Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=sp21.1.1.m&rgn=div6
Timestamp: 2020-07-14 14:22:41
Document Index: 313338328

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Title 21 → Chapter I → Subchapter A → Part 1 → Subpart M
Subpart M—Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
§1.600 What definitions apply to this subpart?
§1.601 Who is subject to this subpart?
§1.610 Who is eligible to seek recognition?
§1.611 What legal authority must an accreditation body have to qualify for recognition?
§1.612 What competency and capacity must an accreditation body have to qualify for recognition?
§1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition?
§1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?
§1.615 What records procedures must an accreditation body have to qualify for recognition?
§1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
§1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
§1.622 How must a recognized accreditation body monitor its own performance?
§1.623 What reports and notifications must a recognized accreditation body submit to FDA?
§1.624 How must a recognized accreditation body protect against conflicts of interest?
§1.625 What records requirements must an accreditation body that has been recognized meet?
§1.630 How do I apply to FDA for recognition or renewal of recognition?
§1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
§1.632 What is the duration of recognition?
§1.633 How will FDA monitor recognized accreditation bodies?
§1.634 When will FDA revoke recognition?
§1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition?
§1.636 How do I request reinstatement of recognition?
§1.640 Who is eligible to seek accreditation?
§1.641 What legal authority must a third-party certification body have to qualify for accreditation?
§1.642 What competency and capacity must a third-party certification body have to qualify for accreditation?
§1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
§1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?
§1.645 What records procedures must a third-party certification body have to qualify for accreditation?
§1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective?
§1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
§1.652 What must an accredited third-party certification body include in food safety audit reports?
§1.653 What must an accredited third-party certification body do when issuing food or facility certifications?
§1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
§1.655 How must an accredited third-party certification body monitor its own performance?
§1.656 What reports and notifications must an accredited third-party certification body submit?
§1.657 How must an accredited third-party certification body protect against conflicts of interest?
§1.658 What records requirements must a third-party certification body that has been accredited meet?
§1.660 Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application?
§1.661 What is the duration of accreditation by a recognized accreditation body?
§1.662 How will FDA monitor accredited third-party certification bodies?
§1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
§1.664 When would FDA withdraw accreditation?
§1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
§1.666 How do I request reaccreditation?
§1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation?
§1.671 How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?
§1.672 What is the duration of direct accreditation?
§1.680 How and when will FDA monitor eligible entities?
§1.681 How frequently must eligible entities be recertified?
§1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
§1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request?
§1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
§1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
§1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
§1.695 Are the records obtained by FDA under this subpart subject to public disclosure?
§1.700 Who is subject to a user fee under this subpart?
§1.705 What user fees are established under this subpart?
§1.710 How will FDA notify the public about the fee schedule?
§1.715 When must a user fee required by this subpart be submitted?
§1.720 Are user fees under this subpart refundable?
§1.725 What are the consequences of not paying a user fee under this subpart on time?
Source: 80 FR 74650, Nov. 27, 2015, unless otherwise noted.
(a) The FD&C Act means the Federal Food, Drug, and Cosmetic Act.
(b) Except as otherwise defined in paragraph (c) of this section, the definitions of terms in section 201 of the FD&C Act apply when the terms are used in this subpart.
(c) In addition, for the purposes of this subpart:
Accreditation means a determination by a recognized accreditation body (or, in the case of direct accreditation, by FDA) that a third-party certification body meets the applicable requirements of this subpart.
Accreditation body means an authority that performs accreditation of third-party certification bodies.
Accredited third-party certification body means a third-party certification body that a recognized accreditation body (or, in the case of direct accreditation, FDA) has determined meets the applicable requirements of this subpart and is accredited to conduct food safety audits and to issue food or facility certifications to eligible entities. An accredited third-party certification body has the same meaning as accredited third-party auditor as defined in section 808(a)(4) of the FD&C Act.
(i) With respect to an accreditation body, an evaluation by FDA of the competency and capacity of the accreditation body under the applicable requirements of this subpart for the defined scope of recognition. An assessment of the competency and capacity of the accreditation body involves evaluating the competency and capacity of the operations of the accreditation body that are relevant to decisions on recognition and, if recognized, an evaluation of its performance and the validity of its accreditation decisions under the applicable requirements of this subpart.
