Introduction to the Bill

Exposure Draft

Agricultural and Veterinary Chemicals Legislation Amendment Bill 2011

The Australian Government is committed to reforms to the registration and review of agvet chemicals that improve the efficiency and effectiveness of the current regulatory arrangements, and provide greater certainty to the community that chemicals approved for use in Australia are safe.

The reforms aim to encourage the development of modern and safer chemicals by providing more flexible and streamlined regulatory processes with high levels of transparency and predictability for business seeking approval for agvet chemicals to enter the market. The reforms would result in a more straightforward assessment process that is easier to understand and more cost effective to administer. In many cases, particularly for low risk products, the reformed system as established by these amendments may be faster, would deliver more predictable outcomes and should result in improved health and environmental protection for the broader community.

The reforms also seek to provide greater assurance for all stakeholders about the safety of new and existing agvet chemicals. This will be achieved by implementing a systematic approach to regular review of existing chemical approvals and registrations, tailored to the Australian chemicals market, and by enhancing the APVMA’s ability to ensure compliance with its decisions and to manage issues of non-compliance.

Over the next three months the government is consulting with stakeholders on the draft Bill and associated reforms. It is expected the final Bill will be introduced and passed in 2012 for commencement thereafter.

Reforms

The reforms in the draft Bill will cover five areas:

1. Enhancing the consistency, efficiency and transparency of agvet chemical approvals, registrations and reviews through developing, publishing and implementing a risk framework, and legislative amendments to align regulatory effort with chemical risk;
2. Improving the efficiency and effectiveness of assessment processes for agvet chemicals applications for approval/registration and variation, and improving the timeliness of agvet chemical approvals, registrations and chemical reviews;
3. Ensuring the ongoing safety of agvet chemicals and improving the effectiveness and efficiency of current agvet chemical review arrangements by implementing a mandatory approval/registration continuation regime, designed to minimise impacts on affected businesses.
4. Improve the ability of the APVMA to enforce compliance with its regulatory decisions by providing the APVMA with a graduated range of compliance enforcement powers and introducing a power to apply statutory conditions to registrations/approvals.
5. Improve consistency in data protection provisions and remove disincentives for industry to provide data in support of ongoing registration of agricultural and veterinary chemicals

Outcomes:

Business will benefit through increased certainty over regulatory requirements and timeliness, reduced application requirements where permitted by appropriate risk management, improved data protection provisions and increased community confidence in regulatory outcomes.

Benefits to human health and the environment will flow particularly from improved access to newer and safer chemistry, increased scrutiny of currently available chemicals for their human and environmental health and safety impacts and from an improved regime to ensure compliance with regulatory decisions.

Other issues

In line with a broader consideration of the role agvet chemicals play in our agricultural system, the government will develop a strategic policy on the sustainable use of agvet chemicals to guide further reforms of agvet regulations.

To address industry concerns about the quality of some chemicals, DAFF will convene an industry-government roundtable to discuss the issue of manufacturing standards and the importation of chemicals.

The minster will establish a science panel, independent of industry and the APVMA, to regularly review and report progress of the APVMA’s performance on chemical reviews and assessing chemicals efficiently according to risk. This will include reporting on performance in meeting required timeframes.

Schedule 6 of the Bill provides for an agency other than the APVMA to collect the chemical products levy, should it be cost effective to do so.