APVMA is preparing its Operational Plan for 2011-12.  The Operational Plan is intended to achieve the objectives and strategies of APVMA’s Corporate Plan.  The Corporate Plan is flawed.  The current Corporate Plan needs to be re-written.  Its objectives need to be discarded and replaced with objectives that are meaningful and achievable.

The Objectives in the Corporate Plan drive the strategies and ultimately the operations of the APVMA.  Examination of those objectives sheds light on some of the problems with APVMA’s operations.  The objectives are:

1.    Promote confidence through consistent, predictable and transparent decision-making. We are well into the 2009-2012 Corporate Plan period and I cannot say that APVMA’s decision-making is either consistent or predictable.  We see different decisions being made in similar situations.  Is this because individuals within APVMA interpret requirements differently or are the requirements changing?  In either case, decision-making is neither consistent nor predictable.

2.    Enhancing awareness of how APVMA’s regulatory activities protect people, the environment and trade. It is 2011, more than half way through the Corporate Plan period and I doubt if too many people are “aware” of how APVMA’s activities protect people, the environment or trade.  Take endosulfan as an example.  In 2009, following calls for APVMA to de-register endosulfan after New Zealand revoked approvals for endosulfan, APVMA announced it had decided to not review endosulfan.  APVMA argued “country specific factors” can lie behind decisions made in specific countries and there was no need to review endosulfan in Australia.  Following ongoing media reports about endosulfan, in October 2010 APVMA advised registrations of products containing endosulfan had been cancelled.  Was the decision made by the APVMA or by the media?  The definite impression is the media.  We also see the courts not supporting APVMA decisions. The “Record of Approved Active Constituents” has the following statement at the top of the page:  “Evergreen Nurture as a site of manufacture is known to be non-existent. Approvals have been restored to the Record pursuant to a Federal Court Order dated 13 October 2008”.  How does allowing a non-existent source to be used for supply of active constituents for use in Australia enhance confidence in the regulatory process?  How can we have confidence in a regulator whose decisions are overturned by the courts and who appears to respond to media pressure?

3.    Engaging with other government agencies to enhance regulatory efficiency.  Well yes – of course.  APVMA needs to work with other government agencies.

4.    Enhancing the capability of our people and our systems. I cannot argue with this but is this not something the Government has been promoting for all business?  Does it need to be stated in a corporate plan?

The current Corporate Plan will not achieve its objectives because the objectives are too imprecise.  APVMA is required to promote confidence.  Who should have confidence in APVMA?  We know that every time a registration is granted there is a segment of the population who will say APVMA failed by allowing yet another noxious substance to be used.  Every time a registration is refused, somebody will claim APVMA failed by refusing the application.  The same decision (to register or deny registration) can result in one group within the community losing confidence in APVMA while another group gains confidence — until the next decision is made by APVMA.

The Corporate Plan needs to be discarded and re-written with new, meaningful objectives.

The former Agriculture Minister Tony Burke, talking at the Outlook 2010 conference stated:  “We want to make sure that when a chemical is dangerous, we can restrict it and restrict it quickly”.  He went on to say “We also want to make sure that when a chemical is clearly safe, it can be made available and made available quickly, and done so in a way that provides the minimal amount of red tape for everybody involved”.  Are these not the true objectives for APVMA?

My suggestion for meaningful objectives:

1.    Quickly restrict chemicals found to be dangerous.

2.    Quickly make available products that pose acceptable risk.

3.    Cut red tape.

The Operational Plan can discuss how to identify and restrict dangerous chemcials, how to identify products with acceptable risk, what is meant by “quick” and how to cut red tape.

There are many companies supplying agricultural and veterinary chemicals in Australia. Their ability to operate in the Australian market, and the ability of larger companies to operate in the market, is dependent on a dysfunctional regulatory system. Industry associations and individuals have been arguing the regulatory system needs to be improved for some time. The Government appears to be listening and changes are being proposed. This blog is designed to provide a forum for debating the changes, offering suggestions and comments and becoming informed.

To ensure changes are “palatable”, it is necessary to participate in the reform process. Most companies are not participating. Most are relatively small — 92% of companies are considered to be small in terms of sales of agricultural and veterinary chemicals in Australia. These small companies account for only 14% of total agvet chemical sales in Australia. The majority of these companies do not have in-house regulatory expertise. They do not have time to become involved in preparing responses to government proposals to reform the regulatory system – but their survival often depends on the regulatory system that allows them to participate in the market, to develop new products, and to grow their business.

Most companies in the Australian agricultural and veterinary chemical industry are not members of any industry association. Remaining fully informed about the regulatory system is difficult and smaller companies have little time to comment on proposed changes. Many companies can feel alone, thinking they are the only ones having problems with the regulatory process in Australia.

The best way to ensure you are fully informed is to be an active member of a relevant industry association. This site contains links to relevant industry associations including ACCORD, Australasian Compliance Institute, CropLife Australia and PACIA.

Maybe you are a member of an industry association. Maybe you are not. Irrespective, the changes proposed in the policy discussion paper are important. They deserve open discussion and debate. The discussion document is available at: http://www.daff.gov.au/agriculture-food/food/regulation-safety/ag-vet-chemicals/better-regulation-of-ag-vet-chemicals.

In the past, I have responded to earlier proposals by involvement in a working group. I have chaired a number of working groups for the Australasian Compliance Institute. This time, with the discussion paper being released in November with responses originally due in January, a time when most businesses slow down and people take holidays, it was determined we would have difficulty in convening a working group. I therefore prepared a response and submitted it personally (see my submission in the “Shared Documents” tab).

The document I prepared contains my views. This blog gives others an opportunity for everybody to comment in a public forum. It allows debate on topics and issues.

The objective of this blog is to foster public discussion about regulation of agricultural and veterinary chemicals in Australia; to bring the issues of concern into the open and to debate ways to address those issues. The ultimate objective is to provide a forum for people, whether members of industry associations or not, to contribute to the debate and help ensure we get a regulatory system that we can live with.

While this is an open forum, there are some rules for participation:

• Anybody can read the posts and comments. However, this is a forum for exchange of information and debate. The views expressed are not necessarily those of N&F Pty Ltd. N&F Pty Ltd does not and cannot warrant the accuracy of any statements, views or comments expressed on this site. Before relying upon any statements, advice or suggestions, you should check the accuracy/relevance/applicability of such statements, advice or suggestions to your specific situation.
• To leave comments, you need to register. We require some personal details to reduce the possibility of comments being inappropriately generated. The personal details will not be shared or sold. They will not be disclosed to APVMA or any other third party. Your comments will appear under the pseudonym you choose during registration.
• All comments will be moderated before they are made public. Comments that are defamatory, obscene or contain commercial messages will be edited or deleted. Comments should not perpetuate rumours about APVMA, any company, organisation or individual.
• Similarly, mass postings, including where a large number of people attempt to post the same comment, will be edited. We will publish the first comment and state that a large number of similar comments were received.

I hope this blog will be useful. The only way for it to achieve its objectives is for people to comment – whether you agree or disagree. I invite you to raise issues not raised by others, to give examples, to provide suggestions and comments. If preferred, feel free to contact me (Mike Tichon) at:

Telephone (office): +61 (0)2 8861 5000
Telephone (mobile): +61 (0)422 300 747
Email: mike.tichon@competitive-advantage.com.au

The regulatory system that controls agricultural and veterinary chemicals in Australia is dysfunctional. Registration of new products takes too long, registration of new products costs too much, data requirements are excessive and the approach to regulation is overly conservative. Changes to the regulation of agricultural and veterinary chemicals have now been proposed by the Government. However, caution is required in implementing some of the proposals. We need to ensure that useful products are not lost because re-registration is too expensive. We need to ensure that products available for use in other countries are not prevented from being available because of an overly expensive and overly conservative regulatory system.

