1. CU-IBC Institutional Biosafety Committee formerly the Recombinant DNA Committee Frank Cantone, Interim IBC Chair Cornell University Biological Safety Officer Maria Golonski, Executive Secretary

2. What does the IBC do? Review all University research and teaching activities involving the use of REGULATED biological agents, toxins, and recombinant DNA molecules. Ensure that personnel and facilities are in compliance with all external regulations and applicable University policies. Recommend policies to guide principal investigators and EH&S in carrying out the University's Biosafety Program, i.e., acquisition, use, training, transfer, storage, disposal, and emergency response procedures for all biohazardous materials emphasizing the protection of personnel, the general public, and the environment. Safety - Containment - Training

3. NIH Guidelines for Membership Standing Committee of the Faculty Senate Vice Provost for Research –> SPS & EH&S Is now affiliated with ORIA (Office of Research Integrity & Assurance) – Compliance Office CU Faculty and Staff with various expertise from different fields At least two members shall not be affiliated with the university Who is the IBC?

4. IBC Members Jean Bonasera – Plant Pathology Frank Cantone (Interim Chair)– EH&S Alice Churchill – Plant Pathology Walter DeJong – Plant Genetics Ed Dubovi – Vet. Diagnostic Lab. Hazel Fromm – Community Member Susheng Gan – Horticulture Paul Jennette – Biosafety Engineer Pat McDonough – Pop Med & Diag Christy Michaels – Community Member Keith Perry – Plant Pathology Mark Roberson – Biomedical Science Jean Siracusa – Community Member Chris Smart – Plant Pathology Geneva Martin Wiedmann – Food Science Charlie Fay – VP Res. Admin. Charles Walcott – Assoc. Dean Faculty Steve Hughes - Gannett Clinic Bob Richardson - Vice Provost Res. Maria Golonski – Executive Secretary

5.  Recombinant DNA – NIH CU regulates all rDNA projects, incl. NIH-exempt projects  Infectious Pathogens – CDC, USDA, NIH, ABSA Human, Animal, Plant  Biological Toxins - CDC All research projects involving regulated biohazardous materials must be registered with the CU-IBC via a MUA ( Memorandum of Understanding and Agreement)

6. Step 1: SPS Receives Form 10 If rDNA, GMO or Biological Agent, boxes are checked - it triggers an SPS (IBC) response. PI receives an email indicating that an MUA is required prior to the release of funds. Some agencies require approval when grant is submitted.

7. Step 2 Determine need for a MUA New or Revised PI will be informed of status of MUA and will be directed to submit a new protocol or an ammendment Information, Instructions, and Forms are on the website http://www.ibc.research.cornell.edu This should be consulted prior to submitting a Form 10 and any MUA forms.

8. Step 3: PI Completes Forms Proper forms must be completed in full Electronic submission is here!! Questions regarding the forms can be directed to Maria Golonski (mg352) at 255-7219 or Frank Cantone (fac2) at 254-4888

9. Step 4: Committee Review Committee Chair and Biological Safety Officer review all MUAs Exempt projects are approved by the chair Non-exempt projects are assigned to a 3 person subcommittee for review Subcommittee reports on review and recommends project for approval Provisional approval may be granted at that time Funding cannot be released prior to this

10. Step 5: IBC Meetings The IBC meets the third Thursday of even months All meetings are open to the public – announced in the Ithaca Journal and Cornell Daily Sun At the meetings, all non-exempt proposals with completed subcommittee reviews are discussed and voted upon

11. MUA Lifetime All MUAs are good for 3 years from the date it was approved, HOWEVER….. Each year an annual questionnaire is required. A full review by the IBC is required every third year on all proposals

12. Compliance Issues Reminders to submit the Annual Updates is emailed to PI at: 2 months prior to due date – 1 month prior to due date - 2 week prior to due date 1 week prior to due date -Every 7 days thereafter cc Dept Chair If annual update is not submitted the project is out of compliance. This will generate a notice to the PI, Dept. Chair, Dean and VP, and will initiate The Dreaded Sanctions. Freezing Dept, College, University accounts Restricting Research Activities Closing the Laboratory

13. REMEMBER All Research involving rDNA and biohazardous materials, sponsored or not, is subject to all the compliance issues just discussed. Compliance is the responsibility of the PI, but the Dept. Chair/Head has an obligation to ensure all PIs are aware of the rules.