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(a) Requesting permission. A LAAF-accredited laboratory may request permission to submit abridged analytical reports for each major food testing discipline: Biological, chemical, and physical.
(1) FDA will grant permission to submit abridged analytical reports for a single major food testing discipline if all of the following conditions are met:
(i) The LAAF-accredited laboratory is not on suspension or probation for any method within the major food testing discipline that is the subject of its request (see § 1.1121(b) or § 1.1161(b));
(ii) The LAAF-accredited laboratory has successfully implemented any required corrective action under § 1.1121(a) or § 1.1161(a); and
(iii) The last five full analytical reports for the major food testing discipline contain no shortcomings that call into question the validity of the test results or repeated administrative errors.
(2) FDA will notify the LAAF-accredited laboratory if permission is granted or denied.
(b) FDA review of abridged analytical reports. (1) FDA will review all abridged analytical reports submitted.
(2) FDA will notify the LAAF-accredited laboratory if FDA identifies a shortcoming that calls into question the validity of the test results or repeated administrative errors, will require corrective action under § 1.1161(a), and may revoke permission to submit abridged analytical reports for the specific major food testing discipline.
(3) If FDA identifies a shortcoming that calls into question the validity of the test results or repeated administrative errors in abridged analytical reports from a LAAF-accredited laboratory that has previously had its permission to submit abridged analytical reports revoked for any major food testing discipline, FDA may put the LAAF-accredited laboratory on probation for one or more methods under § 1.1161(b). Under § 1.1162(a), a laboratory on probation for one or more methods may not submit abridged analytical reports for the major food testing disciplines of which the probationary methods are a part.
(4) A LAAF-accredited laboratory that has had permission to submit abridged analytical reports revoked for one or more major food testing disciplines may request permission to submit abridged analytical reports as described in paragraph (a) of this section for each major food testing discipline.
(c) Contents of abridged analytical reports. In addition to the documentation required to be submitted with all test results (see § 1.1152(c)), an abridged analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d); and
(2) Quality control results (including the expected result and whether it is acceptable).
(d) Exceptions. FDA may require additional documentation or a full analytical report from a LAAF-accredited laboratory permitted to submit abridged analytical reports in the following circumstances:
(1) FDA may require a full analytical report related to an FDA investigation or FDA enforcement proceeding.
(2) Occasionally, for the purposes of auditing abridged analytical reports and otherwise protecting the public health and the integrity of this food testing program, FDA will require additional documentation or a full analytical report within 72 hours of FDA's request.
(e) Consequence of omission. If FDA does not receive all information required to be submitted to FDA under paragraph (c) of this section, FDA may consider the related food testing to be invalid.
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