GAO and DOE’s inspectors general for years over problems securing their computer hardware and their information over networks, as well as their ability to repel possible terrorist attacks.”
5. “There have been a number of computer-related security breaches at Los Alamos in recent years, including the theft of hard drives containing sensitive data by an employee, as well as the loss of nine data disks by lab contractors.”
6. “The vulnerability of yellow networks has been brought into sharp relief by recent DOE security exercises, according to Glenn Podonsky, director of DOE’s Office of Health, Safety and Security. For example, a “red team” of six DOE computer experts managed to take over the yellow networks at two of DOE’s non-nuclear science labs and download over 40,000 documents, including sensitive material, Podonsky said at the Dingell hearing. The team also took over the network of a DOE lab site office, he said.”

Law Enforcement, Nuclear, Lab Security

2009

National Science Advisory Board For Biosecurity, “Enhancing Personnel Reliability among Individuals with Access to Select Agents” May 2009. http://oba.od.nih.gov/biosecurity/meetings/200905T/NSABB%20Final%20Report%20on%20PR%205-29-09.pdf

1. ”Recommendation” 1: “It is appropriate to enhance personnel reliability measures for individuals with access to select agents, but the promulgation of a formal, national Personnel Reliability Program is unnecessary at this time.”
2. ”Recommendation” 2: “Incorporate into the SRA [Security Risk Assessment] process the periodic cross-checking of individuals with favorable SRAs against federal databases. …Expand the SRA prohibition regarding terrorism. …Strengthen screening of foreign individuals. …Clarify the reference to “mental defective” on the SRA form.
3. ”Recommendation” 3: “The culture of responsibility and accountability should be enhanced at institutions that conduct select agent research.”
4. ”Recommendation” 4: “Professional societies should continue to encourage an ongoing dialogue about personnel reliability to maintain vigilance about biosecurity issues throughout the research community and to foster community-based solutions.”
5. ”Recommendation” 5: “The List of Select Agents and Toxins33 should be reduced or stratified.”
6. “Personnel reliability measures aim to ensure that individuals granted access to sensitive materials are trustworthy, responsible, and stable, and can competently perform their duties. (p.4)”
7. “Certain research facilities (notably federal) have instituted formal Personnel Reliability Programs to provide additional measures to help ensure that individuals with access to select agents meet additional standards of reliability. Current PRPs are modeled after those within the traditional surety programs and may include extensive background investigations with interviews of character references, security clearances, medical evaluations that may include a review of complete medical records, psychological testing, drug and alcohol testing, polygraph examinations, credit checks, and a comprehensive review of service and employment records. PRPs usually also involve formal mechanisms for ongoing monitoring that can include requirements for self-reporting, peer-reporting, ongoing monitoring by supervisors, and penalties for noncompliance. (p.5)”
8. “The potential benefits of enhanced personnel reliability measures must be carefully weighed against the more likely negative consequences that such measures could have on the research community…The promulgation of additional reliability measures could serve as a powerful disincentive to those who wish to and would responsibly conduct research on select agents because the most talented young researchers, those with many options for research paths, may be far more likely to enter fields with less onerous regulatory requirements. Thus, a burdensome national personnel reliability program may not only drive scientists from important select agent research, but also drive select agent research out of academia and potentially out of the U.S. into countries with less stringent regulations. (p.6)”
9. “Paradoxically, measures aimed at enhancing the biosecurity of select agent research could have the unintended consequence of actually decreasing national security if such measures diminished the capacity for the U.S. to prepare for, and respond to, emerging threats by diminishing the U.S.’ ability to recruit top scientists and develop vaccines, treatments, and other countermeasures. Furthermore, the institution of reliability measures could isolate select agent researchers from the mainstream scientific community, and such isolation might increase the risk of the insider threat. (p.6)”
10. “Under the current Select Agent Rules implemented by the U.S. Department of Health and Human Services and USDA/APHIS, an individual requiring unescorted access to select agents as a part of his or her job must have a Security Risk Assessment by which his or her potential status as a restricted or prohibited person is evaluated…An individual must provide fingerprints and disclose aspects of possible criminal history, use of illicit drugs, mental-health history, and whether dishonorably discharged from the U.S. Armed Services…Federal databases are then utilized to examine an individual’s possible criminal background, potential terrorist ties, and immigration status. (p.3)”

