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B IOSECURITY C OMMONS R EVIEW D EVELOPMENTS , T RENDS & I SSUES FOR THE
B IOSECURITY C OMMONS R EVIEW D EVELOPMENTS , T RENDS & I SSUES FOR THE

BIOSECURITY COMMONS REVIEW

DEVELOPMENTS, TRENDS & ISSUES FOR THE YEAR ENDING MAY 2010

ANNUAL EDITION

Maryland, USA Vol. 1, Issue 1, May 2010

Brian J. Gorman, Towson University, Editor

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--With a debt of gratitude to many friends and colleagues in the public and private sectorslikewise pursuing public health, security, and peaceful progress through the sciences--for providing innumerable facts, insights, and collegiality in support of this project.

© Biosecurity Commons 2010

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CONTENTS

EXECUTIVE SUMMARY

4

INTRODUCTION

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CHAPTER ONE

The Swine Flu Scare of 2009

Brian J. Gorman

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CHAPTER TWO

Global Pandemic and Asset Allocation

Brian J. Gorman and Jennifer Kallal

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CHAPTER THREE

Biosurveillance

Brian J. Gorman and Alex Cardenas

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CHAPTER FOUR

The 2009 Emergency Declaration for Influenza

Brian J. Gorman, Jennifer Kallal, and Michael Carnucci

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CHAPTER FIVE

Risk & Reliability of Laboratory Personnel

Brian J. Gorman and J. Corey Creek

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CHAPTER SIX

Review of the 2009 Lab Security Report Process

Brian J. Gorman and Jennifer Kallal

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APPENDIX

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EXECUTIVE SUMMARY

The Review identified a number of key issues and provided several policy recommendations related to biosecurity developments for the year ending May 2010. Key findings noted the problems of continued reliance on foreign vaccine supply for pandemic and other large scale public health emergencies. A feasibility study was recommended to look into the domestic production of vaccine for pandemic. In addition, revisions of private international laws concerning contracts for vaccinations during pandemic were recommended in case the U.S. continues to rely on foreign production of vaccine for public health emergencies.

EXECUTIVE SUMMARY The Review identified a number of key issues and provided several policy recommendations related

Analysis of the events surrounding the 2009 flu scare revealed that domestic health actions are uniquely tied to foreign relations during pandemic. Domestic public health policies would have likely caused serious harm to international relations had the pandemic stayed on its forecasted path. Therefore, public health recommendations should be made with foreign policy implications in mind. Moreover, it was noted that the International Health Regulations of 2005 should be revisited after the 2009 H1N1 scare in like manner to the review following the SARS outbreak. This would provide an opportunity to increase harmonization of pandemic response efforts for all nations via dual benefit strategies.

A review of the major reports on lab security released in 2009 is also provided. The main findings include the observations that centralized federal oversight is needed to standardize Personnel Reliability Programs for high containment labs. A committee membership analysis was also conducted and recommendations were made to improve flaws in the committee process by allowing for dissenting opinions in expert committee reports.

Brian J. Gorman, Director, Biosecurity Commons

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A determined adversary cannot be prevented from obtaining very dangerous biological materials

intended for nefarious purposes

...

The best we can do is to make it more difficult. We need to

recognize this reality and be prepared to mitigate the effects of a biological attack. We, as a

nation, are not prepared. 1

1 See OFFICE OF THE UNDER SECRETARY OF DEFENSE FOR ACQUISITION, TECHNOLOGY, AND LOGISTICS, REPORT OF THE DEFENSE SCIENCE BOARD TASK FORCE ON DEPARTMENT OF DEFENSE BIOLOGICAL SAFETY AND SECURITY

PROGRAM, at X (May 2009).

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INTRODUCTION

The first edition of the Biosecurity Commons Review is the capstone of a new information project at BiosecurityCommons.org (BsC). The Review is the cumulative effort of a transparent web-based think tank partnership between faculty and students. The goal of the project is to provide biosecurity stakeholders with a telescopic resource that provides:

-A succinct status brief of topical areas in biosecurity, -A cache of key findings that are cross-listed across thematic areas within the site, & -An annual review of major events, emerging trends and timely policy recommendations.

The BsC ―web-tank‖ works in three steps. First, BsC researchers mine research databases from the many disciplines and sectors related to biosecurity for key facts, findings and developments in the field. Then, team members cite, brief, and cross-post critical facts and findings from primary source materials within a chronological and thematic format on the BsC website.

Second, the status brief is completed once a critical mass of primary source information is acquired for a topic area. The status brief provides a succinct summary of the history, development, issues, and leading proposals related to the area. Status briefs are updated as the topic area is populated with new findings to provide stakeholders with current briefings.

Finally, status briefs and developments in topic areas are reviewed on a quarterly basis for consideration of further analysis in the Biosecurity Commons Annual Review (AR). The AR ties loose ends within topic areas and explores issues that have emerged between topic areas. Examples for this edition being the examination of ―Global Pandemic and Asset Allocation‖ and the ―Review of the 2009 Lab Security Report Process‖ discussed in chapters two and six, respectively. The core issues covered in these chapters emerged between the boundaries of the BsC grid. The remainder explores and analyzes major developments in the field for the year ending May 2010.

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1 The Swine Flu Scare of 2009

Brian J. Gorman

  • 1. Introduction.

The outbreak of the H1N1 influenza virus, otherwise known as swine flu, was clearly one of the biggest events of concern to stakeholders in biosecurity over the last year. It is believed that swine flu originated in March of 2009 2 and reached as many as 168 countries with infections of more than a million people by September 2009. 3 The swine flu was not as virulent as initially predicted, but the response to it exercised some of the capabilities of national and international public health systems. As a result, a number of lessons were learned from the experience. In particular, a number of systemic shortcomings that need further examination came to light. Chief among them were vaccine supply management, global harmonization of public health policies, international communications, and intersectoral cooperation in addition to the public‘s response to the public health crisis.

  • 2. Pharmaceuticals and Pandemic.

On one hand, the prospect of a devastating pandemic revealed some achievements between and amongst businesses, nation states, and NGOs. On the other, however, it revealed some tensions. Each of these entities has different obligations and these differences became apparent during the swine flu scare of 2009. Therefore, an important caveat needs to be mentioned before pointing to flaws found from the experience. That is to say, criticism of these entities must be balanced with an understanding of the primary obligations of each party, i.e. businesses have a duty to make a profit for stock holders, a nation state has a primary duty to its citizenry, and global NGOs can be chartered with a humanitarian duty for all regardless of territory. It is necessary to remember that criticism of some actions by stakeholders may not be fair criticisms unless their respective obligations are kept in mind. The best solutions are likely to be found by working with and around the core duties of stakeholders.

A. Supply, Demand, & Market Failure. Vaccine supply arose as the premier issue as dire forecasts predicted that the swine flu could progress into a pandemic of historic proportion. The flu scare of 2009 demonstrated the dramatic shift in supply and demand from a perilous shortage to a sudden excess of supply. At one point in October 2009, the national supply was running far below expectations with only 16 million doses on hand, instead of the 40 million that were

  • 2 Gardiner Harris, Questions Linger Over the Value of a Global Illness Surveillance System , N.Y. TIMES, May 1, 2009. Available at http://www.nytimes.com/2009/05/02/health/02global.html.Llast checked March 23, 2010.

  • 3 Donald, G. McNeil, One Shot Seen as Protective For Swine Flu: Vaccine Should cover High-Risk Groups, N.Y. TIMES, Sept. 11, 2009 at A1. "The H1N1 swine flu pandemic has now reached 168 countries. It arrived in the United States late in the spring and infected more than one million people."

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expected. 4 Just three months later, however, the U.S. was cancelling vaccine orders and trying to get rid of a surplus supply. 5 The unpredictable nature of flu outbreak and the fact that only 3 companies were seriously dedicated to the manufacture of flu vaccine 6 did little to steady the fluctuations in supply and demand.

Each year, seasonal influenza creates a demand for vaccine, yet there is market failure for this much needed prophylaxis. Demand varies from season to season depending on the severity of the strain, making vaccine development a speculative business for pharmaceutical companies. In addition to these unstable market forces, other factors such as the appeal of producing more profitable and less fragile drugs contributes to this dilemma. 7 The fear of litigation over flu vaccines was also seen as contributing to the market failure for flu vaccine production. The understanding is that drug companies tend to shy away from flu vaccine development because the product is geared in large part to children, who, as a population, happen to present with a greater risk of litigation if there are actual or perceived injuries from the product. 8 The U.S. government continuously works to correct market failure for this vital product by subsidizing vaccine development with hundreds of millions of dollars in grants while simultaneously allowing the pharmaceutical company to keep the profits. 9

The forecast of a possible global pandemic increased demand for a vaccine, but the potential supply remained limited due to a ceiling in production capability. Dose production estimates of H1N1 vaccine reached as much as 4.9 billion. 10 The prospect of billions of doses, however, did not deter reports of price gouging over the limited supplies that were on hand. 11 The supply and demand dilemma was not new. That lesson was learned with the 2004 flu season when

  • 4 Michael D. Shear, Obama declares flu emergency to ease restrictions for hospitals, WASH. POST, Oct. 25,2009.

  • 5 Donald G. McNeill, Transfers of Surplus Flu Vaccine Are Going Slowly to Countries That Need It, N.Y. TIMES, Feb. 2, 2010 at A15.

  • 6 Tadataka Yamada, Poverty, Wealth, and Access to Pandemic Influenza Vaccines, NEW ENG. J. MED. (Sept. 17, 2009). at 1129-1131, ―only a few countries in the world have plants for manufacturing influenza vaccine and 3 companies account for most of the world's manufacturing capacity: GlaxoKlineSmith, Sanofi-Aventis, and

Novartis.‖

  • 7 Donald, G. McNeil, Nation Is Facing Vaccine Shortage For Seasonal Flu: An Increase in Demand, N.Y. TIMES, Nov. 5, 2009 at A1.

  • 8 Id.

  • 9 Andrew Pollack, New Drug For H1N1 Flu Offers Hope, N.Y. Times, Nov. 6, 2009 at B1. "Virtually all money to develop the drug comes from $180 million in grants from the Department of Health and Human Services. Yet the company gets to keep as profit anything it makes from selling the drug to the federal government or to other governments." 10 Nicolas Collin, Xavier de Radiguès, Vaccine production capacity for seasonal and Pandemic (H1N1) 2009 influenza, VACCINE 27 (2009) at 5184–5186 ―The potential output of 4.9 B doses of pandemic vaccine per year reported in the present survey is a best-case scenario.‖ 11 Donald, G., McNeill, Shifting Vaccine For Flu To Elderly, N.Y. TIMES, Nov. 24, 2009 at D1. "reports of price gouging have grown more frequent. That also happened in 2004, when sterility problems at a British plant cut the American flu vaccine supply in half; prices shot up as high as $90 a dose, from the normal level of $8 to $9."

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unexpected production problems cut the U.S. flu supply in half and drove dose prices from $8 and $9 to upwards of $90. 12

  • B. Breach of Contract A Dangerous Practice. The global vaccine marketplace is not

only influenced by the gentle hand of market support, but also the sharp bite of retaliation for

breach of contract. Thus, public health systems and the free market need to be harnessed to work together to meet the challenges of seasonal flu, pandemic, or other extraordinary crises requiring prophylaxis. As demonstrated through the flu scare of 2009, conflicting priorities are bound to clash as tensions rise between the public and private spheres. This was best evidenced by the ominous admonition from Daniel Vasella, the CEO of the Swiss pharmaceutical company Novartis. Mr. Vasella made it clear that there will be consequences for breaking vaccine

contracts with his company upon the next threat of pandemic. He stated, ―Reliable partners will be treated preferentially.‖ 13

Vasella‘s admonition can be viewed as an ominous threat callously holding the well-being of innocent lives hostage in exchange for maximal profit or it can be seen as a warning to governments to be fair to those few specialized businesses relied upon for assistance in a global crisis. It is perfectly reasonable for businesses to expect performance on contracts if the business relied on these orders to their detriment and had forgone other profitable endeavors. On the other hand, however, the swine flu scare of 2009 also revealed how private companies manufacturing vaccines can unfairly breach contracts to the detriment of governments placing orders in contemplation of pandemic.

The U.S. was left vulnerable when an Australian vaccine manufacturer breached its contract for 36 million doses of swine flu vaccine after succumbing to pressure from the Australian government to keep its vaccine in the home country when there was an apparent vaccine shortage. 14 The U.S. government appeared to reply in kind as one would in a free market by placing that same vaccine manufacturer, CSL, on the top of the list when it came to canceling orders upon the realization of a vaccine surplus. The U.S. cancelled 22 million of its order for 36 million doses by February 2010. 15

  • C. Public Policy & Dosing Strategies. A number of issues arose in relation to U.S.

vaccination strategy. Controversial decisions abound when designing a national vaccination strategy in response to a potential pandemic. Key among them this past season was the decision to go with 2 doses as opposed to 1 dose, whether to target the young or elderly first, and how to

handle social equity issues at national and international levels.

  • 12 Id. 13 See supra note 5 at A15. 14 See supra note 7 at A1.

  • 15 See supra note 5 at A15.

