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Notice

Workshop on Biosecurity

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Information about this document as published in the Federal Register.

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ACTION:

Notice of meeting.

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?Start Printed 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 levinson@ostp.eop.gov, or fax your request/comments to (202) 456-6027.

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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.

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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.

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Dated: March 18, 2004.

Stanley S. Sokul,

Counsel, Office of Science and Technology Policy.

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[FR Doc. 04-6517 Filed 3-22-04; 8:45 am]

BILLING CODE 3170-01-P