Personnel Reliability, Lab Security

 

Editors, “Ebola vials found in car trunk: Ex-Winnipeg scientist arrested at U.S. border,” Toronto Star, A29, May 14, 2009,

1. ”Konan Michel Yao, 42, is in U.S. custody charged with smuggling.”
2. ”The U.S. Centers for Disease Control, which has possession of the missing vials, has determined some contain small amounts of genetic Ebola material, said Plummer.”
3. ”Dr. Frank Plummer, head of the Winnipeg lab, said Yao did not have security clearance to work with high-level pathogens such as the Ebola virus. But he was allowed to work on an Ebola vaccine project in the facility’s special pathogens unit.”
4. ”The vials, according to court documents, were in a glove, wrapped in aluminum foil and placed in a plastic bag. They were found in the trunk of the scientist’s car.”
5. ”But he [Plummer] added the material poses no risk to public health. ‘It was not infectious,’ Plummer told reporters yesterday. ‘The only thing (Yao) could have done with it would be to make an Ebola vaccine.’”
6. “Yao left work in January when his research fellowship ended and he signed a document swearing he had not taken any government property, said Plummer.”

Law Enforcement, Ebola, Lab Security, Canada

 

Greenberger, Michael, “Strengthening Security and Oversight at Biological Research Laboratories” September 22, 2009 http://judiciary.senate.gov/pdf/09-09-22%20Greenberger%20testimony.pdf

1. “Since 2001, funding for biodefense research has substantially increased. In 2001 the National Institutes of Health Biodefense Research Funding totaled $25 million, but by 2005 had increased to $1.7 billion. (p.3)”
2. “The National Science Advisory Board on Biosecurity, the Commission on the Prevention of W/md Proliferation and Terrorism, and the Government Accountability Office were independently charged with investigating different aspects of biosecurity at biosafety laboratories. (p.3)”
3. “Security Risk Assessments are mandated by the PHBPA, for every individual who seeks to work with Select Agents. Using the criteria from the PATRIOT Act, the SRA is intended to preempt “Restricted Persons” from gaining access to these potentially harmful bioagents…The SRA most notably involves comparing an applicants fingerprints against criminal and terrorist databases and must be renewed every 5 years. (p.10)”
4. “The CDC notified the NSABB that recently the FBI has begun to bi-annually cross-check approved individuals against specified databases to verify that the individuals have not slid into a restricted category…However, the FBIs interim crosscheck is not presently required by law or regulation. (p.11)”
5. PRPs are more commonly used in military research laboratories, and are more extensive than the SRA. *”A culture of strict security has always been the norm in these (military) facilities and so the PRP are not seen as a hindrance to the recruitment and retention of talented scientists. (p.11)”
6. “Apart from the Select Agent regulations, there is no current federal requirement for the development of a biosecurity program, as distinct from a biosafety program at any of the BSL-1 through BSL-4 laboratories. The Select Agent regulations require that a biosecurity plan exist, but they do not establish the specific components of the plan. (p.13)”
7. Recommendation: “The PHBPA and the ABPA grant oversight for select agents to the HHS and USDA respectively. Additionally agents, which overlap the human, animal, and plant categories because of their potential to impact each species, can be registered with either agency. Recombinant DNA research is additionally covered by NIH guidelines. Depending on the nature of the action, multiple other agencies and regulations may also be involved. (p.24)”
8. Recommendation: “Incidents should be reported promptly to one centralized agency for BSL-3 and 4 laboratories. Reports should be regularly reviewed on a timely basis. The review should not be punitive in nature and should be geared towards improving security and safety across labs. The review should be expeditiously shared with all BSL-3 and 4 institutions, so that investigators working with these agents can learn from each other and share solutions in an organized manner. (p.25)”
9. Recommendation: “Each laboratory is subject to inspection and site visits to assess compliance with the Select Agent regulations. (p.26)”
10. Recommendation: “Improve the SRA to achieve more stringent screening while not imposing the onerous process of a formal PRP. (p.26)”
11. Recommendation: “The informal practice of checking the names of individuals with favorable SRAs against the Counterterrorism Watchlist and other databases by the FBI that is now occurring about every six months should be formally incorporated into the SRA process. (p.27)”
12. Recommendation: “The NSABB also identified optimal personnel characteristics that should be considered for candidates for employment in high containment labs. Research on the reliability and practicality of assessing for these characteristics should be undertaken and the accreditation process should be adapted to the results of that research. (p.27)”
13. Recommendation: “Military institutions have fully developed security models in place that are not practical for the private sector. A non-military model is needed for BSL-3 and 4 biosecurity. An ideal model of this sort would take into account the need for integrating biosecurity measures with the open educational nature of university campuses. (p.27)”

