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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