Understanding fungicide registration

I often speak with lawn and landscape professionals who want to know when that new fungicide they’ve heard about will be available. Turf and ornamental professionals are also curious why their industry peers in different states can access a fungicide that’s not available in their own market.

So why does it seem fungicides take a long time to reach the market, or never become available at all? All new pesticides must undergo many tests and trials to prove they’re safe for the environment and won’t harm people or animals.

So what takes so long? The federal government heavily regulates pesticide use, which requires manufacturers to provide extensive data before a new fungicide product can be approved for the market. Because of this, a new active ingredient takes, on average, 10 years to reach end users.

With only a limited number of basic manufacturers investing in new fungicide, herbicide and insecticide modes-of-action, turf and ornamental professionals are seeing less new chemistry.

A recent CropLife America study found that bringing a new product to market reached an average of $256 million per product in 2005-2008 and the number of products actually making it through the research and development stages to market introduction declined from four in 1995 to only 1.3 in 2005-2008.

Before the U.S. Environmental Protection Agency (EPA) can register a fungicide, it mandates that manufacturers verify the fungicide won’t hurt you or the environment when used according to the label. To prove this, the product undergoes as many as 120 tests which include:  

• Human toxicology studies assure users the fungicide doesn’t harm humans. Researchers look for any short-term effects, such as what happens if the fungicide is inhaled or comes in contact with the skin. Researchers also look for any long-term health effects, such as reproductive or hormonal disruptions. These tests are very similar to those conducted by pharmaceutical companies.
• Eco-toxicology tests study the effects on wildlife. Researchers determine if the fungicide affects birds, fish and other aquatic animals. Compounds are also tested to ensure non-targeted plants and insects aren’t affected.
• Formulation optimization tests analyze the best way to package the product based on its chemical makeup. For example, researchers may determine the product is best used as a liquid versus a granular. These tests also determine the best method for applying the product.
• Turf transferable residue studies showcase how fungicide residues may be transferred, such as on shoes, mowers or maintenance equipment, from treated turf to other surfaces.
• Biology efficacy trials determine how well the product works for its intended purpose. Although this data isn’t submitted as part of the federal registration package, it must be available if the EPA requests to review. Of course, this information often becomes apparent once people begin using the product – if it doesn’t work, it won’t sell.

All trials are designed to determine how, when and where it’s appropriate to use the fungicide. For example, if the product is shown to cause skin irritation in laboratory tests, labeling on the product will require applicators to wear protective equipment, such as gloves or long sleeves. Or pre-registration research may determine that a product has the potential for leaching in certain soil types – that’s why the label will say, for example, it’s okay to use on turf but not on sand.
These rigorous studies can take up to six years to complete. Once all the necessary data is ready, the manufacturer submits it to the EPA for review.

EPA Approval. During registration review, the EPA thoroughly evaluates all the results. The EPA can take up to 21 months to review a fungicide for turf or ornamental use. If manufacturers are seeking additional use sites on the label, the review time will increase. If the EPA agrees with the manufacturer’s findings, the EPA registers the fungicide and the manufacturer receives an approved label. The label details exactly how to use the product to achieve the best results, so those coming in contact with a treated area and the environment aren’t harmed in the process. This is why manufacturers stress that you must carefully read and always follow label instructions.

But the approval process doesn’t end there. Once a manufacturer receives federal EPA approval, each state reviews the fungicide. The state registration process typically takes four to six weeks to complete.

However, some states, such as New York and Massachusetts, can take up to 15 months to review the pesticide. California also generally takes longer to gain local product registration because products must pass the California Department of Pesticide Regulation’s individual tests that meet their unique state requirements. In addition, products don’t always pass individual state registration because of local laws. That’s why you sometimes see an industry peer in another state with access to a fungicide that is unavailable to you.

After many years of review, the product is finally ready to reach distributors’ shelves, and ultimately lawn and landscape professionals.
 
The author is a technical specialist for BASF Professional Turf & Ornamentals and licensed state of California pest control advisor and qualified applicator, based in Visalia, Calif.