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A review of the environmental safety of the Cry1Ac protein

Published online by Cambridge University Press:  30 April 2012

Abstract

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Type
Review Article
Copyright
© Center for Environmental Risk Assessment, ILSI Research Foundation

References

Accinelli, C.Koskinen, W. C., Becker, J. M. and Sadowsky, M. J. (2008). Mineralization of the Bacillus thuringiensis Cry1Ac endotoxins in soil. Journal of Agricultural and Food Chemistry. 56:1025-1028. CrossRefGoogle ScholarPubMed
Aronson, A. I. and Shai, Y. (2001). Why Bacillus thuringiensis insecticidal toxins are so effective : unique features of their mode of action. FEMS Microbiology Letters 195:1-8. CrossRefGoogle ScholarPubMed
Baker, H.G. (1974). The evolution of weeds. Annual Review of Ecology and Systematics 5:1-24. CrossRefGoogle Scholar
Baltazar, B.M., Sanchez-Gonzales, J. J., Cruz-Larios, L., and Schoper, J.B. (2005). Pollination between maize and teosinte : an important determinant of gene flow in Mexico. Theoretical Applied Genetics 110:519-526. CrossRefGoogle ScholarPubMed
Berberich, S. A., Ream, J. E., Jackson, T. L., Wood, R., Stipanovic, R., Harvey, P., Patzer, S. and Fuchs, R. L. (1996). The composition of insect-protected cottonseed is equivalent to that of conventional cottonseed. Journal of Agricultural and Food Chemistry 44(1) :365-371. CrossRefGoogle Scholar
Blumenthal, D. (2005). Interrelated causes of plant invasion. Science 310:243-244CrossRefGoogle ScholarPubMed
Bravo, A.Gill, S. S. and Soberon, M. (2007). Mode of action of Bacillus thuringiensis Cry and Cyt toxins and their potential for insect control. Toxicon. 49(4) :423-435. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1857359CrossRefGoogle ScholarPubMed
CERA. (2010). GM Crop Database. Center for Environmental Risk Assessment (CERA), ILSI Research Foundation, Washington D.C. http://cera-gmc.org/index.php?action=gm_crop_database
Crecchio, C. and Stotsky, G. (1998). Insecticidal activity and biodegradation of the toxin from Bacillus thuringiensis subsp. Kurstaki bound to humic acids from soil. Soil Biology and Biochemistry 30(4) :463-470. CrossRefGoogle Scholar
Crickmore, N., Zeigler, D. R., Feitelson, J., Schnepf, E., Van Rie, J., Lereclus, D., Baum, J. and Dean, D. H. (1998). Revision of the nomenclature for the Bacillues thuringiensis pesticidal crystal proteins. Microbiology and Molecular Biology Reviews 62(3) :807-813. Google ScholarPubMed
Crickmore N., Zeigler D.R., Schnepf E., Van Rie J., Lereclus D., Baum J., Bravo A., and Dean D.H. (2005). Bacillus thuringiensis Toxin Nomenclature (Homepage). [cited January 2010]. http://www.lifesci.sussex.ac.uk/Home/Neil_Crickmore/Bt/.
Duan, JJ,Marvier, M,Huesing, J,Dively, G,Huang, ZY (2008) A meta-analysis of effects of Bt crops on honey bees (Hymenoptera : Apidae). PLoS ONE 3(1) :e1415CrossRefGoogle Scholar
Duan, JJ,Lundgren, JG,Naranjo, S,Marvier, M (2010) Extrapolating non-target risk of Bt crops from laboratory to field. Biol Lett 6:7477CrossRefGoogle ScholarPubMed
Ellstrand, N.C. (2003). Current knowledge of gene flow in plants : implications for transgene flow. Philosophical Transactions of the Royal Society, Series B. 358:1163-1170. Google Scholar
Hamilton, K. A., Pyla, P.D., Breeze, M., Olson, T., Li, M., Robinson, E., Gallagher, S. P., Sorbet, R. and Chen, Y. (2004). Bollgard II cotton : compositional analysis and feeding studies of cottonseed from insect-protected cotton (Gossypium hirsutum L.) producing the Cry1Ac and Cry2Ab2 proteins. Journal of Agricultural and Food Chemistry 52:6969-6976. CrossRefGoogle ScholarPubMed
Head, G., Surber, J. B., Watson, J. A., Martin, J. W. and Duan, J. J. (2002). No detection of Cry1Ac protein in soil after multiple years of transgenic Bt cotton (Bollgard) use. Environmental Entomology 43(1) :30-36. CrossRefGoogle Scholar
