1. I receive no funding from NIH. Do I have to register?
Yes. If your research involves infectious agents, potentially infectious material, or recombinant nucleic acids, you must register with the University of Kentucky Institutional Biosafety Committee. Since the University receives funding from NIH grants, ALL research conducted at the University has to comply with NIH Guidelines and University policies.

2. I receive no external funding. Do I have to register?
Yes. If your research involves infectious agents, potentially infectious material, or recombinant nucleic acids, you must register with the University of Kentucky Institutional Biosafety Committee. Since the University receives funding from NIH grants, ALL research conducted at the University has to comply with NIH Guidelines and University policies.

3. I only work with plants and Agrobacterium. Do I have to register?
Yes, you must register with the IBC and comply with the USDA guidelines and regulations for containment of transgenic plant and plant materials. If your research involves infectious agents, potentially infectious material, or recombinant nucleic acids, you must register with the University of Kentucky Institutional Biosafety Committee. Since the University receives funding from NIH grants, ALL research conducted at the University has to comply with NIH Guidelines and University policies. Complete and submit Parts 1-5 Plant (Word ), and Attachment P (Word ).

4. I only perform transgenic research in Arabidopsis. Do I have to register?
Yes, you must register with the IBC and comply with the USDA guidelines and regulations for containment of transgenic plant and plant materials. If your research involves infectious agents, potentially infectious material, or recombinant nucleic acids, you must register with the University of Kentucky Institutional Biosafety Committee. Since the University receives funding from NIH grants, ALL research conducted at the University has to comply with NIH Guidelines and University policies. Complete and submit Parts 1-5 Plant (Word ), and Attachment P (Word ).

5. I work with Drosophila and create mutants of Drosophila with P element-mediated transformation. Do I have to complete the IBC form?
Yes, you must register with Parts 1-5 (Word ) and Attachment R (Word ). Whether this research has to have full IBC review and approval depends upon the genes being introduced back into the Drosophila. The BSO will determine whether full review and approval are required.

6. I work with mouse tissue culture and mouse gene transfections. Sometimes I use human tissue cultures. I have never registered with the IBC because I am exempt from the NIH Guidelines. Why do I have to fill out forms now and why am I considered to be doing BSL2 research now?

The University of Kentucky Institutional Biosafety Committee is now charged with registering ALL recombinant DNA research on UK campus, even "exempt" work. Whether this research has to have full IBC review and approval depends upon the genes being introduced into the tissue culture. The BSO will make this decision. Any work with human cell or tissue culture, even commercially derived (e.g. ATCC), is considered to be "other potentially infectious material" (OPIM) unless the investigator or commercial source characterizes and documents the material to be free of contamination from human hepatitis viruses, human immunodeficiency viruses, and other recognized or latent blood borne pathogens. This is the OSHA interpretation of the Bloodborne Pathogens Standard (29CFR 1910.1030, http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051 ). Usually, the only additional procedures that are required are in the disposal of the "biohazardous waste" (bleach disinfection of flasks before pouring down the drain, bleach disinfection of pipettes in a flat tray in BSC then drain and dispose of pipettes in glass box, etc) or autoclaving everything that has come in contact with the cells.
The other implications include the requirement that all personnel complete the Blood Borne Pathogen training offered on-line by the OSHA Department of Environmental Health and Safety at http://ehs.uky.edu/ehs_webquiz/quizzes/takequiz.asp?id=MXPNG. Copies of the certificates must be in the laboratory safety manual. The laboratory safety template at http://ehs.uky.edu/hmm/safeprac.html incorporates the required elements of the BBP "Exposure Control Plan" ( http://ehs.uky.edu/docs/doc/bio_attachment_ecp.rtf ) Use this template to write the laboratory specific procedure and put a copy in the laboratory safety manual.

More information on this designation is available from the BSO or at website for human cell lines.
Complete and submit Parts 1-5 (Word ), and Attachment TC (Word ).

7. I only work with BL1 agents, so I am exempt from any registration. Why are you bothering me?

The compliance required of you depends upon what exactly you are doing and with which agents. It may be that the wildlife you have been working with for ten years is now infected with a zoonotic, infectious agent. Or it may be that the NIH Guidelines and interpretations of those Guidelines have changed. The BSO can determine whether you must simply register (which involves completing the forms for BSO review) or whether the IBC must review and approve your work. Contact the BSO (Marcia Finucane, mfinu2@email.uky.edu, 323-5728) to discuss what you are doing in your research, present documentation of the biosafety level for the agents, and to determine whether full review and approval are required.

