National Biosafety Stewardship Month: Participate Now and Keep the Momentum All Year Betsy Gilman Duane, MS, RBP, CBSP September 10, 2014

eheinc.com2 NIH Director’s Message Resources: “ Promoting Health, Science, and Public Trust through Laboratory Safety “ Posted August 27, 2014, by Drs. Francis Collins, Sally Rockey, Lawrence Tabak, and Amy Patterson

eheinc.com3 “ “ September 2014 During National Biosafety Stewardship Month, institutions should highlight the importance of the requirements and activities that are already part and parcel of a robust biosafety program. It is also an opportunity to further optimize biosafety oversight and strengthen the institutional safety culture. -National Institutes of Health

eheinc.com4 Key Elements of the NIH Request Reexamine current policies and procedures for biosafety practices and oversight to ascertain whether they require modification to optimize their effectiveness; Conduct inventories of infectious agents and toxins in all laboratories (regardless of whether they involve recombinant or synthetic nucleic acids) to ensure that the institution has a record of which infectious agents and toxins are being utilized;

eheinc.com5 Key Elements of the NIH Request Reinforce biosafety training of investigators, laboratory staff, and members of IBCs to include: – Reexamining training materials and practices – Updating materials as appropriate – Ascertaining the appropriate frequency of training and conduct training when the interval between training or other considerations warrant it

eheinc.com6 So Much To Do – So Little Time How deep should we dive? How will we get it all done? How can I get the PI’s to participate?

eheinc.com7 How About the Rest of the Year? Calling attention to biosafety in September is beneficial But what about the rest of the year? Biosafety should not be a one-time event A robust program is the result of continuous assessment and improvement.

eheinc.com8 Employ a Biorisk Management System CWA 15793:2008 – A technical agreement, developed by a working group (ABSA, EBSA, others) through consensus within the CEN (European Committee for Standardization) framework – A comprehensive management standard for biosafety and biosecurity – Compatible with ISO and OHSAS CWA 15793:2011 – Editorial Changes

eheinc.com9 Biorisk Management System Plan, Do, Check, Act Voluntary, does not replace or supersede any regulatory requirements Keys to Success: – Commitment from Senior Leadership – Focus on Continuous Improvement

eheinc.com10 Benchmarking What are your challenges? What are your opportunities? What have you implemented to date? What will you do after September?

Betsy Gilman Duane For more information: