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Reaction to new PMRA guidelines for unlabelled tank mixes

The move by the Pest Management Regulatory Agency (PMRA) to allow the use of unlabelled tank mixes of pest control products for crop production or vegetation has been met with mostly favourable reviews. Crop protection industry insiders say the new guidelines should give farmers greater flexibility and quicker access to the mixes supported by the manufacturers.

In October 2009, the PMRA clarified its position on the use of unlabelled tank mixes under certain conditions. A key condition limits the tank mixes that fall within the registered use pattern for each tank- mix partner. This limitation means that products have to be registered on the crop, and must be used in accordance with the label recommendations.

Wayne Barton, BASF market manager of fungicides, says the PMRA’s decision is a positive step for the manufacturers and farmers. “It doesn’t mean that you recommend anything and that there are no more rules,” explains Barton. “It means the manufacturers can now recommend tank mixes that they can support in the marketplace and they don’t have to wait for a PMRA review of those mixtures.”

He says the companies put a great deal of effort into evaluating the performance and safety of their products before submitting them for review. But he notes that the waiting period for a decision can be lengthy, with reviews taking as long as six to 14 months. With the PMRA’s move, Barton says the manufacturers can publish their recommendations of tank mixes as soon the information is available. “Again, these are all products that are registered in those crops and for those uses. We’re just putting them together in combinations of value and needs in the market.”

Mike Cowbrough, field crops weed specialist with the Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA), agrees that reducing the regulatory waiting period is a positive step. He says the result should give farmers more options for management decisions, particularly in trying to control difficult weeds. “I think now it provides a lot of flexibility for people to use a tank mix when it makes sense to address a weakness, without having to worry about whether it’s registered or not,” says Cowbrough.

Dave Latter, a regulatory consultant based in Toronto, says the PMRA decision should also clear up a lot of the “grey area” for farmers who have been mixing registered tank-mix partners already, even though the combination was not labelled. “And when new generic products come on the market, it makes it a lot easier for farmers to tank mix them, without having to wait for the label to catch up with all the tank mixes that might be on the original product,” says Latter.

Less government involvement, yet the potential for more liability
Besides making things easier for farmers, Latter says the new guidelines should reduce some of the regulatory burden of the PMRA, allowing the agency to focus more of its attention on other types of product approvals.

His view is shared by Barton, who hopes the PMRA can shift its resources from reviewing tank mixes to other  areas such as new crops and technologies. He cautions that such a development remains to be seen. “We’re hopeful that they will achieve some efficiency at their end that will see a streamlined regulatory process and growers will get access to new technology quicker. That’s a big question, but I think if you can make the regulatory process focus on what’s most important, then I think that is a good thing,” says Barton.

Although the new guidelines bring some significant advantages for farmers, they are also causing some significant concerns, especially in the area of liability. According to the PMRA’s memo, anyone who recommends or applies an unlabelled tank mix does so at their own risk and liability because it has not been reviewed by the agency.

John Waterer, Canadian agronomy manager for Cargill AgHorizons, says liability has been shifted from the manufacturers to retailers, agronomists and/or farmers. “If the tank mix was registered, the manufacturers clearly had the liability. Now they don’t, so long as the two products are registered. If an agronomist recommends an unlabelled tank mix, the agronomist is essentially liable now,” says Waterer.

Given the potential for expensive liability claims, Waterer says Cargill spent a significant amount of time making a list of not only tank mixes the manufacturers would support, but also the ones the company would not be comfortable recommending. “If the manufacturer is not willing to support it, we will not recommend it because it’s simply not in the farmer’s best interest to take on that much risk,” says Waterer.

Need for open communications increasing
In this landscape of shifting liability, the best advice for farmers about using unlabelled tank mixes is to make sure the manufacturers support them. Brian Wintonyk, cereal crop specialist for Dow AgroSciences, says his company has developed a list of products that can be safely tank-mixed together as unlabelled mixes. “We are trying to be as transparent as possible with retail and grower customers and let them know what a good combination is, and also the situation where they may be looking at a tank-mix combination that we feel is not the best mixture or concept,” says Wintonyk. “We do have a published list of unregistered mixes that we will support based on tests conducted, but there are other mixtures that we do not support with no basis of tests, and if we do not support a mixture, we will alert growers and advise them of potential risks to ensure they make an informed decision.”

Barton concurs, saying BASF has taken careful steps to ensure its recommendations are science-based and are easily understood. “The last thing we want is somebody to use our product and not have a great experience with it.”

Waterer agrees that the major manufacturers have come forward with the information.

Although he says the quality of the information has been good, farmers and others will still have to perform some due diligence. “From an overall perspective, the information growers need to know is not easily available. They really need to check with their agronomist to make sure that the mix is safe and supported by the manufacturer. Otherwise, in today’s farm economy, I don’t think a farmer can afford to take that risk on himself,” says Waterer.

With a premium placed on information, communication with growers is going to take on increased importance in the years to come.

Waterer says now that the PMRA has taken a step back on unlabelled tank mixes, manufacturers may be less inclined to spend the same amount of resources on future tank mixes.

“The fact that the manufacturer doesn’t really have to stand behind it any longer is going to limit the tank mixes that they are going to research or register. So that information that is going to be available, long term, might actually decrease because they are not going to be forced to do the tank-mix research any longer,” says Waterer.

Latter does not see any great concerns going forward. He expects the good interaction between the manufacturers, the dealers and the farmers will continue. “I think everybody has done their homework. We have lots of experiences with these things and it’s working well.”

As a means to ensure that growers will have access to information, Cowbrough says the Ontario Weed Committee is forming a sub-committee to study the issue to ensure that best practices for tank mixing will be communicated. “It’s basically to examine what type of information is critical to minimize any risk,” says Cowbrough. “I think what we need to do is get everyone on the page and explain why it is a good idea to mix some products and why it is not a good idea to mix others.”

Cowbrough will chair the committee, which will include various industry stakeholders.

While the new group prepares to give farmers and agronomists the key information about unlabelled tank mixes in the future, growers should be aware of the PMRA’s six conditions:

1. Each tank-mix partner is registered for use in Canada on the crop of interest, including genetically modified crops.
2. The tank mix only includes an adjuvant when specifically required by one of the tank-mix partner labels. If an adjuvant is not required on the label of any tank-mix partner, then no adjuvant may be added to the tank mix.
3. The application timings of all tank-mix partners are compatible with regards to crop and pest staging.
4. Each tank-mix partner is applied in accordance with its registered product label (for example, Directions for Use, Precautions, Buffer Zones, etc.). In cases where information on the tank-mix  partner labels differs between them, the most restrictive directions must be followed.
5. The tank mix is not specifically excluded or contraindicated on either tank-mix partner label.
6. The use of the tank mix provides additional value to the user (for example, increased scope of pests controlled, contributes to resistance management or integrated pest management, cost or time savings).