Personnel Reliability, Lab Security

 

Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins, National Research Council of The National Academies, Report Released September 30, 2009. http://www.nap.edu/catalog.php?record_id=12774

1. “The Committee was asked to consider the appropriate framework of laboratory security and personnel reliability measures that will optimize benefits, minimize risk, and facilitate the productivity of research.”
2. ”Recommendation” 1: “…personnel with access to select agents and toxins should receive training in scientific ethics and dual-use research.”
3. ”Recommendation” 2: “… a Biological Select Agents and Toxins Advisory Committee (BSATAC) should be established. … [to]… Promulgate guidance of the Select Agent Program; … Promote harmonization of regulatory policies and practices.”
4. ”Recommendation” 3: “The list of select agents and toxins should be stratified in risk groups according to the potential use of the agent as a biothreat agent, …mechanisms for the timely inclusion or removal of an agent or toxin from the list are necessary and should be developed.”
5. ”Recommendation” 4: “Because biological agents have an ability to replicate, accountability is best achieved by controlling access to archived stocks and working materials. …[as opposed to] counting the number of vials.”
6. ”Recommendation” 5: The appeals process for Security Risk Assessments should be broadened beyond mere checks for factual errors.
7. ”Recommendation” 6: “… define minimum cross-agency physical security needs.”
8. ”Recommendation” 7: Dedicated funding should support an independent evaluation of the Select agent Program to assess benefits and consequences of the program.
9. ”Recommendation” 8: “Inspectors of select agent laboratories should have scientific and laboratory knowledge and experience, as well as appropriate training in conducting inspections specific to BSAT research.  Inspector training and practice should be harmonized across federal, state, local, and other agencies.”
10. ”Recommendation” 9: A  separate category of support should be allocated for BSAT research due to the costs of security.

Ethics, Dual Use, Misconduct, Law Enforcement, Lab Security, Law

 

Associated Press, “6 at Harvard Were Sickened by Tainted Coffee,” NYT A15, Oct. 26, 2009.

1. “Six medical researchers at Harvard University were poisoned in August after drinking coffee tainted with a chemical preservative.”
2. “the coffee came from a machine near the researchers’ laboratory that later tested positive for sodium azide, a common preservative used in laboratories.”
3. “‘We are in the process of installing additional security cameras throughout our buildings,’ it continued, ‘and we are strengthening the security systems that manage access to the laboratories during both normal business hours and off hours.'”

Lab Security

 

Madigan, Nick, “Ex-UM Researcher Whose Fiancee Died is Indicted,” Baltimore Sun, 5, Oct. 27, 2009.

1. “A Baltimore grand jury indicted a former University of Maryland School of Medicine researcher Monday on 14 drug-related counts.”
2. “McCracken was charged by police after the Sept. 27 death of his 29-year-old fiancee, Carrie John, a fellow doctoral lab researcher at Maryland.  [According to McCracken]…she injected herself with … a fluid containing the narcotic buprenorphine.  … McCracken also possessed with intent to distribute the stimulant methlphenidate and the anti-anxiety drug clonazepam.  …McCracken is no longer employed by Maryland.”

Law Enforcement, Lab Security, Misconduct

 

Ippolito, Giuseppe, et al “European Perspective of 2-Person Rule for Biosafety Level 4 Laboratories,” Emerging Infectious Diseases, P. 1858,  Vol. 15, No. 11, November 2009.

