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

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At the foundation seed plant• Teams are specially trained for higher standards ofconsistency and record keeping.• Equipment is specially designed for complete cleanoutbetween different varieties.• For smaller quantities, the use of boxes and batchprocessing eliminates the need for conveyors betweenactivities and the need to clean the conveyors.• Drying equipment is specialized depending on the sizeof the lot. Some seed is dried in special boxes designedto be easily and completely cleaned.• Small quantities of seed are stored in labeled boxes thatcan be completely cleaned.• High value seed may be stored for long periods, increasingthe importance of well organized record keeping.• Foundation discards are managed carefully because ofthe value of the seed.Most of the issues relevant to the confined productionof plant-manufactured pharmaceutical and -industrialcompounds have analogous issues in foundation seedproduction: isolation, field shape and placement, avoidanceof loss, sampling issues, rigid quality control, recordkeeping for processes and materials, and postharvestverification of genotype. Individuals who are familiarwith foundation seed production have an immediate graspof the issues that impact the ability to maintain containmentin field production of PMPs and PMIs.Although the production of foundation seed providesa model for production of PMPs and PMIs, it does notimply that there are no new issues; for example, theprotection of seed stocks from the possible presence ofPMPs and PMPs (see Protection of Seed Stocks above).TABLE 1. CHARACTERISTICS OF PRODUCTION CATEGORIESGRAIN SEED FOUNDATIONFIELD PRODUCTIONMultiyear Management No No YesManagement byexperienced professionals No Yes YesDistance to supervision NA Higher LowerTrained to performprocedures. No Yes YesField contractedfor season No No YesQuality objectives No Medium HighGenetic purity standards No Medium HighISO certified No Yes YesWritten andcomputer records No Medium HighLocations and growersare chosen carefully No Yes YesIsolation standards higherpriority in selection No Medium HighIsolations standardsand inspection No Yes YesStandards fertile plantsin sterile females NA Medium HighManagement of buffers NA Medium HighSpecial standards fortransgenic crops Low Medium HighProduct specific practices No Yes YesHand harvest use No No YesSpecialized equipmentfor planting and harvest No Yes YesFemale plants aredetasseled or male sterile No Yes YesBuffers restrict theflow of pollen No Yes YesOff-type plantsare removed No Yes YesTeams in the field atpollination time No Yes YesSeed is harvested onthe ear early No Yes YesPlots are harvested witheasy to clean pickers No Yes YesHusk-on pickers dislodgevery few kernels No Yes YesCustom transportequipment No No Some
TABLE 2. CHARACTERISTICS OF PRODUCTION CATEGORIESGRAIN SEED FOUNDATIONPROCESSINGTrained teams managed No Yes YesCare in record keeping Low Medium HighProcessing incontained building No Yes UsuallyFacilities and equipmentcleaned between products No Yes YesEase of cleanoutof equipment Low Medium HighTest can identify products No Yes YesBatch processing processesfor separation Low Medium HighSpecialized equipment fordrying small lots No Some YesIntegrated computersystems track weightsand purity No Yes YesLevel of careconcerning loss Low Medium HighQuality checked beforerelease of product No Yes YesSize of storage Large Medium SmallLong-term storage No Some MoreSystems to manage discards NA Some MoreLarger Scale Production 55
Page 5: A necessary first step in the proje
Page 8 and 9: There are no other restrictions on
Page 10 and 11: IntroductionIt is our expectation t
Page 12 and 13: take place, we suggest that in prac
Page 14 and 15: DefinitionsSystem: A set of interre
Page 16 and 17: Laboratory andGreenhouse ProcessesR
Page 18 and 19: NIH GUIDELINES AND PMPS OR PMISWe h
Page 20 and 21: The event-specific probe becomes a
Page 23 and 24: PCR,Expression &Copy NumberTestsA t
Page 25 and 26: Lab Checks onPMP IdentityEvent Info
Page 27 and 28: Event InfoDatabasePlan Action forNe
Page 29 and 30: 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: • Specialized equipment is used f
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 and 82: E. Product storage and disposition
Page 83 and 84: No system is risk free, but some sy

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