21 CFR § 123.16 - Process controls.

---
identifier: "/us/cfr/t21/s123.16"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 123.16 - Process controls."
title_number: 21
title_name: "Food and Drugs"
section_number: "123.16"
section_name: "Process controls."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "123"
part_name: "FISH AND FISHERY PRODUCTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264."
regulatory_source: "60 FR 65197, Dec. 18, 1995, unless otherwise noted."
cfr_part: "123"
---


# 123.16 Process controls.

In order to meet the requirements of subpart A of this part, processors of smoked and smoke-flavored fishery products, except those subject to the requirements of part 113 or 114 of this chapter, shall include in their HACCP plans how they are controlling the food safety hazard associated with the formation of toxin by *Clostridium botulinum* for at least as long as the shelf life of the product under normal and moderate abuse conditions.