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U.S. regulatory approval predictable for biologicals

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If you supply all the documents and answer all questions through the review process, you can be almost guaranteed you will have that registration in 18 months.

Because of the characteristics of biological pesticides, new products are almost always guaranteed to receive regulatory approval in the United States within 18 months as long as all of the data and studies are provided, according to Paula Marcon, chief technology officer of AgBiTech.

“One good thing about the U.S. is it is very predictable, very organized, compared to other countries. U.S. regulators give an 18-month timeline for review, and if you supply all the documents and answer all their questions through the review process, you can be almost guaranteed you will have that registration in 18 months,” Marcon said in an interview with Southeast Farm Press.

Marcon says it’s a different story in Europe where regulatory approval can take up to six years, while in Brazil, regulatory approval tends to be faster than the United States.

AgBiTech is a Fort Worth-based crop protection company that manufactures biological insect management products.

Marcon said biological baculovirus-based insecticides are classified as a biochemical by the EPA, and there are waivers on some of the toxicological studies and requirements, but the regulatory timeline is the same as for chemical pesticides. She notes that baculovirus-based insecticides are recognized as a safe and natural insecticide and that EPA just wants to make sure that companies have a solid manufacturing process and that the formulations are safe in every batch.

As a biological insecticide used to control worms, baculovirus-based insecticides are sprayed in the same rate and same manner as chemical insecticides.

“From that perspective, a grower doesn’t need to change his or her operation. The real change is understanding that you don’t want to wait until you have an acute problem to react. You need to react in an earlier stage, and you have to be more watchful,” Marcon said.

Marcon said baculovirus-based insecticides work mainly on the larval stages and are much more effective when the tiny caterpillars are coming out of the eggs. The challenge is that growers often wait until caterpillars are very large to make an application and the product works much slower and by then the caterpillars are causing a lot of damage and eating a lot more leaves.

Timeliness is critical, she emphasizes.

“These are the challenges. You need an understanding of the characteristics, the attributes, and the benefits of this new technology and how do you incorporate it into production systems,” she said.

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