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1. National vs. International Dosing Goals. The U.S. disregarded the World Health Organization‘s (W.H.O.) dosing recommendation for H1N1. The W.H.O. recommended 1 dose for all individuals, but the U.S. disregarded that advice and recommended 2 doses for U.S. children. 16 The W.H.O. recommendation reflected a global priority of providing minimally effective dosage levels with intent to stretch the limited vaccine supply as far as possible throughout the world. In contrast, the U.S. policy reflected maximally effective dosages for vulnerable segments of the U.S. population, in part due to political pressure. Dr. Anthony Fauci, of the National Institute of Allergy and Infectious Diseases, said that, ―There's a concern that people would be reluctant to get vaccinated,‖ if the unproven adjuvant was used with the vaccine. 17

The U.S. refrained from using adjuvants--a mixture of water and oil that increases the immune response of single doses. 18 Many European countries and Canada used adjuvants, but the U.S. steered clear of them in part due to anti-vaccine lobbyists who campaigned against them. 19 The decision to ignore W.H.O. recommendations to stretch the vaccine supply may legitimately garner criticism from some, especially since clinical studies supported the effectiveness of a single dose of H1N1 vaccine. 20 But in fairness to U.S. policy makers, there were legitimate concerns over public acceptance of unproven adjuvants given the high profile controversies over vaccinations in U.S. courts and media. As these policy decisions were under consideration, high profile cases were underway in a special federal court for vaccine liability. The widely reported cases alleged that additives in children‘s vaccines caused autism. These cases were decided in March of 2010, and held that there was no connection between the additives and autism, but anti-vaccine sentiments are likely to continue. 21 It is unlikely that all impassioned advocates will discontinue their beliefs about the deleterious effects of additives in vaccines as result of a court case. Further, evidence of the government‘s concern over public perception was demonstrated through a preemptive public relations strategy employed by the CDC warning the public not to confuse ordinarily occurring maladies with adverse side effects from vaccination. 22

  • 16 Donald, G. McNeill, New Advice on Swine Flu Doses for Pregnant Women, N.Y. TIMES, Nov. 3, 2009 at A16.

  • 17 Andrew Pollack, In Vaccine Additive, Benefit and Doubt, N.Y. TIMES, Sept. 22, 2009, at D1. 18 See supra note 16 at A16 ..

  • 19 Id.

  • 20 A1. "

See supra note 3 at

clinical

trials are showing that the new H1N1 swine flu vaccine protects with one dose

instead of two, so the vaccine supplies now being made will go twice as far as had been predicted."

  • 21 See multiple court decisions available at http://www.uscfc.uscourts.gov/node/5026.

last checked April 29, 2010.

  • 22 Donald, G. McNeill, Swine Flu Officials Message: Don't Blame Shots for All Ills, N.Y. TIMES, Sept. 28, 2009 at A1. ―Preemptive public relations strategy by CDC targeting media for reporting coincidental maladies and powerful antivaccine activists. Due in part from lessons learned from 1976 flu vaccination campaign which was suspended

due to questions over relationship with Guillain_Barre syndrome.‖

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  • 3. Prioritizing Immunity.

Richard Zimmerman predicted in 2007 that the next threat of pandemic would require ethical policy choices of an egalitarian or utilitarian nature, but concluded that the ―W‖ shaped mortality pattern affecting young adults during the 1918 pandemic should be taken into consideration for subsequent pandemics. 23 The U.S. government decided to vaccinate children first during the swine flu epidemic of 2009. The U.S. policy of focusing on youth first during the swine epidemic was subsequently validated with the recent release of a Canadian study. 24 The study found a 60 percent protective effect for the whole community when children were targeted for vaccination. 25 Dr. Bridges went so far as to say that, ―giving flu shots only to school children would protect the elderly just as well as giving flu shots to the elderly themselves.‖ 26

  • 4. International Communications.

Communication over disease outbreak has been a long standing priority of nation states. 27 But problems persist as evidenced by the SARS epidemic and the swine flu of 2009. Unfortunately, finger pointing during the swine flu scare was directed at both Mexican officials and the W.H.O. for a delay in identifying and responding to the swine flu outbreak. Unnamed sources in the Obama Administration appeared to be the source of criticisms of Mexico‘s handling of swine flu reported in a Washington Post article. In contrast, a Mexican official publicly blamed the W.H.O. for a slow response to Mexico‘s notification of the brewing epidemic. The Washington Post article spoke of Mexico‘s apparent failure to abide by the International Health Regulations (IHR) of 2005 which requires global notification of public health emergencies. 28 The current IHR, forged in the wake of the SARS crisis, states:

Each State Party shall assess events occurring within its territory by using the decision instrument in Annex 2. Each State Party shall notify WHO, by the most efficient means of communication available, by way of the National IHR Focal Point, and within 24 hours of assessment of public health information, of all events which may constitute a public health emergency of international concern within its territory in accordance with the decision

23 Richard Zimmerman, Rationing of influenza vaccine during a pandemic: Ethical Analyses, VACCINE, 25, (2007), at 20192026.

  • 24 Donald, G. McNeill, Flu Shots in Children Can Help All Ages, Study Says, N.Y. TIMES, March 10, 2010 at A16.

  • 25 Id.

  • 26 Id. 27 Hugh, S. Cumming, The International Sanitary Conference, AMER J. PUB. HLTH. (Oct. 1926) at. 975, ―As early as

    • 1881 the United States Government invited the maritime powers to meet for the purpose of considering an

international system of notification as to the actual sanitary conditions of ports and places under the jurisdiction of

such powers.‖

  • 28 David Brown, System Set Up After SARS Epidemic Was Slow To Alert Global Authorities, WASH. POST, Apr 30,

    • 2009 at A01.

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instrument, as well as any health measure implemented in response to those events. 29

The criticism from Post sources asserted that international authorities were not fully aware of the outbreak, until there were about 800 H1N1 cases and at least 50 deaths. 30 The criticism of Mexico, however, was not universal and was met with a vigorous defense by Mexico‘s chief epidemiologist, Dr. Miguel Angel Lezana, who actually called for an investigation of W.H.O.‘s handling of the affair since there was an eight day delay before the W.H.O. took action after being notified of an unusually late rash of flu and pneumonia cases in Mexico. 31 Experts, such as Peter Singer, took a sobering look at the controversy by noting that the identification of a novel virus [without prior notice of its existence] is like finding a needle in a haystack. He praised Mexico‘s transparency during the epidemic. Singer also recommended, however, that Mexican authorities review their response to the crisis to err on the side of caution. 32 Dr. Michael Ryan and Dr. Scott Dowell, officials at the W.H.O. and Centers for Disease Control respectively, were actually quick to praise Mexican authorities for a swift response to queries from the W.H.O. and they agreed that the difference of a few days would have hardly mattered in a global response to the outbreak. 33

Dr. Mauricio Hernández-Ávila, Mexico's deputy health minister for disease prevention, defended the gap between awareness of Mexico‘s investigation on April 16, 2009 and W.H.O.‘s announcement of an epidemic on April 24, 2009. He said, "PAHO [i.e. the Pan American Health Organization--a division of the W.H.O.] for some reason did not report. That is the fly in the soup. It looks as if we did something wrong, but we did not." Dr. Keiji Fukuda, the W.H.O. official in charge of flu, explained the delay in identifying an unusual disease as reasonable during flu season. Dr. Fukuda acknowledged that, "the countries which were affected earlier, they really were communicating in a very appropriate way." 34

Reports speculate that the index case of H1N1 originated with a 5 year old Mexican child in late March 2009. 35 It was also reported that the W.H.O. had been aware of the situation since

  • 29 INTERNATIONAL HEALTH REGULATIONS, (2005) at Part II, 5.1.

30 See supra note 28 at A01.

  • 31 ASSOCIATED PRESS, ―Mexico's epidemiology boss faults WHO,‖ THE INDEPENDENT, May, 1, 2009. Available at

http://www.independent.co.uk/news/world/americas/mexicos-epidemiology-boss-faults-who-1677396.htm

  • 32 Peter, A. Singer, Grading a pandemic; It's now been a fortnight since Swine Flu hit us. How have we handled it, and what have we learned?, NATL. POST, May 11, 2009 at A14.

  • 33 See supra note 2 at http://www.nytimes.com/2009/05/02/health/02global.html. last checked March 23, 2010

  • 34 ASSOCIATED PRESS, ―Mexico's epidemiology boss faults WHO,‖ THE INDEPENDENT, May, 1, 2009. Available at

  • 35 Anastasia Moloney, Questions Raised Over Response To Influenza A Outbreak, THE LANCET, (May 9, 2009), at

1591.

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April 10, 2009 due to the submission of reports by Mexican authorities regarding unusual respiratory cases which they claimed did not rise to the level of an epidemic. 36 Six days later, however, Mexican authorities reported to the PAHO that a possible epidemic was brewing. 37 According to Dr. Dowell, H1N1 probably jumped from pigs to humans sometime between late November and January, and the virus probably began infecting large numbers of people sometime in mid-March. 38

Dr. Ryan was puzzled over the finger pointing and controversy caused over the difference of a couple of days. 39 Therefore, this dynamic of conflict and blame are important factors to include in a review of international reporting and cooperation obligations during disease outbreak. The lesson being that the best of allies can turn to counter-productive finger pointing when faced with an international public health emergency.

5. Vaccination Participation.

Scrutiny of public authorities and private entities providing products and services to fight pandemic are essential, but evaluating public response to a public health emergency is no less important. China claimed success in thwarting the spread of H1N1 through liberal use of tough measures such as quarantine and medical detentions. 40 Less authoritarian nations, however, face greater challenges in controlling disease outbreak with populations that enjoy greater freedoms and autonomy.

A. Mandatory Vaccinations. Mandatory vaccination programs requiring flu vaccinations for health care workers have proven controversial and have had mixed results. Mandatory vaccination programs appear to have been successful in a number of health care systems. At least two hospital systems throughout the country claim to have successfully implemented mandatory flu vaccination programs for employees. The New York Times noted in September of 2009 that the Virginia Mason and BJC hospital systems, in Seattle and St. Louis respectively, were the only two systems known to make employees get vaccination or face dismissal. 41 In this connection, the BJC Health Care system boasts a 98 percent compliance rate with its mandatory flu vaccination program. 42

36

Id. Id. 38 See supra note 2 at http://www.nytimes.com/2009/05/02/health/02global.html. Last checked March 23, 2010. 39 Id. Dr. Ryan said, ―I‘m struggling to understand anyone who thinks the public health response would have been different if this was reported globally on April 20th or 22nd instead of the 23 rd .‖ 40 Edward Wong, China's Tough Policy Seems to Slow Swine Flu, N.Y. TIMES, Nov. 12, 2009 at A1. 41 Donald, G. McNeill & Karen Zraick, New York Health Care Workers Resist Flu Vaccine Rule, N.Y. TIMES, Sept. 21, 2009 at A17. 42 The Associated Press State & Local Wire, BJC gets results with mandatory flu policy, Feb. 4, 2010 Thursday 10:02 AM GMT.

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Mandatory vaccination programs, however, have faced legal challenges in New York, Iowa, and Washington State. In the summer of 2009, New York‘s State Health Department required all home and health hospice workers to take the seasonal and swine flu vaccinations as a condition of employment. 43 Former director of the CDC, Dr. Julie Gerberding, applauded the move since she had long advocated for mandatory vaccinations to protect the health of workers and the patients in their care. 44 The current director of the CDC, Thomas R. Frieden, however, opposes the notion of mandatory vaccinationsa position consistent with the union representing health care workers in New York. 45 A judge in New York suspended the mandatory vaccination requirement by October 16, 2009 46 and New York authorities subsequently rescinded the program a few days later. 47

The workers at University of Iowa Hospitals and Clinics were also successful in challenging mandatory vaccinations through a legal challenge. 48 The Washington State Nurses Association, representing more than 16,000 registered nurses, likewise made a legal challenge against an employer, MultiCare Health System, to challenge mandatory vaccination as a condition of employment. 49 A search of Lexus-Nexus which provided the press release regarding the application for injunctive relief, however, failed to reveal a subsequent press release or news story on its outcome as of this writing and requests for follow-up information from the Nurses‘ Association have gone unanswered to date.

B. Public Participation in Vaccination Programs. Anecdotal evidence points to the public‘s perception of the risk of an infection as a strong predictor of public compliance with vaccination programs. No doubt factors such as availability, cost, and perception of the safety of vaccinations play a role in public participation rates of vaccination programs, but it appears that compliance rises in proportion to awareness of the lethality of the pathogen. For instance, in the absence of a sense of public fear, some six months after the outbreak at St. Francis Prep in Queens settled down, 50 fewer than half of New York City parents gave permission for their children to receive the H1N1 vaccination. 51 This is in contrast to parents in areas experiencing

  • 43 See supra note 40 at A17.

  • 44 Id. 45 Id.

  • 46 The Associated Press State & Local Wire, NY judge temporarily blocks mandatory flu vaccines,‖ Oct. 16, 2009 Friday 5:33 PM GMT. 47 Valerie Bauman, Associated Press Online, NY officials rescind mandatory H1N1 flu shot order, Oct. 23, 2009 Friday 3:10 AM GMT.

  • 48 Cindy Hadish, Rulings end mandatory flu shots , THE GAZETTE, (Cedar Rapids, Iowa), Nov. 3, 2009.

  • 49 PR Newswire, Washington State Nurses Association Seeks Injunction in Federal Court to Block Mandatory Vaccination Policy by MultiCare Health System, Oct. 1, 2009, 3:12 EST.

  • 50 Anahad O‘Connor, Swine Flu Fears at a Private School in Queens, N.Y. TIMES, April 25, 2009, available at http://www.nytimes.com/2009/04/25/nyregion/25sick.html, last checked March 23, 2010.

  • 51 Jennifer Medina, In New York, Opting Out of Schools' H1N1 Vaccine, N.Y. TIMES, Oct. 29, 2009 at A4.

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higher rates of swine flu infection, such as Charleston, West Virginia where parental permission rates were found to be much higher. 52

A more dramatic anecdotal report, however, comes from France. A poll asking whether or not French residents would take the swine flu vaccine indicated that 80 percent would decline. 53 The initial disinterest reflected in the poll appeared to fade after a few deaths attributed to swine flu were reported --such huge lines formed in Lyon that the riot police were called in to control the crowds. 54

52

Id. 53 See supra note 5 at A15. Id.

