This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/19151
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Product regulation according to risk
Agricultural and veterinary (agvet) chemicals are regulated according to their risks—in terms of both the likelihood of being exposed to them and the potential effects of exposure.
The APVMA approaches risk via a risk analysis framework—which involves separating risk assessment, risk management and risk communication. Using this framework the APVMA then aligns its regulatory efforts with chemicals to their risk. This helps reduce the regulatory burden on industry—especially for products and chemicals of low regulatory concern—while increasing the efficiency of APVMA operations.
APVMA scientific risk assessments consider both the effect and likelihood of exposure.
Risk analysis framework
APVMA risk assessments focus on the scientific analysis of information and data relating to an agvet chemical. The assessment is evidence-based and considers information relating to the health and safety of people, animals, crops and the environment.
The APVMA will also assess trade risks including potential impacts on Australia’s international trade interests, obligations and agreements.
The APVMA’s risk management activities consider the outcomes of risk assessments, regulatory policies and other relevant information. The APVMA can then develop, recommend and implement options to manage identified risks and continue to maintain health and safety.
To manage risks, agvet chemical products and active constituents can—among other things—be regulated by:
- enforcing compliance, including cancelling or suspending a registration, approval or permit
- imposing registration or permit conditions
- restricting access to a chemical
- requiring certain information to be communicated on a product label.
APVMA risk communications are influenced by both risk assessment and risk management activities. This ensures appropriate communications are distributed to effectively help manage potential risks from using agvet chemicals.
The communication process is two-way between the APVMA and its stakeholders. It involves:
- industry stakeholders communicate aspects risk information to the APVMA by supplying research data and information
- chemical users and the general community—such as farmers, veterinarians, pest controllers and other chemical users— can report, non-compliance or provide input to the APVMA to help prioritise chemicals to review
- the APVMA communicating health and safety information with industry, users and the community, by publishing information for chemical users and details of registered products and chemical reviews on the website, as well as distributing the APVMA Gazette and information for the media.
Those responsible for a registered product or approved active constituent must adhere to the labelling codes. Certain information—the relevant particulars—need to be on the product label to effectively communicate the risks associated with a chemical or product and how to minimise them.
Aligning regulatory effort with risk
The Agvet Code sets out a legislative framework for the APVMA to align its regulatory efforts with risk.
The legislative framework allows the APVMA some discretion when determining if certain criteria have been met in an application. It also allows the APVMA to prioritise compliance and enforcement activities based on risk and allocate internal resources proportionately.
This reduces the regulatory burden on industry while increasing the efficiency and effectiveness of the APVMA—without compromising the safety of people, animals, crops and the environment.