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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR1.1138]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 1 -- GENERAL ENFORCEMENT REGULATIONS

Subpart R - Laboratory Accreditation for Analyses of Foods

LAAF-Accreditation of Laboratories

Sec. 1.1138 What are the eligibility requirements for a LAAF-accredited laboratory?

(a) A laboratory that is LAAF-accredited or seeking LAAF-accreditation must demonstrate it is capable of conducting each method of food testing for which it is or will be LAAF-accredited by meeting all of the following requirements:

(1) For each method, the laboratory is accredited by a recognized accreditation body to ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101).

(2)(i) Except as provided in paragraph (a)(2)(ii) of this section, the laboratory has successfully passed a proficiency test provided by a competent proficiency testing organization within the last 12 months for each method within the scope of LAAF-accreditation.

(ii) If the laboratory determines there is no proficiency testing program available or practicable for a method, it may use a comparison program. A laboratory must request approval from the recognized accreditation body regarding the determination prior to using a comparison program in lieu of an annual proficiency test. The laboratory is required to demonstrate competency through participation in the comparison program.

(iii) A laboratory must submit all proficiency test and comparison program results, regardless of outcome, to the recognized accreditation body within 30 calendar days of receipt.

(3) The laboratory ensures that its procedures for monitoring the validity of the results of testing it conducts under this subpart include the use of reference materials or quality control samples with each batch of samples it tests under this subpart.

(b) Will comply with all additional requirements for LAAF-accredited laboratories under this subpart while LAAF-accredited.

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