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2 Global Pandemic and Asset Allocation

Brian J. Gorman and Jennifer Kallal

  • 1. Introduction.

The recent swine flu scare revealed unexpected problems with asset acquisition and deployment. Before the arrival of the actual crisis, it appeared reasonable for U.S. policy to rely on arms length contractual obligations with foreign vaccine manufacturers, and acceptable to let developing countries rely on impromptu charity for its vaccine supply. Upon review of the crisis--which was fortunately fleeting compared to expectationsit is clear that U.S. health and security would likely be compromised with continued reliance on extant policies.

The H1N1 crisis revealed an unanticipated sequence of events and provided insight into the likely choices stakeholders would make in the future with a more lethal pandemic. Thus, policy makers need to review the decisions made in response to the H1N1 crisis for lessons learned and issues arisen. Chief among these being whether or not governments should reduce the risk of relying on private enterprise for prophylaxis and increase harmonization of pandemic response efforts for the benefit of all nations.

  • 2. Private Sector Prophylaxis Supply.

As identified supra in Chapter 1 at 2.B., under, ―Breach of Contract A Dangerous Practice,there are delicate and precarious supply and demand issues when it comes to prophylaxis and pandemic. One lesson learned was that the wealthiest of countries can face unexpected shortages of prophylaxis if international suppliers breach contracts for much needed supplies. Another lesson learned was that the discretionary power of private business can hold sway over a limited and essential supply of prophylaxis in the global market. Private pharmaceutical companies are free to contract with whomever they wish and are primarily obligated to make business decisions in the interests of shareholders as opposed to the public weal. Thus, the best public health planning can far too easily be undermined by unexpected factors.

A. Government Prophylaxis Production. A feasibility study may be warranted to determine whether or not the U.S. government should establish vaccine manufacture facilities. The study should evaluate the cost/risk/benefit ratios of directly operating production facilities or going into partnerships with domestic manufacturers. The government heavily subsidizes vaccine makers to produce a vaccine supply for seasonal flu due to an unreliable demand and the high product liability associated with the product. Therefore, factors to address include, but are not limited to, the fact that the U.S. is already committed to a deliberately steep price tag for vaccines, so it may not be a costly new expenditure. The advantages of government production would include greater reliability of vaccine supply and reduction of liability costs since legal doctrine holds that the sovereign can hold itself immune from liability. On the other hand, the

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down side would include greater concerns from the political movement against vaccinations and questions over the efficiency of government manufactured vaccines, which may undermine vaccine program participation. But that point is moot if the vaccine is voluntary and if the virus presents with a high morbidity ratewhich as noted earlier, usually assures compliance with public vaccination programs.

B. Amend International Private Laws Governing Prophylaxis Supply for Public Health

Crises. In the absence of domestic production of vaccines it would be wise to revisit international laws governing prophylaxis supply during a public health emergency. One of the most surprising developments of the H1N1 crisis was the breach of contract by an Australian vaccine manufacturer. It apparently came as a surprise to U.S. officials that foreign governments, even close allies, could interfere with the export of flu vaccine during a pandemic. While it appears that the Australian government caused a disruption in CSL‘s H1N1 vaccine shipment to the U.S., officials should not be entirely surprised to find that the U.S. vaccine supply during a highly morbid global pandemic may be subject to disruption out of necessity, greed, or malevolence from any number of parties. Thus, reliance on arms length business partners in foreign countries may pose some previously unforeseen security risks for the U.S.

If the U.S. continues to rely on foreign vaccine manufacturers, greater legal protections may need to be put in place. While the U.S. may choose a forum in the United States for litigation over a contract with a foreign manufacturer, it may not prove helpful if time is of the essence, specific performance is demanded, or an award of damages and financial penalties is used to compel compliance if the foreign company operates beyond the reach of U.S. authority. Thus, the U.S. and other countries importing vaccine supply for epidemic or pandemic may want to revisit substantive laws under the United Nations Convention on Contracts for the International Sale of Goods (1980) (hereinafter CISG). For example, under Article 28 of the CISG, specific performance can only be enforced if the court hearing the matter would otherwise have that authority absent the CISG. Specific performance would be essential for any contract on vaccine supply with a foreign manufacturer and the CISG could be amended to reflect this special circumstance if litigation is brought in the exporting venue. In like manner, compatible procedural laws in the courts likely to host pandemic asset litigation are necessary to assure the highest docketing priority since time would be of the essence.

3. Global Harmonization of Pandemic Response Efforts.

The consequences of failing to harmonize pandemic response efforts were also made apparent through the H1N1 flu crisis. Despite the United States‘ unparalleled legacy of international crisis relief and promises to share its H1N1 vaccine supply with developing countries, the U.S. was subject to criticism and viewed as uncooperative and wasteful at the expense of others. As discussed in Chapter 1, supra at Part 2.C.1., ―National vs. International Dosing Goals,‖ the U.S. diverged from W.H.O. dosing guidelines which were based on undisputed clinical findings that one dose was an effective prophylaxis for H1N1.

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The negative effect this time around was short-lived criticism from a number of international stakeholders. 55 However, the global reaction to this situation is likely to be far worse in the face of a pandemic with high morbidity rates. U.S. interests are so dependent on the international cooperation of partners in business and security, that the backlash from the perception that the U.S. is intentionally super-dosing and reducing the global supply of vaccine for political reasons rather than clinically justifiable reasons must be carefully considered.

  • A. International Health Regulations (2005). The International Health Regulations (IHR)

were amended in 2005 to bring to bear the force of international law on certain responsibilities nations have in the face of disease outbreak that could cause harm beyond territorial borders. The IHR revisions of 2005 were driven in large part by the SARS crisis. 56 Therefore, the question now is whether or not the lessons learned from the H1N1 flu crisis are enough to inspire another revision of the IHR.

At present, the scope of the IHR fundamentally obligates States Parties to develop certain minimum core public health capacities, notify the W.H.O. of certain public health emergencies, and make recommendations on travel and commerce of consequence to the international spread of disease. 57 The question remains whether future revisions could embrace agreed upon priorities detailing responses and duties of those holding prophylactic assets during a highly morbid pandemic.

Debate in this area will likely address several issues affecting the nexus of domestic and international public health policies. Questions include whether or not States Parties can agree to meet certain protocols, priorities, and duties in planning and responding to global pandemic.

For instance, issues include whether or not States Parties could agree to:

a.) Use minimal dosage of prophylaxis to further global supplies.

b.) Use any and all safe practices to increase the supply of prophylaxis.

c.) Refrain from interfering with the export of prophylaxis supply.

d.) Assure highest docketing priority and expeditious civil procedure for the immediate enforcement of contract provisions in jurisdictions chosen to host contractual disputes over prophylaxis supply.

e.) Agree to contribute a designated percentage of prophylaxis supply to countries in need.

  • 55 See supra note 17 at D1.

  • 56 INTERNATIONAL HEALTH REGULATIONS, (2005) at 1.

  • 57 Id.

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f.) Make good faith efforts to contribute to the delivery of prophylaxis to countries in need.

4. Dual-Benefit Strategies.

Unlike the term of art in the security sector known as dual use, which speaks to concern over the possible malevolent use of civilian knowledge or technology, the adoption of dual benefitstrategies could result in win-win scenarios for which domestic political forces might be willing to approve. For instance, global strategies that prevent or contain pandemic in one country can aid many other countries by preventing or lessening a global health crisis.

Pandemic is different. All states are equal partners in fighting the global spread of disease because the frailties of one nation compromises others the world over. The challenge is whether or not new thinking can help forge a web of dual benefit strategies that clearly provide States Parties a primary benefit from self-preservation measures and a secondary benefit by reducing the threat of pandemic by enhancing resistance amongst other States Parties.

A paradigm shift from an open competition for a limited supply of prophylaxis to one of global partnership using a dual benefit strategy will not be easy. Policy debates on these questions will no doubt be extensive since they straddle the delicate issues of sovereignty, security, and resources. Notwithstanding the challenges that lie ahead, a review of the H1N1 crisis should help identify the first steps in moving toward effective preparation for a highly lethal pandemic.

A. Public Health Security by Maintaining the Strength of Global Partners. There is literature on the duty wealthy nations have toward developing nations during a pandemic. Clearly ethical and moral arguments supporting the public welfare of these nations are just. But when it comes to a high morbidity pandemic the thinking may best be suited to a global partner- to-partner perspective rather than to a donor-to-receiver framework. Pandemic is different because disease resistance of individuals in one country has direct bearing on another. As is oft spoken, disease knows no borders. Moreover, vaccines are not usually 100% effective, leaving prophylaxis strategy dependent on mass vaccination efforts. Thus, making vaccine available in far off nations in need, during a high morbidity pandemic is no less important than making vaccine available to the few U.S. states with low infection rates during an epidemic within the nation.

Without implementing dual benefit strategies to assist global partners in developing countries, the U.S. and other wealthy countries run the risk of incurring higher rates of infection that typically afflicts countries with far less resources. 58 Thus, lack of access to prophylaxis in

58 Jonathan Suk, et.al, Wealth, Inequality, and Tuberculosis Elimination in Europe, EMERGING INFEC. DIS., Vol. 15, No. 11, (November 2009).

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developing countries is not only a moral issue, but it should be recognized as a priority for all stakeholders since global prophylaxis is directly related to the financial well being, personal health, and security of all U.S. citizens.

An analysis of national pandemic preparedness plans has exposed that very little consideration is given to providing for the needs of developing nations. 59 If these plans are not changed to help meet the necessities of the most impoverished who face the greatest risk, than the U.S. runs the risk of getting hit with a pandemic of even greater force than need be.

  • B. Vaccine Distribution. Vaccine distribution in developing countries is an acute if not

intractable problem. The W.H.O. requires each country needing vaccines to submit a plan proving that it has the capability to store, refrigerate, distribute, safely inject, and provide a medical follow-up. 60 Ninety-five countries told the W.H.O. last year that they had no means of getting the flu vaccine. 61

  • C. Efforts to Strengthen Global Partners in Pandemic. A number of efforts were made to

assist developing countries during the H1N1 crisis. Despite emerging with a bruised image from the pandemic, some private pharmaceuticals are leading in improving the public health within developing countries. For instance, Glaxo Smith Kline promised to keep all Glaxo drugs in developing countries priced at no more than 25% of what was charged in wealthy ones and to donate a fifth of all profits made in poor countries toward building their health systems. 62 With respect to the H1N1 pandemic, W.H.O. Director Margaret Chan, asked vaccine manufacturers to reserve part of their production capacity for those that have restricted access to vaccines. 63 A number of wealthier countries also provided outright donations of vaccine supplies. President Obama‘s pledge to share 10% of the U.S. H1N1 vaccine supply with developing nations through the W.H.O. was prominent among these efforts. 64 Otherwise, some countries helped expand the vaccine supply by using single doses and adjuvants (see also Chapter 1 supra at 2.C.1.)

Maintaining reliance on current policies that result in mere transfers of excess supplies to developing countries may prove costly in a highly morbid pandemic. 65 The question is whether or not stakeholders take advantage of the rare glimpse into the dynamics of the genuine pandemic crisis of 2009 to modify policies, agreements, and laws in the best interests of all stakeholders.

  • 59 Joshua P. Garoon, Patrick S. Duggan, Discourses of disease, discourses of disadvantage: A critical analysis of National Pandemic Influenza Preparedness Plans, SOC. SCI. & MED., 67, (2008) at 11331142.

  • 60 See supra note 5 at A15.

  • 61 Id.

  • 62 Donald G. McNeill, Ally for the Poor in an Unlikely Corner, N.Y. TIMES, Feb. 9, 2010.

  • 63 Collin, Nicolas, de Radiguès, Xavier, "Vaccine production capacity for seasonal and Pandemic (H1N1) 2009 influenza," VACCINE 27 (2009) 51845186.

  • 64 Associated Press, U.S. to Share Vaccine, Obama Says" N.Y. TIMES, Sept. 18, 2009 at A22. 65 See supra note5 at A15.

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3 Biosurveillance

Brian J. Gorman and Alex Cardenas

1. Introduction.

Biosurveillance refers to the detection and reporting of infectious disease from either

natural or manmade origin. Disease surveillance has ancient origins dating back to at least the

  • 14 th century and can be documented in the U.S. as far back as 1741 when Rhode Island tavern

keepers were required to notify authorities of patrons with contagious diseases. 66 Subsequent biosurveillance efforts in 1878 included the monitoring of morbidity rates for infectious diseases in foreign countries to guard against the influx of lethal diseases from abroad. 67 Notwithstanding the long tradition of disease surveillance, the perceived need for it grew to unprecedented levels after the anthrax attacks of 2001. Thus, in the years immediately following 2001, disease surveillance turned to the threat of bioterrorism and ―biosurveillance,which soon became a new

term of art. Biosurveillance can be viewed broadly in two categories consisting of the tracking and detection of infectious agents.

Department of Homeland Security (DHS) officials defined biosurveillance as many different components that work in complementary fashion to achieve a comprehensive awareness. This takes the form of both traditional and novel methods of early event detection including environmental detection systems, clinical syndromic surveillance, reportable disease and laboratory-based surveillance, monitoring of agricultural and wildlife activity, testing of the food supply, and monitoring mail and open-source analysis to name a few. 68

Biosurveillance with regard to bioterrorism is a high priority for both the national security and public health communities. The recent threat of pandemic from the H1N1 strain of influenza reinforced the notion that, regardless of origin, health and security matters are uniquely interwoven in the 21 st century. While the detection and mitigation of bioterrorism is driving the current wave of interest in biosurveillance, advancements in this area are working in concert to address the detection of disease from both natural and manmade origin.

