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Applications and Amendments

As a result of the many changes to the way Texas A&M University handles biological research agents and toxins, the rDNA and CIB Committees have been reorganized into one Committee, the Institutional Biosafety Committee (IBC). This committee will follow NIH guidelines to review relevant research on the Texas A&M University campus.

With the reorganization, a new process for approving applications, along with a revised application form that now covers human/animal/plant pathogens, toxins, recombinant DNA, and select agents is in place. Applications will be reviewed and approved for a three-year period, and individual submissions for each grant application will no longer be required. Registration of your laboratory, by completing the new IBC application, is required for utilization of agents in projects.

For example, if you are working with E. coli (specific strain), you need only complete the application one time in order to “register” your lab to work with E. coli for three years unless there is significant change in your specific strain, research agenda, personnel, or lab location, etc. In this case, an amendment will need to be completed to update the registration. An annual audit will be completed to ensure the research is still active and no changes have occurred.

New Application for IBC Permit:

Application Process Flowchart

 

Existing Protocol Forms:

IBC Amendment Form

Adverse Event Reporting Form Main Application 4-08 (revised 4-18-08)

Permit Renewal Form

Select Biological Agents and Toxins (SBAT) Forms:

SBAT Amendment Process Flowchart

FBI FD-961 Form

IBC Amendment - Part IIA - Plan Review

Agent Access Log  (click here to download instructions)

Facility Access Log

Personnel Change Form

Intra-facility Transfers


Additional References:

Appendix I - Definition of Risk Group and Biosafety Level (s)

Appendix II - APHIS, HHS, USDA, Cross Agent List

 

Additional Resources:

The NIH Guidelines can be accessed online at:

(HTML) - http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm

(PDF) - http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlnes_lnk_2002z.pdf

 

The CDC Guidelines can be accessed online at:

http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf

 

The CDC’s Select Agent list can be accessed online at: 

http://www.cdc.gov/od/sap/docs/salist.pdf

 

The Biosafety in Microbiological and Biomedical Laboratories (BMBL)- 5th edition can be accessed at:

http://cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm