Supplemental Record of Decision; Final Supplementary Risk Assessment for the Boston University National Emerging Infectious Diseases Laboratories, 110-112 [2012-31509]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[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