Frequently Asked Questions - draft Agricultural and Veterinary Chemicals Legislation Amendment Bill 2011

Why has the Australian Government initiated these agvet chemicals legislative reforms?

The proposed reforms aim to cut unnecessary red tape for business and encourage the development of safer and more modern chemicals. They will result in a more straightforward assessment process that is easier to understand and more cost effective to administer. The reforms also aim to reduce the backlog of chemicals requiring review and remove the disincentive for companies to invest in cutting edge technologies. In many cases, particularly for low risk products, the proposed amendments will reform the current system to provide more timely outcomes.

The proposed reforms also introduce a time limit–or sunset date–on the approval and registration of agvet chemicals to provide for periodic review of a chemical’s safety.

Overall, these reforms will result in improved health and environmental protection for the broader community. The reforms also enhance the APVMA’s business and operational functions and deliver greater business certainty for approval holders and registrants.

How will the reforms affect me?

The proposed reforms will affect different stakeholders in different ways.
For the community, the reforms will enhance confidence in agricultural and veterinary chemical regulation. The reforms will deliver greater transparency and more predictable outcomes for applications and chemical reviews. The reforms will be supported with contemporary compliance and enforcement measures. This means that consumers can continue to be confident that the Australian fresh food they buy and eat, if treated with chemicals, is safe.

For the chemical industry, the main impact will be a systematic approach to regular safety reviews of chemical products. A new re-registration (called continuation in the draft Bill) scheme is proposed that will require regular review of existing approvals and registrations. This will introduce a sunset provision for all chemicals. This will bring our system into line with the regulatory schemes in other developed countries.

The reforms will also provide more predictable and timely outcomes for those wishing to supply agvet chemicals, and free up the APVMA’s resources to deliver approval, registration and chemical review outcomes within prescribed overall timeframes.

For chemical users, the proposed improvements, such as to data protection and use of overseas data, are anticipated to result in an increased availability of safer and more modern chemical products.

How will the proposed risk-based framework be used?

The reforms include changes to promote consistent and transparent decision-making by the APVMA and its regulatory partners, using a risk-based framework. In parallel with legislative reforms, the APVMA is developing, and will publish and implement a risk framework for decisions about approvals, registrations and reviews of agvet chemicals. The framework will include all relevant guidelines, standards and methods which guide regulatory decisions made under the agvet chemicals legislation. The proposed reforms will allow the APVMA to utilise this framework to assist it determine the scale of an assessment appropriate to each application or chemical review. The risk framework will also assist applicants to determine what type of application they are best placed to make, and provide greater business certainty in determining what information will be required.

The risk framework will enhance the consistency, efficiency and transparency of decision making about approvals, registrations and reviews of agvet chemicals.

What is the scheme for the continuation of approvals and registrations?

In contrast to many other countries Australia has no requirement for chemical once approved to be regularly reviewed. Instead Australia’s approach has relied on an ad hoc system whereby chemicals of concern are scheduled for review after being brought to the regulators attention by the community, chemical users or, chemical companies or at the regulators own initiative. Although many chemicals have had a history of safe use, the community expects the regulator to actively monitor any issues that may impact their health or the environment.

The reforms will introduce a mandatory scheme for the approvals for active constituents and registrations of chemical products (including listed registration) to be checked periodically. Under the scheme, registrants or approval holders will need to apply to continue approvals for active constituents and registrations of chemical products after a period between seven and 15 years. The APVMA would then consider these applications to determine if registration or approval should be continued (with or without changes to conditions) or subjected to a reconsideration (ie full chemical review).

The scheme is intended to ensure currently available chemicals continue to meet appropriate contemporary standards for safety. The scheme has also been designed to ensure the administration of the scheme will not unnecessarily reduce the availability of safe and useful chemicals to the community.

The principle of the scheme is that registration and approval should be continued where there is no reason, founded in evidence, to doubt that the product or active constituent would not meet contemporary standards. This includes that product use would not pose an unacceptable risk to human or environmental health. Consistent with international practice, the scheme will introduce a systematic approach to regular safety reviews of chemical products in which chemical companies will be required to demonstrate, at regular intervals, that their products remain safe.

What changes will occur for applications and chemical reviews?

There are many changes proposed in the draft Bill to make this process more efficient and timely, including allowing electronic submission of information to the APVMA to streamline the processes for giving and receiving information.

The changes also include measures requiring the APVMA to refuse defective applications at preliminary assessment. This will focus the APVMA resources on complete applications and limit the preliminary assessment to an administrative check of details. This will limit the ability for applicants to use the APVMA as a consulting service to correct foreseeable problems with their applications.

Changes will be made to the use of overseas data to ensure that it can be used to its maximum extent possible, taking into account Australian conditions.
New regulations will also prescribe limits on the overall time allowed for assessment of applications, with extensions possible with mutual consent between the applicant and the APVMA, as well as timeframes for reconsiderations (chemical reviews) of approvals or registrations. Combined with the other reforms, this will reduce the backlog of chemical reviews and provide certainty to applicants about expected timeframes to market for new products.

What compliance and enforcement changes are being made?

The reforms will provide the APVMA with a graduated range of investigative, compliance and enforcement powers. Schedule 4 of the draft Bill includes an improved evidence collection authority, the ability to give enforceable directions to people and companies responsible for supplying agvet chemicals and the inclusion of civil penalty provisions, including penalty infringement notices. These tools will only be used to respond to non-compliance and not for the purpose of compelling information to assist the conduct of a review.

The inclusion of civil penalties provides the APVMA with alternatives to deal with breaches when a criminal penalty is not warranted. Civil penalties are considered a more appropriate mechanism for addressing corporate behaviour. 

