[Federal Register Volume 78, Number 1 (Wednesday, January 2, 2013)]
[Notices]
[Pages 110-112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31509]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Supplemental Record of Decision; Final Supplementary Risk
Assessment for the Boston University National Emerging Infectious
Diseases Laboratories
Responsible Official: Daniel G. Wheeland, Director, Office of
Research Facilities Development and Operations, National Institutes of
Health.
SUMMARY: The Department of Health and Human Services, the National
Institutes of Health (NIH), has decided, after completion of a Final
Supplementary Risk Assessment and a thorough consideration of public
comments on the Draft and Final Supplementary Risk Assessment, to
implement the Proposed Action, which is identified as the Preferred
Alternative in the Final Environmental Impact Statement (EIS). This
action reaffirms the NIH's previous decision to partially fund the
construction of a state-of-the-art National Biocontainment Laboratory
(NBL), the National Emerging Infectious Diseases Laboratories (NEIDL),
at the Boston University Medical Campus (BUMC) in Boston,
Massachusetts.
FOR FURTHER INFORMATION CONTACT: For further information on the Record
of Decision: Valerie Nottingham, Chief, Environmental Quality Branch,
Office of Research Facilities, National Institutes of Health, 9000
Rockville Pike, Bld. 13/2S11, Bethesda, MD 20892 nihnepa@mail.nih.gov.
For further information on the Supplementary Risk Assessment: Kelly
Fennington, Senior Health Policy Analyst, Office of Science Policy,
National Institutes of Health, 6705 Rockledge Drive, Suite 750,
Bethesda, MD 20892, 301-496-9838 NIH_BRP@od.nih.gov.
SUPPLEMENTARY INFORMATION: The National Institutes of Health (NIH), an
operating division of the Department of Health and Human Services
(HHS), has decided, after completion of a Final Supplementary Risk
Assessment for the Boston University (BU) National Emerging Infectious
Diseases Laboratories (NEIDL) and a thorough consideration of the
public comments on the Draft and Final Supplementary Risk Assessments,
that the NEIDL, in its current location in the BioSquare Research Park,
poses minimal risk to the community surrounding the facility. The Final
Supplementary Risk Assessment extensively evaluated scenarios involving
the potential human health consequences of an exposure to laboratory
workers and members of the general public as a result of unintentional
or malevolent events. The Final Supplementary Risk Assessment also
analyzed the potential human health impacts of siting the NEIDL at two
alternate locations from the current site in Boston. The Final
Supplementary Risk Assessment concluded that the risk to the public was
generally low, regardless of where the facility was located. The
analysis also showed there was no disproportionate impact to the
residents living in the environmental justice communities adjacent to
the NEIDL's current location or to any environmental justice
communities at either of the two alternative locations analyzed. Based
on the results of the Final Supplementary Risk Assessment, NIH is
reaffirming its prior Record of Decision of January 26, 2006, published
in the Federal Register on February 2, 2006.
On January 26, 2006, the NIH signed the Record of Decision (ROD) to
partially fund the construction of a state-of the-art National
Biocontainment Laboratory, which is now known as the NEIDL, on the
Boston University Medical Campus in Boston, Massachusetts. The NEIDL is
a research facility that was designed to include high- and maximum-
containment laboratories for research on emerging and re-emerging
infectious diseases. The ROD was posted in the Federal Register on
February 2, 2006, and described the Proposed Action and alternatives
considered in the NIH's Environmental Impact Statement for the NEIDL.
The ROD also described many of the physical characteristics of the
NEIDL and the safeguards that would be in place for research conducted
in the building.
