Technology Review

Biosecurity: Progress and Challenges

Jennifer Gaudioso,* Lisa Astuto Gribble, and Reynolds M. Salerno
International Biological Threat Reduction, Sandia National Laboratories
Albuquerque, NM

ioscience facilities are essential to the efforts to (accidental) and biosecurity (deliberate) risks.
Keywords:
biosecurity,
B combat both naturally occurring infectious diseases
and bioterrorism. But both the general public and policy
Recent high-profile biosafety breaches include the
laboratory-acquired infections of Severe Acute Respi-
biosafety, makers are questioning how bioscience institutions ratory Syndrome (SARS)1 and the foot-and-mouth
biorisk, disease outbreak in the United Kingdom.2 The an-
address the safety and security risks of handling infectious
bioterrorism thrax attacks of 2001 are the most well-known exam-
disease causing organisms. As a result, new regulations at
ple of a breach in laboratory biosecurity; in that case,
the national level in many countries and international authorities believe that the perpetrator of the attack
initiatives from the United Nations, World Health stole the anthrax bacteria from the U.S. government
Organization, and others are having direct consequences laboratory where he worked as a leading scientist.3
for the operation of bioscience. In particular, laboratory These examples explain why policy makers and the
biosecurity is a relatively new and evolving paradigm for public are increasingly scrutinizing how bioscience
bioscience facilities, which have an obligation to ensure laboratories manage the safety and security of their
their facilities operate safely and securely. However, operations.
although progress has been made in these areas, According to the World Health Organization
numerous challenges remain throughout the world, and (WHO), laboratory biosafety is the term used to
much work remains. It is the responsibility of both the describe the containment principles, technologies,
and practices that are implemented to prevent unin-
scientific community and policy makers to work
tentional exposure to pathogens and toxins, or their
collaboratively to ensure responsible use of pathogens and
accidental release, and laboratory biosecurity is
toxins, equipment, and expertise. ( JALA 2009;14:141–7) the institutional and personal security measures
designed to prevent the loss, theft, misuse, diversion,
or intentional release of pathogens and toxins.4 Lab-
INTRODUCTION oratory biosecurity is more than simply physical se-
curity; it also includes personnel management,
Bioscience facilities face increased responsibilities material control and accountability, information
for managing the risks associated with pathogens security, transport security, and program manage-
and toxins. These biorisks comprise both biosafety ment.5 A failure in either laboratory biosafety or
biosecurity may affect the staff, community, and
SAND No. 2009-0421J. Sandia is a multiprogram laboratory
operated by Sandia Corporation, a Lockheed Martin Company,
environment, and may jeopardize the institution’s
for the U.S. Department of Energy’s National Nuclear Security operations.
Administration under Contract DE-AC04-94AL85000. Although bioscience facilities that use pathogens
*Correspondence: Jennifer Gaudioso, Ph.D., International Biological and toxins must devote the necessary attention to
Threat Reduction, Sandia National Laboratories, Albuquerque,
NM 87111; Phone: þ1.505.284.9489; Fax: þ1.505.284.0609;
managing laboratory biorisks, biosafety and biose-
E-mail: [email protected] curity must be instituted in a balanced manner that
1535-5535/$36.00 preserves and supports an environment for legiti-
Copyright c
 2009 by The Association for Laboratory Automation mate and lifesaving microbiological research, diag-
doi:10.1016/j.jala.2009.01.001 nosis, and disease control activities. Pathogens and

