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15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271.
42 FR 15553, Mar. 22, 1977, unless otherwise noted.
86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.
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(a) In addition to meeting the impartiality and conflict of interest requirements of § 1.1113(a), a recognized accreditation body must:
(1) Ensure that the recognized accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) does not own or have a financial interest in, manage, or otherwise control any laboratory (or any affiliate, parent, or subsidiary) it LAAF-accredits, subject to the exceptions in paragraphs (c) and (d) of this section; and
(2) Prohibit, subject to the exceptions in paragraph (e) of this section, officers, employees, or other agents involved in LAAF-accreditation activities of the recognized accreditation body from accepting any money, gift, gratuity, or other item of value from any laboratory the recognized accreditation body LAAF-accredits or assesses for LAAF-accreditation.
(b) The financial interests of any children younger than 18 years of age or a spouse of a recognized accreditation body's officers, employees, and other agents involved in LAAF-accreditation activities are considered the financial interests of such officers, employees, and other agents involved in LAAF-accreditation activities.
(c) An accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) may have an interest in a publicly traded or publicly available investment fund (e.g., a mutual fund), or a widely held pension or similar fund if the accreditation body (and its officers, employees, or other agents involved in LAAF-accreditation activities) neither exercises control nor has the ability to exercise control over the financial interests held in the fund.
(d) A recognized accreditation body's agent that is a contract assessor will be permitted to own or have a financial interest in, manage, or otherwise control a LAAF-accredited laboratory if all of the following circumstances apply:
(1) The contract assessor's primary occupation is owning or having a financial interest in, managing, or otherwise controlling a LAAF-accredited laboratory;
(2) The assessor contracts with the recognized accreditation body to provide assessment services on an intermittent or part-time basis;
(3) The contract assessor does not assess the LAAF-accredited laboratory that the assessor owns or has a financial interest in, manages, or otherwise controls; and
(4) The contract assessor and the recognized accreditation body inform any laboratory that the contract assessor may assess or reassess for LAAF-accreditation that the contract assessor owns or has a financial interest in, manages, or otherwise controls a LAAF-accredited laboratory. The laboratory seeking LAAF-accreditation assessment or reassessment must acknowledge that the contract assessor owns or has a financial interest in, manages, or otherwise controls a LAAF-accredited laboratory and be provided the option to be assessed by a different representative of the recognized accreditation body.
(e) The prohibited items of value specified in paragraph (a)(2) of this section do not include:
(1) Money representing payment of fees for LAAF-accreditation services or reimbursement of direct costs associated with an onsite assessment or reassessment of the laboratory; or
(2) Meal of de minimis value provided during the course of an assessment or reassessment and on the premises where the assessment or reassessment is conducted, if necessary for the efficient conduct of the assessment or reassessment.
(a) A recognized accreditation body must conduct an initial assessment of a laboratory seeking LAAF-accreditation in accordance with the requirements of this subpart, to determine whether the laboratory meets the requirements of § 1.1138.
(b) Subject to the exception in paragraph (c) of this section, the initial assessment must be conducted onsite, although certain assessment activities may be conducted remotely if it will not aid the assessment to conduct them onsite.
(c) If, within the previous 2 years, the recognized accreditation body conducted an onsite assessment of the laboratory in accordance with ISO/IEC 17011:2017(E) (incorporated by reference, see § 1.1101) to assess whether the laboratory meets the requirements of ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101), then the initial assessment under this section:
(1) May be conducted remotely, and
(2) Need only address whether the laboratory meets the requirements of § 1.1138(a)(2) and (3) and (b).
(d) A recognized accreditation body must oversee the performance of a laboratory it LAAF-accredits in accordance with the requirements of § 1.1113(a), except as otherwise provided by this subpart, to determine whether the LAAF-accredited laboratory continues to meet the applicable requirements of this subpart.
(e) A recognized accreditation body must conduct a reassessment of a LAAF-accredited laboratory in accordance with this subpart at least every 2 years. Such reassessment must be conducted onsite, although certain reassessment activities may be conducted remotely if it will not aid in the reassessment to conduct the activities onsite.
(f) If the recognized accreditation body conducted the initial assessment of the LAAF-accredited laboratory remotely in accordance with paragraph (c) of this section, the recognized accreditation body must conduct its first reassessment of the LAAF-accredited laboratory no later than 2 years after the recognized accreditation body last conducted an onsite assessment of the laboratory.
(g) The reassessment at the end of the LAAF-accredited laboratory's ISO/IEC 17025:2017-accreditation cycle, which the recognized accreditation body must conduct in accordance with this subpart, must be conducted onsite, although certain reassessment activities may be conducted remotely if it will not aid the reassessment to conduct them onsite.
(h) Any assessments or reassessments conducted by a recognized accreditation body in addition to the assessments or reassessments referred to in paragraphs (a), (e), and (g) of this section may be conducted remotely if it will not aid the assessment or reassessment to conduct it onsite.
