Bio Security Commons AR May 2010

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
Biosecurity Commons Review, Annual Edition, May 2010 2
--With a debt of gratitude to many friends and colleagues in the public and private sectors–
likewise 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

CONTENTS
EXECUTIVE SUMMARY
4
INTRODUCTION
6
CHAPTER ONE
The Swine Flu Scare of 2009
Brian J. Gorman
7
CHAPTER TWO
Global Pandemic and Asset Allocation
Brian J. Gorman and Jennifer Kallal
16
CHAPTER THREE
Biosurveillance
Brian J. Gorman and Alex Cardenas
21
CHAPTER FOUR
The 2009 Emergency Declaration for Influenza
Brian J. Gorman, Jennifer Kallal, and Michael Carnucci
26
CHAPTER FIVE
Risk & Reliability of Laboratory Personnel
Brian J. Gorman and J. Corey Creek
28
CHAPTER SIX
Review of the 2009 Lab Security Report Process
49
APPENDIX
58
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.
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
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).
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.
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 20092 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."
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 vaccine6 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."
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
15
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
See supra note 3 at A1. "...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.‖
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 2019–2026.
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.
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
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
http://www.independent.co.uk/news/world/americas/mexicos-epidemiology-boss-faults-who-1677396.htm.
35
Anastasia Moloney, Questions Raised Over Response To Influenza A Outbreak, THE LANCET, (May 9, 2009), at
1591.
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.
37
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.
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 vaccinations—a 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, 200946 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
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.
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
54
Id.
2 Global Pandemic and Asset Allocation

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 expectations—it 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
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 rate—which 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.
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.
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 benefit‖
strategies 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).
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 1133–1142.
60
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) 5184–5186.
64
Associated Press, U.S. to Share Vaccine, Obama Says" N.Y. TIMES, Sept. 18, 2009 at A22.
65
See supra note5 at A15.
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
14th 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 21st 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
http://www.cdc.gov/ncphi/disss/nndss/nndsshis.htm. Last checked 3/7/10. ―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).
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.
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.
82
Id. .
83
Id.
84
Id..
85
Id.
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.
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.
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.
100
FluView: 2008-2009 Influenza Season Week 29 ending July 25, 2009, CDC. Last updated July 31, 2009.
101
FluView: 2008-2009 Influenza Season Week 38 ending September 26, 2009, CDC, Available at
http://www.cdc.gov/flu/weekly/weeklyarchives2008-2009/weekly38.htm. Last checked April 29, 2010.
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
4/26/09: First Public Health

Emergency due to H1N1
determined by Acting HHS 25,925 positive
Secretary Charles E. Johnson flu specimens
HHS PHE (type A & B) YTD
disregarded as of 4/18/09
by President CDC
Obama
On June 11, the World Health
Organization raised the pandemic
7/24/09: Second Public Health alert level from Phase 5 to Phase 6
Emergency due to H1N1 indicating that an influenza
determined by HHS Secretary pandemic was underway. CDC
Kathleen Sebelius
29,019 positive
flu specimens
Obama responds to (type A & B) YTD
notice of PHE from HHS as of 7/25/09
by invoking National CDC
Emergencies Act 10/24
36,999 positive flu

specimens (type A &
10/1/09: Third Public Health B) YTD as of 9/26/09
Emergency due to H1N1 Permits use of
determined by HHS Secretary emergency operation *Pneumonia and
Kathleen Sebelius plans at U.S. health influenza deaths
care facilities in below the epidemic
response to H1N1 threshold.
epidemicEnables U.S.
health care facilities CDC
permit
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
http://oba.od.nih.gov/biosecurity/meetings/200905T/NSABB%20Final%20Report%20on%20PR%205-29-09.pdf.
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
(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
112
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.
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.
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
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.
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 ―dissent‖
report was only a fraction of the Board‘s activities, but was nonetheless supported with
124
See discussions on PRP‘s by voting NSABB committee members: (Dec. 10, 2008) avaliable at
http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html#dec2008; (April 3, 2009) available at
http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html#apr2009, last checked April 23, 2010.
125
See NSABB Meeting Webcast, at approximately hour 3, Dec. 2008. Available at
http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html#dec2008. Last checked April 23, 2010.
126
See supra note 105 at ii.
127
Michael Leavitt, National Science Advisory Board for Biosecurity Charter Renewal, Health and Human Services,
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.‖
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.

