Biological Research Laboratories: Issues Associated with the	 
Expansion of Laboratories Funded by the National Institute of	 
Allergy and Infectious Diseases (22-FEB-07, GAO-07-333R).	 
                                                                 
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. 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.				 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-333R					        
    ACCNO:   A66124						        
  TITLE:     Biological Research Laboratories: Issues Associated with 
the Expansion of Laboratories Funded by the National Institute of
Allergy and Infectious Diseases 				 
     DATE:   02/22/2007 
  SUBJECT:   Anthrax						 
	     Biological research				 
	     Biological warfare 				 
	     Biomedical research				 
	     Facility construction				 
	     Hazardous substances				 
	     Infectious diseases				 
	     Laboratories					 
	     Research and development				 
	     Research and development facilities		 
	     Safety regulation					 
	     Strategic planning 				 
	     Facility security					 
	     Federal regulations				 
	     Public safety					 
	     Government agency oversight			 

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GAO-07-333R

   

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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.^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.^2 According to NIH, a shortage of high-level biocontainment
laboratories exists.

^1The U.S. Army Medical Research Institute of Infectious Diseases conducts
research to develop vaccines and diagnostics to protect servicemembers
from biological threats.

^2Other 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.

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.^3 HHS's guidelines, entitled Biosafety in Microbiological
and Biomedical Laboratories (BMBL),^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.^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.^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.

^3NIAID awarded funding for up to 75 percent of the cost of the project.

^4Department of Health and Human Services, Biosafety in Microbiological
and Biomedical Laboratories, 4th ed. (Washington, D.C.: May 1999).

^5According 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.

^6Construction is complete on only one of the RBLs.

                                   - - - - -

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 [email protected]. 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,

Cynthia A. Bascetta
Director, Health Care

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.^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:

           o 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.

           o 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.

           o 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.
			  
^7NIAID'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.

           Table 1: Summary of NIAID's NBL and RBL Awards and Projected
           Completion Dates

                Number                     
                  of                       
                awards         Projected   
                  by          construction 
                fiscal         completion  
          Total  year           dates^a    
Type  number Fiscal Fiscal              Calendar Calendar Calendar Calendar 
of        of   year   year                  year     year     year     year 
award awards   2003   2005                  2007     2008     2009     2010 
NBL        2      2      0                     0        2        0        0 
RBL       13      9      4                     3        6        2        1 
Total     15     11      4                     3        8        2        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.

           ^aConstruction was completed at one RBL in 2006.

           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.^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:

           o 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.

           o 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.

           o 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.

           o The National Environmental Policy Act of 1969^9 (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.^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.^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:

           o NIH Guidelines for Research Involving Recombinant DNA
           Molecules^12 (NIH rDNA Guidelines) applies to research involving
           recombinant DNA (rDNA).^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.

           o For facilities registered with CDC and APHIS that possess, use,
           or transfer select agents, the Select Agent Regulations^14 require

                        o 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,

                        o written biosafety and incident response plans,

                        o 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,
                        o 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,

                        o possible inspection by CDC or APHIS of the facility
                        and its records prior to issuance of the certificate
                        of registration,^15

                        o records relating to the activities covered by the
                        Select Agent Regulations, and

                        o facility registration with CDC or APHIS that
                        indicates

                                     o each select agent the entity intends
                                     to possess, use, or transfer;

                                     o the building where it will be used and
                                     stored and the laboratory safety level;

                                     o a list of people authorized to have
                                     access to the select agents;

                                     o the objectives of the work for each
                                     select agent, including a description of
                                     the methodologies or laboratory
                                     procedures to be used;

                                     o a description of the physical security
                                     and biosafety plans; and

                                     o assurance of security and biosafety
                                     training for individuals who have access
                                     to areas where select agents are handled
                                     and stored.

           o 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.^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

                        o 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";

                        o register the IBC with NIH's OBA;

                        o submit an annual report to OBA that includes a
                        roster and description of each of the IBC committee
                        members;

                        o upon request, provide to the public the IBC meeting
                        minutes, committee rosters, and biographical sketches
                        of members; and

                        o appoint a biological safety officer (BSO) if the
                        institution conducts rDNA research at BSL-3 or -4 or
                        engages in large-scale research.^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^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."^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.^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.^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.^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,^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:

                        o association with the Regional Centers of Excellence
                        for Biodefense and Emerging Infectious Diseases
                        Research (RCE); ^24

                        o ability to support the desired scope of work;

                        o pertinent experience of the principal investigator
                        and team;

                        o 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;

                        o the ability to serve the purposes of the NIAID
                        biodefense research agendas and to conduct research
                        identified by NIAID as important to program goals;

                        o the ability to document the availability of
                        matching funds; and

                        o 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^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.^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:
           o Will the project

                        o include the use of wetlands (swamps, marshes,
                        etc.)?

