Appendix 3
Australian Pesticides and Veterinary Medicines Authority
Chemical Review Process
The following is an overview of the stages of the APVMA's
chemical review process.
Nomination
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APVMA becomes aware of concerns about a chemical (active constituent),
product and label and decides a review is warranted based on credible new
scientific information available at the time.
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Prioritisation
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Review is prioritised based on urgency and nature of the
concerns.
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Scoping
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A detailed outline is prepared about the reason(s) for the
review and assessment components to be considered as part of the review
(including toxicology, environmental impact, occupational health and safety,
residues).
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Data call-in
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APVMA notifies chemical companies with active constituent
approvals and registered products (registrants and approval holders) and asks
them to submit data relevant to the scope of the review. APVMA also calls for
public submissions which address the current usage of, or problems with, the
continued registration of the chemical under review.
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Assessment
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All submissions and scientific data are evaluated by the
APVMA and external advisory Australian Government agencies as appropriate.
Depending on the concerns outlined in the scope of the review, these assessments
commonly include toxicology, residues, occupational health and safety and
environmental safety.
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Draft Regulatory Measure
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Following the assessment stage, the APVMA develops a draft
regulatory approach to the chemical under review.
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Consultation
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The draft report and draft regulatory measure are released
for public comment for up to three months.
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Regulatory Decision
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Based on evidence gathered during the assessment and
consultation phases, the APVMA CEO makes the final decision about the future
use of the chemical under review. Note that an interim regulatory decision
may be approved if identified risks can be managed through modified
instructions of use or if generation and evaluation of additional data may be
required.
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Implementation
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Review participants are notified of the outcome and
regulatory actions implemented. Outcomes of the review are published in the
APVMA Gazette.
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