Confined Production Processes for Non-Food Corn - Seed Science ...

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ConclusionNew technology frequently changes the value of existingresources. Technology can take something that had novalue previously and give it a value. It becomes the taskof citizens, their institutions, and their traditions to assignownership and responsibility for the new resource. Thisprocess can be assisted by knowledge about the resourceand how it is used. Our society now finds that it has aresource of PMP- and PMI-free corn. Consumers andfarmers cannot effectively preserve that resource actingindependently. We have assumed that much of theresponsibility will be divided between the PMP ownersand users and the government regulators. The task of policycreation and deciding how to divide the responsibility willbe made easier with increased knowledge of the systemsthat will be used and the risk associated with the possibilityof loss of PMPs and PMIs.Formalized risk assessment allows for a science-basedcharacterization of risk. This assessment can subsequentlybe integrated with broader societal concerns in policyformulation considering both the risks and benefits ofthe technology. Use of science-based risk characterizationmakes the convergence of opinion in the broader discussionmore likely.No system is risk free. In areas where corn is produced,some amount of outflow will occur, especially with highwinds and equipment movement. Determination of adistribution of probable loss from confinement will allowspecifications of the kind or level of hazard for which sucha system should be used. In this report, good practices arepresented in process flow diagrams and in process outlinesthat break process flows into logical systems descriptionsas a hierarchy of relevant processes, subprocesses, andactivities intended to achieve high levels of confinementintegrity. Explicitly stated practice standards are a necessaryfirst step in understanding the degree of exposure andconsequent risk that may occur with varying typesof PMP or PMI development and production underconfinement. These practices will serve as a starting pointin the analysis of the strengths and weaknesses of asystem and its possible variants.The study of this system should provide the membersof the broader public with information about theapproaches and stringencies jointly adhered to byproducers and regulators. This information will assistmembers of the public to put PMP or PMI riskin perspective.Having established these practice standards, BIGMAPwill evaluate their integrity through quantitative exposureassessment. Quantitative exposure assessment recognizesthat for each activity there are various likelihoods ofprocedural conformity and nonconformity. For conformityand nonconformity, there are probability distributions forpossible outcomes. Working through the system flowchart,we can model all the process and calculate probabilities ofthe various final outcome states. If we can value the variouspossible outcomes, then we can generate a probable“cost” for the complete PMP or PMI production system.The model can be used to evaluate the impact of changesin processes on the performance of the system as awhole. In policy making, the cost also can be comparedsubjectively or objectively with the expected benefits fromthe production of the PMP or PMI to make a judgmentas to whether the net benefit to society is positive or negative.Although the focus of this document is on the sourcefield, different kinds of recipient fields also can effect therisk distributions. The most serious form of failure ofconfinement for a toxic PMP or PMI would be one inwhich breeder’s seed or foundation seed were contaminated,because this would allow for the possibility for anundetected PMP or PMI to be conserved and replicatedin seed stocks. Understanding of the distributions ofpossible outcomes from the source field will allow thequantification of outcomes associated with various kindsof source and target fields in subsequent studies.
