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ORA FIELD MANAGEMENT DIRECTIVE No. 151

PURPOSE

This Field Management Directive (FMD) provides guidance and criteria for the post analytical compliance review and entry of District Conclusions for domestic and import Bovine Spongiform Encephalopathy (BSE) samples.

BACKGROUND

This Field Management Directive (FMD) applies to all ORA headquarters and field offices including laboratory facilities performing regulatory analyses. All BSE sample results require timely, accurate and determinative completion of the District Conclusion section of the Sample Dispositions screen in FACTS following completion of the sample analysis.

RESPONSIBILITIES

Office and Regional Directors

Office Directors and Regional Directors are responsible for assuring that operating divisions within their chain of command have implemented this procedure. They are also responsible for assuring that each of their operating divisions have implemented internal audit procedures and controls to verify the effectiveness of this procedure.

District Directors

District Directors are responsible for assuring that internal audit procedures have been implemented to monitor the effectiveness of this procedure.

Compliance Branch Directors

Compliance Branch Directors are responsible for assuring that a Compliance review has been conducted for all Lab Class 2 and 3 domestic and import BSE samples in accordance with this procedure. The DCB will assure that District Conclusions have been entered into FACTS for all BSE samples. The DCB will implement corrective and preventive actions as necessary when audit findings reveal non-conformance with this procedure.

Compliance Officers

Compliance Officers will be responsible for performing the compliance review of Lab Class 2 and 3 BSE samples in accordance with established Agency guidelines. The Compliance Officer will document completion of the compliance review by entering the District Conclusion information into FACTS in accordance with this procedure.

Laboratory Directors

Laboratory Directors will assure the timely analysis of BSE samples, communication of analytical findings and forwarding of analytical packages to the responsible District. Laboratory Directors will also assure that internal audit procedures have been implemented to monitor the effectiveness of this procedure.

Supervisory Analysts

Supervisory Analysts will assure that BSE samples are processed in a timely manner. Supervisory Analysts may enter District Conclusions for Lab Class 1 samples. The Supervisory Analyst will implement corrective and preventive actions as necessary when audit findings reveal non-conformance with this procedure.

PROCEDURE

1. All BSE sample results require completion of the District Conclusion section of the Sample Dispositions screen in FACTS. This section of the Sample Dispositions screen contains the following four fields which must be completed:
   1. District Conclusion
   2. District Conclusion Made By
   3. District Conclusion Date
   4. District Conclusion Remarks
2. District Conclusions for Lab Class 1 samples can be entered by Supervisory Analysts or Compliance Officers. Supervisory Analysts should enter the District Conclusion as NAI and enter brief remarks about the sample analysis. The home district Compliance Branch assumes the final responsibility for ensuring that a District Conclusion has been entered for Lab Class 1 BSE samples.
3. Laboratory personnel shall not enter District Conclusions for Lab Class 2 and 3 BSE samples. This function must be performed by a DCB or Compliance Officer.
4. Following completion of each Lab Class 2 or 3 BSE sample analysis, the analyzing laboratory will promptly notify the home district DCB via e-mail. The e-mail will contain the Sample Number and Lab Class.
5. All Lab Class 2 and 3 BSE samples must be reviewed by the home District Compliance Branch. The review will include all readily accessible information such as review of firm’s inspection and compliance history; relevant FDA or state inspection reports including the report of inspection for compliance with 21 CFR 589.2000; and product labeling. If insufficient information exists to make a final conclusion, the Compliance Branch will promptly issue a FACTS assignment requesting an inspection, investigation and potentially additional sample collection of finished feed or feed ingredients to determine the type and source of the mammalian protein.
6. The home District Compliance Branch will document the final District Conclusion in FACTS within 30 working days following receipt of the analytical results from the laboratory. If the sample was analyzed by more than one laboratory, then the sample will have sub numbers representing each lab classification. Entries for each separate laboratory classification must be made in all four data fields. The four data fields will be populated as follows:
   1. District Conclusion contains a drop down menu from which a selection is made. The available selections are NAI, VAI, OAI, Referred to State, Referred to Center and Criminal Investigation.
   2. District Conclusion Made By will self populate the name of the FACTS user making the conclusion.
   3. District Conclusion Date will self populate the current date.
   4. District Conclusion Remarks is to be completed by the individual making the final District Conclusion and should contain a brief narrative description of the deliberative process used to make the final district conclusion. Concise information must be entered to explain the reason for the District Conclusion. A listing of related documents that were used to support the conclusion should also be included in this field. If an assignment is generated for further follow-up, the FACTS Assignment Number along with a brief description of the requested action must also be recorded in the remarks.
7. Changes to the laboratory sample classification shall not be made by the Compliance Branch. Only the laboratory may change the sample classification. If Compliance Branch finds disagreement with a final classification made by the laboratory, this should be discussed by the Compliance and Laboratory Directors to resolve the disagreement.
8. In addition to domestic samples, this procedure also applies to import samples. At this time, District Conclusion information cannot be entered into OASIS and automatically transferred into FACTS. Until such time as the OASIS/FACTS issues are resolved, District Conclusions for import BSE samples must be entered in FACTS.

REFERENCES

Regulatory Procedures Manual
Laboratory Procedures Manual

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