Hellmich, R. L.Siegfried, B. D., Sears, M. K., Stanley-Horn, D. E., Daniels, M. J., Mattila, H. R., Spencer, T., Bidne, K. G. and Lewis, L. C. (2001). Monarch larvae sensitivity to Bacillus thuringiensis-purified proteins and pollen. Proceedings of the National Academies of Science (U.S.A.) 98(21) :11925-11930. CrossRefGoogle ScholarPubMed
Hofte, H. and Whiteley, H. R. (1989). Insecticidal crystal proteins of Bacillus thuringiensis. Microbiological Reviews 53(2) :242-255. Google ScholarPubMed
Jenkins, J. L., Lee, M. K., Sangadala, S., Adang, M. J. and Dean, D. H. (1999). Binding of Bacillus thuringiensis Cry1Ac toxin to Manduca sexta aminopeptidase-N receptor is not directly related to toxicity. FEBS Letters 462:373-376. CrossRefGoogle ScholarPubMed
Jesse, L. C. H. and Obrycki, J. J. (2000). Field deposition of Bt transgenic corn pollen : lethal effects on the monarch butterfly. Oecologia 125:241-248. CrossRefGoogle Scholar
Keane, R. M. and Crawley, M. J. (2002). Exotic plant invasions and the enemy release hypothesis. Trends in Ecology and Evolution 17(4) :164-170. CrossRefGoogle Scholar
Koskella, J. and Stotzky, G. (1997). Microbial utilization of free and clay-bound insecticidal toxins from Bacillus thuringiensis and their retention of insecticidal activity after incubation with microbes. Applied and Environmental Microbiology 63(9) :3561-3568. Google ScholarPubMed
Kumar, P. A., Sharma, R. P. and Malik, V.S. (1996). The insecticidal proteins of Bacillus thuringiensis. Advances in Applied Microbiology 42:1-43. CrossRefGoogle ScholarPubMed
Losey, J. E., Rayor, L. S., Carter, M. E. (1999). Transgenic pollen harms monarch larvae. Nature 399:214. CrossRefGoogle ScholarPubMed
Mack, R.N. (1996) Predicting the identity and fate of plant invaders : emergent and emerging approaches. Biological Conservation 78:107-121. CrossRefGoogle Scholar
Mallory-Smith, C., and Zapiola, M. (2008). Gene flow from glyphosate-resistant crops. Pest Management Science 64:428-440. CrossRefGoogle ScholarPubMed
Marchetti, E., Accinelli, C., Talame, V. and Epifani, R. (2007). Persistence of Cry toxins and cry genes from genetically modified plants in two agricultural soils. Agronomy for Sustainable Development 27(3) :231-236. CrossRefGoogle Scholar
Marvier, M., McCreedy, C., Regetz, J., Kareiva, P. (2007). A meta-analysis of effects of Bt cotton and maize on nontarget invertebrates. Science 316:14751477. CrossRefGoogle ScholarPubMed
Mason, P., Braun, L., Warwick, S.I., Zhu, B., Stewart, Jr. C.N. (2003) Transgenic Bt-producing Brassica napus : Plutella xylostella selection pressure and fitness of weedy relatives. Environmental Biosafety Research 2:263-276. CrossRefGoogle ScholarPubMed
Naranjo, S.E. (2005a) Long-term assessment of the effects of transgenic Bt cotton on the abundance of non-target arthropod natural enemies. Environmental Entomology 34:11931210. CrossRefGoogle Scholar
Naranjo, S.E. (2005b) Long-term assessment of the effects of transgenic Bt cotton on the function of the natural enemy community. Environmental Entomology 34:1211-1223. CrossRefGoogle Scholar
Naranjo S. E. (2009). Impacts of Bt crops on non-target invertebrates and insecticide use patterns. CAB Reviews : Perspectives in Agriculture, Veterinary Science, Nutrition and Natural Resources 4(11) : http://fbae.org/2009/FBAE/website/images/pdf/imporatant-publication/impacts-of-bt-crops-on-non-target-invertebrates-and-insecticide-use-patterns.pdfCrossRef
Nickson T. E. and McKee M. J. (2002). Ecological assessment of crops derived through biotechnology. In Thomas J. A. and Fuchs R. L. (eds.) Biotechnology and safety assessment (third edition)(pp233-252). Academic Press, San Diego, CA
NRC (1989). Field testing genetically modified organisms : framework for decisions. National Academy of Sciences, National Research Council (NRC) committee on Scientific Evaluation of the Introduction of Genetically Modified Microorganisms and Plants into the Environment. National Academy Press, Washington, D.C.
