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E9
UNITED STATES HIGH-CONTAINMENT BIOLOGICAL LABS AND
REGULATIONS
United States National Research Council Staff
1. What high-containment biological research facilities exist in the United States?
Since 2001, the number of facilities that can conduct high-containment biological research
(United States Centers for Disease Control [CDC] and Prevention Biological Safety 3 or 4 level—BSL 3-4)
in the United States has increased and is expected to continue increasing in the immediate future as
planned labs are completed and become operational (United States GAO, 2009a).
A rough estimate of the number of BSL-3 labs can be based on the number of labs registered
with the Select Agent Program, the main regulatory program for United States high-risk biological
research, which is described in the next section. As of 2010, 1,495 laboratories were registered with the
Select Agent Program through the CDC (Kaiser, 2011). This provides only a rough estimate of the
number of BSL-3 labs as some select agents can be handled at the BSL-2 level, while some pathogens
that necessitate BSL-3 precautions are not select agents.1 Also, some laboratories registered with the
Select Agent Program reside outside of the United States.
In 2011, 6 United States entities collectively contained 8 laboratories operating at the BSL-4 level
(Table E9-1). Six other BSL-4 laboratories were in the planning or construction phase, one of which will
replace an existing laboratory (Table E9-2). BSL-4 facilities, such as the National Institutes of Health’s
(NIH) small BSL-4 lab in Bethesda, Maryland, that currently operate only at a lower containment level
(United States GAO, 2007) were not included in those totals.
Table E9-1 Operational BSL-4 Labs in the United States.
Laboratory Location
National Institute of Allergy and Infectious Diseases (NIAID) Rocky Mountain Lab Hamilton, MT
Texas Biomedical Research Institute1 San Antonio, TX
University of Texas Medical Branch: Robert E Shope Lab and Galveston National Laboratory Galveston, TX
Georgia State University Atlanta, GA
CDC Special Pathogens Branch: Building 15 and Building 18 Atlanta, GA
United States Army Medical Research Institute for Infectious Diseases (USAMRIID) Fort Detrick, MD
1
Formerly Southwest Foundation for Biomedical Research
SOURCE: Kaiser, 2011; United States GAO, 2009a
Table E9-2 Planned BSL-4 Labs in the United States That Were not Operational as of September 2011.
Laboratory Location
NIAID Integrated Research Facility Fort Detrick, MD
National Biodefense Analysis & Countermeasures Center Fort Detrick, MD
USAMRIID Recapitalizationa Fort Detrick, MD
Boston University National Emerging Infectious Diseases Laboratories (NEIDL)b Boston, MA
Virginia Division of Consolidated Laboratoriesc Richmond, VA
National Bio- and Agro-Defense Facility Manhattan, KS
SOURCE: Kaiser, 2011.
a
This lab will replace the existing USAMRIID facility, which will be decommissioned.
b
For more information see: http://www.bu.edu/dbin/neidl/en/. Accessed October 6, 2011.
c
The Virginia DCLS facility will be built according to BSL-4 specifications, but due to lack of funding for personnel, will likely operate
as a BSL-3+. See: http://vaperforms.virginia.gov/agencylevel/stratplan/spReport.cfm?AgencyCode=194. Accessed October 6,
2011.
1
For a list of Select Agent Pathogens, see:
http://www.selectagents.gov/resources/List%20of%20Select%20Agents%20and%20Toxins_111708.pdf
. Accessed October 6, 2011.
193
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194 Biosecurity Challenges
Private companies, non-profits, academic institutions as well as state, local, and federal agencies
maintain high-containment facilities. The Department of Defense (DOD), the Department of Homeland
Security (DHS), and the Department of Health and Human Services (HHS) operate the main government
facilities, sometimes through contracts with private organizations. DOD operates the United States Army
Medical Research Institute for Infectious Diseases (USAMRIID).2 DHS operates the new National
Biodefense Analysis and Countermeasures Center (NBACC) through a contract with Battelle National
Biodefense Institute and maintains the Plum Island Animal Disease Center, which is scheduled to be
replaced eventually by the National Bio and Agro-Defense Facility (NBAF) in Manhattan, Kansas.3 HHS
funds multiple BSL-3 facilities at the NIH and BSL-4 facilities at the CDC. In addition, HHS, through the
National Institute of Allergy and Infectious Diseases (NIAID), partially funded construction of the
Galveston and Boston University National Laboratories (BSL-4) and 13 BSL-3 Regional Biocontainment
Laboratories (Table E9-3).4 These laboratories are distributed across the United States to conduct
research and assist with public health efforts during emergencies. Additionally, HHS funds the
Laboratory Response Network (LRN) that includes over 140 Reference Laboratories that have BSL-3
capabilities and can perform confirmatory testing.5 LRN Reference Laboratories include state and local
public health labs as well as military, federal, and international (i.e., Canada, Australia, and United
Kingdom) facilities.
