An environmental risk assessment of IPD079Ea: a protein derived from Ophioglossum pendulum with activity against Diabrotica spp.In maize

References

• Williams A, Hubbs T. Feed Outlook: 2023, FDS-23e, U.S. Department of Agriculture, Economic Research Service. 2023.
   Google Scholar
• Ransom J. Root lodging in corn. Crop and pest report. North Dakota State University. 2011. https://www.ag.ndsu.edu/cpr/plant-science/root-lodging-in-corn-7-28-11.
   Google Scholar
• Gassmann AJ. Resistance to bt maize by western corn rootworm: effects of pest biology, the pest-crop interaction and the agricultural landscape on resistance. Insects. 2021 Feb 5;12(2):136. PMID: 33562469; PMCID: PMC7915852. doi:10.3390/insects12020136.
   PubMed Web of Science ®Google Scholar
• Simmons CR, Herman RA. Lower plants are emerging gene sources for agriculture and insect control proteins. Plant J. Accepted Author Manuscript. 2023;116(1). doi:10.1111/tpj.16349.
   PubMed Web of Science ®Google Scholar
• US-EPA. Guideline for Ecological Risk Assessment. United States Environmental Protection Agency, EPA/630/R-95/002F. 1998; 63(93):26846–26924.
   Google Scholar
• Anderson JA, Staley J, Challender M, Heuton J. Safety of Pseudomonas chlororaphis as a gene source for genetically modified crops. Transgenic Res. 2018;27(1):103–113. doi:10.1007/s11248-018-0061-6.
   PubMed Web of Science ®Google Scholar
• US-EPA. 40 CFR Part 160: Federal Insecticide, Fungicide And Rodenticide Act (FIFRA); Good Laboratory Practice Standards United States Environmental Protection Agency. 2011. https://www.govinfo.gov/content/pkg/CFR-2011-title40-vol24/xml/CFR-2011-title40-vol24-part160.xml#seqnum160.1
   Google Scholar
• Boeckman CJ, Ballou S, Gunderson T, Huang E, Linderblood C, Olson T, Stolte B, LeRoy K, Walker C, Wang Y. et al. Characterization of the spectrum of activity of IPD079Ea: a protein derived from ophioglossum pendulum (ophioglossales: ophioglossaceae) with activity against western corn rootworm [diabrotica virgifera virgifera (coleoptera: chrysomelidae)]. J Econ Entomol. 2022;115(5):1531–38. doi:10.1093/jee/toac079.
   PubMed Web of Science ®Google Scholar
• Carlson AB, Mathesius CA, Ballou S, Fallers MN, Gunderson TA, Hession A, Mirsky H, Stolte B, Zhang J, Woods RM. et al. Safety assessment of the insecticidal protein IPD079Ea from the fern, ophioglossum pendulum. Food Chem Toxicol. 2022;166. doi:10.1016/j.fct.2022.113187.
   PubMed Web of Science ®Google Scholar
• LeRoy K, Wang Y, Gunderson T, Challender M. Characterizing the bioactivity of IPD079Ea protein derived from DP-915635-4 maize and protein lots PCF-0046, PCF-0049, and PCF-0052 derived from a microbial expression system. Pioneer Hi-Bred International, Inc. Study No. PHI-2021-230. 2022.
   Google Scholar
• Carstens K, Cayabyab B, De Schrijver A, Gadaleta PG, Hellmich RL, Romeis J, Storer N, Valicente FH, Wach M. Surrogate species selection for assessing potential adverse environmental impacts of genetically engineered insect-resistant plants on non-target organisms. GM Crops Food: Biotechnol In Agri Food Chain. 2014;5(1):1–5. doi:10.4161/gmcr.26560.
   PubMedGoogle Scholar
• Wach M, Hellmich RL, Layton R, Romeis J, Gadaleta PG. Dynamic role and importance of surrogate species for assessing potential adverse environmental impacts of genetically engineered insect-resistant plants on non-target organisms. Transgenic Res. 2016;25(4):499–505. Epub 2016 Feb 27. PMID: 26922585; PMCID: PMC4925689. doi:10.1007/s11248-016-9945-5.