(ii) With respect to a third-party certification body, an evaluation by a recognized accreditation body (or, in the case of direct accreditation, FDA) of the competency and capacity of a third-party certification body under the applicable requirements of this subpart for the defined scope of accreditation. An assessment of the competency and capacity of the third-party certification body involves evaluating the competency and capacity of the operations of the third-party certification body that are relevant to decisions on accreditation and, if accredited, an evaluation of its performance and the validity of its audit results and certification decisions under the applicable requirements of this subpart.
Audit means the systematic and functionally independent examination of an eligible entity under this subpart by an accredited third-party certification body or by FDA. An audit conducted under this subpart is not considered an inspection under section 704 of the FD&C Act.
Audit agent means an individual who is an employee or other agent of an accredited third-party certification body who, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party certification body. An audit agent includes a contractor of the accredited third-party certification body but excludes subcontractors or other agents under outsourcing arrangements for conducting food safety audits without direct control by the accredited third-party certification body.
Consultative audit means an audit of an eligible entity:
(i) To determine whether such entity is in compliance with the applicable food safety requirements of the FD&C Act, FDA regulations, and industry standards and practices;
(ii) The results of which are for internal purposes only; and
(iii) That is conducted in preparation for a regulatory audit; only the results of a regulatory audit may form the basis for issuance of a food or facility certification under this subpart.
Direct accreditation means accreditation of a third-party certification body by FDA.
Eligible entity means a foreign entity in the import supply chain of food for consumption in the United States that chooses to be subject to a food safety audit under this subpart conducted by an accredited third-party certification body. Eligible entities include foreign facilities required to be registered under subpart H of this part.
Facility means any structure, or structures of an eligible entity under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, holds, grows, harvests, or raises animals for food for consumption in the United States. Transport vehicles are not facilities if they hold food only in the usual course of business as carriers. A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership. The private residence of an individual is not a facility. Non-bottled water drinking water collection and distribution establishments and their structures are not facilities. Facilities for the purposes of this subpart are not limited to facilities required to be registered under subpart H of this part.
Facility certification means an attestation, issued for purposes of section 801(q) or 806 of the FD&C Act by an accredited third-party certification body, after conducting a regulatory audit and any other activities necessary to establish whether a facility complies with the applicable food safety requirements of the FD&C Act and FDA regulations.
Food has the meaning given in section 201(f) of the FD&C Act, except that food does not include pesticides (as defined in 7 U.S.C. 136(u)).
Food certification means an attestation, issued for purposes of section 801(q) of the FD&C Act by an accredited third-party certification body, after conducting a regulatory audit and any other activities necessary to establish whether a food of an eligible entity complies with the applicable food safety requirements of the FD&C Act and FDA regulations.
Food safety audit means a regulatory audit or a consultative audit that is conducted to determine compliance with the applicable food safety requirements of the FD&C Act, FDA regulations, and for consultative audits, also includes conformance with industry standards and practices. An eligible entity must declare that an audit is to be conducted as a regulatory audit or consultative audit at the time of audit planning and the audit will be conducted on an unannounced basis under this subpart.
Foreign cooperative means an autonomous association of persons, identified as members, who are united through a jointly owned enterprise to aggregate food from member growers or processors that is intended for export to the United States.
Recognized accreditation body means an accreditation body that FDA has determined meets the applicable requirements of this subpart and is authorized to accredit third-party certification bodies under this subpart.
Regulatory audit means an audit of an eligible entity:
(i) To determine whether such entity is in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations; and
(ii) The results of which are used in determining eligibility for certification under section 801(q) or under section 806 of the FD&C Act.
Relinquishment means:
(i) With respect to an accreditation body, a decision to cede voluntarily its authority to accredit third-party certification bodies as a recognized accreditation body prior to expiration of its recognition under this subpart; and
(ii) With respect to a third-party certification body, a decision to cede voluntarily its authority to conduct food safety audits and to issue food and facility certifications to eligible entities as an accredited third-party certification body prior to expiration of its accreditation under this subpart.
Self-assessment means an evaluation conducted by a recognized accreditation body or by an accredited third-party certification body of its competency and capacity under the applicable requirements of this subpart for the defined scope of recognition or accreditation. For recognized accreditation bodies this involves evaluating the competency and capacity of the entire operations of the accreditation body and the validity of its accreditation decisions under the applicable requirements of this subpart. For accredited third-party certification bodies this involves evaluating the competency and capacity of the entire operations of the third-party certification body and the validity of its audit results under the applicable requirements of this subpart.