                        o decrease the volume of water in a lake, river
                        table, reservoir, etc.?

                        o not comply with the local and state land use
                        planning?

                        o increase identifiable ambient air pollution levels
                        from a new emission source or from existing sources?

                        o generate solid wastes that cannot be properly
                        disposed of by existing facilities?

           o Could the proposed project disrupt

                        o food supplies, water supplies, or electrical power
                        for 48 hours?

                        o existing health services' response in case of a
                        disaster?

           o 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.^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.^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.^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.^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.^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 2002^32 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:

                        o any spill or accident that results in an exposure
                        and

                        o any illness among persons caused or potentially
                        caused by the specified biological agents or an
                        attenuated strain^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.^34 As a result of this
           incident, the university developed a policy for strain
           verification prior to a researcher's beginning any work.^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.^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.
			  
^8Construction is complete on only one of the RBLs.

^9Pub. L. No. 91-190, 83 Stat. 852 (1970) (codified at 42 U.S.C. ch. 55,
as amended).

^10After 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.

^11The 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.

^1266 Fed. Reg. 57970 (Nov. 19, 2001).

^13DNA 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.

^1442 C.F.R. pt. 73 (2006), 7 C.F.R. pt. 331 (2006), and 9 C.F.R. pt. 121
(2006).

^15According 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.

^16Research 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.

^17The NIH rDNA Guidelines describe large-scale research as involving more
than 10 liters of culture.

^18The 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.

^19NIH 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.

^20Convention 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.

^21Pub. L. No. 101-298, 104 Stat. 201 (codified at 18 U.S.C. SS 175 et
seq.).

^22NIAID-funded research will not include research on bioweapons.

^23Exec. Order No. 13292--Further Amendment to Executive Order 12958, as
amended 68 Fed. Reg. 15315 (Mar. 28, 2003).

^24There 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.

^25NEPA, S 102, as implemented by Exec. Order No. 11514, 35 Fed. Reg. 4247
(Mar. 5, 1970).

^26A 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.

^27HHS 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.)

^28A 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.

^29Institutions 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.

^3042 C.F.R. S 73.19 (2006), 7 C.F.R. S 331.19 (2006), and 9 C.F.R. S
121.19 (2006).

^31APHIS/CDC Form 3.

^32Pub. L. No. 107-188, S 201, 116 Stat. 594, 637, 645.

^33An attenuated strain is a strain of a microorganism that has been
altered to diminish its virulence.

^34Researchers 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.

^35The Occupational Safety and Health Administration conducted an
inspection of the facility, but it did not issue a citation for the
exposure.

^36The 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."

			  Enclosure II

  NIAID Category A, B, and C Priority Pathogens and Those Designated as Select
                                     Agents
												 