NRC (2000). Genetically modified pest-protected plants : science and regulation. National Academy of Sciences, National Research Council (NRC). National Academy Press, Washington D.C.
NRC (2002). Environmental effects of transgenic plants : the scope and adequacy of regulation. National Academy of Sciences, National Research Council (NRC). National Academy Press, Washington D.C.
Pleasants J. M., Hellmich R. L., Dively G. P., Sears M. K., Stanley-Horn D. E., Mattila H. R., Foster J. E., Clark P. and Jones G. D. (2001). Corn pollen deposition on milkweeds in and near cornfields. Proceedings of the National Academies of Sciences (USA) 98(21) : 11919-11924. http://www.pnas.org/content/98/21/11919.fullCrossRef
Rose R.I. (ed.) (2007) White paper on tier-based testing for the effects of proteinaceous insecticidal plant-incorporated protectants on non-target invertebrates for regulatory risk assessment. USDA-APHIS and US Environmental Protection Agency, Washington, DC, USA. http://www.epa.gov/pesticides/biopesticides/pips/non-target-arthropods.pdf
Romeis, J., Meissle, M. and Bigler, F. (2006). Transgenic crops expressing Bacillus thuringiensis toxins and biological control. Nature Biotechnology 24(1) :63-71. CrossRefGoogle ScholarPubMed
Romeis J., Barsch D., Bigler F., Candolfi M. P., Gielkens M. M. C., Hartley S.E., Hellmich R. I., 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., and Wolt J. D. (2008). Assessment of risk of insect-resistant transgenic crops to nontarget arthropods
Serratos J.A., Wilcox M.C., Castillo F. (Eds.) (1995). Proceedings of a Forum : Gene flow among maize landraces, improved maize varieties, and teosinte : implications for transgenic maize. The Mexican National Institute of Forestry Agriculture and Livestock Research (INIFAP), The International Maize and Wheat Improvement Center (CIMMYT), and The Mexican National Agricultural Biosafety Committee (CNBA).
Schnepf, E., Crickmore, N., van Rie, J., Lereclus, D., Baum, J., Fetelson, J., Ziegler, D. R. and Dean, D. H. (1998). Bacillus thuringiensis and its pesticidal crystal proteins. Microbiology and Molecular Biology Reviews 62(3) :775-806. Google ScholarPubMed
Tabashink, B.E. (1992). Evaluation of synergism among Bacillus thuringiensis toxins. Applied and Environmental Microbiology 58(10) :3343-3346. Google Scholar
Wolfenbarger, L. L., Naranjo, S. E., Lundgren, J. G., Bitzer, R. J. and Watrud, L. S. (2008). Bt crops effects on functional guilds of non-target arthropods : a meta-analysis. PloS One 3(5) :e2118http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2346550/pdf/pone.0002118.pdfCrossRefGoogle ScholarPubMed
Zhang, X., Candas, M., Griko, N. B., Taussig, R., Bulla, L. A. Jr. (2006). A mechanism of cell death involving an adenylyl cyclase/PKA signaling pathway is induced by the Cry1Ab toxin of Bacillus thuringiensis. Proceedings of the National Academies of Science (U.S.A.) 103(26) :9897-9902. CrossRefGoogle ScholarPubMed
ANZFA (2002) Draft assessment report application A380 : Food from insect-protected and glufosinate ammonium-tolerant DBT418 corn. Australia New Zealand Food Authority (ANZFA), Canberra, Australia and Wellington, New Zealand.
APVMA (2010). Public Chemical Information System (PUBCRIS) [Search for Bacillus thuringiensis]. Australian Pesticides and Veterinary Management Authority (AVPMA), Symonston, Australia. http://services.apvma.gov.au/PubcrisWebClient/welcome.do
CBD (2000a). Cartagena Protocol on Biosafety. Secretariat of the Convention on Biological Diversity (CBD), Montreal. http://www.cbd.int/biosafety/protocol.shtml.