Table E9-3 Regional Biocontainment Laboratories (RBL).
Laboratory Location
Tufts Regional Biosafety Laboratory North Grafton, MA
Regional Biocontainment Laboratory at Biomedical Science Tower 3 Pittsburgh, PA
Center for Predictive Medicine Louisville, KY
Colorado State University Regional Biocontainment Laboratory Ft. Collins, CO
George Mason University RBL Manassas, VA
Global Health Research Building Durham, NC
Howard T Ricketts Laboratory RBL Chicago, Il
Pacific RBL (under construction) Honolulu, HI
Southeast Biosafety Laboratory Birmingham, AL
Tulane National Primate Research Center Covington, LA
University of Missouri- Columbia RBL Columbia, MO
University of Tennessee RBL Memphis, TN
New Jersey Medical School Center for Infectious Disease Research RBL Newark, NJ
SOURCE: Kaiser, 2011 and
http://www.niaid.nih.gov/LabsAndResources/resources/dmid/NBL_RBL/Pages/site.aspx. Accessed
October 6, 2011.
2. What government organizations in the United States are responsible for oversight, safety, and
security of high-containment biological (high BSL) laboratories?
No single government entity has total responsibility for the safety and security of high-
containment laboratories (United States GAO, 2007; see page 4). Instead, oversight is provided by
multiple organizations under a number of regulatory frameworks, including:
2
To learn more about USAMRIID, see: http://www.usamriid.army.mil/. Accessed October 6, 2011.
3
To learn more about NBACC see: http://www.bnbi.org/. To learn more about NBAF see: http://
www.dhs.gov/nbaf. Accessed October 8, 2011.
4
Available at: http://www.niaid.nih.gov/LabsAndResources/resources/dmid/NBL_RBL/Pages/site.aspx.
Accessed October 6, 2011.
5
See: http://www.bt.cdc.gov/lrn/pdf/lrn-overview-presentation.pdf. Accessed October 6, 2011.
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195
Appendix E: Country and Region Overviews
Select Agent Program
One of the major regulatory programs for high-containment labs in the United States is the Select
Agent Program. The program was established in 1996 via the Antiterrorism and Effective Death Penalty
Act (P.L. 104-132).1 This law required the Department of Health and Human Services (HHS) to identify a
set of organisms and toxins (“Select Agents”) that could be used for bioterrorist attacks and to regulate
the transport of those pathogens. Later, the 2001 Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act: P.L. 107-56) and
the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (P.L. 107-188)
added restrictions on the possession, use, and transfer of select agent pathogens and toxins. More
information on the history of the Select Agent Program may be found in the National Research Council
report on Responsible Research with Biological Select Agents and Toxins (NRC, 2009).
The current Select Agent Program covers two lists of pathogens and toxins. The agents on the
HHS list are human health threats while those on the United States Department of Agriculture (USDA) list
are animal and plant pathogens. Some agents are on both the HHS and USDA lists (overlap agents).
