[Federal Register Volume 69, Number 56 (Tuesday, March 23, 2004)]
[Notices]
[Pages 13527-13528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6517]


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OFFICE OF SCIENCE AND TECHNOLOGY POLICY


Workshop on Biosecurity

ACTION: Notice of meeting.

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SUMMARY: This notice sets forth an announcement of a public workshop on 
Laboratory Biosecurity: A Culture of Responsibility, and describes the 
purpose of the workshop.
    Dates, Address and Time: April 12, 2004, Bethesda, Maryland. The 
meeting will be held in Room E1/E2 of the Natcher Conference Center, 
National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892 
from 1 p.m. to approximately 4 p.m.
    Type of Meeting: Open.
    Who Should Attend: This workshop is relevant to all biological 
laboratory settings, from research to clinical laboratories, including 
laboratories which are not involved in work with select agents.
    Public Comments: The purpose of this workshop is to solicit 
comments on the successes and challenges associated with implementing 
biosecurity procedures and protocols. The outcome of the discussion may 
help identify good practices and help guide recommendations. Of 
particular interest is public comment on the following issues:

     What information should be contained in a 
BMBL chapter on biosecurity in order to provide sufficient guidance 
to assess biosecurity risk and develop a risk-management plan?
     What do you need in the way of outreach to 
facilitate putting a biosecurity program in place?
     Does your facility feel confident to 
implement risk management decisions?

[[Page 13528]]

     What, in your institution, is the best way to 
conduct biosecurity training and what should it consist of?
     What is the role for Institutional Biosafety 
Committees in biosecurity at your facility?
     To what extent has the cost of implementing 
biosecurity procedures had an impact on your facility/institution? 
Do existing facilities make retrofitting to accommodate biosecurity 
difficult? Have you found alternative methods to achieve compliance?
     What personnel requirements are applied 
toward biosecurity at your facility? Are these measures appropriate 
for small institutions? Do you have suggestions for compliance 
guidance in this area?
     Can you provide examples of how low cost 
measures have been put in place that have precluded the need for 
``high-tech'' solutions? An example might be a protocol for assuring 
personnel reliability, instead of mounting and monitoring cameras.)
     How best can biosecurity measures be 
instituted in clinical microbiological labs so as to avoid 
interfering with patient care?
     What have been the positive impacts of 
biosecurity implementation in your institution?
     What have been the negative impacts of 
biosecurity implementation in your institution?
     If you represent a company that has not yet 
incorporated biosecurity as part of its overall business plan, how 
difficult would it be to do so, and how would it impact business 
planning and intellectual property protection?

    The public comment time is designed for substantive commentary on 
the successes and challenges of biosecurity implementation at 
laboratory facilities. Please submit a request for the opportunity to 
make an oral public comment five (5) days in advance of the meeting. 
The time for oral public comments will be limited to no more than 5 
minutes per person. Written comments are also welcome and will be 
distributed at the meeting if provided electronically at least five (5) 
days in advance of the meeting. Please submit your request to make an 
oral comment or copy of written comments to: Rachel E. Levinson, OSTP, 
at [email protected], or fax your request/comments to (202) 456-
6027.

FOR FURTHER INFORMATION CONTACT: For further information, please call 
(202) 456-6130, prior to 3 p.m. on Friday, April 9, 2004. Please note 
that public seating for this meeting is limited and is available on a 
first-come, first-served basis.

SUPPLEMENTARY INFORMATION: 

Background

    The publication entitled, ``Biosafety in Microbiological and 
Biomedical Laboratories,'' better known as the BMBL, is a publication 
of the U.S. Department of Health and Human Services Centers for Disease 
Control and Prevention (CDC) and the National Institutes of Health 
(NIH) that outlines recommended safety practices for research and 
clinical laboratories and research animal facilities. It describes the 
combinations of standard and special microbiological practices, safety 
equipment, and facilities constituting Biosafety Levels 1-4, which are 
recommended for work with a variety of infectious agents in various 
laboratory settings. The recommendations in the BMBL are advisory. They 
are intended to provide a voluntary guide or code of practice as well 
as goals for upgrading operations. They also are offered as a guide and 
reference in the construction of new laboratory facilities and in the 
renovation of existing facilities.
    The most current version, the Fourth Edition, was published in May 
1999. The 4th edition of the BMBL was the first edition to address 
laboratory security concerns. Appendix F of the BMBL was updated in 
December 2002 to provide assistance to facility managers with meeting 
the Select Agent regulatory mandate of 42 Code of Federal Regulation 
(CFR) 73. These guidelines are intended for laboratories where select 
agents are used. Appendix F (Dec. 2002) provides a summary of issues 
that should be considered when evaluating laboratory security in 
facilities that utilize Select Agents. An electronic copy of the BMBL 
4thed. is available at: http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm.
    In September 2003, CDC and NIH initiated efforts to update the 
BMBL. This revision process occurs every 5-years extending over an 18-
24 month period. Completion of the 5th edition is anticipated by Summer 
2005. This new edition will include for the first time a chapter on 
biosecurity.
    This workshop is an opportunity for the public to provide input 
into the chapter on biosecurity, as well as an appendix providing 
supplementary information related to select agents. Public comments on 
the successes and challenges in implementing biosecurity will be taken 
into consideration when drafting the new chapter.

    Dated: March 18, 2004.
Stanley S. Sokul,
Counsel, Office of Science and Technology Policy.
[FR Doc. 04-6517 Filed 3-22-04; 8:45 am]
BILLING CODE 3170-01-P