(a) General requirements. (1) All notifications, results, reports, and studies required to be submitted to FDA by a LAAF-accredited laboratory under this subpart must:
(i) Include the name and street address of the LAAF-accredited laboratory;
(ii) Identify a point of contact for the LAAF-accredited laboratory, including email and telephone number, whom FDA may contact with questions or comments;
(iii) Display an identification unique to the test results, report, notification, or study; and
(iv) Be true, accurate, unambiguous, and objective.
(2) The LAAF-accredited laboratory that conducts the analysis of the sample under this subpart is responsible for the submission of all notifications, results, reports, and studies to FDA as required by this section.
(3) If the LAAF-accredited laboratory becomes aware that any aspect of the submitted material is inaccurate, the LAAF-accredited laboratory must immediately inform FDA and submit a corrected version. Such corrections must meet the requirements for amendments to reports specified by ISO/IEC 17025:2017(E) (incorporated by reference, see § 1.1101) section 7.8.8.
(4) Any opinions and interpretations in any notification, result, report, or study submitted to FDA under this subpart must meet the requirements in ISO/IEC 17025:2017(E) section 7.8.7 and any statements of conformity to a specification or standard in any notification, result, report, or study submitted to FDA under this subpart must meet the requirements of ISO/IEC 17025:2017(E) section 7.8.6.
(b) Test results. (1) The LAAF-accredited laboratory must submit the results of all testing required to be conducted under this subpart directly to FDA via the location specified by the website described in § 1.1109, unless another location is specified by FDA regarding testing conducted under § 1.1107(a)(2) or (3).
(2) The test results must be clear and identify:
(i) The name and street address of the owner or consignee for which the testing was conducted,
(ii) As appropriate, the U.S. Customs and Border Protection entry and line number(s), and
(iii) The associated notifications, reports, and studies required to be submitted with the test results under this subpart.
(c) Documentation required to be submitted with test results. The following documentation must be included with each full analytical report (see paragraph (d) of this section) and each abridged analytical report (see § 1.1153) submitted to FDA under this subpart:
(1) All sampling plans and sample collection reports related to the food testing conducted as developed or obtained by the LAAF-accredited laboratory in accordance with § 1.1149;
(2) Written documentation of the sampler's qualifications or an indication that the sampler's qualifications have been submitted previously, in accordance with § 1.1149(a)(1);
(3) For any validation studies required by § 1.1151(c)(1), the documentation required by § 1.1151(c)(2);
(4) For any verification studies required by § 1.1151(d)(1), the documentation required by § 1.1151(d)(2);
(5) The justification for any modification to or deviation from the method(s) of analysis used and documentation of the LAAF-accredited laboratory's authorization for the modification or deviation; and
(6) A certification from one or more members of the LAAF-accredited laboratory's management certifying that the test results, notifications, reports, and studies are true and accurate; and that the documentation includes the results of all tests conducted under this subpart. The certification must include the name, title, and signature of any certifiers.
(d) Full analytical report contents. In addition to the documentation required to be submitted with all test results (see paragraph (c) of this section), a full analytical report must include:
(1) All information described by ISO/IEC 17025:2017(E) sections 7.8.2.1(a) through (p) and 7.8.3.1(a) through (d);
(2) Documentation of references for the method of analysis used;
(3) Name and signature of the analyst who conducted each analytical step, including any applicable validation and verification steps, and the date each step was performed;
(4) Calculations, presented in a legible and logical manner;
(5) As applicable, references to chromatograms, charts, graphs, observations, photographs of thin layer chromatographic plates, and spectra. References must be in color when appropriate and presented in a clear order;
(6) Identification of the source and purity of reference standards used, and, as applicable: Certified reference materials, certified reference cultures traceable to a nationally or internationally recognized type culture collection (including concentration, units, preparation, and storage conditions), and reference standard preparation information (including who prepared the reference standard, date of preparation, expiration date, chemical balance, and solvent used);
(7) A copy of the label from any immediate container sampled, if available, and any additional labeling needed to evaluate the product;
(8) All original compilations of raw data secured in the course of the analysis, including discarded, unused, or re-worked data, with the justification for discarding or re-working such data, corresponding supporting data, and quality control results (including the expected result and whether it is acceptable), all identified with unique sample identification, date, and time, associated with the test;
(9) Any other relevant additional supporting information such as the storage location of analyzed samples, appropriate attachments such as instrument printouts, computer generated charts and data sheets, and photocopies or original labels for the product analyzed;
(10) Identification of any software used;
(11) Any certificate of analysis for standards and software; and
(12) The following information about the qualifications of each analyst involved in the analysis conducted under this subpart, if the LAAF-accredited laboratory has not previously submitted documentation of the analyst's qualifications to FDA or the analyst's qualifications have significantly changed since the LAAF-accredited laboratory last submitted documentation of the analyst's qualifications to FDA:
(i) The analyst's curriculum vitae;
(ii) Training records for the applicable methods that the analyst is qualified to perform, including the dates of such training and the name of the trainer or training provider; and
(iii) Any other documentation of the analyst's ability to perform the method properly in the context of the food testing to be conducted, pursuant to § 1.1150(b).
(e) Additional information about non-standard methods. If the LAAF-accredited laboratory conducts the analysis using a method that is not published in a reputable international or national standard or that is otherwise not publicly and readily available, upon request by FDA the LAAF-accredited laboratory must submit documentation of the method to FDA.
(f) Immediate notification of significant changes. The LAAF-accredited laboratory must notify FDA and the recognized accreditation body that LAAF-accredited the laboratory of changes that affect the LAAF-accreditation of the laboratory within 48 hours, including a detailed description of such changes, and an explanation of how such changes affect the LAAF-accreditation of the laboratory. LAAF-accredited laboratories are not required to notify FDA of changes that a recognized accreditation body must provide to FDA under § 1.1123(d).
(g) Consequence of omission. If FDA does not receive all information required to be submitted to FDA under this section, FDA may consider the related food testing to be invalid.