  • 66 Joseph, S. Lombardo, The ESSENCE II Disease Surveillance Test Bed for the National Capital Area, JOHNS HOPKINS APL TECH. DIG, Vol. 24, No. 4, 2003 at 327.

  • 67 See Centers for Disease Control, National Notifiable Diseases Surveillance System: History. Available at

―In 1878, Congress authorized the U.S.

Marine Hospital Service (i.e., the forerunner of the Public Health Service [PHS]) to collect morbidity reports

regarding cholera, smallpox, plague, and yellow fever from U.S. consuls overseas; this information was to be used for instituting quarantine measures to prevent the introduction and spread of these diseases into the United States.‖

  • 68 Robert Hooks, Eric Myers, and Jeffrey Stiefel, Joint Prepared Statement for “One Year Later, Implementing the

Biosurveillance Requirements of the 9/11 Act, Before the U.S. House of Representatives, Committee on Homeland Security, Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology, Washington, DC, (July 16, 2008).

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2. National Biosurveillance Integration Center.

The National Biosurveillance Integration Center (NBIC) and Biowatch are programs under the Department of Homeland Security that are designed to help stop an outbreak from becoming an epidemic or an attack from becoming a catastrophic event through early detection, identification, tracking, and response. 69 The NBIC was authorized by Congress through Pub. L. 110-53 to fulfill the requirements of Homeland Security Presidential Directive 9, ``Defense of U.S. Food and Agriculture,'' issued in January 2004, or better known as HSPD-9. 70 The primary mission of the NBIC is ―to rapidly identify, characterize, localize, and track a biological event of national concern; integrate and analyze data relating to human health, animal, plant, food, water; and disseminate alerts and pertinent information.‖ 71 To this end, the NBIC monitors over 530 information feeds…includ[ing] interagency communications and 165 open-source sites. These open-source sites include 20 organizational sites, 14 Federal Government sites, 85 State, local, or territorial government health and agriculture sites, 35 foreign government sites, and 2 commercial sites.‖ 72

The NBIC is an unprecedented effort to create one unified system that integrates all the streams of biosurveillance data collected by Federal, State, local, and private entities. 73 The NBIC is a collaborative effort. As of 2008, twelve Federal Member Agencies were integrated into the NBIC community. But plans are designed to eventually include State, local and tribal entities, and potentially the private sector and international stakeholders. 74

Although reasonable on its face, a recent controversy indicates that caution should be taken before relying on the cooperation of private industry for self-monitoring and biosurveillance. Some of the nation‘s largest slaughter houses recently resisted testing for E. coli in their own products for fear its discovery would lead to recalls of their beef and loss of business to competitors. 75 Thus, awareness of the profit dilemma must be taken into consideration before putting business managers in a position with conflicting duties.

The NBIC is a new endeavor and as such some deficiencies were noted by a recent Government Accountability Office report with regard to its progress. The GAO found that DHS has:

made progress making NBIC fully operational by September 30, 2008, as required by the Implementing Recommendations of the 9/11 Commission Act of

  • 69 Id. Hon. James R. Langevin, (Chairman Presiding).

  • 70 Id. Langevin.

  • 71 Id. Robert Hooks, Eric Myers, and Jeffrey Stiefel.

  • 72 Id.

  • 73 Id. Michael T. McCaul, (Ranking Member).

  • 74 Id. Robert Hooks, Eric Myers, and Jeffrey Stiefel,.

  • 75 Michael Moss, Companies Strike Deal on Testing for E. Coli, N.Y. TIMES, Oct. 8, 2009 at A23.

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2007, but it is unclear what operations the center will be capable of carrying out at that point. DHS has acquired facilities and hired staff for the center but has not yet defined what capabilities the center will have in order to be considered fully operational. DHS has also started to coordinate biosurveillance efforts with other agencies, but DHS has not yet formalized some key agreements to fulfill NBIC‘s integration mission. 76

2. Biowatch.

The ―BioWatch Program, ―was established in January 2003 with a mission to deploy and maintain a national 24/7 early warning system capable of detecting the intentional release of select aerosolized biological agents in order to speed response and recovery efforts.‖ 77 The Biowatch program provides operational and consequence management to federal, state, local and tribal entities, but its resources limit coverage to select high value targets, despite having the long range goal of covering the general population. 78

Biowatch laboratories have been in continuous operation since 2003 and they have expanded to over 30 metropolitan areas. 79 Projections for 2006 estimated that upwards of 80% of the population will be covered by the expansion of Biowatch. 80 The first five year period of the operation resulted in the analysis of over 7 million samples by the Laboratory Response Network without one false positive. 81 A ―Biowatch Actionable Result‖ (BAR) is issued if the system detects the presence of a bio-agent of concern. 82 Two hours after a BAR is issued, local and federal officials hold a teleconference to reach consensus on the findings. 83 Dozens of BARs have been reported in multiple jurisdictions, but all the findings were attributed to naturally occurring environmental sources. 84

It currently takes between 10 and 34 hours to analyze collection filters in laboratories, but it is hoped that the Generation 3 system will enable analysis of samples with on-site detectors, reducing analysis to the range of 4 to 6 hours. 85 The detectors in the next generation of

  • 76 See Supra note 68, William, O. Jenkins, (Prepared Testimony on behalf of the GAO).

  • 77 Id. Robert Hooks, Eric Myers, and Jeffrey Stiefel. 78 Id.

  • 79 Id. 80 Editors, US BioWatch program seeks new technologies, INSTRUMENT BUS. OUTLK. (Feb. 15, 2006). Available at

http://www.allbusiness.com/specialty-businesses/873079-1.html. Last checked March 7, 2010. ―In 2006, BioWatch plans an expansion of 20 additional outdoor monitors in 10 unnamed US metro areas. The expansion will increase

the population protected from a rate of 50% to 80%.‖

  • 81 See supra note 68, Robert Hooks, Eric Myers, and Jeffrey Stiefel. Id.

82

.

83

Id.

84

Id..

85

Id.

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equipment under development are known as the Bio-Agent Autonomous Networked Detectors (BAND). DHS refers to the BAND project as ―an automated, fully integrated ‗lab-in-a-box‘ that is capable of aerosol collection, molecular analysis and identification, and reporting of results with networking capability for real-time control of the entire sensor network.‖ 86

The importance of a rapid response to an anthrax attack was reaffirmed by a recent study. The study found that quick detection and treatment were essential for an effective response and any delay exceeding three days would overwhelm hospitals with critically ill people." 87 The study predicted that a public health campaign initiated two days after exposure to an anthrax attack would protect as many as 87 percent of exposed individuals. 88

3. ESSENCE I & II.

The ESSENCE II project from the Johns Hopkins Applied Physics Laboratory, in collaboration with the Department of Defense, is an example of a biosurveillance system designed to balance health privacy while effectively monitoring public health and disease outbreak within critical time constraints. ESSENCE II is an acronym for the Electronic Surveillance System for the Early Notification of Community-Based Epidemics. Simply put, ESSENCE II is a prototype syndromic surveillance system for capturing and analyzing public health indicators for early detection of disease outbreaks. 89 ESSENCE II has policies and takes measures to carefully protect civilian privacy while monitoring streams of information necessary to get timely information on disease outbreak. 90

The first generation, Essence I, was designed to provide, ―worldwide surveillance for military personnel and their dependents at all military treatment facilities by using ambulatory records generated for TriCare, the military's health-care system.‖ In contrast, the second generation, ESSENCE II is a regional system that supports advanced surveillance within the National Capital Region (NCR) test bed.‖ 91 ESSENCE II collects a vast array of data including, but not limited to: chief-complaint data from hospital emergency rooms, ICD-9-CM codes used for billing patients at private practices, over-the-counter sales of pharmaceuticals that can be

  • 86 See Department of Homeland Security, at http://www.dhs.gov/files/programs/gc_1228845015753.shtm#0 Last checked March 7, 2010.

  • 87 New York-Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College, Early Detection And Quick Response Are Key To Defense Against Anthrax Attack, DRUG WEEK, (Aug 14, 2009) at 94.

  • 88 Id.

  • 89 Joseph S. Lombardo, H. Burkom, J. Pavlin, ESSENCE II and the Framework for Evaluating Syndromic Surveillance Systems, MMWR, Vol. 53 (Sup), (Sept. 24, 2004) at 159-165 .

  • 90 See supra note 66 at 331. Most data available to ESSENCE II can be resolved down to only the patient zip code… Separate user names and passwords are provided so that ESSENCE II can recognize each authorized user

and give only the data the user is authorized to

view.

...

a

director of epidemiology would have access to all the

information within his or her jurisdiction as well as the shared information from the surrounding jurisdictions.‖

  • 91 See supra note 88 at 159-165.

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used for self-medication; nurse hotline calls; and school absentee records. 92 The data collected is then parsed into, ―text strings into syndrome groupings, and [then it] applies multiple temporal and spatio-temporal outbreak-detection algorithms.‖ 93

The early results of ESSENCE II are promising. ―During a recent DARPA evaluation exercise, ESSENCE algorithms detected a set of health events with a median delay of 1 day after the earliest possible detection opportunity.94 A report on ESSENCE II concluded that, ESSENCE II has provided excellent performance with respect to the framework and has proven to be a useful and cost-effective approach for providing early detection of health events.95

4. Conclusion.

Biosurveillance systems hold great expectations and are subject to great scrutiny. The scrutiny is reflected in the criticism found in a recent Bipartisan Congressional report released in October 2009 which stated that U.S. surveillance programs are falling short. 96 Creating an effective biosurveillance system is a daunting task which may take some time to perfect. Thus, novel efforts that adequately protect privacy such as ESSENCE II are critical to establishing comprehensive biosurveillance systems that are effective and balance privacy standards established through the law.

  • 92 See supra note 89 at 327.

  • 93 See supra note 88 at 159-165.

  • 94 Id..

  • 95 Id.

  • 96 Mimi Hall, Bioterror Failings Criticized in Report, USA TODAY, (Oct. 21, 2009) at 1A.

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4 The 2009 Emergency Declaration for Influenza

Brian J. Gorman, Jennifer Kallal, and Michael Carnucci

1. Public Health Emergency Declaration.

The Secretary of Health and Human Services determines whether or not there is a Public Health Emergency (PHE) meeting the criteria of Sec. 1135 of the Social Security Act. The President, however, must ratify the Public Health Emergency by declaring an emergency or major disaster under the authority provided in the National Emergencies Act or the Stafford Act before Sec. 1135 waivers may be granted. Sec. 1135 waivers are limited to particular needs within specified geographic areas with temporal limits.

A. Determinations and Declarations. President Obama‘s declaration of a national emergency for the H1N1 pandemic on October 24, 2009 came 6 months after the first Public Health Emergency was determined by HHS.

On April 26, 2009, the first Public Health Emergency was proposed by, then acting, HHS Secretary Charles E. Johnson. 97 However, President Obama disregarded the PHE despite the 25,925 positive flu specimens (type A & B) documented as of April 18, 2009. 98 Furthermore, on June 11, the W.H.O. raised the level of the H1N1 pandemic alert level from a phase five to a phase six, indicating that an influenza pandemic was underway. 99

The Public Health Emergency declaration was renewed on July 24, 2009 by current HHS Secretary Kathleen Sebelius. This PHE was again declined by President Obama despite the increase in positive flu specimens to 29,019. 100 President Obama finally declared a Public Health Emergency by invoking the National Emergencies Act in October 2009 when flu specimens grew to 36,999. 101

See next page for Diagram 1.

97 Kathleen Sebelius, Renewal of Determination that a Public Health Emergency Exists, FLU.ORG. (Oct. 1, 2009). Available at http://www.flu.gov/professional/federal/h1n1emergency100109.html. Last checked April 15, 2010. 98 FluView: 2008-2009 Influenza Season Week 15 ending April 18, 2009, CDC. Last updated April 24, 2009. Available at http://www.cdc.gov/flu/weekly/weeklyarchives2008-2009/weekly15.htm. Last checked April 15, 2010. 99 FluView: 2008-2009 Influenza Season Week 29 ending July 25, 2009, CDC. Last updated July 31, 2009. Available at http://www.cdc.gov/flu/weekly/weeklyarchives2008-2009/weekly29.htm. Last checked April 15, 2010.

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H1N1 Emergency Declaration of 2009:

The Secretary of HHS has the authority to declare a Public Health Emergency under Sec. 1135 of the Social Security Act. The President, however, must ratify the Public Health Emergency by declaring an emergency or major disaster via the National Emergencies Act or the Stafford Act before Sec. 1135 waivers may be granted. Sec. 1135 waivers are limited to particular needs within specified geographic areas with temporal limits.

HHS PHE disregarded by President Obama
HHS PHE
disregarded
by President
Obama

4/26/09: First Public Health Emergency due to H1N1 determined by Acting HHS Secretary Charles E. Johnson

HHS PHE disregarded by President Obama
HHS PHE
disregarded
by President
Obama
25,925 positive flu specimens (type A & B) YTD as of 4/18/09 CDC
25,925 positive
flu specimens
(type A & B) YTD
as of 4/18/09
CDC

On June 11, the World Health Organization raised the pandemic alert level from Phase 5 to Phase 6 indicating that an influenza pandemic was underway. CDC

29,019 positive flu specimens (type A & B) YTD as of 7/25/09 CDC
29,019 positive
flu specimens
(type A & B) YTD
as of 7/25/09
CDC

7/24/09: Second Public Health Emergency due to H1N1 determined by HHS Secretary Kathleen Sebelius

Obama responds to notice of PHE from HHS by invoking National Emergencies Act 10/24
Obama responds to
notice of PHE from HHS
by invoking National
Emergencies Act 10/24

Permits use of emergency operation plans at U.S. health care facilities in response to H1N1

36,999 positive flu specimens (type A & B) YTD as of 9/26/09

*Pneumonia and influenza deaths below the epidemic threshold.

