Justify residue acceptance limits
Carryover limits require toxicological justification and consideration of equipment trains.
CV-REQ-000002
VISUAL GUIDE 02
HBEL → PDE → MACO
Connect the toxicological concept to a product-pair carryover assessment without confusing the values.
THE A3 FIELD POSTER
Understand the number
Follow exposure, carryover and units through a worked MACO example.
- HBEL, PDE and MACO distinguished
- A complete example with visible assumptions
- Unit checks and operational-limit context
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CLEAN VALIDATED / VISUAL GUIDE 02
HBEL → PDE → MACO
CONCEPT
HBEL
A health-based exposure limit describes an acceptable exposure in a defined assessment.
EXPRESSION
PDE
Permitted Daily Exposure is one expression of an HBEL. It is not a separate limit obtained by converting an HBEL.
APPLICATION
MACO
A product-pair carryover calculation combines the exposure basis with justified next-product and equipment assumptions.
This is a conceptual map, not a calculation tool. Route, units, dose, batch size and equipment allocation need review. The resulting safety basis is not automatically the routine operating limit.
LEARNING OBJECTIVE
What this guide helps you explain
Distinguish an exposure limit from a carryover quantity and an operational cleaning limit.