Biological Research Laboratories
Issues Associated with the Expansion of Laboratories Funded by the National Institute of Allergy and Infectious Diseases Gao ID: GAO-07-333R February 22, 2007The fall 2001 anthrax attacks revealed gaps in the nation's preparedness for public health emergencies resulting from bioterrorism. Among the tools needed for responding to such emergencies are vaccines to prevent the spread of disease; tests for rapid diagnosis; and therapeutics, including drugs, for treatment. Because the pathogens that could be used in bioterrorist attacks carry the risk of significant morbidity or are potentially lethal, biological research aimed at providing the tools needed to combat these agents is required to be conducted in facilities known as biocontainment laboratories. These facilities are to be designed, constructed, and operated in a manner to prevent accidental release of infectious or hazardous agents within the laboratory and to protect laboratory workers and the environment external to the laboratory, including the community, from exposure to these research materials. The National Institute of Allergy and Infectious Diseases (NIAID) is the primary institute at the Department of Health and Human Services' (HHS) National Institutes of Health (NIH) that is responsible for research on pathogens that could be used in a bioterrorist attack and for research on emerging infectious disease pathogens. The Centers for Disease Control and Prevention (CDC) is also responsible for research on such pathogens. Following the anthrax attacks, NIAID expanded its research program to emphasize biodefense research. In February 2002, it issued the NIAID Strategic Plan for Biodefense Research, which outlined a need for research aimed at the development of vaccines, diagnostics, and therapeutics and construction of additional biocontainment laboratories in which to conduct the research. According to NIH, a shortage of high-level biocontainment laboratories exists. In response to the Strategic Plan, NIAID established the National Biocontainment Laboratory (NBL) and Regional Biocontainment Laboratory (RBL) construction programs. The overall objective of the NBL construction program is to provide funding to design and construct state-of-the-art biosafety level (BSL) 4, 3, and 2 laboratories, including associated research and administrative support space, and the objective of the RBL construction program is to provide similar facilities containing BSL-3 and -2 laboratories. As of January 2007, the NBLs and RBLs are at various stages of design and construction and are not yet operational. Because the deliberate or accidental release of biological pathogens from a biocontainment laboratory could have disastrous consequences, concerns exist about the oversight of these laboratories. This report responds to Congress's November 30, 2005, request that we provide information associated with the construction of NBLs and RBLs funded by NIAID in fiscal years 2003 and 2005. Congress's questions covered requirements and guidance for these laboratories, funding award factors, communication with the public, and research agendas. Enclosure I provides background information for these questions and our answers to the questions, enclosure II provides lists of infectious agents with the potential to be used in bioterrorism, and enclosure III provides examples of regulations and guidelines applicable to NBL and RBL operations and security procedures.
GAO-07-333R, Biological Research Laboratories: Issues Associated with the Expansion of Laboratories Funded by the National Institute of Allergy and Infectious Diseases
This is the accessible text file for GAO report number GAO-07-333R
entitled 'Biological Research Laboratories: Issues Associated with the
Expansion of Laboratories Funded by the National Institute of Allergy
and Infectious Diseases' which was released on February 22, 2007.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as part
of a longer term project to improve GAO products' accessibility. Every
attempt has been made to maintain the structural and data integrity of
the original printed product. Accessibility features, such as text
descriptions of tables, consecutively numbered footnotes placed at the
end of the file, and the text of agency comment letters, are provided
but may not exactly duplicate the presentation or format of the printed
version. The portable document format (PDF) file is an exact electronic
replica of the printed version. We welcome your feedback. Please E-mail
your comments regarding the contents or accessibility features of this
document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
February 22, 2007:
The Honorable Bart Gordon:
Chairman:
Committee on Science and Technology:
House of Representatives:
Subject: Biological Research Laboratories: Issues Associated with the
Expansion of Laboratories Funded by the National Institute of Allergy
and Infectious Diseases:
Dear Mr. Chairman:
The fall 2001 anthrax attacks revealed gaps in the nation's
preparedness for public health emergencies resulting from bioterrorism.
Among the tools needed for responding to such emergencies are vaccines
to prevent the spread of disease; tests for rapid diagnosis; and
therapeutics, including drugs, for treatment. Because the pathogens
that could be used in bioterrorist attacks carry the risk of
significant morbidity or are potentially lethal, biological research
aimed at providing the tools needed to combat these agents is required
to be conducted in facilities known as biocontainment laboratories.
These facilities are to be designed, constructed, and operated in a
manner to prevent accidental release of infectious or hazardous agents
within the laboratory and to protect laboratory workers and the
environment external to the laboratory, including the community, from
exposure to these research materials.
The National Institute of Allergy and Infectious Diseases (NIAID) is
the primary institute at the Department of Health and Human Services'
(HHS) National Institutes of Health (NIH) that is responsible for
research on pathogens that could be used in a bioterrorist attack and
for research on emerging infectious disease pathogens.[Footnote 1] The
Centers for Disease Control and Prevention (CDC) is also responsible
for research on such pathogens. Following the anthrax attacks, NIAID
expanded its research program to emphasize biodefense research. In
February 2002, it issued the NIAID Strategic Plan for Biodefense
Research, which outlined a need for research aimed at the development
of vaccines, diagnostics, and therapeutics and construction of
additional biocontainment laboratories in which to conduct the
research.[Footnote 2] According to NIH, a shortage of high-level
biocontainment laboratories exists.
In response to the Strategic Plan, NIAID established the National
Biocontainment Laboratory (NBL) and Regional Biocontainment Laboratory
(RBL) construction programs. The overall objective of the NBL
construction program is to provide funding to design and construct
state-of-the-art biosafety level (BSL) 4, 3, and 2 laboratories,
including associated research and administrative support space, and the
objective of the RBL construction program is to provide similar
facilities containing BSL-3 and -2 laboratories.[Footnote 3] HHS's
guidelines, entitled Biosafety in Microbiological and Biomedical
Laboratories (BMBL),[Footnote 4] specify four BSLs, which consist of
combinations of laboratory practices and techniques, safety equipment,
and facilities that are recommended for laboratories that conduct
research on potentially dangerous pathogens and toxins, with BSL-4
being the highest level.[Footnote 5] In fiscal year 2003, NIAID awarded
funding to two universities to construct NBLs and to nine universities
to construct RBLs, and in fiscal year 2005, NIAID awarded funding to
four more universities to construct RBLs. As of January 2007, the NBLs
and RBLs are at various stages of design and construction and are not
yet operational.[Footnote 6]
Because the deliberate or accidental release of biological pathogens
from a biocontainment laboratory could have disastrous consequences,
concerns exist about the oversight of these laboratories. This report
responds to your November 30, 2005, request that we provide information
associated with the construction of NBLs and RBLs funded by NIAID in
fiscal years 2003 and 2005. Your questions covered requirements and
guidance for these laboratories, funding award factors, communication
with the public, and research agendas. Enclosure I provides background
information for these questions and our answers to the questions,
enclosure II provides lists of infectious agents with the potential to
be used in bioterrorism, and enclosure III provides examples of
regulations and guidelines applicable to NBL and RBL operations and
security procedures.
To address these issues, we reviewed federal laws, regulations, and
guidelines for these facilities. However, we could not examine
laboratory operational activities, such as facility inspections,
employee investigations, and research oversight because none of the
NBLs and RBLs are operational. We also reviewed certain related state
and local requirements. We interviewed NIH, NIAID, and CDC officials
and local government representatives of some of the localities where
the NBLs and RBLs are being built about the planned oversight of the
new laboratories. We conducted site visits at the two universities
where the NBLs are being built and at four universities where RBLs are
being built and conducted a telephone conference with officials from a
fifth university where an RBL is being built. We also interviewed NIAID
officials regarding the NBL and RBL award process. We conducted our
review from December 2005 through January 2007 in accordance with
generally accepted government auditing standards. We provided a draft
of this report to HHS for comment. The department provided technical
comments, which we incorporated as appropriate.
- - - --:
We are sending copies of this report to the Secretary of Health and
Human Services and other interested parties. We will also make copies
available to others on request. In addition, the report will be
available at no charge on GAO's Web site at http://www.gao.gov.
If you or your staff have any questions about this report, please
contact me at (202) 512-7101 or bascettac@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. Other key contributors to this report
were Michael T. Blair, Jr., Assistant Director; Lesia Mandzia; Roseanne
Price; and Shannon Slawter.
Sincerely yours,
Signed by:
Cynthia A. Bascetta:
Director, Health Care:
[End of section]
Enclosure I: Background and Response to the Request Letter Questions:
Background:
The administration and the Congress responded to the 2001 terrorist
attacks by increasing funding for biodefense preparedness and research.
The National Institute of Allergy and Infectious Diseases (NIAID) has
allocated its increased biodefense research funding to developing
vaccines, therapeutics, and diagnostics against a range of bioterrorist
threats. NIAID identified certain pathogens, such as viruses and
bacteria, that could be used in a bioterrorist attack and placed them
into three categories--A, B, and C--depending on how easily they could
be spread and the severity of illness or extent of death they could
cause.[Footnote 7] NIAID's categorization is used for setting research
priorities. In February 2002, the National Institutes of Health (NIH)
convened the Blue Ribbon Panel on Bioterrorism and Its Implications for
Biomedical Research. Incorporating advice from the Blue Ribbon Panel,
NIAID developed three key documents to guide its biodefense research
program:
* The NIAID Strategic Plan for Biodefense Research outlines plans for
addressing research needs in the broad area of bioterrorism and
emerging and reemerging infectious diseases and for constructing
appropriate biocontainment laboratories in which to do the research.
* The NIAID Biodefense Research Agenda for CDC Category A Agents
provides priorities and goals for research on Category A agents, also
known as Category A priority pathogens, which cause diseases that
include anthrax, smallpox, plague, botulism, tularemia, and viral
hemorrhagic fevers. Category A agents are easily transmitted and would
cause high mortality and social disruption, require special public
health preparedness, and present the greatest bioterrorism danger.
* The NIAID Biodefense Research Agenda for Category B and C Priority
Pathogens provides priorities and goals for research on Category B and
C priority pathogens, also known as Category B and C agents. Category B
agents, such as hepatitis A virus and salmonella, are easily
transmitted, but they would result in lower mortality than Category A
agents, and present the second greatest danger to the public. Category
C agents, such as Crimean-Congo hemorrhagic fever virus and multidrug-
resistant tuberculosis, are emerging pathogens that in the future might
present a danger of potentially high rates of morbidity if they become
readily available and easy to produce.
According to NIH, although many U.S. institutions and companies with
infectious disease research programs have the biosafety level (BSL) 3
laboratories needed to perform their research, most such laboratories
are small, dedicated to particular uses, or in need of modernization.
In addition, NIH reported that as of May 2006 there were only four
operational BSL-4 laboratories in the United States. One component of
NIAID's Strategic Plan is to provide increased capacity through the
construction of biocontainment facilities in which to conduct research
on potentially dangerous pathogens safely and securely. As table 1
shows, in fiscal year 2003, NIAID awarded funding to two universities
to construct National Biocontainment Laboratories (NBL) that will
provide additional capacity for research at BSL-4, -3, and -2, and nine
universities to construct Regional Biocontainment Laboratories (RBL)
that will provide additional capacity for research at BSL-3 and -2. In
addition, in fiscal year 2005, NIAID awarded funding to four more
universities to construct RBLs that will include BSL-3 and -2
laboratories.
Table 1: Summary of NIAID's NBL and RBL Awards and Projected Completion
Dates:
Type of award: NBL;
Total number of awards: 2;
Number of awards by fiscal year: Fiscal year 2003: 2;
Number of awards by fiscal year: Fiscal year 2005: 0;
Projected construction completion dates[A]: Calendar year 2007: 0;
Projected construction completion dates[A]: Calendar year 2008: 2;
Projected construction completion dates[A]: Calendar year 2009: 0;
Projected construction completion dates[A]: Calendar year 2010: 0.
Type of award: RBL;
Total number of awards: 13;
Number of awards by fiscal year: Fiscal year 2003: 9;
Number of awards by fiscal year: Fiscal year 2005: 4;
Projected construction completion dates[A]: Calendar year 2007: 3;
Projected construction completion dates[A]: Calendar year 2008: 6;
Projected construction completion dates[A]: Calendar 2009: 2;
Projected construction completion dates[A]: Calendar year 2010: 1.
Type of award: Total;
Total number of awards: 15;
Number of awards by fiscal year: Fiscal year 2003: 11;
Number of awards by fiscal year: Fiscal year 2005; 4;
Projected construction completion dates[A]: Calendar year 2007: 3;
Projected construction completion dates[A]: Calendar year 2008: 8;
Projected construction completion dates[A]: Calendar year 2009: 2;
Projected construction completion dates[A]: Calendar year 2010: 1.
Source: NIAID.
Note: NBL and RBL awards were not provided in fiscal years 2004 or
2006. NIAID does not intend to make any additional NBL or RBL awards.
[A] Construction was completed at one RBL in 2006.
[End of table]
The NBLs and RBLs were funded to support NIAID's biodefense research
agendas for Category A, B, and C priority pathogens. A number of the
Category A, B, and C priority pathogens have also been designated by
the Department of Health and Human Services' (HHS) Centers for Disease
Control and Prevention (CDC) and the Department of Agriculture's (USDA)
Animal and Plant Health Inspection Service (APHIS) as select agents.
(Enc. II contains a list of NIAID's Category A, B, and C priority
pathogens and indicates whether they have been designated as select
agents.) Like Category A, B, and C priority pathogens, select agents
are pathogens and toxins that are capable of causing substantial harm
to public health and safety. While NIAID's list is for setting research
priorities, the HHS and USDA list is for controlling and monitoring
access to select agents. NBLs and RBLs that intend to possess, use, or
transfer select agents are required to register with CDC or APHIS. CDC
is responsible for the registration and oversight of laboratories that
possess, use, or transfer select agents that could pose a threat to
human health. APHIS is responsible for the registration and oversight
of laboratories that possess, use, or transfer select agents that could
pose a threat to animal or plant health or animal or plant products.
Some select agents, such as anthrax, pose a threat to both human and
animal health and are regulated by both agencies.
Response to Request Letter Questions:
1. What federal requirements and guidelines apply to NBL and RBL
laboratory operations and security procedures?
The NBLs and RBLs are subject to a number of federal requirements and
guidelines for laboratory operations and security procedures. (See enc.
III for a list of some of these requirements and guidelines.) As a
condition of the award, each NBL and RBL must attest that it will
comply with applicable federal, state, and local regulations. As of
January 2007, the NBLs and RBLs are at various stages of design and
construction and are not yet operational.[Footnote 8] The NBLs and RBLs
must be designed and constructed in compliance with federal regulations
and guidelines--a process that is being monitored by NIAID--and once
operational, they will be subject to federal regulations intended to
ensure a safe and secure environment in which to conduct research on
dangerous biological pathogens and toxins.
According to NIAID officials, during design and construction, the NBL
and RBL awardees work with NIAID staff and NIAID's Construction Quality
Management contractor to ensure that their facility design is in
compliance with NIH policy, which reflects federal standards. In
addition, NIAID staff must review and approve the design and cost
estimates before bids and proposals can be solicited by the awardees
for construction activities. NIAID officials also told us that NIAID
monitors the awardees through monthly meetings, frequent site visits,
and teleconferences. During the design and construction phase, the NBLs
and RBLs must comply with the following:
* The NIH Design Policy & Guidelines, which establishes policy, design
standards, and technical criteria for use in designing and constructing
biomedical research laboratories and animal research facilities. This
document includes a section on research laboratories and addresses
biological safety of BSL-3 and -4 laboratories, including the
restricted access of laboratories; heating, ventilation, and air
conditioning systems; and the use of biological safety cabinets.
* Physical Security Design Guidelines for Projects Using NIH
Construction Grants, which provides grantees, institute-designated
officials, and grantees' architects and engineers with assistance in
meeting the desired levels of protection of NIH-funded facilities and
outlines requirements pertaining to perimeter barriers, controlled
entrance access points, the storage of select agents, and additional
security requirements for BSL-3 and -4 laboratories, such as closed-
circuit television coverage of internal laboratory spaces.
* The NIH Model Commissioning Guide, which describes the means to
ensure that (1) all building systems are installed and perform
interactively according to the design intent, (2) the systems are
efficient and cost effective and meet the user's operational needs, (3)
the installation is adequately documented, and (4) the operators are
adequately trained.
* The National Environmental Policy Act of 1969[Footnote 9] (NEPA),
which, according to the Environmental Protection Agency, requires the
preparation of detailed statements involving an assessment of the
impact of major federal actions significantly affecting the
environment. The statements include a description of the purpose and
need for the project, the alternatives to the proposed project, and a
description of the affected environment and environmental consequences
of the project.[Footnote 10]
Once operational, the NBLs and RBLs will be subject to additional
guidelines and regulations. For example, the Biosafety in
Microbiological and Biomedical Laboratories (BMBL) describes the
combinations of standards, special practices, and safety equipment for
BSL-1 through -4 facilities.[Footnote 11] BMBL states that biosafety
procedures must be incorporated into the laboratory's standard
operating procedures or biosafety manual, personnel must be advised of
special hazards and are required to read and follow instructions on
practices and procedures, and personnel must receive training on the
potential hazards associated with the work involved and the necessary
precautions to prevent exposures. In addition, BMBL contains guidelines
for laboratory security and emergency response, such as controlling
access to areas where select agents are used or stored. It also states
that a plan must be in place for informing police, fire, and other
emergency responders as to the type of biological materials in use in
the laboratory areas.
Furthermore, each NBL and RBL will be required to submit to NIAID an
annual progress report that describes its activities and
accomplishments during the prior funding period. The research
activities of the NBLs and RBLs, once operational, will dictate which
other regulations and guidelines apply to the NBLs and RBLs. For
example:
* NIH Guidelines for Research Involving Recombinant DNA
Molecules[Footnote 12] (NIH rDNA Guidelines) applies to research
involving recombinant DNA (rDNA).[Footnote 13] These guidelines set the
standards and procedures for research involving rDNA that institutions
must follow when they receive NIH funding for this type of research.
This includes the requirement to establish an institutional biosafety
committee (IBC). The IBC is responsible for reviewing rDNA research
conducted at or sponsored by the institution for compliance with the
NIH rDNA Guidelines and for approving those research projects that are
found to conform with the NIH rDNA Guidelines. IBCs also periodically
review ongoing rDNA research to ensure continued compliance with the
NIH rDNA Guidelines.
* For facilities registered with CDC and APHIS that possess, use, or
transfer select agents, the Select Agent Regulations[Footnote 14]
require:
- a Federal Bureau of Investigation security risk assessment for a
number of individuals, including each person who is authorized to have
access to select agents and toxins,
- written biosafety and incident response plans,
- training of individuals with access to select agents and of
individuals who will work in or visit areas where select agents or
toxins are handled and stored,
- a security plan sufficient to safeguard the select agent or toxin
against unauthorized access, theft, loss, or release, designed
according to a site-specific risk assessment, and that provides
protection in accordance with the risk of the agent or toxin,
- possible inspection by CDC or APHIS of the facility and its records
prior to issuance of the certificate of registration,[Footnote 15]
- records relating to the activities covered by the Select Agent
Regulations, and:
- facility registration with CDC or APHIS that indicates:
* each select agent the entity intends to possess, use, or transfer;
* the building where it will be used and stored and the laboratory
safety level;
* a list of people authorized to have access to the select agents;
* the objectives of the work for each select agent, including a
description of the methodologies or laboratory procedures to be used;
* a description of the physical security and biosafety plans; and:
* assurance of security and biosafety training for individuals who have
access to areas where select agents are handled and stored.
* Public Health Service Policy on Humane Care and Use of Laboratory
Animals applies if research involves animals and is supported by the
Public Health Service. This policy requires the creation of an
institutional animal care and use committee to oversee and evaluate all
aspects of the institution's animal care and use program.
2. What are the requirements for the IBCs, including their role and
responsibilities in reviewing research projects at the NBLs and RBLs?
The IBC is responsible for reviewing rDNA research conducted at the
institution to ensure that it is in compliance with the NIH rDNA
Guidelines. If an institution receives any NIH funding for rDNA
research, it must observe the NIH rDNA Guidelines for all research
involving rDNA molecules.[Footnote 16] Thus, even if an institution has
only one NIH-funded project subject to the NIH rDNA Guidelines, all
rDNA research projects conducted at that institution must also adhere
to the NIH rDNA Guidelines. The guidelines describe the institutional
review, biosafety and containment, and oversight practices that must be
observed by an institution receiving NIH funding for rDNA research and
should be implemented by the institution to ensure that proper
biosafety and containment practices are employed. NIH's Office of
Biotechnology Activities (OBA) oversees rDNA research and develops and
implements the NIH rDNA Guidelines.
To comply with the NIH rDNA Guidelines an institution must:
* establish an IBC having a minimum of five members, at least two of
whom are not affiliated with the institution and "represent the
interest of the surrounding community with respect to health and
protection of the environment"
* register the IBC with NIH's OBA;
* submit an annual report to OBA that includes a roster and description
of each of the IBC committee members;
* upon request, provide to the public the IBC meeting minutes,
committee rosters, and biographical sketches of members; and:
* appoint a biological safety officer (BSO) if the institution conducts
rDNA research at BSL-3 or -4 or engages in large-scale
research.[Footnote 17] The BSO's duties include conducting periodic
inspections to ensure that standards are followed, developing emergency
plans, investigating accidents, and reporting any violations to the
IBC.
The principal investigator[Footnote 18] is responsible for submitting
the initial research protocol and any subsequent changes to the IBC for
review. The IBC's review should include the following: an assessment of
the BSL required for the research; an assessment of the facilities,
procedures, practices, and training and expertise of personnel involved
in the research; and a review of the emergency plans for handling
accidental spills and personnel contamination. IBCs should capture the
proceedings of their reviews in minutes. OBA guidance states that
minutes should "offer sufficient detail to serve as a record of major
points of discussion and the committee's rationale for particular
decisions."[Footnote 19]
All of the NBL and RBL awardees have an IBC currently registered with
OBA. Because the NIH rDNA Guidelines apply only to research involving
rDNA, the NBLs and RBLs are not required by the NIH rDNA Guidelines to
submit all research projects to an IBC for review; however, officials
at each of the seven universities we interviewed use an IBC or another
institutional body to review all research involving pathogens and
toxins. Five of the seven universities use an IBC to review all
research involving biological pathogens and toxins. The remaining two
universities review all research involving biological pathogens and
toxins but use different organizational bodies to conduct the research
review. The first university uses the IBC to review research with rDNA
or select agents and uses the university's occupational and
environmental safety office to review all other research involving
hazardous biological pathogens and toxins. The second uses the IBC to
review all research involving biological pathogens and uses a chemical
safety committee to review all research involving biological toxins.
3. What guidance and oversight was provided by NIH to the NBLs and RBLs
regarding adherence to our treaty obligations under the 1972 Biological
and Toxin Weapons Convention (BWC)?
NIH did not provide specific guidance to the NBL or RBL awardees
regarding adherence to the 1972 BWC.[Footnote 20] Article 1 of the 1972
BWC prohibits the development, production, stockpiling, acquisition, or
retention of biological pathogens and toxins that are not used to
develop or produce a protective medicine or for other peaceful
purposes, and weapons or other equipment that could be used to deliver
biological pathogens and toxins for hostile purposes or in armed
conflict. The BWC was implemented in federal law through the Biological
Weapons Anti-Terrorism Act of 1989.[Footnote 21]
According to NIH officials, NIH has programs and policies governing
compliance with all pertinent federal, state, and local laws, including
provisions of the BWC. The NIH Grants Policy Statement mandates that
applicants for and recipients of NIH awards adhere to all applicable
federal, state, and local laws, statutes, regulations, ordinances, and
policies. All recipients of NIH awards agree, as a term of award, that
they will comply with all relevant federal, state, and local laws and
regulations. While the BWC is not specifically highlighted, NIH
officials stated that it falls within the scope of federal laws that
must be followed. In the case of the NBLs and RBLs, NIH is funding the
construction of the laboratories; should NIH fund research at these
laboratories once they are operational, the same term of award will be
applied. Additionally, the Notice of Grant Award for the NBLs and RBLs
requires the awardees to use the space in support of the NIAID
Biodefense Agenda or other NIAID-approved biomedical research
activities. NIAID has clearly stated that bioweapons research is not
part of that agenda.
Furthermore, NIH uses the peer review process to ensure that research
funded by the agency facilitates the exchange of equipment, materials,
and scientific and technological information for the use of biological
agents and toxins for peaceful purposes, which is a requirement under
the BWC. The NIH peer review process provides assurances to NIH and HHS
that agency funds are being used to support research for "prophylactic,
protective or other peaceful purposes" in compliance with the BWC. NIH
officials stated that ultimately, it is the awardee's responsibility to
ensure proper use of NIH-awarded funds and ensure their compliance with
the terms and conditions of the award. It is the responsibility of the
awardee to ensure that its employees are not conducting illegal
activities on its property or in its buildings, whether the facilities
are federally or nonfederally supported.
4. Are the NBLs and RBLs barred from doing classified research, or can
individual researchers obtain funding from other sources to do
classified research at the facility? If classified work is permitted,
who would oversee that work? What obligations, if any, would the
facility have to inform local authorities or the local community that
classified work was being done at the facility?
NIAID officials stated that the NBLs and RBLs would not be barred from
conducting classified research with non-NIAID monies. They further
stated that NIAID would not require each of the NBLs and RBLs to
develop a policy for conducting such research. However, the officials
said that NIAID did not fund classified research and that it had no
plans to do so.[Footnote 22] Representatives of the two NBLs stated
that while neither institution had policies prohibiting classified
research, it would not be conducted at their laboratories. Of the five
RBLs whose officials we interviewed, three have institutional policies
prohibiting classified research. Representatives at the two remaining
RBLs stated that their institutions did not prohibit classified
research and that they would consider it.
According to NIAID, if the NBLs and RBLs were to conduct classified
research, they would have to comply with all federal, state, and local
regulations regarding the oversight of classified research. Pursuant to
executive order,[Footnote 23] an agency head or senior agency official
must establish controls to prevent access by unauthorized persons to
classified information. There are no federal requirements that local
authorities or the local community must be informed that classified
work is being done at the facility.
5. What factors did NIAID consider when awarding funding for
construction of the NBLs and RBLs? Did the award factors include
consideration of the capability of the local public health authority to
respond in the event of an accident, the relationship between the
laboratory and the surrounding community, and the demographic and
geographic environment of the laboratory that might affect risks to the
laboratory or the community?
The following factors, which were required as part of the application,
were considered by NIAID during the review and selection process for
NBL and RBL awardees:
* association with the Regional Centers of Excellence for Biodefense
and Emerging Infectious Diseases Research (RCE);[Footnote 24]
* ability to support the desired scope of work;
* pertinent experience of the principal investigator and team;
* community relations plan, which describes how they propose to
establish and maintain a strong community relations effort throughout
the planning, design, construction, and operation of the facility;
* the ability to serve the purposes of the NIAID biodefense research
agendas and to conduct research identified by NIAID as important to
program goals;
* the ability to document the availability of matching funds; and:
* geographic distribution of the facilities.
