Galveston National Laboratory Record of Decision, 18408-18413 [05-7249]
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Federal Register / Vol. 70, No. 68 / Monday, April 11, 2005 / Notices
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Dated: April 5, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05–7160 Filed 4–8–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Galveston National Laboratory Record
of Decision
ACTION:
Notice.
SUMMARY: The Department of Health and
Human Services, the National Institutes
of Health (NIH), has decided, after
completion of a Final Environmental
Impact Statement (EIS) and a thorough
consideration of the public comments
on the Draft EIS to implement the
Proposed Action, which is identified as
the Preferred Alternative in the Final
EIS. This action is to partially fund the
construction of a state-of-the-art
National Biocontainment Laboratory
(NBL), which will be known as the
Galveston National Laboratory (GNL),
on the University of Texas Medical
Branch (UTMB) Campus in Galveston,
Texas.
FOR FURTHER INFORMATION CONTACT:
Valerie Nottingham, Chief of the
Environmental Quality Branch, Division
of Environmental Protection, Office of
Research Facilities Development and
Operations, NIH, Building 13, Room
2W64, 9000 Rockville Pike, Bethesda,
MD 20892, telephone 301–496–7775,
Fax 301–480–8056, e-mail
nihnepa@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
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Decision
After careful review of the
environmental consequences in the
Final Environmental Impact Statement
for the Galveston National Laboratory
for Biodefense and Emerging Infectious
Diseases Research Facility in Galveston,
TX (Final GNL EIS), and consideration
of public comment throughout the
NEPA process, the NIH has decided to
implement the Proposed Action
described below as the Selected
Alternative.
Selected Alternative
The NIH plans to partially fund the
construction of a state-of the-art
National Biocontainment Laboratory,
which will be known as the Galveston
National Laboratory (GNL), on the
UTMB Campus in Galveston, Texas. The
total cost of the proposed GNL project
is estimated at approximately $147
million. NIH will fund approximately
$110 million with UTMB providing the
remaining approximately $37 million.
The proposed GNL will enhance
national security through the
development and evaluation of
improved diagnostics, therapeutics, and
vaccines for protection against diseases,
including those that have the potential
for bioterrorism. The proposed GNL will
not conduct research to develop
biological weapons.
The proposed GNL facility will be a
new reinforced concrete seven-story
building that will be constructed within
the footprint of a recently demolished
building on the UTMB campus. The
proposed GNL, with a total net area of
approximately 82,411 square feet, will
house Biosafety Level (BSL)–4, BSL–3,
and BSL–2 facilities, BSL–4 and BSL–3
animal facilities, Arthropod
Containment Level (ACL)–3 insectary,
offices, conference rooms, and support
facilities including an effluent treatment
room, secure loading dock, and
dedicated mechanical floors to enhance
containment and minimize the risk of
exposure.
The proposed GNL facility will be
designed to safely support all of the
superimposed loads applied to the
building and to resist 140 mile-per-hour
hurricane force winds. Also, as required
by the National Earthquake Hazards
Reduction Program, it will be designed
and constructed to the highest building
protection classification category of IV.
Furthermore, the proposed GNL will be
designed with regard to its location
within a 100-year flood plain. For
example, the BSL–4 laboratories will be
located above the extreme 25-foot storm
surge that might occur during a category
4 or 5 hurricane. In addition to standby
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generators to provide power in the event
of a power outage, the proposed GNL
facility will have a distributed on-line
uninterruptible power supply module or
a fuel cell power supply to power the
BSL–4 biosafety cabinets, BSL–3
enhanced biosafety cabinets, critical
building control panels and alarms.
In addition to designing for severe
weather conditions, operating
procedures will call for a lockdown of
all infectious materials and
decontamination of high-level
biocontainment laboratories in the event
of an approaching hurricane. Storm
preparedness will be based on
approximately 24-hour notice of
probable landfall, taking into account
the predicted strength of a storm. This
allows sufficient time to close down
high containment operations, should
this be deemed necessary, including the
management of animals.
The building also will be provided
with an environmental monitoring
system to assess room pressure
differentials (to ensure negative pressure
in the biocontainment areas), smoke
detection, automatic watering system
pressure and flow, and the condition of
high efficiency particulate air (HEPA)
filters. Visual indications (such as
pressure gauges) and audible or strobic
alarms will alert GNL personnel to an
emergency or a situation that requires
corrective action. The proposed GNL
will have fire protection systems that
meet or exceed requirements specified
by the National Fire Protection
Association and all applicable local,
State, Federal, and UTMB requirements.
The design of the proposed GNL
facility’s BSL–4, –3, and –2 laboratories
will comply with the recommendations
and requirements of the Centers for
Disease Control (CDC) and the NIH joint
publication addressing biosafety in
laboratories, the 4th Edition Biosafety in
Microbiological and Biomedical
Laboratories, as well as NIH’s Design
Policies and Guidelines for Biomedical
Research Laboratories. The BSL–4, –3,
–2 animal laboratories will further
comply with the recommendations and
requirements of the latest edition of
Guide for Care and Use of Laboratory
Animals published by the National
Research Council. The four biosafety
levels have increasingly stringent
design, security, and containment
requirements. The safety levels are
determined based on the biological
materials used in research and the ways
they affect the human population. BSL–
1 facilities have no requirements for
safety equipment, while BSL–4 facilities
have extensive and multiple
requirements for safety equipment and
facility design such as isolation, buffer
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zones, airflow and pressure
requirements, and HEPA filtration.
The BSL–4 laboratory environment
employs the concept of a ‘‘box-withina-box’’ principle, whereby the
laboratory is built within a pressurecontrolled buffer. The BSL–4
laboratories will be physically and
functionally independent from other
laboratory functions. All penetrations in
the walls, ceilings, and floor will be
sealed. The control system for
maintaining the required pressure
differentials will be capable of being
monitored inside and outside of the
laboratory. The BSL–4 laboratories will
utilize a series of airlocks for entry and
exit, will use positive pressure
ventilation suits and will have
dedicated supply and exhaust
ventilation. A chemical shower will be
provided to decontaminate the surface
of the suit before a worker could leave
the area. Prior to emission through
stacks on the building roof, exhaust air
from the negatively pressurized BSL–4
laboratories will pass through dual
HEPA filters mounted in series in a
dedicated sealed exhaust system. The
exhaust will also pass through bioseal
isolation dampers that will be ‘‘bubble
tight’’ and will close in less than one
second upon receipt of a containment
isolation signal. In addition, each
laboratory will be equipped with
multiple Class II Biosafety Cabinets with
their own HEPA exhaust system. Liquid
waste will be sterilized in a biowaste
cooker system before discharge. Solid
waste will be sterilized in autoclaves
prior to leaving containment areas.
The proposed GNL BSL–3
laboratories, BSL–3 animal laboratories,
and ACL–3 insectary will be separated
by restricted traffic flow within the
building and access to the laboratory
will be restricted by the use of
electronic recognition devices. A
ventilated airlock will separate the
common corridors from the containment
facility. The airlock doors will be
interlocked to prevent simultaneous
opening of doors between the outside
corridor and the containment areas.
Directional airflow will be provided
through the airlock with differential
pressure monitoring.
Similar to the BSL–4 requirements, all
electrical conduit, plumbing piping,
supply and exhaust ducts and
miscellaneous penetrations will be
sealed at the point of penetration into
the BSL–3 laboratory to ensure a tight
structure. Tap water entering the BSL–
3 laboratories through spigots in the
sinks will have backflow preventors to
protect the potable water distribution
system from contamination. All BSL–3
laboratories will operate under negative
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air pressure. A dedicated, ducted HVAC
system will draw air into the BSL–3
laboratories from the surrounding areas
toward and through the BSL–3
laboratories with no recirculation from
the laboratories to other areas of the
building. This direction of airflow into
the laboratories and the biosafety
cabinets will be verifiable with
appropriate gauges and an audible alarm
system to notify personnel of HVAC
problems or system failure. All air will
be discharged outside the building
through HEPA filters. Each BSL–3
laboratory will be equipped with Class
II biosafety cabinets. Each BSL–3
laboratory will be provided with
shower-out facilities for researchers
along with autoclaves for solid waste
removal. Liquid waste from Enhanced
BSL–3 laboratories will be sterilized in
a biowaste cooker system before
discharge.