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 Initiative128 2008129 OVERSIGHT
BIOSECURITY Reliability …
May 2009 AMER. ASSOC/ Biological Self- March 17, PROTEST LOCAL
FOR THE Safety Training initiated 2009130 OVERSIGHT
ADVANCEMENT Programs …
OF SCIENCE
May 2009 DEPARTMENT Report of the Internal six week SECURITY FEDERAL
OF DEFENSE Defense Science Review study131 CENTRIC OVERSIGHT*
132
Board Task
Force …
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 2009 CENTRIC OVERSIGHT
Reliability
September THE NATIONAL Responsible Executive Jan+/- SECURITY UNIVERSAL
2009 ACADEMY OF Research w/ Initiative133 2009 CENTRIC COORDINATED
SCIENCES Biological … OVERSIGHT134
October VAR. FEDERAL Rpt of the Wk Exec. Order January SECURITY FEDERAL
2009 OFFICIALS Grp on Following 2009 CENTRIC OVERSIGHT136
Strengthening Graham Rrt
the Biosecurity Guidance135
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
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.
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.
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
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
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.‖)
152
153
American Association for the Advancement of Science, ― Report Warns that New Lab Security Measures Could
Undercut Biological Research‖ available at
http://www.aaas.org/news/releases/2009/0529high_containment_labs.shtml. Last checked May 2, 2010.
154
See supra note 130, available at http://cstsp.aaas.org/content.html?contentid=2049. Last checked May 2, 2010.
155
Id.
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
157
Id at 2.
158
Id at X.
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.
160
Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight (2009) available
at http://www.hhs.gov/aspr/omsph/biosafetytaskforce/biosafetycontainmentrpt092009.pdf last checked May 2, 2010.
at 5. (―The issues of biosecurity and personnel reliability, although related to laboratory biosafety and
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
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.
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.
171
Supra note 113 at 2.
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 characteristics172 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,
(2009) at 1.
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
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 level179
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
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.‖
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 controls‖ of 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
189
Id at 4.
Tabular Summary of Executive Order National Science National Academy DoD 2006
Security Enhancement Working Group Advisory Board of Sciences Report *Instruction 5210.89
Options 2009 (NSABB) 2009 2009 **BPRP
i iv
Background check Yes Yes. Periodic checks Yes, and database Yes
against federal expansion is not
ii iii
databases. needed
v vi vii
Polygraph Exam No (implied) No Yes (Implied)
ix xi
Drug/Alcohol testing Yes, initial & No (Implied) Yes; mandatory Yes. Initial & random
viii x
random drug test
xii xiii xiv xv
Psychiatric Exam Yes No (implied) Yes (implied) Yes (Implied)
xvi xviii
Medical Record Yes Only at BSL-3 and Yes
xvii
Evaluation BSL-4 Labs
xix xx
Supervisor Monitoring Yes Yes
xxi xxiii xxiv
Peer Reporting Yes Yes-local option, no Yes Yes
xxii
mandate by feds
xxvi
SRA Re-evaluations Yes, SRA should be Yes
performed every 3
xxv
years
xxvii xxix
Increase Screening of Yes Yes. “Strengthen Yes
xxviii
Foreigners screening”
xxx
Revisit Select Agent Yes Yes. Reduce or Stratify in risk
Categorization stratify Select Agent groups…
xxxi
List mechanisms for
xxxii
routine updating
xxxiv
Security Check No, extant local Yes
xxxiii
only
xxxv xxxvi xxxvii
Credit checks No No Yes
Soft Guidance Yes, Training on Yes, Culture of Yes. Ethics

xxxix
Suitability awareness training
xxxviii
Criteria
xl
Control Select Agents by Yes Yes
Personnel Access
xli
Select Agent Control by No
Inventory Accounting
Allow appeal of adverse Yes. Not just factual

