US FDA/CFSAN - BSE and Cosmetics: FDA Risk Assessment and Management Perspectives
December 7, 2006
BSE Risk Assessment
- Conclusions
- vCJD - may be caused by BSE "prions"
- Primary source of exposure - Ingestion of infected beef
- Secondary routes of exposure - Topical (abraded skin), Ocular, or Oral/Buccal potentially possible, even if unlikely
- Dose/Response (cattle) - Small doses still infectious but require longer incubation periods
- Species Barrier - Human = ca. 101 - 104 (cattle)
- Quantitative Risk Assessment - difficult due to much "Uncertainty" in assumptions and available data
- Risk Management
- Effectiveness of cosmetic manufacturing processes for inactivating BSE prions is unknown
- Best control of risk through cosmetics is to avoid and control exposure to high-risk cattle raw materials used in the manufacture of cosmetics.
