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

aparupa.sengupta@rutgers.eduABSA 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

2

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

5

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

6

Plant/ Related Research Specific Training

7

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

8

Greenhouse In-house Inspection

9

Greenhouse In-house Inspection

BSL-1 Waste

C ll tiCollection

Transgenic Non-

10

Label Transgenic Label

PROGRESSAgricultural Field In-house Inspection

Bagging

Access Control

gg g

Control Labeling

Volunteer Monitoring Waste disposal (plants

d il)

11

and soil) Field equipment cleaning Pest Program

Challenges

Limited Plant-Related Research Regulations

Regulation Ambiguity

Communication Challenges

Training and Administrative Management

12

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

13

Acknowledgement

Rutgers EHS (Biosafety) Team

Rutgers’ IBC Members

Greenhouse Facility Managers and Staff

Plant Departments/ NJAES Leadership

14

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