The changes will improve compliance with the APVMA’s regulatory decisions and maintain public confidence in agvet chemical regulation. It will also allow a more proportionate approach to addressing non-compliance (including counterfeit products). The inclusion of these measures does not prevent the APVMA from continuing its existing strategies for maximising voluntary compliance.

Will data protection be improved?

Yes. The reforms will improve existing data protection. This will be achieved by promoting consistency in data protection requirements for applications and chemical reviews. It is anticipated that these changes will remove disincentives for industry to provide data in support of reviews to promote ongoing registration or approval of agvet chemicals. 

Schedule 5 of the draft Bill includes amendments to the Code Act to further protect data submitted for regulatory purposes. This will provide extra encouragement for innovation in the development of new agvet chemicals and protect data generators from unfair commercial use (free riding) by competitors.

The measures expand the range of data that are eligible for protection and address some inconsistencies in current data protection requirements. The government also proposes to improve the protection for information submitted in relation to chemical reviews. Under the proposed system, data will be protected from the time they are submitted to a date eight years after the first regulatory decision is taken. This will be a significant increase on the current system under which the maximum protection period is seven years from the date of submission and which can often be eaten up by the time taken for assessment. This, combined with clear timeframes for assessments, will provide businesses with a clearer indication of the time they will have to capitalise on their investment on research and development for agvet chemicals. There will also be changes to the notification arrangements in relation to mediation or arbitration over terms of compensation.

In addition, data submitted in support of applications which are withdrawn or refused will also continue to be eligible for data protection.

What reforms are proposed for collecting levies?

For efficiency, transparency and to improve confidence in the APVMA, the government proposes to amend the Levy Act to enable any Commonwealth agency to collect the levy.

Schedule 6 of the draft Bill includes amendments to the Levy Act to enable the minister to appoint any Commonwealth agency to collect the levy on product sales on behalf of the APVMA. The amendments will provide greater scope to improve administrative efficiency.  There is no change to the levy structure or rate as a result of this draft Bill.

The APVMA will retain its current levy assessment and determination function as well as the current enforcement powers.

Why is the draft Agricultural and Veterinary Chemicals (agvet chemicals) Legislation Amendment Bill being released now for community comment?

In 2008 the Productivity Commission reported that regulation of chemicals and plastics was a priority area for reform. Since that time the government has implemented a range of “early harvest” reforms in this area. However, more substantial reform in this area is required. The Australian Government recognises the importance of allowing the community the opportunity to have their say on proposed laws. This is a complex area of regulation and industry and other stakeholders can contribute valuable information by providing their views on the exposure draft of the amending legislation.

How can I submit my comments on the Bill?

If you wish to provide a written statement or submission on this draft legislation you can provide your comments to the Department of Agriculture, Fisheries and Forestry at the addresses below by 29 February 2012. This reform Bill is proposed to be introduced to the Commonwealth Parliament as soon as possible following the close of the comment period, with passage later in 2012. It is therefore important that stakeholders provide comments as soon as possible.

While submissions may be lodged electronically or by post, electronic lodgement by email is preferred. For accessibility reasons, please email responses in a Word or RTF format. An additional PDF version may also be submitted.

For further information on this process, please contact the department via the following means:

Agvet Chemicals - Early Harvest and APVMA Reforms Team
Agricultural Productivity Division
Department of Agriculture, Fisheries and Forestry
Email: APVMA Reforms Team
Phone: +61 2 6272 3933

Post:
GPO Box 858
CANBERRA  ACT  2601

Who will read my comments?

All information (including name and address details) contained in submissions will be made available to the public on the department’s website, unless you indicate that you would like all or part of your submission to remain in confidence. Automatically generated confidentiality statements in emails do not suffice for this purpose. Respondents who would like all or part of their submission to remain in confidence should provide this information marked as such in a separate attachment.

A request made under the Freedom of Information Act 1982 (Commonwealth) for a submission marked ‘confidential’ to be made available will be determined in accordance with that Act, which was recently amended.

When do I need to submit my comments by?

It would be of assistance if you could provide any comments as soon as possible, but at the latest 29 February 2012.

Comments received after this time may not be able to be considered. The government has provided this extended consultation period due to the complex nature of the proposed reforms and in consideration of the time of year.

What other changes are proposed?

The draft Bill includes other proposed improvements to the operation and administrative efficiency of the APVMA and remove out of date provisions in the legislation.

The amendments to the Code Act also include measures to ensure there is no impediment to an appropriate use of overseas data.   

What are the proposed agvet chemical legislative amendments currently being drafted by the Australian Government?

The draft Agricultural and Veterinary Chemicals Legislation Amendment Bill 2011 (‘the draft Bill’) proposes amendments to the Agricultural and Veterinary Chemicals (Administration) Act 1992 (‘Admin Act’) and the Agricultural and Veterinary Chemicals Code Act 1994 (‘Code Act’). These proposed amendments will improve the efficiency and effectiveness of the current regulatory arrangements for agricultural and veterinary chemicals, and provide better protection for human health and the environment.

The draft Bill also includes amendments to the Agricultural and Veterinary Chemical Products (Collection of Levy) (Levy Act), which aim to improve administrative efficiency.

When is the Agricultural and Veterinary Chemicals Legislation Amendment Bill likely to be introduced to the Commonwealth Parliament?

The agvet chemicals legislative reforms are proposed to be introduced to the Commonwealth Parliament as soon as possible following the close of the comment period. It is therefore important that stakeholders provide comments as soon as possible. Officials will be available to discuss the detail of the proposals to assist stakeholders to understand them.