xlii
decision on merits errors
PRP Measures should be Yes Yes Yes Yes

Improved
6 Review of the 2009 Lab Security Report Process

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
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.
January 9, 2009 Oct. 1, 2009 ―Report of the
December 2008 Executive Order 13486: Working Group on
July 22, 2004
―World at Risk‖ released, A ―Strengthening Laboratory Strengthening the Biosecurity
9/11 Commission
bi-partisan report states that Biosecurity in the United of the United State‖ -Focus on
Report Released
a biological or nuclear attack States‖ -demands report on all high and max containment
likely within five years bio labs labs.
Key Rec: Enhance SRA‘s by
vetting of U.S. citizens and
May 2009
foreign nationals, continuous
AAAS Workshop Report
monitoring via supervisor
on Personnel Reliability
accountability, self- and peer-
Released. reporting for BSAT access
-Pro non-gov‘t
anonymous database for
exposures
-Pro status quo
‘04 10/07 09/08 12/08 01/09 05/09 07/09 10/09
May 2009
NSABB Report:
―Enhancing Personnel
October 4, 2007
September, 2008 Reliability‖
HHS announced
GAO Report finds
formation of Trans-
flaws with perimeter
Federal Task Force on
security at BSL-4 labs
Optimizing Biosafety
and Biocontainment at
Congressional hearing
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
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
http://oba.od.nih.gov/biosecurity/meetings/200812/NSABB%20Public%20Mtg%20121008%20-%20Kasper.pdf.
last checked April 25, 2010.
194
Id.
195
See supra note 174 at viii.
196
See supra note 128 available at http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html#dec2008 Last
checked April 25, 2010.
Table 3.
Expert Affiliation NSABB NAS Trans-Fed WGEO AAAS CongTst DOD Rpt
Bane HHS Member Member
Barnes HHS Member Member
Beardsley FBI/DoJ N/V ex off Member
Berke HHS Member Member
Blose DoD Member Presenter
Boehm NIST/DoC N/V ex off Member
Bondurant DoD Member Site Visit
Bonham HHS N/V Fed. Rep. Member
Burnett Vanderbilt Speaker Member
Butera DoS N/V Fed. Rep. Member
Cohen, M. Frntln Fndn Voting Mmbr Speaker
SubGrp
Cole DoD N/V Fed. Rep. Chair
Cullen HHS Member Site Visit
Divan USDA Member Member
Dixon HHS/NIH N/V Fed. Rep. Member
Edwards HHS/CDC Member Site Visit
Firko USDA Member Member
Franz Midw Res Inst Voting Mmbr Member
Frasca HHS Member Member
Gard DoE Presenter Member
George DHS N/V ex off Member
Greenbaum DHS Member Member
Groesch HHS/NIH Staff Member Member
Hall DHS N/V Fed. Rep. Member Member
Hawley Midw Res. Inst Member Member
Henkel HHS/CDC Member Speaker
Holt HHS/CDC Member Member
Humpton DoD Presenter Presenter
Isaac USDA Member Member
Co-Exec
Jones DoD Member Sec. Exec. Sec
Jones-Meehan DHS Member Member
Jutro EPA N/V ex off Member
Kappes USDA Chair Speaker
Kerr ODNI N/V Fed. Rep. Member
Kozlovac USDA N/V Fed. Rep. Site Visit Member Member Member
Co-Exec
Kwinn HHS Member Sec.
Lawrence HHS N/V Fed. Rep. Member Member
Linden HHS N/V Fed. Rep. Speaker Member Co-Chair
Lushniak HHS/FDA N/V ex off Member
Mazanec HHS N/V ex off Chair

Metzger CIMD Panelist Speaker
Morse HHS/CDC Member Member
Nazario DoS Member Member
Nicholson HHS/CDC N/V ex off Member Member
Pasco DHS Member Tstmny
Patterson, A. HHS/NIH Exec. Director Member Member
Patterson, J. SFBR Member Site Visit
Perkins HHS N/V Fed. Rep. Member Member Member
Petro HSC N/V Fed. Rep. Speaker
Reed DoD Co-Chair Tstmny
Rice USDA Member Member
Sanders HHS/CDC Member Member Site Visit
Shipp HHS/NIH Staff Member
Shoemaker USAMRIID Member Site Visit
Skvorak USAMRIID Speaker Site Visit
Thomassen DoE N/V ex off Member Member
Tucker HHS Member Member
Vandegrift FBI/DoJ N/V Fed. Rep. Member
Walz DoD Member Presenter
SubGrp
Weyant HHS/CDC N/V Fed. Rep. Speaker Member Chair Site Visit
Wilson HHS/NIH Member Member Site Visit
Wirth DHS Member Member
Worsham DoD Member Site Visit
You FBI/DoJ N/V ex off Member
3. Diversity of Influence and Expertise.
The cluster of lab security reports provides an opportunity to compare and examine some
qualitative aspects of the committee process. Prof. Spencer Overton argued that the
independence and quality of an advisory committee could be judged by a number of factors
including whether or not the committee relied on as many top experts as possible, including
contrary opinions.197 Further inquiry of committee involvement by affiliation revealed that the
overlapping expertise was derived primarily from government expertise. Thus, a breakdown of
agency affiliation of overlapping participants was provided in Diagram 3. The results indicate
that HHS affiliated experts had the greatest number of overlapping participation with 25
197
See Spencer Overton, Establishing Procedures for Credible Advisory Commissions, ―A well-functioning
independent commission should hear testimony from as many of the top experts as possible, including contrary
opinions on all matters under review.‖ Available at http://www.carterbakerdissent.com/procedure.php last checked
April 25, 2010.
individuals, DoD followed at a distant second with 8 overlapping employees. There were 13
individuals connected to 3 or more committees, 2 individuals connected to 4 committees, and 2
individuals connected to 5 committees. A review of agency representation of overlapping
members is provided since they arguably have greater influence on the process than others. The
results of the distribution from 2009 reports, however, indicates that there was arguably a fair
balance of experts from security oriented agencies and those from agencies with a scientifically
based culture. (See Diagram 3.)
Agency Distribution of Overlapping Committee Personnel

