Senate inquiry November 2018 opening address—Dr Chris Parker

20 November 2018

Thanks for the opportunity to address the inquiry.

The APVMA operates as part of a larger agvet chemical regulatory framework and our responsibilities extend from registration and manufacturing through to the point of sale.

Compliance and monitoring powers in our legislation provide a mechanism to undertake post-market surveillance and testing that ensure the continued safety and effectiveness of registered products and we collaborate with state and territory authorities, who regulate chemical use.

Like many reputable regulators here and overseas, the APVMA operates a cost-recovered model. We are funded through a mechanism that reflects the Australian Government Charging Framework and the Cost Recovery Guidelines. It is Australian Government policy for the industry that creates a risk and or benefits from a regulatory activity to pay for that regulation to be administered.

The assessment of risk, scientific analysis, and weighing of the evidence against Australia’s legal agvet chemical requirements must be appropriately resourced and we are currently reviewing our Cost Recovery Implementation Statement to refine our fees and levies structure and return the APVMA to a sustainable, financial footing.

We maintain lines of communication with registrants, with industry groups and stakeholders and this collaboration gives us a clear view of our operating context, and is an essential part of good regulation as described in the Australian Government Regulator Performance Framework.

We regulate over 11,500 agvet chemicals products, managed by over 900 registrants. In that environment, we engage both industry and stakeholders to strike a balance between agricultural productivity and safeguarding.

APVMA email correspondence exceeds a million sent and received in an average year.

We respond to more than 6,300 phone calls to our general enquiries line and answer and respond to feedback through our online systems and website.

It is not unusual to have a few hundred emails, largely on administrative matters, to be sent between our agency and any one industry body.

Communication with industry and registrants is essential for responsive regulation.

Last month, we issued new, stricter label instructions for 2,4-D to reduce incidents of spray drift.

This action will help minimise crop losses this spray season and minimise environmental damage.

It was through effective engagement with growers, industry groups, and other regulators that the APVMA was able to introduce these new instructions and gain the cooperation of users.

We take a thorough, collaborative, and risk-based approach to the science of agvet chemical regulation.

The bar for registration is high. Industry must demonstrate that their products are safe and effective. The tests have rigour and take time.

The data and the evidence must satisfy our regulatory scientists that these products are effective and can be used – and continue to be used – safely.

That is why when the APVMA looked at the International Agency for Research on Cancer’s report on glyphosate, we evaluated all 264 studies referenced in that report, plus further studies and data.

We took the time to get the science right, found that on balance of scientific information, we did not see a need to change our stance on glyphosate, and published our evaluation only last year.

It’s true that our chemical review program is behind schedule, and this must, and is being, addressed.

However, I am confident that the risks made evident through our ongoing progress with chemical reviews are being managed.

It is routine for the APVMA to take interim regulatory action in the early stages of a chemical review to suspend registrations, remove uses or adjust label directions as a precaution.

It is also common for us to reinstate uses once they have assessed additional data that’s provided throughout the review process and that’s then finalised our regulatory decision.

We did this with dimethoate. We did it with diuron, and we did it with fenthion.

This is the system working as intended. It balances the spectrum of community, user and industry perspectives by applying the scientific evidence to what can only be at times an emotive debate over the safety of agricultural and veterinary chemicals.

Like any system, improvements can be made and we are taking steps to strengthen that system.

I note that other regulators have heavily invested in post-market activities, including chemical review functions.

I have recently reorganised our post-market and science quality functions into a single unit under the direction of our Chief Regulatory Scientists.

This realignment of market surveillance, intelligence and regulatory review functions will further enhance scientific quality.

We have capable people in our post-market teams but I see opportunities for improvement and we are already working on implementing these within our current cost base.

Half of our organisation is made up of scientists, and many of them have PhDs.

These people know what they’re doing when assessing whether a chemical product is safe and effective.

We bolster our scientific capability with specialist external assessors, as we did with the evaluation of the IARC glyphosate report and when new, credible scientific information comes to our attention, we consider it and take action where appropriate.

The relocation to Armidale has disrupted our operations and the departure of staff has impacted our productivity and brought many underlying, historical faults to the surface.

The relocation is a challenge and there are risks that we continue to manage.

However, there are some positives. The relocation has provided an opportunity to take a fresh look at our operations and fix some of these long-standing problems.

We have an enthusiastic group in Armidale made up of people who have relocated from Canberra and talented recruits from the New England region and elsewhere.

These staff are supported by our experienced and highly skilled regulatory scientists and decision makers in Canberra.

I applaud the commitment of APVMA staff who have worked diligently to maintain our improved operational performance this past year and our increased focus on clearing the overdue chemical reviews is another example of this commitment.

We continue to focus on the very important task that this inquiry is concerned with – ensuring the APVMA remains free of influence, from all parties, and maintaining the highest quality regulation services to keep our community, our animals, and our environment safe.

Thank you Chair.

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