   PubMed Web of Science ®Google Scholar
• OECD. Guidance document on honey bee larval toxicity test following repeated exposure. Organisation for Economic Co-operation and Development, ENV/JM/MONO(2016)34. 2016.
   Google Scholar
• OECD. OECD guidelines for the testing of chemicals 245: honey bee (apis mellifera L.), chronic oral toxicity test (10-day feeding). Organisation for Economic Co-operation and Development. 2017.
   Google Scholar
• OECD. Guidance Document on Daphnia magna Reproduction Test. Organisation for Economic Co-operation and Development. 2012.
   Google Scholar
• US-EPA. Ecological Effects Test Guidelines, OCSPP 850.2100: Avian Acute Oral Toxicity Test. EPA 712-C-025. January 2012.
   Google Scholar
• OECD. Test No. 423: Acute Oral toxicity - Acute Toxic Class Method. Organisation for Economic Co-operation and Development. 2002.
   Google Scholar
• Gibbons JD, Chakraborti S. The general two-sample problem. In: Gibbons JD, and Chakraborti S. editors. Nonparametric statistical inference 3rd ed. New York: Marcel Dekker, Inc;1992. pp. 184–225.
   Google Scholar
• Ives M. CETIS, comprehensive environmental toxicity information System^TM, user’s guide. McKinleyville, California: Tidepool Scientific Software; 2019.
   Google Scholar
• Mann HB, Whitney DR. On a test of whether one of two random variables is stochastically larger than the other. Ann Math Statist. 1947;18(1):50–60. doi:10.1214/aoms/1177730491.
   Google Scholar
• Wilcoxon F. Individual comparisons by ranking methods. Biometrics Bull. 1945;1(6):80–83. doi:10.2307/3001968.
   Web of Science ®Google Scholar
• Pauli B, Deege L, Huang E, Brustkern S, Sitzmann B. Expressed trait protein concentrations of a maize line containing event DP-915635-4: U.S. and Canada test sites. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-015. 2020.
   Google Scholar
• Brødsgaard HF, Brødsgaard CJ, Hansen H, Lövei GL. Environmental risk assessment of transgene products using honey bee (Apis mellifera) larvae. Apidologie. 2003;34(2):139–45. doi:10.1051/apido:2003003.
   Web of Science ®Google Scholar
• Malone LA, Pham-Delègue M-H. Effects of transgene products on honey bees (Apis mellifera) and bumblebees (Bombus sp.). Apidologie. 2001;32(4):287–304. doi:10.1051/apido:2001130.
   Web of Science ®Google Scholar
• Babendreier D, Kalberer N, Romeis J, Fluri P, Bigler F. Pollen consumption in honey bee larvae: a step forward in the risk assessment of transgenic plants. Apidologie. 2004;35(3):293–300. doi:10.1051/apido:2004016.
   Web of Science ®Google Scholar
• Crailsheim K, Schneider LHW, Hrassnigg N, Bühlmann G, Brosch U, Gmeinbauer R, Schöffmann B. Pollen consumption and utilization in worker honeybees (Apis mellifera carnica): dependence on individual age and function. J Insect Physiol. 1992;38(6):409–419. doi:10.1016/0022-1910(92)90117-V.
   Web of Science ®Google Scholar
• Bachman PM, Huizinga KM, Jensen PD, Mueller G, Tan J, Uffman JP, Levine SL. Ecological risk assessment for DvSnf7 RNA: a plant-incorporated protectant with targeted activity against western corn rootworm. Regul Toxicol Pharmacol. 2016;81:77–88. doi:10.1016/j.yrtph.2016.08.001.
   PubMed Web of Science ®Google Scholar
• Jones R, Leahy J, Mahoney M, Murray L, Odenkirchen E, Petrie R, Stangel C, Sunzenauer I, Vaituzis Z, Williams AJ. Overview of the ecological risk assessment process in the office of pesticide programs, U.S. Environmental protection agency: endangered and threatened species effects determination. United States Environmental Protection Agency. 2004. http://www.epa.gov/scipoly/sap/meetings/2008/october/overview_doc_2004.pdf.
