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Title 21

This content is from the eCFR and is authoritative but unofficial.

Displaying title 21, up to date as of 9/15/2026. Title 21 was last amended 9/11/2026.
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  1. Title 21 —Food and Drugs
  2. Chapter I —Food and Drug Administration, Department of Health and Human Services
  3. Subchapter A —General
  4. Part 1 —General Enforcement Regulations
  5. Subpart R —Laboratory Accreditation for Analyses of Foods
  6. General Requirements
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General Requirements

§ 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:

(ii) Shell eggs. Sections 118.4(a)(2)(iii), 118.5(a)(2)(ii) and (b)(2)(ii), and 118.6(a)(2) and (e) of this chapter; and

(iii) Bottled drinking water. Section 129.35(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;

(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) 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) 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) of the Federal Food, Drug, and Cosmetic Act.

(4) In support of admission of an article of food under section 801(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) 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) of the Federal Food, Drug, and Cosmetic Act pursuant to paragraph (a)(4) or (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.

§ 1.1108 When and how will FDA issue a directed food laboratory order?

(a) FDA may require the owner or consignee to conduct food testing, or to have food testing conducted on their behalf, under this subpart to address an identified or suspected food safety problem, as FDA deems appropriate.

(b) The directed food laboratory order will specify the food product or environment to be tested; whether the food testing may be conducted using a LAAF-accredited laboratory that is owned, operated, or controlled by the owner or consignee; the timeframe in which the food testing must be conducted; and the manner of the food testing, such as the methods that must be used.

(c) The directed food laboratory order will contain all the elements required by § 16.22(a) of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter. An affected owner or consignee may request a regulatory hearing on a directed food laboratory order pursuant to § 1.1174.

§ 1.1109 How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?

FDA will place on its website a publicly available registry listing of:

(a) Recognized accreditation bodies, including for each: the name, contact information, and duration of recognition of the recognized accreditation body;

(b) Accreditation bodies that have a change in recognition, including for each: the name of the accreditation body, the specific change in recognition (i.e., probation, revocation of recognition, denial of renewal of recognition, relinquishment of recognition, or expiration of recognition) and the effective date of the change;

(c) LAAF-accredited laboratories, including for each: the name, contact information, and scope of LAAF-accreditation, and the name and contact information of the recognized accreditation body that has LAAF-accredited the laboratory; and

(d) Laboratories that have a change in LAAF-accreditation, including for each: the name of the laboratory, the specific change in LAAF-accreditation (i.e., suspension, reduction of scope, or withdrawal of LAAF-accreditation by the recognized accreditation body, probation or disqualification by FDA, or relinquishment of LAAF-accreditation), and the effective date of the change.

§ 1.1110 What are the general requirements for submitting information to FDA under this subpart?

(a) All applications, reports, notifications, and records submitted to FDA under this subpart must be submitted electronically and in English unless otherwise specified. If FDA requests inspection or submission of records that are maintained in any language other than English, the recognized accreditation body or LAAF-accredited laboratory must provide an English translation within a reasonable time.

(b) A program applicant must provide any translation and interpretation services needed by FDA during the processing of the application, including during any onsite assessments of the applicant by FDA.

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