What Is A Microbiological Screen?
A microbiological screen is a series of tests that report the amount of molds, yeasts, and bacteria in a sample. This report commonly identifies molds, yeasts, and bacteria in Colony Forming Units (CFU).
Why Is A Microbiological Screen Important?
We are surrounded by molds, fungi, and a multitude of microorganisms on a daily basis. For those with compromised immune systems, some can be more harmful than others and individuals may experience adverse reactions to molds and yeasts.
What Level Of Molds Or Mildew Will Be Considered Useable Under HB 3460?
Oregon Law and OAR 333-008-1190 allow for a mold and mildew limit of 10,000 CFU/g.
We at Green Leaf Lab believe this limit is too high, as there is not enough peer-reviewed scientific research that shows this limit is safe for medicinal patients.
Do I Have To Get Testing For Aerobic Microbial Count Or Other Bacteria To Comply With HB 3460?
No, Currently, HB 3460 does not require testing of Aerobic microbial, or pathogenic strains such as E.coli or Salmonella.
Providers that may want to offer medicinal cannabis for patients who have compromised immune systems can order additional testing for aerobic microbial counts and bacteria.
If I Get Additional Microbiological Testing For Bacteria, What Are The Current Standards?
While there are no current requirements under HB3460 for Aerobic Microbial Counts ( bacteria) or E.coli and Salmonella screens, the USP Pharmacopeia and the American Herbal Pharmacopoeia have published guidelines.
The USP Pharmacopeia, Section 1111 (May, 2009) limits for preparations for inhalation use
- Total Aerobic Microbial Count (bacteria) limit: 10² or 200 cfu
- Escherichia coli (1 g or 1 mL): Absence or Not Detected at 1g or 1 mL
The American Herbal Pharmacopoeia (December, 2013) limits for orally consumed botanical products
- Total Viable Aerobic Bacteria limit for Unprocessed Materials: 10⁵
- Total Viable Aerobic Bacteria Limit for Processed Materials: 10⁵
- Total Viable Aerobic Bacteria limit for CO2 and solvent-based extracts: 10⁴
- Escherichia coli for Unprocessed Materials: Not detected in 1g
- Escherichia coli for Processed Materials: Not detected in 1g
- Escherichia coli for CO2 and solvent-based extracts: Not detected in 1g
- Salmonella for Unprocessed Materials: Not detected in 1g
- Salmonella for Processed Materials: Not detected in 1g
- Salmonella for CO2 and solvent-based extracts: Not detected in 1g