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Global registration process means quicker access to new products

The global review process has been made possible by the spirit of co-operation between participating countries and their registration authorities.

Craig Hunter has spent the past 30 years working within the world of pesticide registration. Seldom has he seen a more important advancement for Canadian growers than what happened last year.

Years of research culminated in the registration of a new insecticide in numerous countries in 2008. For the first time, Canada, the United States, the European Union and Australia worked together to register a product for use on numerous crops, simultaneously.

Hunter is an expert advisor on pesticides to the Ontario Fruit and Vegetable Growers Association. He also has served as an advisor on such issues to the Canadian Horticultural Council.

The registration of DuPont Coragen, with the active ingredient rynaxypyr, is important for growers and would likely not have happened nearly as quickly without some innovative thinking by the company and government. “Growers get the advantage of a new product,” says Hunter. “A new mode of action like this also helps for resistance management of pests.”

Coragen is the first product in a new chemical class with a new mode of action, Group 28, anthranilic diamide. It is registered for control of Colorado potato beetle and European corn borer in potatoes and has a different mode of action than other insecticides. It also received an emergency registration for the control of corn earworm in sweet corn in 2008. Hunter notes that DuPont did take a considerable risk by being the first company to pursue a global registration. “The risk was that by sending the registration package out to numerous countries at once, if only one of them was slow in turning it around it would have affected everyone,” says Hunter. “They had a good package and good co-operation from government.”

Typically, companies submit comprehensive registration packages to the appropriate government agency in each country in which they want to sell a product. The United States has the Environmental Protection Agency. Canada has the Pest Management Regulatory Agency.

 In this case, DuPont broke new ground: each country’s government organization had a lead role in particular areas of the review. This resulted in a much more efficient process for the agencies. It is true that in the past, some companies have chosen to send a product for review in both Canada and the US simultaneously. But this was the first time that such a broad representation of countries was involved.

It is very expensive to get a product registered. A registration package includes information on toxicology, residue, efficacy and other relevant data.

Sometimes companies make the decision that the acreage of crop within a country cannot sustain the expense of registration. As Hunter says, if it is going to cost $300,000 to register a fungicide for use on a crop and the total revenue expected to be made from that product is $100,000 a year, it will take a long time to repay the expense of registering it. “By doing the registration for each country at the same time and sharing the resources globally, costs are spread around,” says Hunter.

The main players were the PMRA, EPA, Australia, and the government organizations from Ireland and the UK, which represented the European Union. They essentially shared the work, with each agency taking the lead on a different part of the registration package, and then reviewing each other’s findings. The PMRA was the lead reviewer on efficacy and product chemistry. “We submitted a complete data package to each country,” says Adam Vaughan, product registration manager at DuPont. “Everything that Australia got, Canada got. There are large parts of the package that are common to all countries.”

The scientists poring over the data in the different countries were satisfied because they were getting more data, not less, yet the massive job of reviewing all the data was shared between the different countries. “This process greatly improved the registration timeline,” says Vaughan. “From start to finish it was 15 months, which was really fast. It allows everyone to work more co-operatively and to make more consistent decisions. You end up with the same or similar decisions being made in all these countries.”

That means growers are getting equal access to technologies at the same time. Instead of farmers in one country looking longingly over the border at the latest products being used by their neighbours, growers in the participating countries were placed on a level playing field.

Also extremely important, it was one of the first times that minor use registrations were included in the initial submission. That is because what may be a minor crop in Canada might be a major crop when the market in numerous countries is taken into account.

This process also has changed the way DuPont does business. “We are trying to apply a much broader vision to research and development to make sure crops on the US label will be on our label too,” says Vaughan. “There is a lot more international co-operation within our company. It’s been a total shift for our company from looking at individual countries to the whole globe and making sure we have equal access to products for growers in all the countries.”

It is easy to see how this will mean more products coming to market and being registered at a quicker pace for Canadian growers. But a global review process also has advantages for trade. “By sharing the review of the information, we can ensure there are maximum residue limits in many important export countries, at the same time as getting the registration in Canada,” says Vaughan. “When these residue limits are set in a consistent way amongst the different countries, it ensures that residue limits are not a barrier to international trade.”

It was a lot of work, and perhaps carried some risk that things would get bogged down in bureaucracy, slowing down the commercialization of the product. But Hunter says it has positioned DuPont well for the future. “My understanding is that when at all possible this will be the approach they will be using in the future,“ says Hunter. “Sometimes when you’re the first to take the biggest risk you get the biggest rewards.”

“Now we know how to work internationally,” says Vaughan. “We can work with regulatory bodies to get new active ingredients approved more quickly and across international borders, which is good news for growers. We take our hats off to the PMRA and other agencies involved for taking this next step towards greater global co-operation.”