October 2015
The Australian Government is improving access to agricultural chemicals and veterinary medicines
(agvet chemicals) as part of the Agricultural Competitiveness White Paper. Our plan to build a stronger, more prosperous agricultural sector and economy.
This paper seeks your views on one of the proposed reforms to the agvet chemicals system. It is proposed that the Agricultural Pesticides and Veterinary Medicines Authority (APVMA) CEO (or their delegate) act on behalf of the Secretary of the Department of Health when making scheduling decisions.
This paper will be used as a basis for discussion at workshops to be held in Canberra, Perth,
Brisbane, Sydney and Melbourne from 27 October to 13 November 2015. If you are unable to attend these workshops and would like to provide feedback on the reforms, please email agvetreform@agriculture.gov.au by 30 November 2015.
The APVMA must have regard to the poisons classification of any ingredients in an agvet chemical when assessing if a chemical product meets safety criteria for registration. APVMA must also considers the poisons classification of an agvet chemical when approving a product label.
The Secretary of the Department of Health, or their delegate, classifies a substance for the poisons standard either on their own initiative or on application. In general, the scheduling decision for agvet chemicals is made on application from the APVMA on behalf of the applicant. In making a decision, the Secretary (or delegate) may refer a matter to the Advisory Committee on Chemicals Scheduling
(ACCS). The situations where a delegate may make a decision outside of the ACCS are set out in a policy framework. Between a quarter and a third of agvet chemical scheduling decisions are made without the advice of the ACCS.
Scheduling of innovative chemical products containing a new (to Australia) active constituent is routinely sought by the APVMA. While only a few new active constituents are introduced into
Australia annually, the need to complete the scheduling process adds up to six months to the time taken to make a final decision.
The Therapeutic Goods Administration (TGA) must also consider the poisons classification of ingredients of products that they are responsible for regulating. A delegate of the Secretary of the
Department of Health exists within the TGA. This allows, in some circumstances, TGA to make the scheduling decision and reduce unnecessary delays. Delegating the same power to the APVMA Chief
Executive Officer (CEO) could deliver improvements in assessment timeframes for chemicals that must be classified in the poisons standard.
While this scheduling issue affects only a small number of products annually, the impact on these products can be great. The use of chemical products in Australia is highly seasonal, matching the

pest pressures experienced by producers. A delay of weeks in registering a product can result in a delay of market release by up to a year, awaiting the next season.
This is a measure that was not included in our discussion paper earlier in the year. The reform is included now because of the feedback we received from some chemical industry stakeholders over the last few months. The proposal has not been considered by the Department of Health—we will engage the department if stakeholders consider the proposal has some merit.
Innovator chemical manufacturers expressed their frustration at the delay in a product’s registration as a result of scheduling. Any reform to improve this situation would have direct impact on chemical access to Australian farmers.
Should the Secretary of the Department of Health agree, the proposal would have the Secretary delegate the CEO of the APVMA (or their delegate) to act on their behalf to make scheduling decisions, within the policy set by the Australian Health Ministers’ Advisory Council’s (AHMAC) scheduling policy framework. The framework specifies the circumstances where the Secretary of the
Department of Health (or their delegate) is unable to make a decision on scheduling and where a scheduling decision must go to one of the advisory committees for chemicals scheduling.
With the experience of the APVMA in agvet chemicals coupled with the established processes for delegation of decision, the AHMAC scheduling policy framework and role for the scheduling committees, we do not expect that risks to human health (either in the user or produce consumer) would increase over the current situation.
The current scheduling process recognises (through general exemptions that apply in all but a few individual cases) that the APVMA is best positioned to develop all other product specific warning statements, safety directions and packaging requirements. The APVMA routinely makes decisions about the risks posed by chemical substances. The APVMA is recognised as an experienced, skilled and expert regulator within the Australian Government for agvet chemicals. Senior APVMA officers are skilled in the management of human and animal health risks. The APVMA has the necessary skill to make poisons scheduling decisions in line with the policy of the Department of Health. This is demonstrated by the process for making amendments to the Food Standards Code for maximum residue limits of agvet chemicals. Since 2010, the APVMA has itself amended the Food Standards
Code without intervention by Food Standards Australia New Zealand.
We have been encouraged by stakeholder input on this measure to date and believe it is a reform that could be delivered in the early stages of the wider reform package.
We will be hosting a series of workshops for all interested stakeholders to attend and provide their views on the proposed reform measures. To attend one of these workshops please fill in a registration form .

If you are unable to attend one of the workshops or would like to provide feedback separately, contact the department via email at agvetreform@agriculture.gov.au
.
When providing your feedback you might like to consider addressing the following questions:
 Do you support the proposed reform in its current form or would you like further detail?
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If you don’t support it, could the reform be amended to achieve your support? If so how?
Are there any unintended consequences arising from this reform?
 Does the proposed reform result in new issues for you?
Please provide your feedback by 30 November 2015 so we can consider it before finalising a policy paper outlining a comprehensive reform package. The final policy paper will be released for stakeholder comment in the first quarter of 2016.