JALA June 2009 141

Technology Review

toxins are required in an array of activities, such as basic and

applied research, education, quality control, pharmaceutical
research and development, manufacturing, and food produc-
tion. This paper aims to give readers an overview of the
evolving norms for biosafety, and, especially, the dynamic
field of biosecurity. The overview provides a foundation for
an examination of significant biosecurity challenges that pol-
icy makers and bioscience institutions face in the coming
years and demonstrates the need for partnerships between
the technical and policy communities to address these
challenges.
Although only in its infancy, biosecurity is already ex-
panding beyond the control of pathogens and toxins to also
address legitimate equipment and expertise that could be
misused to construct a biological weapon or to conduct bio-
terrorism. Controlling ‘‘dual-use’’ equipment and knowledge
in a manner that does not unduly jeopardize the science is
extremely difficult, because user intent is often the only
distinguishing factor between illegitimate and legitimate
applications. Unfortunately, this is not simply an academic
concern; although biological weapons are banned by interna-
tional law, there is a long history of interest in and develop-
ment of biological weapons by both state and nonstate
actors.
Figure 1. Many new domestic and international biosafety and bi-
osecurity regulations, guidelines, initiatives, and legislation have
CURRENT BIOSECURITY SITUATION IN THE UNITED successfully helped to mitigate the risks associated with pathogen
STATES AND INTERNATIONALLY
research conducted in bioscience facilities around the world.
Laboratory biosafety and biosecurity are now fundamental 1a. A US Center for Disease Control’s (CDC) researcher is fol-
components of bioscience laboratory operations. They are lowing good laboratory practices pipetting specimens in a biosafety
based on many common principles, but biosafety is the more cabinet of a Biosafety Level 3-enhanced laboratory in Atlanta, GA.
well-established discipline. Figure 1 shows examples of good 1b. A well-designed Argentinean laboratory was constructed in
biosafety. The first WHO Laboratory Biosafety Manual was 2008 using technical guidance provided by the US Biosafety in Mi-
published in 1983, but the initial WHO guidance on labora- crobiological and Biomedical Laboratories (BMBL) manual, WHO
tory biosecurity was only released in 2006.6 Likewise, Laboratory Biosecurity Guidance Manual, and the WHO Labora-
Biosafety in Microbiological and Biomedical Laboratories,7 tory Biosafety Manual, among others.
the seminal biosafety guidance in the United States, was first
issued in 1984, but only the fifth edition in 2007 included approach,11 with regulatory requirements for security based
a section on the principles of biosecurity. on schedules of pathogens and toxins. For example, Singa-
Another key difference in the United States and elsewhere is pore,12 Japan,13 South Korea,14 and Denmark15 have all re-
that biosecurity currently tends to be implemented through cently implemented biosecurity legislation, with specific lists
regulatory requirements, while the implementation of bio- of pathogens and toxins subject to controls. These exemplar
safety is primarily driven by worker safety, best practices, national laws and regulations are important steps in securing
and guidance. For example, over the last decade, the U.S. gov- dangerous pathogens and toxins worldwide, but they are only
ernment enacted extensive biosecurity legislation,8 including first steps. Many countries have yet to adopt laws specific to
criminal and civil penalties, giving the U.S. Department of laboratory biosafety or biosecurity. Furthermore, some of
Health and Human Services and the U.S. Department of Ag- the countries that have developed biosecurity regulations to
riculture regulatory authority to establish controls on the pos- date focus only on pathogens and toxins that impact human
session, use, and transfer of select biological agents (‘‘select health, neglecting those that can impact animal and plant
agents’’), and all U.S. bioscience institutions that possess those health (e.g., Japan and Demark). Agricultural facilities also
agents must be in compliance. Other U.S. federal agencies regularly handle zoonotic pathogens and toxins. It is crucial
have their own regulations for the distribution of infectious that any biosecurity regulatory framework be extended to
materials, including the export control regulations of the all institutions with materials of concern, including those in
Department of Commerce9 and the Department of State.10 the health, agricultural, academic, and private sectors.
Not many countries have implemented biosecurity regula- Although national regulations are critical to enhancing
tions yet, but those that have typically take a similar biosecurity, the bioscience community needs to adjust to

