National Emerging Infectious Diseases Laboratories Record of Decision, 5670-5675 [E6-1402]
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21–654 was approved on November 10,
2004.
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[FR Doc. E6–1365 Filed 2–1–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Emerging Infectious Diseases
Laboratories Record of Decision
hsrobinson on PROD1PC71 with NOTICES
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 (FEIS) and a thorough
consideration of the public comments
on the Draft EIS and Supplemental EIS,
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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), to be
called the National Emerging Infectious
Diseases Laboratories (NEIDL), at the
Boston University Medical Center
(BUMC) Campus in Boston,
Massachusetts.
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, 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 National Emerging Infectious
Diseases Laboratories (Final NEIDL 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 National
Emerging Infectious Diseases
Laboratories (NEIDL), on the Boston
University Medical Center Campus in
Boston, Massachusetts. The NIH will
fund approximately $128 million
dollars. The proposed NEIDL will
enhance national security through the
development and evaluation of
improved diagnostics, therapeutics, and
vaccines for the protection against
naturally emerging and re-emerging
diseases, including those that have the
potential for bioterrorism. The proposed
NEIDL will not conduct research to
develop biological weapons.
The proposed NEIDL facility will be
a new steel and reinforced concrete
seven-story building that will be
constructed within the BioSquare
Research Park, with a total assignable
area of 84,100 square feet, and will
house Biosafety Level (BSL)–4, BSL–3,
and BSL–2 facilities, BSL–4 and BSL–3
animal facilities, an Arthropod
Containment Level (ACL)–3 insectary,
offices, conference rooms, and support
facilities including an effluent treatment
room, secure loading dock, and
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dedicated mechanical floors to enhance
containment features of the building.
The proposed NEIDL facility will be
designed to safely support all the
superimposed loads applied to the
building and will be constructed to the
requirements of Seismic Performance
Category C, which assures that the
building structure stays functional after
a seismic event. In addition to standby
generators to provide power in the event
of a power outage, the NEIDL facility
will have a distributed on-line
uninterruptible power supply to power
the BSL–4 laboratory biosafety cabinets,
critical building control panels and
alarms. 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 zones, airflow and
pressure requirements, and high
efficiency particulate air (HEPA)
filtration.
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, and the pressure drop
condition HEPA filters. Visual
indicators (such as pressure gauges) and
audible or strobic alarms will alert
NEIDL personnel in the event of an
emergency or situation that requires
corrective action or other response. The
NEIDL will have fire protection systems
that meet or exceed requirements
specified by the National Fire Protection
Association and all applicable local,
state, Federal, and BUMC requirements.
The design of the proposed NEIDL
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 current 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 BSL–4 laboratory environment
employs the concept of a ‘‘box-withina-box’’ principle, whereby the
laboratory is built within a pressure-
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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 have dedicated supply and
exhaust ventilation, and workers in the
BSL–4 laboratories will use positive
pressure ventilation suits.
Workers will be required to take a
chemical shower to decontaminate the
surface of their suits before they can
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 isolation
dampers that will close within seconds
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 NEIDL 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
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the laboratories and the biosafety
cabinets will be verifiable with
appropriate visual and audible alarm
systems 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
treatment prior to removal. Liquid waste
will be chemically decontaminated
prior to discharge and solid waste will
be sterilized in autoclaves prior to
leaving the laboratories.
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
NEIDL facility will address security
concerns. Security measures are
discussed below. Scenarios involving
terrorist or intentionally destructive acts
at the NEIDL have been analyzed in an
independent Threat and Risk
Assessment (TRA). The design as well
as security plans and procedures of the
NEIDL facility will address the TRA
analysis and recommendations.
The NEIDL will be surrounded by a
protective fencing system that allows for
controlled access at staffed checkpoints
for both vehicles and pedestrians and to
create setbacks of approximately 100
feet from any location that could
accommodate unscreened pedestrian
traffic. Vehicular access would be
strictly limited to BUMC vehicles and
selected delivery and service vehicles.
The service and loading area will be
located on the south side of the facility
within the secure perimeter. Pedestrian
access to the building will be limited to
a single entrance and security officers
will be assigned to provide protective
services at the site twenty-four hours a
day, monitoring both the building and
the grounds.
Access to the NEIDL facility will be
strictly controlled by various measures.
All employees will undergo background
and security checks prior to being
assigned to a laboratory area. Strict
operational protocols, including specific
training, would be imposed on
laboratory personnel prior to working in
the facility. Security officers will be on
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duty twenty-four hours a day to monitor
controlled access. All employees will be
required to wear security badges.
Furthermore, security cameras will be in
use, biometric access systems will be
utilized, and all deliveries will be
screened.
Access to the BSL–4 laboratory will
be restricted to people whose presence
is required and authorized. Air pressure
resistant, lockable doors will be
monitored and controlled by the
security system. A log of persons
entering and exiting the laboratory with
name, time, date, and reason for
entering the lab will be maintained and
the log would be frequently audited by
BUMC’s Office of Environmental Health
and Safety (OEHS).
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
NEIDL). Previously, NIH examined
several sites and various facility
designs. Sites for the NBL were
evaluated if there was a reasonable
expectation that a facility could be
constructed with the available funding,
in a reasonable time, and while meeting
federal safety criteria. To meet these
constraints, two minimum siting criteria
were established. These criteria
included: (1) The site must be
controlled (owned or currently leased)
by Boston University (to remain within
funding and timing constraints); and (2)
The lot size must be sufficient to
accommodate a minimum building size
of 190,000 square feet (sf) and at the
same time meet federal security setback
requirements. Applying the above
screening criteria reduced the potential
sites for detailed evaluation to four
locations and four designs, one of which
became the Proposed Action. The three
other alternatives considered were a site
on the 210 acre BU Corporate Education
Center in Tyngsborough, Massachusetts;
a site at the BU Charles River Campus;
and a site at the BU Sargent Center for
Outdoor Education in Petersborough,
New Hampshire. These other sites and
designs were considered technically
inferior, provided no environmental
advantage compared to the Proposed
Action, or would 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
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the Draft EIS, the Supplemental 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 national shortage of
biological containment facilities
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 support in the case of a national,
state, or local disease outbreak or
bioterrorism emergency. Locating a new
national biocontainment laboratory at
the Boston University Medical Center
campus takes advantage of BU’s
extensive expertise in biological
medical research, and its infrastructure
as a regional medical center.
hsrobinson on PROD1PC71 with NOTICES
Resources Impacts
The Final EIS describes potential
environmental effects of the Selected
Alternative. These potential effects are
documented in Chapter 4 of the Final
EIS. Any potential adverse
environmental effects will be 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 Boston from
construction and operation of the
NEIDL.
Summary of Impacts
The following is a summary of
potential impacts resulting from the
Selected 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 longterm productivity of the national and
world health communities. Biomedical
research conducted at the NEIDL facility
will have the potential to advance
techniques in disease prevention,
develop disease immunizations, and
prepare defenses against naturally
emerging and re-emerging diseases and
against bioweapons. Additionally, the
local community will benefit from
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increased employment, income and,
government and public finance.
Housing
Temporary impacts during
construction are expected to have a
minimal effect on the existing
residential neighborhoods. The BostonNBL site is bounded by a regional
commercial wholesale florist market on
the east, a highway on the south, the
Boston University Medical Center on
the north, and the BioSquare Phase 1
Research Park on the west. Residential
neighborhoods are found north of the
site on two side streets off Albany Street
and one block north of the site off of
Harrison Avenue. Construction traffic
will avoid residential areas and rely on
Albany Street for access.
With over 250,000 housing units in
the City of Boston, the Project would
have no adverse impact on housing
stock. As required by local ordinance,
the Project would participate in the City
of Boston’s Affordable Housing Program
through a contribution to the City’s
Neighborhood Housing Trust in the
amount of approximately $920,000 to be
used for the creation of new affordable
housing. NIH funds would not be used
for this contribution.
Education
The current public school capacity in
the South End would be adequate to
accommodate the expected minimal
growth caused by the Boston-NBL
facility.
Transportation
The results of a traffic analysis
conducted for the BioSquare Phase II
Final Environmental Impact Report/
Project Impact Report (EIR/PIR)
demonstrates that the transportation
infrastructure is adequate to support the
Project. The 70 trips entering and
leaving the site during each of the a.m.
and p.m. peak hours that are specifically
attributed to the NBL represents only
15–16 percent of the additional peak
hour traffic; they are not sufficient in
and of themselves to change operations
significantly at any of the study area
locations. The potential introduction of
new access to and from the regional
highway system would remove existing
and future vehicle trips from the
congested corridors of Massachusetts
Avenue and Albany Street. Traffic flow
on the Massachusetts Avenue Connector
(MAC) is limited by the signalized
intersections at Massachusetts Avenue/
Southampton Street/Melnea Cass
Boulevard/MAC and Massachusetts
Avenue/Albany Street, which are
presently at capacity. By creating an
access point to BioSquare from the
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highway system, the Project would
reduce existing and future site generated
traffic from these critical intersections.
Community Safety and Risk
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 have 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 at NIAID supported
laboratories and no documented cases of
a laboratory worker’s family members or
the public acquiring a disease from
NIAID laboratory operations.
Records of all reported laboratory
accidents were reviewed from the past
ten years by the BUMC Occupational
and Environmental Medicine
Department and it has been confirmed
by that BUMC did not have any
laboratory-acquired infections from
research work at BSL–2 and BSL–3 with
the exception of an incident in 2004 in
which three research laboratory workers
were accidentally infected with
tularemia bacteria in their BSL–2 lab.
Corrective actions already identified
and implemented to prevent this type of
accident from occurring again include
increased safety training and procedures
for lab workers; strengthened laboratory
safety procedures; unannounced safety
inspections of BUMC laboratories;
applying additional tests and safeguards
to infectious material sent to BUMC for
research purposes; and working with
the Boston Public Health Commission to
improve the notification process.
With approximately 14 million hours
of operating time in the laboratories
during the ten year period described
above there were nine incidents of
animal bites; sixteen incidents of
percutaneous penetration; and two
incidents of eye splashes that occurred
within BSL–2 laboratories. None of the
exposures listed above, with the
exception of the tularemia incident led
to illness or evidence of serological
exposure.
Operation of the NEIDL is expected to
result in beneficial human health
impacts. The NEIDL facility will allow
the development of diagnostic tests,
management strategies, and vaccines for
a number of emerging viral diseases and
agents that may be used to cause
intentional harm. The NEIDL facility
will also allow for the training of
additional scientists in maximum
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biocontainment conditions, and
increase the laboratory space available
for conducting experiments that require
maximum containment in response to
emerging and re-emerging infectious
diseases.
To ensure that the project does not
create any adverse public health
impacts, an analysis was prepared to
address the potential risk to the public
of a ‘‘worst case scenario’’ involving loss
of containment systems in the BSL–4
laboratory that coincides with a release
within the facility. A quantitative risk
assessment was performed with regard
to a theoretical infectious agent release
to the surrounding community from the
Boston-NBL. The risk assessment
examined a laboratory accident within
the BSL–4 laboratory that coincided
with potential catastrophic failure of
containment equipment. The ‘‘worst
case scenario’’ also included an analysis
of a scenario depicting a laboratory
acquired infection; a scenario depicting
a release due to failure to decontaminate
exhaust air; a scenario depicting the
escape of an infected animal; a scenario
depicting a biological material
shipment; and a scenario depicting an
unauthorized removal of biological
material from containment area. The
results of these studies showed the
predicted maximum exposure to any
member of the community from the
‘‘worst case scenario’’ is 0.29 spores
over the entire duration of the event. As
the exposure to a partial spore is not
feasible, the risk of public harm is so
minute that it may be described as
negligible.
In order to address the concerns about
community safety that were raised in
public comments, the NIH prepared an
additional risk assessment. An
additional exposure modeling strategy
was applied to the proposed Boston
University site. The ‘‘Maximum Possible
Risk’’ or MPR model was developed by
the NIH in response to comments from
the public. Fifteen different scenarios
were subjected to analysis using the
MPR model. The MPR model analysis
included three scenarios depicting spills
and work disruptions; one scenario
depicting a spill on the floor with no
HEPA filter in the HVAC system; one
scenario depicting a spill on the floor
during a power outage; two scenarios
depicting physical removal of biological
material; two scenarios depicting fire;
and seven scenarios depicting
explosions. The conclusions of the MPR
model showed that all fifteen scenarios
had no probability of public health
harm.
In summary, twenty-one different risk
scenarios, six in the original risk
assessment and fifteen in the
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supplemental risk assessment, were
examined in total. All twenty-one
scenarios supported the conclusion that
the facility poses negligible risk to the
community.
Employment
The Boston-NBL facility will create
approximately 1,300 temporary
construction jobs and 660 new
permanent positions. These new
positions include all types and levels
including environmental services, lab
technicians, scientists, and
administrative staff. The majority of
positions would require skilled and
experienced workers.
During construction, the project will
comply with the City of Boston Jobs
Policy through the creation of a Boston
Residents Construction Plan,
establishing goals for the recruitment of
local residents for construction
employment.
BUMC is committed to working with
City agencies to ensure that Boston
residents have the opportunity to
benefit from the new employment
generated by the facility. Toward this
end, there would be opportunities for
local residents to obtain training for
various positions, such as laboratory
staff, which would in turn benefit the
local economy. The Boston-NBL facility
will contribute approximately $185,000
to the City of Boston’s Neighborhood
Jobs Trust for training purposes.
Income
The Boston-NBL facility, like other
BUMC facilities, would bring large
infusions of outside money to the area
to finance the laboratory’s work. The
NEIDL will have positive economic
impact on the South End and
surrounding neighborhoods throughout
the construction and operation phases.
The total direct wages to be paid per
year at the Boston-NBL is projected to
be $33,000,000, of which 21.4%, or a
total of $7,062,000, is expected to go to
Boston residents.
Environmental Justice
During the construction phase of the
project, neighborhoods immediately
abutting the Project site, including
Environmental Justice communities
(communities where 25% or more of the
population is defined as a minority),
may experience temporary impacts from
construction because of their location
and proximity. There will be no
disproportionate effect on
Environmental Justice communities.
The project will develop a Construction
Management Plan to minimize
construction related transportation
impacts.
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The worst case scenario analysis
shows that during operations of the
laboratory there will be negligible risk to
public health for the entire community.
Therefore, there will be no
disproportionate impact on
Environmental Justice communities
during operations.
Visual Quality
The project has been designed to
complement the existing urban design
context of the project area. The site plan
and massing of the project would help
to mend the irregular urban edge that
now exists along Albany Street. The site
design and building massing have been
reviewed with the Boston
Redevelopment Authority (BRA) urban
design staff as part of the design review
process to assure compliance with BRA
guidelines and recommendations.
Noise
Construction of the project will result
in a temporary increase in daytime
sound levels near the site. The
maximum L10 (sound level exceeded
10% of the time) during construction is
estimated to be 71 dBA, which complies
with the City of Boston Noise Control
Regulation that permits L10 levels from
construction operations to exceed 75
dBA. To reduce noise from construction
the project would install high-grade
mufflers on the diesel powered
construction equipment and generators;
combine noisy operations to occur for
short durations during the same time
periods; and perform construction
activities only between the hours of 7
a.m. to 5 p.m.
Air Quality
The laboratory exhaust system will be
designed to avoid any air quality
impacts inside or outside the building
under normal operations. The potential
air quality effects from the laboratories
will be minimized by: (1) Combining the
exhaust vents from the internal
laboratory hoods into groups before
connecting to rooftop exhaust fans, thus
providing enhanced dilution of any
laboratory chemical emissions before
they reach ambient air; (2) designing the
rooftop stacks to have exit velocities of
at least 3,000 feet per minute as a stack
exit velocity of this magnitude would be
sufficient to avoid stack tip downwash,
a phenomenon in which the emissions
from the stack are drawn downward as
strong winds blow by the stack; (3)
carefully controlling and limiting the
storage of all chemicals within the
building to minimize chemical
emissions, liquid chemicals would not
be left exposed to the air and would
always be contained and transferred
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within closed glassware; and (4)
handling liquid chemicals in small
quantities to reduce the potential air
quality impacts in the event of an
accidental spill.
The National Ambient Air Quality
Standards (NAAQS) were established to
protect public health and welfare, with
a margin for safety. An air quality
dispersion modeling analysis was
performed for the generators, boilers
and laboratory vents at the Boston-NBL
in accordance with the U.S. EPA and
state Department of Environmental
Protection (DEP) modeling guidelines.
The dispersion modeling results
demonstrated that the maximum
cumulative concentrations of criteria air
pollutants from the boilers and
generators, modeled with the existing
interactive sources, and with
background air pollutant concentrations
added, will be safely in compliance
with the NAAQS for all of the criteria
air pollutants analyzed.
During the construction period, the
project will comply with the state DEP
Diesel Retrofit Program to reduce
emissions from construction-related
vehicle exhaust.
sterilized effluent from the BSL–4 areas
will be cooled and neutralized before
discharge. The discharges from the
facility will have no adverse effect on
the wastewater treatment system.
Existing public water supply systems
have been significantly upgraded in the
past several years and has more than
adequate capacity to service the BostonNBL. The project will have no adverse
effect on water supply.
Wastewater/Water Supply
The daily sewage flows are estimated
at 45,825 gallons per day (gpd) based on
existing flows at similar BUMC labs.
The project does not require
improvements to existing sewage
infrastructure. Sanitary sewage for the
proposed project would be carried by
the New Albany Street Interceptor,
which is designed to carry a theoretical
flow of 16 million gallons per day
(mgd). This project anticipates a total
new daily flow of 45,825 gpd, or
approximately 0.29% of the theoretical
capacity of the interceptor. The
estimated peak sewage flow of 137,475
gpd would be approximately 0.86% of
the system capacity. At the time the
New Albany Street Interceptor was
designed, much larger flows were
expected from this area. Accordingly,
there is more than sufficient capacity in
the system to accommodate the
additional flows from this project and
the project will have no adverse effects
on existing wastewater systems
The Boston-NBL will have a
segregated plumbing system that will
carry laboratory wastewater from every
non-BSL–4 area to mixing tanks in the
basement where pH adjustment and
compliance sampling would occur prior
to discharge to the sanitary system. The
BSL–4 areas of the Boston-NBL building
would feature a sterilization system
designed to use heat to kill any
biological agents that might exist in the
wastewater from these BSL–4 areas. The
All practicable means to avoid or
minimize adverse environmental effects
from the Selected Action have been
identified and incorporated into the
action. The proposed NEIDL facility will
be subject to the existing BUMC
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 developed
and followed to appropriately address
the construction and operation of the
NEIDL and comply with applicable
regulatory and NIH requirements. No
additional mitigation measures have
been identified.
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Historic Resources
The proposed project will be sited in
an area of large commercial, industrial
and institutional uses near the South
End Landmark District and National
Register District. The Project is located
within the South End Harrison/Albany
Protection Area, which covers a
transitional area adjacent to the above
districts. The proposed Project meets
the goals of the Protection Area and thus
has no adverse effects on historic
resources.
Practicable Means To Avoid or
Minimize Potential Environmental
Harm From the Selected Alternative
Pollution Prevention
Pollution prevention measures are
described in Chapter 2 of the FEIS and
reflect standard spill prevention
procedures. Additional pollution from
the NEIDL 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
Adhering to current BUMC waste
management practices.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Monitoring and Enforcement Program
for Mitigation Measures
During the preparation of the FEIS,
several potential environmental issues
associated with implementation of the
Selected Alternative were identified.
The local community is concerned
about transportation impacts.
Transportation of agents to and from the
NEIDL is a concern for some. Strict rules
and regulations govern how agents are
packaged, labeled, handled, tracked,
and transported. The transportation of
agents will comply with all rules and
regulations. According to the World
Health Organization (WHO), worldwide,
there have never been any cases of
illness attributable to the release of
infectious materials during
transportation. There have been reports
of damage to outer packaging. The risk
to the community from the transport of
infectious agents or other biologicallyderived material is negligible.
Emergency planning was raised as a
concern. BUMC has an existing Incident
Command System and a detailed
Disaster Operations Plan that is
regularly reviewed and will be revised
to include the operations of the NEIDL.
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 NEIDL 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 current
edition of 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 Selected Alternative to
partially fund the construction of a
state-of the-art national biocontainment
laboratory, which will be known as the
National Emerging Infectious Diseases
Laboratories (NEIDL) on the Boston
University Medical Campus (BUMC) in
Boston, Massachusetts.
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 BUMC’s extensive expertise in
biological medical research, its
experience in operating BSL–2, and –3
laboratories, and its infrastructure as a
regional medical center being able to
E:\FR\FM\02FEN1.SGM
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Federal Register / Vol. 71, No. 22 / Thursday, February 2, 2006 / Notices
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: January 26, 2006.
Juanita M. Mildenberg,
FAIA Acting Director, Office of Research
Facilities Development and Operations,
National Institutes of Health.
[FR Doc. E6–1402 Filed 2–1–06; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
hsrobinson on PROD1PC71 with NOTICES
Notice of Meeting: Secretary’s
Advisory Committee on Genetics,
Health, and Society
Pursuant to Public Law 92–463,
notice if hereby given of the ninth
meeting of the Secretary’s Advisory
Committee on Genetics, Health, and
Society (SACGHS), U.S. Public Health
Service. The meeting will be held from
9 a.m. to 5 p.m. on March 27, 2006 and
9 a.m. to 5 p.m. on March 28, 2006 at
the National Institutes of Health,
Building 31, C Wing, Conference Room
6, 31 Center Drive, Bethesda, MD 20892.
The meeting will be open to the public
with attendance limited to space
available. The meeting will be webcast.
The first day of the meeting will
include sessions on pharmacogenomics
and large population studies of genetic
variation, the environment and common
disease. The pharmacogenomics session
will include a review of Federal efforts
in pharmacogenomics and deliberation
on draft recommendations in this area.
The large population studies session
will involve discussion of a draft report
that identifies policy issues associated
with mounting a large population study
in the United States.
The second day will be devoted to
sessions on genetic discrimination and
patents and licensing issues. The
genetic discrimination session will
include an update on the status of
Federal genetic non-discrimination
legislation. The patents and licensing
session will involve a presentation on
the findings and conclusions of a
National Academy of Sciences’ report
on intellectual property rights in
genomic research and innovation, and a
discussion on whether there are other
issues in this arena that warrant
SACGHS’s further attention.
Time will be provided each day for
public comments. The Committee
VerDate Aug<31>2005
15:26 Feb 01, 2006
Jkt 208001
would welcome hearing from anyone
wishing to provide public comment on
any issue related to genetics, health and
society. Individuals who would like to
provide public comment or who plan to
attend the meeting and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
SACGHS Executive Secretary, Ms. Sarah
Carr, by telephone at 301–496–9838 or
e-mail at sc112@nih.gov. The SACGHS
office is located at 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892.
Under authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service
Act, as amended, the Department of
Health and Human Services established
SACGHS to serve as a public forum for
deliberations on the broad range of
human health and societal issues raised
by the development and use of genetic
technologies and, as warranted, to
provide advice on these issues. The
draft meeting agenda and other
information about SACGHS, including
information about access to the webcast
will be available at the following Web
site: https://www4.od.nih.gov/oba/
sacghs.htm.
Dated: January 26, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–979 Filed 2–1–06; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Meeting: Secretary’s
Advisory Committee on Genetics,
Health, and Society
Pursuant to Public Law 92–463,
notice is hereby given of the ninth
meeting of the Secretary’s Advisory
Committee on Genetics, Health, and
Society (SACGHS), U.S. Public Health
Service. The meeting will be held from
9 a.m. to 5 p.m. on March 27, 2006 and
9 a.m. to 5 p.m. on March 28, 2006 at
the National Institutes of Health,
Building 31, C Wing, Conference Room
6, 31 Center Drive, Bethesda, MD 20892.
The meeting will be open to the public
with attendance limited to space
available. The meeting will be webcast.
The first day of the meeting will
include sessions on pharmacogenomics
and large population studies of genetic
variation, the environment and common
disease. The pharmacogenomics session
will include a review of Federal efforts
in pharmacogenomics and deliberation
on draft recommendations in this area.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
5675
The large population studies session
will involve discussion of a draft report
that identifies policy issues associated
with mounting a large population study
in the United States.
The second day will be devoted to
sessions on genetic discrimination and
patents and licensing issues. The
genetic discrimination session will
include an update on the status of
Federal genetic non-discrimination
legislation. The patents and licensing
session will involve a presentation on
the findings and conclusions of a
National Academy of Sciences report on
intellectual property rights in genomic
research and innovation, and a
discussion of whether there are other
issues in this area that warrant
SACGHS’s further attention.
Time will be provided each day for
public comments. The Committee
would welcome hearing from anyone
wishing to provide public comment on
any issue related to genetics, health and
society. Individuals who would like to
provide public comment or who plan to
attend the meeting and need special
assistance, such as sign language
interpretation or other reasonable
accommodation, should notify the
SACGHS Executive Secretary, Ms. Sarah
Carr, by telephone at 301–496–9838 or
e-mail at sc112c@nih.gov. The SACGHS
office is located at 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892.
Under authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service
Act, as amended, the Department of
Health and Human Services established
SACGHS to serve as a public forum for
deliberations on the broad range of
human health and societal issues raised
by the development and use of genetic
technologies and, as warranted, to
provide advice on these issues. The
draft meeting agenda and other
information about SACGHS, including
information about access to the webcast
will be available at the following Web
site: https://www4.od.nih.gov/oba/
sacghs.htm.
Dated: January 26, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–978 Filed 2–1–06; 8:45 am]
BILLING CODE 4140–01–M
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[Federal Register Volume 71, Number 22 (Thursday, February 2, 2006)]
[Notices]
[Pages 5670-5675]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Emerging Infectious Diseases Laboratories 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 (FEIS) and a thorough consideration of
the public comments on the Draft EIS and Supplemental 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), to be
called the National Emerging Infectious Diseases Laboratories (NEIDL),
at the Boston University Medical Center (BUMC) Campus in Boston,
Massachusetts.
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, 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 National Emerging Infectious
Diseases Laboratories (Final NEIDL 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
National Emerging Infectious Diseases Laboratories (NEIDL), on the
Boston University Medical Center Campus in Boston, Massachusetts. The
NIH will fund approximately $128 million dollars. The proposed NEIDL
will enhance national security through the development and evaluation
of improved diagnostics, therapeutics, and vaccines for the protection
against naturally emerging and re-emerging diseases, including those
that have the potential for bioterrorism. The proposed NEIDL will not
conduct research to develop biological weapons.
The proposed NEIDL facility will be a new steel and reinforced
concrete seven-story building that will be constructed within the
BioSquare Research Park, with a total assignable area of 84,100 square
feet, and will house Biosafety Level (BSL)-4, BSL-3, and BSL-2
facilities, BSL-4 and BSL-3 animal facilities, an 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 features of the
building.
The proposed NEIDL facility will be designed to safely support all
the superimposed loads applied to the building and will be constructed
to the requirements of Seismic Performance Category C, which assures
that the building structure stays functional after a seismic event. In
addition to standby generators to provide power in the event of a power
outage, the NEIDL facility will have a distributed on-line
uninterruptible power supply to power the BSL-4 laboratory biosafety
cabinets, critical building control panels and alarms. 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 zones, airflow and pressure requirements, and high
efficiency particulate air (HEPA) filtration.
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, and the
pressure drop condition HEPA filters. Visual indicators (such as
pressure gauges) and audible or strobic alarms will alert NEIDL
personnel in the event of an emergency or situation that requires
corrective action or other response. The NEIDL will have fire
protection systems that meet or exceed requirements specified by the
National Fire Protection Association and all applicable local, state,
Federal, and BUMC requirements.
The design of the proposed NEIDL 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 current 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 BSL-4 laboratory environment employs the concept of a ``box-
within-a-box'' principle, whereby the laboratory is built within a
pressure-
[[Page 5671]]
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 have dedicated supply and exhaust ventilation, and workers
in the BSL-4 laboratories will use positive pressure ventilation suits.
Workers will be required to take a chemical shower to decontaminate
the surface of their suits before they can 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 isolation dampers that will close within
seconds 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 NEIDL 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 visual and audible alarm
systems 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 treatment prior to
removal. Liquid waste will be chemically decontaminated prior to
discharge and solid waste will be sterilized in autoclaves prior to
leaving the laboratories.
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 NEIDL facility will address
security concerns. Security measures are discussed below. Scenarios
involving terrorist or intentionally destructive acts at the NEIDL have
been analyzed in an independent Threat and Risk Assessment (TRA). The
design as well as security plans and procedures of the NEIDL facility
will address the TRA analysis and recommendations.
The NEIDL will be surrounded by a protective fencing system that
allows for controlled access at staffed checkpoints for both vehicles
and pedestrians and to create setbacks of approximately 100 feet from
any location that could accommodate unscreened pedestrian traffic.
Vehicular access would be strictly limited to BUMC vehicles and
selected delivery and service vehicles. The service and loading area
will be located on the south side of the facility within the secure
perimeter. Pedestrian access to the building will be limited to a
single entrance and security officers will be assigned to provide
protective services at the site twenty-four hours a day, monitoring
both the building and the grounds.
Access to the NEIDL facility will be strictly controlled by various
measures. All employees will undergo background and security checks
prior to being assigned to a laboratory area. Strict operational
protocols, including specific training, would be imposed on laboratory
personnel prior to working in the facility. Security officers will be
on duty twenty-four hours a day to monitor controlled access. All
employees will be required to wear security badges. Furthermore,
security cameras will be in use, biometric access systems will be
utilized, and all deliveries will be screened.
Access to the BSL-4 laboratory will be restricted to people whose
presence is required and authorized. Air pressure resistant, lockable
doors will be monitored and controlled by the security system. A log of
persons entering and exiting the laboratory with name, time, date, and
reason for entering the lab will be maintained and the log would be
frequently audited by BUMC's Office of Environmental Health and Safety
(OEHS).
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 NEIDL). Previously, NIH examined several sites and
various facility designs. Sites for the NBL were evaluated if there was
a reasonable expectation that a facility could be constructed with the
available funding, in a reasonable time, and while meeting federal
safety criteria. To meet these constraints, two minimum siting criteria
were established. These criteria included: (1) The site must be
controlled (owned or currently leased) by Boston University (to remain
within funding and timing constraints); and (2) The lot size must be
sufficient to accommodate a minimum building size of 190,000 square
feet (sf) and at the same time meet federal security setback
requirements. Applying the above screening criteria reduced the
potential sites for detailed evaluation to four locations and four
designs, one of which became the Proposed Action. The three other
alternatives considered were a site on the 210 acre BU Corporate
Education Center in Tyngsborough, Massachusetts; a site at the BU
Charles River Campus; and a site at the BU Sargent Center for Outdoor
Education in Petersborough, New Hampshire. These other sites and
designs were considered technically inferior, provided no environmental
advantage compared to the Proposed Action, or would 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
[[Page 5672]]
the Draft EIS, the Supplemental 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 national shortage of biological containment facilities
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 support in the case of a national, state, or local
disease outbreak or bioterrorism emergency. Locating a new national
biocontainment laboratory at the Boston University Medical Center
campus takes advantage of BU's extensive expertise in biological
medical research, and its infrastructure as a regional medical center.
Resources Impacts
The Final EIS describes potential environmental effects of the
Selected Alternative. These potential effects are documented in Chapter
4 of the Final EIS. Any potential adverse environmental effects will be
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 Boston from construction and operation of the NEIDL.
Summary of Impacts
The following is a summary of potential impacts resulting from the
Selected 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 NEIDL facility will have the potential to advance techniques in
disease prevention, develop disease immunizations, and prepare defenses
against naturally emerging and re-emerging diseases and against
bioweapons. Additionally, the local community will benefit from
increased employment, income and, government and public finance.
Housing
Temporary impacts during construction are expected to have a
minimal effect on the existing residential neighborhoods. The Boston-
NBL site is bounded by a regional commercial wholesale florist market
on the east, a highway on the south, the Boston University Medical
Center on the north, and the BioSquare Phase 1 Research Park on the
west. Residential neighborhoods are found north of the site on two side
streets off Albany Street and one block north of the site off of
Harrison Avenue. Construction traffic will avoid residential areas and
rely on Albany Street for access.
With over 250,000 housing units in the City of Boston, the Project
would have no adverse impact on housing stock. As required by local
ordinance, the Project would participate in the City of Boston's
Affordable Housing Program through a contribution to the City's
Neighborhood Housing Trust in the amount of approximately $920,000 to
be used for the creation of new affordable housing. NIH funds would not
be used for this contribution.
Education
The current public school capacity in the South End would be
adequate to accommodate the expected minimal growth caused by the
Boston-NBL facility.
Transportation
The results of a traffic analysis conducted for the BioSquare Phase
II Final Environmental Impact Report/Project Impact Report (EIR/PIR)
demonstrates that the transportation infrastructure is adequate to
support the Project. The 70 trips entering and leaving the site during
each of the a.m. and p.m. peak hours that are specifically attributed
to the NBL represents only 15-16 percent of the additional peak hour
traffic; they are not sufficient in and of themselves to change
operations significantly at any of the study area locations. The
potential introduction of new access to and from the regional highway
system would remove existing and future vehicle trips from the
congested corridors of Massachusetts Avenue and Albany Street. Traffic
flow on the Massachusetts Avenue Connector (MAC) is limited by the
signalized intersections at Massachusetts Avenue/Southampton Street/
Melnea Cass Boulevard/MAC and Massachusetts Avenue/Albany Street, which
are presently at capacity. By creating an access point to BioSquare
from the highway system, the Project would reduce existing and future
site generated traffic from these critical intersections.
Community Safety and Risk
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 have 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 at NIAID supported laboratories and no
documented cases of a laboratory worker's family members or the public
acquiring a disease from NIAID laboratory operations.
Records of all reported laboratory accidents were reviewed from the
past ten years by the BUMC Occupational and Environmental Medicine
Department and it has been confirmed by that BUMC did not have any
laboratory-acquired infections from research work at BSL-2 and BSL-3
with the exception of an incident in 2004 in which three research
laboratory workers were accidentally infected with tularemia bacteria
in their BSL-2 lab. Corrective actions already identified and
implemented to prevent this type of accident from occurring again
include increased safety training and procedures for lab workers;
strengthened laboratory safety procedures; unannounced safety
inspections of BUMC laboratories; applying additional tests and
safeguards to infectious material sent to BUMC for research purposes;
and working with the Boston Public Health Commission to improve the
notification process.
With approximately 14 million hours of operating time in the
laboratories during the ten year period described above there were nine
incidents of animal bites; sixteen incidents of percutaneous
penetration; and two incidents of eye splashes that occurred within
BSL-2 laboratories. None of the exposures listed above, with the
exception of the tularemia incident led to illness or evidence of
serological exposure.
Operation of the NEIDL is expected to result in beneficial human
health impacts. The NEIDL facility will allow the development of
diagnostic tests, management strategies, and vaccines for a number of
emerging viral diseases and agents that may be used to cause
intentional harm. The NEIDL facility will also allow for the training
of additional scientists in maximum
[[Page 5673]]
biocontainment conditions, and increase the laboratory space available
for conducting experiments that require maximum containment in response
to emerging and re-emerging infectious diseases.
To ensure that the project does not create any adverse public
health impacts, an analysis was prepared to address the potential risk
to the public of a ``worst case scenario'' involving loss of
containment systems in the BSL-4 laboratory that coincides with a
release within the facility. A quantitative risk assessment was
performed with regard to a theoretical infectious agent release to the
surrounding community from the Boston-NBL. The risk assessment examined
a laboratory accident within the BSL-4 laboratory that coincided with
potential catastrophic failure of containment equipment. The ``worst
case scenario'' also included an analysis of a scenario depicting a
laboratory acquired infection; a scenario depicting a release due to
failure to decontaminate exhaust air; a scenario depicting the escape
of an infected animal; a scenario depicting a biological material
shipment; and a scenario depicting an unauthorized removal of
biological material from containment area. The results of these studies
showed the predicted maximum exposure to any member of the community
from the ``worst case scenario'' is 0.29 spores over the entire
duration of the event. As the exposure to a partial spore is not
feasible, the risk of public harm is so minute that it may be described
as negligible.
In order to address the concerns about community safety that were
raised in public comments, the NIH prepared an additional risk
assessment. An additional exposure modeling strategy was applied to the
proposed Boston University site. The ``Maximum Possible Risk'' or MPR
model was developed by the NIH in response to comments from the public.
Fifteen different scenarios were subjected to analysis using the MPR
model. The MPR model analysis included three scenarios depicting spills
and work disruptions; one scenario depicting a spill on the floor with
no HEPA filter in the HVAC system; one scenario depicting a spill on
the floor during a power outage; two scenarios depicting physical
removal of biological material; two scenarios depicting fire; and seven
scenarios depicting explosions. The conclusions of the MPR model showed
that all fifteen scenarios had no probability of public health harm.
In summary, twenty-one different risk scenarios, six in the
original risk assessment and fifteen in the supplemental risk
assessment, were examined in total. All twenty-one scenarios supported
the conclusion that the facility poses negligible risk to the
community.
Employment
The Boston-NBL facility will create approximately 1,300 temporary
construction jobs and 660 new permanent positions. These new positions
include all types and levels including environmental services, lab
technicians, scientists, and administrative staff. The majority of
positions would require skilled and experienced workers.
During construction, the project will comply with the City of
Boston Jobs Policy through the creation of a Boston Residents
Construction Plan, establishing goals for the recruitment of local
residents for construction employment.
BUMC is committed to working with City agencies to ensure that
Boston residents have the opportunity to benefit from the new
employment generated by the facility. Toward this end, there would be
opportunities for local residents to obtain training for various
positions, such as laboratory staff, which would in turn benefit the
local economy. The Boston-NBL facility will contribute approximately
$185,000 to the City of Boston's Neighborhood Jobs Trust for training
purposes.
Income
The Boston-NBL facility, like other BUMC facilities, would bring
large infusions of outside money to the area to finance the
laboratory's work. The NEIDL will have positive economic impact on the
South End and surrounding neighborhoods throughout the construction and
operation phases. The total direct wages to be paid per year at the
Boston-NBL is projected to be $33,000,000, of which 21.4%, or a total
of $7,062,000, is expected to go to Boston residents.
Environmental Justice
During the construction phase of the project, neighborhoods
immediately abutting the Project site, including Environmental Justice
communities (communities where 25% or more of the population is defined
as a minority), may experience temporary impacts from construction
because of their location and proximity. There will be no
disproportionate effect on Environmental Justice communities. The
project will develop a Construction Management Plan to minimize
construction related transportation impacts.
The worst case scenario analysis shows that during operations of
the laboratory there will be negligible risk to public health for the
entire community. Therefore, there will be no disproportionate impact
on Environmental Justice communities during operations.
Visual Quality
The project has been designed to complement the existing urban
design context of the project area. The site plan and massing of the
project would help to mend the irregular urban edge that now exists
along Albany Street. The site design and building massing have been
reviewed with the Boston Redevelopment Authority (BRA) urban design
staff as part of the design review process to assure compliance with
BRA guidelines and recommendations.
Noise
Construction of the project will result in a temporary increase in
daytime sound levels near the site. The maximum L10 (sound
level exceeded 10% of the time) during construction is estimated to be
71 dBA, which complies with the City of Boston Noise Control Regulation
that permits L10 levels from construction operations to
exceed 75 dBA. To reduce noise from construction the project would
install high-grade mufflers on the diesel powered construction
equipment and generators; combine noisy operations to occur for short
durations during the same time periods; and perform construction
activities only between the hours of 7 a.m. to 5 p.m.
Air Quality
The laboratory exhaust system will be designed to avoid any air
quality impacts inside or outside the building under normal operations.
The potential air quality effects from the laboratories will be
minimized by: (1) Combining the exhaust vents from the internal
laboratory hoods into groups before connecting to rooftop exhaust fans,
thus providing enhanced dilution of any laboratory chemical emissions
before they reach ambient air; (2) designing the rooftop stacks to have
exit velocities of at least 3,000 feet per minute as a stack exit
velocity of this magnitude would be sufficient to avoid stack tip
downwash, a phenomenon in which the emissions from the stack are drawn
downward as strong winds blow by the stack; (3) carefully controlling
and limiting the storage of all chemicals within the building to
minimize chemical emissions, liquid chemicals would not be left exposed
to the air and would always be contained and transferred
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within closed glassware; and (4) handling liquid chemicals in small
quantities to reduce the potential air quality impacts in the event of
an accidental spill.
The National Ambient Air Quality Standards (NAAQS) were established
to protect public health and welfare, with a margin for safety. An air
quality dispersion modeling analysis was performed for the generators,
boilers and laboratory vents at the Boston-NBL in accordance with the
U.S. EPA and state Department of Environmental Protection (DEP)
modeling guidelines. The dispersion modeling results demonstrated that
the maximum cumulative concentrations of criteria air pollutants from
the boilers and generators, modeled with the existing interactive
sources, and with background air pollutant concentrations added, will
be safely in compliance with the NAAQS for all of the criteria air
pollutants analyzed.
During the construction period, the project will comply with the
state DEP Diesel Retrofit Program to reduce emissions from
construction-related vehicle exhaust.
Wastewater/Water Supply
The daily sewage flows are estimated at 45,825 gallons per day
(gpd) based on existing flows at similar BUMC labs. The project does
not require improvements to existing sewage infrastructure. Sanitary
sewage for the proposed project would be carried by the New Albany
Street Interceptor, which is designed to carry a theoretical flow of 16
million gallons per day (mgd). This project anticipates a total new
daily flow of 45,825 gpd, or approximately 0.29% of the theoretical
capacity of the interceptor. The estimated peak sewage flow of 137,475
gpd would be approximately 0.86% of the system capacity. At the time
the New Albany Street Interceptor was designed, much larger flows were
expected from this area. Accordingly, there is more than sufficient
capacity in the system to accommodate the additional flows from this
project and the project will have no adverse effects on existing
wastewater systems
The Boston-NBL will have a segregated plumbing system that will
carry laboratory wastewater from every non-BSL-4 area to mixing tanks
in the basement where pH adjustment and compliance sampling would occur
prior to discharge to the sanitary system. The BSL-4 areas of the
Boston-NBL building would feature a sterilization system designed to
use heat to kill any biological agents that might exist in the
wastewater from these BSL-4 areas. The sterilized effluent from the
BSL-4 areas will be cooled and neutralized before discharge. The
discharges from the facility will have no adverse effect on the
wastewater treatment system.
Existing public water supply systems have been significantly
upgraded in the past several years and has more than adequate capacity
to service the Boston-NBL. The project will have no adverse effect on
water supply.
Historic Resources
The proposed project will be sited in an area of large commercial,
industrial and institutional uses near the South End Landmark District
and National Register District. The Project is located within the South
End Harrison/Albany Protection Area, which covers a transitional area
adjacent to the above districts. The proposed Project meets the goals
of the Protection Area and thus has no adverse effects on historic
resources.
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 NEIDL facility will be subject to the
existing BUMC 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 developed and followed
to appropriately address the construction and operation of the NEIDL
and comply with applicable regulatory and NIH requirements. No
additional mitigation measures have been identified.
Pollution Prevention
Pollution prevention measures are described in Chapter 2 of the
FEIS and reflect standard spill prevention procedures. Additional
pollution from the NEIDL 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
Adhering to current BUMC waste management practices.
Monitoring and Enforcement Program for Mitigation Measures
During the preparation of the FEIS, several potential environmental
issues associated with implementation of the Selected Alternative were
identified.
The local community is concerned about transportation impacts.
Transportation of agents to and from the NEIDL is a concern for some.
Strict rules and regulations govern how agents are packaged, labeled,
handled, tracked, and transported. The transportation of agents will
comply with all rules and regulations. According to the World Health
Organization (WHO), worldwide, there have never been any cases of
illness attributable to the release of infectious materials during
transportation. There have been reports of damage to outer packaging.
The risk to the community from the transport of infectious agents or
other biologically-derived material is negligible.
Emergency planning was raised as a concern. BUMC has an existing
Incident Command System and a detailed Disaster Operations Plan that is
regularly reviewed and will be revised to include the operations of the
NEIDL. 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 NEIDL 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 current edition of 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 Selected Alternative to partially fund the construction
of a state-of the-art national biocontainment laboratory, which will be
known as the National Emerging Infectious Diseases Laboratories (NEIDL)
on the Boston University Medical Campus (BUMC) in Boston,
Massachusetts.
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 BUMC's
extensive expertise in biological medical research, its experience in
operating BSL-2, and -3 laboratories, and its infrastructure as a
regional medical center being able to
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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: January 26, 2006.
Juanita M. Mildenberg,
FAIA Acting Director, Office of Research Facilities Development and
Operations, National Institutes of Health.
[FR Doc. E6-1402 Filed 2-1-06; 8:45 am]
BILLING CODE 4140-01-P