Streamlining Data Requirements for the Environmental Risk Assessment of Genetically Modified (GM) Crops for Cultivation Approvals




environmental risk assessment, genetically modified plant, problem formulation, data requirements, cultivation


Genetically modified (GM) crops have been cultivated safely for more than 25 years, and the framework for conducting an environmental risk assessment (ERA) is well-established. Currently, there is alignment of broadly-stated protection goals across global jurisdictions; however, there is a lack of consistency for the data that are required by regulators. Risk assessors have over 25 years of collective experience assessing the environmental safety of GM crops and have conducted hundreds of ERAs to evaluate GM crop safety. This experience provides a scientific basis to help determine which data informs the ERA, and which data does not inform the safety assessment. The goals of this paper are to: 1) define the process for identifying potential pathways to harm based on robust problem formulation; 2) provide an overview of data that inform the science-based ERA for cultivation approval; 3) provide examples of data that are routinely or occasionally required but do not inform the ERA; and 4) make recommendations for harmonization of global ERA data requirements. Refinement and harmonization of data requirements across global regulatory authorities will add transparency and predictability to the ERA of GM crops globally, while ensuring that each country's protection goals are respected.

doi: 10.21423/jrs-v09i1anderson


Albright, V. C., III., Wong, C. R., Hellmich, R. L., & Coats, J. R. (2017). Dissipation of double‐stranded RNA in aquatic microcosms. Environmental Toxicology and Chemistry, 36(5), 1249-1253.

Alix, A., Bakker, F., Barrett, K., Bruhl, C. A., Coulson, M., Hoy, S., Jansen, J-P., Jepson, P. C., Lewis, G., Neumann, P., Sussenbach, D., & van Vliet, P. J. (2012, January). ESCORT 3: Linking Non-Target Arthropod Testing and Risk Assessment with Protection Goals. CRC SETAC Press.

Anderson, J. A., Gipmans, M., Hurst, S., Layton, R., Nehra, N., Pickett, J., Shah, D. M., Souza, T. L. P. O., & Tripathi, L. (2016). Emerging Agricultural Biotechnologies for Sustainable Agriculture and Food Security. Journal of Agricultural and Food Chemistry, 64(2), 383-393.

Bachman, P. M., Burns, A., Chakravarthy, S., Goodwin, L., Privalle, L., Song, S., Storer, N., & Anderson, J. (2021). Data Transportability for Studies Performed to Support an Environmental Risk Assessment for Genetically Modified (GM) Crops. Journal of Regulatory Science, 9(1), 38-44. doi: XXX

Baker, H. G. (1965). Characteristics and Modes of Origin of Weeds. In H. G. Baker, G. L. Stebbins (Eds.). Genetics of Colonizing Species (p. 147-172). Academic Press.

Baker, H. G. (1974). The Evolution of Weeds. Annual Review of Ecology and Systematics, 5(1), 1-24.

Biotechnology Regulatory Services & Biopesticides and Pollution Prevention Division. (2007). White Paper on Tier-Based Testing for the Effects of Proteinaceous Insecticidal Plant-Incorporated Protectants on Non-Target Arthropods for Regulatory Risk Assessments. United States Department of Agriculture Animal Plant Health Inspection Service, United States Environmental Protection Agency. Retrieved from

Brink, K., Anitha, S. C., Beatty, M. K., Anderson, J. A., Lyon, M., Weaver, J., & Dietrich, N. (2019). Comparison of Southern-by-Sequencing (SbSTM) technology and Southern Blot Analysis for Molecular Characterization of Genetically Modified Crops. Journal of Regulatory Science, 7, 1-14.

Brune, P., Chakravarthy, S., Graser, G., Mathesius, C., McClain, S., Petrick, J. S., Sauve-Ciencewicki, A., Schafer, B., Silvanovich, A., Brink, K., Burgin, K.,Bushey, D., Cheever, M. L., Edrington, T., Fu, H., Habex, V., Herman, R., Islamovic, E., Lipscomb, E. A., Motyka, S., Privalle, L., Ranjan, R., Roper, J., Song, P., Tilton, G., Zhang, J., Waters, S., Ramos, A., Culler, A. H., Hunst, P., Gast, R., Mahadeo, D., & Goodwin, L. (2021). Core and supplementary studies to assess the safety of genetically modified (GM) plants used for food and feed. Journal of Regulatory Science, 9(1), 45-60. doi: XXX

Cade, R., Burgin, K., Schilling, K., Lee, T-J., Ngam, P., Devitt, N., & Fajardo, D. (2018). Evaluation of Whole Genome Sequencing and an Insertion Site Characterization Method for Molecular Characterization of GM Maize. Journal of Regulatory Science, 6(1), 1-14.