142 JALA June 2009

 Technology Review

this security paradigm because regulations impact day-to- introduced, for the first time, laboratory biosecurity. Other
day laboratory operations. Once regulations are enacted, influential WHO documents include Biorisk management:
laboratories typically must receive government approval Laboratory Biosecurity Guidance,17 which promotes the
to possess the listed pathogens and toxins, and to ship protection and control of laboratory biological materials to
specimens to collaborating institutions. Laboratories will prevent intentional misuse, and the Guidance on Regulations
need to comply with specific detailed requirements for re- for the Transport of Infectious Substances.18
cord keeping and may be subject to inspections. The bio- In 2007, the Organization for Economic Cooperation and
science community has not previously faced government Development (OECD) published the OECD Best Practice
oversight that limits where work is conducted or who does Guidelines for Biological Resource Centers.19 This compre-
the work. hensive report describes a rationale for establishing a global
network for biological resource centers (BRCs), and contains
RECENT INTERNATIONAL BIOSECURITY INITIATIVES four sets of best practice guidelines, including the Best Prac-
tice Guidelines on Biosecurity for BRCs. Other organizations,
Realization of the threat of bioterrorism and biocrime has such as the World Organization for Animal Health, have
prompted many international and national initiatives on lab- also recently published guidelines that endorse good bio-
oratory biosafety and biosecurity beyond regulations. Inter- safety and biosecurity practices in laboratory environments.
national agreements, including the Biological and Toxins Three of the most important include The Terrestrial Animal
Weapons Convention16 (BWC) and United Nations Security Health Code (2007), Manual of Diagnostic Tests and Vac-
Council Resolution 1540 (UNSCR 1540), compel countries cines for Terrestrial Animals (2004), and Quality Standard
to strengthen their implementation of biosecurity. Since the and Guidelines for Veterinary Laboratories: infectious diseases
2003 Experts Group Meeting of the BWC, much attention (2008).20 All of these publications are available online, and
has been devoted by the international community to raising have been translated into multiple languages.
awareness about the importance of laboratory biosecurity These international initiatives are designed to strengthen
for bioscience laboratories. the implementation of biosafety and biosecurity at the labora-
On 28 April 2004, the United Nations Security Council tory level. In particular, UNSCR 1540 should compel more
unanimously passed UNSCR 1540, which established, for countries to enact national legislation that addresses biosecur-
the first time, binding obligations on all UN member states ity. And the guidance from WHO and other international
under Chapter VII of the UN Charter, to take and enforce organizations should help establish a new international norm,
effective measures against the proliferation of weapons setting the expectation that laboratories will implement needed
of mass destruction, their means of delivery, and related changes to ensure that pathogens and toxins are handled safely
materials. One way that countries can demonstrate their and securely.
compliance with UNSCR 1540 is through the implementa-
tion of laboratory biosecurity measures that secure biological LOOKING AHEAD: BIOSECURITY CHALLENGES
weapons source materials in bioscience facilities. In fact,
UNSCR 1540 specifically calls on countries to secure biolog- Despite these international initiatives and national regulations,
ical materials in production, use, storage, and transport, and biosafety and biosecurity problems continue to arise (e.g.,
implement physical protection measures, border controls, Fig. 2), perhaps indicating the need for stronger partnerships
other law enforcement efforts, and end-user controls. between the scientific and policy communities to help create
The passage of the World Health Assembly Resolution a culture of safety and security in the bioscience community.
58.29 in 2005 is another landmark measure that recognizes For example, the laboratory-acquired infections of SARS in
the importance of laboratory biosafety and biosecurity. This 2003 occurred in biosafety level 3 (BSL3) and BSL4 (maximum
resolution specifically urged member states of the WHO to containment) laboratories. A WHO investigation attributed
implement an integrated approach to laboratory biosafety, these infections to negligent program management (e.g., poor
including containment of microbiological agents and toxins. laboratory practices, insufficient training). Similarly, even the
Member states were advised to review protocols for ensuring most sophisticated security systems can be circumvented if
the safe handling of harmful biological agents. States were the people with access to dangerous pathogens are not trust-
also instructed to establish biosafety practices in accordance worthy, reliable, and trained to abide by the security protocols.
with WHO guidance. Mobilization of national and financial In 2007, the Associated Press noted that there had been more
resources sufficient to accomplish these goals, as well as the than 100 biosafety and biosecurity incidents at laboratories in
requisite international support and cooperation, were also the United States since 2003.21 For example, Texas A&M Uni-
recognized as important components. The WHO has also versity received a $1 million USD fine, and had to suspend all of
developed a number of benchmark documents, including its select agent research because of failures to properly and ac-
the third edition of the Laboratory Biosafety Manual in curately report incidents.22 Pirbright Laboratory in the United
2004.14 This document serves as a global resource that offers Kingdom inadvertently released foot-and-mouth disease virus
practical guidance on biosafety for all types of laboratories into the community through a leak in its effluent pipes, which
and biosafety levels; the third edition includes a chapter that were known to need maintenance.2

