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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 April 1 2017.

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]
[Revised as of April 1, 2017]
[CITE: 21CFR1.664]



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 M--Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications

Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart

Sec. 1.664 When would FDA withdraw accreditation?

(a) Mandatory withdrawal. FDA will withdraw accreditation from a third-party certification body:

(1) Except as provided in paragraph (b) of this section, if the food or facility certified under this subpart is linked to an outbreak of foodborne illness or chemical or physical hazard that has a reasonable probability of causing serious adverse health consequences or death in humans or animals;

(2) Following an evaluation and finding by FDA that the third-party certification body no longer complies with the applicable requirements of this subpart; or

(3) Following its refusal to allow FDA to access records under 1.658 or to conduct an audit, assessment, or investigation necessary to ensure continued compliance with this subpart.

(4) If payment of the third-party certification body's annual fee is not received within 90 days of the payment due date, as specified in 1.725(c)(3).

(b) Exception. FDA may waive mandatory withdrawal under paragraph (a)(1) of this section, if FDA:

(1) Conducts an investigation of the material facts related to the outbreak of human or animal illness;

(2) Reviews the relevant audit records and the actions taken by the accredited third-party certification body in support of its decision to certify; and

(3) Determines that the accredited third-party certification body satisfied the requirements for issuance of certification under this subpart.

(c) Discretionary withdrawal. FDA may withdraw accreditation, in whole or in part, from a third-party certification body when such third-party certification body is accredited by an accreditation body for which recognition is revoked under 1.634, if FDA determines there is good cause for withdrawal, including:

(1) Demonstrated bias or lack of objectivity when conducting activities under this subpart; or

(2) Performance that calls into question the validity or reliability of its food safety audits or certifications.

(d) Records access. FDA may request records of the accredited third-party certification body under 1.658 and, where applicable, may request records under 1.625 of an accreditation body that has been recognized under 1.625, when considering withdrawal under paragraph (a)(1), (a)(2), or (c) of this section.

(e) Notice to the third-party certification body of withdrawal of accreditation. (1) FDA will notify a third-party certification body of the withdrawal of its accreditation through issuance of a withdrawal that will state the grounds for withdrawal, the procedures for requesting a regulatory hearing under 1.693 on the withdrawal, and the procedures for requesting reaccreditation under 1.666.

(2) Within 10 business days of the date of issuance of the withdrawal, the third-party certification body must notify FDA electronically, in English, of the name of the custodian who will maintain the records required by 1.658, and provide contact information for the custodian, which will at least include an email address, and the street address where the records will be located.

(f) Effect of withdrawal of accreditation on eligible entities. A food or facility certification issued by a third-party certification body prior to withdrawal will remain in effect until the certification terminates by expiration. If FDA has reason to believe that a certification issued for purposes of section 801(q) or 806 of the FD&C Act is not valid or reliable, FDA may refuse to consider the certification in determining the admissibility of the article of food for which the certification was offered or in determining the importer's eligibility for participation in VQIP.

(g) Effect of withdrawal of accreditation on recognized accreditation bodies. (1) FDA will notify a recognized accreditation body if the accreditation of a third-party certification body it accredited is withdrawn by FDA. Such accreditation body's recognition will remain in effect if, no later than 60 days after withdrawal, the accreditation body conducts a self-assessment under 1.622 and reports the results of the self-assessment to FDA as required by 1.623(b).

(2) FDA may revoke the recognition of an accreditation body whenever FDA determines there is good cause for revocation of recognition under 1.634.

(h) Public notice of withdrawal accreditation. FDA will provide notice on the Web site described in 1.690 of its withdrawal of accreditation of a third-party certification body and provide a description of the basis for withdrawal.

[80 FR 74650, Nov. 27, 2015, as amended at 81 FR 90193, Dec. 14, 2016]

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