HPHC Testing to Evidence: Turning Your Lab Results into a §910(b) Package

Answers: “HPHC testing PMTA evidence §910(b)”

You already pay a lab to measure Harmful and Potentially Harmful Constituents (HPHCs). The question is how to convert those raw numbers into the toxicological evidence a §910(b) submission needs — without weeks of manual work.

The conversion path

1. Input measured HPHC concentrations.
2. Apply the corrected IUR library (OEHHA/EPA IRIS/IARC).
3. Compute Σ ELCR, expressed as % of the 1R6F reference.
4. Auto-tier into FDA's 5-level concern scale.
5. Export a §1114.7-formatted section with traceable citations.

The traditional route — manual IUR calculation plus external tox review — takes weeks. The computed route takes minutes, using the same lab inputs you already hold.

Pros vs. cons. Pro: your existing lab spend does double duty; the toxicology section becomes reproducible and auditable. Con: ELCR quality is only as good as the HPHC panel completeness — omitted constituents mean an incomplete risk sum.

Who should NOT buy: applicants without HPHC lab data yet (get testing first), or those with a complete tox dossier already written.