In addition, to comply with NEPA, prior to submitting the application
for consideration, applicants were required to make a public disclosure
to announce the construction project[Footnote 25] and to analyze the
probable environmental impact of proposed projects. Each of the
awardees conducted this assessment using a checklist provided by NIH
called the Environmental Analysis Form.[Footnote 26] This form asked
applicants to answer yes or no to a series of specific questions
regarding the potential impact of the NBL or RBL construction projects.
The analysis was intended to convey available environmental information
with the initial award application. For example, see the following
questions:
* Will the project:
- include the use of wetlands (swamps, marshes, etc.)?
- decrease the volume of water in a lake, river table, reservoir, etc.?
- not comply with the local and state land use planning?
- increase identifiable ambient air pollution levels from a new
emission source or from existing sources?
- generate solid wastes that cannot be properly disposed of by existing
facilities?
* Could the proposed project disrupt:
- food supplies, water supplies, or electrical power for 48 hours?
- existing health services' response in case of a disaster?
* Will the proposed project encroach upon any historical,
architectural, or archeological cultural property?
Applicants were required to provide a brief description of the impact
if the answer to any question was yes.
The NBL and RBL Request for Proposals and Applications did not require
applicants to address the following factors in their applications: the
capability of the local public health authority to respond in the event
of an accident, the relationship between the laboratory and the
surrounding community, and the demographic and geographic environment
of the laboratory that might affect the risks to the laboratory or the
community. Therefore, if applicants did not address these factors, they
were not penalized. However, if the information was submitted as part
of the application, it may have been considered by peer reviewers
because peer reviewers are instructed to evaluate the application as a
whole.
6. In the event that containment of an NBL or RBL has been breached in
some manner, what are the obligations of the facility to inform NIH,
CDC, and the local public health authorities?
The containment of pathogens, including select agents, can be breached
through theft, loss, or release.[Footnote 27] According to NIAID, it
does not have requirements that pertain to instances of the theft,
loss, or release of Category A, B, and C priority pathogens.[Footnote
28] However, laboratories must report such instances as required by the
NIH rDNA Guidelines and the Select Agent Regulations and may be
required to report such instances under state or local laws.
The NIH rDNA Guidelines specify reporting requirements for significant
problems, violations of the NIH rDNA Guidelines, or any significant
research-related accidents and illnesses. In general, all such events
should be reported to NIH's OBA within 30 days of their occurrence,
unless they fit the description of events that must be reported on a
more expedited basis. Spills or accidents in the BSL-2 laboratories
resulting in an overt exposure must be immediately reported to the IBC
and NIH's OBA.[Footnote 29] Spills or accidents occurring in BSL-3 or
BSL-4 laboratories resulting in an overt or potential exposure must be
immediately reported to the IBC, BSO, and NIH's OBA.
The Select Agent Regulations require that upon discovery of the theft
or loss of a select agent, an individual or entity must immediately
notify CDC or APHIS and appropriate federal, state, or local law
enforcement agencies.[Footnote 30] While NIAID does not have
requirements for reporting theft or loss, CDC and APHIS regulations
require that theft or loss of a select agent must be reported even if
the select agent is subsequently recovered or the responsible parties
are identified.
Upon discovery of a release of a select agent causing occupational
exposure or release of a select agent outside the primary barriers of
the biocontainment area, an entity or individual must immediately
notify CDC or APHIS. After the initial reporting of a theft, loss, or
release the entity must submit within 7 calendar days a completed
Report of Theft, Loss, or Release of Select Agents and Toxins
form.[Footnote 31] The guidance document for completing this form also
states that in the event of theft, loss, or release of select agents or
toxins, entities should notify the appropriate local, state, and
federal health agencies. Additionally, the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002[Footnote 32] states
that if the Secretary of HHS determines, in the case of a release of a
select agent, that the release poses a threat to public health or
safety, the Secretary must take appropriate action to notify relevant
state and local public health authorities, other federal authorities,
and if necessary, the public.
State and local health departments in some of the NBL and RBL locations
at which we conducted interviews have certain reporting requirements
related to select agents. For example, one state requires that every
laboratory possessing HHS select agents and conducting business in the
state submit an annual report to the state's department of health. In
the event of a suspected theft, loss, or release of any select agent,
the laboratory's responsible official is required to report to the
state's department of health within 24 hours. A local public health
authority in a different state requires that an entity immediately
report to the local public health department any of the following
circumstances that involve specified biological agents, including
select agents:
* any spill or accident that results in an exposure and:
* any illness among persons caused or potentially caused by the
specified biological agents or an attenuated strain[Footnote 33] of the
specified biological agents.
A 2004 incident involving the release of a select agent at a university
resulted in that awardee's deciding to develop procedures to prevent
this situation in the future. The awardee experienced an inadvertent
release of the select agent Francisella tularensis in one of its
existing laboratories. While CDC and the local public health department
had concerns that gaps may have existed in the university's biosafety
program that led to the exposure, after reviewing the events, CDC
concluded that the university complied with the Select Agent
Regulations notification requirements and took adequate actions after
the exposure to prevent similar events from occurring.[Footnote 34] As
a result of this incident, the university developed a policy for strain
verification prior to a researcher's beginning any work.[Footnote 35]
7. What degree of transparency and communication with the community is
required of NBLs or RBLs with respect to their individual research
projects?
NIAID does not have regulations that address transparency and
communication with the community regarding individual research projects
at NBLs and RBLs, but it supports a policy of encouraging publication
and dissemination of research findings. Public information on federally
funded biomedical research projects can be accessed through an Internet-
based database called the Computer Retrieval of Information on
Scientific Projects (CRISP). CRISP is maintained by NIH and contains
information on biomedical research projects funded by a number of HHS
agencies, including NIH and CDC. As part of the application for the
award, NIAID asked the awardees to develop plans that describe their
approach to developing community relations. Further, NIAID employs a
community relations consultant, who is available to assist and advise
the awardees on their ongoing community relations plans and practices.
NIAID also holds annual community relations workshops for the NBLs and
RBLs, where they can learn from each other and from NIAID how best to
maintain positive relations with their communities and the general
public. For example, one university representative at the community
relations workshop held in April 2006 described the membership
application process and guidelines for a community liaison committee
the university was in the process of establishing.
A recent example of a local requirement that promotes transparency and
communication with the community is a new regulation promulgated by a
local health department in one location where an NBL is being
constructed. This regulation applies to BSL-3 and -4 laboratories that
operate within the health department's jurisdiction and will apply to
any NBLs or RBLs that will operate in the jurisdiction. One of the
regulation's requirements is that each entity hold an IBC meeting that
is open to the public at least once per calendar year.[Footnote 36] The
regulation stipulates that during this meeting the IBC should review
the type and nature of the biological research at BSL-3 and -4 that is
conducted by the entity.
