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U.S. Department of Health and Human Services

Animal & Veterinary

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Welcome, Purpose and Objectives of Workshop

Welcome to CVM’s Public Meeting on the Use of Antimicrobial Drugs in Food Animals and the Establishment of Regulatory Thresholds on Antimicrobial Resistance

Comments by Claire M. Lathers, PhD, FCP
Director, Office of New Animal Drug Evaluation

Center for Veterinary Medicine
Food and Drug Administration
Rockville, MD

January 22, 2001

THE PUBLIC HEALTH CHARGE TO THE CENTER FOR VETERINARY MEDICINE

GIVES CVM THE REGULATORY RESPONSIBILITY OF ENSURING THAT USE OF ANTIMICROBIAL DRUGS IN FOOD-ANIMALS DOES NOT RESULT IN ADVERSE HEALTH CONSEQUENCES TO HUMANS

VETERINARY PUBLIC HEALTH IS ANOTHER FRONTIER

  • IN THE FIGHT AGAINST HUMAN DISEASE WITH RESPONSIBILITY TO DETERMINE WHICH ANTIBIOTICS ARE AVAILABLE FOR USE IN
    • HUMANS OR
    • ANIMALS
  • HOW TO CATEGORIZE ANTIMICROBIAL USE IN ANIMALS ACCORDING TO THEIR IMPORTANCE IN HUMAN MEDICINE

BACKGROUND

  • FRAMEWORK DOCUMENT
    • PUBLISHED FEDERAL REGISTER JAN 6, 1999
    • FIRST INTRODUCED CONCEPT OF ESTABLISHING REGULATORY THRESHOLDS
  • THRESHOLD DISCUSSION DOCUMENT
    • AVAILABLE ON DECEMBER 22, 2000
    • OUTLINED THE  CVM APPROACH FOR ESTABLISHING THRESHOLDS

PURPOSE OF THIS MEETING

  • DISCUSS RISKS AND BENEFITS OF ANTIMICROBIAL DRUG USE IN FOOD ANIMALS
  • CONSIDER APPROACHES FOR ESTABLISHING REGULATORY THRESHOLDS ON ANTIMICROBIAL RESISTANCE

OBJECTIVES OF THIS MEETING

  • CVM WILL OBTAIN
    • BROAD STAKEHOLDER INPUT ON THE USE OF ANTIMICROBIAL DRUGS IN FOOD ANIMALS
    • COMMENTS ON THE THRESHOLD APPROACH OUTLINED IN THE CVM DISCUSSION DOCUMENT
    • INPUT ON POSSIBLE ALTERNATIVES TO CVM’S APPROACH

GOALS FOR MEETING

  • Listen To Public Comments
    Provide Opportunity To Consider All Perspectives
    Receive
    • Specific Feedback On The CVM Approach
    • Input On Panel Discussion Questions
    • Ideas For Alternative Approaches
  • Encourage Discussion Of All Relevant Concerns

THIS MONDAY MORNING  JANUARY 22

  • GENERAL OVERVIEW OF THE CVM APPROACH TO THE ESTABLISHMENT OF THRESHOLDS
    PERSPECTIVES ON ANTIMICROBIAL DRUG USE IN FOOD ANIMALS SESSION 2

MORNING SESSION 2

  • PERSPECTIVES ON ANTIMICROBIAL DRUG USE IN FOOD ANIMALS
  • INCLUDES TOPICS RELATED TO
    • ANIMAL HUSBANDRY AND DISEASE CONTROL
      • CATTLE, SWINE, POULTRY, AQUACULTURE
  • ALTERNATIVES TO ANTIMICROBIAL DRUG USE
  • HUMAN HEALTH RISKS
  • CONSUMER PERSPECTIVES

AFTERNOON SESSION 2

  • PANEL DISCUSSION ON ANTIMICROBIAL DRUG USE IN FOOD ANIMALS
    • CONSIDER SESSION 2 QUESTIONS
  • PUBLIC COMMENT PERIOD

TUESDAY JANUARY 23 SESSION 3

  • ESTABLISHING HUMAN HEALTH THRESHOLDS
  • AFTERNOON PANEL DISCUSSION ON HUMAN HEALTH THRESHOLDS
    • DISCUSS SESSION 3 QUESTIONS
  • PUBLIC COMMENT PERIOD

WEDNESDAY MORNING JANUARY 24  SESSION 4

  • CVM APPROACH: USE OF RISK MODELTO ESTABLISH RESISTANCE THRESHOLDS
  • PANEL DISCUSSION OF RESISTANCE THRESHOLDS
    • DISCUSS SESSION 4 QUESTIONS
  • PUBLIC COMMENT PERIOD

WEDNESDAY AFTERNOON JANUARY 24  SESSION 5

  • ALTERNATIVE APPROCHES TO CVM PROPOSAL
  • PUBLIC COMMENT PERIOD
  • CLOSING COMMENTS: SUMMARY AND NEXT STEPS

ADDITIONAL COMMENTS 

  • GROUND RULES
    • FDA OFFICE OF CHIEF COUNCIL REQUIRES THERE WILL BE NO DISCUSSION BY CVM PERSONNEL OF THE PENDING NOOH
  • SEND COMMENTS ON THE THRESHOLD DOCUMENT TO DOCKET #00D-1677
    • BY APRIL 9, 2001
  • TRANSCRIPT WILL BE AVAILABLE ON CVM’S WEBSITE AT A LATER DATE
    • CVM's Home Page

SESSION 1 

  • WE WILL NOW BEGIN SESSION 1 WITH A    PRESENTATION BY DR. STEPHEN SUNDLOF
  • THE CVM APPROACH TO THE ESTABLISHMENT OF THRESHOLDS - A GENERAL OVERVIEW