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

Summary: ProcessDescriptionsThe general philosophy for compliant confinementsystems is for planning the overall system and individualprocesses to comprise a logical flow of redundant tasksthat can be clearly managed and tracked. The confinementmanagement activities are described here as a hierarchyof procedures, subprocedures, activities, and subactivitiesnecessary to achieve corn confinement consistent withcurrent regulatory standards (that is “good practice”standards). These management activities are describedhere as generalized “activity group descriptions” andare more explicitly detailed in the corresponding flowdiagrams. The approach represented in these descriptionsis one where for each subprocess (for example, fieldproduction management represents a subprocess for fieldproduction) or activity grouping (for example, preplantingrepresents an activity grouping under the field productionmanagement operation), there are nests of subactivitiesdescribed entailing(i)development or confirmation of appropriate protocols,standard operating procedures (SOPs), and training;(ii) execution of management activities compliant withthe protocols, standards, and training; and(iii) quality control or quality assurance (QC/QA) actionsto confirm and document compliance with protocols,standards, and training.Effective management of confinement operationswill be most impacted by human failures in planning,implementation, and follow-up. These process descriptionsand the corresponding flow diagrams are intended as aresource for minimizing system error rates. These “goodpractices” are meant to exemplify only one of manyalternative management schemes that can meet regulatoryexpectations for confinement.PROCESS DESCRIPTION OUTLINEI. PLANT TRANSFORMATION AND GREENHOUSEA. Planning Stage• Assign staff with appropriate training andexperience in construction of cloning vector• Develop QA/QC plan for transformation vector• Prepare detailed vector development plan• Achieve appropriate resource planning, includingthe intellectual property issues associatedwith vector• Achieve necessary regulator approval, if required• Check identity of vectorB. Plant Transformation• Assign trained personal for transformation• Prepare transformation plan (Agrobacterium vs.biolistic transformation method)• Develop SOP for transformation• Implement transformation SOP fortransformation process• Implement aseptic techniques• Label individual transformation plates withvector identification• Document transformation procedure and resultsC. Selection of Transformant and Regeneration• Use trained personnel• Develop SOP for selection and regenerationof transformant• Implement aseptic strategy during the process• Identify individual transformants properly• Select stable transformant• Regenerate transformant• Collect quality information