23 July 2010

[Federal Register: July 23, 2010 (Volume 75, Number 141)]
[Notices]               
[Page 43184-43187]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy10-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

 
Transport of Laboratory Personnel Potentially Exposed to 
Infectious Agents From Fort Detrick, Frederick, MD to the National 
Institutes of Health Clinical Research Center, Bethesda, MD; (NIH 
Transportation EIS); Record of Decision

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH), a part of the U.S. 
Department of Health and Human Services (DHHS), has decided, after 
completion of a Final NIH Transportation EIS and a thorough 
consideration of the public comments on the Draft NIH Transportation 
EIS, to implement the Proposed Action, which was identified as the 
Preferred Alternative in both the Draft EIS and the FEIS. This action 
involves the transport of laboratory personnel suspected of having 
potential occupational exposure to infectious agents under study at the 
NIBC located at Fort Detrick, Maryland, to the Special Clinical Studies 
Unit at the NIH Bethesda, Maryland Campus for observation and, if 
necessary, treatment.

FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Chief of 
Environmental Quality Branch, DEP,

[[Page 43185]]

ORF, NIH, Building 13, Room 2S11, 9000 Rockville Pike, Bethesda, MD 
20892. Fax (301) 480-8056. nihnepa@mail.nih.gov.

SUPPLEMENTARY INFORMATION: 

Decision

    After careful review of the environmental consequences in the FEIS 
for the Transport of Laboratory Personnel Potentially Exposed to 
Infectious Agents from Fort Detrick, Maryland to the National 
Institutes of Health Clinical Center, Bethesda, Maryland, 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 Selected Alternative is the Preferred Alternative, identified 
in the Draft and Final NIH Transportation EIS as the transport of 
laboratory personnel suspected of having occupational exposure to 
infectious agents under study at the NIBC, located at Fort Detrick, 
Maryland, to the Special Clinical Studies Unit, at the NIH Bethesda, 
Maryland Campus.

Background

    The National Institute of Allergy and Infectious Diseases (NIAID), 
a component of NIH, is the occupant of an Integrated Research Facility 
(IRF) at Fort Detrick, Maryland, as part of the National Interagency 
Biodefense Campus (NIBC). The IRF and other participating agencies 
within the NIBC will contain specially designed laboratories (referred 
to as bio-safety level -2, -3, and -4 laboratories) and animal research 
facilities for conducting biodefense and emerging infectious disease 
research. It is proposed that laboratory personnel suspected of having 
potential occupational exposure to infectious agents under study at the 
NIBC located at Fort Detrick, Maryland, be transported to the Special 
Clinical Studies Unit at the NIH Bethesda, Maryland Campus for 
observation and, if necessary, treatment.
    The NIH Special Clinical Studies Unit is a state-of-the-art 
facility located on the NIH Bethesda, Maryland Campus. The special 
design of the Special Clinical Studies Unit allows for optimal 
evaluation and treatment of employees with potential occupational 
exposure to infectious pathogens. This facility will be fully staffed 
with experts in infectious diseases who will be conducting applied 
research. This unit could easily be made available to laboratory 
personnel potentially exposed to infectious pathogens while conducting 
research within biocontainment laboratories located at Fort Detrick. 
Evaluation and/or treatment at the Special Clinical Studies Unit would 
also allow for consultations from prominent infectious disease 
scientists resident at other facilities of the NIH Bethesda, Maryland 
Campus.
    On June 20, 2008, the NIH published a Notice of Intent (NOI) in the 
Federal Register (73 FR 35145) announcing its intent to prepare the NIH 
Transportation EIS and start the public scoping period. The scoping 
period started with the NOI, and continued through August 4, 2008. The 
NOI also invited interested parties to attend two public scoping 
meetings which were held on July 8, 2008, at the C. Burr Artz Library, 
in Frederick, Maryland, and on July 10, 2008, at the Bethesda-Chevy 
Chase Service Center in Bethesda, Maryland. The NIH invited the public 
to submit comments during the scoping period by U.S. mail, electronic 
mail, and through written and verbal comments submitted at the public 
scoping meetings. All comments received during the public scoping 
comment period, as well as written and oral comments received at the 
two public scoping meetings were considered during the preparation of 
the Draft EIS. A summary of the major comments received from the 
scoping comment period was included in the Draft EIS.
    The Draft NIH Transportation EIS was distributed to interested 
parties. A notice of availability for the Draft NIH Transportation EIS 
was published in the Federal Register on May 22, 2009 (74 FR 24006). 
The formal comment period for the Draft NIH Transportation EIS lasted 
for 60 days beginning on May 25, 2009, and ending on July 24, 2009. 
During this comment period, public meetings were held in Frederick, 
Maryland on June 15, 2009, and Bethesda, Maryland on June 18, 2009. In 
addition, Federal agencies, state and local government entities were 
provided copies of the Draft NIH Transportation EIS and encouraged to 
submit comments via the U.S. mail, e-mail, and in person at two public 
meetings. The NIH considered all comments in evaluating the accuracy 
and adequacy of the Draft NIH Transportation EIS and to determine 
whether its text needed to be corrected, clarified, expanded, or 
otherwise revised. The Draft NIH Transportation was then edited and 
amended, as appropriate, and a Final EIS prepared. A Comment Resolution 
Appendix, showing how comments on the draft were addressed, was added 
to the document as Appendix C.

Alternatives Considered

    The Final NIH Transportation EIS analyzed two alternatives, the No 
Action Alternative and the Proposed Action Alternative; to transport 
laboratory personnel potentially exposed to infectious agents from Fort 
Detrick, Maryland to the Special Clinical Studies Unit at the NIH 
Bethesda, Maryland Campus, for monitoring, evaluation and, if 
necessary, treatment. The NIH identified the Preferred Alternative as 
the Proposed Action Alternative based on several factors. First, the 
special design of the Special Clinical Studies Unit allows for optimal 
evaluation and treatment of employees with potential occupational 
exposure to infectious pathogens. This facility will be fully staffed 
with experts in infectious diseases who will be conducting applied 
research. This unit could easily be made available to laboratory 
personnel potentially exposed to infectious pathogens while conducting 
research from biocontainment laboratories located at Fort Detrick. 
Evaluation and/or treatment at the Special Clinical Studies Unit would 
also allow for consultations from infectious disease scientists 
resident at other facilities of the NIH Bethesda, Maryland Campus. 
Second, the NIH has taken great care to analyze the safety and security 
aspects of all such activities and has developed procedures and 
requirements to assure the safety of employees, visitors, patients, and 
the surrounding communities. A Vulnerability Assessment (VA) was also 
developed in order to complement the basic EIS process. This VA, 
developed on the same premise as a Threat Risk Assessment was developed 
in accordance with the requirements stipulated in Federal regulations, 
as specified in Title 9, Part 121, Section 11, and guidance provided by 
the DHS (FEMA 2007). Based on this VA it was concluded that any risk 
during transportation was negligible and would not pose an unacceptable 
level of risk. Any transport of patients would be well coordinated with 
the NIH, Fort Detrick Directorate of Emergency Services, Frederick 
County Police, Montgomery County Police, and the Maryland State Police. 
Based on the potentially exposed individual's condition, security 
concerns, weather conditions, traffic conditions, and other factors, a 
transport plan and route would be developed, notification to the 
appropriate security, police, and fire departments made, and a request 
for escort services placed with the Maryland State Police.

[[Page 43186]]

    The NIH considered varying alternative actions, such as upgrading 
the existing clinic at Fort Detrick, constructing a new facility at 
Fort Detrick, and the use of existing medical facilities, Frederick 
Memorial Hospital (FMH) in Frederick, Maryland area. All of these 
alternative actions were determined to be unable to provide the 
required level of care for the laboratory personnel who will be working 
at NIBC. Committing FMH space and staff for the continued observation 
required for such a situation would impact normal operations, have a 
negative impact on the quality of medical services FMH could provide on 
a regular basis, and not provide the potentially exposed individual 
with the best possible care. Most importantly, however, should these 
individuals become symptomatic, use of such health care facilities 
would not provide the level of care necessary for optimal treatment 
unable to assure an acceptable level of protection of the health and 
safety of the general public. This possible alternative was, therefore, 
determined to be unacceptable and was eliminated from further analysis.
    Upgrading the existing facility or constructing a health care 
facility within the Fort Detrick Campus was also considered 
unreasonable. A treatment health care facility that could provide for 
an acceptable level of services and allow for an extended stay of 
individuals potentially exposed to infectious agents and medical staff 
would require a full time medical and scientific staff. Such a staff 
would have to be sufficient to meet all potential needs for 
observation, monitoring and medical care. Such a facility and staff 
would be inactive most of the time. Such an alternative, moreover, 
would remove these key scientific experts from other active projects 
and would be disruptive to ongoing research projects.

Factors Involved in the Decision

Resource Impacts
    The FEIS describes potential environmental effects of the Selected 
Alternative. These potential effects are documented in Chapter 4 of the 
Final NIH Transportation EIS. Any adverse environmental effects will be 
avoided or mitigated through strict adherence to procedures and 
compliance with regulatory and NIH requirements. Potential impacts on 
air quality and noise levels are all within government standards 
(Federal, state, and local). The NIH does not expect any long-term 
negative effects on the environment or on the members of the 
communities through which transport may occur.
Summary of Impacts
    The following is a summary of potential impacts resulting from the 
Selected Alternative that the NIH considered when making its decision. 
No adverse cumulative effects were identified during the NEPA process. 
Likewise, no unavoidable or adverse impacts from implementation of the 
Selected Alternative were found.
Land Use
    The Selected Alternative would not be expected to have the 
potential to impact existing land use patterns.
Climate
    The Selected Alternative would not be expected to have the 
potential to impact climate.
Air Quality
    The Selected Alternative would not be expected to have the 
potential to significantly impact air quality within the effected area.
Water Resources
    The Selected Alternative would not be expected to have the 
potential to impact water resources within the effected area.
Ecology
    The Selected Alternative would not be expected to have the 
potential to significantly impact the ecology of the affected area.
Parks and Recreational Facilities
    The Selected Alternative would not be expected to have the 
potential to impact the parks and recreational facilities of the 
effected area.
Socioeconomic Environment
    The Selected Alternative would not be expected to have the 
potential to impact the socioeconomic environment of the effected area.
Environmental Justice
    The Selected Alternative would not be expected to have 
disproportionately high or adverse impact on low income or minority 
populations of the effected area.
Geology and Soils
    The Selected Alternative would not be expected to have the 
potential to impact the geology or soils of the effected area.
Historic and Archeological Resources
    The Selected Alternative would not be expected to have the 
potential to impact the historical or archeological resources of the 
effected area.
Noise
    The Selected Alternative would not be expected to have the 
potential to significantly impact existing noise levels of the effected 
area.
Emergency Response
    The Selected Alternative would not be expected to have the 
potential to impact the delivery of emergency services to the effected 
area.
Safety and Security
    The NIH has established procedures, which include notification of 
first responder units of the effected area and a request for escort 
services from the Maryland State Police, prior to any transport of 
laboratory personnel suspected of incurring occupational exposure to 
infectious agents while conducting research at the NIBC at Fort 
Detrick, Maryland to the NIH Bethesda, Maryland Campus. Accordingly, 
the Selected Alternative would not be expected to have the potential to 
impact the safety and security of the effected area.
Cumulative Impacts
    The Selected Alternative, when considered in conjunction with other 
known and proposed actions would not be expected to have a significant 
cumulative impact on the effected area.

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 action will be subject to the existing 
NIH pollution prevention, waste management, and safety, security, and 
emergency response procedures as well as existing environmental permits 
where applicable. Best management practices, spill prevention and 
control plans and all safety and security measures will be followed 
appropriately. All personnel involved in transport would be trained on 
pre-planned responses in the event of an accident or mechanical 
failure. All Emergency Response Technicians (EMT) or EMT-Paramedics 
would be medically certified. No additional mitigation measures have 
been identified.

Pollution Prevention

    All federal, state, and local requirements to protect the 
environment and public health will be met with the Selected 
Alternative.

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Monitoring and Enforcement Program

    The NIH will develop a monitoring and enforcement program to ensure 
that all practicable mitigation measures developed for under the 
Selected Alternative are fully implemented.

Conclusion

    Based upon review and careful consideration, the NIH has decided to 
implement the Selected Alternative.
    The decision was based upon review and careful consideration of the 
potential impacts identified in the FEIS and public comments received 
throughout the NEPA process.

    Date: July 19, 2010.
Daniel G. Wheeland,
Director, Office of Research Facilities Development and Operations, 
National Institutes of Health.
[FR Doc. 2010-18106 Filed 7-22-10; 8:45 am]
BILLING CODE 4140-01-P