   Google Scholar
• Carstens K, Anderson J, Bachman P, De Schrijver A, Dively G, Federici B, Hamer M, Gielkens M, Jensen P, Lamp W. et al. Genetically modified crops and aquatic ecosystems: considerations for environmental risk assessment and non-target organism testing. Transgenic Res. 2012;21(4):813–842. doi:10.1007/s11248-011-9569-8.
   PubMed Web of Science ®Google Scholar
• Raybould A, Vlachos D. Non-target organism effects tests on Vip3A and their application to the ecological risk assessment for cultivation of MIR162 maize. Transgenic Res. 2011;20(3):599–611. doi:10.1007/s11248-010-9442-1.
   PubMed Web of Science ®Google Scholar
• Wolt JD, Peterson RKD. Prospective formulation of environmental risk assessments: probabilistic screening for Cry1A(b) maize risk to aquatic insects. Ecotox Environ Safe. 2010;73(6):1182–1188. doi:10.1016/j.ecoenv.2010.06.001.
   PubMed Web of Science ®Google Scholar
• Raybould A, Stacey D, Vlachos D, Graser G, Li X, Joseph R. Non-target organism risk assessment of MIR604 maize expressing mCry3a for control of corn rootworm. J Appl Entomol. 2007;131(6):391–99. doi:10.1111/j.1439-0418.2007.01200.x.
   Web of Science ®Google Scholar
• Rose RI. White paper on tier-based testing for the effects of proteinaceous insecticidal plant-incorporated protectants on non-target arthropods for regulatory risk assessments. USDA-APHIS and US Environmental Protection Agency. 2007. http://www.epa.gov/pesticides/biopesticides/pips/non-target-arthropods.pdf
   Google Scholar
• US-EPA. Revised Addendum To Environmental Risk Assessment For a FIFRA Section 3 Registration Of MON89034 X TC1507 X MON87411 X DAS-59122-7 Combined Trait Maize Expressing Cry 1A.105, Cry2Ab2, Cry 1 F, Cry3Bb1, Cry34/35Ab1 Bacillus thuringiensis Derived Insecticidal Protein, And DvSnf7 Double Stranded RNA (DsRNA). United States Environmental Protection Agency. 2017. https://cfpub.epa.gov/si/si_public_pra_view.cfm?Lab=OPP&dirEntryID=337950
   Google Scholar
• Olson T, Huang E, Stolte B, Challender M. 2020) Dissipation of IPD079Ea protein incorporated in loam, sandy loam, and silt loam soils. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-237
   Google Scholar
• Crocker D, Hart A, Gurney J, McCoy C. Project PN0908: methods for estimating daily food intake of wild birds and mammals. Final Report. Department for Environment, Food and Rural Affairs. 2002.
   Google Scholar
• US EPA-SAP. Product characterization, human health risk, ecological risk, and insect resistance management for Bacillus thuringiensis (Bt) cotton products. Transmittal of meeting minutes of the FIFRA Scientific Advisory Panel Meeting held June 8-10 at the Holiday Inn Ballston, Arlington, VA. 2004.
   Google Scholar
• Garcia-Alonso M, Jacobs E, Raybould A, Nickson TE, Sowig P, Willekens H, Van Der Kouwe P, Layton R, Amijee F, Fuentes AM. et al. A tiered system for assessing the risk of genetically modified plants to non-target organisms. Environ Biosafety Res. 2006;5(2):57–65. doi:10.1051/ebr:2006018.
   PubMedGoogle Scholar
• Romeis J, Bartsch D, Bigler F, Candolfi MP, Gielkens MMC, Hartley SE, Hellmich RL, Huesing JE, Jepson PC, Layton R. et al. Assessment of risk of insect-resistant transgenic crops to nontarget arthropods. Nat Biotechnol. 2008;26(2):203–208. doi:10.1038/nbt1381.
   PubMed Web of Science ®Google Scholar
• US-EPA. Biopesticides registration action document: Cry1Ab and Cry1F Bacillus thuringiensis (Bt) corn plant-incorporated protectants. United States Environmental Protection Agency. 2010b. www.epa.gov/opp00001/biopesticides/pips/cry1f-cry1ab-brad.pdf.