                          NIAID category                                      
NIAID Category A, B,                                                       
or C priority                         Select                               
pathogen^a              A    B    C   agent  Notes                         
Antimicrobial                     fS         While not a specific          
resistance, excluding                        pathogen, antimicrobial       
research on sexually                         resistance is on the NIAID    
transmitted organisms                        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.   
Bacillus anthracis      fS              fS                                 
(anthrax)                                                                  
Brucella species             fS              Three Brucella                
(brucellosis)                                species--Brucella abortus,    
                                                Brucella melitensis, and      
                                                Brucella suis--are select     
                                                agents.                       
Burkholderia mallei          fS         fS                                 
(glanders)                                                                 
Burkholderia                 fS         fS                                 
pseudomallei                                                               
Caliciviruses                fS                                            
California                   fS                                            
encephalitis                                                               
Campylobacter jejuni         fS                                            
Clostridium botulinum   fS              fS                                 
[Botulinum neurotoxin                                                      
producing species of                                                       
Clostridium]                                                               
Coxiella burnetii (Q         fS         fS                                 
fever)                                                                     
Crimean-Congo                     fS    fS                                 
hemorrhagic fever                                                          
virus                                                                      
Cryptosporidium parvum       fS                                            
Cyclospora                   fS                                            
cayatanensis                                                               
Dengue                  fS                                                 
Diarrheagenic E. coli        fS                                            
Ebola                   fS              fS                                 
EEE [eastern equine          fS         fS                                 
encephalitis virus]                                                        
Entamoeba histolytica        fS                                            
Epsilon toxin of             fS         fS                                 
Clostridium                                                                
perfringens                                                                
Francisella tularensis  fS              fS                                 
(tularemia)                                                                
Giardia lamblia              fS                                            
Guanarito virus [South  fS              fS                                 
American hemorrhagic                                                       
fever: Guanarito^b]                                                        
Hantaviruses            fS                                                 
Hepatitis A                  fS                                            
Influenza                         fS         Two influenza strains--Avian  
                                                influenza virus (highly       
                                                pathogenic) and reconstructed 
                                                1918 influenza virus--are     
                                                select agents.                
Japanese encephalitis        fS         fS                                 
virus                                                                      
Junin virus [South      fS              fS                                 
American hemorrhagic                                                       
fever: Junin]                                                              
Kyasanur Forest virus        fS         fS                                 
[Tick-borne                                                                
encephalitis complex                                                       
(flavi) virus:                                                             
Kyasanur Forest                                                            
disease]                                                                   
LaCrosse                     fS                                            
Lassa fever             fS              fS                                 
LCM (Lymphocytic        fS                                                 
choriomeningitis                                                           
virus)                                                                     
Listeria monocytogenes       fS                                            
Machupo virus [South    fS              fS                                 
American hemorrhagic                                                       
fever: Machupo]                                                            
Marburg                 fS              fS                                 
Microsporidia                fS                                            
Multidrug-resistant TB            fS                                       
Nipah virus                       fS    fS                                 
Other Rickettsias                 fS         One Rickettsia species,       
                                                Rickettsia rickettsii, is a   
                                                select agent and is a NIAID   
                                                Category B pathogen.          
Pathogenic vibrios           fS                                            
Rabies                            fS                                       
Ricin toxin (from            fS         fS                                 
Ricinus communis)                                                          
Rift Valley fever       fS              fS                                 
virus                                                                      
Salmonella                   fS                                            
Severe acute                      fS                                       
respiratory                                                                
syndrome-associated                                                        
coronavirus (SARS-CoV)                                                     
Shigella species             fS              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. S 73.3, shigatoxin and 
                                                shiga-like ribosome           
                                                inactivating proteins are     
                                                select agents.                
Staphylococcus               fS         fS   Only staphylococcus           
enterotoxin B                                enterotoxin B is a NIAID      
[staphylococcal                              Category B pathogen; however, 
enterotoxins]                                all staphylococcal            
                                                enterotoxins are select       
                                                agents.                       
Tick-borne                        fS         Five species of tick-borne    
encephalitis viruses                         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.                 
Toxoplasma                   fS                                            
Typhus fever                 fS         fS                                 
(Rickettsia                                                                
prowazekii)                                                                
Variola major           fS              fS   In addition to Variola major, 
(smallpox) and other                         camel pox virus, goat pox     
pox viruses                                  virus, sheep pox virus,       
                                                monkey pox virus, and Variola 
                                                minor virus (Alastrim) are    
                                                select agents and NIAID       
                                                Category A pathogens.         
VEE [Venezuelan equine       fS         fS                                 
encephalitis virus]                                                        
WEE (Western equine          fS                                            
encephalitis virus)                                                        
West Nile virus              fS                                            
Yellow fever                      fS                                       
Yersinia                     fS                                            
enterocolitica                                                             
Yersinia pestis         fS              fS                                 

           Source: GAO.

           aTaxonomic 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.

           bThere 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.
			  
			  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

           o 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).

           o 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.

           o 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.

           o 29 C.F.R. S 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.

           o 29 C.F.R. S 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.

           o 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.^37

           o 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.

           o 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

           o 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.

           o "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.

           o 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.

           o 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).^38 Under these regulations, the facility and its records
           are subject to inspection by FDA.

^3772 Fed. Reg. 92 (Jan. 3, 2007).

^38The awardees are also required in the Notice of Grant Award to design
the NBLs and RBLs in accordance with the Good Laboratory Practice
guidelines.

           (290516)

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