In November 2010 the Minister of Agriculture, Fisheries and Forestry, Senator the Hon. Joe Ludwig released a discussion paper titled “Better Regulation of Agricultural and Veterinary Chemicals”.  In his forward, the Minister stated, “The Australian Government recognises the system is not working as effectively as it should and is looking at options for reform, to better protect human health and the environment; and increase the authority’s efficiency and effectiveness”.

What is proposed in this document and will the proposed reforms improve the regulation of agricultural and veterinary chemcials?

1.      Implementing a risk framework for agricultural and veterinary chemicals.  The Agricultural and Veterinary Chemicals Code Act 1994 requires APVMA to register a product unless APVMA is not satisfied the product will not pose an undue hazard to people, animals, the environment and trade.  What is an “undue hazard”?  APVMA’s approach to this questions is to publish a long list of information in its guidelines and require applicants address everything on that list, whether relevant to the specific application or not.  By asking for unnecessary information APVMA not only delays registration but frequently imposes significant additional costs.  The regulated community needs to understand the risks APVMA is concerned about, propose how to mitigate those risks and, when mitigation proposals are accepted, be required to implement and maintain those mitigation measures — not show they can generate all the information, whether relevant or not, listed in the APVMA website.

2.      Improving the quality and efficiency of assessments and registration. I have argued for a long time that Screening of applications is a complex, registration delaying process.  The Australasian Compliance Institute met with the then Minister of Finance Lindsay Tanner and outlined a number of problems.  Screening was one issue, giving the example of an application submitted to APVMA which, at the time of the meeting, was still in Screening.  The same product took a few weeks to clear Screening when submitted to the US EPA.  There are stories of applications for which the Evaluation timeframe stated in the Regulations was 3 months taking significantly longer to complete Screening.  Why?  These same products are registered in other countries.   Is the regulator more concerned with process or outcomes?

3.      Using overseas assessments to their full extent. Australia, with 2-3% of the global market for agricultural chemicals, is a small market.  We cannot afford to have a regulatory system that considers the regulatory process in other advanced countries incompetent.  These regulatory authorities that apparently do not do an adequate job in assessing products are the same ones that have completed reviews of chemicals and found some products to be no longer suitable for use.  Eventually — after media pressure — APVMA concludes that the regulatory decisions by these same overseas regulators were correct and bans were appropriate, as in the case of endosulfan. Are the decisions being made by the media, by overseas regulators or APVMA? If APVMA is coming to the same scientific conclusions as the overseas regulators why is it necessary for APVMA, before granting registration in Australia, to re-assess all the data assessed by overseas regulators, to charge fees and to delay commercialisation of products?  I have proposed that:

a.      APVMA only assess those data that relate to aspects unique to Australia, e.g. environmental considerations.

b.      APVMA accept overseas regulatory decisions for those aspects not unique to Australia.

c.      To protect proprietary rights to data, APVMA require applicants to submit all data.  If the full dataset, as used by overseas regulators cannot be provided, the applicant should not be allowed to rely on an overseas regulator’s decision.

d.      Providing the full dataset also allows APVMA to review relevant aspects of the data and, where necessary, engage in informed discussion with overseas regulators.

e.      If a product is registered overseas for similar uses to those proposed in Australia, allow expedited registration with the registrant being required to submit additional required information, including efficacy data, in accordance with a timeline agreed between APVMA and the registrant.

There are additional changes related to operations that I will discuss in the next blog. In the interim, what do you think:

1.      Do we need an improved regulatory system for agricultural and veterinary chemicals in Australia?

2.      How does the current regulatory system affect you decisions with regard to introducing new products into Australia?  Why?

3.      Do you agree or disagree with our proposals for use of overseas regulatory decisions?