The listed agents are to be reviewed every two years. The program also addresses two other areas—
people who have access to select agents and facilities where select agents are used. Additionally, the
program monitors the quantity of each agent held by each person at each facility. Scientists who conduct
research with pathogens on the select agent list must undergo a background check called a Security Risk
Assessment (SRA) with the Department of Justice (DOJ). These clearances are pathogen and institution
specific, nontransferable, and valid for three years.2 (Prior to June 1, 2011, clearances were valid for five
years.) Facilities that possess or use select agents must develop and implement a security plan to
protect the select agents from theft or improper access and identify a Responsible Official (RO). The RO
has the authority and responsibility to ensure compliance with the regulations and report any incidents to
the proper authorities.3 Depending on the pathogen, security plans are submitted either to CDC, USDA’s
Animal and Plant Health Inspection Service (APHIS), or both for overlap pathogens. A plan must include
a site-specific risk assessment, an agent-specific risk assessment, a threat assessment, a vulnerability
assessment, and information about physical security, inventory control, and information systems control.4
CDC and APHIS conduct routine inspections every three years (annually for BSL-4 labs) and may
conduct additional inspections at any time if an entity requests a change to its registration.5 During
inspections, both APHIS and CDC use standardized checklists to ensure compliance.6 Any problems
found during an inspection are reported to the institution and must be addressed. If, for example, CDC
finds significant problems at a laboratory the following actions may be taken:
“Administrative actions: CDC can decide to suspend or revoke a registered
entity’s certificate of registration (a suspension can be for all work at a registered
entity or be specific to particular agents or particular types of experiments). Also,
CDC can deny an entity’s application to possess, use, or transfer select agents;
Referral to HHS-Office of the Inspector General (OIG): CDC can refer possible
violations of the select agent regulations to HHS-OIG. HHS-OIG can levy civil
monetary penalties (up to $250,000 for an individual for each violation and up to
$500,000 for an entity for each violation) or recommend criminal enforcement
(imprisonment for up to five years, a fine, or both).
1
To view the law see: http://frwebgate.access.gpo.gov/cgi-
bin/getdoc.cgi?dbname=104_cong_public_laws&docid=f:publ132.104. Accessed October 6, 2011.
2
To learn more about SRAs, see: http://www.selectagents.gov/sra.html. Accessed October 6, 2011.
3
See: http://www.selectagents.gov/resources/Session%201%20-%20RO%20Responsibilities.pdf.
Accessed October 6, 2011.
4
For more information see:
http://www.selectagents.gov/resources%5CSecurity%20Information%20Document.pdf. Accessed
October 6, 2011.
5
See: http://www.hhs.gov/asl/testify/2007/10/t20071004c.html. Accessed October 6, 2011.
6
To view the checklists see: http://www.selectagents.gov/Checklists.html. Accessed October 6, 2011.
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196 Biosecurity Challenges
Referral to FBI: CDC can refer possible violations involving criminal negligence
or a suspicious activity or person to the FBI for further investigation.”7
Through June 29, 2011, the HHS Office of Inspector General (OIG) had accepted a total of
$2,127,000 from 16 different organizations to settle allegations of failure to comply with select agent
regulations.8
To provide oversight of the CDC and APHIS’s implementation, the HHS and USDA OIG also
conduct audits of the Select Agent Program. In a 2006 HHS audit of 15 universities, OIG found that 8 had
inventory weaknesses, 6 had weak security plans, and 6 had access control problems.9 In a 2006 USDA
audit, OIG found multiple weaknesses with the methods that APHIS was using to oversee and regulate
the Select Agent Program including an inadequate review of security plans, use of an out-of-date list of
individuals with access, and inadequate facility inspections (OIG, USDA, 2006).
In July 2010, Executive Order (EO) 13546, “Optimizing the Security of Biological Select Agents
and Toxins in the United States,” created the Federal Experts Security Advisory Panel (FESAP), which
was tasked to make recommendations to improve the Select Agents Program (Obama, 2010). To better
match precautions to actual risks and reduce the impact of excessive security, EO 13546 instructed
FESAP to (1) designate a subset of the select agent list as “Tier 1” agents and propose appropriate
additional precautions and (2) consider whether any current select agents or toxins might be removed
from the list. FESAP subsequently recommended 12 agents and toxins be designated as Tier 1 and 25
agents and toxins be removed from the list (FESAP, 2010).
NIH
The NIH’s Guidelines for Research Involving Recombinant DNA Molecules (RAC)10 provides
oversight of laboratories whose investigators receive NIH funding and conduct experiments with
recombinant DNA. While many experiments can be reviewed at the institutional level, some experiments
require approval from the NIH. Many institutions that do not receive NIH funds voluntarily comply with the
RAC guidelines as these are viewed as establishing best practices.
The RAC guidelines require institutions to establish an Institutional Biosafety Committee (IBC) to
review research proposals that would require the use of recombinant DNA. Reviews should include an
assessment of the procedures, facilities, and practices that would be used in the experiment. The IBC can
approve proposals or make recommendations for modifying experiments. In addition, the institution must
have a biological safety officer who periodically inspects laboratories, reports violations to the IBC, and
prepares emergency plans for dealing with accidental exposures or spills.