1. ”Recently, the directors of Biosafety Level 4 (BSL-4) laboratories in the United States published their views of the requirement of having ≥2 persons present at all times while biological work is undertaken in a BSL-4 laboratory.”
2. ”we support the authors’ initiative and broadly agree with their position.  The consensus among European BSL-4 experts is that, in the interest of safety, standard practice should be for all laboratories to perform a risk assessment before any activity is undertaken.”
3. ”They concluded that safety and security would be better assured in some situations by video monitoring systems rather than by the presence of a fellow scientist.”
4. ”A 2-person rule is inappropriate simply because the best approach is not to have inflexible rules that are not objectively assessed according to laboratory-specific circumstances.”
5. ”Surveillance video monitoring and data storing have their place in protecting laboratory facilities from unauthorized access and theft of materials, but their effectiveness for ensuring proper handling of pathogens is quite limited.”

Lab Security, Biosecurity, Personnel Reliability, Europe

 

Clavert, Scott, “Researcher did not die of overdose autopsy says: Allergic reaction, not bupe, killed UM pharmacologist,” Baltimore Sun, P. 1, Nov. 13, 2009.

1. “University of Maryland pharmacologist Carrie John died from an allergic reaction and not because she injected a seemingly tainted batch of the narcotic buprenorphine.”
2. “The [autopsy] results suggest that McCracken, 33, might have unwittingky bought phony narcotics.”
3. “Her death stunned the school, where the two postdoctoral fellows did brain research and she studied drug abuse.”
4. “He (McCracken] said he and and John soaked a 2 mg pill in water, filtered it, then filled two syringes with the solution.”
5. “The couple met as graduate students at Wake Forest University.  …Before that he was at the University of Pittsburgh.  he is no longer at Maryland.”

Law Enforcement, Lab Security, Misconduct

2010

Ruiz, Rebecca, “More Foreign Students Applying to Graduate Schools,” NYT, A15, April 6, 2010.

1. “International applications to graduate programs in the United States increased by 7 percent this year, according to a report to be released Tuesday by the Council of Graduate Schools.”
2. “Applications from China, India, the Middle East and Turkey grew by doubledigit figures over the last year.”

Open Science, Jurisdiction, Lab Security, China, India, Middle East, South Korea, Turkey

 

Editors, “Lugar Touts U.S. Effort to Safeguard Disease Materials,” NTI, Global Security Newswire, November 9, 2010.

1. “U.S. Senator Richard Lugar (R-Ind.) described in an address yesterday how the nation’s Cooperative Threat Reduction program was seeking to secure potential biological-weapon ingredients beyond the former Soviet Union.”
2. “he Nunn-Lugar program has already helped to shutter biological weapons capabilities in one-time Soviet states, but deadly biological agents including Ebola, Marburg and anthrax remained largely unprotected at research facilities in Africa. Lugar is set to travel with Defense Department experts to examine scientific facilities in Burundi, Kenya and Uganda.”
3. “‘The footprint of weapons-producing laboratories and the size of today’s strategic weapons grow smaller every day,” he said. “A delivery system may be as mundane as a commercial cargo carrier. In the case of infectious pathogens, the delivery system could be an individual human being.’”
4. “As we look to the future of the Nunn-Lugar program, biological threat reduction is an area that is rapidly increasing in importance. The work of securing dangerous pathogens, building central reference laboratories and establishing disease surveillance and monitoring is critically needed in many parts of the world.”
5. “Nunn-Lugar biological engagement directly serves vital U.S. interests, including safeguarding the welfare of our troops overseas, preventing terrorist use of deadly pathogens, and detecting emerging infectious diseases and pandemics before they threaten the American people.”

Lab Security, Biodefense, Biosecurity

2011

Editors, “High-Tech Security Monitors Scientists at Army Research Site,” 11 August 2011, Global Security Newswire http://gsn.nti.org/gsn/nw_20110811_3252.php Last Checked 13 August 2011.

