Are there any US regulations I should be aware of related to handling mammalian cell cultures?
Are there any US regulations I should be aware of if I want to start a lab that handles mammalian cell cultures? Are such regulations feasible for a DIY lab? Where could I learn about such regulations?
Answer from a Biosafety Officer:
February 18, 2014
Great question. The main regulation to consider is likely to be the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard.The type of cells that would be used in the lab will have an impact. If the cells are human, then the OSHA Bloodborne Pathogen's Standard applies, otherwise it does not.
Depending on type of cell lines you are planning on working, your lab should be designed to meet either biosafety level 1 (BL1) or BL2 standards. Documents that accompany cell line purchases may describe the appropriate biosafety level for which the cells should be worked with. As a default, all human cells should be worked with at BL2.
Descriptions of the practices, equipment, and laboratory facilities required for both BL1 and BL2 can be found in Section IV of the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL).
The other OSHA regulations that apply to labs are directed primarily at chemical exposures and therefore may or may not apply, such as the OSHA Laboratory Safety Standard, the Hazard Communication Standard, and Occupational Exposure to Hazardous Chemicals in Laboratories.
Other regulations to consider:
- Fire code can also come into play as well when dealing with chemicals, especially flammable solvents such as ethanol.
- Local and state medical waste handling regulations would come into play depending upon the type of cells handled.
We believe it would generally be feasible for a DIY lab to comply with these and other applicable regulations.
1. OSHA Bloodborne Pathogens Standard. 29 CFR 1910.1030. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051 Accessed 02/03/2014.
2. Wilson, D., and L. Chosewood, editors. Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th edition. Centers for Disease Control and Prevention and National Institutes of Health. 2009. http://www.cdc.gov/biosafety/publications/bmbl5/ Accessed 02/03/2014.