OSHA
The Occupational Safety and Health Administration (OSHA) has several mandatory laboratory
standards. For example, OSHA Standard 29 CFR 1910.1450 (Occupational Exposure to Hazardous
Chemicals in the Laboratory) requires, among other things, that laboratories have a Chemical Hygiene
Plan, mandatory employee training, personal protective equipment (PPE) for certain chemicals, and
accessible material safety data sheets for all hazardous chemicals.11 OSHA has also issued a
Bloodborne Pathogen Standard, which provides guidance on preventing and responding to worker
7
See: http://www.hhs.gov/asl/testify/2007/10/t20071004c.html. Accessed October 6, 2011.
8
See: http://oig.hhs.gov/fraud/enforcement/cmp/agents_toxins.asp. Accessed October 6, 2011.
9
See: http://oig.hhs.gov/oas/reports/region4/40502006.pdf. Accessed October 6, 2011.
10
For the full NIH Guidelines for Research Involving Recombinant DNA Molecules, see:
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm. Accessed October 6, 2011.
11
Available at:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10106.
Accessed October 6, 2011.
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197
Appendix E: Country and Region Overviews
exposure to blood.12 OSHA standards apply to public health laboratories and research laboratories at all
biosafety levels.
Other Regulators
Many other government entities also play a role in regulation of biosafety and biosecurity in high-
containment laboratories. The Departments of State, Commerce, and Treasury, for example, oversee
export controls on biological products. Additionally, the Department of Transportation, the United States
Postal Service, the International Civil Aviation Organization,13 and the International Air Transport
Association14 all have regulations regarding the transportation of biological agents.
3. In the United States, are there established criteria for deciding:
a. Whether or not to establish high-containment facilities?
b. Where to place such facilities?
The decision to establish facilities depends on whether the facility is funded by the federal
government or will be privately funded. There are, in general, no established criteria for privately funded
facilities at universities or private sector institutions on when and where to build facilities. Government
facilities or facilities at universities or elsewhere that are funded by the government are established based
on the needs and research agendas of individual agencies, and no single government agency has the
overall responsibility for determining needed laboratory capacity (United States GAO, 2009a). For
example, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 increased
laboratory construction to support research efforts in several areas, including antimicrobial resistance and
countermeasures research. Decisions on where to locate facilities are often made through a competitive
bid process that solicits proposals from competing entities. The final location is picked based on the
scientific and technical merit of a proposal as well as other factors, such as public support, transportation,
and site accessibility. Risk assessments are conducted to assess the likelihood and consequences
associated with possible pathogen releases (NRC, 2008). Construction of federally funded facilities also
requires preparation of environmental impact statements and increasingly involves engaging the local
community.
c. What research will be done in such facilities?
High-containment biological laboratories are used for basic research, applied research, medical
product testing and evaluation, and animal efficacy15 studies (United States GAO, 2007). The research
done at government-funded facilities includes both investigator-proposed projects and projects proposed
by the sponsoring agencies. Grants are awarded competitively. DOD, NIH, and other government
entities fund research grants.
d. What scientific, technical, and management advice is available to governments when
making their decisions?
A number of groups and organizations provide advice on the subject including:
National Research Council
The National Research Council (NRC), which is a part of the National Academies, writes
independent, expert reports to advise the government and increase public understanding on matters
12
Available at:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.
Accessed October 6, 2011.
13
For more information, see: http://www.icao.int. Accessed October 6, 2011.
14
For more information, see: http://www.iata.org. Accessed October 6, 2011.
15
Information about “Animal Rule” studies to demonstrate efficacy for Food and Drug Administration
(FDA) product licensure may be found in 21 CFR Parts 314 and 601:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=314 and
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=601. Accessed
October 6, 2011.
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198 Biosecurity Challenges
related to science, engineering, and medicine.16 The NRC has commented on risk assessments for
several high-containment labs including facilities at Fort Detrick, Maryland (NRC, 2010a); Boston,
Massachusetts (NRC, 2007); and Manhattan, Kansas (NRC, 2010b). The NRC has also issued a number
of reports on biosafety and biosecurity.
