Panel Discussion Friday

1
Panel Discussion -- Friday

• Paul A. Locke, JD, DrPH
• Johns Hopkins Bloomberg School of Public Health
• Center for Alternatives to Animal Testing
• DNT II Reston, VA
• 14 November 2008

2
Role of Policy in advancing DNT

• You cannot legislative, regulate, or use other
  coercive policy tools to guarantee scientific
  advances
• BUT
• You can create a legislative, regulatory and
  policy culture in which in vitro and
  non-mammalian toxicology is valued, and its
  development and use are encouraged for DNT
  decision-making

3
Some Policy Challenges

• YESTERDAY
• Moving from single test to test battery for
  decision-making
• Refining/expanding/fine tuning the concepts of
  validation and regulatory acceptance
• TODAY
• Incentives the development and use of in-vitro
  and replacement alternatives
• Global harmonization

4
Incentives for in vitro DNT

• Creating a policy culture that encourages the
  development of, and uses for, in vitro DNT data
• Need for additional resources?
• Carry out bench research
• New methods exploration/creation
• Bring in vitro DNT data in the risk assessment
  process
• Need for new policies?
• Explicit acknowledgement of role of in vitro DNT
• EU model explicit goals to reduce animal use

5
Global Harmonization

• Different governmental approaches to
  decision-making
• EU Cosmetics Directive/7th Amendment, REACH,
  86/609 EEC
• USA TSCA/FIFRA/ICCVAM law/PHS Act (NIEHS)
• Rationale for harmonization business is global,
  serves international markets
• Harmonization challenges political, not
  scientific good science crosses political
  boundaries