(a) Corrective action. A recognized accreditation body may require corrective action using the procedures described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 8.7 to address any deficiencies identified while assessing and overseeing a LAAF-accredited laboratory.
(1) The recognized accreditation body must notify the LAAF-accredited laboratory of all deficiencies requiring corrective action and will either specify a deadline to implement corrective action or will require the LAAF-accredited laboratory to submit a corrective action plan and timeframe for implementation to the recognized accreditation body for approval.
(2) The LAAF-accredited laboratory must implement appropriate corrective action under ISO/IEC 17025:2017(E) section 8.7, and submit the results of the corrective action to the recognized accreditation body.
(3) The recognized accreditation body will review the corrective action and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(b) Suspension. If a recognized accreditation body determines that a laboratory it LAAF-accredits has not effectively implemented corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may temporarily suspend the LAAF-accredited laboratory for one or more LAAF-accredited methods, and require corrective action under paragraph (a) of this section.
(1) The recognized accreditation body must notify the LAAF-accredited laboratory of the grounds for the suspension, the LAAF-accredited methods subject to the suspension, and all deficiencies that must be addressed via the process described in paragraph (a) of this section.
(2) The recognized accreditation body must notify FDA of the suspension under this section in accordance with the requirements of § 1.1123(d)(5). FDA will provide notice of the LAAF-accredited laboratory's suspension on the website described in § 1.1109.
(3) The recognized accreditation body will review the corrective action required under paragraph (b) of this section and will notify the LAAF-accredited laboratory whether the corrective action is acceptable.
(4) A LAAF-accredited laboratory shall remain suspended until it demonstrates to the recognized accreditation body's satisfaction that the LAAF-accredited laboratory has successfully implemented appropriate corrective action.
(5) If the recognized accreditation body determines that a LAAF-accredited laboratory on suspension has failed to implement appropriate corrective action or otherwise fails to address deficiencies identified, the recognized accreditation body may reduce the scope of or withdraw the LAAF-accreditation of the laboratory under paragraph (c) of this section.
(c) Reduction of scope or withdrawal of LAAF-accreditation. A recognized accreditation body must reduce the scope of or withdraw the LAAF-accreditation of a laboratory it LAAF-accredits when the laboratory substantially fails to comply with this subpart. When only certain methods within the laboratory's scope of LAAF-accreditation are affected by the noncompliance, the recognized accreditation body may reduce the scope of the laboratory's LAAF-accreditation for only those affected methods. If all methods are affected, the recognized accreditation body must withdraw the laboratory's LAAF-accreditation.
(d) Procedures for reduction of scope or withdrawal of LAAF-accreditation.
(1) The recognized accreditation body must notify the laboratory of any reduction of scope or withdrawal of LAAF-accreditation, including:
(i) The grounds for the reduction of scope or withdrawal of LAAF-accreditation;
(ii) The method(s) to which the reduction of scope applies;
(iii) The procedures for appealing the reduction of scope or withdrawal of LAAF-accreditation as described in § 1.1122; and
(iv) The date the reduction of scope or withdrawal of LAAF-accreditation is effective.
(2) The recognized accreditation body must notify FDA of the reduction of scope or withdrawal of LAAF-accreditation under this section in accordance with the requirements in § 1.1123(d)(4). FDA will provide notice of the reduction of scope or withdrawal of the laboratory's LAAF-accreditation on the website described in § 1.1109.
(e) Records request associated with suspension, reduction of scope, or withdrawal of LAAF-accreditation. To assist the recognized accreditation body in determining whether a suspension, reduction of scope, or withdrawal of LAAF-accreditation is warranted under this section, the recognized accreditation body may require the submission of records that the LAAF-accredited laboratory is required to maintain under § 1.1154.
(f) Consequences of suspension, reduction of scope, or withdrawal of LAAF-accreditation.
(1) A LAAF-accredited laboratory may not conduct food testing under this subpart using suspended methods.
(2) If the recognized accreditation body withdraws the laboratory's LAAF-accreditation, the laboratory is immediately ineligible to conduct any food testing under this subpart. If the recognized accreditation body reduces the laboratory's scope of LAAF-accreditation, the laboratory is immediately ineligible to use the methods to which the reduction of scope applies to conduct food testing under this subpart.
A recognized accreditation body must consider a laboratory's appeal regarding a decision to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation in accordance with the requirements of § 1.1113(a). Appeals must be reviewed and decided by a competent person(s) free from bias or prejudice who has not participated in the LAAF-accreditation decision and is not the subordinate of a person who participated in the LAAF-accreditation decision. For the purposes of appeals, the competent person(s) may be external to the recognized accreditation body.