NSABB
The National Science Advisory Board for Biosecurity (NSABB) was formed by 42 U.S.C. 217a,
section 222 of the Public Health Service Act and is governed by the Federal Advisory Committee Act. The
NSABB was created in response to the recommendations made in the 2004 NRC report, Biotechnology
Research in an Age of Terrorism.17 It includes non-governmental voting members and non-voting
members from 15 federal agencies and departments. Members’ areas of expertise cover a wide range of
topics, including: microbiology, biodefense, food production, export controls, law, and others.18 The
NSABB advises the Secretary of HHS and other government leaders on policies related to dual use
research in the life sciences by issuing reports and recommendations. For example, in September 2011,
NSABB released a report on Guidance for Enhancing Personnel Reliability and Strengthening the Culture
of Responsibility (NSABB, 2011).
Working Group on Strengthening the Biosecurity of the United States
Executive Order 14386,19 Strengthening Biosecurity of the United States, created the Working
Group on Strengthening the Biosecurity of the United States on January 9, 2009. The Secretary of
Defense and Secretary of HHS chair the group, which also consists of the Director of National
Intelligence, the Director of the National Science Foundation, the Attorney General, and the Secretaries of
State, Commerce, Agriculture, Transportation, and Energy. The group reviewed existing laws,
regulations, and practices and made recommendations to the President in November 2009 in a report
titled National Strategy for Countering Biological Threats.20
4. What standards exist for high biological containment laboratories in the United States for
engineering and construction, licensing, safety, security, regular oversight, and certification?
General Standards
The CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL),
which is currently in its 5th edition, has served as the standard code of practice for biosafety since 1984
(United States HHS, 2009). The BMBL provides guidance on all areas of biosafety and biosecurity
including decontamination, transportation, containment level recommendations, and agent-specific
practices. BMBL guidelines have been widely adopted and are mandatory for research conducted using
federal grants. Noncompliance may result in the loss of funding (CRS, 2009). Federal laboratories, and
most other facilities built using federal funds, are built to standards established by the funding agency.
For example, to receive NIH money, laboratory engineering and construction must comply with the NIH
16
See: http://www.nationalacademies.org/about/. Accessed October 6, 2011.
17
To view the report, go to: http://www.nap.edu/catalog.php?record_id=10827. Accessed October 6,
2011.
18
For more information on the NSABB see:
http://oba.od.nih.gov/biosecurity/PDF/NSABB_Charter_508_accessible.pdf or
http://oba.od.nih.gov/biosecurity/biosecurity.html. Accessed October 6, 2011.
19
To view the Executive Order see: http://edocket.access.gpo.gov/2009/E9-818.htm. Accessed October
6, 2011.
20
The report can be found at:
http://www.whitehouse.gov/sites/default/files/National_Strategy_for_Countering_BioThreats.pdf.
Accessed October 6, 2011.
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199
Appendix E: Country and Region Overviews
Design Requirements Manual.21 Additionally, those laboratories that work with select agents or
recombinant DNA must abide by those programs’ previously mentioned standards.
Training
Training is required for personnel whose labs fall under the jurisdiction of the OSHA standards,
the NIH guidelines, or the Select Agent Program. Rather than being standardized, training is specialized
to the agents, risks, and activities in which the trainee will engage. In the case of select agent work,
refresher training must be provided annually (CRS, 2009). High-containment labs commonly supplement
didactic training with mentored, within-laboratory training (Le Duc et al., 2008).
Many organizations provide resources and guidelines for biosafety and biosecurity training:
• The Sandia National Laboratories’ International Biological Threat Reduction Program aims to
reduce biological threats worldwide by, among other things, promoting the responsible use of
biological agents, equipment, and expertise and improving the understanding of accidental and
deliberate biological risks.22
• The CDC has online course modules and exercises for training in biosafety and biosecurity.23
• University of Texas Medical Branch maintains the National Biocontainment Training Center that
provides training in biosafety and biosecurity to United States and international students, as well as
on-site fellowships offering mentored training for individuals preparing for work at BSL-4 and for
containment laboratory managers and engineers.24
• Yale Center for Public Health has online course resources for biosafety training based on a course
taught at the school, designed in part for those interested in implementing biosafety and biosecurity
courses at their own facilities.25
• Biosafety and animal safety training tools are available on the American Biological Safety
Association (ABSA) website.26
Commissioning Labs
Although there is no formal regulatory requirement for “commissioning,” when a new lab is built, a
commissioning process may take place to ensure the lab meets safety standards. Agencies often
contract out the process of commissioning a laboratory. Some agencies, for example the NIH, have
specific checklists27 and guidelines28 for commissioning. A similar process occurs in other agencies and
generally follows the recommendations of the BMBL. The commissioning documents are part of what
must be presented during the select agent inspection that will eventually authorize high-containment labs
to begin work with select agents (CRS, 2009).
