Notes from BSE USDA workshop held in Sept.98

[Guest guest]

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 ative Association

4301 Boulevard

Arlington, VA 22203-1850

September 28, 1998

8:30 - 9:30 Registration

9:30 - 9:45 Opening Remarks

Dr. Alwynelle S. Ahl

Director

Office of Risk Assessment and Cost Benefit Analysis

United States Department of Agriculture

9:45 - 10:00 Overview of Risk Analysis and Scope of Work

Dr. M. Gray

Research Associate & Instructor in Risk Analysis

Harvard University

School of Public Health

10:00 - 12:30 Open Discussion/Comments

Facilitator

Santos

Focus Group

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Risk Assessment for BSE

For Further Comment

Until October 16, 1998

Dr. Gray

email: ggray@...

USDA Contact

Dr. Alwynelle (Nell) Ahl

email: aahl@...

phone: 202/720-8022

Press Inquiries Only

Mr. 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

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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- 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.

Assessment potential pathways for entry of transmissible spongiform agents,

including the BSE agent, into U.S. cattle.

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.

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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- 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 ative 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. 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. 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@...>

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.

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Analyzing the Potential for BSE in the United States

text of slides

M Gray, Ph.D.

K. Hammitt, Ph.D.

Sylvia Kreindel, D.V M., M.S.

, 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

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Our Goals

Seek advice

Seek data

Hope to establish lines of communication

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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

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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

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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

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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

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Some HCRA Areas of Interest

Chemicals in the environment

Climate Change

Automobile injuries

Risks and benefits of medical treatments

Food safety and agriculture

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Multidisciplinary Teams

Biology/Toxicology

Engineering

Decision Analysis

Economics

Veterinary Science

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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

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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

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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

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Example Pathway-Live Cattle

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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

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Live Animal Import and Export - 1996

One single country potential pathway

UK Belgium/Luxembourg US

Three two country pathways

UK France Germany US

UK Netherlands Germany US

UK Spain Mexico US

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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

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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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