CBD (2000b). Cartagena Protocol on Biosafety Annex III : Risk Assessment. Secretariat of the Convention on Biological Diversity (CBD), Montreal. http://www.cbd.int/biosafety/articles.shtml?a=cpb-43
CFIA (1996). Decision document 96-14 : Determination of environmental safety of Bollgard insect resistant cotton (Gossypium hirsutum L.). Canadian Food Inspection Agency (CFIA) Ottawa, Canada. http://www.inspection.gc.ca/english/plaveg/bio/dd/dd9614e.shtml
CFIA (1997). Decision Document 98-23 : Determination of Dekalb Genetics Corporation’s European Corn Borer Resistant Corn (Zea mays L.) Line DBT418. Canadian Food Inspection Agency (CFIA) Ottawa, Canada. http://www.inspection.gc.ca/english/plaveg/bio/dd/dd9823e.shtml
CFIA (2002). Canada – U.S. bilateral agreement on agricultural biotechnology Appendix II : environmental characterization data for transgenic plants intended for unconfined release. http://www.inspection.gc.ca/english/plaveg/bio/usda/appenannex2e.shtml
CFIA (2003). Decision document DD2003-45 : Determination of the safety of Monsanto’s insect resistant Bollgard II cotton (Gossypium hirsutum L.). Canadian Food Inspection Agency (CFIA) Ottawa, Canada. http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0345e.shtml
CFIA (2005). Decision document DD2005-51 : Determination of the safety of Dow AgroSciences Inc. insect resistant cotton (Gossypium hirsutum) event 3006-210-23. Canadian Food Inspection Agency (CFIA) Ottawa, Canada. http://www.inspection.gc.ca/english/plaveg/bio/dd/dd0551e.shtml
CFIA (2009). Introduction to CFIA’s policy on managing cases of non-compliance. Canadian Food Inspection Agency (CFIA) Ottawa, Canada. http://www.inspection.gc.ca/english/plaveg/bio/nonapp/nonappe.shtml.
Codex (2003a). Principles for the risk analysis of foods derived through modern biotechnology. Codex Alimentarius Commission (Codex), Rome http://www.codexalimentarius.net/download/standards/10007/CXG_044e.pdf.
Codex (2003b). Guideline for the conduct of food safety assessment of foods derived from recombinant DNA plants. Codex Alimentarius Commission (Codex), Rome http://www.codexalimentarius.net/download/standards/10021/CXG_045e.pdf.
CTNBio (2005). Commercial release of genetically modified cotton, Bollgard Cotton (531). Brazilian National Biosafety Technical Commission (CTNBio), Sao Paulo http://www.ctnbio.gov.br/index.php/content/view/3663.html
CTNBio (2009). Commercial release of genetically modified cotton, Bollgard Cotton (MON 15985) : Technical Opinion no. 1832/2009. Brazilian National Biosafety Technical Commission (CTNBio), Sao Paulo.
EC (2001). Directive 2001/18/EC of the European Parliament and of the Council. European Commission, Brussels Belgium. http://ec.europa.eu/environment/biotechnology/pdf/dir2001_18.pdf.
EFSA (2006a). Guidance document of the scientific panel on genetically modified organisms for the risk assessment of genetically modified plants and derived food and feed. European Food Safety Authority (EFSA), Brussels, Belgium. http://www.efsa.europa.eu/en/scdocs/doc/gmo_guidance_derived_feed_food.pdf.
EU DG ARD (2007). Economic impact of unapproved GMOs on EU feed imports and livestock production. European Directorate General of Agriculture and Rural Development (EU DG ARD), Brussels, Belgium.
EU DG SANCO (2010). EU Pesticides Database [Search for Bacillus thuringiensis]. European Union Directorate General, Health and Consumers (EU DG SANCO) Brussels, Belgium http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=activesubstance.selection
EU SCP (1998). Opinion of the scientific committee on plants on the genetically modified cotton in, insect-tolerant notified by the Monsanto company (notification C/ES/96/02). European Commission Health and Consumer Protection Scientific Committee on Plants, Brussels.
FAO/WHO (1996). Biotechnology and food safety. Report of a Joint FAO/WHO Consultation. Food and Agriculture Organization (FAO)/ World Health Organization (WHO), Food and Nutrition Paper 61, Rome, Italy. http://www.fao.org/ag/agn/food/pdf/biotechnology.pdf.
FAO/WHO (2006). Food safety risk analysis : a guide for national food safety authorities. Food and Agriculture Organization (FAO) and World Health Organization (WHO), Rome. http://www.who.int/entity/foodsafety/publications/micro/riskanalysis06.pdf.
FSANZ (2004). Final assessment report application A518 : Food derived from insect-protected, herbicide-tolerant cotton line MXB-13. Food Safety Australia New Zealand (FSANZ) Canberra, Australia and Wellington, New Zealand. http://www.foodstandards.gov.au/standardsdevelopment/applications/applicationa518foodd2314.cfm
Japan BCH (1997). Outline of the biological diversity and risk assessment report (Mon-00531-6). Japan Biosafety Clearing House (BCH). Tokyo, Japan.
