Microbial pest control agents: Regulatory perspectives of product identity and characterization in the EU and US

Microbial pest control agents or MPCAs are the active ingredients that drive the efficacy of biologically derived pesticides. Although they are regulated differently in both the United States and Europe, a commonality that they share is the necessity to correctly identify the microorganisms that make up these MPCAs; this forms a critical part of the evaluation of the pesticidal formulation. A specific microorganism can have multiple strains, so understanding and identifying it correctly helps to determine the organisms’ effect on both humans and the environment.

This paper examines how MPCAs are identified and characterized in both the United States and Europe.

What is an MPCA?

Biologically derived pesticides or “biopesticides” are typically naturally occurring and often specific to the target species, with unique and less toxic modes of action as compared to conventional pesticides. The active ingredients (AI) of the biopesticides referred to as microbial pest control agents (MPCAs) include (but are not limited to) bacteria, algae, fungi, viruses, and protozoa, both naturally occurring and those improved by genetic manipulation or natural selection. Examples of commonly used biopesticides in the agricultural sector include biofungicides (Trichoderma, Pseudomonas, Bacillus), bioherbicides (Phytophthora), and bioinsecticides (Bacillus thuringiensis or “Bt”).

How are they regulated?

In the United States, the Biopesticides and Pollution Prevention Division (BPPD) in the Office of Pesticide Programs (OPP) at the Environmental Protection Agency (EPA or Agency) is responsible for the regulation of biopesticides, which includes microbial and biochemical pesticides. The EPA recognizes biopesticides as distinct from conventional chemical pesticides and has developed specific data requirements and testing guidelines for this category of pesticide. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), MPCAs and all other pesticides must be evaluated for their risks and benefits to humans and the environment by the EPA. Testing is required in the areas of product analysis, toxicology, residue analysis on food crops, ecological effects, and environmental expression.