5. Have there been any high-containment lab accidents in the United States?
a. If yes, how and why did accidents at high-containment facilities occur?
b. How, to whom and when are they reported?
c. Who has authority to investigate accidents?
21
See: http://orf.od.nih.gov/NR/rdonlyres/AF690C46-0388-4180-9603-
3060F3078F5F/25782/NIHDesignRequirementsManualver711.zip. Accessed October 6, 2011.
22
See: http://biosecurity.sandia.gov/. Accessed October 6, 2011.
23
See: http://www.cdc.gov/od/ohs/biosecurity_training/page2790.html. Accessed October 6, 2011.
24
See: http://www.utmb.edu/nbtc. Accessed October 6, 2011.
25
See: http://publichealth.yale.edu/ycphp/biosafety/biosafety.html. Accessed October 6, 2011.
26
See: http://www.absa.org/trainingtools.html. Accessed October 6, 2011.
27
Department of Health and Human Services, National Institutes of Health, Biosafety Level 3-
Laboratory Certification Requirements.
28
The NIH is currently working on a new version of The NIH Model Commissioning Guide. Section 1-7 of
the NIH Design Requirements Manual discusses commissioning:
http://orf.od.nih.gov/NR/rdonlyres/AF690C46-0388-4180-9603-
3060F3078F5F/25782/NIHDesignRequirementsManualver711.zip. Accessed October 6, 2011.
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200 Biosecurity Challenges
d. What disciplinary or legal actions can be taken?
e. Have any steps been taken to minimize BSL laboratory accidents?
Accidents, some of which result in laboratory-acquired infections (LAIs), occur regularly albeit at a
low level in United States high-containment laboratories. For example, between 1982 and 2003,
personnel at NIAID intramural laboratories worked with microorganisms for more than 3 million hours in
BSL-3 laboratories or BSL-2 laboratories with BSL-3 practices and experienced a total of 29 exposures of
which only 1 resulted in a clinical infection and 4 resulted in silent infections (Johnson, 2004). Laboratory
accidents may result from either human error or equipment or engineering malfunction, and often the
specific cause of a suspected LAI cannot be determined (Pike, 1979). FESAP recently proposed that
occupational health programs be mandatory for individuals with access to Tier 1 agents, which would aid
in identifying LAIs (FESAP, 2010). Table E9.4 contains a partial list of United States laboratory accidents.
Additional information about LAIs observed in conjunction with United States containment lab work may
be found in the NRC report, Protecting the Frontline in Biodefense Research: The Special Immunizations
Program (NRC, 2011).
Table E9-4 Examples of Accidents in United States Biosafety Labs.