Third-party certification body has the same meaning as third-party auditor as that term is defined in section 808(a)(3) of the FD&C Act and means a foreign government, agency of a foreign government, foreign cooperative, or any other third party that is eligible to be considered for accreditation to conduct food safety audits and to certify that eligible entities meet the applicable food safety requirements of the FD&C Act and FDA regulations. A third-party certification body may be a single individual or an organization. Once accredited, a third-party certification body may use audit agents to conduct food safety audits.
(a) Accreditation bodies. Any accreditation body seeking recognition from FDA to accredit third-party certification bodies to conduct food safety audits and to issue food and facility certifications under this subpart.
(b) Third-party certification bodies. Any third-party certification body seeking accreditation from a recognized accreditation body or direct accreditation by FDA for:
(1) Conducting food safety audits; and
(2) Issuing certifications that may be used in satisfying a condition of admissibility of an article of food under section 801(q) of the FD&C Act; or issuing a facility certification for meeting the eligibility requirements for the Voluntary Qualified Importer Program under section 806 of the FD&C Act.
(c) Eligible entities. Any eligible entity seeking a food safety audit or a food or facility certification from an accredited third-party certification body under this subpart.
(d) Limited exemptions from section 801(q) of the FD&C Act—(1) Alcoholic beverages. (i) Any certification required under section 801(q) of the FD&C Act does not apply with respect to alcoholic beverages from an eligible entity that is a facility that meets the following two conditions:
(A) Under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 et seq.), the facility is a foreign facility of a type that, if it were a domestic facility, would require obtaining a permit from, registering with, or obtaining approval of a notice or application from the Secretary of the Treasury as a condition of doing business in the United States; and
(B) Under section 415 of the FD&C Act, the facility is required to register as a facility because it is engaged in manufacturing/processing one or more alcoholic beverages.
(ii) Any certification required under section 801(q) of the FD&C Act does not apply with respect to food that is not an alcoholic beverage that is received and distributed by a facility described in paragraph (d)(1)(i) of this section, provided such food:
(A) Is received and distributed in prepackaged form that prevents any direct human contact with such food; and
(iii) Any certification required under section 801(q) of the FD&C Act does not apply with respect to raw materials or other ingredients that are imported for use in alcoholic beverages provided that:
(A) The imported raw materials or other ingredients are used in the manufacturing/processing, packing, or holding of alcoholic beverages;
(B) Such manufacturing/processing, packing, or holding is performed by the importer;
(C) The importer is required to register under section 415 of the Federal Food, Drug, and Cosmetic Act; and
(D) The importer is exempt from the regulations in part 117 of this chapter in accordance with §117.5(i).
(2) Certain meat, poultry, and egg products. Any certification required under section 801(q) of the FD&C Act does not apply with respect to:
(i) Meat food products that at the time of importation are subject to the requirements of the United States Department of Agriculture (USDA) under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);
(ii) Poultry products that at the time of importation are subject to the requirements of the USDA under the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); and
(iii) Egg products that at the time of importation are subject to the requirements of the USDA under the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
An accreditation body is eligible to seek recognition by FDA if it can demonstrate that it meets the requirements of §§1.611 through 1.615. The accreditation body may use documentation of conformance with International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17011:2004, supplemented as necessary, in meeting the applicable requirements of this subpart.
(1) In the case of a foreign government or an agency of a foreign government, such reviews and audits of the government's or agency's food safety programs, systems, and standards as are necessary to determine that it meets the eligibility requirements of §1.640(b).
(2) In the case of a foreign cooperative or any other third-party seeking accreditation as a third-party certification body, such reviews and audits of the training and qualifications of agents conducting audits for such cooperative or other third party (or in the case of a third-party certification body that is an individual, such individual) and such reviews of internal systems and any other investigation of the cooperative or other third party necessary to determine that it meets the eligibility requirements of §1.640(c).
(b) A recognized accreditation body must require a third-party certification body, as a condition of accreditation under this subpart, to comply with the reports and notification requirements of §§1.652 and 1.656 and to agree to submit to FDA, electronically and in English, any food or facility certifications it issues for purposes of sections 801(q) or 806 of the FD&C Act.
(d) A recognized accreditation body must notify any third-party certification body of an adverse decision associated with its accreditation under this subpart, including denial of accreditation or the withdrawal, suspension, or reduction in the scope of its accreditation. The recognized accreditation body must establish and implement written procedures for receiving and addressing appeals from any third-party certification body challenging such an adverse decision and for investigating and deciding on appeals in a fair and meaningful manner. The appeals procedures must provide similar protections to those offered by FDA under §§1.692 and 1.693, and include requirements to:
(4) Maintain records under §1.625 of appeals, final decisions on appeals, and the bases for such decisions.
(a) A recognized accreditation body must annually conduct a comprehensive assessment of the performance of each third-party certification body it accredited under this subpart by reviewing the accredited third-party certification body's self-assessments (including information on compliance with the conflict of interest requirements of §§1.643 and 1.657); its regulatory audit reports and notifications submitted to FDA under §1.656; and any other information reasonably available to the recognized accreditation body regarding the compliance history of eligible entities the accredited third-party certification body certified under this subpart; or that is otherwise relevant to a determination whether the accredited third-party certification body is in compliance with this subpart.
(a) A recognized accreditation body must annually, and as required under §1.664(g), conduct a self-assessment that includes evaluation of compliance with this subpart, including:
(2) The compliance of the recognized accreditation body and its officers, employees, and other agents involved in accreditation activities, with the conflict of interest requirements of §1.624; and
(b) As a means to evaluate the recognized accreditation body's performance, the self-assessment must include onsite observation of regulatory audits of a representative sample of third-party certification bodies it accredited under this subpart. In meeting this requirement, the recognized accreditation body may use the results of onsite observations performed under §1.621(b).
(3) Establish and maintain records of any such corrective action(s) under §1.625.
(d) The recognized accreditation body must prepare, and as required by §1.623(b) submit, a written report of the results of its self-assessment that includes the following elements. Documentation of conformance to ISO/IEC 17011:2004 may be used, supplemented as necessary, in meeting the requirements of this paragraph.
(2) A statement disclosing the extent to which the recognized accreditation body, and its officers, employees, and other agents involved in accreditation activities, complied with the conflict of interest requirements in §1.624; and
(a) Reporting results of assessments of accredited third-party certification body performance. A recognized accreditation body must submit to FDA electronically, in English, a report of the results of any assessment conducted under §1.621, no later than 45 days after completing such assessment. The report must include an up-to-date list of any audit agents used by the accredited third-party certification body to conduct food safety audits under this subpart.
(1) A report of the results of an annual self-assessment required under §1.622, no later than 45 days after completing such self-assessment; and
(2) For a recognized accreditation body subject to §1.664(g)(1), a report of such self-assessment to FDA within 60 days of the third-party certification body's withdrawal. A recognized accreditation body may use a report prepared for conformance to ISO/IEC 17011:2004, supplemented as necessary, in meeting the requirements this section.
(3) Determining that a third-party certification body it accredited failed to comply with §1.653 in issuing a food or facility certification under this subpart, and include:
(1) Applications for accreditation and renewal of accreditation under §1.660;
(3) Challenges to adverse accreditation decisions under §1.620(c);
(4) Its monitoring of accredited third-party certification bodies under §1.621;
(5) Self-assessments and corrective actions under §1.622;
(7) Any reports or notifications to FDA under §1.623, including any supporting information; and
(c) An accreditation body that has been recognized must not prevent or interfere with FDA's access to its accredited third-party certification bodies and the accredited third-party certification body records required by §1.658.
(a) Applicant for recognition. An accreditation body seeking recognition must submit an application demonstrating that it meets the eligibility requirements in §1.610.
(d) Issuance of denial of recognition or renewal application. FDA will notify an applicant that its recognition or renewal application has been denied through issuance of a denial of recognition or denial of a renewal application that will state the basis for such denial and provide the procedures for requesting reconsideration of the application under §1.691.
(e) Notice of records custodian after denial of an application for renewal of recognition. An applicant whose renewal application was denied must notify FDA electronically, in English, within 10 business days of the date of issuance of a denial of a renewal application, of the name and contact information of the custodian who will maintain the records required by §1.625(a) and make them available to FDA as required by §1.625(b). The contact information for the custodian must include, at a minimum, an email address and the physical address where the records required by §1.625(a) will be located.
