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From: TSS ()
Subject: [Docket No. FSIS–2006–0011] Harvard Risk Assessment of Bovine Spongiform Encephalopathy (BSE) Update; Notice of Availability and Technical Meeting
Date: July 12, 2006 at 12:59 pm PST

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Federal Register / Vol. 71, No. 133 / Wednesday, July 12, 2006 / Notices

Estimated Total Annual Burden on Respondents: 227,209 hours.

Total Annual Reporting/ Recordkeeping Requirements: 462,362 hours.

Dated: July 6, 2006.

Roberto Salazar,

Administrator, Food and Nutrition Service.

[FR Doc. E6–10960 Filed 7–11–06; 8:45 am]

BILLING CODE 3410–30–P

DEPARTMENT OF AGRICULTURE

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 report.

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 Regulations.gov.
• 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.

SUPPLEMENTARY INFORMATION:

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

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 State.

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

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.

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Federal Register / Vol. 71, No. 133 / Wednesday, July 12, 2006 / Notices

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,

Administrator.

[FR Doc. E6–10928 Filed 7–11–06; 8:45 am]

BILLING CODE 3410–DM–P

DEPARTMENT OF AGRICULTURE

http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2006-0011.pdf

Docket No. FSIS-2006-0011 | PDF
Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States (Nov 26, 2001; PDF only)
Review of the Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States (Oct 31, 2002; PDF only)
Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States Response to Reviewer Comments submitted by Research Triangle Institute (Oct 2003; PDF only)
Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States (Nov 26, 2001; PDF only)
Risk Assessments


BOVINE SPONGIFORM ENCEPHALOPATHY (BSE)

2005 Harvard Risk Assessment of Bovine Spongiform Encephalopathy Update (Oct 2005)
Report (PDF Only)
Appendix 1, Base Case Parameter File Changes From Earlier Analysis (PDF Only)
Appendix 2, Detailed Simulation Output (PDF Only)
Appendix 2A (PDF Only; 1.8MB)
Appendix 2B (PDF Only; 935kb)
Appendix 2C (PDF Only; 32MB)
Appendix 3, Numerical Stability of Simulation Output (PDF Only)
Appendix 4, Response to Peer Review Comments (PDF Only; 849 KB)
Model (ZIP compressed file containing multiple files and instructions; 1MB)

2003 Harvard BSE Risk Assessment (Oct 2003)

http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp

Agenda


AGENDA, Harvard BSE Risk Assessment Technical Meeting

July 25, 2006
Jefferson Auditorium

Draft Agenda
12:30 p.m. Registration
1:00 p.m. Opening Remarks
Richard A. Raymond, M.D.
Under Secretary
Office of Food Safety
U. S. Department of Agriculture

Barbara J. Masters, D.V.M.
Administrator
Food Safety and Inspection Service
U. S. Department of Agriculture
1:15 p.m. Technical Updates to the Harvard BSE Risk Assessment
Joshua T. Cohen, Ph.D.
Lecturer
Tufts University School of Medicine
2:15 p.m FSIS Scenario Analyses
Uday Dessai, Ph.D., M.P.H.
Director
Microbiology Division
Office of Public Health Science
Food Safety and Inspection Service
U. S. Department of Agriculture
3:15 p.m. Moderated Questions & Answers
David Goldman, M.D., M.P.H.
Assistant Administrator
Office of Public Health Science
Food Safety and Inspection Service
U.S. Department of Agriculture

4:00 p.m. Closing Remarks
David Goldman, M.D., M.P.H.
Adjourn


http://www.fsis.usda.gov/News_&_Events/Agenda_BSE_Tech_Meeting_072506/index.asp

http://www.fsis.usda.gov/regulations_&_policies/2006_Notices_Index/index.asp

Suppressed peer review of Harvard study October 31, 2002


http://www.fsis.usda.gov/oa/topics/BSE_Peer_Review.pdf


Greetings,

SINCE the first Harvard BSE Risk Assessment was so flawed and fraught with error after the PEER REVIEW assessment assessed this fact, how do you plan on stopping this from happening again, will there be another peer review with top TSE Scientist, an impartial jury so-to-speak, to assess this new and updated Harvard BSE/TSE risk assessment and will this assessment include the Atypical TSE and SRM issues ?

WITH A NINE STATE MAD COW FEED BAN RECALL in the past few months, then another Mad Cow feed ban warning letter in May, IT should seem prudent to ask why our feed bans continue to fail in 2006, and continue to fail today ?

WHY still now only partial feed ban ?

WHAT does USDA/FDA ET AL intend to do about the risks of atypical BSE/TSE in cattle now that shows infectivity in tissue samples other than CNS in Japan, the fact now that the last Texas mad cow and that last mad cow in Alabama were indeed of the atypical strain, the fact that the studies long ago in Mission, Texas of USA sheep scrapie transmission to the USA bovine, which proved an 'atypical tse' in the USA bovine, the fact also that USDA/FDA are still floundering on the last SRM regulations, but with the BASE strain now in cattle that is not similar to nvCJD, but very similar to the sporadic CJD, and sporadic CJD has tripled in the last few years in the USA. what do you plan to do (if anything$) to protect human health from these atypical strains of TSE, in relations to SRMs ?

THE 2004 Enhanced BSE surveillance program, that tested all those cows, but then we found just how terribly flawed the program was, from testing protocols, to testing the most likely to have BSE i.e. high risk, to the geographical distribution of the testing and high risk areas, to letting the tissue samples of one mad cow sit on a shelf for 7+ months and then having to have an act of Congress to ever get that cow finally confirmed, to that other Texas mad cow they decided to not even bother testing at all, just rendered that very suspect cow, to suspect to test evidently, back to that Alabama mad cow that they could only give a guess as to age with dentition where we all know that the age of that cow was so close to 10 years it could have been 9 years 7 months to 10 years 3 months, thus possibly being an BAPB i.e. USA 'born after partial ban', to all those rabies suspect cows that did not have rabies, and DID NOT get tested for BSE/TSE in that June 2004 enhanced surveillance program, even though the common lay person knows the suspect rabies negative cows are suppose to be BSE/TSE tested, how does one correct all these blatant failures ?

WHAT happened to the test results and MOUSE BIO-ASSAYS of those imported sheep from Belgium that were confiscated and slaughtered from the Faillace's, what sort of TSE did these animals have ?

WHY is it that the Farm of the Mad Sheep of Mad River Valley were quarantined for 5 years, but none of these farms from Texas and Alabama with Atypical TSE in the Bovine, they have not been quarantined for 5 years, why not ?

Scrapie in sheep and goat, CWD in deer and elk, are both running rampant and have been for decades, you cannot and have not controled it, what do you plan to do about that, anything different since everything else has failed so far ?

WITH ANIMAL TSE in the USA rampant (the USA is the most documented Nation in the world with the most species with TSE, all of which have been rendered and fed back to animals for human and animal consumption for decades), with atypical TSE now in the USA, when will you start testing all animals susceptible to a TSE ?

I have many more questions, I could go on, really, but you get my gist, it's as obvious as day and night, either Larry, Curley, and Mo have been at the helm of the USDA/APHIS/FSIS/FDA/CDC et al, or the incompetence of these agencies are so inept, either through ignorance and or just too overweight with industry reps., they then should be all done away with and a single agency brought forth. ...

TSS




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