§1.1138. What are the eligibility requirements for a LAAF-accredited laboratory? — Inbound Citations

(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.

(2) 2017(E), General requirements for the competence of testing and calibration laboratories, Third edition, November 2017, IBR approved for §§ 1.1120(c), 1.1121(a), 1.1138(a), 1.1139(b) and (c), 1.1141(a), 1.1152(a) and (d), 1.1153(c), and 1.1161(a).

In addition to the sample analysis requirements of § 1.1138(a):

In addition to the requirements of § 1.1138(a), a LAAF-accredited laboratory must meet the following requirements:

(a) In addition to the records requirements of § 1.1138(a), a LAAF-accredited laboratory must maintain, for 5 years after the date of creation, records created and received while it is LAAF-accredited that relate to compliance with this subpart, including:

(1) Documents related to the LAAF-accredited laboratory's grant of LAAF-accreditation (and, if applicable, extensions and reductions of scope of LAAF-accreditation) from its recognized accreditation body, including all required proficiency test and comparison program records for each method within the scope of LAAF-accreditation under § 1.1138(a)(2);

(2) Documentation of food testing the LAAF-accredited laboratory conducted under this subpart sufficient to account for all information required by § 1.1152(d), in accordance with § 1.1150(d);

(3) All documents that the LAAF-accredited laboratory was required to submit to FDA under §§ 1.1152 and 1.1153, and associated correspondence between the LAAF-accredited laboratory (and its officers, employees, and other agents) and the owner or consignee (and its officers, employees, and other agents) regarding food testing under this subpart;

(4) All requests for food testing from an owner or consignee that would be conducted under this subpart;

(5) Documentation of any internal investigations, internal audits, and corrective action taken to address any problems or deficiencies related to activities under this subpart;

(6) All documentation related to suspension, probation, reduction of scope, or withdrawal of LAAF-accreditation, or laboratory disqualification under this subpart; and

(7) Documentation of changes to its management system or food testing activities that may affect its compliance with this subpart.

(a) In addition to the impartiality and conflict of interest requirements in § 1.1138(a)(1), a LAAF-accredited laboratory must, subject to the exceptions in paragraph (b) of this section, prohibit the LAAF-accredited laboratory's employees, contractors, and agents involved in food testing under this subpart and related activities from accepting any money, gift, gratuity, or other item of value from the owner or consignee of the food that is being tested or will be tested by the LAAF-accredited laboratory.

(2) Need only address whether the laboratory meets the requirements of § 1.1138(a)(2) and (3) and (b).

(1) The LAAF-accredited laboratory must submit to FDA documentation of the LAAF-accredited laboratory's most recent internal audit, required under § 1.1154(a)(5), documentation showing compliance with the conflict of interest requirements in § 1.1147, and documentation of the most recent proficiency test or comparison program result for each test method within the laboratory's scope of LAAF-accreditation, to show compliance with § 1.1138(a)(2); and

(1) Documents related to the LAAF-accredited laboratory's grant of LAAF-accreditation (and, if applicable, extensions and reductions of scope of LAAF-accreditation) from its recognized accreditation body, including all required proficiency test and comparison program records for each method within the scope of LAAF-accreditation under § 1.1138(a)(2);

(2) Need only address whether the laboratory meets the requirements of § 1.1138(a)(2) and (3) and (b).

(2) Need only address whether the laboratory meets the requirements of § 1.1138(a)(2) and (3) and (b).