JALA June 2009 143

Technology Review

Figure 2. Although substantial progress has been made in generating biosafety and biosecurity awareness, numerous challenges remain
throughout the world, and much work remains, in both developed and developing regions. It is not uncommon to identify numerous bio-
safety and biosecurity violations in the daily operation of both US and international bioscience facilities, such as the easy identification and
accessibility of dangerous pathogens (Figure 2a and 2b), the lack of appropriate physical security to protect pathogens from theft (2c), and
substandard laboratory equipment (2d).

As a result of these and other incidents, public and political of dual-use pathogens, equipment, and expertise. The follow-
concerns about the safety and security of high-containment ing section will explore these three areas in additional detail.
bioscience facilities have intensified in recent years. For exam- The people who work with the pathogens and toxins are
ple, the Oversight and Investigations Subcommittee of the the most important aspect of the laboratory biosafety and
U.S. House of Representatives Committee on Energy and biosecurity systems; the best engineered controls only work
Commerce held hearings in October 2007 and May 2008 ‘‘to if people use the equipment correctly.25 For example, a bio-
examine the risks associated with the recent proliferation of safety cabinet provides little to no protection to a user who
high-containment biological research laboratories.’’23 And, does not follow the proper procedures, and electronic card
in December 2008, the Congressionally mandated Commis- key access controls do not prevent someone from opening
sion on the Prevention of Weapons of Mass Destruction the door for an individual who does not have approved
(WMD) report, World at Risk,24 recommended that the access. Because individuals are the linchpin for controlling
United States ‘‘conduct a comprehensive review of the domes- biorisks in facilities, ensuring that individuals are properly
tic program to secure dangerous pathogens, .tighten govern- qualified, screened, and trained to have access to pathogens
ment oversight of high-containment laboratories, and or toxins is the most important task facing managers of bio-
promote a culture of security awareness in the life sciences science facilities. There are many factors to consider before
community.’’ This increased attention places bioscience facili- qualifying such individuals, such as their technical qualifica-
ties in the proverbial fishbowl as everyone watches how the fa- tions, technical experience, medical clearance, mental health,
cilities address current and emerging biosecurity challenges. and training.
Changes in three main areas, in particular, are likely to From a biosecurity perspective, mechanisms must be in
have major repercussions on the future operations of biosci- place to provide some level of assurance that individuals
ence facilities: ensuring that the increasing number of indi- are trustworthy. As more individuals work in the biosciences,
viduals who work in bioscience laboratories are adequately the odds of a biologist becoming a terrorist or an individual
screened, qualified, and trained; ensuring that rigorous bio- intent on causing harm increase.26 When the Federal Bureau
risk management programs are implemented at bioscience of Investigations (FBI) publicly identified a scientist at the
facilities across the globe; and understanding and managing U.S. Army Medical Research Institute of Infectious Diseases
the rapid advances in bioscience to ensure adequate control as the perpetrator of the anthrax letters, Congress

