Today’s Regulatory Framework Doesn’t Work for Biologicals

- Molly Cadle-Davidson

When it comes to agriculture, innovation and the regulatory arena, there’s no shortage of concerns. Most everyone recognizes that the U.S. regulatory system needs to be updated; however, how it is updated and the definitions associated with certain products and methods are up for debate.

One area that concerns me is how and to what degree biologicals are regulated. Should a biological be treated the same way as a manmade chemical? For instance, if you make a disease control claim, the product is automatically regulated by the Environmental Protection Agency (EPA), regardless of whether it’s a chemical or biological. Generally speaking, chemicals are synthetic. The problem with this approach is that crop protectants fall somewhere on a continuum — it’s not black and white.

There is a whole spectrum of agents that can be used to control Pythium, from metalaxyl to biologicals. Metalaxyl doesn’t exist in nature and is purely manmade. There are effective control chemicals extracted from nature, and chemicals, such as salicylic acid (aspirin), that are found in nature but produced synthetically. Functional control agents can be produced by and extracted from living organisms or the organisms themselves (biologicals) can be used. All of these methods can be used to control Pythium, and they are all regulated in the same manner.

As you can see, there’s a great deal of variation along the continuum, and just because something is found in nature doesn’t necessarily mean it’s good — LSD and many other toxins, neurotoxins, allergens, and poisons are found in nature. Because of this continuum and because we can’t say that all biologicals are safe, there’s a lot of pull on both sides of the spectrum when it comes to regulating them.

EPA has placed biological products into a reduced risk category that is designed to be different from standard chemistry. That said, a lot of the required data are the same. So, while biologicals registrations are touted as more straightforward, nothing is a foregone conclusion when a package is submitted to EPA. Uncertainties in the process can trigger classification of what should be a safe organism (according to the scientific literature) into something requiring significantly more time, money and data.

I’m in favor of updating the regulatory system, and we as an industry need to work together and with the government to provide guidance, expertise, and feedback throughout the process. At the same time, we need real-world researchers and people who understand science and agriculture, and all its complexities, in government and helping to

set the foundation for an updated regulatory framework. There are a lot of revenues to be earned from products of this type and we need to be certain that, as an industry, our conflict of interest in how we are regulated does not outweigh honest application of scientific results. There are a number of associations working on this front; I encourage you to get involved, provide feedback and your expertise and help to get a framework in place that can take us into the future and support the goal of increasing production while using fewer resources for a growing global population.