   Google Scholar
• US-EPA. Biopesticides Registration Action Document: Bacillus thuringiensis Cry3Bb1 Protein And The Genetic Material Necessary For Its Production (Vector PV-ZMIR13L) In MON 863 Corn (OECD Unique Identifier: MON-ØØ863-5) And Bacillus thuringiensis Cry3Bb1 Protein And The Genetic Material Necessary For Its Production (Vector PV-ZMIR39) In MON 88017 Corn (OECD Unique Identifier: MON-88Ø17-3). United States Environmental Protection Agency. 2010a. http://www.epa.gov/oppbppd1/biopesticides/pips/cry3bb1-brad.pdf
   Google Scholar
• Romeis J, Hellmich R, Candolfi M, Carstens K, De Schrijver A, Gatehouse A, Herman R, Huesing J, McLean M, Raybould A. et al. Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants. Transgenic Res. 2011;20(1):1–22. doi:10.1007/s11248-010-9446-x.
   PubMed Web of Science ®Google Scholar
• Romeis J, Raybould A, Bigler F, Candolfi MP, Hellmich RL, Huesing JE, Shelton AM. Deriving criteria to select arthropod species for laboratory tests to assess the ecological risks from cultivating arthropod-resistant genetically engineered crops. Chemosphere. 2013;90(3):901–909. doi:10.1016/j.chemosphere.2012.09.035.
   PubMed Web of Science ®Google Scholar
• Patnaude MR. IPD079Ea protein: 10-day oral toxicity test with the adult honey bee (apis mellifera). Pioneer Hi-Bred International, Inc., Study No. PHI-2019-153. 2020a.
   Google Scholar
• Linderblood C, Huang E, Wang Y, Challender M. Evaluation of IPD079Ea Protein Activity Against Multiple Insect Species. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-131. 2020.
   Google Scholar
• Olson T, Wang Y, Stolte B, Challender M. Evaluation of IPD079Ea Protein Activity Against Folsomia candida. Pioneer Hi-Bred International, Inc., Study No. PHI-2021-216. 2022.
   Google Scholar
• Carstens KL, Hayter K, Layton RJ. A perspective on problem formulation and exposure assessment of transgenic crops. GMOs In Integrated Plant Production, IOBC/Wprs Bulletin. 2010;52:23–30.
   Google Scholar
• Olson T, Huang E, Stolte B, Challender M. Evaluation of IPD079Ea Protein Activity Using Coleomegilla maculata. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-150. 2019.
   Google Scholar
• Fallers MN. IPD079Ea Protein: Acute Oral Toxicity Study in Mice. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-224. 2020.
   Google Scholar
• Barry JK, Simmons CR, Nelson ME. Beyond Bacillus thuringiensis: new insecticidal proteins with potential applications in agriculture. Advances in Insect Physiology. 2023.
   Google Scholar
• Patnaude MR. IPD079Ea protein: honey bee (apis mellifera) larval toxicity test, repeated exposure. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-152. 2020b.
   Google Scholar
• Shaw AC. IPD079Ea protein - full life-cycle toxicity test with water fleas (daphnia magna) under daily static-renewal conditions. Johnston, Iowa: Pioneer Hi-Bred International, Inc; 2021. pp. HI-2021–048.
   Google Scholar
• Stanfield K. Recombinant IPD079Ea Protein: Northern Bobwhite (Colinus virginianus) Acute Oral Toxicity Limit Test. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-225. 2020.
   Google Scholar
• Sturtz K, Wang Y, Gunderson T, Challender M. Evaluation of IPD079Ea protein activity using chrysoperla rufilabris. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-148. 2019.
   Google Scholar
• Sturtz K, Huang E, Challender M. Evaluation of IPD079Ea protein activity using hippodamia convergens. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-158. 2020a.
   Google Scholar
• Sturtz K, Wang Y, Stolte B, Challender M. Evaluation of IPD079Ea Protein Activity Against Pediobius foveolatus. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-201. 2020b.
   Google Scholar
• Woods R, Wang Y, Challender M. Evaluation of IPD079Ea Protein Activity Using Dalotia coriaria. Pioneer Hi-Bred International, Inc., Study No. PHI-2019-183. 2020.
   Google Scholar