[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11140-11141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Availability of the Draft Supplementary Risk Assessment for the 
Boston University (BU) National Emerging Infectious Diseases 
Laboratories (NEIDL); Public Hearing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice; public hearing announcement.

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SUMMARY: The National Institutes of Health has placed in the docket for 
public review and comment the Draft Supplementary Risk Assessment for 
the NEIDL, which is intended to respond to the concerns of the local 
community, courts, the National Research Council, and the general 
public regarding possible impacts of the laboratory. The purpose of the 
Draft Supplementary Risk Assessment for the NEIDL is to present the 
human health consequences of a potential accidental event or malevolent 
action resulting in the release of a pathogen or loss of biological 
containment at the NEIDL. Furthermore, this risk assessment compares 
the potential public health consequences resulting from the potential 
loss of biocontainment in a

[[Page 11141]]

range of population density areas that represent urban, suburban, and 
rural environments. The urban, suburban, and rural sites that were 
selected for the purposes of the comparative analysis include the 
Boston University Medical Campus (BUMC) BioSquare Research Park, 
Boston, where the NEIDL has been constructed; the BU Corporate 
Education Center in Tyngsborough, Massachusetts; and the BU Sargent 
Center for Outdoor Education near Peterborough, New Hampshire. The Risk 
Assessment also examines whether locating the NEIDL in Boston would 
have a disproportionately high and adverse impacts on low-income and 
minority populations.

DATES: Comments on the Draft Supplementary Risk Assessment for the 
NEIDL must be postmarked no later than May 1, 2012. A public hearing to 
solicit public comment on the document will be held on April 19, 2012, 
from 6:30-9:30 p.m. at Roxbury Community College, 1234 Columbus Avenue, 
Boston, MA 02120.

ADDRESSES: Written comments should be sent to The National Institutes 
of Health, Office of Biotechnology Activities, ATTN: NEIDL Risk 
Assessment, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland, 20892. 
Email comments should be sent to <a href="/cdn-cgi/l/email-protection#baf4f3f2e5f8e8eafad5de94d4d3d294ddd5cc"><span class="__cf_email__" data-cfemail="b7f9feffe8f5e5e7f7d8d399d9dedf99d0d8c1">[email protected]</span></a>. Please note that 
comments sent by email must be received by 11:59 p.m. on the last day 
of the comment period May 1, 2012.

FOR FURTHER INFORMATION CONTACT: National Institutes of Health Office 
of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, 
Maryland, 20892. Telephone number: 301-496-9838. Electronic mail 
address: <a href="/cdn-cgi/l/email-protection#551b1c1d0a170705153a317b3b3c3d7b323a23"><span class="__cf_email__" data-cfemail="80cec9c8dfc2d2d0c0efe4aeeee9e8aee7eff6">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The National Institutes of Health awarded a 
construction grant to Boston University Medical Campus to partly fund 
the design and construction of one of two National Biocontainment 
Laboratories. These advanced biomedical research laboratories are 
essential to the civilian biodefense initiative, providing critically 
needed Biosafety Levels 2, 3 and 4 research space. The basic and 
translational research to be conducted in these laboratories over the 
next 20 years would result in development of new rapid diagnostic 
assays, vaccines and therapeutics for protection of the American public 
against intentional misuse or release of harmful biological agents or 
toxins and naturally emerging and re-emerging infectious diseases.
    The NIH completed and published a final Environmental Impact 
Statement (EIS) and published a Record of Decision as required for 
major federal actions under the National Environmental Policy Act. 
Construction of the NEIDL began at the BioSquare II Research Park on 
Albany Street, Boston, Massachusetts adjacent to the BUMC.
    During the preparation of the EIS, the NIH conducted a thorough 
review of the possible impacts of the NEIDL on the public and the 
environment. Based on that review, the NIH concluded that the 
construction and operation of the NEIDL in its current location posed a 
negligible risk to the surrounding community in which the laboratory 
was sited.
    Several residents and public interest groups filed a federal 
lawsuit challenging the adequacy of the final EIS prepared for the 
NEIDL and whether the potential risks of the research would vary 
depending on the location of the facility in a suburban or rural area. 
A state lawsuit was also filed challenging the adequacy of a separate 
environmental review prepared pursuant to a Massachusetts law.
    The Draft Supplementary Risk Assessment for the NEIDL addresses the 
issues raised by the public and the courts regarding pathogen release, 
facility location, and environmental justice concerns.
    Throughout the preparation of the Draft Supplementary Risk 
Assessment for the NEIDL, NIH has sought the input of the public 
regarding scenarios and pathogens they wished to see included in the 
Risk Assessment. In addition, NIH established an independent Blue 
Ribbon Panel (BRP) to provide scientific and technical advice to the 
agency in assessing any potential public health risks associated with 
the operation of the NEIDL and to assess strategies for mitigation. The 
BRP was convened with 16 members having expertise in relevant fields, 
including infectious diseases, public health and epidemiology, risk 
assessment, environmental justice, risk communications, bioethics, 
biodefense, biosafety, and infectious disease modeling. The NIH has 
also sought guidance from the National Research Council (NRC) committee 
that was critical of the draft of an earlier risk assessment prepared 
by the NIH.

Availability of Copies and Electronic Access

    Given the highly technical nature of the report and in order to 
assist the reader, a reader's guide will be provided with each copy of 
the draft supplementary risk assessment .
    Copies of the Draft Supplementary Risk Assessment Report for the 
Boston University National Emerging Infectious Diseases Laboratory and 
the reader's guide document may be obtained at no cost by calling 301-
496-9838, or by emailing requests to <a href="/cdn-cgi/l/email-protection#80cec9c8dfc2d2d0c0efe4aeeee9e8aee7eff6"><span class="__cf_email__" data-cfemail="97d9dedfc8d5c5c7d7f8f3b9f9feffb9f0f8e1">[email protected]</span></a>. The document 
will also be available electronically at: http://nihblueribbonpanel-bumc-neidl.od.nih.gov/default.asp.
    A copy of the draft supplementary risk assessment and the reader's 
guide will also be available for review at each of the following 
locations. Central Branch of the Boston Public Library, 700 Boylston 
Street, Boston, MA, South End Library, 685 Tremont Street, Boston, MA, 
Grove Hall Library, 42 Geneva Avenue, and Dudley Library, 65 Warren 
Street, Boston, MA.
    Public Meeting: The National Institutes of Health will hold a 
public meeting on Thursday, April 19, 2012, from 6:30-9:30 p.m. at 
Roxbury Community College, 1234 Columbus Avenue, Boston, MA 02120. The 
purpose of the meeting is to solicit public comments regarding the 
Draft Supplementary Risk Assessment for the National Emerging 
Infectious Diseases Laboratories. Comments provided during the meeting, 
as well as those received during the public comment period will be 
considered in the Final Supplementary Risk Assessment for the National 
Emerging Infectious Diseases Laboratories. Individuals wishing to 
provide oral comments at the meeting must sign-in prior to the start of 
the meeting. Sign-in will begin at 5:30 p.m. In order to ensure 
everyone has the opportunity to speak, comments must be limited to no 
longer than three minutes. This public meeting is part of the 67-day 
public comment period initiated with the publication of a Notice of 
Availability in the Federal Register on February 24, 2012. The 67-day 
comment period began on February 24, 2012 and will end on May 1, 2012. 
Comments can also be sent to: The National Institutes of Health, Attn: 
NEIDL Risk Assessment, 6705 Rockledge Drive, Suite 750, Bethesda, MD 
20892, or emailed to <a href="/cdn-cgi/l/email-protection#ace2e5e4f3eefefcecc3c882c2c5c482cbc3da"><span class="__cf_email__" data-cfemail="c48a8d8c9b86969484aba0eaaaadaceaa3abb2">[email protected]</span></a>. For further information 
concerning this meeting, please contact Office of Biotechnology 
Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 
750, Bethesda, MD 20892, telephone 301-496-9838, email: <a href="/cdn-cgi/l/email-protection#682a3a383726212028070c46060100460f071e"><span class="__cf_email__" data-cfemail="2b69797b746562636b444f05454243054c445d">[email protected]</span></a>.

    Dated: February 16, 2012.
Amy Patterson,
Associate Director for Science Policy, National Institutes of Health.
[FR Doc. 2012-4266 Filed 2-23-12; 8:45 am]
BILLING CODE 4140-01-P


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