1. 1 David Loschke18 March 2005 New Zealand Timber Preservation Council Annual Conference 2005 The Australian Pesticides & Veterinary Medicines Authority Review of Arsenic Timber Treatments

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

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

4. 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. 5 Human health must be protected

6. 6 The environment must be protected

7. 7 Australia’s international trade must be protected too

8. 8 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 CRITERIA FOR ASSESSMENT

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

10. 10 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 KEY DATA REQUIREMENTS

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

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

13. 13 Studies for 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. 14 Arsenic Timber Treatments Review

15. 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. 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. 17 Implementation ActionRegulatory ToolAgency or Body Stop certain uses Specify permitted uses APVMA Label & State Control of Use Powers States & Territories Stop treated timber from being used in certain types of situations Australian Building Codes Australian Standards And through Policy & dissemination of information ABCB Standards Australia State Agencies (Parks & Wildlife, DOCS, Education Depts.) Local Governments School Boards Other major timber users Kidsafe

18. 18 Why were some uses discontinued?

19. 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. 20 Extreme well water exposures to arsenic

21. 21 Australian estimates of exposure

22. 22 Extreme well water exposures to arsenic

23. 23 Australian estimates of exposure

24. 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. 25 Considerations for Arsenic Critical Points  Proven human carcinogen  Mechanism not understood  Group at risk = children  Product variability

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

27. 27 Australian estimates of exposure

28. 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. 29 Thank You