Per NIH guidelines (http://osp.od.nih.gov/officebiotechnology-activities/biosafety/nih-guidelines) and the Stanford University Administrative Panel on Biosafety policy (see Chapter 5, Charge to the APB), the APB requires researchers to have an approved APB protocol and follow specific guidelines for working with prions and prion-like proteins.
For APB oversight, prions and prion-like proteins are defined as proteins (human or animal) that fall into one of the below categories:
- Proteins that are highly associated with proteinopathies, including, but not limited to
- Major prion protein/PrP/CD230 (Creutzfeldt-Jakob Disease [CJD], variant Creutzfeldt-Jakob Disease [vCJD], Kuru, fatal familial insomnia, bovine spongiform encephalopathy, Gerstmann-Straussler-Scheinker syndrome),
- Alpha-synuclein (Parkinson’s disease),
- Tau, beta-amyloid (Alzheimer’s disease),
- Tau, RNA-binding protein Fused in Sarcoma (FUS) (Frontotemporal lobar dementias),
- Polyglutamine-containing proteins (polyQ) (Huntington’s disease),
- Superoxide dismutase 1 (SOD1); transactivation response element (TAR) DNA-binding protein-43 (TDP-43); FUS; Ubiquilin (ALS/Lou Gehrig’s disease).
- Proteins that confer a disease state that is transmissible from cell to cell.
- Proteins that have a fibrillar or aggregated form that has been shown to “seed” a pathology associated with a disease.
Specific in vitro or in vivo work with such proteins is classified as BSL2 or ABSL2 and requires an APB approved protocol. This includes, but is not limited to, the following types of work:
- Synthesis, use or production of protein in high concentration
- Generation or use of mutated proteins
- Generation or use of fibrillar or misfolded forms of proteins
APB protocols must include established prion disinfection/decontamination and destruction / disposal protocols, or specific Standard Operating Procedures (SOPs). These SOPs must be provided for review by the APB. If necessary, contact Biosafety for appropriate methods. Refer to the following references for established infection control guidelines for disinfection /decontamination:
- World Health Organization Infection Control Guidelines http://www.who.int/csr/resources/publications/bse/WHO_CDS_CSR_APH_2000_3/en/
- Centers for Disease Control Prion Diseases https://www.cdc.gov/prions/index.html
- Biosafety in Microbiology and Biomedical Laboratories http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_sect_VIII_h.pdf
- Biosafety Manual (see Chapter 11, Waste and Decontamination)