Nomination

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.

Prioritisation

Review is prioritised based on urgency and nature of the concerns.

Scoping

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).

Data call-in

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.

Assessment

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.

Draft Regulatory Measure

Following the assessment stage, the APVMA develops a draft regulatory approach to the chemical under review.

Consultation

The draft report and draft regulatory measure are released for public comment for up to three months.

Regulatory Decision

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.

Implementation

Review participants are notified of the outcome and regulatory actions implemented. Outcomes of the review are published in the APVMA Gazette.