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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.

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