In another community, one awardee is working to promote transparency by
forming a committee that consists entirely of individuals from the
community who are not affiliated with the university. This university
would like this committee to help the university better understand the
interests and concerns of the community, enhance the dissemination of
information to the community about both the risks and the safety
measures undertaken, and help the university develop an incident
communication plan.
8. Who is responsible for setting the research agenda and establishing
the research protocols for NBLs and RBLs--individual scientists or the
manager of the facility?
While the NBLs and RBLs that NIAID funded are intended to conduct
research on NIAID's Category A, B, and C priority pathogens in support
of the NIAID biodefense agendas or other NIAID-approved biomedical
research activities for 20 years, NIAID left it to the discretion of
each awardee to establish the research agenda and the research
protocols. The NBLs, RBLs, and RCEs are partners in the NIAID
Biodefense Network, which helps define the direction and scope of
biodefense and emerging infectious disease research activities within
the NBLs, RBLs, and RCEs and ensures that the programs are meeting the
goals of the NIAID Biodefense Strategic Plan and Research Agendas. The
NIAID Biodefense Network meets at least annually, or as needed in the
event of a biodefense emergency or an emerging infectious disease
emergency. The purpose of these meetings is to share scientific
information, assess scientific progress, identify new research and
development and collaboration opportunities, and establish research
priorities. Additionally, the facilities must be available and prepared
to assist national, state, and local public health efforts in the event
of a bioterrorist emergency. In addition, NIAID staff will be able to
monitor the research conducted at each NBL and RBL by conducting
periodic site visits to the facilities and reviewing the annual
progress report that awardees are required to submit, which is supposed
to describe the activities and accomplishments during the prior year.
Enclosure II: NIAID Category A, B, and C Priority Pathogens and Those
Designated as Select Agents:
NIAID category: Antimicrobial resistance, excluding research on
sexually transmitted organisms;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: While not a specific pathogen, antimicrobial resistance is on
the NIAID list. Antimicrobial resistance is the result of microbes
changing in ways that reduce or eliminate the effectiveness of drugs,
chemicals, or other agents to cure or prevent infections.
NIAID Category A, B, or C priority pathogen[A]: Bacillus anthracis
(anthrax);
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Brucella species
(brucellosis);
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: Three Brucella species--Brucella abortus, Brucella melitensis,
and Brucella suis--are select agents.
NIAID Category A, B, or C priority pathogen[A]: Burkholderia mallei
(glanders);
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Burkholderia
pseudomallei;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Caliciviruses;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: California
encephalitis;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Campylobacter jejuni;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Clostridium botulinum
[Botulinum neurotoxin producing species of Clostridium];
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Coxiella burnetii (Q
fever);
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Crimean-Congo
hemorrhagic fever virus;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Cryptosporidium parvum;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Cyclospora
cayatanensis;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Dengue;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Diarrheagenic E. coli;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Ebola;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: EEE [eastern equine
encephalitis virus];
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Entamoeba histolytica;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Epsilon toxin of
Clostridium perfringens;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Francisella tularensis
(tularemia);
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Giardia lamblia;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Guanarito virus [South
American hemorrhagic fever: Guanarito[B]];
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Hantaviruses;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Hepatitis A;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Influenza;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: Two influenza strains--Avian influenza virus (highly pathogenic)
and reconstructed 1918 influenza virus--are select agents.
NIAID Category A, B, or C priority pathogen[A]: Japanese encephalitis
virus;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Junin virus [South
American hemorrhagic fever: Junin];
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Kyasanur Forest virus
[Tick-borne encephalitis complex (flavi) virus: Kyasanur Forest
disease];
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: LaCrosse;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Lassa fever;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: LCM (Lymphocytic
choriomeningitis virus);
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Listeria monocytogenes;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Machupo virus [South
American hemorrhagic fever: Machupo];
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Marburg;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Microsporidia;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Multidrug-resistant TB;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Nipah virus;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Other Rickettsias;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: One Rickettsia species, Rickettsia rickettsii, is a select agent
and is a NIAID Category B pathogen.
NIAID Category A, B, or C priority pathogen[A]: Pathogenic vibrios;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Rabies;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Ricin toxin (from
Ricinus communis);
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Rift Valley fever
virus;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Salmonella;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Severe acute
respiratory syndrome-associated coronavirus (SARS-CoV);
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Shigella species;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: The bacterial Shigella species are not select agents. Some
bacterial Shigella species express a potent toxin called shiga toxins
(shigatoxin) or shiga-like ribosome-inactivating proteins. Above a
certain threshold amount listed at 43 C.F.R. § 73.3, shigatoxin and
shiga-like ribosome inactivating proteins are select agents.
NIAID Category A, B, or C priority pathogen[A]: Staphylococcus
enterotoxin B [staphylococcal enterotoxins];
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: Only staphylococcus enterotoxin B is a NIAID Category B
pathogen; however, all staphylococcal enterotoxins are select agents.
NIAID Category A, B, or C priority pathogen[A]: Tick-borne encephalitis
viruses;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: Five species of tick- borne encephalitis viruses are also select
agents: central European tick-borne encephalitis, Far Eastern tick-
borne encephalitis, Omsk hemorrhagic fever, and Russian spring and
summer encephalitis.
NIAID Category A, B, or C priority pathogen[A]: Toxoplasma;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Typhus fever
(Rickettsia prowazekii);
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Variola major
(smallpox) and other pox viruses;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: In addition to Variola major, camel pox virus, goat pox virus,
sheep pox virus, monkey pox virus, and Variola minor virus (Alastrim)
are select agents and NIAID Category A pathogens.
NIAID Category A, B, or C priority pathogen[A]: VEE [Venezuelan equine
encephalitis virus];
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: WEE (Western equine
encephalitis virus);
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: West Nile virus;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Yellow fever;
NIAID category: A: [Empty];
NIAID category: B: [Empty];
NIAID category: C: Check;
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Yersinia
enterocolitica;
NIAID category: A: [Empty];
NIAID category: B: Check;
NIAID category: C: [Empty];
Select agent: [Empty];
Notes: [Empty].
NIAID Category A, B, or C priority pathogen[A]: Yersinia pestis;
NIAID category: A: Check;
NIAID category: B: [Empty];
NIAID category: C: [Empty];
Select agent: Check;
Notes: [Empty].
Source: GAO.
[A] Taxonomic names of pathogens are given in italics. If the name of
the pathogen as designated by HHS or USDA differs from the NIAID
designation, the select agent designation is given in brackets.
[B] There are six South American hemorrhagic fevers that are NIAID
Category A pathogens and also select agents; however, only four are
listed above--Guanarito, Junin, Lassa fever, and Machupo. The other two
are Flexal and Sabia.
