VMAC Fall 2003 Public Meeting Presentations - Matheson

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					Cloning of Animals with
Known Genetic Merit - Next
Steps to a Decision

            John C. Matheson
    FDA, Center for Veterinary Medicine
          Rockville, Maryland
 Goals of the Animal Cloning Risk
         Analysis Process
• Science-based Decisionmaking

• Education about Cloning

• Transparency of Decisionmaking Process

• Establish a Basis for Risk Management
  Proportionate with Level of Risk
     Risk Assessment/Risk
Management/Risk Communication


                Risk
             Management



          Risk         Risk
       Assessment   Communication
Risk Assessment/Risk Management/Risk Communication




                           Option
          Option             A
            X
                                    Option
                                      B

                                    Option
                                      C
 Does The RA Change CVM’s Position
    on Food Derived from Clones?

• No!
• Risk Assessment is the basis for Risk
     Management
• Risk Management action will establish any
     new policy
• Risk Management actions available to FDA
     include Guidance, Policy Statements,
     Regulations, Compliance Policy Guides
      Risk Management Process
• Risk Management - Burden and Benefits,
     Uncertainty
• Legal and Enforcement Issues Considered
  – Ability to Enforce a Policy Efficiently,
    Domestically and in International Trade
  – Detection of Non-Compliance
  – Consequences for Non-Compliance
• Role of Other Public and Private Groups
        No Policy Is Ever Final

• “Final” Guidance - Policy
  – Continuously Open for Comments
• Monitoring for Effectiveness
• Considering Effects of Changes in the
     Technology on Guidance
• Revising Guidance as Needed
  Communicating a Policy for Animal
          Clones - 2004
• US Stakeholders
• International Harmonization - Underway
  – OECD

  – Canada, Australia, Japan, UK, Italy, France,
     etc. Country by Country
     CVM’s Web Site is:
      www.fda.gov/cvm
See CVM’s Biotechnology Page

				
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