10/1/09: Third Public Health Emergency due to H1N1 determined by HHS Secretary Kathleen Sebelius

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5 Risk & Reliability of Laboratory Personnel

Brian J. Gorman and J. Corey Creek

  • 1. Introduction.

Laboratory safety and personnel reliability garnered very serious attention in 2009 with the release of a stream of reports and testimony on the topic from a variety of sources. Over 359 professionals in science and security participated in the making of these reports. 102 Reports and testimony on personnel reliability were issued through Congressional testimony, a scientific membership organization, government committees, and a federal advisory board. The impetus for the reports came from the accumulation of a number of factors. Chief among them was the growing realization that an ―insider‖ might have been responsible for the anthrax attacks of

  • 2001. 103 Internationally, concern also arose from the discovery, reported by The Guardian, that

terrorists tried to infiltrate labs as postgraduate students to acquire WMD expertise and materials in the U.K. 104 U.S. authorities responded by assembling expert committees to address all aspects of lab security from the physical plant to personnel reliability.

  • 2. Personnel Reliability Programs (PRPs).

PRPs are structured efforts designed to, ―help ensure that individuals with access to sensitive materials are trustworthy and reliable. …PRPs may include background investigations, security clearances, medical examinations, psychological evaluations, polygraph testing, drug and alcohol screening, credit checks, and systems of ongoing monitoring.‖ 105 Diane Rodi noted the same list with the addition of, ―monitoring by supervisors, [and] peer reporting.‖ 106

  • 3. Security Risk Assessments vs. Personnel Reliability Programs.

The Security Risk Assessment (SRA) is a mandatory safety measure administered every five years, under the Select Agent Rules, to every individual whose work requires the use of Select Agents. 107 The SRA was designed to prevent unauthorized persons from gaining access to

agents and toxins which could be used in a harmful manner. It relies in part on federal databases

to ascertain an individual‘s criminal history, among other things, and helps determine whether a

candidate should be prohibited from gaining access to Biological Select Agents and Toxins

  • 102 See infra Chapter 6.

  • 103 Amy Patterson, National Science Advisory Board for Biosecurity: Minutes of Meeting, Rockville, MD (Dec. 10, 2008). At 3.

  • 104 Id.

  • 105 See NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY, ENHANCING PERSONNEL RELIABILITY AMONG INDIVIDUALS WITH ACCESS TO SELECT AGENTS, (2009) at iv. available at

Last checked May 2, 2010.

  • 106 Diane J. Rodi, ―Working Group on Strengthening the Biosecurity of the United States,Public Consultation Meeting, May 2009, Slide 24.

  • 107 See supra note 105 at 3.

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(BSAT). 108 The SRA requires fingerprints, disclosure of possible criminal history, use of illicit drugs, mental-health history, and whether or not the candidate was dishonorably discharged from the U.S. Armed Services. 109 From the inception of SRA screenings in 2003 to September 2009,

  • 208 individuals have been restricted out of 32,742 SRAs conducted by the F.B.I. 110 In this

connection, there are a total of 324 labs and centers conducting work with BSAT as of 2008. 111

In addition to the SRA, many agencies have also created their own personnel reliability

programs (PRPs) to ensure that employees are holding up to reliability standards.

For example,

the Department of Defense has created their own Biological Personnel Reliability Program

(BPRP). The DoD states that, ―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.‖ 112 (Sic) PRPs are most commonly found in federal agencies, particularly the military, because they have existed in some form or another within their security programs for many years. 113

4. Federal vs. Local Oversight.

The threshold issue that emerged in 2009 deliberations over personnel reliability was whether or not there should be federal oversight of Personnel Reliability Programs at high containment life science laboratories, i.e. BSL-3 and BSL-4. The attributes of the various PRP components were discussed, but that analysis was secondary to the threshold issue of whether or not there should be some form of uniform oversight standards for all BSAT labs.

The issue of federal oversight of BSAT labs was raised as early as 2005 through a proposal which called for a federal oversight body for the life sciences along the lines of the Nuclear Regulatory Commission, called in like manner, the ―Biologic Regulatory Commission.‖ 114 The analogy drawn between the NRC and the need for a similarly situated agency for BSAT remains apt. A review of the Energy Reorganization Act of 1974 draws striking parallels between the need for the creation of the NRC then and the need for the establishment of a BRC with national

  • 108 Id at 7.

  • 109 Id. at 3.

  • 110 Daniel, D. Roberts, "Strengthening Security and Oversight at Biological Research Laboratories", testimony before the Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security, Washington DC (Sept. 22, 2009) p. 4. “Since the inception of the program, the BRAG [the F.B.I.’s Bioterrorism Risk Assessment Group] has completed 32,742 SRAs, two hundred and eight individuals have been restricted.”

  • 111 See supra note 1 at 8.

  • 112 See supra note 1 at 23.

  • 113 Michael Greenberger, "Strengthening Security and Oversight at Biological Research Laboratories", testimony before the Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security, Washington, DC (Sept. 22, 2009) at. 11.

  • 114 See Brian J. Gorman, Balancing National Security and Open Science: A Proposal for Due Process Vetting, 7 YALE J.L. & Tech. 510 (2005). Available at http://www.yjolt.org/files/gorman-7-YJOLT-491.pdf.

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regulatory authority over all high and maximum biocontainment facilities. 115 The subsequent call for federal oversight of BSAT labs from the Graham Report combined with other developments, however, inspired the call to action on this issue in 2009. Bob Graham reiterated the need for federal oversight in Congressional testimony in September of 2009.

Fragmentation of oversight should be eliminated in pathogen security. In our Report [World at Risk], we concluded that the fragmentation of government oversight of laboratories was a national security problem. We determined that there should be one set of requirements concerning pathogens for the scientific community to follow, instead of having separate regulatory programs from multiple departments. The authority to oversee and enforce these requirements must be vested in one lead agency so that the regulated community has a single coherent, consolidated and streamlined set of regulations to follow. 116

Three out of four government sponsored committees in 2009 advocated for some form of federal oversight or comprehensive review apparatus for high containment labs. The DoD also produced a report on PRPs but it focused on an evaluation of its own labs and was essentially silent on oversight of non-DoD labs. The DoD‘s position in favor of a national standardization of best practices, however, was articulated by the Deputy Assistant to the Secretary for Nuclear, Chemical, and Biological Defense Programs through congressional testimony in 2009. 117 The DoD report on PRPs was consistent with this position when it noted that it is impossible to eliminate the insider threat, but making it more difficult is the responsible position. 118 Additional expert testimony before Congress by Prof. Michael Greenberger, likewise favored some form of federal oversight (see infra).

Two of the federally sponsored reports shied away from the notion of federal oversight. It appears, however, that the infusion of a sufficient balance of national security, safety and other expertise on the National Academy of Sciences (NAS) committee led to a result that linguistically fell short of an endorsement of federal oversight, but actually made the case in substance. Regardless of shades of interpretation of the NAS report, it is far from the anti- regulation stance found in the National Science Advisory Board for Biosecurity (NSABB) report. NSABB, however, produced nothing short of a report dissenting from its charge and the

  • 115 See U.S. Nuclear Regulatory Commission at http://www.nrc.gov/about-nrc/governing-laws.html. Last checked April 17, 2010.

  • 116 Bob Graham, "Strengthening Security and Oversight at Biological Research Laboratories", testimony before the Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security on September 22, 2009, p 4 italics in original.

  • 117 Reed, Jean, "Strengthening Security and Oversight at Biological Research Laboratories", testimony before the Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security on September 22, 2009, p. 2. ―It‘s imperative that the implementation of best practices on a national scale optimize the security of biological agents while providing minimal impact to life science research necessary to develop public health and medical countermeasures against these agents.‖

  • 118 See supra note 1 at X.

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notion of federal oversight. The apparent cause of this imbalance was apparently due to skewed membership toward bench scientists--leaving national security experts relegated to non-voting ex-officio positions. The imbalance in membership appeared to leave NSABB with the outlier report which was akin to what would be expected of a scientific membership organization like the American Association for the Advancement of Science (AAAS) which likewise advocated against federal oversight for the lab workers they represent. The NSABB report inartfully nuanced its dissent with incompatible propositions such as the following:

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. … NSABB recommendations. … 1. It is appropriate to enhance extant personnel reliability measures, but the promulgation of a formal, national Personnel Reliability Program is unnecessary at this time. 119

Tension between the national security community and the scientific community is nothing new since 9/11, and thus the discovery of tensions between these communities over proposals for a new oversight framework should come as no surprise. In fact, the tension could be beneficial if it is harnessed to strike the best balance between competing perspectives in pursuit of a common goal.

  • A. Local oversight is an unsustainable policy. The insider threat from high containment

labs is a fairly uniform dilemma at similarly situated labs and the security measures within a common territory must likewise be uniform to maintain minimum safeguards from threats within the territory. The maintenance of Balkanized PRP programs within U.S. territories would have an unacceptable detrimental effect on lab security. The failure to set minimum PRP levels for high containment labs in the U.S. would create market forces driving down PRP program integrity. There are 324 high containment labs competing for a limited pool of talent interested in working on select agents. 120 So long as there are no federally mandated PRP requirements for working in BSAT labs, the labs with the least bothersome PRPs will have the greatest advantages in personnel recruitment. Moreover, the counter-security incentive would be accelerated by lower administrative costs of running a PRP program wanting of integrity.

  • B. Options.

The federal government has a number of options including: a.) Balkanized

PRP programs with incentives for those programs instituting more rigorous PRP programs, b.) federally mandated minimum PRP criteria, or c.) federal funding contingent on desired PRP levels for high containment labs. The federal government could also follow the lead of the

  • 119 See supra note 105 at iv.

  • 120 See supra note 1 at 8.

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Department of Homeland Security which runs a compliance inspection program for the 42 labs that work on DHS-funded research. 121 More options can be crafted, but all options must assure a minimum level of security and extinguish counter-security incentives that reward high risk management practices at BSAT labs.

5. The Urgent Call for Advice on Laboratory Security Enhancements.

The many reports released on lab security in 2009 had fundamentally similar objectives and even some common recommendations, yet there were some stark differences. A review of the reports reveal that most reports had a security orientation consistent with their charge while the NSABB and AAAS reports appeared to speak with a tone of dissent from their official charge or even protest against the notion of enhanced security measures respectively. It is not surprising for different committees to come up with unique findings, but the near experimental phenomenon of so many reports being conducted concurrently with such similar charges begs further scrutiny of the similarities and differences of report findings. The uniqueness of this situation is heightened all the more by the fact that the field of experts was overwhelmingly drawn from two sectors, i.e. science and security, which are known to have a rocky relationship. 122 In addition, the lab security reports are unique because approximately 18% of the experts involved in the collection of reports actually overlapped duties between committees-- begging questions of waste and influence.

Approximately 359 professionals participated in the parade of lab security reports released in 2009. Clearly, a community of 359 professionals could certainly produce an inestimable number of reports bringing even more to the table. But, the question is how many concurrent committees are needed to address the same issues with overlapping personnel before it is wasteful and counterproductive. A review of the 2009 reports provides some guidance on that question.

It is argued that on the whole, the overlapping reports on laboratory security in 2009 resulted in a degree of waste, redundancy, and confusion. But the blame for this waste was due to reliance on ill-fitting committee protocols. Expert committees are relying on the consensus model when a format allowing for dissenting opinions are indicated for a contentious intersectoral policy area such as biosecurity. 123 Thus, President Bush and his offices exercised appropriate leadership by marshalling redundant reports on lab security since reliance on the

  • 121 See Pasco, Brandt, "Strengthening Security and Oversight at Biological Research Laboratories", testimony before the Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security on September 22, 2009, p. 3.

  • 122 See Nathaniel Hafer et al., How Scientists View Law Enforcement, Science Progress, Available at http://www.scienceprogress.org/2008/12/science-and-law-enforcement/. Last checked 12/23/2008. ―Anecdotal evidence, including several high-profile cases of scientists under criminal investigation, has led to the impression that many in the scientific community hold a negative view of law enforcement.‖

  • 123 See infra Chapter 6 for further analysis of report protocols.

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wrong expert committee could so easily yield biased results despite the appearance of membership diversity.

Emotions and concerns amongst scientists have been on the rise with the influx of scrutiny and enhanced security measures since the terrorist attacks of 9/11. Evidence of this can be found in the exaggerated fears of the destruction of the scientific enterprise reflected in some committee discussions as well as committee reports. 124 For instance, deliberations at the NSABB on PRPs turned into justifications against enhancing security measures because acquiescence to security enhancements now would lead to the regulation of other less dangerous biological agents and so on, down the slippery slope. 125 It is argued that this anti-regulation thinking resulted in unbalanced deliberations, and the production of some reports that presented as overly defensive and bordering on outright advocacy for special interests.