30 25
25
20
15
10 8 8
6 6
5 2 2 2 2 3
0
4. Reforming Report Protocol: Authoritative v. Informed Choice Models.
It was argued in Chapter 5 that a new paradigm for biosecurity committee reports is
warranted. Reports from committees with a broad base of expertise should provide truly
unanimous or majority with dissenting opinions from their deliberations. The traditional model,
which only shares a single view, silences the minority opinion and is a disservice to sophisticated
stakeholders in the information society. This practice is especially inappropriate when the report
is charged to inform those making policy and drafting laws. The result of withholding dissenting
opinions or the full range of options functionally substitutes committee judgment for that of the
lawmakers, since they are deprived of the full breadth of options.
Members of the executive and legislative branches should be given all of the facts and tools
necessary to make informed decisions, especially when it comes to complex intersectoral
security matters. While the opportunity for a dissenting opinion in the NSABB report would
have proven beneficial, the option would have been especially helpful in other reports such as the
NAS, WGEO, and TFTF since they had voting members from more diverse backgrounds.
A. Precedent for the Dissent Model.
1. The Judicial Model. One need not look further than the judicial system for a storied
and successful use of dissent within reports. Legal doctrine, like matters of public policy,
evolves over time. Thus legal opinions are designed to address the immediate issue with the
majority opinion, but also help future deliberations through the public preservation of the
dissenting opinion. Dissenting opinions are invaluable resources even though they are not the
law. Dissenting opinions help provide context for the majority opinion, insights for other matters
in need of guidance, and can actually be the basis of a future reversals or revisions. The
paradigm is a hallmark of the judicial system and would prove beneficial for reports informing
public policy for the scientific community.
2. Precedent from the Carter-Baker Commission. Reports informing lawmakers on

controversial public policy matters have already begun to offer dissenting opinions. The Carter-
Baker report on election reform serves as a model because it provided main findings and yet
provided opportunities for dissenting opinions by members on various points raised in the report.
An outlet such as this provides a voice for contrary opinions and also provides additional insights
into the majority through the ability to judge the quality of the arguments made by the dissenting
members. There was, however, at least one criticism of the dissent model used in the Carter-
Baker report. Prof. Spencer Overton argued that the 250 word limit for dissenting opinions in
that report was inadequate.198
3. Back-Channel Dissent. Continued reliance on the one-voice majority model is

