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
* [1]PDF6-Ordering Information.pdf
* [2]Order by Mail or Phone
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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