---
kind: "section"
citation: "21 C.F.R. § 117.430"
title: "21"
number: "117.430"
heading: "Conducting supplier verification activities for raw materials and other ingredients."
url: "https://uscodex.org/cfr/21/117.430"
---

# §117.430. Conducting supplier verification activities for raw materials and other ingredients.

- (a) Except as provided by paragraph [(c)](#c), [(d)](#d), or [(e)](#e) of this section, one or more of the supplier verification activities specified in [§ 117.410(b)](/cfr/21/117.410.md?p=b), as determined under [§ 117.410(d)](/cfr/21/117.410.md?p=d), must be conducted for each supplier before using the raw material or other ingredient from that supplier and periodically thereafter.
- (b)
  - (1) Except as provided by [paragraph (b)(2)](#b-2) of this section, when a hazard in a raw material or other ingredient will be controlled by the supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans:
    - (i) The appropriate supplier verification activity is an onsite audit of the supplier; and
    - (ii) The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter.
  - (2) The requirements of [paragraph (b)(1)](#b-1) of this section do not apply if there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled.
- (c) If a supplier is a qualified facility as defined by [§ 117.3](/cfr/21/117.3.md), the receiving facility does not need to comply with paragraphs [(a)](#a) and [(b)](#b) of this section if the receiving facility:
  - (1) Obtains written assurance that the supplier is a qualified facility as defined by [§ 117.3](/cfr/21/117.3.md):
    - (i) Before first approving the supplier for an applicable calendar year; and
    - (ii) On an annual basis thereafter, by December 31 of each calendar year, for the following calendar year; and
  - (2) Obtains written assurance, at least every 2 years, that the supplier is producing the raw material or other ingredient in compliance with applicable FDA food safety regulations (or, when applicable, relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States). The written assurance must include either:
    - (i) A brief description of the preventive controls that the supplier is implementing to control the applicable hazard in the food; or
    - (ii) A statement that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries.
- (d) If a supplier is a farm that grows produce and is not a covered farm under [part 112](/cfr/21/part112.md) of this chapter in accordance with [§ 112.4(a)](/cfr/21/112.4.md?p=a), or in accordance with §§ [112.4(b)](/cfr/21/112.4.md?p=b) and [112.5](/cfr/21/112.5.md), the receiving facility does not need to comply with paragraphs [(a)](#a) and [(b)](#b) of this section for produce that the receiving facility receives from the farm as a raw material or other ingredient if the receiving facility:
  - (1) Obtains written assurance that the raw material or other ingredient provided by the supplier is not subject to [part 112](/cfr/21/part112.md) of this chapter in accordance with [§ 112.4(a)](/cfr/21/112.4.md?p=a), or in accordance with §§ [112.4(b)](/cfr/21/112.4.md?p=b) and [112.5](/cfr/21/112.5.md):
    - (i) Before first approving the supplier for an applicable calendar year; and
    - (ii) On an annual basis thereafter, by December 31 of each calendar year, for the following calendar year; and
  - (2) Obtains written assurance, at least every 2 years, that the farm acknowledges that its food is subject to [section 402](/cfr/21/402.md) of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that its food is subject to relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States).
- (e) If a supplier is a shell egg producer that is not subject to the requirements of [part 118](/cfr/21/part118.md) of this chapter because it has less than 3,000 laying hens, the receiving facility does not need to comply with paragraphs [(a)](#a) and [(b)](#b) of this section if the receiving facility:
  - (1) Obtains written assurance that the shell eggs produced by the supplier are not subject to [part 118](/cfr/21/part118.md) because the shell egg producer has less than 3,000 laying hens:
    - (i) Before first approving the supplier for an applicable calendar year; and
    - (ii) On an annual basis thereafter, by December 31 of each calendar year, for the following calendar year; and
  - (2) Obtains written assurance, at least every 2 years, that the shell egg producer acknowledges that its food is subject to [section 402](/cfr/21/402.md) of the Federal Food, Drug, and Cosmetic Act (or, when applicable, that its food is subject to relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or has determined to be equivalent to that of the United States).
- (f) There must not be any financial conflicts of interests that influence the results of the verification activities listed in [§ 117.410(b)](/cfr/21/117.410.md?p=b) and payment must not be related to the results of the activity.

## Notes

### Authority

Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.

### Source

Source: 80 FR 56145, Sept. 17, 2015, unless otherwise noted.