Download - David Loschke18 March 2005
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David Loschke 18 March 2005
New Zealand Timber Preservation New Zealand Timber Preservation Council Annual Conference 2005Council Annual Conference 2005
The Australian Pesticides & Veterinary Medicines Authority
Review of Arsenic Timber Treatments
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APVMA is an independent statutory authority
APVMA regulates up to point of retail sale
States & Territories control usage
NATIONAL REGISTRATION SCHEME FOR AGVET CHEMICALS
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APVMA OPERATING ENVIRONMENTAPVMA 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
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APVMA ROLESAPVMA 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
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Human health must be protectedHuman health must be protected
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The environment must be protectedThe environment must be protected
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Australia’s international trade must be protected tooAustralia’s international trade must be protected too
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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
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Regulatory ScienceRegulatory Science
Technical science functionAssessing hazardsAssessing risks
Policy aspectDetermining adequate safety marginsEstablishing formal health standards
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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
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Chemical HazardsChemical Hazards
Acute Toxic EffectsImmediate or short term toxic effects
Longer Term EffectsCancerBirth Defects
Threshold Effect
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Studies for Toxic HazardStudies for Toxic Hazard
Acute Toxic Effects (immediate)
Oral
Dermal
Inhalation
Eye and skin irritancy
Skin sensitisation
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Studies for Toxic HazardStudies for Toxic Hazard
Longer Term EffectsRepeat 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
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Arsenic Timber Treatments Review
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Review FindingsReview 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
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Review FindingsReview 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
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ImplementationImplementation
Action Regulatory Tool Agency 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
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Why were some uses discontinued?
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Natural Human ExposuresNatural 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
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Extreme well water exposures to arsenicExtreme well water exposures to arsenic
Natural Human Exposure to Arsenic
0
100
200
300
400
500
600
700
800
900
1
micrograms/kg bw/day
Range of Exposures
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Australian estimates of exposureAustralian estimates of exposure
Australian Children's Arsenic Exposure
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
1 2 3
micrograms/kg bw/day
CCA Decks
Background
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Extreme well water exposures to arsenicExtreme well water exposures to arsenic
Natural Human Exposure to Arsenic
0
100
200
300
400
500
600
700
800
900
1
micrograms/kg bw/day
Range of Exposures
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Australian estimates of exposureAustralian estimates of exposure
Australian Children's Arsenic Exposure
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
1 2 3
micrograms/kg bw/day
CCA Decks
Background
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Words from the Legislation 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”
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Considerations for ArsenicConsiderations for Arsenic
Critical Points
Proven human carcinogen
Mechanism not understood
Group at risk = children
Product variability
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Considerations for ArsenicConsiderations for Arsenic
Critical Points
Proven human carcinogen
Mechanism not understood
Group at risk = children
Product variability
Inadequate Exposure Data
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Australian estimates of exposureAustralian estimates of exposure
Australian Children's Arsenic Exposure
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
1.8
2
1 2 3
micrograms/kg bw/day
CCA Decks
Background
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Words from the Legislation 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”
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Thank You