144 JALA June 2009

 Technology Review

immediately began to question whether the current screening laboratories should be improved, the experts overwhelmingly
process for granting individuals access to select agents is suf- agree that existing biosafety and biosecurity training pro-
ficient.27 There will undoubtedly be more attention devoted grams need to be expanded, and new programs need to be de-
to the issue of personnel reliability for individuals who work veloped. The current training programs do not have the
in containment laboratories or otherwise have access to path- capacity to train workers for all of the existing facilities,
ogens and toxins. Trustworthy persons are also fundamental and, yet, the growing numbers of these facilities will require
to the integrity of the scientific process. Recent high-profile increasing numbers of workers.33 New training programs in-
cases of scientific fraud,28 such as the discredited papers on tended to help fill these gaps include the National Biosafety
embryonic stem cell lines by Woo Suk Hwang, highlight an- and Biocontainment Training Program,34 Emory Universi-
other reason that institutions should have mechanisms in ty’s Science and Safety Training,35 Sandia National Labora-
place to provide some degree of confidence in the personal in- tories’ Controlling Laboratory Biorisks Training Course,36
tegrity of their employees. and the Canadian Science Center’s International High
Managing personnel is only one aspect of bioscience labora- Containment Biosafety Workshop.37
tory management. Ultimately, if an incident where a pathogen However, even if managers of bioscience facilities ensure
or toxin accidentally escapes from a facility or is misused and that their staff who have access to pathogens and toxins are
can be traced back to a specific institution with reasonable cer- appropriately qualified, screened, and trained, and also im-
tainty, that institution could be liable if it has not implemented plement robust biorisks management programs for labora-
best practices in biosafety or biosecurity. How does an institu- tory biosafety and biosecurity, steady advances in
tion demonstrate that it is implementing best practices? To ad- biotechnology pose clear challenges to the notion of labora-
dress this question, several efforts are underway to create tory biosecurity. Practicing the current state of the art, lead-
professionally developed standards for managing laboratory ing laboratories can create organisms through de novo
biorisks. Laboratories could voluntarily seek accreditation synthesis, and modify the pathogenic properties of wild-type
to these standards to demonstrate that they are implementing strains through site-directed mutagenesis, directed evolution,
best practices. In 2007, a collaborative effort by biosafety and and other techniques.38 Already some experts are concerned
biosecurity professionals used the European Committee for about terrorists creating pathogens that are not found in na-
Standardization (CEN) process to develop the Laboratory ture.39 Perhaps, as the technology advances, it may eventu-
Biorisk Management Standard.29 The American Biological ally become easier for a terrorist to synthesize a pathogen
Safety Association has also proposed to develop an indepen- than to steal it from a laboratory. The Industry Association
dent laboratory accreditation program based on the CEN of Synthetic Biology recently announced that its members
standard and the U.S. biosafety guidelines.30 Accreditation would review DNA orders for dangerous sequences,40 but
initiatives such as these may also eventually provide a frame- standards for determining how to review sequences and data-
work for better biorisk management, which will help maintain bases of sequences of concern have not yet been created. In
citizens and investors confidence in the bioscience facilities 2004, the U.S. National Academies of Science published Bio-
that are critical in the continued work with infectious diseases. technology in an Age of Terrorism, which examines biological
Recognizing the need for improving laboratory biorisk research in light of U.S. national security concerns.41 The
management, the American Society for Microbiology (ASM) publication, also known as the Fink Report, noted that those
made a series of recommendations to improve biosafety train- with malicious intent could misuse the tools and intellectual
ing, oversight, resources, reporting, and biosecurity in their advances produced by the growing global bioscience indus-
recent testimony to the U.S. House of Representatives Energy try. One outcome of this report was the creation of the
and Commerce Committee Subcommittee on Oversight and U.S. National Science Advisory Board on Biosecurity42 to
Investigations.31 ASM specifically called for mandatory, support the development of oversight mechanisms and in-
periodic training through formal training programs for all crease awareness and collaboration in an effort to minimize
personnel who work in containment laboratories. ASM also the risks and harm that could result from malevolent use of
urged for the creation of a harmonized system of oversight legitimate research.
for all pathogens in the United States. Furthermore, the U.S.
Government recently established a Trans-Federal Task Force CONCLUSIONS
on Optimizing Biosafety Oversight, which is tasked with
analyzing the current U.S. system for biosafety oversight and In essence, laboratory biosecurity (pathogen control) is now
developing options to address any identified gaps.32 The Task a subset within the larger emerging field of biosecurity. To
Force is just beginning their analysis, but, similar to the World implement biosecurity broadly defined in an effective, sus-
at Risk report, the Task Force study will likely highlight the tainable manner will require policy makers and bioscience
lack of a single regulatory authority for biocontainment institutions to work in partnership to develop solutions to
laboratories in the United States, and the lack of clear imple- the challenges that emerge in parallel with the growth and
mentation standards for biosafety and biosecurity. advances in bioscience. Already, it is difficult to define or
Although there are a variety of studies underway that ex- measure the advancement of laboratory biosafety and biose-
amine how oversight of high-containment bioscience curity. Although there has clearly been a significant increase