Canadian Food Inspection Agency. (1994). The Biology of Zea mays (L.) (Maize). Retrieved from

Clark, B. W., Phillips, T. A., & Coats, J. R. (2005). Environmental Fate and Effects of Bacillus thuringiensis (Bt) Proteins from Transgenic Crops: a Review. Journal of Agricultural and Food Chemistry, 53(12), 4643-4653.

Codex Alimentarius Commission. (2009). Foods derived from modern biotechnology, Second edition. Food and Agriculture Organization of the United Nations and World Health Organization, Rome. Retrieved from

Cong, B., Maxwell, C., Luck, S., Vespestad, D., Richard, K., Mickelson, J., & Zhong, C. (2015). Genotypic and Environmental Impact on Natural Variation of Nutrient Composition in 50 Non Genetically Modified Commercial Maize Hybrids in North America. Journal of Agricultural and Food Chemistry, 63(22), 5321-5334.

CropLife International. (2017). Plant Biotechnology Pipeline. Retrieved from

CropLife International. (n.d.). Agricultural Innovation. Retrieved from

de Vries, J., & Wackernagel, W. (2005). Microbial horizontal gene transfer and the DNA release from transgenic crop plants. Plant and Soil, 266(1), 91-104.

Delaney, B., Astwood, J. D., Cunny, H., Conn, R. E., Herouet-Guicheney, C., MacIntosh, S., Meyer, L. S., Privalle, L., Gao, Y., Mattsson, J., & Levine, M. (2008). Evaluation of protein safety in the context of agricultural biotechnology. Food and Chemical Toxicology, 46(Suppl 2), S71-S97.

Devos, Y., Romeis, J., Luttik, R., Maggiore, A., Perry, J. N., Schoonjans, R., Streissl, F., Tarazona, J. V., & Brock, T. C. M. (2015). Optimising environmental risk assessments: Accounting for ecosystem services helps to translate broad policy protection goals into specific operational ones for environmental risk assessments. EMBO Reports, 16(9), 1060-1063.

Dubelman, S., Fischer, J., Zapata, F., Huizinga, K., Jiang, C., Uffman, J., Levine, S., & Carson, D. (2014). Environmental Fate of Double-Stranded RNA in Agricultural Soils. PLoS One, 9(3), e93155.

EFSA Panel on Genetically Modified Organisms. (2011). Guidance for risk assessment of food and feed from genetically modified plants. EFSA Journal, 9(5).

Fischer, J. R., Zapata, F., Dubelman, S., Mueller, G. M., Jensen, P. D., & Levine, S. L. (2016). Characterizing a novel and sensitive method to measure dsRNA in soil. Chemosphere, 161, 319-324.

Fischer, J. R., Zapata, F., Dubelman, S., Mueller, G. M., Uffman, J. P., Jiang, C., Jensen, P. D., & Levine, S. L. (2017). Aquatic fate of a double‐stranded RNA in a sediment-water system following an over-water application. Environmental Toxicology and Chemistry, 36(3), 727-734.

Garcia-Alonso, M., & Raybould, A. (2014). Protection goals in environmental risk assessment: a practical approach. Transgenic Research, 23(6), 945-956.

Glenn, K. C., Alsop, B., Bell, E., Goley, M., Jenkinson, J., Liu, B., Martin, C., Parrott, W., Souder, C., Sparks, O., Urquhart, W., Ward, J. M., & Vicini, J. L. (2017). Bringing New Plant Varieties to Market: Plant Breeding and Selection Practices Advance Beneficial Characteristics while Minimizing Unintended Changes. Crop Science, 57(6), 2906-2921.

Guttikonda, S. K., Marri, P., Mammadov, J., Ye, L., Soe, K., Richey, K., Cruse, J., Zhuang, M., Gao, Z., Evans, C., Rounsley, S., & Kumpatla, S. P. (2016). Molecular Characterization of Transgenic Events Using Next Generation Sequencing Approach. PLoS One, 11(2), e0149515.