Japan BCH (1999). Biological diversity risk assessment report : DBT418. Japan Biosafety Clearing House (BCH). Tokyo, Japan.
Japan BCH (2007). Outline of the biological diversity risk assessment report : Type 1 use approval for cotton LLCotton25 x MON15985 (ACS-GHØØ1-3 x MON-15985-7). Japan Biosafety Clearing House (BCH). Tokyo, Japan.
OECD (1992). Recombinant DNA safety considerations. Organization for Economic Cooperation and Development (OECD), Paris, France.
OECD (1993). Safety considerations for biotechnology : scale-up of crop plants. Organization for Economic Cooperation and Development (OECD), Paris, France.
OECD (2003a). Consensus document on the biology of Zea mays subsp. Mays. Organization for Economic Cooperation and Development (OECD), Paris, France.
OECD (2003b). Description of selected key generic terms used in chemical hazard/risk assessment. Organization for Economic Cooperation and Development (OECD), Paris. http://www.olis.oecd.org/olis/2003doc.nsf/LinkTo/NT00004772/$FILE/JT00152557.PDF
OECD (2006). Points to consider for consensus documents on the biology of cultivated plants. Organization for Economic Cooperation and Development (OECD), Paris, France. CrossRef
OECD (2007) Consensus Document on Safety Information on Transgenic Plants Expressing Bacillus thuringiensis - Derived Insect Control Protein. Series on Harmonisation of Regulatory Oversight in Biotechnology, No. 42. Organisation for Economic Co-operation and Development, Paris.
OECD (2008). Consensus document on the biology of cotton (Gossypium spp.). Organization for Economic Cooperation and Development (OECD), Paris, France.
OECD (2009). OECD schemes for the varietal certification or the control of seed. Organization for Economic Cooperation and Development (OECD), Paris, France.
OGTR (2002a).DIR 012/2002 Risk Assessment and Risk Management Plan : Commercial Release of Bollgard II cotton. Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir012-2002
OGTR (2003a) Notification of decision to issue a license on cotton application DIR023/2002. Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir023-4/$FILE/dir023notific.rtf
OGTR (2003b) Risk assessment and risk management plan for DIR023/2002. Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir023-3/$FILE/dir023finalrarmp.pdf
OGTR (2003c). DIR 022/2002 - Application and license for dealings involving an intentional release into the environment : Commercial release of insecticidal (INGARD event 531) cotton. Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir022-4/
OGTR (2005). Full risk assessment and risk management plan for commercial release of genetically modified cotton lines (MON-15985-7, MON-88913-8). Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir059-3/$FILE/dir059finalrarmp1.pdf
OGTR (2006a). Dir 059/2005 Notification of decision to issue a license. Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir059-3/$FILE/dir059notific.pdf
OGTR (2006b). Full risk assessment and risk management plan (RARMP) for commercial release of genetically modified (GM) herbicide tolerant and/or insect resistant cotton lines north of latitude 22o south. Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir066-3/$FILE/dir066rarmp2.pdf
OGTR (2006c). Decision on issuing a license for application DIR 066/2006 : Commercial release of five herbicide tolerant and/or insect resistant GM cotton lines in Northern Australia. Office of the Gene Technology Regulator (OGTR), Canberra, Australia. http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/dir066-3/$FILE/dir066notifc.pdf
OGTR (2008). The biology of Gossypium hirsutum L. and Gossypium barbadense L. Office of the gene technology regulatory (OGTR) Department of Health and Ageing, Canberra, Australia.
OGTR (2009a). Risk analysis framework. Office of the gene technology regulatory (OGTR) Department of Health and Ageing, Canberra, Australia.
OGTR (2009b). Operations of the gene technology regulator annual report (08-09). Office of the gene technology regulatory (OGTR) Department of Health and Ageing, Canberra, Australia.
PMRA (2008). Re-evaluation decision document : Bacillus thuringiensis. Health Canada, Pest Management Regulatory Agency (PMRA), Ottawa. [accessed Feb18, 2010] http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/rvd2008-18/index-eng.php
USDA APHIS (1994). Petition for determination of non-regulated status : Bollgard cotton line 531 (Gossypium hirsutum L.) with the gene from Bacillus thuringiensis subsp. kurstaki. http://www.aphis.usda.gov/brs/aphisdocs/94_30801p.pdf.