JALA June 2009 145

Technology Review

in the number of leading publications and national legisla- biosecurity regulations primarily because of concerns about
tion to address biosecurity in the last 5 years, there have bioterrorism, and to meet international obligations, such as
been no studies demonstrating that these efforts have led the BWC and UNSCR 1540, bioscience facilities have ad-
to direct improvements in laboratory biosafety and biose- ditional motives for enhancing the management of labora-
curity at bioscience facilities. Furthermore, there is very lit- tory biorisks. In today’s world, bioscience research requires
tle information available in the open-source literature that the support of the public, so bioscience laboratories must
reports the number of biosafety accidents or biosecurity do what they can to establish and maintain public confi-
breaches worldwide. Better data on laboratory biosafety dence in their work. Even in the absence of concrete direction
and biosecurity incidents and ‘‘near misses’’ would help pol- from policy makers, bioscience facilities can individually take
icy makers assess and ultimately improve their ability to ad- steps to be open, transparent, and implement best practices
dress these risks. for work with pathogens and toxins, dual-use equipment,
The concept of laboratory biosafety and biosecurity inter- and expertise, demonstrating good corporate citizenship to
nationally is still in its infancy, and the international commu- the community.
nity faces many challenges in achieving comprehensive
implementation in a manner that does not unduly constrain
the bioscience efforts that are critical to advancing public REFERENCES
and agricultural health. Do resources for strengthening bio- 1. Taylor, J.; Wentworth, D. E.; Bernard, K. A.; Masters, P. S.; Trimarchi,
safety and biosecurity come at the expense of research re- C. V. ‘‘SARS Coronaviruses and Highly Pathogenic Influenza Viruses:
sources? Do more rigorous requirements for training and Safety and Occupational Health for Laboratory Workers [conference
background screening make it more difficult for laboratories summary].’’ Emerg. Infect. Dis. 2005, Available from http://www.cdc.
to attract the best technical personnel? How will any biosecur- gov/ncidod/EID/vol11no04/04-1304.htm.
ity regulatory regime keep pace with the rapid advance of bio- 2. Health and Safety Executive ‘‘Final report on potential breaches to
science? Although stricter regulations have been enacted by biosecurity at the Pirbright site,’’ 2007. Available from http://www.hse.
some countries, the absence of global norms constitutes a vital gov.uk/news/archive/07aug/footandmouth.htm.
security risk, because those with malicious intent can simply 3. FBI Amerithrax Investigation, http://www.fbi.gov/anthrax/amerithrax-
seek out the weakest control points globally in their search links.htm: Shane, S. ‘‘Portrait emerges of anthrax suspect’s troubled
for materials, equipment, and expertise. Developing effective life.’’ New York Times January 3, 2009, http://www.nytimes.com/2009/
global norms will require both bottom-up efforts at individual 01/04/us/04anthrax.html?scp¼2&;sq¼ivins&st¼cse.
