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?