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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
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Food Safety and Inspection
Service United States Department of Agriculture Washington, D.C. 20250-3700 |
HACCP/Pathogen Reduction
January 1997
TO: District Managers, Area Supervisors, Circuit Supervisors, Import District Managers, Import Field Officers and Compliance Officers
Enclosed is the COMPLIANCE OFFICER GUIDE FOR PREPARING REPORTS OF APPARENT VIOLATIONS FOR FAILURE TO MEET SSOP REQUIREMENTS. This guide clarifies the responsibilities of Compliance Officers and other enforcement personnel in documenting and reviewing investigative reports that support suspension or withdrawal actions for an establishment's failure to meet SSOP requirements, and forwarding such reports for formal action.
While the target audience for this guide is field Compliance and Investigation Division, District Enforcement Operations personnel, all FSIS personnel should be familiar with its content. It supplements procedures that are discussed in FSIS Directive 11,100.3 "Evaluating, Verifying, and Enforcing A Sanitation Standard Operating Procedure" and the "Supervisory Guide for the Evaluation Process of the SSOP Regulatory Requirement."
You will note that the guide also includes as an Attachment, a "Notice of Suspension of Inspection." This notice should be used by the Area Supervisor/District Manager/Import District Manager to provide the plant, in writing, as promptly as circumstances permit, the disposition of any enforcement action.
Please share a copy of this guide with the multi-IPPS supervisors that are assigned to you. In addition, we encourage you to share this document with Inspectors-in-Charge, Import Inspectors, and industry officials so that everyone is aware of what procedures will be followed if an investigative report is documented.
In most situations, we expect that SSOP failures will be resolved and that the preparation of an investigative report by Compliance Officers will not be needed. However, in the event that an investigative report is prepared, it is important that all FSIS personnel are aware of their responsibilities, and follow the procedures in this guide.
Enclosure
Carol M. Seymour
Assistant Deputy Administrator
District Enforcement Operations
This document provides guidance for preparing Reports of Apparent Violation for the suspension and withdrawal of inspection service when an establishment has failed to meet Sanitation Standard Operating Procedure (SSOP) requirements.
This document supplements procedures discussed in FSIS Directive 11,100.3, "Evaluating, Verifying, and Enforcing A Sanitation Standard Operating Procedure," and the "Supervisory Guide for the Evaluation Process of the SSOP Regulatory Requirement." It is written to clarify the responsibilities of Compliance Officers and other enforcement personnel in documenting and reviewing investigative reports that form the basis of suspension or withdrawal actions for an establishment's failure to meet SSOP requirements, and forwarding such reports for formal action.
It is the role of the Compliance Investigative Division (CID), District Enforcement Operations (DEO), personnel to support in-plant personnel in taking actions to suspend or withdraw inspection services for an establishment's failure to meet SSOP requirements. Compliance Officers in CID will collect evidence and will prepare FSIS Form 8050-1, Report of Apparent Violation, to report findings and incorporate evidence obtained to support administrative, criminal, civil or other actions for failure to comply with SSOP requirements. CID supervisory officials have the discretion to deviate from the use of the FSIS Form 8050-1 format in favor of a modified report format when deemed necessary.
The narrative section of the Report of Apparent Violation shall contain the following:
1. Predication - which states briefly how the Compliance Officer became involved in the matter.
2. Synopsis of Facts - which states in concise terms, the who, what, when, where, and why of the violation.
3. Compliance History - which shows any past history of violation.
4. List of Exhibits - exhibits will be numbered and listed in order on FSIS Form 8000.7, Compliance Exhibit Sheet. The exhibits may include the following:
a. Copies of documents (i.e., retain/reject tags, etc.) showing what steps have been taken to refuse to allow meat and poultry products to be labeled, marked, stamped, or tagged as "inspected and passed" or "inspected for wholesomeness."
b. Copies of applicable Process Deficiency Records (PDR's), plant records, and associated correspondence concerning the alleged failure to meet the SSOP requirement.
c. Photographs and signed statements.
The original and two copies of the completed Report of Apparent Violation will be forwarded to the appropriate Area Supervisor/District Manager or Import District Manager for review and appropriate action. If it is determined that a suspension action should be sustained, the original and one copy of the investigative report will be forwarded to the Evaluation and Enforcement Division (EED), DEO, for use in administrative, criminal, civil or other actions. Copies of all PDR's and other written notifications concerning the failure to comply with SSOP requirements prepared by Circuit Supervisors, Area Supervisors/District Managers, and Import District Managers shall be included in the investigative report.
Note: As addressed in the "Supervisory Review Guide for the Evaluation Process of the SSOP Regulatory Requirement," the AS/DM/IDM is required to provide the plant, in writing, as promptly as circumstances permit, the disposition of any enforcement action. A "Notice of Suspension of Inspection" issued by the AS/DM/IDM will serve as such written notification (copy attached).
EED enforcement personnel will review and evaluate the Report of Apparent Violation to determine the adequacy of evidence, and to ensure that administrative, civil, criminal or other sanctions are carried out uniformly and consistently. EED, in consultation with AS/DM/IDM, shall also determine that decisions to hold enforcement actions in abeyance are uniform.
If the evidence is adequate, EED shall notify the plant in writing, as promptly as circumstances permit, of the intent to initiate a complaint to withdraw inspection. EED refers the case to USDA's Office of General Counsel (OGC) for review and preparation of the complaint and has the responsibility to interact with OGC on all related matters. OGC represents the Agency in these legal proceedings or negotiations.
"Notice of Suspension of Inspection" (file in .pdf format; Adobe Acrobat Reader required)
"Report of Apparent Violation" (file in .pdf format; Adobe Acrobat Reader required)
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For Further Information Contact:
FSIS District Enforcement Operations
Richard T. VanBlargan
Deputy Assistant Deputy Administrator
Phone: (202) 418-8874
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