(i) No later than 60 days after FDA's issuance of the notice of the denial of recognition renewal, conducts a self-assessment under §1.655 and reports the results of the self-assessment to FDA under §1.656(b); and
(2) FDA may withdraw the accreditation of a third-party certification body whenever FDA determines there is good cause for withdrawal of accreditation under §1.664(c).
(h) Public notice of denial of an application for renewal of recognition of an accreditation body. FDA will provide notice on the Web site described in §1.690 of the date of issuance of a denial of a renewal application and will describe the basis for the denial.
(1) Refusal by the accreditation body to allow FDA to access records required by §1.625, or to conduct an assessment or investigation of the accreditation body or of a third-party certification body it accredited to ensure the accreditation body's continued compliance with the requirements of this subpart.
(i) The accreditation of a third-party certification body it accredited is withdrawn by FDA under §1.664(a);
(ii) A significant deficiency is identified through self-assessment under §1.622, monitoring under §1.621, or self-assessment by one or more of its accredited third-party certification bodies under §1.655; or
(iii) Failure to pay the annual user fee within 90 days of the payment due date, as specified in §1.725(b)(3).
(b) Records request associated with revocation. To assist in determining whether revocation is warranted under paragraph (a) of this section, FDA may request records of the accreditation body required by §1.625 or the records, required by §1.658, of one or more of the third-party certification bodies it accredited under this subpart.
(c) Issuance of revocation of recognition. (1) FDA will notify an accreditation body that its recognition has been revoked through issuance of a revocation that will state the grounds for revocation, the procedures for requesting a regulatory hearing under §1.693 on the revocation, and the procedures for requesting reinstatement of recognition under §1.636.
(2) Within 10 business days of the date of issuance of the revocation, the accreditation body must notify FDA electronically, in English, of the name of the custodian who will maintain the records and make them available to FDA as required by §1.625. The contact information for the custodian must provide, at a minimum, an email address and the physical address where the records will be located.
(i) No later than 60 days after FDA's issuance of the notice of revocation, conducts a self-assessment under §1.655 and reports the results of the self-assessment to FDA under §1.656(b); and
(f) Public notice of revocation of recognition. FDA will provide notice on the Web site described in §1.690 of the issuance of the revocation of recognition of an accreditation body and will describe the basis for revocation.
(a) Notice to FDA of intent to relinquish or not to renew recognition. A recognized accreditation body must notify FDA electronically, in English, at least 60 days before voluntarily relinquishing recognition or before allowing recognition to expire without seeking renewal. The recognized accreditation body must provide the name and contact information of the custodian who will maintain the records required under §1.625(a) after the date of relinquishment or the date recognition expires, as applicable, and make them available to FDA as required by §1.625(b). The contact information for the custodian must include, at a minimum, an email address and the physical address where the records required by §1.625(a) will be located.
(b) Notice to accredited third-party certification bodies of intent to relinquish or not to renew recognition. No later than 15 business days after notifying FDA under paragraph (a) of this section, the recognized accreditation body must notify any currently accredited third-party certification body that it intends to relinquish recognition or to allow its recognition 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.
(i) No later than 60 days after the date of relinquishment or the date of expiration of the recognition, conducts a self-assessment under §1.655 and reports the results of the self-assessment to FDA under §1.656(b); and
(e) Public notice of voluntary relinquishment or expiration of recognition. FDA will provide notice on the Web site described in §1.690 of the voluntary relinquishment or expiration of recognition of an accreditation body under this subpart.
(a) Application following revocation. An accreditation body that has had its recognition revoked may seek reinstatement by submitting a new application for recognition under §1.630. The accreditation body must submit evidence that the grounds for revocation have been resolved, including evidence addressing the cause or conditions that were the basis for revocation and identifying measures that have been implemented to help ensure that such cause(s) or condition(s) are unlikely to recur.
(b) Application following relinquishment. An accreditation body that previously relinquished its recognition under §1.635 may seek recognition by submitting a new application for recognition under §1.630.
(b) A foreign government or an agency of a foreign government is eligible for accreditation if it can demonstrate that its food safety programs, systems, and standards meet the requirements of §§1.641 through 1.645.
(c) A foreign cooperative or other third party is eligible for accreditation if it can demonstrate that the training and qualifications of its agents used to conduct audits (or, in the case of a third-party certification body that is an individual, such individual) and its internal systems and standards meet the requirements of §§1.641 through 1.645.