Location Agent Description Date Source
Human Error
New Hampshire Vaccinia Accidental exposure from needlestick 9/2007 CDC, 2008
unknown Potential exposure when employee stuck self 8/2007 Field, 2007
Yersinia pestis
with broken scalpel blade
Maryland Vaccinia Accidental exposure from needlestick 8/2007 CDC, 2008
University of South Worker drops plate and splashes self 7/2007 Field, 2007
Ricketssia
Alabama prowazekii
U.C. Davis Potential exposure due to needlestick 7/2007 Field, 2007
Brucella
University of Iowa Tularemia Potential exposure due to needlestick 5/2007 Field, 2007
Iowa Vaccinia Accidental exposure from needlestick 5/2007 CDC, 2008
UT San Antonio Tularemia Workers entered lab wihout PPE, unlikely 4/2007 Field, 2007
exposure
unknown Researcher ill because of improper 4/2007 Field, 2007
Brucella
decontamination procedures
Pennsylvania Vaccinia Accidental exposure from needlestick 10/2006 CDC, 2008
Saint Louis monkeypox Worker exposed from needlestick 8/2006 CDC, 2008
University
University of Anthrax Worker exposed to Anthrax after needlestick 7/2006 CDC, 2008
Chicago
Connecticut Vaccinia Accidental exposure from needlestick 3/2005 CDC, 2008
Children's Hospital Anthrax Scientists exposed after live anthrax samples 6/2004 CDC, 2008
and Research accidentally get shipped to the lab
Center Oakland, CA
USAMRIID Ebola Accidental exposure from needlestick 2/2004 Kaiser,
2007
unknown West Nile Virus Lab worker contacts virus after accidentally 12/2002 CDC, 2008
cutting finger with scalpel
unknown West Nile Virus Lab worker contracts virus after needlestick 8/2002 CDC, 2008
University of Texas Cutaneous anthrax of lab worker 4/2002 Field, 2007
Anthrax
USAMRIID Junin virus Bone fragment from monkey punctured finger 12/1982 Johnson,
during autopsy 2004
USAMRIID Lassa virus Accidental needle stick in finger 11/1979 Johnson,
2004
Equipment/Engineering Error
University of GA none Flooding occurred twice of high-containment 2008 Schneider
laboratory after sterilizer failed to shut off and Hart,
2008
CDC CDC used duct tape to secure facility after air 2007 Young,
Coxiella
filtration system failed during maintenance 2008
burnetii
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201
Appendix E: Country and Region Overviews
University of Anthrax Potential exposure from broken flask spill 8/2007 Field, 2007
Mississippi Medical
Center
University of Texas Anthrax Potential exposure after fluid discovered in 5/2007 Field, 2007
Health Science bottom of centrifuge
Center
unknown Potential exposure after cap came off tube 8/2006 Field, 2007
Brucella
University of Virginia Tularemia Potential exposure from cracked tube 8/2006 Field, 2007
University of Worker exposed after autoclave bag leaked 5/2006 Field, 2007
Yersinia Pestis
Kentucky
Tufts University Botulinum Potential exposure after broken vial found in 4/2006 Field, 2007
neurotoxin centrifuge
unknown Potential exposure after broken vial 9/2005 Field, 2007
Coccidioides
containing agent found in centrifuge
immitis
Plum Island 3 hour power failure 12/2003 Santora,
2002
Rocky Mountain Open container fell off shaker 2001 Johnson,
Yersinia pestis
Laboratory 2004
Unknown/Miscellaneous Error
unknown Blood tests show potential exposures of 10 2007 Field, 2007
Coxiella
people to agents
burnetii
unknown Tularemia Potential exposure after bitten by infected 7/2007 Field, 2007
animal
unknown Lab worker potentially scratched by infected 4/2007 Field, 2007
Yersinia pestis
animal
Lovelace Lab worker bit by infected animal 9/2006 Field, 2007
Yersinia pestis
Respiratory
Research Institute
Texas A&M Lab workers infected while cleaning aerosol 2/2006 United
Brucella
chamber; failure to report to CDC States
GAO, 2007
Public Health Infected mice missing 8/2005 Field, 2007
Yersinia pestis
Research Institute at
UMDNJ
UNC-Chapel Hill Venezuelan Blood test show possible exposure 9/2004 Field, 2007
equine
encephalitis
Medical College of Lab worker contracts coccidioidomycosis, 8/2004 Field, 2007
Coccidioides
Ohio unknown route of exposure
immitis
Boston University Tularemia 3 scientists infected with Tularemia over 5 2004 Field, 2007
Medical Center months
Rocky Mountain Skin test converted; cause was likely 2000 Johnson,
Mycobacterium
Laboratory improperly inactivated samples 2004
tuberculosis
Rocky Mountain Worker hospitalized and successfully treated 1998 Johnson,
Chlamydia
Laboratory with antibiotics; no specific cause determined 2004
trachomatis
Yerkes Primate Simian Exposed research assistant dies 6/1998 Wrobel,
Center Herpesvirus 1998
Rocky Mountain Skin test converted; no specific cause 1996 Johnson,
Mycobacterium
Laboratory determined 2004
tuberculosis
Yale University Sabia Researcher contracts virus and exposes 75 8/1994 Glass, 1994
other co-workers
Plum Island Foot and Accidental release of virus into holding pens 1978 Margasak,
mouth disease 2008
SOURCE: NRC Staff.
