Policy Integration in Developmental Neurotoxicology

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Policy Integration in Developmental
Neurotoxicology 
Paul A. Locke, MPH, JD, DrPH Johns Hopkins
Bloomberg School of Public Health Center for
Alternatives to Animal Testing 13 March 2006
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Overview of Presentation
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Address three questions

• What is policy integration?
• What are current challenges facing, and
  opportunities for, policy integration?
• What changes in approaches (in policy and in
  science) will smooth the way for timely,
  effective, meaningful DNT testing?

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What is policy integration?
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Policy integration

• Policy and policy makers keeping pace with
  science
• Science and scientists being responsive to policy
  needs and public demands

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Policy keeping pace with new/emerging science and
technology

• Event at cellular, subcellular, molecular,
  genetic levels
• Conservation across species of fundamental
  processes and mechanisms
• Genomics, proteomics, omics technologies
• Decoding genome of humans and animals

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Gene expression profiles--also called
fingerprints or signatures--of known toxicants or
toxicant families may, in the future, be used to
identify potential toxicity. In this example, the
genetic signature of test compound 1 is identical
to that of known peroxisome proliferators,
whereas that of test compound 2 does not match
any known toxicant family. (Source Rockett
Dix, Environmental Health Perspectives, 1999 Aug.
107(8) 651-8)
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Science responsive to policy needs -- public
demands

• Use fewer animals in testing
• Deploy more alternatives and practice humane
  science
• Conduct more testing to bridge toxic ignorance
  gap
• Make testing cheaper, faster and more reliable
• Design new tests that produce science that is as
  good as, or better than, science from old tests
• Protect sensitive subpopulations such as fetuses,
  infants and children from toxic compounds
• Harmonize tests across national borders

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A complex situation

• Science does not always advance in a linear or
  predictable fashion
• Cannot always plan for or chart success
• More research helps, but can create additional
  uncertainties
• Some things very difficult to study
• The public is rarely unified and does not speak
  with one voice
• Simultaneous demand to achieve dissonant goals

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Challenges and Opportunities
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Challenges

• Meeting the needs of different stakeholders
• Working with less-than-optimal laws, regulations
  and policies
• Working with different governmental institutions
  with nations and internationally
• Refining new scientific techniques and knowledge
  and comparing it to existing science and
  technology

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Opportunities

• Frustration with current situation has fostered
  growing understanding of need for another
  approach to DNT
• Humane science and alternatives
• Model for similar situations?
• Massive investment in science that holds great
  promise as alternatives
• New laws, policies, seeking additional
  information about toxicology of compounds (e.g.,
  REACH, HPV program)

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REACH
Registration, Evaluation, Assessment of Chemicals

• 30,000 Chemicals
• 40 Years
• 11 Billion Dollars
• 13 Million Animals
• Base set of tests?

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Chemical Toxicity Testing

• Required for all NEW chemicals (TSCA) and
  pesticides (FIFRA)
• Not required for chemicals on the market when
  TSCA was passed
• Toxic ignorance gap -- 71 of chemicals lack
  basic screening data
• Actions needed to fill gap
• Get more and better information
• Get information on more endpoints

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Better policy integration
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Data Sharing

• Increase data generation
• Data about DNT
• Data about new techniques
• integration with existing data
• Assessment of strengths and weaknesses
• Increase data sharing
• Release data from in vitro and alternative tests
• Make data available to risk assessors and the
  public

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Validation

• Validation has a policy aspect
• Consider tiered testing schemes for screening and
  prioritization
• Information generated by non-validated tests has
  merit
• Validation of in vitro or alternative tests for
  which no animal test model is available
• Link validation and regulatory acceptance

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Conclusions

• An effective DNT testing system will integrate
  policy and science
• Meet competing societal demands
• More information about DNT
• Reduce use of animals
• Take advantage of new science and technology
• Humane science and alternatives provide a
  platform for effective policy integration and a
  DNT testing regime