Work with moderate-risk biological
material will be conducted in BSL–2
laboratories. The air supply system will
be designed to maintain negative air
pressure in relationship to
administrative space, offices, and
corridors. There will be no HEPA
filtration for BSL–2 exhaust. Liquid
waste will be chemically
decontaminated prior to discharge and
solid waste will be sterilized in
autoclaves prior to leaving the
laboratories.
The design and construction of the
proposed GNL facility will address
security concerns. Security measures are
discussed below. Scenarios involving
terrorist or intentionally destructive acts
at the proposed GNL have been
analyzed in an independent Threat and
Vulnerability Assessment (TVA). The
design as well as security plans and
procedures of the proposed GNL facility
will address the TVA analysis and
recommendations.
Vehicular traffic to the proposed GNL
facility will be controlled by the
creation of a security perimeter that will
include the existing surrounding
buildings and constructed barriers that
are outside of the 200-foot radius
around the proposed GNL facility. Only
two streets currently allow vehicular
traffic within 200 feet of the proposed
GNL site, and access to these sites will
be controlled.
The main entrance to the security
perimeter of the proposed facility will
be located on The Strand and 11th
Streets, in the northwest corner of the
perimeter. A security booth will be
constructed on The Strand and manned
by UTMB Police Department personnel.
Only authorized and inspected vehicles
will be allowed to enter per acceptable
protocol. Traffic control gate arms will
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be installed on either end of the booth
and pop-up vehicle wedge barriers will
be installed on the inbound and
outbound lanes. A secondary entrance
will be locked at all times and only will
be used for fire department access in
emergencies and for infrequent, large
deliveries. Around the security
perimeter, where space could allow
four-wheeled vehicles to penetrate the
200-foot radius, high security walls or
bollards will be constructed or boulders
will be placed.
Access into the proposed GNL facility
will be controlled by various measures.
Employees will have to undergo
background checks and their handcarried items may be screened at
anytime. Visitors will have to be cleared
and escorted by an UTMB employee at
all times. Visitor hand-carried items will
be screened.
Exit only doors will be monitored and
alarmed. Security hardware will be
provided for manholes or hatches.
Exterior utility and roof doors will be
card access-controlled. Roof doors also
will have an intercom station or
emergency phone installed outside each
door. Closed-circuit television (CCTV)
cameras will monitor all exterior doors.
Interior doors for building systems
rooms and laboratories will be card
access-controlled doors, as appropriate.
BSL–2 labs will be card accesscontrolled. CCTV surveillance of
entrances and emergency exits will be
provided. BSL–3 and –4 labs will be
controlled with card readers, pin code
readers, plus biometric readers. CCTV
surveillance of entrances and exits will
be provided. CCTV coverage of internal
lab spaces will be monitored by
laboratory personnel within the
containment laboratory for the
monitoring of procedures and safety.
Animal receiving areas will be card
access controlled, and CCTV
surveillance will be provided.
Laboratories will be locked and
accessible to authorized personnel only.
CCTV cameras will monitor areas where
biological agents are stored.
Alternatives Considered
The NIH considered the two
reasonable alternatives identified and
considered in the Final EIS: (1) The
Proposed Action Alternative (now the
selected alternative) and (2) the No
Action Alternative (not constructing the
GNL). Previously, NIH examined nine
sites and various facility designs.
Applying screening criteria reduced the
potential sites for detailed evaluation to
three locations and three designs, one of
which became the Proposed Action. The
two other alternatives considered were
a six-level building with a total of
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208,300 gross square feet located
elsewhere on the UTMB campus and a
three-level building with a total of
207,000 gross square feet located off
campus near the Primary Care Pavilion.
These other sites and designs were
considered technically inferior,
provided no environmental advantage
compared to the Proposed Action, and
will not meet the purpose and need as
efficiently as the Proposed Action.
Therefore, they were eliminated from
detailed analysis in the EIS.
Factors Involved in the Decision
Several factors were involved in the
NIH’s decision to proceed with the
Proposed Action. Based on analyses in
the Draft EIS and Final EIS, the
Proposed Action best satisfies the stated
Purpose and Need, which is to rectify
the national shortage of biological
containment facilities with laboratories
and procedures for handling potentially
lethal infectious agents. This condition
represents a substantial impediment to
conducting research on infectious
diseases and is a national biodefense
vulnerability. To be most effective, these
facilities must be located where
established teams of researchers are
already working on related scientific
problems. Additionally, the biological
containment facilities should be located
in an area with existing infrastructure
critical to providing timely public
health assistance in the case of a
national, state, or local disease outbreak
or bioterrorism emergency. Locating a
new national biocontainment laboratory
on the UTMB campus takes advantage
of UTMB’s extensive expertise in
biological medical research, its
experience in operating BSL–2, –3 and
–4 laboratories (only five other
operational BSL–4 laboratories exist in
the United States), and its infrastructure
as a regional medical center.
UTMB is a complex of educational,
medical, and research facilities, with 6
interconnected hospitals with over 809
hospital beds. There are over 2,000
students enrolled in UTMB’s four
schools: the School of Medicine, the
Graduate School of Biomedical
Sciences, the School of Nursing, and the
School of Allied Health Sciences.
UTMB provides nearly 400,000 square
feet of space designed for research and
houses one of the largest research
libraries in the southwest. Instruction
and research take place within 15
clinical and 6 basic science
departments, in addition to
interdisciplinary centers and programs
within the School of Medicine.
UTMB researchers and clinicians
have considerable specialized expertise
in infectious diseases, including tropical
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and newly emerging viral diseases, as
they have been conducting research on
biodefense and emerging infectious
diseases for more than 20 years. In
particular, UTMB possesses distinctive
research capabilities in emerging
arthropod-borne and rodent-associated
viruses. Scientists in other fields such as
molecular virology, immunology, and
structural biology, who contribute to the
biomedical discovery of new drugs and
treatments, will complement the
expertise in infectious diseases present
at UTMB.
In support of infectious disease
research, UTMB has safely operated
several large suites of BSL–3 and
Animal BSL (ABSL) laboratories for
several years. UTMB currently operates
a suite of eight BSL–3 laboratories
comprising a total of over 5,200 square
feet and 2,400 square feet of ABSL–3
laboratories. UTMB also operates a
2,100-square foot BSL–4 facility. In
addition, UTMB houses one of the most
complete reference collections of
bacteria, fungi, and viruses.
UTMB was the lead institution in
organizing a consortium of over 20
universities, regional primate centers,
and national laboratories that filed an
application with the National Institute
of Allergy and Infectious Diseases
(NIAID) in January 2003 for funding as
the Region VI Center of Excellence for
Biodefense and Emerging Infectious
Disease Research (RCE). NIAID awarded
UTMB an RCE grant in September 2003.
The RCE program’s primary role is to
foster the physical and intellectual
environments in which wide-ranging
research on infectious diseases can
proceed productively and safely. NIH
selected the proposed GNL site based on
UTMB’s ability to contribute to the
overall NIAID biological defense
research agenda. The No Action
Alternative will result in the GNL not
being built, and will impair the NIH’s
ability to counter the serious strategic
national shortage of biological
containment facilities.
Resources Impacts
The Final EIS describes potential
environmental effects of the selected
action. These potential effects are
documented in Chapter 3 of the Final
EIS. The GNL will result in insignificant
impacts to the environment, human
health, and the surrounding community.
A larger impact will be to the UTMB
community and its patrons with regard
to restricted vehicular traffic near the
proposed GNL. Adverse environmental
effects are avoided or mitigated through
design elements, procedures, and
compliance with regulatory and NIH
requirements. Potential impacts on air
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quality are all within government
standards (federal, state, and local). NIH
does not expect negative effects on the
environment or on the citizens of
Galveston from construction and
operation of the proposed GNL.
Summary of Impacts
The following is a summary of
potential impacts resulting from the
Proposed Action that the NIH
considered when making its decision.
No adverse cumulative effects have been
identified during the NEPA process.
Likewise, no unavoidable or adverse
impacts from implementation of the
Selected Action have been identified.
The Selected Action will be beneficial
to the long-term productivity of the
national and world health communities.
Biomedical research conducted at the
proposed GNL facility will have the
potential to advance techniques in
disease prevention, develop disease
immunizations, and prepare defenses
against bioweapons. Additionally, the
local community will benefit from
having world-class biomedical expertise
available at the GNL facility on the
UTMB campus.
Land Use
The proposed GNL facility will
occupy approximately 1 acre and be
constructed within the footprint of the
recently demolished building. The total
construction area will be 6.9 acres,
including the plaza space within the
200-foot security perimeter as it will be
reconstructed to include security walls,
boulders, and bollards. The operation of
the proposed GNL facility will be
consistent with the current land use
patterns on and within the immediate
vicinity of the UTMB campus.
Geology, Soils, and Seismicity
Despite the historical record of low
seismicity in the region, the risk for an
earthquake exists in association with the
Gulf Coast Normal Faults Region. To
mitigate any potential damage from an
earthquake, and as required by the
National Earthquake Hazards Reduction
Program, the proposed GNL facility will
be designed and constructed to the
highest building protection
classification category of IV, which is
required for all buildings that are
classified as having essential facilities
and that contain hazardous substances.
There are no identified long-term effects
to either geology or soils in the region
from the proposed GNL facility.
Infrastructure
Construction and operation of the
proposed GNL facility will include
small increases in water, electricity, and
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natural gas consumption, demand on
sewage treatment and stormwater
management systems, and steam and
chilled water usage. These increases
will not exceed the capacity of these
services.
Transportation
During construction, some local
vehicular and pedestrian traffic may be
re-routed to avoid construction areas.
Post construction, there will be no
permanent closing, restriction, or rerouting of municipal streets or
municipal traffic patterns. However, on
the UTMB campus, The Strand and
Ninth Streets within 200 feet of the
proposed GNL facility will be closed to
regular vehicular traffic. Transportation
accidents involving micro-organisms are
not expected to increase.
Human Health and Safety
Records from the past 21 years of
accidents at NIAID laboratories indicate
an outstanding record of safety showing
that in more than 3 million hours of
exposure, there has been only one
clinical infection and four silent
infections (no manifestation of disease
symptoms). In this 21-year period, there
has been no agent released from any of
these laboratories to cause infection in
the general population. Nationwide,
there have been no clinical infections
from working with BSL–4 agents during
the past 31 years and no documented
case of a laboratory worker’s family
members or the public acquiring a
disease from CDC laboratory operations.
UTMB has been conducting research
on emerging infectious diseases and
biodefense for more than two decades.
Safety is a major concern in working
with and preventing the spread of
highly infectious disease agents.
UTMB’s safety record for its BSL–3
containment facilities from May 2002 to
May 2004 indicate that there have been
no non-animal related accidental
exposures in any of the BSL–3
laboratories. There have been two
animal bites but neither resulted in
infection. Additionally, there have been
no animal escapes from UTMB’s
biocontainment laboratories. Key UTMB
scientists and support personnel have a
combined experience of over 82 years in
working with infectious diseases at the
BSL4 level.
The proposed GNL could result in
beneficial human health impacts. The
proposed GNL facility will allow UTMB
to become a leader in developing
diagnostic tests, management strategies,
and vaccines for a number of emerging
viral diseases and potential biological
weapons. The proposed GNL facility
will also allow for the training of
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additional scientists for high level
biocontainment conditions, provide a
state-of-the-art telemedicine system, and
increase the laboratory space available
for conducting experiments.
Community Safety
A quantitative risk assessment using
the Maximum Possible Risk model and
anthrax as the worst-case scenario agent
concluded that there will be no risk to
the public from the accidental release of
anthrax spores at the proposed GNL
facility. Six risk scenarios, assuming the
use of a powder-like preparation of
purified B. anthracis containing 1x106
spores, were run and the maximum
number of spores released into the
environment was calculated to be 120
spores per cubic meter of air (2,083
spores per cubic meter is needed to
establish human infection). In all
scenarios, there was no probability of
harm to the public from an accidental
release of anthrax spores due to the
level of safety and redundancy
incorporated into the design of the
facility (e.g., use of biosafety cabinets,
HEPA filters, emergency backup power
sources, and pressure monitoring
devices and alarms).
Air Quality
Galveston County and the city of
Galveston, including UTMB, lie within
the Houston/Galveston Ozone
Nonattainment Area, as designated by
the Texas Commission on
Environmental Quality and the
Environmental Protection Agency
(EPA), for both the 1-hour and 8-hour
ozone standards. Concentrations of
ozone exceeding the National Ambient
Air Quality Standards (NAAQS) are
attributed to industrial and vehicular
emissions including emissions of
volatile organic compounds and
nitrogen oxide compounds (NOX).
Galveston County is in attainment of the
NAAQS for all other criteria pollutants
for which EPA has made attainment
designations. During site preparation
and construction, the use of heavy
equipment, delivery vehicles, and
construction workers’ personal
transportation will generate combustion
engine exhaust containing air pollutants
associated with fuel (e.g., diesel). The
amount of construction equipment and
number of construction workers at the
GNL site are anticipated to be small and
of short duration, approximately 637
workers and a three year construction
time. The quantities of air pollutants
produced by vehicles and equipment
associated with construction will be a
minimal contribution to the total
emissions from mobile sources already
operating in the area. During normal
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operations of the proposed GNL facility,
gaseous and particulate air contaminant
emissions (including biological toxins,
chemical agents, and hazardous air
pollutants) generated will be prevented
from escaping to the outdoor air through
the use of engineering controls
including a double HEPA-filtration
system. Discharges from the facility are
expected to be small and have minimal
impact to NAAQS. Emergency
generators will be added to existing
generators in the Basic Science Building
located immediately west of the
proposed GNL facility. Emissions of
regulated pollutants may increase and a
permit review will need to be conducted
and a possible modification to the
permit needed.
Noise
During construction of the proposed
GNL facility, there will be increased
noise levels of 10 to 15 dB from the
daytime ambient levels for
approximately 80dB. However, this
effect will be temporary and
intermittent. During operation of the
proposed GNL facility, a low level of
noise will be generated, but this noise
will be consistent with the operation of
similar laboratory/academic facilities on
the UTMB campus.
Waste Management
The waste and wastewater amounts
estimated for the proposed GNL facility
are small increments, 0.4%, above the
volumes generated by the UTMB
campus. The offsite treatment and
disposal facilities that receive waste and
wastewater from the UTMB campus
have available capacity. The proposed
GNL facility will be designed to treat the
liquid biohazardous waste by chemical
decontamination or sterilization. This
waste will then be released into the
building effluent treatment system
where it will be sterilized, cooled, and
then discharged into the sanitary sewer
system. The solid waste that will be
generated in the laboratories and animal
areas will also be considered
biohazardous. Solid waste from the
BSL–2 laboratories will be placed into
biohazard red bags for incineration or
will be autoclaved and disposed of as
solid waste. BSL–3 and -4 wastes will be
sterilized in an autoclave then placed in
boxes for incineration. UTMB has a
protocol for disposal of all biohazardous
waste from the existing BSL–4
laboratory. This same protocol will be
applied to the biohazardous waste
generated by the proposed GNL BSL–4
facilities.
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Socioeconomics
The short-term economic benefits
from construction of the proposed GNL
facility will be temporary and diminish
as the project reaches completion at the
end of the 3-year construction period
(2005–2008). Construction of the
proposed GNL facility is estimated to
employ more than 637 direct workers
during peak construction and will
generate additional employment in
associated sectors in the Region of
Influence (ROI) Galveston County.
During construction, personal income
will increase by more than $30 million,
or about 0.4 percent over the baseline of
$7.7 billion. Operation of the proposed
GNL facility will commence in the year
2008 and will continue for at least 20
years. The proposed GNL facility
workforce will consist of a mix of
scientific and administrative staff,
including students. Although a total
resident population for the proposed
GNL facility has not been established, it
is estimated that the facility will
generate about 270 new direct jobs. The
proposed GNL facility will generate a
total of 328 permanent jobs (direct,
indirect, and induced) in the Region of
Influence (ROI) of Galveston County.
The majority of the indirect and
induced jobs will be in the retail trade
and services sectors. Given the small
number of secondary jobs created by the
Proposed Action relative to the regional
economy, the available labor force in the
ROI will likely be able to meet the
increased demand for workers. Minor
short-term benefits will be expected.
Tax revenues will exceed $2.2 million.
The majority of the tax revenue will
derive from payroll taxes and will not
remain in the ROI. Total additional
business output will be about $14.7
million.
Environmental Justice
The selected action will result in
minor positive changes to economic
indicators, including personal income
and employment. No health and
environmental impacts are projected for
any population within the ROI,
including minority or low-income
communities. Therefore, no
environmental justice issues will be
expected.
Cultural Resources
Construction activities for the
proposed GNL facility will not have an
impact on adjacent historical buildings.
The proposed GNL facility will be one
laboratory building located among many
others and will have an exterior facade
similar to the other UTMB campus
buildings around it. Thus, the view of
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17:45 Apr 08, 2005
Jkt 205001
that portion of the campus from any
historic properties will remain
essentially as it is now. Most of the
activities related to operation of the
proposed GNL facility will occur within
the facility. Those activities conducted
outside will be similar to those already
conducted in relation to the campus
buildings in the vicinity. Thus, there
will be no impact to historic properties
or Recorded Texas Historical Landmarks
from operations of the proposed GNL
facility.
Ecological Resources
The proposed GNL facility will be
located within the built environment in
the heart of the UTMB campus.
Vegetation consists of grasses, shrubs,
and trees characteristic of a landscaped
environment. Wildlife present are
common species that have adapted to a
landscaped and built environment
bustling with human activity. There are
no wetlands or natural aquatic
environments within the UTMB
campus. A review of U.S. Fish and
Wildlife Service files indicated that no
federally listed threatened or
endangered species are likely to occur
on the campus and the campus is not
located within officially designated
critical habitat.
Practicable Means To Avoid or
Minimize Potential Environmental
Harm From the Selected Alternative
All practicable means to avoid or
minimize adverse environmental effects
from the selected action have been
identified and incorporated into the
action. The proposed GNL facility will
be subject to the existing UTMB
pollution prevention, waste
management, and safety, security, and
emergency response procedures as well
as existing environmental permits. Best
management practices, spill prevention
and control, and stormwater
management plans will be revised and
followed to appropriately address the
construction and operation of the
proposed GNL and comply with
applicable regulatory and NIH
requirements. No additional mitigation
measures have been identified.
With regard to the restriction of
vehicular traffic surrounding the
proposed GNL facility, UTMB has taken
steps to ensure continued patient access
to the University Hospital Clinics (UHC)
Building. The patient access and dropoff area (with a new covered walkway)
has been relocated to the opposite side
of the UHC Building.
Pollution Prevention
Pollution prevention measures are
described in Chapter 2 of the FEIS and
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Fmt 4703
Sfmt 4703
reflect standard spill prevention
procedures. Additional pollution from
the GNL facility is not anticipated. Air
quality permit standards will be met, as
will all Federal, State, and local
requirements to protect the environment
and public health. Additional pollution
prevention methods will include:
Reducing construction waste by
recycling materials wherever possible;
Water efficient landscaping; and
Use of heat reflective roofing material.
Monitoring and Enforcement Program
for Mitigation Measures
During the preparation of the FEIS,
several potential environmental issues
associated with implementation of the
Proposed Action were identified. The
local community is concerned about
transportation impacts including patient
access to the University Hospital Clinics
Building. To mitigate this impact to
patients, a new patient access drop-off
area with a covered walkway will be
accessible on the opposite side of the
Hospital. Non-ambulatory patient
assistance will continue as usual.
Transportation of agents to and from
the GNL is a concern for some. Strict
rules and regulations govern how agents
are packaged, labeled, handled, tracked,
and transported. The risk to the
surrounding community from the
transport of biological material is as
negligible as anywhere else along the
transport path.
Emergency planning was raised as a
concern. UTMB has an existing
Institutional Emergency Operations Plan
that is regularly reviewed and that will
be updated before the GNL becomes
operational. Emergency responders in
the area are confident that they will be
capable of handling emergency
situations.
In addition, possible adverse health
and safety impacts on laboratory
workers in the proposed GNL and on
nearby residents during the operational
phase of the project were evaluated. The
risks were deemed to be negligible, and
mitigable through adherence to
guidelines outlined in the 4th Edition
Biosafety in Microbiological and
Biomedical Laboratories, a joint
publication of the NIH and CDC, as well
as other standards for safe operational
practices.
Conclusion
Based upon review and careful
consideration, the NIH has decided to
implement the Proposed Action to
partially fund the construction of a
state-of the-art national biocontainment
laboratory, which will be known as the
Galveston National Laboratory (GNL),
on the University of Texas Medical
E:\FR\FM\11APN1.SGM
11APN1
Federal Register / Vol. 70, No. 68 / Monday, April 11, 2005 / Notices
Branch (UTMB) Campus in Galveston,
Texas.
The decision was based upon review
and careful consideration of the impacts
identified in the Final EIS and public
comments received throughout the
NEPA process. The decision was also
based on UTMB’s extensive expertise in
biological medical research, its
experience in operating BSL–2, –3 and
–4 laboratories (only five other
operational BSL–4 laboratories exist in
the United States), and its infrastructure
as a regional medical center being able
to fulfill the purpose and need to
provide national biocontainment
facilities. Other relevant factors
included in the decision, such as
NIAID’s mandate to conduct and
support research on agents of emerging
and re-emerging infectious diseases
were carefully considered.
Dated: March 29, 2005.
Leonard Taylor, Jr.,
Acting Director, Office of Research Facilities
Development and Operations, National
Institutes of Health.
[FR Doc. 05–7249 Filed 4–8–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Best Practices for the Licensing of
Genomic Inventions: Final Notice
National Institutes of Health,
Public Health Service, Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: On November 19, 2004 the
National Institutes of Health (NIH)
published for public comment in the
Federal Register proposed Best
Practices for the Licensing of Genomic
Inventions [69 FR 67747]. These Best
Practices are recommendations to the
intramural Public Health Service (PHS)
technology transfer community as well
as to PHS funding recipients. Comments
on the proposed Best Practices were
requested with a deadline of January 18,
2005. This Notice presents the NIH’s
final Best Practices for the Licensing of
Genomic Inventions together with NIH’s
response to the public comments
received.
FOR FURTHER INFORMATION CONTACT:
Bonny Harbinger, Ph.D., J.D., NIH Office
of Technology Transfer, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Fax: (301) 402–3257; Email: harbingb@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
17:45 Apr 08, 2005
Jkt 205001
NIH recognizes the importance of
public involvement in the development
of best practices and sought comment
and participation by the biomedical
research and development communities
regarding the proposed Best Practices
for the Licensing of Genomic Inventions
(Best Practices). To this end, NIH sought
comments from the public as well as
grantees and academic, not-for-profit,
and private sector participants in the
biomedical research and development
communities. In order to solicit
comments from as many interested
parties as possible, the draft was
presented in various venues. In addition
to the publication on November 19,
2004 in the Federal Register, the
proposed Best Practices were made
available on the NIH Office of
Technology Transfer Web site and were
highlighted in a variety of publications.
In response to the November 19, 2004
proposal, NIH received 12 letters, each
of which contained one or more
comments. Comments were received
from an academic institution, scientific
foundations, a biotechnology company,
industry trade associations, professional
societies, individual researchers, and
other individual respondents.
Comments and Agency Response
National Institutes of Health
VerDate jul<14>2003
Background
The majority of comments generally
supported the Best Practices and some
expressly stated support for nonexclusively licensing of genomic
inventions. Most requested further
clarification about a variety of different
issues. A general response to the
comments is provided below.
Respondents criticized the singling
out of this area of technology for special
treatment as poor policy precedent. NIH
disagrees with this representation.
Genomic inventions have evoked
special attention in the legal community
as evidenced by various U.S. Patent and
Trademark (USPTO) guidelines and
court decisions directed to the criteria
required to meet the non-obviousness,
utility, and written description
patentability standards for genomic
inventions and discoveries. Similarly,
the availability of genomic inventions
for diagnostic testing and research
purposes has been an area of active
debate and controversy. As a major
source of funding and research leading
to the discovery of genomic inventions,
NIH has an obligation to address these
special issues to promote and advance
the best possible balance between
research availability and commercial
development of these important
technologies. In this regard, NIH
considers the fundamental principles
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Sfmt 4703
18413
and concepts addressed by these Best
Practices to be consistent with our grant
recipients’ responsibilities under the
Bayh-Dole Act as well as our prior
publications, including our Principles
and Guidelines for Recipients of NIH
Research Grants and Contracts on
Obtaining and Disseminating
Biomedical Research Resources.
Respondents commented on the
identification of these recommendations
as ‘‘best’’ practices as opposed to
‘‘good’’ practices. The respondents
reasoned that use of the term ‘‘best
practices’’ would imply these
recommendations would be viewed as
mandates and auditable prescriptive
regulation. One respondent indicated
that these Best Practices would lead to
an added burden for university
technology transfer licensing offices, as
grantees would feel compelled to
document and justify reasons for any
departures from them in individual
licensing situations. In response, it is
noted that the Best Practices document
clearly and specifically articulates that
the recommendations are not intended
to constitute additional regulations,
guidelines, or conditions of award for
any contract or grant. These Best
Practices create no new auditable
regulation. While not imposing
regulations or requirements on any
licensing situation, it is generally the
object of best practices to inform
practicing professionals to a set of
principles against which they should
test their judgments in any particular
fact situation. As such, best practices
serve as an industry benchmark for the
most current, innovative, and advanced
practices. In this regard, as in all others,
our grantees should expect no less than
the best guidance possible from NIH.
A respondent criticized the proposed
Best Practices document for not clearly
defining genomic inventions. According
to this respondent, the Best Practices
document does not distinguish
compositions of matter and diagnostic
technologies from basic research tools.
Consequently, this broad definition of
basic genomic inventions undermines a
company’s ability to obtain an exclusive
license to a composition of matter or a
commercially viable diagnostic test. In
response, it is noted that NIH intends
the Best Practices to apply broadly to all
genetic inventions. Contrary to
respondent’s conclusion, the proposed
Best Practices document contemplates
intellectual property and exclusive
licensing to be appropriate for certain
genomic inventions. The determination
of when patent protection and exclusive
licensing is necessary derives from the
specific fact situation attendant the
nature of the invention and its market;
E:\FR\FM\11APN1.SGM
11APN1
Agencies
[Federal Register Volume 70, Number 68 (Monday, April 11, 2005)]
[Notices]
[Pages 18408-18413]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7249]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Galveston National Laboratory Record of Decision
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services, the National
Institutes of Health (NIH), has decided, after completion of a Final
Environmental Impact Statement (EIS) and a thorough consideration of
the public comments on the Draft EIS to implement the Proposed Action,
which is identified as the Preferred Alternative in the Final EIS. This
action is to partially fund the construction of a state-of-the-art
National Biocontainment Laboratory (NBL), which will be known as the
Galveston National Laboratory (GNL), on the University of Texas Medical
Branch (UTMB) Campus in Galveston, Texas.
FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Chief of the
Environmental Quality Branch, Division of Environmental Protection,
Office of Research Facilities Development and Operations, NIH, Building
13, Room 2W64, 9000 Rockville Pike, Bethesda, MD 20892, telephone 301-
496-7775, Fax 301-480-8056, e-mail nihnepa@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
Decision
After careful review of the environmental consequences in the Final
Environmental Impact Statement for the Galveston National Laboratory
for Biodefense and Emerging Infectious Diseases Research Facility in
Galveston, TX (Final GNL EIS), and consideration of public comment
throughout the NEPA process, the NIH has decided to implement the
Proposed Action described below as the Selected Alternative.
Selected Alternative
The NIH plans to partially fund the construction of a state-of the-
art National Biocontainment Laboratory, which will be known as the
Galveston National Laboratory (GNL), on the UTMB Campus in Galveston,
Texas. The total cost of the proposed GNL project is estimated at
approximately $147 million. NIH will fund approximately $110 million
with UTMB providing the remaining approximately $37 million. The
proposed GNL will enhance national security through the development and
evaluation of improved diagnostics, therapeutics, and vaccines for
protection against diseases, including those that have the potential
for bioterrorism. The proposed GNL will not conduct research to develop
biological weapons.
The proposed GNL facility will be a new reinforced concrete seven-
story building that will be constructed within the footprint of a
recently demolished building on the UTMB campus. The proposed GNL, with
a total net area of approximately 82,411 square feet, will house
Biosafety Level (BSL)-4, BSL-3, and BSL-2 facilities, BSL-4 and BSL-3
animal facilities, Arthropod Containment Level (ACL)-3 insectary,
offices, conference rooms, and support facilities including an effluent
treatment room, secure loading dock, and dedicated mechanical floors to
enhance containment and minimize the risk of exposure.
The proposed GNL facility will be designed to safely support all of
the superimposed loads applied to the building and to resist 140 mile-
per-hour hurricane force winds. Also, as required by the National
Earthquake Hazards Reduction Program, it will be designed and
constructed to the highest building protection classification category
of IV. Furthermore, the proposed GNL will be designed with regard to
its location within a 100-year flood plain. For example, the BSL-4
laboratories will be located above the extreme 25-foot storm surge that
might occur during a category 4 or 5 hurricane. In addition to standby
generators to provide power in the event of a power outage, the
proposed GNL facility will have a distributed on-line uninterruptible
power supply module or a fuel cell power supply to power the BSL-4
biosafety cabinets, BSL-3 enhanced biosafety cabinets, critical
building control panels and alarms.
In addition to designing for severe weather conditions, operating
procedures will call for a lockdown of all infectious materials and
decontamination of high-level biocontainment laboratories in the event
of an approaching hurricane. Storm preparedness will be based on
approximately 24-hour notice of probable landfall, taking into account
the predicted strength of a storm. This allows sufficient time to close
down high containment operations, should this be deemed necessary,
including the management of animals.
The building also will be provided with an environmental monitoring
system to assess room pressure differentials (to ensure negative
pressure in the biocontainment areas), smoke detection, automatic
watering system pressure and flow, and the condition of high efficiency
particulate air (HEPA) filters. Visual indications (such as pressure
gauges) and audible or strobic alarms will alert GNL personnel to an
emergency or a situation that requires corrective action. The proposed
GNL will have fire protection systems that meet or exceed requirements
specified by the National Fire Protection Association and all
applicable local, State, Federal, and UTMB requirements.
The design of the proposed GNL facility's BSL-4, -3, and -2
laboratories will comply with the recommendations and requirements of
the Centers for Disease Control (CDC) and the NIH joint publication
addressing biosafety in laboratories, the 4th Edition Biosafety in
Microbiological and Biomedical Laboratories, as well as NIH's Design
Policies and Guidelines for Biomedical Research Laboratories. The BSL-
4, -3, -2 animal laboratories will further comply with the
recommendations and requirements of the latest edition of Guide for
Care and Use of Laboratory Animals published by the National Research
Council. The four biosafety levels have increasingly stringent design,
security, and containment requirements. The safety levels are
determined based on the biological materials used in research and the
ways they affect the human population. BSL-1 facilities have no
requirements for safety equipment, while BSL-4 facilities have
extensive and multiple requirements for safety equipment and facility
design such as isolation, buffer
[[Page 18409]]
zones, airflow and pressure requirements, and HEPA filtration.
The BSL-4 laboratory environment employs the concept of a ``box-
within-a-box'' principle, whereby the laboratory is built within a
pressure-controlled buffer. The BSL-4 laboratories will be physically
and functionally independent from other laboratory functions. All
penetrations in the walls, ceilings, and floor will be sealed. The
control system for maintaining the required pressure differentials will
be capable of being monitored inside and outside of the laboratory. The
BSL-4 laboratories will utilize a series of airlocks for entry and
exit, will use positive pressure ventilation suits and will have
dedicated supply and exhaust ventilation. A chemical shower will be
provided to decontaminate the surface of the suit before a worker could
leave the area. Prior to emission through stacks on the building roof,
exhaust air from the negatively pressurized BSL-4 laboratories will
pass through dual HEPA filters mounted in series in a dedicated sealed
exhaust system. The exhaust will also pass through bioseal isolation
dampers that will be ``bubble tight'' and will close in less than one
second upon receipt of a containment isolation signal. In addition,
each laboratory will be equipped with multiple Class II Biosafety
Cabinets with their own HEPA exhaust system. Liquid waste will be
sterilized in a biowaste cooker system before discharge. Solid waste
will be sterilized in autoclaves prior to leaving containment areas.
The proposed GNL BSL-3 laboratories, BSL-3 animal laboratories, and
ACL-3 insectary will be separated by restricted traffic flow within the
building and access to the laboratory will be restricted by the use of
electronic recognition devices. A ventilated airlock will separate the
common corridors from the containment facility. The airlock doors will
be interlocked to prevent simultaneous opening of doors between the
outside corridor and the containment areas. Directional airflow will be
provided through the airlock with differential pressure monitoring.
Similar to the BSL-4 requirements, all electrical conduit, plumbing
piping, supply and exhaust ducts and miscellaneous penetrations will be
sealed at the point of penetration into the BSL-3 laboratory to ensure
a tight structure. Tap water entering the BSL-3 laboratories through
spigots in the sinks will have backflow preventors to protect the
potable water distribution system from contamination. All BSL-3
laboratories will operate under negative air pressure. A dedicated,
ducted HVAC system will draw air into the BSL-3 laboratories from the
surrounding areas toward and through the BSL-3 laboratories with no
recirculation from the laboratories to other areas of the building.
This direction of airflow into the laboratories and the biosafety
cabinets will be verifiable with appropriate gauges and an audible
alarm system to notify personnel of HVAC problems or system failure.
All air will be discharged outside the building through HEPA filters.
Each BSL-3 laboratory will be equipped with Class II biosafety
cabinets. Each BSL-3 laboratory will be provided with shower-out
facilities for researchers along with autoclaves for solid waste
removal. Liquid waste from Enhanced BSL-3 laboratories will be
sterilized in a biowaste cooker system before discharge.
Work with moderate-risk biological material will be conducted in
BSL-2 laboratories. The air supply system will be designed to maintain
negative air pressure in relationship to administrative space, offices,
and corridors. There will be no HEPA filtration for BSL-2 exhaust.
Liquid waste will be chemically decontaminated prior to discharge and
solid waste will be sterilized in autoclaves prior to leaving the
laboratories.
The design and construction of the proposed GNL facility will
address security concerns. Security measures are discussed below.
Scenarios involving terrorist or intentionally destructive acts at the
proposed GNL have been analyzed in an independent Threat and
Vulnerability Assessment (TVA). The design as well as security plans
and procedures of the proposed GNL facility will address the TVA
analysis and recommendations.
Vehicular traffic to the proposed GNL facility will be controlled
by the creation of a security perimeter that will include the existing
surrounding buildings and constructed barriers that are outside of the
200-foot radius around the proposed GNL facility. Only two streets
currently allow vehicular traffic within 200 feet of the proposed GNL
site, and access to these sites will be controlled.
The main entrance to the security perimeter of the proposed
facility will be located on The Strand and 11th Streets, in the
northwest corner of the perimeter. A security booth will be constructed
on The Strand and manned by UTMB Police Department personnel. Only
authorized and inspected vehicles will be allowed to enter per
acceptable protocol. Traffic control gate arms will be installed on
either end of the booth and pop-up vehicle wedge barriers will be
installed on the inbound and outbound lanes. A secondary entrance will
be locked at all times and only will be used for fire department access
in emergencies and for infrequent, large deliveries. Around the
security perimeter, where space could allow four-wheeled vehicles to
penetrate the 200-foot radius, high security walls or bollards will be
constructed or boulders will be placed.
Access into the proposed GNL facility will be controlled by various
measures. Employees will have to undergo background checks and their
hand-carried items may be screened at anytime. Visitors will have to be
cleared and escorted by an UTMB employee at all times. Visitor hand-
carried items will be screened.
Exit only doors will be monitored and alarmed. Security hardware
will be provided for manholes or hatches. Exterior utility and roof
doors will be card access-controlled. Roof doors also will have an
intercom station or emergency phone installed outside each door.
Closed-circuit television (CCTV) cameras will monitor all exterior
doors. Interior doors for building systems rooms and laboratories will
be card access-controlled doors, as appropriate. BSL-2 labs will be
card access-controlled. CCTV surveillance of entrances and emergency
exits will be provided. BSL-3 and -4 labs will be controlled with card
readers, pin code readers, plus biometric readers. CCTV surveillance of
entrances and exits will be provided. CCTV coverage of internal lab
spaces will be monitored by laboratory personnel within the containment
laboratory for the monitoring of procedures and safety. Animal
receiving areas will be card access controlled, and CCTV surveillance
will be provided. Laboratories will be locked and accessible to
authorized personnel only. CCTV cameras will monitor areas where
biological agents are stored.
Alternatives Considered
The NIH considered the two reasonable alternatives identified and
considered in the Final EIS: (1) The Proposed Action Alternative (now
the selected alternative) and (2) the No Action Alternative (not
constructing the GNL). Previously, NIH examined nine sites and various
facility designs. Applying screening criteria reduced the potential
sites for detailed evaluation to three locations and three designs, one
of which became the Proposed Action. The two other alternatives
considered were a six-level building with a total of
[[Page 18410]]
208,300 gross square feet located elsewhere on the UTMB campus and a
three-level building with a total of 207,000 gross square feet located
off campus near the Primary Care Pavilion. These other sites and
designs were considered technically inferior, provided no environmental
advantage compared to the Proposed Action, and will not meet the
purpose and need as efficiently as the Proposed Action. Therefore, they
were eliminated from detailed analysis in the EIS.
Factors Involved in the Decision
Several factors were involved in the NIH's decision to proceed with
the Proposed Action. Based on analyses in the Draft EIS and Final EIS,
the Proposed Action best satisfies the stated Purpose and Need, which
is to rectify the national shortage of biological containment
facilities with laboratories and procedures for handling potentially
lethal infectious agents. This condition represents a substantial
impediment to conducting research on infectious diseases and is a
national biodefense vulnerability. To be most effective, these
facilities must be located where established teams of researchers are
already working on related scientific problems. Additionally, the
biological containment facilities should be located in an area with
existing infrastructure critical to providing timely public health
assistance in the case of a national, state, or local disease outbreak
or bioterrorism emergency. Locating a new national biocontainment
laboratory on the UTMB campus takes advantage of UTMB's extensive
expertise in biological medical research, its experience in operating
BSL-2, -3 and -4 laboratories (only five other operational BSL-4
laboratories exist in the United States), and its infrastructure as a
regional medical center.
UTMB is a complex of educational, medical, and research facilities,
with 6 interconnected hospitals with over 809 hospital beds. There are
over 2,000 students enrolled in UTMB's four schools: the School of
Medicine, the Graduate School of Biomedical Sciences, the School of
Nursing, and the School of Allied Health Sciences. UTMB provides nearly
400,000 square feet of space designed for research and houses one of
the largest research libraries in the southwest. Instruction and
research take place within 15 clinical and 6 basic science departments,
in addition to interdisciplinary centers and programs within the School
of Medicine.
UTMB researchers and clinicians have considerable specialized
expertise in infectious diseases, including tropical and newly emerging
viral diseases, as they have been conducting research on biodefense and
emerging infectious diseases for more than 20 years. In particular,
UTMB possesses distinctive research capabilities in emerging arthropod-
borne and rodent-associated viruses. Scientists in other fields such as
molecular virology, immunology, and structural biology, who contribute
to the biomedical discovery of new drugs and treatments, will
complement the expertise in infectious diseases present at UTMB.
In support of infectious disease research, UTMB has safely operated
several large suites of BSL-3 and Animal BSL (ABSL) laboratories for
several years. UTMB currently operates a suite of eight BSL-3
laboratories comprising a total of over 5,200 square feet and 2,400
square feet of ABSL-3 laboratories. UTMB also operates a 2,100-square
foot BSL-4 facility. In addition, UTMB houses one of the most complete
reference collections of bacteria, fungi, and viruses.
UTMB was the lead institution in organizing a consortium of over 20
universities, regional primate centers, and national laboratories that
filed an application with the National Institute of Allergy and
Infectious Diseases (NIAID) in January 2003 for funding as the Region
VI Center of Excellence for Biodefense and Emerging Infectious Disease
Research (RCE). NIAID awarded UTMB an RCE grant in September 2003. The
RCE program's primary role is to foster the physical and intellectual
environments in which wide-ranging research on infectious diseases can
proceed productively and safely. NIH selected the proposed GNL site
based on UTMB's ability to contribute to the overall NIAID biological
defense research agenda. The No Action Alternative will result in the
GNL not being built, and will impair the NIH's ability to counter the
serious strategic national shortage of biological containment
facilities.
Resources Impacts
The Final EIS describes potential environmental effects of the
selected action. These potential effects are documented in Chapter 3 of
the Final EIS. The GNL will result in insignificant impacts to the
environment, human health, and the surrounding community. A larger
impact will be to the UTMB community and its patrons with regard to
restricted vehicular traffic near the proposed GNL. Adverse
environmental effects are avoided or mitigated through design elements,
procedures, and compliance with regulatory and NIH requirements.
Potential impacts on air quality are all within government standards
(federal, state, and local). NIH does not expect negative effects on
the environment or on the citizens of Galveston from construction and
operation of the proposed GNL.
Summary of Impacts
The following is a summary of potential impacts resulting from the
Proposed Action that the NIH considered when making its decision. No
adverse cumulative effects have been identified during the NEPA
process. Likewise, no unavoidable or adverse impacts from
implementation of the Selected Action have been identified. The
Selected Action will be beneficial to the long-term productivity of the
national and world health communities. Biomedical research conducted at
the proposed GNL facility will have the potential to advance techniques
in disease prevention, develop disease immunizations, and prepare
defenses against bioweapons. Additionally, the local community will
benefit from having world-class biomedical expertise available at the
GNL facility on the UTMB campus.
Land Use
The proposed GNL facility will occupy approximately 1 acre and be
constructed within the footprint of the recently demolished building.
The total construction area will be 6.9 acres, including the plaza
space within the 200-foot security perimeter as it will be
reconstructed to include security walls, boulders, and bollards. The
operation of the proposed GNL facility will be consistent with the
current land use patterns on and within the immediate vicinity of the
UTMB campus.
Geology, Soils, and Seismicity
Despite the historical record of low seismicity in the region, the
risk for an earthquake exists in association with the Gulf Coast Normal
Faults Region. To mitigate any potential damage from an earthquake, and
as required by the National Earthquake Hazards Reduction Program, the
proposed GNL facility will be designed and constructed to the highest
building protection classification category of IV, which is required
for all buildings that are classified as having essential facilities
and that contain hazardous substances. There are no identified long-
term effects to either geology or soils in the region from the proposed
GNL facility.
Infrastructure
Construction and operation of the proposed GNL facility will
include small increases in water, electricity, and
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natural gas consumption, demand on sewage treatment and stormwater
management systems, and steam and chilled water usage. These increases
will not exceed the capacity of these services.
Transportation
During construction, some local vehicular and pedestrian traffic
may be re-routed to avoid construction areas. Post construction, there
will be no permanent closing, restriction, or re-routing of municipal
streets or municipal traffic patterns. However, on the UTMB campus, The
Strand and Ninth Streets within 200 feet of the proposed GNL facility
will be closed to regular vehicular traffic. Transportation accidents
involving micro-organisms are not expected to increase.
Human Health and Safety
Records from the past 21 years of accidents at NIAID laboratories
indicate an outstanding record of safety showing that in more than 3
million hours of exposure, there has been only one clinical infection
and four silent infections (no manifestation of disease symptoms). In
this 21-year period, there has been no agent released from any of these
laboratories to cause infection in the general population. Nationwide,
there have been no clinical infections from working with BSL-4 agents
during the past 31 years and no documented case of a laboratory
worker's family members or the public acquiring a disease from CDC
laboratory operations.
UTMB has been conducting research on emerging infectious diseases
and biodefense for more than two decades. Safety is a major concern in
working with and preventing the spread of highly infectious disease
agents. UTMB's safety record for its BSL-3 containment facilities from
May 2002 to May 2004 indicate that there have been no non-animal
related accidental exposures in any of the BSL-3 laboratories. There
have been two animal bites but neither resulted in infection.
Additionally, there have been no animal escapes from UTMB's
biocontainment laboratories. Key UTMB scientists and support personnel
have a combined experience of over 82 years in working with infectious
diseases at the BSL4 level.
The proposed GNL could result in beneficial human health impacts.
The proposed GNL facility will allow UTMB to become a leader in
developing diagnostic tests, management strategies, and vaccines for a
number of emerging viral diseases and potential biological weapons. The
proposed GNL facility will also allow for the training of additional
scientists for high level biocontainment conditions, provide a state-
of-the-art telemedicine system, and increase the laboratory space
available for conducting experiments.
Community Safety
A quantitative risk assessment using the Maximum Possible Risk
model and anthrax as the worst-case scenario agent concluded that there
will be no risk to the public from the accidental release of anthrax
spores at the proposed GNL facility. Six risk scenarios, assuming the
use of a powder-like preparation of purified B. anthracis containing
1x10\6\ spores, were run and the maximum number of spores released into
the environment was calculated to be 120 spores per cubic meter of air
(2,083 spores per cubic meter is needed to establish human infection).
In all scenarios, there was no probability of harm to the public from
an accidental release of anthrax spores due to the level of safety and
redundancy incorporated into the design of the facility (e.g., use of
biosafety cabinets, HEPA filters, emergency backup power sources, and
pressure monitoring devices and alarms).
Air Quality
Galveston County and the city of Galveston, including UTMB, lie
within the Houston/Galveston Ozone Nonattainment Area, as designated by
the Texas Commission on Environmental Quality and the Environmental
Protection Agency (EPA), for both the 1-hour and 8-hour ozone
standards. Concentrations of ozone exceeding the National Ambient Air
Quality Standards (NAAQS) are attributed to industrial and vehicular
emissions including emissions of volatile organic compounds and
nitrogen oxide compounds (NOX). Galveston County is in
attainment of the NAAQS for all other criteria pollutants for which EPA
has made attainment designations. During site preparation and
construction, the use of heavy equipment, delivery vehicles, and
construction workers' personal transportation will generate combustion
engine exhaust containing air pollutants associated with fuel (e.g.,
diesel). The amount of construction equipment and number of
construction workers at the GNL site are anticipated to be small and of
short duration, approximately 637 workers and a three year construction
time. The quantities of air pollutants produced by vehicles and
equipment associated with construction will be a minimal contribution
to the total emissions from mobile sources already operating in the
area. During normal operations of the proposed GNL facility, gaseous
and particulate air contaminant emissions (including biological toxins,
chemical agents, and hazardous air pollutants) generated will be
prevented from escaping to the outdoor air through the use of
engineering controls including a double HEPA-filtration system.
Discharges from the facility are expected to be small and have minimal
impact to NAAQS. Emergency generators will be added to existing
generators in the Basic Science Building located immediately west of
the proposed GNL facility. Emissions of regulated pollutants may
increase and a permit review will need to be conducted and a possible
modification to the permit needed.
Noise
During construction of the proposed GNL facility, there will be
increased noise levels of 10 to 15 dB from the daytime ambient levels
for approximately 80dB. However, this effect will be temporary and
intermittent. During operation of the proposed GNL facility, a low
level of noise will be generated, but this noise will be consistent
with the operation of similar laboratory/academic facilities on the
UTMB campus.
Waste Management
The waste and wastewater amounts estimated for the proposed GNL
facility are small increments, 0.4%, above the volumes generated by the
UTMB campus. The offsite treatment and disposal facilities that receive
waste and wastewater from the UTMB campus have available capacity. The
proposed GNL facility will be designed to treat the liquid biohazardous
waste by chemical decontamination or sterilization. This waste will
then be released into the building effluent treatment system where it
will be sterilized, cooled, and then discharged into the sanitary sewer
system. The solid waste that will be generated in the laboratories and
animal areas will also be considered biohazardous. Solid waste from the
BSL-2 laboratories will be placed into biohazard red bags for
incineration or will be autoclaved and disposed of as solid waste. BSL-
3 and -4 wastes will be sterilized in an autoclave then placed in boxes
for incineration. UTMB has a protocol for disposal of all biohazardous
waste from the existing BSL-4 laboratory. This same protocol will be
applied to the biohazardous waste generated by the proposed GNL BSL-4
facilities.
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Socioeconomics
The short-term economic benefits from construction of the proposed
GNL facility will be temporary and diminish as the project reaches
completion at the end of the 3-year construction period (2005-2008).
Construction of the proposed GNL facility is estimated to employ more
than 637 direct workers during peak construction and will generate
additional employment in associated sectors in the Region of Influence
(ROI) Galveston County. During construction, personal income will
increase by more than $30 million, or about 0.4 percent over the
baseline of $7.7 billion. Operation of the proposed GNL facility will
commence in the year 2008 and will continue for at least 20 years. The
proposed GNL facility workforce will consist of a mix of scientific and
administrative staff, including students. Although a total resident
population for the proposed GNL facility has not been established, it
is estimated that the facility will generate about 270 new direct jobs.
The proposed GNL facility will generate a total of 328 permanent jobs
(direct, indirect, and induced) in the Region of Influence (ROI) of
Galveston County. The majority of the indirect and induced jobs will be
in the retail trade and services sectors. Given the small number of
secondary jobs created by the Proposed Action relative to the regional
economy, the available labor force in the ROI will likely be able to
meet the increased demand for workers. Minor short-term benefits will
be expected. Tax revenues will exceed $2.2 million. The majority of the
tax revenue will derive from payroll taxes and will not remain in the
ROI. Total additional business output will be about $14.7 million.
Environmental Justice
The selected action will result in minor positive changes to
economic indicators, including personal income and employment. No
health and environmental impacts are projected for any population
within the ROI, including minority or low-income communities.
Therefore, no environmental justice issues will be expected.
Cultural Resources
Construction activities for the proposed GNL facility will not have
an impact on adjacent historical buildings. The proposed GNL facility
will be one laboratory building located among many others and will have
an exterior facade similar to the other UTMB campus buildings around
it. Thus, the view of that portion of the campus from any historic
properties will remain essentially as it is now. Most of the activities
related to operation of the proposed GNL facility will occur within the
facility. Those activities conducted outside will be similar to those
already conducted in relation to the campus buildings in the vicinity.
Thus, there will be no impact to historic properties or Recorded Texas
Historical Landmarks from operations of the proposed GNL facility.
Ecological Resources
The proposed GNL facility will be located within the built
environment in the heart of the UTMB campus. Vegetation consists of
grasses, shrubs, and trees characteristic of a landscaped environment.
Wildlife present are common species that have adapted to a landscaped
and built environment bustling with human activity. There are no
wetlands or natural aquatic environments within the UTMB campus. A
review of U.S. Fish and Wildlife Service files indicated that no
federally listed threatened or endangered species are likely to occur
on the campus and the campus is not located within officially
designated critical habitat.
Practicable Means To Avoid or Minimize Potential Environmental Harm
From the Selected Alternative
All practicable means to avoid or minimize adverse environmental
effects from the selected action have been identified and incorporated
into the action. The proposed GNL facility will be subject to the
existing UTMB pollution prevention, waste management, and safety,
security, and emergency response procedures as well as existing
environmental permits. Best management practices, spill prevention and
control, and stormwater management plans will be revised and followed
to appropriately address the construction and operation of the proposed
GNL and comply with applicable regulatory and NIH requirements. No
additional mitigation measures have been identified.
With regard to the restriction of vehicular traffic surrounding the
proposed GNL facility, UTMB has taken steps to ensure continued patient
access to the University Hospital Clinics (UHC) Building. The patient
access and drop-off area (with a new covered walkway) has been
relocated to the opposite side of the UHC Building.
Pollution Prevention
Pollution prevention measures are described in Chapter 2 of the
FEIS and reflect standard spill prevention procedures. Additional
pollution from the GNL facility is not anticipated. Air quality permit
standards will be met, as will all Federal, State, and local
requirements to protect the environment and public health. Additional
pollution prevention methods will include:
Reducing construction waste by recycling materials wherever
possible;
Water efficient landscaping; and
Use of heat reflective roofing material.
Monitoring and Enforcement Program for Mitigation Measures
During the preparation of the FEIS, several potential environmental
issues associated with implementation of the Proposed Action were
identified. The local community is concerned about transportation
impacts including patient access to the University Hospital Clinics
Building. To mitigate this impact to patients, a new patient access
drop-off area with a covered walkway will be accessible on the opposite
side of the Hospital. Non-ambulatory patient assistance will continue
as usual.
Transportation of agents to and from the GNL is a concern for some.
Strict rules and regulations govern how agents are packaged, labeled,
handled, tracked, and transported. The risk to the surrounding
community from the transport of biological material is as negligible as
anywhere else along the transport path.
Emergency planning was raised as a concern. UTMB has an existing
Institutional Emergency Operations Plan that is regularly reviewed and
that will be updated before the GNL becomes operational. Emergency
responders in the area are confident that they will be capable of
handling emergency situations.
In addition, possible adverse health and safety impacts on
laboratory workers in the proposed GNL and on nearby residents during
the operational phase of the project were evaluated. The risks were
deemed to be negligible, and mitigable through adherence to guidelines
outlined in the 4th Edition Biosafety in Microbiological and Biomedical
Laboratories, a joint publication of the NIH and CDC, as well as other
standards for safe operational practices.
Conclusion
Based upon review and careful consideration, the NIH has decided to
implement the Proposed Action to partially fund the construction of a
state-of the-art national biocontainment laboratory, which will be
known as the Galveston National Laboratory (GNL), on the University of
Texas Medical
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Branch (UTMB) Campus in Galveston, Texas.
The decision was based upon review and careful consideration of the
impacts identified in the Final EIS and public comments received
throughout the NEPA process. The decision was also based on UTMB's
extensive expertise in biological medical research, its experience in
operating BSL-2, -3 and -4 laboratories (only five other operational
BSL-4 laboratories exist in the United States), and its infrastructure
as a regional medical center being able to fulfill the purpose and need
to provide national biocontainment facilities. Other relevant factors
included in the decision, such as NIAID's mandate to conduct and
support research on agents of emerging and re-emerging infectious
diseases were carefully considered.
Dated: March 29, 2005.
Leonard Taylor, Jr.,
Acting Director, Office of Research Facilities Development and
Operations, National Institutes of Health.
[FR Doc. 05-7249 Filed 4-8-05; 8:45 am]
BILLING CODE 4140-01-P