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202 Biosecurity Challenges
In the event of a theft, loss, or release of a select agent, the Select Agent Program currently
requires a laboratory to notify the CDC and/or APHIS immediately (within 24 hours).29 Appropriate
federal, state, or local law enforcement must also be notified in the event of loss or theft; health agencies,
such as local employee health services, must be notified if there is a risk of human infection. Additionally,
the facility must submit APHIS/CDC Form 3 within seven days of the incident.30 CDC or APHIS then
conducts an investigation into the incident to determine the cause, actions that can be taken to mitigate
future accidents, and whether further actions such as revocation of approval to work with select agents,
fines, and/or potential criminal enforcement actions are needed.
Laboratories not in the select agent program typically have their own rules for accident reporting.
For example, overt or potential exposures in BSL-3 and BSL-4 labs that occur in the course of research
subject to NIH Recombinant DNA guidelines must be reported to the NIH Office of Biotechnology
Activities immediately.
Increasingly, laboratories are making data on accidents publically available. For example, since
2002, University of Texas Medical Branch has published all incidents of laboratory accidents and potential
exposures occurring in its research laboratories quarterly on its website.31
There have been several recent cases in which laboratories failed to report accidents in a timely
manner. In 2006, Texas A&M did not report laboratory-acquired infections of Brucella and Coxiella
burnetii that were later exposed through a Freedom-of-Information Act (FOIA) request.32 The CDC
ultimately shut down select agent research at the laboratory until all problems identified in the subsequent
investigation were addressed and the university agreed to pay a $1 million fine (Kaiser, 2008). At Boston
University in 2004, three individuals who worked with a vaccine strain of Francisella tularensis (not a
select agent) became ill with tularemia.33 While two of the cases occurred in May and one in September,
none was reported to the public health authorities until November. An investigation revealed that their
stock of the vaccine strain had became contaminated by unknown means with Type A F. tularensis,
which is a select agent. OSHA proposed fines of $8,100 for each of Boston University and Boston
Medical Center Corporation for their failure to ensure proper use of personal protective equipment.34 The
lack of transparency at Boston University has greatly increased public concern about the new National
Emerging Infectious Diseases Laboratory, for which the United States government is preparing additional
risk assessments with advice from the National Research Council.35
6. Have any steps been taken to increase security at high biological containment facilities?
While select agent rules do not mandate specific physical security requirements, BSL-4
laboratories are increasingly employing visible 24/7 armed guards, controlled access, vehicle barriers,
and closed-circuit television monitoring (United States GAO, 2009b). Additionally, since 2008 many
Department of Defense containment laboratories have been subject to Army Regulation 50-1, which
established a biological ‘surety’ program that defines criteria for evaluating personnel reliability
(Department of the Army, 2008).
29
See: http://www.selectagents.gov/resources/CDC-
APHIS_Theft_loss_Release_Information_Document.pdf. Accessed October 6, 2011.
30
CDC/APHIS Form 3 is available at: http://www.selectagents.gov/TLRForm.html. Accessed October 6,
2011.
31
Safety and Security/Incident Reports. Available at: http://www.utmb.edu/gnl/safety/report.shtml.
Accessed October 17, 2011.
32
To learn more about the Texas A&M incident see:
http://www.cidrap.umn.edu/cidrap/content/bt/bioprep/news/sep1907biolab.html and
http://www.sunshine-project.org/TAMU/CDCTAMUReport.pdf. Accessed October 6, 2011.
33
See:
http://www.bphc.org/programs/cib/environmentalhealth/biologicalsafety/forms%20%20documents/tularem
ia_report_2005.pdf. Accessed October 6, 2011.
34
See:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=NEWS_RELEASES&p_id=11351.
Accessed October 6, 2011.
35
To view the NAS report, see: http://www.nap.edu/catalog.php?record_id=12208. Accessed 6 October
2011.
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203
Appendix E: Country and Region Overviews
Additionally, FESAP made a number of security recommendations that will be considered during
the next revision of the Select Agent Regulations (FESAP, 2010). In particular, FESAP:
• Defined appropriate personnel reliability practices, including provisions for on-going monitoring, for
individuals with access to Tier 1 agents and toxins and for individuals with access to other select
agents and toxins;
• Specified physical and cyber security requirements for facilities with Tier 1 agents and for facilities
with other select agents and toxins; and
• Recommended that facilities document protocols for shipping, storing, and receiving select agents
and toxins.
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