Food Safety and Inspection Service United States Department of Agriculture Washington, D.C. 20250-3700

News and Information

United States Department of Agriculture

Risk Analysis for BSE
Agenda

National Rural Electric Cooperative Association
4301 Wilson Boulevard
Arlington, VA 22203-1850
September 28, 1998

Risk Assessment for BSE
For Further Comment

Until October 16, 1998

Dr. George Gray
email: ggray@hsph.harvard.edu

USDA Contact

Dr. Alwynelle (Nell) Ahl
email: aahl@oce.usda.gov
phone: 202/720-8022

Press Inquiries Only

Mr. Andrew Solomon
phone: 202/720 4623

For More Information

• APHIS Website: www.aphis.usda.gov/oa/bse
• FSIS Website: www.fsis.usda.gov/oa/topics/bse.htm

COOPERATIVE AGREEMENT
between
HARVARD CENTER FOR RISK ANALYSIS, and
THE UNITED STATES DEPARTMENT OF AGRICULTURE

Risk Analysis of Transmissible Spongiform Encephalopathies in Cattle and the Potential for Entry of the Etiologic Agent(s) into the US Food Supply.

BACKGROUND

Transmissible spongiform encephalopathies (TSEs) are chronic, fatal diseases affecting the central nervous system of certain species of mammals. TSEs are found in sheep and goats as scrapie; in humans as Creutzfeldt-Jacob Disease (CJD), new variant CJD, Gerstman-StrausslerScheinker disease, fatal familial insomnia, and kuru; in deer and elk as chronic wasting disease (CWD); in cats as feline spongiform encephalopathy, in mink as transmissible mink encephalopathy (TME), and in cattle as bovine spongiform encephalopathy (BSE). Other cases of TSE have been reported in some exotic ruminants and exotic cats.

BSE was first diagnosed in 1986 in the United Kingdom, and has affect more than 170,000 British cattle. Other countries with confirmed cases of BSE in native cattle include Belgium, France, Ireland, Luxembourg, the Netherlands, northern Ireland, Portugal, and Switzerland.

The United States Department of Agriculture (USDA) is responsible for protecting both human and animal health and both will be considered in this analysis. Although BSE has not been detected in the United States, the USDA is sponsoring this study to evaluate the current programs to protect the national herd and human health, and to help identify whether further measures are necessary.

OBJECTIVES, TIME FRAME AND DELIVERABLES

There are two objectives to this study, one focused on animal health and one focused on human health.

1. Assessment potential pathways for entry of transmissible spongiform agents, including the BSE agent, into U.S. cattle.
2. Assess the potential pathways for entry of transmissible spongiform agents, including the BSE agent, into the U.S. food supply.

The study will take two years and result in technical reports to the USDA and one or more manuscripts for publication in a scholarly journal.

Opening Comments for BSE Public Meeting, 9/28/98

Dr. Nell Ahl

1. Welcome to the Public Meeting to discuss plans for a Risk Analysis for Bovine Spongiform Encephalopathy, or BSE.

• We appreciate your taking time from your busy lives to share your ideas about this analysis.
• My name is Nell Ahl and I am the Director of the Office of Risk Assessment and Cost-Benefit Analysis.
• My role is to represent the United States Department of Agriculture in these discussions and serve as the USDA Project Manager for this analysis.

 2. BSE is a fatal neurodegenerative disease of cattle, first identified in the UK in 1986.

• Since that time, USDA has worked actively to prevent BSE from entering the U.S. There has been no case of BSE found in the U.S.
• We have taken a number of actions which are listed in the Chronology, to be found in the meeting packet you received this morning. The Chronology illustrates the kinds of efforts made and studies undertaken to keep BSE out of the U.S.

3. Very recently, scientific studies suggest that BSE may be linked to a new variant of Creutzfeld-Jacob Disease, a fatal neurodegenerative disease in humans, perhaps through   consumption of BSE-containing tissues.

• Since the USDA is responsible for protecting both human and animal health and for ensuring the safety and security of our food supply, we wanted to look comprehensively at both.
• We decided that an outside review of the potential pathways by which the BSE agent could enter the country and the human food supply should be performed.
• Specifically, we want to look at the effectiveness of USDA's mitigation measures to block these pathways.

4. On July 1, 1998, USDA entered into a Cooperative Agreement with the Harvard University School of Public Health, Center for Risk Analysis to conduct the Risk Analysis and evaluation of USDA programs regarding BSE.

• The Risk Analysis is in its early stages.
• The purpose of our meeting today is to seek your input concerning the scope of the Analysis

5. The goal of this Public Meeting is to examine the scope of the Risk Analysis, and provide you an opportunity to comment and make suggestions about the issues the analysis should address. Our role is to sit back and listen.

• I'm going to turn the meeting over to Dr. George Gray and his team from the Harvard Center for Risk Analysis. They will give a brief overview of their proposed scope and approach.
• Once Dr. Gray is done, we have an outside facilitator, Dr. Susan Santos, who will facilitate the rest of the meeting and help ensure that we provide vou an opportunitv to comment and make suggestions about the issues the analvsis should address.

6. The Department's efforts have been effective in excluding BSE from the US.

• This Risk Analysis is yet another step in our continuing efforts to assure continued success.
• Your input can help make this a better analysis by bringing your concerns as citizens to the analysts working on this project.
• Our plan is to run this meeting from 9:30 to 12:30. In addition, you can provide comments via e-mail through October 16. The address for email comment is shown in the last page of the public meeting packet.

Closing Comments for BSE Public Meeting

1. Thank you for your input into this Risk Analysis. We appreciate your comments.

• As I said earlier, comments will be accepted by email until October 16, 1998, at the email address included in your meeting packet: <ggray@hsph.harvard.edu>
• The Harvard Center for Risk Analysis Team will use your comments to assure that the scope of their risk analysis appropriately considers all issues.

2. You may also visit two USDA websites which contain more information on BSE.

• We intend to post quarterly updates of the progress of Harvard's BSE Risk Analysis on these sites. The addresses for these sites are found on the last page of your meeting packet.

3. Once again, thank you for your interest in USDA activities. We remain committed to keeping BSE out of US herds and the US food supply. We appreciate your attendance today to share your knowledge and concerns with us.

Analyzing the Potential for BSE in the United States

text of slides

George M Gray, Ph.D.
James K. Hammitt, Ph.D.
Sylvia Kreindel, D.V M., M.S.
Kimberly Thompson, Sc.D.
Yihsu Chen

Harvard Center for Risk Analysis
Harvard School of Public Health

Overview

• Our goals for this meeting
• How we got involved
• Our approach
• Next Steps

Our Goals

• Seek advice
• Seek data
• Hope to establish lines of communication

Seeking Advice

• Want to understand key questions in assessing the BSE issue
• Cast net broadly as we develop our analysis framework
• Your input is sought and valued

Seeking Data

• Need to determine what data are available
• Different parties will have access to different data
• Data is key to turning anecdote to understanding

Starting Communication

• Give you faces to put with a name and a voice
• Help us get to know stakeholders and their views
• Build lines of communication

How We Got Involved

• Group with long history in risk analysis of hazards to human health and the environment
• Expertise in methods of risk analysis
• Multidisciplinary approach

Some HCRA Areas of Interest

• Chemicals in the environment
• Climate Change
• Automobile injuries
• Risks and benefits of medical treatments
• Food safety and agriculture

Multidisciplinary Teams

• Biology/Toxicology
• Engineering
• Decision Analysis
• Economics
• Veterinary Science

Our Approach

• Define scope of analysis
• Describe potential pathways to BSE infectivity in U.S. herd or food supply
• Characterize and quantify (if possible) steps in each pathway
• Identify key steps for further research or risk management

Scope of Analysis

• Identification and characterization of pathways for BSE (or BSE-like) infectivity in U.S. Cattle
• Identification and characterization of pathways for cattle-derived BSE (or BSE-like) infectivity in the U.S food supply

Analyzing Pathways

• Our method of analysis involves identification of pathways by which BSE could enter the U.S. herd or food supply
• We need your help to identify pathways and their components
• Each step of a pathway must be characterized or quantified to address that pathway

Example Pathway-Live Cattle

Preliminary Pathway Evaluation

• Know number and destinations of cattle exported by UK and other BSE countries (UN Data)
• Identify countries from which US imports live cattle (UN Data)
• Estimate potential flow of animals from BSE countries to US both directly and via one or more other countries

Live Animal Import and Export - 1996

• One single country potential pathway

• Three two country pathways

Identification of Key Pathway Steps

• Final analysis will be made up of tens or even hundreds of pathways
• Understanding of pathways allows investigation of steps critical to potential for BSE infectivity in U.S herd or food supply
• Can identify and make recommendations about the potential for risk management actions to address critical steps or further research needs

Next Steps

• Understand and describe all potential pathways - 6 months
• Identify data to characterize step

For Further Information:

• APHIS Web site: www.aphis.usda.gov/oa/bse
• FSIS Web site: www.fsis.usda.gov/oa/topics/bse.htm
• Harvard Center for Risk Analysis: www.hsph.harvard.edu/Organizations/hcra/hcra.html

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