---
kind: "section"
citation: "21 C.F.R. § 1.1107"
title: "21"
number: "1.1107"
heading: "When must food testing be conducted under this subpart?"
url: "https://uscodex.org/cfr/21/1.1107"
---

# §1.1107. When must food testing be conducted under this subpart?

- (a) Food testing must be conducted under this subpart whenever such testing is conducted by or on behalf of an owner or consignee:
  - (1) In response to explicit testing requirements that address an identified or suspected food safety problem, which are contained in the following provisions:
    - (i) **Sprouts.** Section [112.146(a)](/cfr/21/112.146.md?p=a), [(c)](/cfr/21/112.146.md?p=c), and [(d)](/cfr/21/112.146.md?p=d) of this chapter;
    - (ii) **Shell eggs.** Sections [118.4(a)(2)(iii)](/cfr/21/118.4.md?p=a-2-iii), [118.5(a)(2)(ii)](/cfr/21/118.5.md?p=a-2-ii) and [(b)(2)(ii)](/cfr/21/118.5.md?p=b-2-ii), and [118.6(a)(2)](/cfr/21/118.6.md?p=a-2) and [(e)](/cfr/21/118.6.md?p=a-e) of this chapter; and
    - (iii) **Bottled drinking water.** [Section 129.35(a)(3)(i)](/cfr/21/129.35.md?p=a-3-i) of this chapter (for the requirement to test five samples from the same sampling site that originally tested positive for Escherichia coli);
  - (2) As required by FDA in a directed food laboratory order issued under [§ 1.1108](/cfr/21/1.1108.md);
  - (3) To address an identified or suspected food safety problem and presented to FDA as part of evidence for a hearing under [section 423(c)](/cfr/21/423.md?p=c) of the Federal Food, Drug, and Cosmetic Act prior to the issuance of a mandatory food recall order, as part of a corrective action plan under [section 415(b)(3)(A)](/cfr/21/415.md?p=b-3-A) of the Federal Food, Drug, and Cosmetic Act submitted after an order suspending the registration of a food facility, or as part of evidence submitted for an appeal of an administrative detention order under [section 304(h)(4)(A)](/cfr/21/304.md?p=h-4-A) of the Federal Food, Drug, and Cosmetic Act.
  - (4) In support of admission of an article of food under [section 801(a)](/cfr/21/801.md?p=a) of the Federal Food, Drug, and Cosmetic Act; and
  - (5) **To support removal from an import alert through successful consecutive testing.**
- (b) When food testing is conducted under [paragraph (a)](#a) of this section, analysis of samples must be conducted by a laboratory that is LAAF-accredited for the appropriate analytical method by a recognized accreditation body under this subpart.
- (c) Food testing conducted on articles of food offered for import into the United States under [section 801(a)](/cfr/21/801.md?p=a) of the Federal Food, Drug, and Cosmetic Act pursuant to paragraph [(a)(4)](#a-4) or [(a)(5)](#a-5) of this section may only be conducted after the articles offered for import have arrived in the United States unless the owner or consignee has written approval from FDA that a sample taken prior to arrival is or would be a representative sample of the article offered for import into the United States.

## Notes

### Source

Source: 86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.

### Authority

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.