1. “State-of-the-art technology is used to monitor the actions of scientists who work at a recently refurbished high-security U.S. Army biodefense laboratory in Maryland.”
2. “The Army site aims primarily to prepare vaccines and other medical treatments to defense military personnel against biological warfare materials and other disease dangers.”
3. “Personnel at the modernized research space are observed via windows, watched by video cameras and have their movements tracked by sensors.”
4. “The high level of security and significant safety measures are necessary as BSL-4 laboratories work with deadly diseases for which certified countermeasures have not been developed.”

Lab Security, Scientist

2012

Markon, Jerry, “Case turns the Justice Dept. on itself,” Washington Post, P. A3, January 29, 2012.

1. ”In documents deep in the files of a recently settled Florida lawsuit, Justice Department civil attorneys contradicted their own department’s conclusion that Ivins was unquestionably the anthrax killer. The lawyers said the type of anthrax in Ivins’s lab was “radically different” from the deadly anthrax. They cited several witnesses who said Ivins was innocent, and they suggested that a private laboratory in Ohio could have been involved in the attacks.”
2. ”The documents were filed in a lawsuit over the October 2001 death of Robert Stevens, a Florida photo editor. His survivors accused the government of negligence for experimenting with anthrax at Fort Detrick; the case lingered in court until the Justice Department settled it in November.”
3. ”Justice Department prosecutors and FBI officials said they stand firmly behind their conclusions that Ivins prepared and mailed the anthrax-laced letters, which killed five people and terrified the nation just after Sept. 11, 2001. They said the civil filings were legal hypotheticals designed to shield the government from a negligence lawsuit filed by the family of an anthrax victim.”
4. ”The Justice Department initiated settlement discussions in August, about a month after filing its controversial motions, according to people familiar with the discussions. The settlement, finalized Nov. 28, paid $2.5 million to the Stevens family.”
5. ”Federal officials denied any relationship between their filings and the settlement and characterized it as a victory, since the family initially sought $50 million and the government did not admit liability.”
6. ”Byrne said Ivins didn’t have the technical skill to make the extremely fine powder and both said the Fort Detrick lab’s equipment could not have dried the anthrax so it could be turned into powder without contaminating parts of the facility.”
7. ”Vincent B. Lisi, assistant special agent in charge of the FBI’s Washington Field Office, said in an interview that Ivins, one of the nation’s most respected anthrax experts, “absolutely had the ability” to make the deadly spores and that experiments by FBI scientists showed there would have been no contamination.”
8. ”Katy Delaney, a spokeswoman for Battelle, did not respond directly to the government filings, but said ‘the Stevens case against Battelle was dismissed and the [criminal] investigation of Battelle has been closed.’”

Anthrax, Law, Law Enforcement, Lab Security, Attribution

 

Wald, Matthew, “Exam Said to Be Leaked to Guards at Nuclear Site,” NYT, October 31, 2012, http://www.nytimes.com/2012/11/01/us/guards-at-breached-nuclear-site-in-tennessee-cheated-on-exam-report-says.html Last checked 11/2/12.

1. ”The security guards at a nuclear weapons plant who failed to stop an 82-year-old nun from reaching a bomb fuel storage building earlier this year were also cheating on a recertification exam, according to an internal investigation by the Department of Energy, which owns the weapons plant.”
2. ”A federal security official sent the exam by encrypted e-mail to “trusted agents” at the management contractor, B&W, but did not instruct those executives to keep it secret from the people who would have to take it, according to the report..”
3. ”The security contractor was Wackenhut, but its contract was terminated after a security breach on July 28, when the nun, Sister Megan Gillespie Rice, and two accomplices cut through three layers of fence, splashed blood on a building housing bomb-grade uranium, performed a Christian ritual and then waited to be apprehended. A subsequent investigation found that many security cameras had been disabled long before the break-in.”
4. ”The inspector general, Gregory Friedman, said the failure to secure the exam before it was administered was “inexplicable and inexcusable.” Contractor officials treated the test “as if it were a training aid,” he wrote. Part of the problem, he said, was “contractor governance” by the Energy Department. Almost all the work done by the department is performed by contractors..”
5. ”The inspector general added that “the issue at Y-12 does not appear to be unique to that site.” Sending exams to the contractor for checking is common because federal officials often lack the knowledge to check the tests themselves before they are administered, the report said. Similar episodes may have happened elsewhere but not been discovered, the inspector general found.”