(b) The capability to meet the conflict of interest requirements in §1.657, if accredited.
(b) The capability to meet the quality assurance requirements of §1.655, if accredited.
(4) Is in compliance with the conflict of interest requirements of §1.657 and has no other conflicts of interest with the eligible entity to be audited that might impair the audit agent's objectivity; and
(c) An accredited third-party certification body cannot use an audit agent to conduct a regulatory audit at an eligible entity if such audit agent conducted a consultative audit or regulatory audit for the same eligible entity in the preceding 13 months, except that such limitation may be waived if the accredited third-party certification body demonstrates to FDA, under §1.663, there is insufficient access to audit agents in the country or region where the eligible entity is located. If the accredited third-party certification body is an individual, that individual is also subject to such limitations.
(4) Notify FDA immediately if, at any time during a food safety audit, the accredited third-party certification body (or its audit agent, where applicable) discovers a condition that could cause or contribute to a serious risk to the public health and provide information required by §1.656(c);
(i) For consultative audits, prepare reports that contain the elements specified in §1.652(a) and maintain such records, subject to FDA access in accordance with section 414 of the FD&C Act; and
(ii) For regulatory audits, prepare reports that contain the elements specified in §1.652(b) and submit them to FDA and to its recognized accreditation body (where applicable) under §1.656(a); and
(6) Allow FDA and the recognized accreditation body that accredited such third-party certification body, if any, to observe any food safety audit conducted under this subpart for purposes of evaluating the accredited third-party certification body's performance under §§1.621 and 1.662 or, where appropriate, the recognized accreditation body's performance under §§1.622 and 1.633.
(4) Audit observations and other data and information from the examination, including information on corrective actions, must be documented and must be used to support the findings contained in the audit report required by §1.652 and maintained as a record under §1.658.
(a) Consultative audits. An accredited third-party certification body must prepare a report of a consultative audit not later than 45 days after completing such audit and must provide a copy of such report to the eligible entity and must maintain such report under §1.658, subject to FDA access in accordance with the requirements of section 414 of the FD&C Act. A consultative audit report must include:
(6) Any deficiencies observed that relate to or may influence a determination of compliance with the applicable food safety requirements of the FD&C Act and FDA regulations that require corrective action, the corrective action plan, and the date on which such corrective actions were completed. Such consultative audit report must be maintained as a record under §1.658 and must be made available to FDA in accordance with section 414 of the FD&C Act.
(d) Notice and appeals of adverse regulatory audit results. An accredited third-party certification body must notify an eligible entity of a denial of certification and must establish and implement written procedures for receiving and addressing appeals from eligible entities challenging such adverse regulatory audit results and for investigating and deciding on appeals in a fair and meaningful manner. The appeals procedures must provide similar protections to those offered by FDA under §§1.692 and 1.693, including requirements to:
(4) Maintain records under §1.658 of the appeal, the final decision, and the basis for such decision.
(a) Basis for issuance of a food or facility certification. (1) Prior to issuing a food or facility certification to an eligible entity, an accredited third-party certification body (or, where applicable, an audit agent on its behalf) must complete a regulatory audit that meets the requirements of §1.651 and any other activities that may be necessary to determine compliance with the applicable food safety requirements of the FD&C Act and FDA regulations.
(2) If, as a result of an observation during a regulatory audit, an eligible entity must implement a corrective action plan to address a deficiency, an accredited third-party certification body may not issue a food or facility certification to such entity until after the accredited third-party certification body verifies that eligible entity has implemented the corrective action plan through methods that reliably verify the corrective action was taken and as a result the identified deficiency is unlikely to recur, except onsite verification is required for corrective actions required to address deficiencies that are the subject of a notification under §1.656(c).
(3) An accredited third-party certification body must consider each observation and the data and other information from a regulatory audit and other activities conducted under §1.651 to determine whether the entity was in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations at the time of the audit and whether the eligible entity, given its food safety system and practices, would be likely to remain in compliance for the duration of any certification issued under this subpart.
If an accredited third-party certification body has reason to believe that an eligible entity to which it issued a food or facility certification may no longer be in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations, the accredited third-party certification body must conduct any monitoring (including an onsite audit) of such eligible entity necessary to determine whether the entity is in compliance with such requirements. The accredited third-party certification body must immediately notify FDA, under §1.656(d), if it withdraws or suspends a food or facility certification because it determines that the entity is no longer in compliance with the applicable food safety requirements of the FD&C Act and FDA regulations. The accredited third-party certification body must maintain records of such monitoring under §1.658.