Herman, R. A., Wolt, J. D., & Halliday, W. R. (2002). Rapid degradation of the Cry1F insecticidal crystal protein in soil. Journal of Agricultural and Food Chemistry, 50(24), 7076-7078.

bibitem{icoz2008} Icoz, I., & Stotzky, G. (2008). Fate and effects of insect-resistant Bt crops in soil ecosystems. emph{Soil Biology and Biochemistry, 40}(3), 559-586.

ILSI Research Foundation. (2014). Low-Level Presence in Seed: A Science Based Approach to Expedited Environmental Risk Assessment [Workshop]. Presented at the Center for Environmental Risk Assessment (CERA), Washington, D.C.

International Service for the Acquisition of Agri-biotech Applications. (2018). Global Status of Commercialized Biotech/GM Crops: 2018 (Brief 54). International Service for the Acquisition of Agri-biotech Applications. Retrieved from

Keese, P. (2008). Risks from GMOs due to Horizontal Gene Transfer. Environmental Biosafety Research, 7(3), 123-149.

Kovalic, D., Garnaat, C., Guo, L., Yan, Y., Groat, J., Silvanovich, A., Ralston, L., Huang, M., Tian, Q., Christian, A., Cheikh, N., Hjelle, J., Padgette, S., & Bannon, G. (2012). The Use of Next Generation Sequencing and Junction Sequence Analysis Bioinformatics to Achieve Molecular Characterization of Crops Improved Through Modern Biotechnology. The Plant Genome, 5(3), 149-163.

Marchetti, E., Accinelli, C., Talame, V., & Epifani, R. (2007). Persistence of Cry toxins and cry genes from genetically modified plants in two agricultural soils. Agronomy for Sustainable Development, 27, 231-236.

Mendelsohn, M., Kough, J., Vaituzis, Z., & Matthews, K. (2003). Are Bt crops safe? Nature Biotechnology, 21(9), 1003-1009.

Organisation for Economic Co-operation and Development. (2000). Series on Harmonization of Regulatory Oversight in Biotechnology, No. 15. Consensus document on the biology of Glycine max (L.) Merr. (Soybean), ENV/JM/MONO(2000)9, 1-22. Retrieved from

Organisation for Economic Co-operation and Development. (2003). Series on Harmonisation of Regulatory Oversight in Biotechnology, No. 27. Consensus Document on the Biology of Zea mays subsp. mays (Maize), ENV/JM/MONO(2003)11, 1-49. Retrieved from

Organisation for Economic Co-operation and Development. (2008). Series on Harmonisation of Regulatory Oversight in Biotechnology, No. 45. Consensus document on the biology of Cotton (Gossypium spp.), ENV/JM/MONO(2008)33, 1-64. Retrieved from

Organisation for Economic Co-operation and Development. (2012). Series on Harmonisation of Regulatory Oversight in Biotechnology, No. 54. Consensus document on the biology of Brassica crops (Brassica spp.), ENV/JM/MONO(2012)41, 1-142. Retrieved from

Parker, K. M., Borrero, V. B., van Leeuwen, D. M., Lever, M. A., Mateescu, B., & Sander, M. (2019). Environmental Fate of RNA Interference Pesticides: Adsorption and Degradation of Double-Stranded RNA Molecules in Agricultural Soils. Environmental Science & Technology, 53(6), 3027-3036.

Raybould, A. (2006). Problem formulation and hypothesis testing for environmental risk assessments of genetically modified crops. Environmental Biosafety Research, 5(3), 119-125.

Roberts, A. (2011). Information tools for environmental risk assessment of low level presence - an introduction to the reviews of the environmental safety of proteins used in genetically engineered plants. Environmental Biosafety Research, 10(1), 1-3.

Roberts, A., Devos, Y., Raybould, A., Bigelow, P., & Gray, A. (2014). Environmental risk assessment of GE plants under low-exposure conditions. Transgenic Research, 23(6), 971-983.

Romeis, J., Bartsch, D., Bigler, F., Candolfi, M. P., Gielkens, M. M., Hartley, S. E., Hellmich, R. L., Huesing, J. E., Jepson, P. C., Layton, R., Quemada, H., Raybould, A., Rose, R. I., Schiemann, J., Sears, M. K., Shelton, A. M., Sweet, J., Vaituzis, Z., & Wolt, J. D. (2008). Assessment of risk of insect-resistant transgenic crops to nontarget arthropods. Nature Biotechnology, 26(2), 203-208.

Romeis, J., Hellmich, R. L., Candolfi, M. P., Carstens, K., De Schrijver, A., Gatehouse, A. M. R., Herman, R. A., Huesing, J. E., McLean, M. A., Raybould, A., Shelton, A. M., & Waggoner, A. (2011). Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants. Transgenic Research, 20(1), 1-22.

Romeis, J., & Meissle, M. (2011). Non‐target risk assessment of Bt crops - Cry protein uptake by aphids. Journal of Applied Entomology, 135(1‐2), 1-6.

Romeis, J., Raybould, A., Bigler, F., Candolfi, M. P., Hellmich, R. L., Huesing, J. E., & Shelton, A. M. (2013). Deriving criteria to select arthropod species for laboratory tests to assess the ecological risks from cultivating arthropod-resistant genetically engineered crops. Chemosphere, 90(3), 901-909.

Sanvido, O., Romeis, J., Gathmann, A., Gielkens, M., Raybould, A., & Bigler, F. (2012). Evaluating environmental risks of genetically modified crops: ecological harm criteria for regulatory decision-making. Environmental Science & Policy, 15}(1), 82-91.

Schellenberger, U., Oral, J., Rosen, B. A., Wei, J-Z., Zhu, G., Xie, W., McDonald, M. J., Cerf, D. C., Diehn, S. H., Crane, V. C., Sandahl, G. A., Zhao, J-Z., Nowatzki, T. M., Sethi, A., Liu, L., Pan, Z., Wang, Y., Lu, A. L., Wu, G., & Liu, L. (2016). A selective insecticidal protein from Pseudomonas for controlling corn rootworms. Science, 354(6312), 634-637.

Schnepf, E., Crickmore, N., Van Rie, J., Lereclus, D., Baum, J. A., Feitelson, J., Zeigler, D. R., & Dean, D. (1998). Bacillus thuringiensis and Its Pesticidal Crystal Proteins. Microbiology and Molecular Biology Reviews, 62(3), 775-806.

Shan, G., Embrey, S. K., Herman, R. A., & McCormick, R. (2014). Cry1F Protein Not Detected in Soil After Three Years of Transgenic Bt Corn (1507 Corn) Use. Environmental Entomology, 37(1), 255-262.[255:CPNDIS]2.0.CO;2

Shaw, R. H. (1988). Climate Requirement. In G. Sprague & J. W. Dudley (Eds.), Corn and Corn Improvement (Volume 18, Third Edition, pp. 609-638). American Society of Agronomy, Inc., Crop Science Society of America, Inc., Soil Science Society of America, Inc.

Shelton, A. M. (2010). The long road to commercialization of Bt brinjal (eggplant) in India. Crop Protection, 29(5), 412-414.

Stotzky, G. (2005). Persistence and biological activity in soil of the insecticidal proteins from Bacillus thuringiensis, especially from transgenic plants. Plant and Soil, 266(1), 77-89.

Tripathi, L., Tripathi, J. N., & Tushemereirwe, W. K. (2004). Strategies for resistance to bacterial wilt disease of bananas through genetic engineering. African Journal of Biotechnology, 3(12), 688-692.

U.S. Environmental Protection Agency. (1998). Guidelines for Ecological Risk Assessment, EPA/630/R-95/002F. Retrieved from

Van Frankenhuyzen, K. (2009). Insecticidal activity of Bacillus thuringiensis crystal proteins. Journal of Invertebrate Pathology, 101(1), 1-16.

Waltz, E. (2015). USDA approves next-generation GM potato. Nature Biotechnology, 33, 12-13.

Wolt, J. D., Keese, P., Raybould, A., Fitzpatrick, J. W., Burachik, M., Gray, A., Olin, S. S., Schiemann, J., Sears, M., & Wu, F. (2010). Problem formulation in the environmental risk assessment for genetically modified plants. Transgenic Research, 19(3), 425-436.

World Health Organization & Food and Agriculture Organization of the United Nations. (1991). Strategies for assessing the safety of foods produced by biotechnology: report of a joint FAO/WHO consultation [held in Geneva from 5 to 10 November 1990]. Retrieved from




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