Nuclear, Lab Security, Department of Energy

2013

Malakoff, David, “U.S. Announces More New Rules for Potentially Risky Research“, Science, February 21, 2013 http://news.sciencemag.org/scienceinsider/2013/02/us-announces-more-new-rules-for-.html, Last checked February 27, 2013

1. “Researchers interested in conducting studies with 15 potentially dangerous agents and toxins—including the H5N1 avian influenza virus—face some new hurdles in getting funding from the U.S. government.”
2. “Federal officials today released two policy documents that lay out stricter requirements for institutional and government oversight of studies that pose especially problematic safety concerns.”
3. “One policy, released by the U.S. Department of Health and Human Services (HHS), applies only to scientists seeking funds for experiments that might create new strains of the H5N1 virus that can move between mammals in respiratory droplets.”
4. “Experts fear that such mammal-transmissible H5N1 viruses could spark a deadly human pandemic if they escape from a laboratory or are intentionally released by terrorists. U.S. officials outline the new policy today in Science.”
5. “The other document, released by the White House’s Office of Science and Technology Policy (OSTP), asks for public comment on proposed new rules for scientists, universities, and other institutions working with a broader set of 15 especially dangerous agents and toxins—including H5N1—that could be used to cause harm.”
6. “Both policies are direct responses to a global controversy that emerged in late 2011 after two laboratories, one in the United States and one in the Netherlands, announced they had engineered mammal-transmissible H5N1 viruses.”
7. “Under the proposed rules, scientists would be asked to determine whether a proposed study met the definition of DURC—for example, whether the experiment might make a toxin more deadly or confer resistance to treatments, and whether the results “could be directly misapplied to pose a significant threat” to the public.”
8. “Universities would also be required to establish a new committee—or use an existing one—to do DURC reviews, and appoint an “Institutional Contact for Dual Use Research,” or ICDUR, to oversee potentially problematic projects.”
9. “H5N1 researchers are likely to be happier with the new HHS rules, which were revised following a December 2012 meeting on the topic. The new language removes any mention of classifying problematic studies or results, for instance, instead clarifying that HHS will support only research that can be shared publicly.”

Lab Safety, Public Health, Lab Security

 

Young, Alison, “CDC bioterror labs cited for security flaws in audits“, USA TODAY, February 26, 2013, http://www.usatoday.com/story/news/nation/2013/02/25/cdc-bioterror-labs-cited-for-security-failures-in-audits/1945933/ Last checked March 13, 2013

1. “Laboratories at the Centers for Disease Control and Prevention have been repeatedly cited in private government audits for failing to properly secure potential bioterror agents such as anthrax and plague, and not training employees who work with them, according to “restricted” government watchdog reports obtained by USA TODAY.”
2. “The CDC is the main federal agency that oversees government and private bioterror lab safety involving agents dangerous to people, but it refuses to release copies of its lab inspection reports.”
3. “The IG’s office released its reports to USA TODAY in response to a Freedom of Information Act request.”
4. “The IG reports were heavily redacted by government officials because they contain ‘restricted, sensitive information.” Still Upton, R-Mich., said they ‘show the need for better scrutiny over the handling of select agents … and we intend to immediately look into the issues raised.'”
5. “The issues cited in the IG’s audits include: Failing to ensure the physical security of bioterror agents or restrict access to approved individuals. Failing to ensure that those working with and around potential bioterror agents have received required training. Not ensuring that only approved individuals accepted packages containing potential bioterror agents arriving from other outside labs.”
6. “The CDC would not share copies of its most recent inspection reports, saying it is agency policy not to release them for security reasons.”
7. The Canadian review at the $214 million 11-story lab complex known as Building 18, says it found no issues of “non-compliance” that pose health and safety risks.”