Anti-regulation proponents do not appear to see their position as a special interest. The logic of anti-regulation proponents is clear and appears to run along these lines: science is good for society, what is good for science is good for society, regulations hinder science, therefore, regulations are bad for society. The fallacy of that logic appears to cause the NSABB to substitute its judgment for that of lawmakers by withholding a balanced analysis of security enhancements in its report as per its charge. The NSABB, like other committees, was expected to provide strategies ―for enhancing personnel reliability among individuals with access to select agents and toxins.126 The vast time and effort lent by hundreds of experts to committee participation on lab security was most likely done at personal sacrifice. The work of committee participants is noble public service. But even with great sacrifices by the experts who no doubt lend some of their time at personal expense, a significant amount of tax dollars have been spent on expert committees. For instance, the budget for NSABB alone is hundreds of thousands of dollars per year. 127

It is, therefore, wholly inappropriate for a federally funded advisory board to fundamentally disregard its instant charge and, in fact, argue against it. It should not take months of deliberations to come to the conclusion that it must reject its charge. If a committee has such disproportionate leanings against a charge at the outset, it should state the conflict and recuse itself form deliberating on the matter at the outset. NSABB‘s expenditure on the PRP ―dissentreport was only a fraction of the Board‘s activities, but was nonetheless supported with

March 28, 2008, ―The estimated annual cost for operating the Committee [NSABB], including compensation and

travel expenses for members but excluding staff support, is $382,986. The estimated annual person-years of staff

support is 2.9, at an estimated cost of $369,423.‖

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government funds to some degree between September 2008 and May 2009. Thus, it is important that committee reports charged and funded by the government fulfill their charge in good faith rather than substitute judgment for lawmakers.

The lab security reports released in 2009 are likely to have great influence on the policies and laws affecting the safety of the public, in addition to the progress of science, and the livelihoods of thousands of devoted scientists. Therefore, it is important to read and analyze the results of these competing reports carefully in the interests of all stakeholders.

See next page for Table 1.

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4. Reports and Testimony Related to Personnel Reliability and Lab Security.

Release

Report Source

Report Name

Impetus for

Start

Type

Position on

Report

Oversight

May 2009

THE NATL. SCI.

Enhancing

Executive

September

DISSENT

LOCAL

ADV. BD. FOR

Personnel

Initiative 128

2008

129

OVERSIGHT

BIOSECURITY

Reliability

 

May 2009

AMER. ASSOC/

Biological

Self-

March 17,

PROTEST

LOCAL

FOR THE

Safety Training

initiated

2009

130

OVERSIGHT

ADVANCEMENT

Programs

 

OF SCIENCE

May 2009

DEPARTMENT

Report of the

Internal

six week

SECURITY

FEDERAL

OF DEFENSE

Defense Science Board Task Force

Review

study 131

CENTRIC

OVERSIGHT* 132

July 2009

CO-CHAIRED

Report of the

HHS

October

SECURITY

FEDERAL

BY: HHS AND

Trans-Federal

2007

CENTRIC

OVERSIGHT

THE USDA

Task Force

September

PROF. MICHAEL

Cong. Test. on

Congress

September

SECURITY

FEDERAL

2009

GREENBERGER

Personnel Reliability

2009

CENTRIC

OVERSIGHT

September

THE NATIONAL

Responsible

Executive

Jan+/-

SECURITY

UNIVERSAL

2009

ACADEMY OF

Research w/

Initiative 133

2009

CENTRIC

COORDINATED

SCIENCES

Biological

OVERSIGHT 134

October

VAR. FEDERAL

Rpt of the Wk

Exec. Order

January

SECURITY

FEDERAL

2009

OFFICIALS

Grp on

Following

2009

CENTRIC

OVERSIGHT 136

Strengthening

Graham Rrt

the Biosecurity

Guidance 135

  • 128 See Diane DiEuliis, Address at Meeting of the National Security Advisory Board for Biosecurity. April 3, 2009. http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html. (Last checked April 23, 2010.

  • 129 Personal communication, Allan Shipp, Director of Outreach, NIH Office of Biotechnology Activities, on behalf of Amy Patterson, April 14, 2010. (―In this case, the Executive Office of the President tasked the Board with developing recommendations on personnel reliability programs for individuals with access to Select Agents.‖)

  • 130 American ASSOCIATION FOR THE ADVANCEMENT OF SCIENCE, WORKSHOP REPORT ON BIOLOGICAL SAFETY TRAINING PROGRAMS AS A COMPONENT OF PERSONNEL RELIABILITY, available at

http://cstsp.aaas.org/content.html?contentid=2049. Last checked May 2, 2010. At 5. The PRP Worshop took place

on March 17, 2009, but it was part of a series of workshops on biosafety education originating on November 21, 2008 which addressed dual use research for scientists.

  • 131 See supra note 1 at 3.

  • 132 The DoD position articulated by Jean Reed, the Deputy Assistant to the Secretary for Nuclear, and Chemical and

Biological Defense Programs, was through Congressional testimony.

Reed, Jean, "Strengthening Security and

Oversight at Biological Research Laboratories", testimony before the Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security on September 22, 2009, p. 2. ―It‘s imperative that the

implementation of best practices on a national scale optimize the security of biological agents while providing minimal impact to life science research necessary to develop public health and medical countermeasures against

these agents.‖

  • 133 See supra note 128.

  • 134 The NAS recommendations linguistically shied away from recommending new federal overisght, but fundamentally relied on the same rationale others have used to justify federal oversight. The NAS committee recommended an oversightmechanism through an advisory committee where federal authorities could be mere ex- officio memebrs.

  • 135 Graham, Bob, "Strengthening Security and Oversight at Biological Research Laboratories", testimony before the Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security on September 22, 2009, p 5.

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A. Sum and Substance of the Lab Security Reports.

1. NSABB, May 2009. Enhancing Personnel Reliability among Individuals with Access to Select Agents.

The Executive Office of the President of the United States tasked NSABB with developing recommendations on personnel reliability programs for individuals with access to Select Agents. 137 The charge was issued in September 2008. 138 The NSABB reviewed existing personnel reliability programs with particular interest in the costs, impact, and effectiveness that such measures would have on the scientific community. 139 The NSABB, however, offered findings somewhat inconsistent with its charge. Rather than focusing exclusively on the charge

of ―recommending‖ strategies ―for enhancing personnel reliability among individuals with access

to select agents and toxins,‖ 140 NSABB offered arguments militating against the charge, stating that:

i. The extant select agent program was sufficiently improved to meet personnel reliability demands.

ii. Local institutions were already effective at screening individuals requiring access to BSAT.

iii. There are no additional assessments that could be conducted to detect disqualifying traits.

iv. Institutional leadership was noted as the best way to mitigate the risk of an insider threat. 141

v. Psychological tests are extremely resource-intensive and lack persuasive evidence for effectiveness or their predictive value, and that it would be almost impossible to identify an individual with malevolent intent by using them. 142

  • 136 See Report of the Working Group on Strengthening the Biosecurity of the United States, at127. "Identify or establish a Federal entity to coordinate biosecurity oversight activities, and to ensure comprehensive and effective Federal oversight for all select agent research facilities and activities." Available at http://www.hhs.gov/aspr/omsph/biosecurity/biosecurity-report.pdf. Last checked May 1, 2010.

  • 137 See supra note 129.

  • 138 Patterson, Amy, ―NSABB Personnel Reliability Working Group: Introduction to the Issue and Charge to the

Working Group, Minutes of Meeting, National Science Advisory Board for Biosecurity, December 10, 2008, Rockville, MD.

  • 139 See supra note x at 7

  • 140 See supra note 105 at ii.

  • 141 Id. at iv.

  • 142 Id. 9-10.

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vi. Drug and alcohol testing are not proven to be effective as a personnel reliability measure.

The Executive Summary of the NSABB report immediately established a defiant tone.

After stating the charge, the report started framing an argument against it. All momentum for the

charge was nearly lost after the report identified the task of balancing ―overly burdensome‖ security measures against the risk of having ―measures that are too weak [and] could leave the U.S. vulnerable to those who wish to misuse select agents toward malevolent ends.‖ 143 The

report then defended the need for select agent research, pointed out that controls on select agents

were significantly strengthened after the anthrax mailing ―incident,‖ and argued that PRPs are

more appropriate for chemical and nuclear surety programs.

The distinction on surety programs rested mostly on the observation that research on pathogens is largely open and only newly viewed as a high-consequence threat, and that select agents do not exist in ―discrete quantities,‖ rather they are living and can multiply. 144 It appears that the Report meant to say fixed instead of discrete because select agents can be identified and stored in discrete units and can even be controlled to suspend growth. Corrections aside, it is interesting to note, however, that the NSABB‘s finding of a distinction between bio and other surety programs is in sharp contrast to the expert presentations to the board by Eric Gard of Lawrence Livermore National Laboratory at the December 10, 2008 and April 3, 2009 NSABB meetings. 145 Dr. Gard presented the following in PowerPoint presentations to NSABB:

The Centers for Disease Control and Prevention (CDC) does not require a human reliability program for work with high risk biological materials Select Agents (SA). However, based upon the similarities of high risk nuclear materials and high risk biological materials, LLNL and LANL have implemented a Select Agent Human Reliability Program (SAHRP). In 2003 a working group was convened to define a biosecurity program, which decided a SAHRP was necessary and what its requirements should be. In 2004 LLNL and LANL were instructed by the University of California, which managed both laboratories at the time, to implement a Select Agent Human Reliability Program. Since that time, both LLNL and LANL have had a SAHRP in place. 146

  • 143 Id at ii.

  • 144 Id at ii-iii.

  • 145 See Meeting of the National Security Advisory Board for Biosecurity. Dec. 10, 2008 and April 3, 2009 http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html. (Last checked April 23, 2010).

  • 146 See Id. Eric Gard, NSABB Address, December 10, 2008, ―LLNLS Select Agent Human Reliability Program,‖ at http://oba.od.nih.gov/biosecurity/meetings/200812/NSABB%20Public%20Mtg%20121008%20-%20Gard.pdf. Eric

Gard, NSABB Address, April 3, 2010, ―LLNLS Select Agent Human Reliability Program.‖ At

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Unfortunately, the NSABB report did not explain how the many experts with vast experience working with select agents at Lawrence Livermore National Laboratory (LLNL) and Los Alamos National Laboratory (LANL) were in error. Nor did the NSABB members refute the LLNL and LANL position when Dr. Gard presented it to them in the December 2008 meeting. 147

The report further minimized the insider threat regarding pathogens as ―uncertain‖ and ―small,‖ 148 then boldly and defiantly argued that enhanced PRP measures for pathogenic research may actually increase the insider threat. This assertion was premised on the argument that researchers in this area would be isolated, but the link between researcher isolation and malevolence was not clarified. 149 Researcher isolation is possible under certain circumstances, but the likely result would lead to the loss of personnel to other less secure labs if there are uneven PRP programs in the U.S., and not necessarily a transformation into malevolent action.

Despite the defiant tone of NSABB‘s report, there were in fact some recommendations on improving security. Under recommendation 2, NSABB called for a strengthened Security Risk Assessment (SRA) process through the following:

i. Periodic cross-checking of those with favorable SRAs against federal databases,

ii. Inclusion of domestic terrorism under SRA criteria, and

iii. Strengthened screening of foreign nationals. 150

Unfortunately, however, the brief laundry list of security recommendations was not likely beyond the common sense of any competent official familiar with personnel reliability issues or arguably, the inevitable actions of U.S. security officials. A case in point is that the NSABB was informed on May 20, 2009 by the F.B.I. that recommendation 2 was unnecessary because ―the Department of Justice has reviewed the Bioterrorism Response Act and determined that the prohibitor ‗committing a crime specified in 18 U.S.C 2332b(g)(5)‘ already includes both

domestic and international crimes of terrorism.‖ 151

The NSABB decided not to strike the

http://oba.od.nih.gov/biosecurity/meetings/200904/Gard.pdf. Italics added in quote for emphasis. Last checked April 23, 2010.

  • 147 See supra note 145 at webcast available at http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html. (Last checked April 23, 2010).

  • 148 See supra note 105 at iv.

  • 149 Id.

  • 150 Id at 12.

  • 151 See NATIONAL SCIENCE ADVISORY BOARD FOR BIOSECURITY, (DRAFT REPORT) ENHANCING PERSONNEL RELIABILITY AMONG INDIVIDUALS WITH ACCESS TO SELECT AGENTS, (2009) , at 12, available at

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recommendation from the final version of the report. Unfortunately, the NSABB report appeared to merely offer a tempered obligatory nod to inevitable ―enhance[d] personnel reliability measures.In addition, the NSABB overemphasized the necessary but intangible notion of an ―enhanced culture of research responsibility and accountability at the institution level.‖ Finally, the NSABB argued against a ―federally mandated PRP across the select agent research community,‖ which the NSABB claimed, ―is neither appropriate nor useful at this time.‖ 152

2. AAAS, May 2009. Biological Safety Training Programs as a Component of Personnel Reliability.

In March of 2009, the American Association for the Advancement of Science (AAAS) conducted a review of existing biosafety training programs and argued that extant security programs ―may already address [PRP] concerns.‖ 153 The AAAS report argued that the status quo was sufficient in like manner to the NSABB report. The AAAS report is considered a ―Protest Report,‖ here because it was an unsolicited report by a private membership organization looking out for the interests of its members. The study was clearly inspired as a response to President George W. Bush‘s Executive Order 13486 in January of 2009, which mandated the formation of a Working Group for an interagency review of laboratory biosecurity, including personnel reliability. 154 Clearly, the AAAS was well within their rights to weigh-in with an argument against enhanced security measures. In fact, their input was especially valuable in helping delineate other similarly biased reports from those that substantially met their charge.

The AAAS group consisted of many experts in biosafety, life sciences, biosecurity, architecture, and engineering. The goals of the study were to document and describe existing educational programs and materials on biosafety training programs, make recommendations for developing an educational program on biosafety, and to highlight major challenges in developing and implementing such a program. 155 Thus, the AAAS report can be seen as a protest report to counter the security centric reports that were under development at that time. See report timeline infra at Chapter 6.

http://oba.od.nih.gov/biosecurity/meetings/200905T/NSABB%20Draft%20Report%20on%20PR%205-20-09.pdf. ; Personal communication, Allan Shipp, Director of Outreach, NIH Office of Biotechnology Activities, April 26, 2010. (―The committee decided against striking the language on page 12 concerning the SRA process, thus these sentences remain in the final version.‖)

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3. Department of Defense, May 2009. Report of the Defense Science Board Task Force on: Department of Defense Biological Safety and Security Program.

