To assist USDA’s Animal and Plant Health Inspection Service (APHIS) – Biotechnology Regulatory Services (BRS) scientists in evaluating the plant pest properties of microorganisms under consideration for commercialization as biocontrol organisms, biopesticides, biofertilizers, or bio-stimulants.
To lessen concerns about environmental problems associated with the use of conventional agrochemicals, there is increasing interest in using microorganisms to protect plants from disease, stimulate growth, and aid plants in the absorption of water and nutrients. In some cases, genetic engineering is used to improve a microorganism’s ability to perform those functions. BRS provides oversight of genetically modified organisms that pose plant pest risks. A stakeholder who develops a genetically modified microorganism and wants to release it into the environment must seek authorization from BRS. BRS gathers information about microorganisms to assess whether that organism is subject to USDA regulation and if so, what are the appropriate conditions for release.
A genetically modified microorganism may be regulated by BRS if the organism: is classified taxonomically as a plant pest; contains DNA from a plant pest that can produce a plant pest or cause plant disease; or will be used to control a plant pest (Shams et al., 2024) and poses a plant pest risk. To address these criteria there is a need to gather information on the biological properties of candidate microorganisms to evaluate their plant pest potential.
Ayilara, M,S., B.S. Adeleke, S.A. Akinola Fayose CA, Adeyemi UT, Gbadegesin LA, Omole RK, Johnson RM, Uthman QO, Babalola OO. 2023. Biopesticides as promising alternatives to synthetic pesticides: A case for microbial pesticides, phytopesticides and nanobiopesticides. Front Microbiol. 14:1040901. https://doi.org/10.3389%2Ffmicb.2023.1040901.
Boro, M., S. Sannyasi, D. Chettri, and A. K. Verma. 2022. Microorganisms in biological control strategies to manage microbial plant pathogens: a review. Arch Microbiol 204, 666 (2022). https://doi.org/10.1007/s00203-022-03279-w.
Fox. A.R., G.C. Soto, C Valerde and Daniela Russo. 2016. Major cereal crops benefit from biological nitrogen fixation when inoculated with the nitrogen-fixing bacterium Pseudomonas protegens Pf-3 X940. Environmental Microbiology 18:3522-3534. https://doi.org/10.1111/1462-2920.13376.
Jardin, P.D. 2015. Plant biostimulants: Definition, concept, main categories and regulation. Sci. Hortic. 196(30): 3-14. https://doi.org/10.1016/j.scienta.2015.09.021.
Kremer, R.J. 2005. The role of bioherbicides in weed management. Biopestic. Int. 1(3,4): 127-141.
Shams, A., A Fischer, A. Bodnar and M. Kliegman. 2024. Perspectives on genetically engineered microorganisms and their regulation in the United Sates. ACS Synth. Biol. 13:1412–1423. https://doi.org/10.1021/acssynbio.4c00048.
Biocontrol organisms are natural or modified organisms that antagonize undesirable disease-causing pests and organisms while often promoting the growth of beneficial insects and microorganisms.
Biopesticides are those derived from natural materials. There are three major classes of biopesticides. Biochemical pesticides use natural occurring substances derived from plants, animals, microorganisms, and specific minerals. Microbial pesticides employ the use of microorganisms to produce substances that kill pests. The third class of biopesticides are those where genetic material, usually originating from a microorganism, is incorporated into a plant to induce the plant to produce a substance that kills a pest. Biopesticides within this class are referred to as Plant-Incorporated Protectants (PIPs).
Biofertilizers are substances that contain microorganisms which when added to soil or inert material increase its fertility and promote plant growth.
A plant biostimulant is any substance or microorganism applied to plants with the aim to enhance: uptake of nutrients, abiotic stress tolerance, and/or crop quality traits, regardless of its nutrient content (Jardin, 2015).
