[Federal Register: July 12, 2006 (Volume 71, Number 133)]
[Page 39282-39283]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

[Docket No. FSIS-2006-0011]

Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) 
Update; Notice of Availability and Technical Meeting

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and announcement of technical meeting.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of an updated risk assessment model and report for 
BSE. The previous risk assessment, released in October 2003, was 
revised to incorporate information available through December 2003, 
including the discovery of a BSE-infected cow in Washington State. The 
revised risk assessment model evaluates the impact of measures 
implemented after the discovery of the BSE-positive cow and 
recommendations made by an international BSE panel. FSIS will also hold 
a technical meeting to discuss the updated risk assessment model and 

DATES: The public meeting will be held on July 25, 2006, from 1 p.m. to 
4 p.m. Comments on the updated Harvard Risk Assessment must be received 
by August 11, 2006.

ADDRESSES: The public meeting will take place in the Jefferson 
Auditorium of the South Building of the U.S. Department of Agriculture, 
1400 Independence Avenue, SW., Washington, DC, 20250. Meeting attendees 
must enter the South Building at Wing 1, 14th and Independence Avenue. 
FSIS will finalize an agenda on or before the meeting date and will 
post it on the FSIS Internet Web page http://www.fsis.usda.gov/News/Meetings_&_Events/.
 The updated risk assessment is available for 

viewing by the public in the FSIS docket room and on the FSIS Web site 
at: http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp.

    All comments and the official transcript of the meeting will be 
available for viewing by the public in the FSIS docket room and on the 
FSIS Web site when they become available.
    Comments on the updated Harvard Risk Assessment may be submitted by 
any of the following methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov
 and, in the ``Search for Open Regulations'' box, 

select ``Food Safety and Inspection Service'' from the agency drop-down 
menu, and then click on ``Submit.'' In the Docket ID column, select 
FDMS Docket Number FSIS-2006-0011 to submit or view public comments and 
to view supporting and related materials available electronically. This 
docket can be viewed using the ``Advanced Search'' function in 
     Mail, including floppy disks or CD-ROM's, and hand- or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102 Cotton Annex, Washington, DC 20250.
     Electronic mail: fsis.regulationscomments@fsis.usda.gov.
    All submissions received by mail and electronic mail must include 
the Agency name and docket number FSIS-2006-0011. All comments 
submitted in response to this notice will be available for public 
inspection in the FSIS Docket Room at the address listed above between 
8:30 a.m. and 4:30 p.m., Monday through Friday. The comments also will 
be posted to the regulations.gov Web site and on the Agency's Web site 
at: http://www.fsis.usda.gov/regulations_&_policies/2006_Notices_Index/index.asp

FOR FURTHER INFORMATION CONTACT: Dr. Chuanfa Guo, Senior Risk Analyst, 
Risk Assessment Division, Office of Public Health Science, 1400 
Independence Avenue, SW., Room 344, Aerospace Center, Washington, DC 
20250-3700; Telephone (202) 690-0817, e-mail Chuanfa.guo@fsis.usda.gov.
    Pre-registration for this meeting is recommended. To pre-register, 
please contact Diane Jones at (202) 720-9692 or by e-mail at 
Diane.Jones@fsis.usda.gov. Persons requiring a sign language 

interpreter or special accommodations should contact Ms. Jones as soon 
as possible.

    In April 1998, USDA entered into a cooperative agreement with the 
Harvard Center for Risk Analysis (HCRA) of the Harvard School of Public 
Health and the Center for Computational Epidemiology at Tuskegee 
University to conduct a comprehensive investigation of the BSE risk in 
the United States. The report,\1\ widely referred to as the Harvard 
Risk Assessment, was completed in 2001 and released by USDA in December 
of that year. Following a peer review conducted in 2002, the authors of 
the risk assessment responded to the peer review comments and submitted 
a revised risk assessment to USDA in October 2003.\2\

    \1\ Harvard Center for Risk Analysis, Harvard School of Public 
Health, and Center for Computational Epidemiology, College of 
Veterinary Medicine, Tuskegee University, ``Evaluation of the 
Potential for Bovine Spongiform Encephalopathy in the United 
States,'' http://www.aphis.usda.gov/lpa/issues/bse/risk_assessment/mainreporttext.pdf
, 2001.

    \2\ Research Triangle Institute, ``Review of the Evaluation of 
the Potential for Bovine Spongiform Encephalopathy in the United 
States,'' accessed online at http://www.aphis.usda.gov/lpa/issues/bse/BSE_Peer_Review.pdf
, 2002.

    Harvard Center for Risk Analysis, Harvard School of Public 
Health, ``Evaluation of the Potential for Bovine Spongiform 
Encephalopathy in the United States: Response to Reviewer Comments 
Submitted by Research Triangle Institute,'' http://www.aphis.usda.gov/lpa/issues/bse/ResponsetoComments.pdf
, 2003.

    Harvard Center for Risk Analysis, Harvard School of Public 
Health, and Center for Computational Epidemiology, College of 
Veterinary Medicine, Tuskegee University, ``Evaluation of the 
Potential for Bovine Spongiform Encephalopathy in the United 
States,'' http://www.aphis.usda.gov/lpa/issues/bse/madcow.pdf, 2003.


    Following confirmation on December 23, 2003, of BSE in a cow in 
Washington State, both USDA and the Department of Health and Human 
Service's (HHS's) Food and Drug Administration (FDA) implemented 
measures to strengthen protections against BSE in the United States. In 
May 2004, USDA contracted with the HCRA to revise the Harvard Risk 
Assessment model to reflect information available through December 
2003. USDA also contracted with the HCRA to develop a new baseline for 
the risk assessment model, analyze the effects of the measures 
implemented by USDA and FDA in response to the confirmation of the BSE 
case in Washington State, and analyze recommendations made by an 
international expert BSE panel that was convened at the request of the 
Secretary of Agriculture to review the actions taken by the United 
States in response the confirmation of the BSE case in Washington 
    The authors submitted an updated risk assessment to FSIS in June 
2005, and a peer review of the updated risk assessment was completed in 
September 2005. The final updated risk assessment and the revised risk 
assessment model

[[Page 39283]]

were submitted following the peer review.
    This document announces that FSIS is making the 2005 updated 
Harvard Risk Assessment available to the public. The Agency will also 
hold a public technical meeting to provide information on the 2005 
updated Harvard Risk Assessment. At this meeting, the developers of the 
risk assessment model will explain the modifications that have been 
made to the model and FSIS will present the results of the various risk 
mitigation scenarios that were analyzed using the updated model.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this notice, FSIS will announce it on-line 
through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2006_Notices_Index/index.asp

    The Regulations.gov Web site is the central online rulemaking 
portal of the United States government. It is being offered as a public 
service to increase participation in the Federal government's 
regulatory activities. FSIS participates in Regulations.gov and will 
accept comments on documents published on the site. The site allows 
visitors to search by keyword or Department or Agency for rulemakings 
that allow for public comment. Each entry provides a quick link to a 
comment form so that visitors can type in their comments and submit 
them to FSIS. The Web site is located at http://www.regulations.gov.

    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS Web page. Through 
Listserv and the Web page, FSIS is able to provide information to a 
much broader, more diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/.
 Options range from recalls to 

export information to regulations, directives and notices. Customers 
can add or delete subscriptions themselves and have the option to 
password protect their account.

Barbara J. Masters,
 [FR Doc. E6-10928 Filed 7-11-06; 8:45 am]