(a) General requirements. All reports and notifications required by this section must include:
(1) The name, street address, telephone number, and email address of the recognized accreditation body associated with the report or notification, and the name of an appropriate point of contact for the recognized accreditation body, and
(2) If the report or notification concerns a LAAF-accredited laboratory, the name, street address, telephone number, and email address of the LAAF-accredited laboratory, and the name of an appropriate point of contact for the LAAF-accredited laboratory.
(b) Internal audit reports. A recognized accreditation body must submit to FDA a report of the results of the internal audit conducted pursuant to § 1.1125 within 45 calendar days of completing the audit. The audit report must include:
(1) A description of the internal audit conducted;
(2) A description of any identified deficiencies;
(3) A description of any corrective action taken or planned, including the timeline for such corrective action; and
(4) A statement disclosing the extent to which the internal audit was conducted by personnel different from those who perform the activity or activities that were audited.
(c) Changes affecting recognition. A recognized accreditation body must notify FDA within 48 hours when the recognized accreditation body is aware of a change that would affect the recognition of such accreditation body, and the notification must include:
(1) A description of the change, and
(2) If the change is one made by the recognized accreditation body, an explanation of the purpose of the change.
(d) Changes in LAAF-accreditation. A recognized accreditation body must notify FDA and submit a certificate reflecting the scope of accreditation within 48 hours when any of the following occur:
(1) The recognized accreditation body grants or extends LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation granted, and
(iii) The effective date of the grant or extension;
(2) The recognized accreditation body denies LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation requested by the laboratory,
(ii) The scope of LAAF-accreditation denied, and
(iii) The grounds for the denial;
(3) The recognized accreditation body receives notice that a laboratory it LAAF-accredits intends to relinquish its LAAF-accreditation and the laboratory has not provided notice to FDA 60 calendar days prior to relinquishment as required under § 1.1140. The recognized accreditation body's notification must include:
(i) The scope of LAAF-accreditation to which the relinquishment applies, as applicable, and
(ii) The effective date of the relinquishment;
(4) The recognized accreditation body reduces the scope of or withdraws the LAAF-accreditation of a laboratory, and the notification must include:
(i) The scope of LAAF-accreditation to which the reduction applies,
(ii) The grounds for the reduction of scope or withdrawal, and
(iii) The effective date of the reduction of scope or withdrawal;
(5) The recognized accreditation body suspends or lifts the suspension of a LAAF-accredited laboratory, and the notification must include:
(i) The scope of LAAF-accreditation to which the suspension applies,
(ii) The grounds for the suspension or for lifting the suspension, and
(iii) The effective date of the suspension or date the suspension is lifted.
(e) Laboratory fraud. A recognized accreditation body must notify FDA within 48 hours if the recognized accreditation body knows that a laboratory it LAAF-accredits has committed fraud or submitted material false statements to FDA, and the notification must include:
(1) A description of the basis for the recognized accreditation body's knowledge of the fraud or material false statements,
(2) A description of the fraud or material false statements, and
(3) The action(s) taken by the recognized accreditation body with respect to such LAAF-accredited laboratory.
(a) In addition to meeting the requirements of § 1.1113(a) related to records, a recognized accreditation body must maintain, for 5 years after the date of creation of the records, records created while it is recognized demonstrating its compliance with this subpart, including records relating to:
(1) Applications for LAAF-accreditation;
(2) Assessments, reassessments, and decisions to grant, extend the scope of, renew, deny, reduce the scope of, or withdraw LAAF-accreditation or to suspend or lift the suspension of a LAAF-accredited laboratory;
(3) Appeals of suspensions, denials, reductions of scope of, and withdrawals of LAAF-accreditation, final decisions on such appeals, and the bases for such final decisions;
(4) Its oversight of laboratories it has LAAF-accredited;
(5) Its oversight of its own performance, including all records related to internal audits, complaints, and corrective actions;
(6) Any reports or notifications required to be submitted to FDA under § 1.1123, including any supporting information;
(7) Records of fee payments and reimbursement of direct costs; and
(8) Any documents demonstrating compliance with the requirements for assessment activities by contract assessors with certain financial interests described in § 1.1119(d).
(b) A recognized accreditation body must make the records it is required to maintain by paragraph (a) of this section available for inspection and copying or for electronic submission upon written request of an authorized officer or employee of FDA. If FDA requests records for inspection and copying, the recognized accreditation body must make such records promptly available at the physical location of the recognized accreditation body or at another reasonably accessible location. If FDA requests electronic submission, the records must be submitted within 10 business days of the request.
(c) A recognized accreditation body must not prevent or interfere with FDA's access to the records the LAAF-accredited laboratories it LAAF-accredits are required to maintain under § 1.1154.
As part of the internal audit a recognized accreditation body is required to conduct pursuant to § 1.1113(a), the recognized accreditation body must audit its compliance with the requirements of § 1.1113(d).