8. How do I know what I need for biosafety level 2 research?

The standards for research and clinical laboratories are published by the Centers for Disease Control, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), at http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm.

9. How do I find out what biosafety level I am supposed to use for the infectious agents I work with?

The IBC uses the BMBL (above) or the American Type Culture Collection (ATCC) http://www.atcc.org/), Health Canada (http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index.html) or comparable sources for biosafety levels.

10. I am moving my lab to another building. What do I have to do?

First, follow the lab exit process outlined at http://ehs.uky.edu/ohs/exit.html. Second, complete the Biosafety Modification Form and e-mail to the BSO, mfinu2@email.uky.edu. Third, make an appointment with the BSO for a laboratory audit of the new laboratory location before you are moved in to ensure that it is suitable for your research and to recommend equipment placement. The BSO will also inspect the laboratory after the biological safety cabinet has been recertified to ensure compliance with recommendations.

11. My research involves collecting saliva samples from patients in an outpatient clinic and then culturing for viruses in the research laboratory. Do I have to register with the IBC?
YES, you must register with the IBC. This is research conducted in a research laboratory and by culturing the viruses, the number of infectious particles are increasing therefore increasing the theoretical risk to workers.

12. What about research that involves outpatient samples being analyzed in the clinical laboratory of the hospital?
If the analysis is routine, diagnostic testing: NO
Some research conducted in the clinical laboratory may need to be registered with the IBC. Consult the BSO.

13. I have a fellowship grant to conduct recombinant DNA research. Do I have to register?
Probably not. Check with the Principal Investigator of your fellowship position. If that person is registered with the IBC and your research is part of his/her research, then you do not have to register again. If your research will be quite different from the protocol that received IBC approval, then the Principal Investigator needs to register your project with the IBC.

14. I am working with E. coli K12, plasmids and Saccharomyces. Do I have to register with the IBC?
Yes. Depending upon the types of genetic material being manipulated this may be a simple registration with the BSO or it may require full review and approval by the IBC. Submit Parts 1-5 (Word ) and Attachment R (Word ).

HUMAN CELL LINES vs. STRAINS

DEFINITIONS from OSHA in correspondence with the American Biological Safety Association:

A Human Cell LINE is defined as in vitro or animal passaged (e.g., nude mouse) cultures or human cells that fulfill traditional requirements of a cell line designation. That is, the cells are immortalized cells, transformed by spontaneous mutation or natural or laboratory infection with an immortalizating agent such as Epstein-Barr virus (EBV). EBV is a bloodborne pathogen. It should be noted that human cervical carcinoma cells or other transformed human cell lines like HeLa cells are sometimes adulterated with laboratory pathogens accidentally introduced by cultivation with other cell cultures, or physically contaminated by other cell cultures handled in the same lab. In order to handle human HeLa cells, without having to comply with the requirements of the bloodborne pathogens standard (BPS), human HeLa cells should be documented to be pure HeLa cells and shown to be free of bloodborne pathogens by testing.

Characterization of human cells, for inclusion or exclusion from compliance with the BPS, would include screening of the cells lines or "strains" for viruses characterized as bloodborne pathogens by the Standard, including human immunodeficiency viruses, hepatitis viruses or EBV, if the cells are capable of propagating such viruses. Most cell lines are screened for human mycoplasmas and are free of bacterial and mycotic contaminants. Testing may include antigenic screening for viral or agent markers, co-cultivation with various indicator cells that allow contaminants to grow, or using molecular technology (polymerase chain reaction or nucleic acid hybridization) to identify latent viruses capable of infecting humans such as Herpesviruses (e.g., EBV), or papilloma members of the Papovavirus group, etc. Cell lines that are procured from commercial vendors or other sources with documented testing to be free of human bloodborne pathogens and which have been protected by the employer from environmental contamination may be excluded from the BPS.

Human cell STRAINS are defined as cells propagated in vitro from primary explants of human tissue or body fluids which have finite lifetime (non-transformed) in tissue culture for 20-70 passages. Human cell "strains" must be handled as potential biohazards unless characterized by testing to be free of blood borne pathogens).