Agricultural and Plant Biosafety Program …...In-house Inspection 6 Plant/ Related Research...
Transcript of Agricultural and Plant Biosafety Program …...In-house Inspection 6 Plant/ Related Research...
Agricultural and Plant Biosafety Program Management atProgram Management at
Rutgers University
Aparupa Sengupta, Ph.D., M.S., M.Sc.Aparupa Sengupta, Ph.D., M.S., M.Sc.
Biosafety OfficerRutgers UniversityRutgers University
[email protected] Annual Meeting 2017
Presentation Overview
Diversity of Rutgers’ Agricultural and
Plant Research
Improvements to Plant Biosafety Improvements to Plant Biosafety
Program Management g g
Challenges and Achievements
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Diversity of Research and Locations
PreventStudying Prevent adhesion of E. coli (tested for
Studying mechanisms of action of coli (tested for
human materials)
of action of ricin and shiga
toxin )
Identifying Field study-Identifying genes for improving
Field study-Transgenic
Regulated by 3
p gbiofuel traits
g yUSDA-APHIS
Regulations
Safe to eat
rDNA concerns
Safe to grow
4Environmental
safety
Select Agents/ Pathogens
Program Requirements
IBC Registration (as needed) Permits (as needed)
Lab to Field Control Measures
oEngineering Controls ab to e doEngineering ControlsoAccessoTrainingoTrainingoRecord KeepingoLabeling
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Identifying the Gaps in the Program
IdentifyingIdentifying the Gaps
Outreach to Plant PIs (IBC requirements) Plant Biosafety Training Module Autoclave validation program Implementationg In-house Inspection
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Plant/ Related Research Specific Training
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Autoclave Validation Program
• Autoclave Validation- Bacterial spore testing
• Periodic testingat least once a month- at least once a month
- once per week for transgenic research facilitiestransgenic research facilities
• Record and logRecord and log maintenance checks
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Greenhouse In-house Inspection
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Greenhouse In-house Inspection
BSL-1 Waste
C ll tiCollection
Transgenic Non-
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Label Transgenic Label
PROGRESSAgricultural Field In-house Inspection
Bagging
Access Control
gg g
Control Labeling
Volunteer Monitoring Waste disposal (plants
d il)
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and soil) Field equipment cleaning Pest Program
Challenges
Limited Plant-Related Research Regulations
Regulation Ambiguity
Communication Challenges
Training and Administrative Management
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Achievements
IBC Registration
Plant Research Inventory and Risk Plant Research Inventory and Risk
Assessment
Plant Research Specific Training
Successful USDA-APHIS Inspections
Autoclave Validation Program Autoclave Validation Program
Greenhouse/ Field Inspections PC: http://www.oraetlabora.co.uk/NewsAchievements/index.php
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Acknowledgement
Rutgers EHS (Biosafety) Team
Rutgers’ IBC Members
Greenhouse Facility Managers and Staff
Plant Departments/ NJAES Leadership
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RESOURCESA Practical Guide to Containment: Greenhouse Research with Transgenic Plant and Microbes (click here for pdf version)
USDA-APHIS permits and inspection https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_compliance_and_inspections/ctcompinsp_process_permit_insp_overview
USDA-APHIS Biotechnology Regulatory Services-Permit User’s Guide
click here (for pdf version)
How the federal government regulates biotech plantsHow the federal government regulates biotech plants
http://www.usda.gov/wps/portal/usda/usdahome?contentidonly=true&contentid=biotech-plants.xml
NIH G id li (U d t d A il 2016)NIH Guidelines (Updated April 2016)
http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html#_Toc44694832915