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

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Laboratory andGreenhouse ProcessesResearchers transform plants in laboratory containment.The first generations of recombinant plants are grown inlaboratories and greenhouses to ensure containmentwhile researchers do preliminary selection and gatherthe information necessary for applications for fieldrelease. The purpose of containment at these early stagesof development is to prevent or restrict the transfer ofrecombinant DNA from transgenic organisms inside thelaboratory or greenhouse to reproductively compatibleorganisms in nature. For traits that are intended to enterthe food chain, laboratory and greenhouse containmentcan be thought of as the beginning of a sequence ofsteps, gradually reducing isolation from the environment.For compounds with an inherent hazard, it is moreappropriate to think of laboratory and greenhousecontainment as part of ongoing containment orconfinement that may be adjusted to fit the natureof the risk as knowledge increases.In addition to containment, laboratory and greenhouseoperations are characterized by the possibility of theexistence of different traits (characterized by thecompound to be produced), vectors (characterizedby the genetic sequence to be inserted), and events(characterized by derivation from DNA incorporationon a specific occasion). For reasons discussed below,this report focuses mainly on the possibility of error inearly stages of development that would result in thewrong trait or event being planted in the field.NIH GUIDELINES FOR CONTAINED PROCESSESThe NIH (2002) has set out rules for contained processes.The NIH Guidelines for Research Involving RecombinantDNA Molecules “specify practices for constructing andhandling: (i) recombinant deoxyribonucleic acid (DNA)molecules, and (ii) organisms and viruses containingrecombinant DNA molecules.” These rules are mandatoryfor institutions that receive NIH funding or are affiliatedwith such institutions. They are voluntary for otherparties but are widely adapted for work with PMIs andPMPs. Some detail about the NIH rules is presentedhere as an example of the way in which organizationsparticipating in PMP and PMI development wouldaddress issues associated with biosafety.The NIH guidelines require audits of the safety systemsthat are outlined. Some form of audit of the participantsis an important part of the PMP and PMI biosafetysystem.The NIH guidelines have created a climate withinwhich laboratory biosafety is taken very seriously byparticipants. One of the major requirements is that eachorganization involved creates an Institutional BiosafetyCommittee (IBC) to oversee institutional compliance.Sometimes, responsibility for biosafety in private industryclosely follows corporate lines of authority and a separatecommittee may be superfluous. In other examples,private research may have some of the same organizationalcomplexities that are characteristic of public researchinstitutions, and there would be good rational for theequivalent of an Institutional Biosafety Committee.The oversight under NIH varies depending on the levelof risk involved. There are six categories of experimentsinvolving recombinant DNA: 1) those that requireInstitutional Biosafety Committee approval, ResearchAdvisory Committee (RAC) review, and NIH Director
approval before initiation; 2) those that require NIH/Officeof Biotechnology Activities and Institutional BiosafetyCommittee approval before initiation; 3) those thatrequire Institutional Biosafety Committee andInstitutional Review Board approval and RAC reviewbefore research participant enrollment; 4) those thatrequire Institutional Biosafety Committee approvalbefore initiation; 5) those that require InstitutionalBiosafety Committee notification simultaneous withinitiation; and 6) those that are exempt from the NIHGuidelines. The NIH rules illustrate that oversightof PMPs and PMIs should vary depending on theassociated risk.In the NIH regulations, organisms are classified into riskgroups based on the hazard that they present. Biosafetylevel containment levels correspond to the risk groups.Biosafety level 4 provides the most stringent containmentconditions and biosafety level 1 the least stringent. Forexample, conventional greenhouses (with the possibleaddition of screening and impervious floors) are sufficientas level 1 containment, where recipient species that donot interbreed with weeds are used in combination withdonor species that are not exotic infections agents. Arecipient plant that intercrosses with weeds or a donorthat is an entire exotic infectious agent might requirelevel 2 greenhouses with locks, 30 mesh screen,impervious floors, collection of runoff water, andan autoclave.The NIH biosafety levels depend on the level of hazardand implicitly incorporate the principle that risk is theproduct of the hazard level with the probability ofoccurrence. To maintain a given tolerance for risk, theconditions of containment must ensure a lower probabilityof exposure if the level of hazard is higher. Conversely,where hazard is low, the degree of stringency inconfinement need not be as high. Risk managementprocedures within organizations involved in PMPs andPMIs could establish hierarchies of risk and biosafetyconfinement level that would be equivalent to thoseestablished by the NIH.The relevant containment programs can be divided intofour categories: 1) a set of standard practices that aregenerally used in microbiological laboratories; 2) speciallaboratory procedures, equipment, and installations thatprovide physical barriers that are applied in varyingdegrees according to the estimated biohazard while plantsare in culture and in the laboratory; 3) special greenhouseprocedures, equipment, and installations adapted for largeplants; and 4) biological containment measures that limitthe impact of any unplanned exposure.The following is from http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-052.html (accessed June 9, 2004):Some recombinant DNA requirements requireapproval in advance of initiation of the experiment. Insome instances, approval must be secured from theinstitutional biosafety committee (IBC), and, in others,from the IBC and the Recombinant DNA AdvisoryCommittee of NIH (RAC).Notification to either body must include:a) the source(s) of DNA;b) the nature of the inserted DNA sequences;c) the hosts and vectors to be used;d) a statement of whether a deliberate attempt willbe made to obtain expression of a foreign gene;e) containment conditions specified in the Guidelinesthemselves.Four categories of experiments are exempt from the reviewand approval requirements:a) those that are not in organisms or viruses;b) those that consist entirely of DNA segments froma single nonchromosomal or viral DNA source;c) those that consist entirely of DNA from a prokaryotichost, including its indigenous plasmids or viruseswhen propagated only in that host or whentransferred to another host by well establishedphysiological means; andd) certain specified recombinant DNA moleculesthat consist entirely of DNA segments fromdifferent species that exchange DNA by knownphysiological mechanisms.Minimum Compliance Action: Establish a five-personcommittee charged with the requirements to reviewall research involving the use of recombinant DNAmolecules.The NIH guidelines have been widely copied worldwideas the primary model for regulation of physicallyconfined research.A fully indexed, hyperlinked copy of the NIH Guidelinescan be viewed on line or downloaded athttp://www4.od.nih.gov/oba/rac/guidelines/guidelines.html.Laboratory and Greenhouse Processes 15
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 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 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 and 82:
E. Product storage and disposition
Page 83 and 84:
No system is risk free, but some sy
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