No system is risk free, but some systems have very lowrisks in comparison with systems that society commonlyuses without special concern, for example, automobilesand gasoline trucks. Risks for others may be higher. Thesize of the risk may vary with policies that are adopted.The objective the BIGMAP study is to make future policymaking easier and more meaningful by developing prototypemodels that can be used in determining where on thescale specific types of plant-manufactured pharmaceuticalor -industrial compound production systems shouldbe ranked.VII. REFERENCESAdair, D., Irwin R., and Traynor, P.L. 2001. A practical guide to containment.Blacksburg, VI: Information Systems for Biotechnology.Bateman, A.J. 1947. Contamination of seed crops II, wind pollination.Heredity 1:235–246.Burris, J.S. 2001. Adventitious pollen intrusion into hybrid maize seed productionfields. Association of Official Seed Certifying Agencies [AOSCA]. Accessedelectronically June 9, 2004,http://www.amseed.com/govt_statementsDetail.asp?id=69.Coe, E.H., Jr., Neuffer, M.G., and Hoisington, D.A. 1998. The genetics of corn, pp.81–258. In: Corn and corn improvement, agronomy monograph no. 18, ed. G.F.Sprague and J.W. Dudley, Madison, WI: American Society of Agronomy.Das, K.G.S. 1983. Vicinity distance studies of hybrid seed production in maize(Zea mays L.) at Bangalore. Mysore J. Agric. Sci. 20:320.Eastham, K. and Sweet, J. 2002. Genetically modified organisms (GMOs):The significance of gene flow through pollen transfer. Environ. Issue Rep.No. 28. Copenhagen, Denmark: European Environmental Agency.Emberlin, J., Adams-Groom, B., and Tidmarsh, J. 1999. A report on the dispersalof maize pollen. Worcester, United Kingdom: National Pollen Research Unit,University College.Fonseca, A.E., Westgate, M.E., and Doyle, R.T. 2002. Application of fluorescencemicroscopy and image analysis for quantifying dynamics of maize pollenshed. Crop Sci. 42:2201–2206.Garcia, C., Figueroa, M.J., Gomez, M.R., Townsend, L.R., and Schoper, J. 1998.Pollen control during transgenic hybrid maize development in Mexico.Crop Sci. 38:1597–1602.Hall, A.J., Villela, F., Trapani, N., and Chimenti, C. 1982. The effect of waterstress and genotype on the dynamics of pollen-shedding and silking in maize.Field Crops Res. 5:349–363.Hutchcroft, C.D. 1958. Contamination in seed fields of corn resulting fromincomplete detasseling. Agron J. 66:267–271.Ingram, J. 2000. Report on the separation distances required to ensure crosspollinationis below specified limits in non-seed crops of sugar beet, maize,and oilseed rape. MAFF Project no. RO0123. Accessed electronicallyAugust 7, 2002, http://www.defra.gov.uk/planth/pvs/gmsepdis.pdf.Ireland, D. S., Westgate, M.E., and Ashton, B.A. 2001. Combining ISCST3 andAERMOD particulate dispersion models to quantify maize pollen distribution.ASA-CSSA-SSSA Annual Meetings Abstracts, Charlotte, NC. October 21–25,2001. Madison, WI: American Society of Agronomy.Jemison, J.M. and Vayda, M.E. 2002. Cross pollination from geneticallyengineered corn: wind transport and seed source. AgBioForum 4(2) article 2.Accessed electronically January 12, 2005,http://www.agbioforum.org/v4n2/v4n2a02-jemison.htm.Jones, M.D. and Brooks, J.S. 1950. Effectiveness of distance and border rows inpreventing outcrossing in corn. Oklahoma Agricultural Experimental StationTechnical bulletin No 38. Stillwater, OK: Oklahoma State University.Kawashima et al. 2000. Estimating total corn pollen desposition forenvironmental assessment. Jpn. J. Palynol 46:103–114.Lauer, J. 1998. Successful corn pollination. Wisc Crop Manager 5:104–105.Luna, S., Figueroa, M. J., Baltazar, M. B., Gomez, L. R., Townsend, R., and Shoper,J. B. 2001. Maize pollen longevity and distance isolation requirements foreffective pollen control. Crop Sci. 41:1551–1557.McDonald, M.B. and Copeland, L. O. 1997. Seed production: principles andpractices, pp. 148–170 and 193–205. New York: Chapman & Hall.Ministère de l’Agriculture et de la Pêche. 