[Federal Register Volume 69, Number 116 (Thursday, June 17, 2004)]
[Notices]
[Pages 33923-33926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Integrated Research Facility Record of Decision

ACTION: Notice.

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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 
public comments on the Draft EIS and Supplemental Draft EIS, to 
implement the Proposed Action, which is identified as the Preferred 
Alternative in the Final EIS. This action involves construction and 
operation of an Integrated Research Facility and associated 
infrastructure improvements by the NIH at the Rocky Mountain 
Laboratories campus in Hamilton, Montana.

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 [email protected].

SUPPLEMENTARY INFORMATION:

Decision

    After careful review of the environmental consequences in the Final 
Environmental Impact Statement (FEIS), Rocky Mountain Laboratories 
(RML), Integrated Research Facility, dated May 2004, 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 construct an Integrated Research Facility (IRF) to 
expand the research capability of RML. Research to be conducted within 
the IRF includes infectious disease pathogenesis and immune response 
studies, development of candidate vaccines, diagnostic reagents and 
assays and therapeutic approaches. This work will focus and build upon 
RML's strength in vector-borne disease research. The RML does not and 
will not conduct research to develop offensive-biological weapons.
    The IRF will contain Biosafety Level (BSL)-2, BSL-3, and BSL-4 
laboratories, animal research facilities, administrative support 
offices, conference rooms, and break areas at RML in Hamilton, Montana. 
The facility would encompass approximately 105,000 square feet of 
building constructed within the existing 33-acre RML campus in the 
southwest portion of Hamilton.
    The Integrated Research Facility and research programs would 
require additions and upgrades to the existing RML campus, including:
     A new chilled water plant and emergency power backup 
system;
     A new addition to Boiler Building 26 to house a new 
natural gas-fired boiler; and
     Construction of below grade systems and utility 
distribution tunnels to service the Integrated Research Facility.
    The BSL-4 laboratory would be constructed within the Integrated 
Research Facility to provide the highest possible level of protection 
for scientists and the public. The BSL-4 laboratory would be located 
within the central core of the Integrated Research Facility, surrounded 
by a corridor that serves as a buffer between the laboratory and the 
exterior. Specially designed mechanical ventilating systems assure that 
negative pressure will be maintained for containment purposes. Other 
containment design features such as positive pressure sealed doors and 
airlocks will also be employed to assure containment. All effluent and 
emissions from the proposed laboratory would be treated in accordance 
with stringent, state of the art standards and practices. A facility 
operations manual, developed specifically for the integrated research 
facility, will be prepared and adopted prior to operation of the 
laboratory. Stringent safeguards, including engineering and design 
features and rigorous adherence to procedural requirements are 
necessary in BSL-3 and BSL-4 laboratory facilities to protect workers 
and prevent release of pathogens into the environment. Additionally, 
areas for the secure storage of pathogens will be provided.

Alternatives Considered

    The NIH considered the two reasonable alternatives identified and 
considered in the FEIS: (1) The Proposed Action Alternative (now the 
selected alternative) and (2) the No Action Alternative (not 
constructing the Integrated Research Facility). Other alternatives 
considered but eliminated from detailed analysis included constructing 
the Integrated Research Facility at the NIH Campus in Bethesda, 
Maryland; constructing it at some other location outside RML; moving 
RML to a less populated area; and constructing and administering an 
Integrated Research Facility by another agency or at another National 
Institutes of Health facility. Based on the Purpose and Need for the 
project and environmental consequences of the Proposed Action, only the 
No Action Alternative was considered in detail and effects analysis 
documented. The other alternatives were considered, but not given 
detailed study. They did not meet the Purpose and Need of the Proposed 
Action (FEIS page 2-17).

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, Supplemental 
Draft EIS, and Final EIS, the Proposed Action best satisfies the stated 
Purpose and Need, which is ``to provide a highly contained and secure 
intramural laboratory dedicated to studying the basic biology of agents 
of emerging and re-emerging diseases, some of which have potential as 
bioterrorism agents.'' Because of its traditional strengths in the area 
of vector-borne infectious disease research and the federal funding 
parameters associated with National Institute of Allergy and Infectious 
Diseases' (NIAID)

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intramural research program, the Integrated Research Facility is 
proposed to be located at RML.
    The President and the Congress expanded the NIAID's mission to 
include basic and applied research aimed at addressing specific issues 
outlined in the national bio-defense response plans. The RML in 
Hamilton, Montana is the proposed location for a new high containment 
research facility because of the RML's historic strengths. The long, 
distinguished, and continuing history of RML in vector-borne agents 
would facilitate and expedite research on these agents. To achieve 
these expanded research goals, scientists at RML need additional 
laboratory facilities, particularly those that provide the appropriate 
environment to work on certain high consequence pathogens and emerging 
infectious disease agents.
    The type of research proposed for the Integrated Research Facility 
fits precisely with expertise at RML. Part of the biodefense research 
plan is to study vector-borne (tick and flea) agents. The long, 
distinguished, and ongoing history of RML in this area will facilitate 
and thus expedite research on agents of this type. The level of 
expertise in this area at RML is unmatched at any other possible site. 
The unparalleled scientific climate at RML has for over 100 years 
fostered superior dedication and technical expertise in combating 
infectious and re-emerging infectious diseases. From the discovery of 
the causative agents of Rocky Mountain Spotted Fever by Dr. Howard 
Rickets and Lyme Disease by Dr. Willy Burgdorfer to the development of 
a plague vaccine, which proved to be 100% effective, the RML has been 
and is one of the world's premier research laboratories.
    Integration of new BSL-3 and BSL-4 laboratories into the current 
RML facility provides the most benefit from the public monies to be 
invested and provides additional benefit in terms of the time it will 
take to provide functioning high and maximum containment laboratories 
in which to conduct the needed research invested. Fulfillment of the 
research mandate requires timely and effective response to the threats 
of emerging and re-emerging infectious diseases and bioterrorism, which 
is facilitated by building on the available scientific resources and 
research infrastructure present at RML. Relocation of the RML 
scientific community, if even possible, would result in years of 
unacceptable delay while duplicating the infrastructure already present 
at RML. Replicating the specialized laboratory facility to maintain the 
colonies and collections of the insect vectors necessary for support of 
the RML research mission will result in unacceptable research delays 
even if appropriately trained personnel could be hired at or moved to a 
new location. In addition, moving all or part of this program to 
another location would disrupt the research synergy found within the 
unique scientific community at RML.
    The No Action alternative would result in the laboratory not being 
built at RML. The No Action alternative would not meet the needs of 
NIAID.

Resource Impacts

    The Final Environmental Impact Statement (FEIS) describes potential 
environmental effects of the proposed project. These potential effects 
are documented in the FEIS in Chapter 4. The Integrated Research 
Facility would result in minor to negligible disruption of the physical 
and biological environment. Adverse environmental effects are avoided 
through compliance with existing regulatory requirements, application 
of design features, and adherence to construction requirements. 
Potential impacts on the economy, visual resource, historical 
resources, air quality, water supply, and wastewater are all within 
government standards (federal, state, and local), therefore; the NIH is 
confident that there would not be negative effects on the environment 
or on the citizens of Hamilton.

Summary of Impacts

    The following is a summary of potential impacts resulting from the 
Proposed Action the NIH considered when making its decision.
Social Resources
    Additional employment associated with the proposed Integrated 
Research Facility includes up to 200 workers at the peak of 
construction and up to 100 employees in late 2005/early 2006 when the 
facility would be opened. Based on the Ravalli County rate of 2.45 
persons per household, this would add a total of 245 new residents to 
the county. This represents between 1.4 percent and 3 percent of all 
new residents projected for the County, based on estimates in the 
Ravalli County Economic Needs Assessment (Swanson, 2002). Addition of 
new homes would result in increased business for homebuilders and real 
estate developers. School capacity is adequate for new growth, but 
operating and maintenance costs would increase to accommodate the new 
students. No impact is expected on the ethnic or gender make-up of the 
population.
    Traffic near the RML campus associated with construction and 
delivery of equipment and materials would increase over the 2-year 
construction period. Following construction, traffic levels would 
likely remain elevated due to the 100 new employees at RML 
(approximately 20 percent during peak hours), although large truck 
traffic to support RML would return to current levels.
Community Risk
    Many people stated concerns with the Proposed Action throughout the 
comment periods. These concerns mainly related to the perceived threat 
the facility posed to the local community. In response to the safety 
concerns raised by citizens, NIH completed a risk assessment (FEIS page 
4-5). The risk assessment indicated that there is essentially no risk 
to the community from release of infectious agents. Additionally, the 
safety record of BSL-4 laboratories worldwide is documented (see 
Appendix D of the FEIS) and shows that there has never been a community 
release of a biological agent from a modern maximum containment 
laboratory. The Proposed Action does not pose a measurable risk to the 
neighboring community from escaped agents.
    Qualitative and quantitative risk analysis revealed that the 
potential risk to the community surrounding the Rocky Mountain 
Laboratories and specifically the Integrated Research Facility from a 
release of infectious agents is negligible.
Economic Resources
    The Proposed Action would have direct economic impacts on both the 
City of Hamilton and Ravalli County throughout construction and 
operation. Payroll associated with construction of the Integrated 
Research Facility is estimated at $4.7 million. Using the current 
economic multiplier in the 2002 Ravalli County Needs Assessment, 
approximately $18.9 million in economic activity would be gained in the 
2-year construction period.
    Annual payroll for 100 new employees is estimated at $6.6 million. 
Added to the current $10.4 million annual payroll, RML would contribute 
$17 million annually to the local economy. RML and the proposed 
Integrated Research Facility meet community goals listed in the 2002 
Ravalli County Economic Needs Assessment, Ravalli County Growth Policy, 
and the City of Hamilton Comprehensive Master Plan.
    Public finance revenues would increase from income tax on the 
Integrated Research Facility-related construction and operations 
payrolls, as

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well as income of spouses and older children of anticipated additional 
RML employees, increased number of licensed vehicles, and property tax 
revenues from additional new homes and property assessments.
Noise
    Equipment operated during construction of the Integrated Research 
Facility would result in additional noise at the site. With specified 
noise reduction measures, the Integrated Research Facility would meet 
RML's 2003 noise guidelines. Recently implemented noise reduction 
features and reasonably foreseeable actions have and would reduce noise 
further.
Visual Quality
    The primary visual impact of the Proposed Action would be addition 
of a large building (Integrated Research Facility) into an area of 
existing buildings on the RML campus. Existing and proposed ventilation 
stacks associated with the Boiler Plant would create vertical linear 
contrast to surrounding structures. Ventilation stacks on the 
Integrated Research Facility would not be visible from surrounding 
neighborhoods. Proposed landscaping around the Integrated Research 
Facility would have a positive impact on visual quality at the RML.
Historical Resources
    The Proposed Action would be partially visible from the RML 
Historic District. The Integrated Research Facility could affect the 
view from the historic district, but there would be no adverse effect 
on the qualities inherent in the Historic District.
Air Quality
    Gaseous and particulate air contaminant emissions would be 
generated during normal laboratory operations. Source emissions would 
comply with all air quality standards. Use of the incinerator to 
dispose of refuse generated at the facility, including that generated 
by the Integrated Research Facility, would increase from 2-3 days/week 
to 3-4 days/week. Permit limits (Montana Air Quality Permit 2991-04) on 
the incinerator would not be exceeded.
Water Supply and Wastewater
    The estimated increase in water usage of 17,000 gallons per day 
represents about a 1 percent increase in the amount of water pumped by 
the City of Hamilton Department of Public Works (CHDPW) on a daily 
basis. With respect to available capacity, the Integrated Research 
Facility would use about 5.3 percent (12 gallons per minute of 226 
gallons per minute) of system capacity. Increased demand for water 
caused by operation of the Integrated Research Facility would have a 
minor impact on the CHDPW municipal water supply system, and the system 
would be able to handle the increased demand.
    Approximately 1,000 to 1,200 pounds of solids per day are currently 
handled at the CHDPW. (Lowry 2003). The Integrated Research Facility 
would generate an estimated 28 pounds of additional solids; 
representing a 2.3 to 2.8 percent increase in solids load to the CHDPW 
wastewater facility.
    The Proposed Action would not have an impact on the solids handling 
capacity at the CHDPW because the planned upgrade of the solids 
handling capacity at the facility would accommodate current and future 
needs of Hamilton as well as additional solids produced by the 
Integrated Research Facility.

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.

Pollution Prevention

    Pollution prevention measures are described in Chapter 2 of the 
FEIS and reflect standard spill prevention procedures. Additional 
pollution from the Integrated Research Facility is not anticipated. Air 
quality permit standards would be met, as would all federal, state, and 
local requirements to protect the environment and public health. 
Additional pollution prevention methods would include:
     Reducing construction waste by recycling materials 
wherever possible;
     Applying best management practices (BMPs) during 
construction to minimize soil erosion and potential airborne 
particulate matter; and
     Requiring that IRF activities comply with the NIH waste 
management policies, which emphasize source segregation, inactivation, 
source reduction, reuse, and recycling.

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 noise during 
construction and operation of the Integrated Research Facility. To 
mitigate noise associated with these activities, measures have been 
included to reduce noise during construction, along with noise 
generated by eventual operation of the Integrated Research Facility. 
Noise levels associated with the current facility have been reduced 
through installation of noise deadening equipment. During construction 
of the Integrated Research Facility, hours of construction would be 
limited to avoid disturbing the community at night. A professional 
acoustics contractor would monitor noise periodically, to ensure that 
noise generated at RML is within the established voluntary guidelines.
    RML has facilitated the formation of a group of local community 
representatives (the Community Liaison Group) to maintain communication 
with the community about operation of RML. This group would be able to 
bring community concerns to RML and work on resolutions.
    Emergency planning was raised as a concern. RML currently has an 
emergency plan, which will be updated before the Integrated Research 
Facility becomes operational. Emergency responders in the area are 
confident that they would be capable of handling emergency situations.
    Comments suggested that the Integrated Research Facility would be a 
target for terrorists. Increased security measures required of all 
government facilities today reduce this possibility. Rigorous security 
and surveillance measures will be in place to prevent unauthorized use 
or removal of biological material.
    Redundancy of safety equipment and procedures, operational 
safeguards, and monitoring systems inherent in biocontainment 
laboratories reduce the risk of an accidental release. Theoretically, 
human error or multiple, simultaneous mechanical failures could lead to 
accidental release of biological materials from a laboratory. These 
types of failures were addressed in the risk assessments performed. The 
results of the risk assessments and overall safety record of NIAID 
laboratories indicate that there is little or no increased risk of 
accidental release of infectious agents to the environment.
    Transportation of agents to and from the Integrated Research 
Facility was a concern for some. Strict rules and regulations govern 
how agents are packaged, labeled, handled, tracked and transported. 
There is no greater risk to the surrounding community from the 
transport of biological material than there is anywhere else along the 
transport path.
    In addition, possible adverse health and safety impacts on 
laboratory workers in the proposed IRF and on

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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 Biosafety in 
Microbiological and Biomedical Laboratories, a joint publication of the 
NIH and Centers for Disease Control, 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, the construction of the Integrated 
Research Facility at the Rocky Mountain Laboratories in Hamilton, 
Montana.
    The decision was based upon review and careful consideration of the 
impacts identified in the Final EIS; public comments received 
throughout the National Environmental Policy Act process, including 
comments on the Draft EIS and Supplemental Draft EIS and those provided 
during the required 30-day waiting period for the Final EIS. Other 
relevant factors included in the decision, such as NIAID's mandate to 
conduct research on agents of emerging and re-emerging infectious 
diseases were carefully considered. The unique scientific capabilities 
of the scientists at the RML, who require the selected alternative in 
order to perform their expanded research mission, was also a factor in 
the decision making process.

    Dated: June 7, 2004.
Leonard Taylor, Jr.,
Acting Director, Office of Research Facilities Development and 
Operations, National Institutes of Health.
[FR Doc. 04-13642 Filed 6-16-04; 8:45 am]
BILLING CODE 4140-01-P