Lab Safety, Lab Security, CDC

 

Lupkin, Sydney, “Texas Biolab Loses Deadly Guanarito Virus” ABC News, March 25, 2013, http://abcnews.go.com/Health/galveston-texas-biolab-loses-deadly-guanarito-virus/story?id=18809363&goback=%2Egde_2143039_member_227159385#.UV2gtKW5dSV Last checked April 4, 2013

1. “The Galveston National Laboratory lost one of five vials containing a deadly Venezuelan virus, according to the University of Texas Medical Branch, which owns the $174 million facility designed with the strictest security measures to hold the deadliest viruses in the country.”
2. “Like Ebola, the missing Guanarito virus causes hemorrhagic fever, an illness named for ‘bleeding under the skin, in internal organs or from body orifices like the mouth, eyes, or ears,’ according to the Centers for Disease Control and Prevention.”
3. “The virus could theoretically spread between humans, but it usually only spreads between rodents in Venezuela.”
4. “‘The mortality is anywhere from at least 10 to 20 percent or slightly more,’ Kurilla told ABCNews.com, adding that there is no treatment or cure for Guanarito.”
5. “An investigation is ongoing, but researchers suspect the vial was destroyed ‘during normal laboratory sterilization practices,’ according to Callender’s statement.”
6. “It’s possible investigators will find the clerical error that led to the accidental disposal, but with computerized record keeping, it’s less likely that vial numbers were transposed and the error can be easily traced, Kurilla said.”

Lab Safety, Lab Security, Biosafety

 

Barnes, Diane, “Scientists Aim to Mutate Avian Flu in Lab to Better Understand its Spread” Global Security Newswire, August 8, 2013, http://www.nti.org/gsn/article/scientists-aim-mutate-avian-flu-lab-better-understand-its-spread/ Last checked September 28, 2013

1. “WASHINGTON — Nearly two dozen virologists from around the world on Wednesday said they want to modify an emerging form of avian influenza in ways that could produce more contagious, virulent or drug-resistant forms of the disease.”
2. “The studies would aim to shed light on how the so-called H7N9 virus could threaten humans as it mutates in nature, the 22 researchers wrote in a letter published in the journals Science and Nature.”
3. “Their announcement came one day after scientists said a Chinese woman appeared to have caught the virus directly from her father, ultimately killing both in what might be first case of the germ leaping directly between humans.”
4. “When diseases mutate and take on new capabilities — such as the emerging transmission of avian flu from one human to another — scientists typically seek to study that mutation’s “gain of function.” Such analyses aim to develop a fuller understanding of the mutation as a first step toward fighting it.”
5. “The proposal has already provoked questions from experts doubtful that any scientific benefits from such experiments would outweigh the risk of a modified virus escaping — or being stolen — from a laboratory.”
6. “In an interview with Science, Princeton University molecular biologist Adel Mahmoud said the proposal’s scientific rationale “is very flimsy, to put it mildly.” He added: “The claims that it will lead to anything useful are lightweight.””
7. “Studies should take place under stringent “Biosafety Level 3 enhanced” conditions, involving safeguards used in handling potentially lethal diseases, the researchers said in an accompanying document. Personnel should undergo “relevant background checks” before being cleared to work with modified agent, they said.”
8. “H7N9 produces its most severe human symptoms after taking root in the lungs, but virus particles can also cause localized infections on “any mucous membrane,” including in the mouth, eyes and upper respiratory tract, said Amesh Adalja, a senior associate with the Center for Health Security at the University of Pittsburgh Medical Center.”
9. “Bioterrorism came up only “occasionally” in discussions among officials and researchers, and at no point was there any high-profile look at “the risk of deliberate release by an insider,” he wrote in April’s edition of the Bulletin of the Atomic Scientists.”
10. “Officials and independent experts have generally advised giving laboratory managers considerable freedom in how they decide whom to entrust with high-risk pathogens. The approach, he wrote, “would be deemed … naïve and utterly inadequate” had more people died as a result of the 2001 anthrax attacks controversially blamed on a U.S. Army microbiologist.”
11. “Without addressing whether flu-modification experiments should be continued, Culp said federal and state legislators could alter privacy statutes to “permit more intrusive screening and monitoring” of individuals who handle dangerous biological agents.”

Lab Safety, Lab Security, Biosecurity, Biodefense, Bioterrorism