USDA APHIS (1995). USDA/APHIS determination on a petition 94-308-01 of Monsanto Agricultural Company seeking nonregulated status of lepidopteran-resistant cotton lines 531, 757, 1076. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs2/94_30801p_com.pdf
USDA APHIS (1996). Petition for determination of nonregulated status : Insect protected corn (Zea mays L.) with the cryIA(c) gene from Bacillus thuringiensis subsp. Kurstaki. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs/96_29101p.pdf.
USDA APHIS (1997a). Petition for determination of nonregulated status : Insect resistant tomato line 5345 (Lycopersicon esculentum)producing the Cry1Ac insect control protein of Bacillus thuringiensis subsp. kurstaki. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs/97_28701p.pdf.
USDA APHIS (1997b). Petition for the determination of nonregulated status : BXN with Bt cotton. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs/97_01301p.pdf
USDA APHIS (1997c) USDA/APHIS petition 97-013-01 p for determination of nonregulated status for events 31807 and 31808. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs2/97_01301p_com.pdf
USDA APHIS (1997d). USDA/APHIS petition 96-291-01p for determination of nonregulated status for insect-protected Corn Line DBT418 Environmental Assessment and Finding of No Significant Impact. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs2/96_29101p_com.pdf
USDA APHIS (2000). Request for determination of non-regulated status for the regulated article : Bollgard II cotton event 15985 (Gossypium hirsutum L.) producing the Cry2Ab insect control protein derived from Bacillus thuringiensis subsp. kurstaki. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs/00_34201p.pdf
USDA APHIS (2001). Approval of Monsanto Company Petition (00-342-01p) seeking a determination of nonregulated status for Bollgard II cotton event 15985 producing the Cry2Ab insect control protein derived from Bacillus thuringiensis subsp. kurstaki. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs2/00_34201p_com.pdf
USDA APHIS (2003). Petition for determination of non-regulated status : B.t. Cry1Ac insect-resistant cotton event 3006-210-23. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs/03_03602p.pdf.
USDA APHIS (2004). Approval of Mycogen/Dow petitions 03-036-01p and 03-036-02p seeking determinations of nonregulated status for insect-resistant cotton events 281-24-236 and 3006-210-23 genetically engineered to express synthetic B.t. Cry1F and Cry1Ac, respectively : Environmental Assessment and Finding of No Significant Impact. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C. http://www.aphis.usda.gov/brs/aphisdocs2/03_03601p_com.pdf
USDA APHIS (2007b). APHIS policy on responding to the low-level presence of regulated genetically engineered plant materials. United States Department of Agriculture, Animal and Plant Health Inspection Service, Washington D.C.
USEPA (1992). Framework for ecological risk assessment. Risk Assessment Forum, U.S. Environmental Protection Agency (USEPA), Washington D. C. http://oaspub.epa.gov/eims/eimscomm.getfile?p_download_id=36361 http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=30759.
USEPA (1998). Guidelines for ecological risk assessment. Risk Assessment Forum, U.S. Environmental Protection Agency (USEPA), Washington D. C. http://oaspub.epa.gov/eims/eimscomm.getfile?p_download_id=36512.
USEPA (2001). Bt Plant-Incorporated Protectants October 15, 2001 Biopesticides Registration Action Document. U.S. Environmental Protection Agency (USEPA), Washington D. C. http://www.epa.gov/pesticides/biopesticides/pips/bt_brad.htm
USEPA (2007). White paper on tier-based testing for the effects of proteinaceous insecticidal plant-incorporated protectants on non-target arthropods for regulatory risk assessments. U.S. Environmental Protection Agency (USEPA), Washington D. C. http://www.epa.gov/pesticides/biopesticides/pips/non-target-arthropods.pdf
USEPA (2010). The Office of Prevention, Pesticides and Toxic Substances (OPPTS), Harmonized Test Guidelines. U.S. Environmental Protection Agency (USEPA), Washington D. C. http://epa.gov/oppts/pubs/frs/home/guidelin.htm
USFDA (1997). Biotechnology Consultation Note to the File BNF No. 000047. U.S. Food and Drug Administration, Silver Spring MD. http://www.fda.gov/Food/Biotechnology/Submissions/ucm161166.htm
WHO (1995). Application of the Principles of Substantial Equivalence to the Safety Evaluation of Foods or Food Components from Plants Derived by Modern Biotechnology. A Report of a WHO Workshop. World Health Organisation (WHO), Geneva.