likely to backfire so long as committees are diverse and the information society provides a venue
for dissenting opinions. A recent case in point can be found in recent deliberations from a
committee which has a unique and good reason to speak with one voice. The Business Cycle
Data Committee makes declarations on the official dates of the nation‘s business cycles. Thus,
the committee decides when events like recessions begin and end--decisions uniquely suited to
one voice for public consumption. But even this group, which defines black and white lines for
society, recently experienced a leak from its private deliberations from a lone dissenter of this
very small club. Robert J. Gordon leaked his dissenting opinion to the press which holds that the
financial recession ended last June as opposed to other times the majority of the committee was
apparently leaning toward. 199 This public dissent is consistent with other dissenters who have
leaked opinions due to a sense of legacy or a perceived moral duty.200 The 2009 reports on lab
security provided sufficient expert consensus to lawmakers for the next steps in lab security. It is
hoped, however, that biosecurity committees provide dissenting opinions from their committees
198
See Spencer Overton, ―Establishing Procedures for Credible Advisory Commissions,‖ at
http://www.carterbakerdissent.com/procedure.php last checked April 25, 2010.
199
Sewell Chan, A Dissenter on the Recession Committee, N.Y. TIMES, April 13, 2010 at B2. ‖Robert J. Gordon,
recent dissent on the Business Cycle Data Committee, which officially dates the nation‘s business cycles, broke
from protocol and made a rare public dissent arguing that the recession ended last June. The Committee as a whole,
however, was reluctant to make that announcement unless there were absolutely sure according to Mr. Gordon.‖
200
See Brian J. Gorman, Biosecurity and Secrecy Policy: Problems, Theory and a Call for Executive Action,
I/S: A JOURNAL OF LAW & SOCIETY FOR THE INFORMATION SOCIETY, (Winter 2006), ―There appears to be at least
six well established causes for leaks: (1) mistake, (2) political gain, (3) financial gain, (4) foreign loyalty, (5)
morality, and (6) personal legacy.‖ at 90. Available at http://www.tcf.org/list.asp?type=PB&pubid=554.
for all to view. The expression of these opinions will no doubt prove valuable to lawmakers and
stakeholders alike.
Appendix A
Assistant Editor
Jennifer Kallal
Researchers 2009-2010 Term
Alexander Cardenas
Michael Carnucci
Benjamin P. Chapple
J. Corey Creek
Jennifer Kallal
Kelly Kaltenbacher
Megan Marcucci
Michael Notzon
Andrew Pape
Kate Spano 
Lauren Riedy
Key:
Spring 2009: 
Summer 2009: 
Fall 2009: 
Spring 2010: 
Appendix B
End Notes for ―The Tabular Summary of Security Enhancement Options‖
i
ii
iii
iv
United States Department of Defense, "Instruction Number 5210.89- Minimum Security Standards for
Safeguarding Biological Select Agents and Toxins", April 18, 2006, p.14.
v
See supra note 105 at.8.
vi
See supra note 174 at 75-76
vii
See supra note iv at14.
viii
ix
x
xi
See supra note iv at 24.
xii
xiii
xiv
xv
xvi
See, supra note 136 at 135.
xvii
xviii
xix
xx
xxi
xxii
xxiii
xxiv
xxv
xxvi
xxvii
xxviii
xxix
xxx
xxxi
xxxii
xxxiii
xxxiv
xxxv
xxxvi
xxxvii
xxxviii
xxxix
xl
Id. at 102.
xli
Id. at 100.
xlii
Id. at71.

Bio Security Commons AR May 2010

Uploaded by

Copyright:

Available Formats

Bio Security Commons AR May 2010

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Bio Security Commons AR May 2010

Uploaded by

Copyright:

Available Formats

BIOSECURITY COMMONS REVIEW

© Biosecurity Commons 2010

nation, are not prepared.1

-A succinct status brief of topical areas in biosecurity,

1 The Swine Flu Scare of 2009

2. Pharmaceuticals and Pandemic.

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

instrument, as well as any health measure implemented in response

A. Mandatory Vaccinations. Mandatory vaccination programs requiring flu vaccinations

B. Public Participation in Vaccination Programs. Anecdotal evidence points to the

2 Global Pandemic and Asset Allocation

2. Private Sector Prophylaxis Supply.

As identified supra in Chapter 1 at 2.B., under, ―Breach of Contract –A Dangerous

A. Government Prophylaxis Production. A feasibility study may be warranted to

3. Global Harmonization of Pandemic Response Efforts.

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

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

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

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

A. Public Health Security by Maintaining the Strength of Global Partners. There is

Without implementing dual benefit strategies to assist global partners in developing

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

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

Department of Homeland Security (DHS) officials defined biosurveillance as many

2. National Biosurveillance Integration Center.

It currently takes between 10 and 34 hours to analyze collection filters in laboratories,

The importance of a rapid response to an anthrax attack was reaffirmed by a recent

3. ESSENCE I & II.

4 The 2009 Emergency Declaration for Influenza

1. Public Health Emergency Declaration.

A. Determinations and Declarations. President Obama‘s declaration of a national

See next page for Diagram 1.

H1N1 Emergency Declaration of 2009:

4/26/09: First Public Health

36,999 positive flu

5 Risk & Reliability of Laboratory Personnel

The promulgation of additional reliability measures could serve as a powerful

See next page for Table 1.

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

A. Sum and Substance of the Lab Security Reports.

1. NSABB, May 2009. Enhancing Personnel Reliability among Individuals with

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

ii. Local institutions were already effective at screening individuals

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

v. Psychological tests are extremely resource-intensive and lack

ii. Inclusion of domestic terrorism under SRA criteria, and

iii. Strengthened screening of foreign nationals. 150

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

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

3. Department of Defense, May 2009. Report of the Defense Science Board

Other findings were that:

i. DoD regulations exceed those imposed by the Center for Disease

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

iii. The isolated computer system could represent a serious vulnerability

iv. Detection of an insider threat is difficult even with extensive

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

5. Professor Greenberger’s Testimony, September 2009. In September of 2009,

i. One federal agency should provide oversight for laboratories handling

iii. Each laboratory facility should be accredited to assure uniform

iv. The informal practice of checking the names of individuals with