(a) Submission of accreditation or renewal application to a recognized accreditation body. A third-party certification body seeking accreditation must submit its request for accreditation or renewal of accreditation by a recognized accreditation body identified on the Web site described in § 1.690.

(b) Notice of records custodian after denial of application for renewal of accreditation. An applicant whose renewal application was denied by a recognized accreditation body must notify FDA electronically, in English, within 10 business days of the date of issuance of a denial of accreditation or denial of the renewal application, of the name and contact information of the custodian who will maintain the records required by § 1.658(a) and make them available to FDA as required by § 1.658(b) and (c). The contact information for the custodian must include, at a minimum, an email address and the physical address where the records required by § 1.658(a) will be located.

(c) Effect of denial of an application for renewal of accreditation on food or facility certifications issued to eligible entities. A food or facility certification issued by an accredited third-party certification body prior to issuance of the denial of its renewal application l will remain in effect until the certification expires. 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.

(d) Public notice of denial of an application for renewal of accreditation. FDA will provide notice on the Web site described in § 1.690 of the date of issuance of a denial of renewal of accreditation of a third-party certification body that had previous been accredited.

A recognized accreditation body may grant accreditation to a third-party certification body under this subpart for a period not to exceed 4 years.

(a) FDA will periodically evaluate the performance of each accredited third-party certification body to determine whether the accredited third-party certification body continues to comply with the applicable requirements of this subpart and whether there are deficiencies in the performance of the accredited third-party certification body that, if not corrected, would warrant withdrawal of its accreditation under § 1.664. FDA will evaluate each directly accredited third-party certification body annually. For a third-party certification body accredited by a recognized accreditation body, FDA will evaluate an accredited third-party certification body not later than 3 years after the date of accreditation for a 4-year term of accreditation, or by no later than the mid-term point for accreditation granted for less than 4 years. FDA may conduct additional performance assessments of an accredited third-party certification body at any time.

(b) In evaluating the performance of an accredited third-party certification body under paragraph (a) of this section, FDA may review any one or more of the following:

(1) Regulatory audit reports and food and facility certifications;

(2) The accredited third-party certification body's self-assessments under § 1.655;

(3) Reports of assessments by a recognized accreditation body under § 1.621;

(4) Documents and other information relevant to a determination of the accredited third-party certification body's compliance with the applicable requirements of this subpart; and

(5) Information obtained by FDA, including during inspections, audits, onsite observations, or investigations, of one or more eligible entities to which a food or facility certification was issued by such accredited third-party certification body.

(c) FDA may conduct its evaluation of an accredited third-party certification body through a site visit to an accredited third-party certification body's headquarters (or other location that manages audit agents conducting food safety audits under this subpart, if different than its headquarters), through onsite observation of an accredited third party certification body's performance during a food safety audit of an eligible entity, or through document review.

(a) An accredited third-party certification body may submit a request to FDA to waive the requirements of § 1.650(c) preventing an audit agent from conducting a regulatory audit of an eligible entity if the audit agent (or, in the case that the third-party certification body is an individual, the third-party certification body) has conducted a food safety audit of such entity during the previous 13 months. The accredited third-party certification body seeking a waiver or waiver extension must demonstrate there is insufficient access to audit agents and any third-party certification bodies that are comprised of an individual in the country or region where the eligible entity is located.

(b) Requests for a waiver or waiver extension and all documents provided in support of the request must be submitted to FDA electronically, in English. The requestor must provide such translation and interpretation services as are needed by FDA to process the request.

(c) The request must be signed by the requestor or by any individual authorized to act on behalf of the requestor for purposes of seeking such waiver or waiver extension.

(d) FDA will review requests for waivers and waiver extensions on a first in, first out basis according to the date on which the completed submission is received; however, FDA may prioritize the review of specific requests to meet the needs of the program. FDA will evaluate any completed waiver request to determine whether the criteria for waiver have been met.

(e) FDA will notify the requestor whether the request for a waiver or waiver extension is approved or denied.

(f) If FDA approves the request, issuance of the waiver will state the duration of the waiver and list any limitations associated with it. If FDA denies the request, the issuance of a denial of a waiver request will state the basis for denial and will provide the address and procedures for requesting reconsideration of the request under § 1.691.

(g) Unless FDA notifies a requestor that its waiver request has been approved, an accredited third-party certification body must not use the audit agent to conduct a regulatory audit of such eligible entity until the 13-month limit in § 1.650(c) has elapsed.

(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.

(a) Notice to FDA of intent to relinquish or not to renew accreditation. A third-party certification body must notify FDA electronically, in English, at least 60 days before voluntarily relinquishing accreditation or before allowing accreditation to expire without seeking renewal. The certification body must provide the name and contact information of the custodian who will maintain the records required under § 1.658(a) after the date of relinquishment or the date accreditation expires, as applicable, and make them available to FDA as required by § 1.658(b) and (c). The contact information for the custodian must include, at a minimum, an email address and the physical address where the records required by § 1.658(a) will be located.

(b) Notice to recognized accreditation body and eligible entities of intent to relinquish or not to renew accreditation. No later than 15 business days after notifying FDA under paragraph (a) of this section, the certification body must notify its recognized accreditation body and any eligible entity with current certifications that it intends to relinquish accreditation or to allow its accreditation to expire, specifying the date on which relinquishment or expiration will occur. The recognized accreditation body must establish and maintain records of such notification under § 1.625(a).

(c) Effect of voluntary relinquishment or expiration of accreditation on food or facility certifications issued to eligible entities. A food or facility certification issued by a third-party certification body prior to relinquishment or expiration of its accreditation will remain in effect until the certification expires. 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.

(d) Public notice of voluntary relinquishment or expiration of accreditation. FDA will provide notice on the Web site described in § 1.690 of the voluntary relinquishment or expiration of accreditation of a certification body under this subpart.

(a) Application following withdrawal. FDA will reinstate the accreditation of a third-party certification body for which it has withdrawn accreditation:

(1) If, in the case of direct accreditation, FDA determines, based on evidence presented by the third-party certification body, that the third-party certification body satisfies the applicable requirements of this subpart and adequate grounds for withdrawal no longer exist; or

(2) In the case of a third-party certification body accredited by an accreditation body for which recognition has been revoked under § 1.634:

(i) If the third-party certification body becomes accredited by another recognized accreditation body or by FDA through direct accreditation no later than 1 year after withdrawal of accreditation, or the original date of the expiration of accreditation, whichever comes first; or

(ii) Under such conditions as FDA may impose in withdrawing accreditation.

(b) Application following voluntary relinquishment. A third-party certification body that previously relinquished its accreditation under § 1.665 may seek accreditation by submitting a new application for accreditation under § 1.660 or, where applicable, § 1.670.