After the ROD was released, some members of the public continued to
have concerns about the safety and environmental impact of the
facility. Several citizens and public interest groups filed lawsuits in
Federal court to stop the NIH's partial funding of the NEIDL's
construction. Opponents also filed a lawsuit in Massachusetts state
court challenging the state's approval of the project. Both lawsuits
alleged failure to adequately assess the potential impacts of the NEIDL
on public health in alternative locations. In the Federal court
proceedings, questions were raised specifically about the potential
risks of the biosafety level 4 (BSL-4) laboratory. To address the
concerns raised in these lawsuits, NIH established an independent Blue
Ribbon Panel to advise the agency on comprehensively responding to the
concerns raised by members of the community and by the
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courts. The Blue Ribbon Panel was established as a working group of the
Advisory Committee to the NIH Director and was comprised of experts in
infectious diseases, public health and epidemiology, risk assessment,
environmental justice, risk communications, biosafety, and infectious
disease modeling. At multiple points during the preparation of the
Supplementary Risk Assessment, the NIH also consulted the National
Research Council (NRC) Committee on Technical Input that had been
critical of a previous draft NIH risk assessment for the NEIDL. With
the technical and scientific guidance of the Blue Ribbon Panel and the
NRC Committee on Technical Input as well as extensive public input, NIH
prepared a Draft Supplementary Risk Assessment, which was published in
the Federal Register on February 24, 2012. The publication of the Draft
Supplementary Risk Assessment in the Federal Register began a 67-day
public comment period. After a thorough consideration of comments
received on the Draft Supplementary Risk Assessment, including those
comments received during a public meeting held in Boston on April 19,
2012, NIH prepared a Final Supplementary Risk Assessment, notice of
which was published in the Federal Register on July 6, 2012.
Decision
After careful consideration of the information and analyses
presented in the Final Supplementary Risk Assessment, including the
potential impacts on public health and safety arising from research
involving infectious agents, as well as all public comments received
during and after the assessment's preparation, the NIH has decided to
reaffirm the decision reached in the agency's initial Record of
Decision to implement the Selected Alternative, to partially fund the
construction of a state-of-the-art National Biocontainment Laboratory
(NBL), the National Emerging Infectious Diseases Laboratories (NEIDL),
at the Boston University Medical Campus (BUMC) in Boston, Massachusetts
described in the December 2005 Final EIS. The additional information
provided from the Final Supplementary Risk Assessment results has
reinforced the agency's original decision. The NIH's decision to
reaffirm the ROD does not commit the NIH to support any specific
research in the NEIDL in the future.
Alternatives Considered
The Final Supplementary Risk Assessment considered and compared the
potential public health impacts of a biocontainment failure at three
separate, proposed locations for the NEIDL. Those locations included an
urban (the current BUMC site), a suburban (Tyngsborough, MA), and a
rural (Peterborough, NH) setting. The results of the Supplementary Risk
Assessment showed minimal differences in the risks of infections or
fatalities to lab workers at the three different sites because the
laboratory and its operations would be the same at all three sites.
There are differences in the three sites with regard to population
density and other features of the environment, such as availability of
medical care. The possible effects of these differences on risks to the
public were evaluated. The results show that no statistically
significant differences can be concluded at the suburban and rural
sites (Peterborough and Tyngsborough) compared to the urban site
(Boston).
Factors Involved in the Decision
Throughout the course of the project, NIH engaged in extensive
consultations with the Boston community. During the development of the
Supplementary Risk Assessment for the NEIDL, public input was sought
and considered multiple times before the report was finalized. In
preparing its advice to the NIH for the Supplementary Risk Assessment,
the Blue Ribbon Panel held multiple public meetings, including several
in Boston at locations suggested by community members, to hear the
concerns of the community and to solicit input on what scenarios and
agents the community wished to see analyzed in the document. The
approach taken to perform the Supplementary Risk Assessment, as well as
the types of scenarios and agents studied in the Supplementary Risk
Assessment, were thoroughly discussed and publicly vetted through the
Blue Ribbon Panel and the NRC Committee on Technical Input. These two
independent bodies provided technical advice that was then used to
guide NIH through the risk assessment process. In order to help ensure
that the Supplementary Risk Assessment was as comprehensive and
technically and scientifically sound as possible, the NIH contracted
with a leading consulting firm to perform the assessment. This firm
engaged outside experts in infectious diseases and modeling to assist
in preparing the assessment.
After extensive consultations with the Blue Ribbon Panel, the NRC
Committee on Technical Input, and the public, the contractor preparing
the Supplementary Risk Assessment identified and considered
approximately 300 events that could potentially lead to loss of
containment. The contractor grouped these 300 events initially into 30
categories of related events. Based on their likely risk, several of
these events were selected to represent the overall group. The selected
events include higher- and lower-risk events that occur in a variety of
ways and expose different groups of people or the environment. Taking
these factors into account, the possible events selected for detailed
analysis in the Final Supplementary Risk Assessment were a needlestick
accident, a centrifuge aerosol release, an earthquake, and
transportation accidents.