(a) An accredited third-party certification body must annually, upon FDA request made for cause, or as required under §1.631(f)(1)(i), §1.634(d)(1)(i), or §1.635(c)(1)(i), conduct a self-assessment that includes evaluation of compliance with this subpart, including:
(3) The compliance of the accredited third-party certification body and its officers, employees, and other agents involved in auditing and certification activities, with the conflict of interest requirements of §1.657;
(4) Actions taken in response to the results of any assessments conducted by FDA or, where applicable, the recognized accreditation body under §1.621; and
(3) Under §1.658, establish and maintain records of such corrective action(s).
(2) A statement disclosing the extent to which the accredited third-party certification body, and its officers, employees, and other agents involved in auditing and certification activities, complied with the conflict of interest requirements in §1.657; and
(a) Reporting results of regulatory audits. An accredited third-party certification body must submit a regulatory audit report, as described in §1.652(b), electronically, in English, to FDA and to the recognized accreditation body that granted its accreditation (where applicable), no later than 45 days after completing such audit.
(b) Reporting results of accredited third-party certification body self-assessments. An accredited third-party certification body must submit the report of its annual self-assessment required by §1.655 electronically to its recognized accreditation body (or, in the case of direct accreditation, electronically and in English, to FDA), within 45 days of the anniversary date of its accreditation under this subpart. For an accredited third-party certification body subject to an FDA request for cause, or §1.631(f)(1)(i), §1.634(d)(1)(i), or §1.635(c)(1)(i), the report of its self-assessment must be submitted to FDA electronically, in English, within 60 days of the FDA request, denial of renewal, revocation, or relinquishment of recognition of the accreditation body that granted its accreditation. Such report must include an up-to-date list of any audit agents it uses to conduct audits under this subpart.
(3) Any audit report and other documents resulting from a regulatory audit conducted under this subpart, including the audit agent's observations, correspondence with the eligible entity, verification of any corrective action(s) taken to address deficiencies identified during the audit, and, when sampling and analysis is conducted, laboratory testing records and results from a laboratory that is accredited in accordance with §1.651(b)(3), and documentation demonstrating such laboratory is accredited in accordance with §1.651(b)(3);
(4) Any notification submitted by an audit agent to the accredited third-party certification body in accordance with §1.650(a)(5);
(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.
(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) 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.
(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;
(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.
(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.
(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).
(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:
(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.
(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).
(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.
(2) In the case of a third-party certification body accredited by an accreditation body for which recognition has been revoked under §1.634:
(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.
(3) FDA will provide notice on the Web site described in §1.690 of a determination under paragraph (a)(1) of this section and of a revocation or modification of the determination under paragraph (a)(1) of this section, as described in paragraph (a)(2) of this section.
(b) Application for direct accreditation or renewal of direct accreditation. (1) A third-party certification body seeking direct accreditation or renewal of direct accreditation must submit an application to FDA, demonstrating that it is within the scope of the determination issued under paragraph (a)(1) of this section, and it meets the eligibility requirements of §1.640.
(e) Issuance of denial of direct accreditation. If FDA issues a denial of direct accreditation or denial of a renewal application, the issuance of the denial of direct accreditation will state the basis for such denial and provide the procedures for requesting reconsideration of the application under §1.691.
(f) Notice of records custodian after denial of application for renewal of direct accreditation. An applicant whose renewal application was denied must notify FDA electronically, in English, within 10 business days of the date of issuance of a denial of a 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(b) will be located.
(h) Public notice of denial of renewal of direct accreditation. FDA will provide notice on the Web site described in §1.690 of the issuance of a denial of renewal application for direct accreditation under this subpart.
FDA will place on its Web site a registry of recognized accreditation bodies and accredited third-party certification bodies, including the name, contact information, and scope and duration of recognition or accreditation. The registry may provide information on third-party certification bodies accredited by recognized accreditation bodies through links to the Web sites of such recognized accreditation bodies. FDA will also place on its Web site a list of accreditation bodies for which it has denied renewal of recognition, for which FDA has revoked recognition, and that have relinquished their recognition or have allowed their recognition to expire. FDA will also place in its Web site a list of certification bodies whose renewal of accreditation has been denied, for which FDA has withdrawn accreditation, and that have relinquished their accreditations or have allowed their accreditations to expire. FDA will place on its Web site determinations under §1.670(a)(1) and modifications of such determinations under §1.670(a)(2).