laboratories and top-down national and international efforts. 4. World Health Organization, ‘‘Labortory Biosafety Manual’’, 3rd ed,
Even UNSCR 1540, which requires countries to enact national Geneva, 2004.
biosecurity legislation, has had only limited success in facilitat- 5. Centers for Disease Control and Prevention and National Institutes of
ing the establishment of these global norms. As of November Health Biosafety in Microbiological and Biomedical Laboratories. 5th
2008, 159 countries had submitted a report on the status of ed. Washinton, 2007; Salerno, R. M.; Gaudioso, J. Labortory Biosecurity
their national legal infrastructure concerning WMD-related Handbook. CRC press; 2007.
materials. Yet far fewer, if any, are in compliance with all of 6. http://www.who.int/csr/bioriskreduction/biosafety/en/index.html.
the components of UNSCR 1540. Commonly cited reasons 7. http://www.cdc.gov/od/ohs/biosfty/biosfty.htm.
for noncompliance are the ‘‘insufficient understanding of their 8. Antiterrorism and Effective Death Penalty Act of 1996, http://usinfo.state.
obligations,’’ and the lack of capacity to fulfill the require- gov/infousa/government/branches/antiterrorism_summary.html.Uniting
ments. These excuses for poor compliance with UNSCR and Strengthening America by Providing Appropriate Tools Required to
1540 could be addressed at least in part if countries’ policy Intercept and Obstruct Terrorism (USA PATRIOT ACT) ACT of 2001,
makers relied on the technical expertise inherent in their biosci- http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname¼107_cong_
ence technical communities. public_laws&;docid¼f:publ056.107.pdf; Public Health Security and Bioter-
Better partnerships between the policy and technical rorism Preparedness and Response Act of 2002, http://frwebgate.access.
communities are needed to develop effective strategies for gpo.gov/cgi-bin/getdoc.cgi?dbname¼107_cong_bills&;docid¼f:h3448enr.
addressing current and emerging concerns. Policy makers txt.pdf.
play a vital role in this by setting norms, which create 9. http://www.access.gpo.gov/bis/ear/ear_data.html.
a minimum standard for bioscience institutions, and allo- 10. http://www.pmddtc.state.gov/itar_index.htm.
cating research priorities and resources. Bioscience institu- 11. Organization for Economic Cooperation and Development Biosecurity
tions need to help policy makers understand the Codes website section on legislation, http://www.biosecuritycodes.org/leg.
operational and technical realities to ensure that policy htm.
mandates address the realities of the laboratory. And this 12. Singapore Biological Agents and Toxins Act, Bill No 26, 2005, Septem-
need for laboratory scientists, technicians, and other tech- ber 20, 2005. Available at: http://www.biosafety.moh.gov.sg/bioe/ui/pa-
nical experts to convey the capabilities and limitations of ges/links/abt_bata.htm.
biological science and related technologies to policy makers 13. ‘‘Amendment of the Infectious Diseases Control Law, Japan, as of June
will become ever more critical as the science and its appli- 2007,’’ Infectious Agents Surveillance Report, 28, 185-188, July 2007.
cations advance and expand. Although countries adopt Available at: http://idsc.nih.go.jp/iasr/28/329/tpc329.html.