2002. Rapport de la commissiondu genie biomoleculaire et du comite provisoire de biovigilance surl’expérimentation au champ de plantes transgeniques. Assessedelectronically June 9, 2004,http://www.conso.net/images_publications/Contribution%20CGB.rtf.Mudra, A. 1943. Ùber die reichweite des pollenstaubes bim mais in geschlossenemverband. Verband Züchter 15:29–31.Narayanaswamy, S. et al. 1997. Determination of isolation distance for hybridseed production. Curr. Res. (Univ. Bangalore) 26:193–195.[NIH] National Institutes of Health. 2002. Guidelines for Research InvolvingRecombinant DNA Molecules. April 2002, Accessed electronically June 2004,http://www4.od.nih.gov/oba.National Research Council. 2004. Biological Confinement of Genetically ModifiedOrganisms. Washington, DC: National Academies Press.[OEDC} Organization for Economic Cooperation and Development. 2003. AnnexIX: OECD scheme for the varietal certification of maize and sorghum seedmoving in international trade. OECD Seed Scheme. Accessed electronicallyJune 25, 2004, http://www.oecd.org/dataoecd/40/50/15284225.PDF.Paterniani, E. and Stort, A.C. 1974. Effective maize pollen dispersal in the field.Euphytica 23:129–134.Poehman, J.M. and Sleper, D.A. 1995. Breeding field crops, 4th ed. Ames, IA:Iowa State University Press.Pohl, F. 1937. Die pollenerzeugng der winterbluter. Bei. Bot. Centralb.56A:365–470.Raynor, G.S., Ogden, E.C., and Hayes, J.V. 1972. Dispersion and deposition ofcorn pollen from experimental sources. Agron. J. 64:420–427[USDA] United States Department of Agriculture. 2003a. Field testing of plantsto produce pharmaceutical and industrial compounds. Federal Register68:11337–11340.[USDA] United States Department of Agriculture. 2003b. Introductions of plantsgenetically engineered to produce industrial compounds. Federal Register68:46434–46436.Wych, R.W. 1998. Production of hybrid seed corn. In: Corn and cornimprovement, 3rd ed., ed. G.F. Sprague and J.W. Dudley. Madison, WI:American Society of AgronomyConclusion 81
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A necessary first step in the proje
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There are no other restrictions on
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IntroductionIt is our expectation t
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take place, we suggest that in prac
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DefinitionsSystem: A set of interre
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Laboratory andGreenhouse ProcessesR
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NIH GUIDELINES AND PMPS OR PMISWe h
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The event-specific probe becomes a
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PCR,Expression &Copy NumberTestsA t
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Lab Checks onPMP IdentityEvent Info
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Event InfoDatabasePlan Action forNe
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NURSERIES AND THEIR MANAGEMENTNurse
Page 31 and 32: target field in inverse proportion.
Page 33 and 34: FIGURE 6. NURSERYNurseryManagement
Page 35 and 36: Nursery PlanMark and LabelRanges an
Page 37 and 38: Label, Sign andRecord PlotHistoryNo
Page 39 and 40: PollinationInspection.Remove Off-ty
Page 41 and 42: Pollination ofSurrounding inToleran
Page 43 and 44: Contain PMP PlantMaterialYesAll PMP
Page 45 and 46: Receive Corn,Verify, Label,RecordRe
Page 47 and 48: Nursery PlanRegulatoryTestsEvent In
Page 49 and 50: 5. POLLEN DRIFT CONSEQUENCES,EFFECT
Page 51 and 52: 11. DETASSELING MACHINE16. EMPTYING
Page 53 and 54: Assuming production of PMPs or PMIs
Page 55 and 56: • Specialized equipment is used f
Page 57 and 58: TABLE 2. CHARACTERISTICS OF PRODUCT
Page 59 and 60: APHIS standards do not currently di
Page 61 and 62: Clean PlanterField HistoriesPlanter
Page 63 and 64: AreRoguePlantsNormal?NoIsContaminat
Page 65 and 66: Remove Off-typesAfter FloweringYesW
Page 67 and 68: Processing& StorageFIGURE 10. PROCE
Page 69 and 70: Record Ear andTrack Weight &Moistur
Page 71 and 72: Check All Grainand Trash Weightsand
Page 73 and 74: Clean BinCheck IncomingWeight Again
Page 75 and 76: Destroy VolunteerPlant MaterialChec
Page 77 and 78: • Properly document test results
Page 79 and 80: D. Second Year Field Management•
Page 81: E. Product storage and disposition
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