North American Governments Facilitate Access to Better Crop Protection Tools

I was fortunate to be able to attend the Biopesticide Registration Improvement Course (BRIC) held 13-15 April 2011 at the US EPA headquarters in Arlington Virginia, USA.

Representatives from US EPA, Canada’s Pest Management Regulatory Agency as well as industry representatives from all NAFTA countries were present.

Full marks to the organisers who pulled together an excellent meeting.

An important point from the meeting was the way the US and Canadian Governments are promoting reduced risk products.  The regulators work with industries to facilitate availability of reduced risk products.

  1. The IR-4 program (http://ir4.rutgers.edu/) provides funds for development of selected prducts.  Furthermore, registration applications submitted by IR-4 are exempt from payment of registration fees to US EPA.
  2. The Canadian Government Pesticide Risk Reduction Program, a joint initiative of Agriculture and Agri-Food Canada and Health Canada’s Pest Management Regulatory Agency (PMRA), works to reduce the risks from pesticides used in the agriculture and the agri-food industry in Canada (http://www4.agr.gc.ca/AAFC-AAC/display-afficher.do?id=1288277891464&lang=eng).
  3. The Canadian Pest Management Centre works to improve access to low-risk, environmentally sustainable and economically competitive pest control tools and practices, including biopesticides  (http://www4.agr.gc.ca/AAFC-AAC/display-afficher.do?id=1288727518132&lang=eng).  Besides providing advice, The Pest Management Centre funds development projects.  It works closely with registrants, PMRA and growers to develop high quality submissions.
  4. Both IR-4 and the Canadian Pest Management Centre work closely with the regulatory authorities in their respective countries.

We can compare this with Australia:

  1. There is no support for registration of niche, reduced risk or other products.
  2. HAL, which attempts to cater to the minor use needs of the horticulture industry runs a program to obtain minor use permits – not registrations.  Only already registered products can be given permits and HAL needs to pay for the permits.

A way to reduce cost of commercialising niche products needs to found.  Options might be:

  1. Reduced data requirements where products have a track record of safe use elsewhere or have been evaluated by another acceptable regulator.
  2. Allow confirmatory efficacy data to be obtained during early commercialising rather than prior to submission for registration.
  3. Greater acceptance of overseas data to support registration in Australia.
  4. Reduced fees for such niche products.

The Australian Government must recognise that Australian agriculture needs access to modern tools.  The world is demanding foods be treated with lowest risk pesticides.  Unless the Government introduces measures that facilitate the registration of low risk, niche products, Australian growers will be excluded from international markets.

APVMA Operational Plan based on meaningless objectives

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.

Why this blog?

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