The Department of Defense (DoD) issued a report on personnel reliability and other lab security issues. The impetus for the report was, at least in part, the findings of the Amerithrax investigation which identified a DoD employee and a scientist at USAMRIID as the suspect. 156 The report examined the current status of DoD‘s biological defense labs on safety, security, and personnel reliability against other similar operations in academia, industry, and the federal government. 157

The single overarching finding was that: ―A determined adversary cannot be prevented from obtaining very dangerous biological materials intended for nefarious purposes, if not from DoD labs, then from other sources. The best we can do is to make it more difficult. We need to recognize this reality and be prepared to mitigate the effects of a biological attack. We, as a nation, are not prepared.‖ 158

Other findings were that:

i. DoD regulations exceed those imposed by the Center for Disease Control and Prevention (CDC).

ii. A strong safety record of the laboratories is a good indicator of the general effectiveness of safety measures.

iii. The isolated computer system could represent a serious vulnerability but the task force did not have the resources to verify this.

iv. Detection of an insider threat is difficult even with extensive monitoring of the emotional and mental state of BSAT-certified employees, including transport personnel.

v. Rather than steal BSAT from a DoD lab, other paths appear preferable for an adversary (e.g., natural sources, non-DoD labs, non-U.S. labs, genomic synthesis) except possibly in the case of a blackmailed or disgruntled employee working from the inside.

  • 156 See supra note 1 at 2.

157 Id at

2.

  • 158 Id at X.

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vi. DoD should avoid those measures that are significantly detrimental to the laboratory mission, onerous, or detract from the morale unless the measure significantly improves security or safety.

vii. Public education now is the best way to mitigate public panic later, if there is a loss or perceived loss of containment. 159

  • 4. Trans-Federal Task Force, HHS/USDA, July 2009. Report of the Trans-

Federal Task Force on Optimizing Biosafety and Biocontainment Oversight.

The primary focus of the Trans-Federal Task Force (hereinafter TFTF) was biosafety and biocontainment oversight rather than personnel reliability. 160 TFTF was included here, however, because it was a companion to the constellation of reports on the broader laboratory security issue and its inclusion helps illuminate analysis of other reports on personnel reliability released in 2009. The TFTF report was classified here as a Security Centric report. The report achieved its stated goals, but it did infuse language apparently designed to appease some with minority opinions who were more cautious about increased security measures.

The TFTF was created in October of 2007 to ―propose options and recommendations to improve biosafety and biocontainment oversight of research and research-related activities at high and maximum containment laboratories in the United States, without hindering the progress of science.‖ 161 The task force consisted of officials from the Department of Health and Human Services and the U.S. Department of Agriculture, along with various other representatives from federal agencies responsible for the oversight of select agents. The committee conducted a comprehensive assessment of the current biosafety/biocontainment oversight framework for high-containment facilities and activities in all sectors, developed specific objectives for improving the current biosafety/biocontainment oversight framework, and developed options and recommendations for achieving the objectives. 162

The TFTF report was considered a Security Centric report that properly addressed its charge because it examined security issues without an overwhelming tone of dissent or protest and provided careful, considered, and valuable recommendations. For instance, the TFTF envisioned an expansion of oversight by calling for the creation of a Federal entity to coordinate

159 Id at

XII.

biocontainment, are not the focus of this report but are being addressed by a Federal Working Group established by

Executive Order 13486, Strengthening Laboratory Biosecurity in the United States.‖)

  • 161 Id. at. 5.

  • 162 http://www.hhs.gov/aspr/omsph/biosafetytaskforce/index.html

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biosafety and biocontainment oversight activities. 163 The TFTF expects that entity, ―to ensure comprehensive and effective Federal oversight for all high and maximum containment research facilities and activities in all sectors.‖ 164

Unlike the Dissent or Protest reports of 2009, the TFTF acknowledged facts which warrant increased oversight. The TFTF noted, ―areas of concern, which include lapses in biosafety, lack of timely reporting of incidents, and lack of Federal oversight for research involving pathogens that are neither select agents nor recombinant DNA agents.‖ 165 Thus, the TFTF saw a broadening of oversight. This is in sharp contrast to the NSABB report which actually advocated shrinking extant oversight by narrowing the select agent list. 166

The TFTF also repeatedly emphasized that it undertook its study with a broad scope of consideration for ―all high and maximum containment research laboratories in all sectors (government [Federal, State, Tribal, and municipal], academia, privately funded research institutions, and private industry) utilizing potentially hazardous biological agents.‖ 167 The TFTF was, however, somewhat equivocal on comprehensive national oversight at times. The report stated, ―The Task Force envisions that a national system for biosafety and biocontainment oversight of high and maximum containment research should achieve effective, comprehensive oversight at individual institutions where the research is conducted (local oversight) and at the Federal level.‖ 168 The TFTF did distinguish oversight of private labs from federal labs at times, as well. For instance, the report stated that the TFTF was expecting mandatory compliance with its recommendations from federal and federally funded labs, but merely encouraged private labs to follow their recommendations. 169

The TFTF report concluded that, ―The objectives and recommendations in this report are designed to optimize local biosafety and biocontainment oversight at individual high and maximum containment research facilities; improve and better coordinate Federal oversight of these facilities and their activities.‖ 170 Unfortunately, there appears to be some confusion on the scope of the TFTF report. It may well be reasonable to speculate that some of the discrepancies and confusion in the TFTF report on local versus federal authority may be due in part to those on the committee who align with the anti-regulation position.

Tradition holds that scientific reports making supporting recommendations for public health matters speak with one voice for the appearance of unanimity for increased credibility with the public. It may no longer be practical, however, for large committees on controversial

  • 163 See supra note 160 at 127 (see Recommendation 1 etc.)

  • 164 Id. at 10

  • 165 Id at 4.

  • 166 See supra note 105 at vi. (―5. The List of Select Agents and Toxins should be reduced or stratified.‖)

  • 167 See supra note 160 at 5. (All parenthetical and bracketed material in original report, no additions were inserted.)

  • 168 Id at 8.

  • 169 Id.

  • 170 Id at 128.

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intersectoral issues to speak with one voice for the appearance of unanimity. The audience of reports on security enhancements should indeed have dissent opinions to enhance clarity and provide informed stakeholders with state-of-the-art options.

If the TFTF report had allowed for a dissenting opinion, the two sections might have been presented with greater clarity. In like manner, the minority opinions of members voiced at the public NSABB deliberations on PRPs could have possibly found an outlet in their report. It is unwise to protect stakeholders and policy makers from the contrast of opinions on matters of such importance. Rather, it is far better if lawmakers and the public know the full truth in clear and precise terms before trying to enact complex legislation.

5. Professor Greenberger’s Testimony, September 2009. In September of 2009, Michael Greenberger presented testimony before the Senate Committee on the Judiciary

Subcommittee on Terrorism and Homeland Security, titled ―Strengthening Security and Oversight at Biological Research Laboratories.‖ Greenberger is the founder and director of the

University of Maryland Center for Health and Homeland Security, as well as a professor at the University of Maryland School of Law. On the purpose of his testimony he said, ―It is the thesis of this testimony, that the nation can upgrade security measures at those biosafety level laboratories that handle the most dangerous pathogens, so that the federal government can

develop countermeasures to potential terror attacks without having that research in and of itself pose a threat to national security.‖ 171 He concluded his testimony by presenting a series of recommendations to improve security in laboratories that handle select agents. Some indicate that:

i. One federal agency should provide oversight for laboratories handling BSL-3 and BSL-4 labs. The CDC and APHIS are tasked with similar oversight responsibilities under the PHBPA; however, it is apparent that the CDC may be in a better position to enforce the Select Agent regulations as primary regulator.

ii. One federal agency, charged with oversight, should receive all reports of incidents of loss, theft, or misuse regarding BSL-3 and 4 labs, regardless of whether a Select or non-select Agent is involved.

iii. Each laboratory facility should be accredited to assure uniform standards for biosafety and biosecurity across institutions. Accreditation should require periodic review and assessment.

Biosecurity Commons Review, Annual Edition, May 2010

44

iv. 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.

v. All responses, whether affirmative or negative, to questions asking about past criminal conduct, substance abuse and mental illness should precipitate further inquiry through character references or discussion with the prospective employee.

vi. The accreditation process for employment should include assessment of certain personal characteristics 172 so long as further research on the reliability and practicality of assessing for these characteristics support its validity. 173

6. National Academy of Sciences, September 2009. Responsible Research With Biological Agents and Toxins.

In 2009, the National Academy of Sciences released a report called ―Responsible Research with Biological Select Agents and Toxins.‖ The report was written after hearing an assembly of

experts in various fields such as psychology, biosafety, bio-facility design, in addition to science and security. Select agent researchers were also represented in the report to consider the appropriate framework of laboratory security and personnel reliability measures that would allow researchers to elicit the most benefits from select agents, while diminishing the risk for potential misuse. 174 The report established six principles that should be used when determining regulations for BSAT research, and then continued to present a series of nine recommendations on what the committee believed would enhance the security of laboratory research. Some of the recommendations included:

i. Laboratory leadership and the Select Agent Program should encourage and support the implementation of programs and practices aimed at fostering a culture of trust and responsibility within BSAT entities. These

  • 172 Id. at 27 note 123. ―The optimal personnel characteristics are: no felony convictions, no domestic or international terrorist ties, no history of scientific or professional misconduct in the workplace, emotional stability and capacity for sound judgment, positive attitude toward safety and security measures, and standard operating procedures, and

free of vulnerability to coercion.‖ P. 27, note 123.

  • 173 Id. at 24-27.

  • 174 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, RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS,

Biosecurity Commons Review, Annual Edition, May 2010

45

programs and practices should be designed to minimize potential security and safety risks by identifying and responding to potential personal issues.

ii. To provide continued engagement of stakeholders in oversight of the Select Agent Program, a Biological Select Agent and Toxins Advisory Committee should be established.

iii. 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, with regulatory requirements and procedures calibrated against such stratification. Importantly, mechanisms for timely inclusion or removal of an agent or toxin from the list are necessary and should be developed.

iv. Because biological agents have an ability to replicate, accountability is best achieved by controlling access to archived stocks and working materials. A registered entity should record the identity of all biological select agents and toxins within that entity, where such materials are stored, who has access and when that access is available, and the intended use(s) of the materials.

v. The current Security Risk Assessment screening process should be maintained, but the appeal process should be expanded beyond the simple check for factual errors to include an opportunity to consider the circumstances surrounding otherwise disqualifying factors.

vi. The Select Agent Program should define minimum cross-agency physical security requirements, which recognize that facilities have unique risk-based security needs and associated design components, to assist facilities in meeting their regulatory obligations.

vii. Independent evaluation of the Select Agent Program should be undertaken to assess the relative benefits for achieving security, to consider the consequences of the program on the research enterprise, and to provide useful data about the Select Agent Program. Such evaluation should be provided with dedicated funding.

viii. 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

Biosecurity Commons Review, Annual Edition, May 2010

46

practice should be harmonized across federal, state, local, and other agencies. 175

7. Working Group by Executive Order (WGEO), October 2009. Report of the Working Group on Strengthening the Biosecurity of the United States.

The WGEO is a security centric report which repeatedly calls for recommendations that further enhance and strengthen biosecurity at the federal and local levels. 176 Recommendations included:

i. The refinement of the select agent list to enhance oversight and reduce confusion over the most dangerous pathogens. 177

ii. Improved vetting of U.S. citizens and foreign nationals. 178

iii. Continuous monitoring measures, i.e. (supervisor accountability, self- and peer-reporting) at the local level 179

iv. More frequent security screenings at 3 instead of 5 year intervals. 180

v. Random drug tests. 181

vi. Evaluate the feasibility of reporting derogatory information on physical and mental health to improve management oversight of individuals with BSAT access.‖ 182

The WGEO calls for a number of measures that increase oversight of labs and personnel working with select agents.

5. One Recommendation, Two Goals.

Despite differing orientations, the WGEO and the NSABB made the same recommendation to stratify or reduce the select agent list. 183 The context of the recommendation, however, was

  • 175 Id, at. 1-4

  • 176 See supra note 136 at 5.

  • 177 Id at 126.

  • 178 Id at 134.

  • 179 Id at 136.

  • 180 Id at 135.

  • 181 Id.

  • 182 Id at 37.

  • 183 Id at 4, ―The [select agent] list should be either reduced or stratified so that biosecurity measures can be more easily applied by the registered entities according to the level of risk.‖

Biosecurity Commons Review, Annual Edition, May 2010

47

very different, further demonstrating the differences between a security centric report meeting its charge and a dissent report. The desired outcome from stratifying or reducing the select agent list in the NSABB report was in support of reducing ―stringent controlsof government oversight, 184 i.e. no longer hindering vital research of less pathogenic agents. 185 In contrast, the WGEO argued for a reduction of the select agent list to reduce ―uncoordinated inspections with non-uniform standards, expectations, and interpretations.‖ 186 This is consistent with the intent of legislation proposed by Collins and Lieberman in 2009 which addresses the recommendations of the World at Risk Report. 187 The WGEO recommendation was intended to address the ―confusion regarding appropriate inventory records, formats, and requirements,‖ by registered entities. 188 Thus, the WGEO context is designed to cut loose unnecessary oversight to improve oversight over other pathogenic agents. The WGEO actually seeks to ―enhance U.S.

Government coordination of oversight and inspections…‖ 189 Substantive differences need to be distinguished from confusing nuances of the pen. The substance and rationale behind reports need to be evaluated for context as indicated by the subtle differences between the NSABB and the WGEO on a common recommendation.