[End of table]
[End of section]
Enclosure III: Examples of Regulations and Guidelines Applicable to the
NBLs and RBLs:
All NBLs and RBLs are required to comply with all federal, state, and
local regulations and to sign assurances that they will comply with all
regulations. In addition to the regulations and guidelines described in
enclosure I, listed below are other federal regulations and guidelines
that could affect NBL and RBL operations and security procedures.
Regulations:
* 15 C.F.R. pts. 738, 742, 745, and 774 (2006)--Implementation of
Unilateral Chemical/Biological Controls on Certain Biological Agents
and Toxins--expands export and reexport controls on certain biological
agents and toxins (referred to as select agents and toxins) that have
been determined by CDC (HHS) and APHIS (USDA) to have the potential to
pose a severe threat to human, animal, and plant life, as well as
certain sectors of the U.S. economy (e.g., agriculture).
* 29 C.F.R. pt. 1910.1200 (2006)--Hazard Communication--requires that
the hazards of all chemicals produced or imported are evaluated and
that information concerning the hazards is transmitted to employers and
employees. This transmittal of information is to be accomplished by
means of comprehensive hazard communication programs, which are to
include container labeling and other forms of warning, material safety
data sheets, and employee training.
* 29 C.F.R. pt. 1910.1201 (2006)--Retention of DOT Markings, Placards
and Labels--requires that an employer that receives a package of
hazardous material which is required to be marked or labeled in
accordance with the Department of Transportation's (DOT) Hazardous
Materials Regulations shall retain the markings, placards, and labels
on the package until the packaging is sufficiently cleaned of residue
and purged of vapors to remove any potential hazards.
* 29 C.F.R. § 1910.1030 (2006)--Occupational Exposure to Bloodborne
Pathogens--provides a standard on working safely with human blood and
body fluids. This standard outlines the requirements for employers,
including research laboratories, that are working with human body
fluids, tissues, and potential bloodborne pathogens. The standard
provides information concerning facility requirements, safe work
practices, medical surveillance, personal protection, first-aid
procedures, and worker training.
* 29 C.F.R. § 1910.1450 (2006)--Occupational Exposure to Hazardous
Chemicals in Laboratories--requires that employers develop and carry
out the provisions of a written chemical hygiene plan (CHP). The
purpose of a CHP is to provide the necessary work practices,
procedures, and policies to ensure that laboratory employees are
protected from exposure to potentially hazardous chemicals in use in
their work areas and that employees are trained in the plan.
* 42 C.F.R. pt. 72 (2006)--Interstate Shipment of Etiologic Agents--
specifies packaging and labeling requirements and procedures for
notification of successful delivery or failure of delivery of etiologic
agents. CDC has proposed rescinding this regulation to alleviate
confusion with existing regulations.[Footnote 37]
* 45 C.F.R. pt. 46 (2006)--Protection of Human Subjects--stipulates
substantive and procedural requirements for investigators and
institutions engaged in federally supported or federally conducted
research with humans.
* 49 C.F.R. pts. 171-178 (2006)--Transportation of Hazardous Materials-
-provides regulations for the safe transportation of both biological
and clinical specimens.
Guidelines:
* Guide for the Care and Use of Laboratory Animals assists institutions
in caring for and using animals in ways judged to be scientifically,
technically, and humanely appropriate, and is also intended to assist
investigators in fulfilling their obligation to plan and conduct animal
experiments in accord with the highest scientific, humane, and ethical
principles.
* "Laboratory Security and Emergency Response Guidance for Laboratories
Working with Select Agents," MMWR, December 6, 2002, is intended for
laboratories working with select agents under BSL-2, -3, or -4
conditions as described in sections II and III of BMBL, and includes
recommendations for conducting facility risk assessments and developing
comprehensive security plans to minimize the probability of misuse of
select agents.
* NIH Grants Policy Statement is intended to make available to NIH
awardees, in a single document, the policy requirements that serve as
the general terms and conditions of NIH awards. This document also is
designed to provide information about NIH--its organization, its staff,
and its grant process.
* Good Laboratory Practice for Nonclinical Laboratory Studies applies
if a laboratory conducts studies that support or are intended to
support applications for research or marketing permits for products
regulated by HHS's Food and Drug Administration (FDA).[Footnote 38]
Under these regulations, the facility and its records are subject to
inspection by FDA.
(290516):
FOOTNOTES
[1] The U.S. Army Medical Research Institute of Infectious Diseases
conducts research to develop vaccines and diagnostics to protect
servicemembers from biological threats.
[2] Other biocontainment laboratories already exist in the United
States. These laboratories are located at federal facilities and
universities and in the private sector and are used to conduct
biomedical research.
[3] NIAID awarded funding for up to 75 percent of the cost of the
project.
[4] Department of Health and Human Services, Biosafety in
Microbiological and Biomedical Laboratories, 4th ed. (Washington, D.C.:
May 1999).
[5] According to the BMBL guidelines, BSL-1 laboratories house
pathogens and toxins that do not consistently cause disease in healthy
adult humans. BSL-2 laboratories are capable of housing pathogens and
toxins that are spread through puncture, absorption through mucous
membranes, or ingestion of infectious materials. BSL-3 laboratories are
capable of housing pathogens and toxins that have a potential for
aerosol transmission and that may cause serious and potentially lethal
infection. BSL-4 laboratories are capable of housing pathogens and
toxins that pose a high individual risk of life-threatening disease,
which may be aerosol transmitted and for which there is no available
vaccine or therapy.
[6] Construction is complete on only one of the RBLs.
[7] NIAID's Category A, B, and C Priority Pathogens list is based on
the Centers for Disease Control and Prevention Biological Diseases/
Agents List that identifies agents that could have a significant public
health impact on the U.S. population.
[8] Construction is complete on only one of the RBLs.
[9] Pub. L. No. 91-190, 83 Stat. 852 (1970) (codified at 42 U.S.C. ch.
55, as amended).
[10] After the award and prior to authorizing the use of any
construction funding, NIH required the NBL awardees to prepare an
Environmental Impact Statement (EIS) and the RBL awardees to prepare an
Environmental Assessment (EA). Two public meetings are required for an
EIS. The first meeting provides the public with an opportunity to
comment on what they would like to see in the EIS, and the second
provides an opportunity to comment on the draft report and suggest
changes. Public meetings are not required for an EA; however, anyone
can comment on an EA once it is complete. NIH's Office of Research
Facilities oversees this process, and each EIS and EA becomes an NIH
document once complete.
[11] The awardees were also required by the Notice of Grant Award to
design and construct the NBLs and RBLs to be fully compliant with the
design and construction guidance established in BMBL.
[12] 66 Fed. Reg. 57970 (Nov. 19, 2001).
[13] DNA is the molecule that encodes genetic information in the
nucleus of cells. It determines the structure, function, and behavior
of the cell. In the context of the NIH rDNA Guidelines, rDNA molecules
are defined as molecules that are constructed outside living cells by
joining natural or synthetic DNA segments to DNA molecules that can
replicate in a living cell. The definition also includes those
molecules that result from the replication of those described above.