146 JALA June 2009

 Technology Review

14. South Korea Act on the Prohibition of Chemical and Biological 25. Westfall, S.; Rusk, S.; Crane, J.; Della-Porta, T.; Schantz, J.; Welker, L.
Weapons and the Control of the Production, Export, and Import of ‘‘Designing, building and maintaining Safe BSL Labs can it be done?
Specific Chemicals and Biological Agents (Municipal Law on the A collaborative editorial.’’ Tradeline 2004, http://www.flad.com/news/
BWC), 2006. As of this writing, no English version of the law is avail- tradeline_biosafety_article.pdf.
able. An overview of the law as presented to the 2007 BWC meeting 26. Epstein, G. L. ‘‘Bug off: taking the bioterrorism threat seriously.’’ Natl.
of experts can be found at http://www.brad.ac.uk/acad/sbtwc/btwc/ Strategy Forum Rev. 2007, 17(1) Winter.
new_process/mx2007/bwc_mx07_WP.6_EN.pdf and is titled ‘‘National 27. Hernandez, N.; Rucker, P. Anthrax case raises doubt on security. Wash.
Legislative Measures Adopted by the Republic of Korea to Implement Post August 8, 2008, A01. http://www.washingtonpost.com/wp-dyn/con-
the Biological Weapons Convention’’ tent/article/2008/08/07/AR2008080703462_pf.html.
15. ‘‘Act on Securing Certain Biological Agents, Delivery Systems and 28. Couzin, J. Breakdown of the year: scientific fraud. Science 2006, 314
Related Material,’’ Law 69, Adopted by the Danish Parliament on the (5807), 1853.
3rd hearing, 12 June 2008. 29. European Committee for Standardization, Laboratory biorisk manage-
16. The full name of the BWC is ‘‘The Convention on the Prohibition of the ment standard, CWA 15793:2008, February 1, 2008.
Development, Production and Stockpiling of Bacteriological (Biologi- 30. American Biological Safety Association, Position Paper on Accredita-
cal) and Toxin Weapons and on Their Destruction;’’ it was signed in tion of High Containment Laboratories, www.absa.org.
1972 and entered into force in 1975. 31. American Society for Microbiology, ASM comments on Laboratory
17. World Health Organization. Biorisk management: Laboratory biosecur- biosafety, testimony to the US House of Representatives Energy and
ity guidance. 2006. http://www.who.int/csr/resources/publications/bio- Commerce Committee Subcommittee on oversight and investigations,
safety/WHO_CDS_EPR_2006_6/en/index.html. October 7, 2007. http://www.asm.org/Policy/index.asp?bid¼53313.
18. World Health Organization. Guidance on regulations for the Transport of 32. http://thefdp.org/Present_8_Jan_2008.pdf.
Infectious Substances 2007-2008. http://www.who.int/csr/resources/publi 33. Kwik Gronvall, G.; Fitzgerald, J.; Chamberlain, A.; Inglesby, T. V.;
cations/biosafety/WHO_CDS_EPR_2007_2/en/. O’Toole, T. ‘‘High-containment biodefense laboratories: meeting report
19. Organization for Economic Cooperation and Development. OECD Best and center recommendations’’. Biosecur. Bioterror. 2007, 5(1) DOI:
Practice Guidelines for Biological Resource Centres 2007. http://www. 10.1089/bsp.2007.0902.
oecd.org/document/36/0,3343,en_2649_34537_38777060_1_1_1_1,00.html. 34. http://www.nbbtp.org/.
20. World Organization for Animal Health. Standards. 2006. http://www. 35. http://www.sph.emory.edu/CPHPR/biosafetytraining/index.html.
oie.int/eng/publicat/en_normes.htm. 36. www.biosecurity.sandia.gov.
21. Margasak, L. Accidents on Rise as More US Labs Handle Lethal Germs. 37. http://www.biosafety.ca/home.html.
Associated Press: October 3, 2007. http://www.boston.com/news/nation/ 38. Cello, J.; Paul, A,; Wimmer, E. Science 2002, 297 (1016); Gibson, D. G.; et
washington/articles/2007/10/03/accidents_on_rise_as_more_us_labs_ al. Science 2008, 319 (1215); Smith, H. O; Hutchison, C.A. III; Pfannkoch,
handle_lethal_germs/. C.; Venter, J.C. Proc. Natl. Acad. Sci. U.S.A. 2003, 100 (15440)
22. Kaiser, J. ‘‘Texas A&M to pay $1 million for biosecurity breaches.’’ 39. National Research Council of the National Academies, Department of
Science NOW 20 February 2008, 1. Homeland Security Bioterrorism Risk Assessment: A Call for Change.
23. Stupak, B. Opening statement, ‘‘Germs, Viruses, and Secrets: the Silent (National Academy of Sciences: Washington, DC; 2008), www.nap.edu.
Proliferation of Bio-Laboratories in the United States’’ October 4, 2007. 40. http://www.ia-sb.eu.
http://energycommerce.house.gov/Investigations/BSLLabs.shtml. 41. National Research Council of the National Academies, Biotechnology
24. Graham, B.; Talent, J.; Allison, G.; Cleveland, R.; Rademaker, S.; Research in an Age of Terrorism: Confronting the Dual Use Dilemma.
Roemer, T.; Sherman, W.; Sokolski, H.; Verma, R. World at risk The (National Academy of Sciences: Washington, DC; 2003).
Report of the Commission on the Prevention of WMD Proliferation 42. www.biosecurityboard.gov.
and Terrorism, December, 2008. www.preventwmd.gov.

JALA June 2009 147