(b) A third-party certification body may seek reconsideration of the denial of an application for direct accreditation, renewal of direct accreditation, reaccreditation of directly accredited third-party certification body, a request for a waiver of the conflict of interest requirement in §1.650(b), or a waiver extension no later than 10 business days after the date of the issuance of such denial.
(a) No later than 10 business days after the date of issuance of a denial of an application or waiver request upon reconsideration under §1.691, the requestor may seek internal agency review of such denial under §10.75(c)(1) of this chapter.
(c) Under §10.75(d) of this chapter, internal agency review of such denial must be based on the information in the administrative file, which will include any supporting information submitted under §1.691(c).
(a) Request for hearing on revocation. No later than 10 business days after the date of issuance of a revocation of recognition of an accreditation body under §1.634, an individual authorized to act on the accreditation body's behalf may submit a request for a regulatory hearing on the revocation under part 16 of this chapter. The issuance of revocation issued under §1.634 will contain all of the elements required by §16.22 of this chapter and will thereby constitute the notice of an opportunity for hearing under part 16 of this chapter.
(b) Request for hearing on withdrawal. No later than 10 business days after the date of issuance of a withdrawal of accreditation of a third-party certification body under §1.664, an individual authorized to act on the third-party certification body's behalf may submit a request for a regulatory hearing on the withdrawal under part 16 of this chapter. The issuance of withdrawal under §1.664 will contain all of the elements required by §16.22 of this chapter and will thereby constitute the notice of opportunity of hearing under part 16 of this chapter.
(f) Denial of a request for regulatory hearing. The presiding officer may deny a request for regulatory hearing for a revocation or withdrawal under §16.26(a) of this chapter when no genuine or substantial issue of fact has been raised.
(2) The presiding officer must conduct the regulatory hearing for revocation or withdrawal under part 16 of this chapter, except that, under §16.5(b) of this chapter, such procedures apply only to the extent that the procedures are supplementary and do not conflict with the procedures specified for regulatory hearings under this subpart. Accordingly, the following requirements of part 16 are inapplicable to regulatory hearings under this subpart: §16.22 (Initiation of a regulatory hearing); §16.24(e) (timing) and (f) (contents of notice); §16.40 (Commissioner); §16.60(a) (public process); §16.95(b) (administrative decision and record for decision); and §16.119 (Reconsideration and stay of action).
Records that are established or maintained to satisfy the requirements of this subpart and that meet the definition of electronic records in §11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter.
Source: Sections 1.700 through 1.725 appear at 81 FR 90193, Dec. 14, 2016, unless otherwise noted.
(1) Recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work FDA performs to monitor performance of recognized accreditation bodies under §1.633.
(2) Third-party certification bodies directly accredited by FDA are subject to an annual fee for the estimated average cost of the work FDA performs to monitor directly accredited third-party certification bodies under §1.662.
(3) Third-party certification bodies accredited by recognized accreditation bodies are subject to an annual fee for the estimated average cost of the work FDA performs to monitor third-party certification bodies that are accredited by a recognized accreditation body under §1.662.
(a) An application for recognition or renewal of recognition will not be considered complete for the purposes of §1.631(a) until the date that FDA receives the application fee. An application for direct accreditation or for renewal of direct accreditation will not be considered complete for the purposes of §1.671(a) until FDA receives the application fee.
(1) FDA will notify the accreditation body electronically that its recognition is suspended. FDA will notify the public of the suspension on the Web site described in §1.690.
(3) If payment is not received within 90 days of the payment due date, FDA will revoke the accreditation body's recognition under §1.634(a)(4)(iii), and provide notice of such revocation in accordance with §1.634.
(1) FDA will notify the third-party certification body that its accreditation is suspended, electronically and in English. FDA will notify a recognized accreditation body, electronically and in English, if the accreditation of one if its third-party certification bodies is suspended. FDA will notify the public of the suspension on the Web site described in §1.690.
(3) If payment is not received within 90 days of the payment due date, FDA will withdraw the third-party certification body's accreditation under §1.664(a)(4), and provide notice of such withdrawal in accordance with §1.664.