Adverse Experience Reporting for Agricultural Chemicals

• Make a report online
• Print a reporting form (for experiences involving human health issues)(KP82F02)
• Print a reporting form (for experiences involving crop damage, efficacy or environmental issues)(KP82F03)
• View annual adverse experience reports
• Key documents

What is an adverse experience?

An adverse experience is an unintended or unexpected effect on animals, human beings or the environment, including injury, sensitivity reactions or lack of efficacy associated with the clinical use of agricultural chemical products.

A number of agricultural chemical products¹ have known side effects when used as directed. It is important to report all adverse experiences whether associated with label recommended dosing or not.

Note 1: The terms 'agricultural', 'agricultural chemical' and 'pesticide' products have the same meaning.

Who can report on an adverse experience?

Anyone. Members of the public, farmers, agronomists, "bystanders" (i.e. people who have been exposed to pesticides either directly or indirectly by aerial spraying or ground rig spraying for example or consuming treated produce) and health workers (including doctors, nurses, alternative medicine specialists etc) are encouraged to report any adverse experiences that have occurred after the use of or exposure to pesticides that have been used according to label or APVMA Permit directions to both the APVMA and the product registrant.

About the Adverse Experience Reporting Program (AERP)

The APVMA’s Adverse Experience Reporting Program for agricultural chemicals (AERP Ag) aims to ensure that products on the market remain safe, effective, are of acceptable quality and are used in the best possible way, and that instructions and warnings on labels are appropriate. Recording and investigating reports of adverse experiences is an important step in detecting unusual or rare conditions that were not evident in clinical or field trials and as a result, could not be assessed during the product registration process. The Program helps to ensure that products on the market

• remain safe, effective and of acceptable quality,
• are used in the best possible way, and
• that instructions and warnings on the label are appropriate.

Key Documents

• Consultation Regulation Impact Statement
• Definitions
• Glossary (KP82P02)
• Guidelines for registrants (KP82G02)
• Guidelines for the public (KP82G01)
• Information sheet
• Public Information Package
• Registrant reporting form (periodic summary update) (KP82F05)
• Reporting form (for experiences involving crop damage, efficacy or environmental issues)(KP82F03)
• Reporting form (for experiences involving human health issues)(KP82F02)

Contact

For adverse experiences with agricultural or veterinary chemicals
Phone: (02) 6210 4806 Fax: (02) 6210 4813 AERPCoordinator@apvma.gov.au