21 CFR § 158.3 - Definitions.

---
identifier: "/us/cfr/t21/s158.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 158.3 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "158.3"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "158"
part_name: "FROZEN VEGETABLES"
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, 341, 343, 348, 371."
cfr_part: "158"
---


# 158.3 Definitions.

For the purposes of this part the following definitions shall apply:

(a) *Lot.* A collection of primary containers or units of the same size, type and style manufactured or packed under similar conditions and handled as a single unit of trade.

(b) *Lot size.* The number of primary containers or units (pounds when in bulk) in the lot.

(c) *Sample size.* The total number of sample units drawn for examination from a lot.

(d) *Sample unit.* A container, a portion of the contents of a container, or a composite mixture of product from small containers that is sufficient for the examination or testing as a single unit.

(e) *Defective.* Any sample unit shall be regarded as defective when the sample unit does not meet the criteria set forth in the standards.

(f) *Acceptance number.* The maximum number of defective sample units permitted in the sample in order to consider the lot as meeting the specified requirements. The following acceptance numbers shall apply:

|  |  |  |
| --- | --- | --- |
|  |  |  |
| 4,800 or less | 13 | 2 |
| 4,801 to 24,000 | 21 | 3 |
| 24,001 to 48,000 | 29 | 4 |
| 48,001 to 84,000 | 48 | 6 |
| 84,001 to 144,000 | 84 | 9 |
| 144,001 to 240,000 | 126 | 13 |
| Over 240,000 | 200 | 19 |
|  |  |  |
| Number of Pounds |  |  |
| 20,000 or less | 13 | 2 |
| More than 20,000 to 100,000 | 21 | 3 |
| More than 100,000 to 200,000 | 29 | 4 |
| More than 200,000 to 400,000 | 48 | 6 |
| More than 400,000 to 600,000 | 84 | 9 |
| More than 600,000 to 1,000,000 | 126 | 13 |
| More than 1,000,000 | 200 | 19 |
| = number of sample units. |  |  |
| = acceptance number. |  |  |

(g) *Acceptable quality level* (*AQL*). The maximum percent of defective sample units permitted in a lot that will be accepted approximately 95 percent of the time.

[42 FR 14461, Mar. 15, 1977]