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.
Is it true that the new APVMA guidelines will require new regisatrations to provide data on toxicity and environmental risks or every tank mix nominated on the label?
Not exactly; the guidelines state that “Toxicity of the mixture must also be addressed in the case of deliberate tank mixes where the label instructs that for general, or for a particular use, the product and its active(s) must always be mixed with another different active constituent contained in existing products.” It does not specify HOW the toxicity must be addressed.
In a recent deficiency letter from screening, we were classed as deficient in this area and we have to “address” the toxicity of our proposed tank-mixes, but we were not specifically asked for studies, so I’m assuming we can attempt to address the tank-mix toxicity by argument. However we were also asked to supply data specifically to address the combination toxicity of our new formulation to terrestrial plants.
History has shown us that combinations of different actives are rarely so synegistic ecotoxicologically that they will require significant changes cf. the “worst offender” in the mix, so conducting a suite of studies on tank-mix combinations or even combi formulations is a waste of money (in my view). There is a need to develop a “trigger” that stimulates the need for argument or studies, rather than the catch-all statement of “must be addressed”.
On (3), I can understand that a company who was sold data first (call them Company A) would be concerned about a company who later bought the data (Company B). Company B would have a lesser data protection period than company A as A registered the active first. Once B’s protection expired, A could be affected.
But what I don’t understand is why this needs to be a serious problem – the price paid for the data by company A should reflect the exclusivity (or otherwise) of the data to them. They shouldn’t expect to pay the same price for data that is of greater or lesser value to them than to subsequent purchasers.
The company selling the data can’t expect to be able to achieve the same price for selling a non-exclusive product, just as Company A can’t expect to pay the same price for data for which they would gain a longer protection period, as Anthony suggests.
Dear tortfeaser what you say makes perfect sense and addresses the commercial issues. What doesn’t make sense is the difficulty that the APVMA has with normal non-exclusive sales of data. Their options seem to be: (i) second purchasing party gets no protection or (ii) second purchasing party must get approval from the first purchasing party to access their protected data.
Obviously its an anomaly that can (and is being) solved by the reviewers using a common sense approach.
Some of the biggest problem that must be addressed are:
(1) the long delays in commencing assessments followed by a request for additional data many months after application. If this data needs field trials then the applicant will miss sales another season – often a desperate problem for the applicant,
(2) the reviewers’ requirements are constantly changing. If we resubmit a validated analytical method that passed without question 3 years ago we can generally expect questions,
(3) serious problems with data protection when a company sells data it ownes to two seperate companies who then use it in their independent applications,
(4) the problems of a serial assessment approach, i.e. data is sent for an OH&S review for a few months before it is sent off to the next reviewer. This should all be done concurrently,
(5) the regularity in which a deficiency which “stops the clock” is only found close to the APVMA deadline and,
(6) the request for analytical data that is not in the guidelines. This is especially a problem with applications that have been in the APVMA pipeline for so long that the interpretation of the guidlines has unofficially moved over time.