[14] 42 C.F.R. pt. 73 (2006), 7 C.F.R. pt. 331 (2006), and 9 C.F.R. pt.
121 (2006).
[15] According to CDC officials, prior to possessing select agents, an
entity must be issued a certificate of registration from either the CDC
or the APHIS Select Agent Program. Additionally, the CDC Select Agent
Program currently inspects all entities prior to the initial issuance
of the certificate of registration to ensure that these entities are
compliant with the Select Agent Regulations. As part of an entity's
renewal process that occurs every 3 years, the CDC Select Agent Program
reinspects the entity.
[16] Research not involving rDNA is not subject to the NIH rDNA
Guidelines. Also, the NIH rDNA Guidelines describe particular
experiments involving rDNA that are exempt, generally because
experience with these experiments has shown that they pose negligible
risk to health or the environment.
[17] The NIH rDNA Guidelines describe large-scale research as involving
more than 10 liters of culture.
[18] The principal investigator is the person who is designated by an
applicant institution to direct a research project, oversee the
scientific and technical aspects of the award, and oversee the day-to-
day management of the research.
[19] NIH does not prescribe the level of detail for the IBC meeting
minutes but provides expectations with respect to the preparation of
minutes. OBA suggests that the minutes should include the date and
place of the meeting, names of attendees, indication of whether the
meeting was open or closed, and all motions and points of order. There
is no requirement that IBCs routinely submit their meeting minutes to
OBA.
[20] Convention on the Prohibition of the Development, Production and
Stockpiling of Bacteriological (Biological) and Toxin Weapons and on
Their Destruction, April 10, 1972, 1015 U. N. T. S. 163.
[21] Pub. L. No. 101-298, 104 Stat. 201 (codified at 18 U.S.C. §§ 175
et seq.)
[22] NIAID-funded research will not include research on bioweapons.
[23] Exec. Order No. 13292--Further Amendment to Executive Order 12958,
as amended 68 Fed. Reg. 15315 (Mar. 28, 2003).
[24] There are 10 RCEs. The purpose of the RCE program is to create a
network of institutions with staff and facilities dedicated to
developing therapeutics, vaccines, and diagnostics for NIAID's Category
A, B, and C priority pathogens.
[25] NEPA, § 102, as implemented by Exec. Order No. 11514, 35 Fed. Reg.
4247 (Mar. 5, 1970).
[26] A group of plaintiffs has filed a motion in Federal District
Court, seeking an injunction on federal funding for one of the
awardees. The Court has deferred ruling on the motion for preliminary
injunction in this case until after conclusion of the supplemental
environmental analysis, to be completed in 2007. This analysis will
include an assessment of the public health consequences of the
accidental release of communicable Category A pathogens and an analysis
to determine whether siting of the facility in a less populated area
would result in different public health consequences in the event of a
release. The university has also committed to developing a community
relations plan to improve community input and involvement, and to
discussing DNA research protocols and limitations.
[27] HHS and USDA define theft as the unauthorized removal of a select
agent, loss as the failure to account for a select agent, and release
as occupational exposure or release of a select agent outside of the
primary barriers of the biocontainment area. (See APHIS/CDC Form 3.)
[28] A number of NIAID's pathogens are select agents. Enc. II contains
a list of NIAID's Category A, B, and C priority pathogens and indicates
whether they are select agents.
[29] Institutions working at a maximum containment level of BSL-2 are
not required to have BSOs, and thus the NIH rDNA Guidelines are silent
on reporting these events to the BSO, though OBA highly recommends
reporting to the BSO as well, when one is on staff.
[30] 42 C.F.R. § 73.19 (2006), 7 C.F.R. § 331.19 (2006), and 9 C.F.R. §
121.19 (2006).
[31] APHIS/CDC Form 3.
[32] Pub. L. No. 107-188, § 201, 116 Stat. 594, 637, 645.
[33] An attenuated strain is a strain of a microorganism that has been
altered to diminish its virulence.
[34] Researchers at the laboratory where this release occurred believed
they had been working with a nonvirulent form of tularemia that was not
a select agent and not subject to the Select Agent Regulations. The
researchers became ill, and testing conducted by CDC revealed that the
researchers had actually been working with a virulent form of the
organism that was known to cause severe illness in humans. According to
the local public health department, laboratory practices and safety
measures used in the BSL-2 laboratory were inadequate to prevent
exposure.
[35] The Occupational Safety and Health Administration conducted an
inspection of the facility, but it did not issue a citation for the
exposure.
[36] The NIH rDNA Guidelines, which apply to any institution that
receives any NIH funding for rDNA research, states the following: "when
possible and consistent with protection of privacy and proprietary
interests, the institution is encouraged to open its Institutional
Biosafety Committee meetings to the public."
[37] 72 Fed. Reg. 92 (Jan. 3, 2007).
[38] The awardees are also required in the Notice of Grant Award to
design the NBLs and RBLs in accordance with the Good Laboratory
Practice guidelines.
GAO's Mission:
The Government Accountability Office, the audit, evaluation and
investigative arm of Congress, exists to support Congress in meeting
its constitutional responsibilities and to help improve the performance
and accountability of the federal government for the American people.
GAO examines the use of public funds; evaluates federal programs and
policies; and provides analyses, recommendations, and other assistance
to help Congress make informed oversight, policy, and funding
decisions. GAO's commitment to good government is reflected in its core
values of accountability, integrity, and reliability.
Obtaining Copies of GAO Reports and Testimony:
The fastest and easiest way to obtain copies of GAO documents at no
cost is through GAO's Web site (www.gao.gov). Each weekday, GAO posts
newly released reports, testimony, and correspondence on its Web site.
To have GAO e-mail you a list of newly posted products every afternoon,
go to www.gao.gov and select "Subscribe to Updates."
Order by Mail or Phone:
The first copy of each printed report is free. Additional copies are $2
each. A check or money order should be made out to the Superintendent
of Documents. GAO also accepts VISA and Mastercard. Orders for 100 or
more copies mailed to a single address are discounted 25 percent.
Orders should be sent to:
U.S. Government Accountability Office 441 G Street NW, Room LM
Washington, D.C. 20548:
To order by Phone: Voice: (202) 512-6000 TDD: (202) 512-2537 Fax: (202)
512-6061:
To Report Fraud, Waste, and Abuse in Federal Programs:
Contact:
Web site: www.gao.gov/fraudnet/fraudnet.htm E-mail: fraudnet@gao.gov
Automated answering system: (800) 424-5454 or (202) 512-7470:
Congressional Relations:
Gloria Jarmon, Managing Director, JarmonG@gao.gov (202) 512-4400 U.S.
Government Accountability Office, 441 G Street NW, Room 7125
Washington, D.C. 20548:
Public Affairs:
Paul Anderson, Managing Director, AndersonP1@gao.gov (202) 512-4800
U.S. Government Accountability Office, 441 G Street NW, Room 7149
Washington, D.C. 20548:
