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, 43184-43187 [2010-18106]
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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices
• The name, address, phone number,
e-mail address, and contact information
for the authorized official;
• The name, address, and e-mail
address of each restaurant or similar
retail food establishment being
registered, as well as the name and
contact information for an official
onsite, such as the owner or manager,
for each specific restaurant or similar
retail food establishment;
• All trade names the restaurant or
similar retail food establishment uses;
• Preferred mailing address (if
different from location address for each
establishment) for purposes of receiving
correspondence; and
• Certification that the information
submitted is true and accurate, that the
person or firm submitting it is
authorized to do so, and that each
registered restaurant or similar retail
food establishment will be subject to the
requirements of section 4205.
As described in section II.I of this
document, FDA has created and made
available at a Web site, https://
www.fda.gov/menulabeling, a form that
contains fields requesting this
information. Registrants must use this
form to ensure that complete
information is submitted.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
H. What information must be provided
for the registration of vending machine
operators?
Authorized officials for vending
machine operators must provide FDA
with the following information:
• The name, address, phone number,
e-mail address, and contact information
for the vending machine operator;
• The address of each vending
machine owned or operated by the
vending machine operator, and the
name and contact information,
including e-mail address, of the location
in which each vending machine is
located;
• Preferred mailing address (if
different from location address), for
purposes of receiving correspondence;
and
• Certification that the information
submitted is true and accurate, that the
person or firm submitting it is
authorized to do so, and that each
registered restaurant or similar retail
food establishment will be subject to the
requirements of section 4205.
As described in section II.I of this
document, FDA has created and made
available at a Web site, https://
www.fda.gov/menulabeling, a form that
contains fields requesting this
information. Registrants must use this
form to ensure that complete
information is submitted.
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15:15 Jul 22, 2010
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I. How do authorized officials of
restaurants, similar retail food
establishments, and vending machine
operators register?
Authorized officials of restaurants,
similar retail food establishments, and/
or vending machine operators electing
to be subject to the section 4205
requirements can register by visiting
https://www.fda.gov/menulabeling. FDA
prefers that the information be
submitted by e-mail by typing complete
information into the form (PDF), saving
it on the registrant’s computer, and
sending it by e-mail to https://
menulawregistration@fda.hhs.gov. If email is not available, the registrant can
either fill in the form (PDF) and print it
out (or print out the blank PDF and fill
in the information by hand or
typewriter), and send it to FDA either by
faxing the completed form to 301–436–
2804 or mailing it to the Center for Food
Safety and Applied Nutrition,
Compliance Information Branch (HFS–
681), 5600 Fishers Lane, Rockville, MD
20857.
J. Will each registrant receive a
confirmation of the registration?
Initially, FDA will not provide
automatic confirmation of registrations.
We recommend that registrants save a
copy of the completed form and
evidence that it has been transmitted to
FDA electronically, by fax, or by mail.
K. What does it mean to be ‘‘registered’’?
Pending promulgation of regulations,
FDA considers that an authorized
official of any restaurant or similar retail
food establishment, or of any vending
machine operator, that completely and
accurately provides the information
described in response to sections II.G
and II.H of this document, has registered
the restaurant or similar retail food
establishment, or vending machine
operator.
L. How will future changes to the
voluntary registration program be
announced?
FDA is required to propose
regulations implementing the provisions
of section 4205. We intend to include in
those proposed regulations further
specifications about the voluntary
biannual registration of restaurants,
similar retail food establishments, and
vending machine operators that are not
otherwise subject to the requirements of
section 4205.
III. Paperwork Reduction Act of 1995
This notice refers to previously
approved collections of information
found in the Federal Food, Drug and
Cosmetic Act and established by section
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4205 of the Affordable Care Act. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
section 4205 of the Affordable Care Act
have been approved under OMB control
number 0910–0664.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this notice. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: July 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–18123 Filed 7–21–10; 11:15 am]
BILLING CODE 4160–01–S
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.
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,
SUMMARY:
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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices
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.
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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
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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.
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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.
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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.
Summary of Impacts
Noise
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.
The Selected Alternative would not
be expected to have the potential to
significantly impact existing noise
levels of the effected area.
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.
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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
Pollution Prevention
The Selected Alternative would not
be expected to have the potential to
impact the historical or archeological
resources of the effected area.
All federal, state, and local
requirements to protect the environment
and public health will be met with the
Selected Alternative.
Environmental Justice
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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.
Historic and Archeological Resources
Resource Impacts
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Safety and Security
The Selected Alternative would not
be expected to have the potential to
impact the geology or soils of the
effected area.
Socioeconomic Environment
Factors Involved in the Decision
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The Selected Alternative would not
be expected to have the potential to
impact the delivery of emergency
services to the effected area.
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.
The Selected Alternative would not
be expected to have the potential to
impact the socioeconomic environment
of the effected area.
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.
Emergency Response
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
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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Request for Public Comment and
Consultation Meetings on the Adoption
and Foster Care Analysis and
Reporting System (AFCARS)
Department of Health and
Human Services, Administration for
Children and Families, Administration
on Children, Youth and Families,
Children’s Bureau.
ACTION: Request for Public Comment
and Consultation Meetings on the
Adoption and Foster Care Analysis and
Reporting System (AFCARS).
AGENCY:
Section 479 of the Social
Security Act (the Act) requires that the
Administration for Children and
Families (ACF) develop and write
regulations to implement a system for
the collection by title IV–E agencies of
data relating to adoption and foster care.
The resultant Adoption and Foster Care
Analysis and Reporting System
(AFCARS) has been operating since
1994 and is administered by the
Children’s Bureau (CB) in ACF.
AFCARS collects case level information
on all children in foster care for whom
the title IV–E agency has responsibility
for placement and care and on children
adopted under the auspices of the title
IV–E agency. We issued a Notice of
Proposed Rulemaking (NPRM) on
January 11, 2008 (73 FR 2082) that
proposed to amend the AFCARS
regulations at 45 CFR 1355.40 and the
appendices to part 1355 [https://
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SUMMARY:
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15:15 Jul 22, 2010
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edocket.access.gpo.gov/2008/E724860.htm]. The proposal would modify
the requirements for title IV–E agencies
to collect and report data to ACF on
children in out-of-home care and in
subsidized adoption or guardianship
arrangements with the title IV–E agency.
Due to the enactment of the Fostering
Connections to Success and Increasing
Adoptions Act of 2008 (Pub. L. 110–
351) and the substantial changes it
introduced in title IV–E, we intend to
issue a new AFCARS NPRM. To inform
development of the new NPRM we
request that interested parties comment
on the questions below.
DATES: Written comments must be
submitted to the office listed in the
ADDRESSES section below on or before
October 21, 2010. Please see
SUPPLEMENTARY INFORMATION for
additional details on consultation
meetings.
ADDRESSES: Interested persons may
submit written comments by any of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: CBComments@acf.hhs.gov.
Please include ‘‘Comments on AFCARS
Federal Register Notice’’ in the subject
line of the message.
• Mail or Courier Delivery: Jan
Rothstein, Division of Policy, Children’s
Bureau, Administration on Children,
Youth and Families, Administration for
Children and Families, 1250 Maryland
Avenue, SW., 8th Floor, Washington,
DC 20024.
Instructions: Please be aware that mail
sent to us may take an additional 3–4
days to process due to changes in mail
handling resulting from the anthrax
crisis of October 2001. If you choose to
use an express, overnight, or other
special delivery method, please ensure
first that they are able to deliver to the
above address. We urge you to submit
comments electronically to ensure they
are received in a timely manner. All
comments received will be posted
without change to https://
www.regulations.gov including any
personal information provided.
Comments provided to us during a
meeting or in writing in response to this
Federal Register notice will receive
equal consideration by ACF.
FOR FURTHER INFORMATION CONTACT: Jan
Rothstein, Children’s Bureau, 1250
Maryland Ave., SW., 8th Floor,
Washington, DC 20024; (202) 401–5073.
SUPPLEMENTARY INFORMATION: Please
respond to any or all of the questions
below. It would be helpful if your
comment identifies the question to
which you are responding. If you have
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43187
additional comments, please identify
them by citing to 45 CFR part 1355 or
the 2008 NPRM, as applicable.
Reporting Population
Fostering Connections provides
Tribes with the option to operate a
foster care, adoption assistance and, at
tribal option, a kinship guardianship
assistance program under title IV–E of
the Social Security Act (the Act). The
Secretary is to apply title IV–E of the
Act to Tribes operating the program
directly in the same manner as to States
except where directed by law. Further,
Tribes continue to have the ability to
enter into title IV–E agreements with
States to operate part of the program on
behalf of Indian children.
1. How should data collection and
reporting requirements in AFCARS
change for State and Tribal title IV–E
agencies, if at all, to provide a
comprehensive national picture of
children in foster care and those
adopted with the involvement of a title
IV–E agency?
In the 2008 NPRM, we proposed
expanding the reporting populations to
include children placed in the child
welfare agency’s responsibility for
placement and care wherever they are
placed and to include children in
subsidized guardianships. We believed
this information would facilitate a
greater understanding of a child’s entire
out-of-home care experience, which in
turn affects the foster care experience
and permanency outcomes.
2. Under what circumstances should
a child be included in the AFCARS
reporting population for foster care,
adoption or guardianship?
• What are the barriers to obtaining
information on all children in a child
welfare agency’s placement and care
responsibility?
• What information should an agency
collect on children in its placement and
care responsibility who are placed in
detention, psychiatric facilities and
other settings other than foster family
homes, group homes and child care
institutions?
• What information do agencies
currently collect on children in
finalized adoptions and guardianships?
Federal Oversight Activities
The Children’s Bureau uses AFCARS
data to support a number of our
oversight activities in relation to the
title IV–B and IV–E plans, including the
Child and Family Services Reviews.
3. What case level data on foster care,
adoption and guardianship is important
for agencies to collect and report to ACF
on an ongoing basis that can inform
future Federal monitoring activities,
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]]>Agencies
[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Notices]
[Pages 43184-43187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-18106]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 43187]]
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