To ensure examination of consequences with the most negative
possible outcomes, mitigating features of the building systems, fully
functional personal protective equipment, and standard operating
procedures were not taken into account in the Supplementary Risk
Assessment, which increased the risk by posing failures without taking
into account mitigating features. For example, for purposes of the risk
assessment, it was assumed that a needlestick would not be recognized
and reported. Similarly, the risk assessment considered what would
happen if a centrifuge release went undetected and unreported. In
reality, lab personnel are trained to recognize and report such
incidents, thus mitigating the consequences should such a lab accident
occur.
The Final Supplementary Risk Assessment examined a variety of
possible situations--including those that posed the maximum
realistically expected risk that might expose laboratory workers and
the general public to disease-causing microbes that will be studied in
the NEIDL. While there is no such thing as ``no risk'', the results of
the analysis showed that the risk of infections or fatalities resulting
from accidents or malevolent acts at the NEIDL are generally very low
to only remotely possible. The risk assessment evaluated the NEIDL and
proposed activities in its laboratories as well as the potential
impacts to site-specific populations in the three alternative
geographic locations.
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 adopted. The
NEIDL will be subject to oversight by numerous federal, state, and
local entities including, but not limited to, the Centers for Disease
Control (CDC) and
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Prevention, the NIH, and the Boston Public Health Commission. The NEIDL
will also be subject to federal, state, and local pollution prevention,
waste management, and environmental regulations. This level of
oversight and regulation, in addition to NEIDL-specific laboratory
standard operating procedures and researcher training should greatly
minimize any chance of a pathogen being released into the environment.
Monitoring and Enforcement Program for Mitigation Measures
Boston University has established policies and procedures to ensure
that the NEIDL complies with all applicable Federal, state, and local
regulations. In addition, trained biosafety staff at Boston University
will perform periodic laboratory inspections to ensure safety standards
are rigorously upheld. Laboratory inspections will also be performed by
the Boston Public Health Commission. The CDC will also perform
inspections for those laboratories performing research with Select
Agents. Projects requiring the use of BSL-3 and BSL-4 containment must
be reviewed and approved by the Boston University Institutional
Biosafety Committee (IBC). The Boston University IBC includes at least
two members from the public who are not affiliated with Boston
University. The Boston Public Health Commission will also review and
approve projects requiring BL3 or BL4 containment. Finally, as an NIH
grantee, Boston University is required to comply with the grant terms
and conditions. These terms and conditions require Boston University to
file an annual progress report with NIH that describes the use of any
highly pathogenic agents or Select Agents in the past year.
Conclusion
The Final Supplementary Risk Assessment examined a variety of
possible scenarios, including those that posed the maximum realistic
risk that might result in laboratory workers or the general public
having primary or secondary infections resulting from release of
pathogens that might be studied in the NEIDL. While there can be no
such thing as ``no risk,'' the results of this analysis show that the
risk of infections resulting from accidents or malevolent acts at the
NEIDL are generally very low to only remotely possible. This is largely
due to the safeguards built into the facility, the low amounts of
pathogens that will be present, and the culture of biosafety and
training that will be integrated into everyday practice at the NEIDL
and as well as due to oversight of the NEIDL by regulatory authorities,
like the Boston Public Health Commission and the Centers for Disease
Control and Prevention. The greatest risk posed by research in the
NEIDL is to individuals conducting research in the building, not to the
general public. The analysis did not show any statistically significant
increase in risk to medically vulnerable populations when analyzed as a
group or individually, as compared to what those risks would be at
alternate sites. Based on these factors, NIH is reaffirming its prior
Record of Decision, dated January 26, 2006, and concludes that high and
maximum containment research could be conducted safely at the NEIDL
based upon the current safeguards and engineering controls in place at
the facility.
Dated: December 18, 2012.
Daniel G. Wheeland,
Director, Office of Research Facilities Development and Operations,
National Institutes of Health.
[FR Doc. 2012-31509 Filed 12-31-12; 8:45 am]
BILLING CODE 4140-01-P