6. Report Summaries. In sum, there were a number of leading recommendations on security enhancements from single agency oversight to the encouragement of a culture of security awareness. Other notable security enhancements included increased screening of foreigners, revision of the select agent list, increased background checks, drug & alcohol testing, among others. A tabular reference to some of the security enhancements encouraged or used is provided below.

See next page for Table 2.

  • 184 See supra note 105 at vi.

  • 185 Id.

  • 186 See supra 136 at 4.

  • 187 Graham, Bob, "Strengthening Security and Oversight at Biological Research Laboratories", testimony before the

Senate Committee on the Judiciary Subcommittee on Terrorism and Homeland Security on September 22, 2009, p.3. ―Stratifying the Select Agent list will allow us to focus increased security on genuine risks, and will allow public health-related research involving non-Tier I agents to proceed without excessive regulation.‖

  • 188 See supra note 135 at 4.

189 Id at

4.

Biosecurity Commons Review, Annual Edition, May 2010

48

Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness
Yes, Culture of awareness
Yes, Culture of
awareness
National Science (NSABB) 2009 Advisory Board
National Science
(NSABB) 2009
Advisory Board
Yes. “Strengthen screening” xxviii
Yes. “Strengthen screening” xxviii
Yes. “Strengthen
screening” xxviii
No, extant local only xxxiii
No, extant local only xxxiii
No, extant local
only xxxiii
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
No xxxv
No xxxv
No xxxv
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes-local option, no mandate by feds xxii
Yes-local option, no mandate by feds xxii
Yes-local option, no
mandate by feds xxii
Yes
Yes
Yes
No (implied) xiii
No (implied) xiii
No (implied) xiii
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant

Yes. Reduce or stratify Select Agent List xxxi

Yes. Reduce or stratify Select Agent List
No (implied) v
No (implied) v
No (implied) v

Yes. Periodic checks against federal

databases. ii

Yes. Periodic checks against federal databases.
No (Implied) ix
No (Implied) ix
No (Implied) ix
Only at BSL-3 and BSL-4 Labs xvii
Only at BSL-3 and BSL-4 Labs xvii
Only at BSL-3 and
BSL-4 Labs xvii
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
No xli
No xli
No xli
2009 of Sciences Report National Academy
2009
of Sciences Report
National Academy
Yes; mandatory drug test x
Yes; mandatory drug test x
Yes; mandatory
drug test x
Yes. Ethics training xxxix
Yes. Ethics training xxxix
Yes. Ethics
training xxxix
Yes xxiii
Yes xxiii
Yes xxiii
Stratify in risk groups… mechanisms for routine updating xxxii
Stratify in risk groups… mechanisms for routine updating xxxii
Stratify in risk
groups…
mechanisms for
routine updating xxxii
Yes, and database expansion is not needed iii
Yes, and database expansion is not needed iii
Yes, and database
expansion is not
needed iii
No vi
No vi
No vi
No xxxvi
No xxxvi
No xxxvi
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes (implied) xiv
Yes (implied) xiv
Yes (implied) xiv
Yes. Not just factual errors xlii
Yes. Not just factual errors xlii
Yes. Not just factual
errors
xlii
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes xl
Yes xl
Yes xl
Yes
Yes
Yes
Yes xxx
Yes xxx
Yes xxx
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes xix
Yes xix
Yes xix
Executive Order Working Group 2009
Executive Order
Working Group
2009
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes i
Yes i
Yes i
Yes xxi
Yes xxi
Yes xxi
Yes
Yes
Yes
Yes, initial & random viii
Yes, initial & random viii
Yes, initial &
random viii
Yes, SRA should be performed every 3 years xxv
Yes, SRA should be performed every 3 years xxv
Yes, SRA should be
performed every 3
years
xxv
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes xxvii
Yes xxvii
Yes xxvii
Yes xii
Yes xii
Yes xii
Yes, Training on Suitability Criteria xxxviii
Yes, Training on Suitability Criteria xxxviii
Yes, Training on
Suitability
Criteria xxxviii
Yes xvi
Yes xvi
Yes xvi
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes xxxvii
Yes xxxvii
Yes xxxvii
Yes (Implied) vii
Yes (Implied) vii
Yes (Implied) vii
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes xx
Yes xx
Yes xx

Yes. Initial & random xi

Yes. Initial & random
Yes (Implied) xv
Yes (Implied) xv
Yes (Implied) xv
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes xxiv
Yes xxiv
Yes xxiv
Yes iv
Yes iv
Yes iv
Yes
Yes
Yes
Yes xxxiv
Yes xxxiv
Yes xxxiv
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes xviii
Yes xviii
Yes xviii
Yes
Yes
Yes
Yes xxvi
Yes xxvi
Yes xxvi
Yes xxix
Yes xxix
Yes xxix

**BPRP

DoD 2006 *Instruction 5210.89

Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant

Control Select Agents by Personnel Access

Psychiatric Exam
Psychiatric Exam
Polygraph Exam
Polygraph Exam

PRP Measures should be Improved

Credit checks
Credit checks
Medical Record Evaluation
Medical Record
Evaluation

Increase Screening of Foreigners

Supervisor Monitoring

Allow appeal of adverse decision on merits

Security Check
Security Check
Peer Reporting
Peer Reporting
Background check
Background check
Revisit Select Agent Categorization
Revisit Select Agent
Categorization

Drug/Alcohol testing

Tabular Summary of Security Enhancement Options

SRA Re-evaluations
SRA Re-evaluations

Select Agent Control by Inventory Accounting

Soft Guidance
Soft Guidance
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant
Yes, Culture of awareness National Science (NSABB) 2009 Advisory Board Yes. “Strengthen screening” xxviii No, extant

Biosecurity Commons Review, Annual Edition, May 2010

49

6 Review of the 2009 Lab Security Report Process

Brian J. Gorman and Jennifer Kallal

  • 1. Introduction.

The concurrent production and release of multiple time-sensitive reports from high level committees certainly proves to be one of the more reliable flags of an important matter in public

policy. The fact that the White House and its offices were behind at least three of the reports on

lab security released in 2009 removes any doubt over the urgency of the matter.

The release of

multiple concurrent reports, however, provides a unique window into the process itself and a

more refined analysis of the work product produced by these committees.

For instance, a

number of questions arose from the 2009 lab security reports. The open issues include: the cause of this cluster of reports, the degree of inter-report variability, possible causes for significant divergence, and finally, the lessons learned from the committee process. This final article will address these points as a compliment to the findings in chapter 5 with additional analysis of the expert report enterprise for science related public policy. In addition, recommendations are made for improvements in the report writing protocols.

  • 2. Origins of the 2009 Cluster of Lab Security Reports.

The timeline below in Diagram 2 helps provide visual guidance on the origin of the reports under review. In the broadest sense, the events of 9/11 and the anthrax attacks, following soon thereafter, precipitated the pressure that slowly built up to the growing focus on the extant vulnerabilities in lab security. Within months of the anthrax attacks, clues were publicly available which pointed to possible lab security issues. 190 Otherwise, the 9/11 Commission report started the momentum which grew as other developments came such as the bipartisan World at Risk report that provided a warning about an imminent breach of biosecurity along with a pointed criticism at President Bush.

The first report initiated on lab security, however, was formally announced by HHS on October 4, 2007. It appears that an awareness of the course of the Amerithrax investigation in government circles might have inspired the impetus for the first committee on lab security issues known as the Trans-Federal Task Force (TFTF). Late 2008, however, proved to be a watershed period for lab security committees. The Executive started pressing for reports in earnest after Congressional interest, a terror plot involving lab infiltration in the UK, lab mishaps in Texas, 191

  • 190 David Johnston, William J. Broad , Anthrax in Mail was Newly Made, Investigators Say, N.Y. TIMES, June 23, 2002, at 1.

  • 191 Office of Public Affairs, University of Texas at Austin, Statement Concerning Laboratory Incident Review at The University of Texas at Austin, ―As a result of an inquiry from the National Institutes of Health (NIH) in spring 2007 The University of Texas at Austin began a systematic review of all reported laboratory incidents and adverse events

Biosecurity Commons Review, Annual Edition, May 2010

50

public concerns over possible mishaps at high-containment labs, 192 and the intensifying Amerithrax investigation.

See next page for Diagram 2.

from January 2000 to the present. The review found 13 incidents that occurred in University laboratories, including

five in a laboratory conducting research on Shigella bacteria in 2002-2007

In four cases laboratory workers

... required medical treatment for symptoms that developed subsequent to exposure to Shigella….In each case different laboratory workers and different laboratory events were deemed to have been the cause of the exposure.‖ September 18, 2007. Available at http://www.utexas.edu/news/2007/09/18/lab/ last checked April 24, 2010.

192 MacKenzie, Debora, "Experts Fear Escape of 1918 Flu from Lab ," New Scientist, October 21, 2004. Available at http://www.newscientist.com/article/dn6554-experts-fear-escape-of-1918-flu-from-lab.html.

Biosecurity Commons Review, Annual Edition, May 2010 51 December 2008 January 9, 2009 Executive Order 13486:
Biosecurity Commons Review, Annual Edition, May 2010
51
December 2008
January 9, 2009
Executive Order 13486:
July 22, 2004
9/11 Commission
Report Released
―World at Risk‖ released, A
Oct. 1, 2009 ―Report of the
Working Group on
Strengthening the Biosecurity
bi-partisan report states that
a biological or nuclear attack
likely within five years
―Strengthening Laboratory
Biosecurity in the United
States‖ -demands report on
bio labs
May 2009
AAAS Workshop Report
on Personnel Reliability
Released.
-Pro non-gov‘t
anonymous database for
exposures
-Pro status quo
of the United State‖ -Focus on
all high and max containment
labs.
Key Rec: Enhance SRA‘s by
vetting of U.S. citizens and
foreign nationals, continuous
monitoring via supervisor
accountability, self- and peer-
reporting for BSAT access
‘04
10/07
09/08
12/08
01/09
05/09
07/09
10/09
May 2009
NSABB Report:
October 4, 2007
HHS announced
formation of Trans-
Federal Task Force on
Optimizing Biosafety
and Biocontainment at
Congressional hearing
September, 2008
GAO Report finds
flaws with perimeter
security at BSL-4 labs
―Enhancing Personnel
Reliability‖
July 2009
Trans-Federal Task Force on
Optimizing Biosafety and
Biocontainment Report
Released. Focus: all high &
maximum containment labs

Personnel Reliability Reports Timeline

The initial findings of the NSABB revealed at the public meeting on Personnel Reliability in December 2008 offered some promise for the development of a security centric report consistent with its charge, yet there were indications that the committee was veering from its charge. The NSABB did initially indicate that concrete measures such as peer reporting are necessary, 193 but such glimpses of concrete security recommendations the U.S. Government was seeking, were tempered by anti-regulation rhetoric that eventually flourished in the final report. The early rhetoric spoke of ―unduly encumber[ing] the conduct of science,‖ the benefits of science, the need for awareness of surroundings, awareness of self, and a culture of responsibility and watchful trust, not distrust of personnel working with select agents. 194 These musings and admonitions are certainly important and necessary to keep in mind while formulating security enhancements, but the excessive hand-wringing on the woes of too much security did little to meet the given charge. A question remains, however, on whether or not the Executive urged

The initial findings of the NSABB revealed at the public meeting on Personnel Reliability in Decemberhttp://oba.od.nih.gov/biosecurity/meetings/200812/NSABB%20Public%20Mtg%20121008%20-%20Kasper.pdf . last checked April 25, 2010. Id . See supra note 174 at viii. See supra note 128 available at http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html#dec2008 Last checked April 25, 2010. " id="pdf-obj-51-12" src="pdf-obj-51-12.jpg">

more reports on lab security four months into the NSABB‘s deliberations and after its first public

meeting because it was concerned with the early signs of the orientation of the committee.

Within weeks of NSABB‘s public meeting on December 10, 2008 and the release of the World at Risk report, President Bush issued an Executive Order for the creation of a Working Group to likewise address personnel reliability within 180 days. The National Academy of Sciences was also apparently charged with looking into personnel reliability issues with a time constraint of just three and a half months, 195 in that same window of growing pressure, as well. Diane DiEuliis, of the Executive‘s Office of Science and Technology Policy noted the Executive‘s sudden request for multiple concurrent reports as a desire to hear from the community. 196 The desire to hear from the breadth of the community was certainly achieved in the sense that over 359 professionals participated in these committees as official observers, members, or presenters. The reach of the community, however, was not perhaps as broad as one would think because there was significant overlap of committee participation. In fact, upwards of 18% of the personnel had some sort of participation in two or more committees. A very small fraction (.04%) of these experts had no less than treble duty with these committees. (See Table 3)

  • 193 Kasper, Dennis, NSABB Working Group on Personnel Reliability: Preliminary Findings and Recommendations, Report to NSABB, Slide 8, December 10, 2008. Available at

last checked April 25, 2010.

Biosecurity Commons Review, Annual Edition, May 2010

53

Table 3.

Expert

Affiliation

NSABB

NAS

Trans-Fed

WGEO

AAAS

CongTst

DOD Rpt

Bane

HHS

   

Member

Member

     

Barnes

HHS

   

Member

Member

     

Beardsley

FBI/DoJ

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Berke

HHS

   

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Blose

DoD

     

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NIST/DoC

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Bondurant

DoD

     

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Site Visit

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HHS

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Burnett

Vanderbilt

 

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Butera

DoS

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Cohen, M.

Frntln Fndn

Voting Mmbr

     

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SubGrp

     

Cole

DoD

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Cullen

HHS

     

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Divan

USDA

   

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Dixon

HHS/NIH

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