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David Loschke 18 March 2005

New Zealand Timber Preservation Council Annual Conference 2005. The Australian Pesticides & Veterinary Medicines Authority Review of Arsenic Timber Treatments. David Loschke 18 March 2005. NATIONAL REGISTRATION SCHEME FOR AGVET CHEMICALS. APVMA is an independent statutory authority

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David Loschke 18 March 2005

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  1. New Zealand Timber Preservation Council Annual Conference 2005 The Australian Pesticides & Veterinary Medicines Authority Review of Arsenic Timber Treatments David Loschke 18 March 2005

  2. NATIONAL REGISTRATION SCHEME FOR AGVET CHEMICALS • APVMA is an independent statutory authority • APVMA regulates up to point of retail sale • States & Territories control usage

  3. APVMA OPERATING ENVIRONMENT PARLIAMENT External Advisers State Agricultural Departments Office of Chemical Safety Dept. Environment and Heritage Office of Gene Technology Regulator Stakeholders State Agricultural and Environmental Departments Agvet Chemical Industry Grower Organisations Consumers and the Community MINISTER BOARD APVMA Internal Service Providers

  4. APVMA ROLES • Assessment of Chemicals • Before sale (registration) • On the market • (review) • On-Going Quality • of Chemicals • Vet GMP • Ag Quality Assurance • Compliance • Surveillance and enforcement • Adverse experience reporting

  5. Human health must be protected

  6. The environment must be protected

  7. Australia’s international trade must be protected too

  8. CRITERIA FOR ASSESSMENT • Section 14 Agvet Code • Can only approve if • Is not an undue hazard to people (handling or residues) • No unintended harmful effect on plants, animals or the environment • Does not unduly prejudice trade (residues) • Is effective • Cannot trade risk against benefit

  9. Regulatory Science • Technical science function • Assessing hazards • Assessing risks • Policy aspect • Determining adequate safety margins • Establishing formal health standards

  10. KEY DATA REQUIREMENTS • Environment • Toxicology / human health • Occupational Health and Safety • Efficacy and Crop Safety • Residues, including overseas trade aspects of residues in food commodities • Chemistry and Manufacture

  11. Chemical Hazards • Acute Toxic Effects • Immediate or short term toxic effects • Longer Term Effects • Cancer • Birth Defects • Threshold Effect

  12. Studies for Toxic Hazard Acute Toxic Effects (immediate) • Oral • Dermal • Inhalation • Eye and skin irritancy • Skin sensitisation

  13. Studiesfor Toxic Hazard Longer Term Effects • Repeat dose studies • Short-term (28 day), Subchronic (3 to 12 months), Chronic/Carcinogenicity (lifetime studies in 2 species) • Reproduction studies • Developmental studies • Genotoxicity studies • Neurotoxicity studies • Immunotoxicity studies • Endocrine effect studies

  14. Arsenic Timber Treatments Review

  15. Review Findings For CCA Products • Treatment plants to meet Australian Standards • Certain end uses to be discontinued • Labels specify circumstances where CCA used • Treated timber must be branded • Product label instructions to be improved

  16. Review Findings • In addition • CCA proposed to be a Restricted Chemical Product • CCA Worker exposure data to be supplied • Arsenic trioxide anti-termite treatments OK’d

  17. Implementation

  18. Why were some uses discontinued?

  19. Natural Human Exposures Severe arsenic exposure can come from well water in certain areas of the world. • Argentina and Chile • Bangladesh and northern India • Japan • Taiwan

  20. Extreme well water exposures to arsenic

  21. Australian estimates of exposure

  22. Extreme well water exposures to arsenic

  23. Australian estimates of exposure

  24. Words from the Legislation – the Authority must be “satisfied” that use of the chemical product “would not be an undue hazard to the safety of people exposed to it” and “would not be likely to have an effect that is harmful to human beings”

  25. Considerations for Arsenic Critical Points • Proven human carcinogen • Mechanism not understood • Group at risk = children • Product variability

  26. Considerations for Arsenic Critical Points • Proven human carcinogen • Mechanism not understood • Group at risk = children • Product variability • Inadequate Exposure Data

  27. Australian estimates of exposure

  28. Words from the Legislation – the Authority must be “satisfied” that use of the chemical product “would not be an undue hazard to the safety of people exposed to it” and “would not be likely to have an effect that is harmful to human beings”

  29. Thank You

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