I. PURPOSE

This directive provides the methodologies that Office of Investigation, Enforcement and Audit (OIEA), Compliance and Investigations Division (CID) Investigators are to apply when preparing a Report of Investigation (ROI).  Investigators prepare a ROI to support findings of apparent violations, food safety incidents, or other allegations under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), the Egg Products Inspection Act (EPIA), the Humane Methods of Slaughter Act (HMSA) (the Acts), and related laws and regulations.  FSIS is reissuing this directive in its entirety to update information related to the ROI.

KEY POINTS:

• Describes the format and components of a ROI
• Updates the process for submission and review of the ROI
• Clarifies the process for referring and transferring a ROI

II. CANCELLATION

FSIS Directive 8010.4, Revision 5, Report of Investigation, 4/28/17

III. BACKGROUND

The purpose of the ROI is to present findings and supporting evidence that Investigators develop in investigating apparent violations, food safety incidents, or other allegations relating to the Acts, using the methodology in FSIS Directive 8010.2, Investigative Methodology.  The ROI is used to support Agency decisions and any enforcement or legal actions that result from investigations.  The ROI is also used to document investigations that may not result in a violation or that result in a referral to another authority.

IV. THE ROI

A. A well-written ROI chronicles the nature of the alleged violations and the applicable statutes and regulations.  The findings and supporting evidence are to be organized in a manner that allows the reader to evaluate and assess whether the ROI and evidence support the allegations and determine if violations occurred.  The ROI is to be factually correct, impartial, concise, clear, logically organized, and completed in a timely manner.

B. Each ROI is to contain clear and concise statements of findings that present the relevant evidence, identify sources for the evidence, and report the evidence or other case information in context (e.g., fact as fact, observations as observations).  The ROI is to summarize the investigative findings and refer the reader to particular exhibits for additional supporting information.

C. Investigators are to ensure that the ROI:

1. Communicates the purpose, scope, sources of information, facts, and findings of the investigation appropriately;
2. Includes information that is important and relevant to the scope and objectives of the investigation;
3. Provides facts in a manner that facilitates reader comprehension;
4. Includes a statement of the applicable law or regulation that was allegedly violated or that formed the basis for the investigation;
5. Is factual, objective, and does not contain personal opinions, views, or editorials;
6. Avoids unanswered questions and does not leave matters open to interpretation;
7. Records or references relevant evidence and investigative activities; and
8. Contains enough relevant and reliable evidence to support the findings.

D. Investigators are to complete the ROI within 10 business days of receipt of the last piece of evidence collected to meet the performance measures for timely completion and action on ROIs.

E. Investigators are to limit distribution of the ROI to officials responsible for taking action on the matter investigated and to authorized officials who need to know the results of the investigation (e.g., an FSIS Assistant Administrator, OIEA Enforcement Operations Staff (EOS) personnel, the USDA Office of General Counsel (OGC), or Assistant United States Attorney).  Investigators are not to distribute the ROI without authorization.

V. ROI FORMAT

A. Title Page – Investigators are to use AssuranceNet (ANet) to prepare and generate a Title Page, FSIS Form 8500-1, Report of Investigation, for the ROI.

B. Title Page Contents – ANet auto-populates the Title Page, which includes the following information:

1. Agency organizational information, including the Region, City, and State of the CID Regional Office completing the ROI.
2. Title Block containing the following information:
   1. Investigation Number;
   2. Violation Date (i.e., date that the most current alleged violation occurred if there are multiple violation dates);
   3. Name and address of the primary violator (i.e., firm or individual that is the subject of the investigation); and
   4. Case type and violation type.
3. Signatures and date:
   1. ANet auto-populates the Title Page with the name, electronic signature, and signature date of the Investigator and Regional Director (RD) or designee.
   2. ANet auto-populates the signature and date based on the:
      1. Last Investigator to forward the investigation to a supervisor and the date the investigation was forwarded to the supervisor; and
      2. Last RD, or designee, who checked the Signature Approval box on the ROI Review tab and the date when the Signature Approval box was checked.

C. Continuation Title Page – If the ROI involves multiple firms or individuals that are subjects of the investigation (i.e., alleged violators), Investigators are to prepare a separate, Continuation Title Page, using Microsoft Word, label the document with the heading “Title Continued,” and enter the additional firm or individual names and addresses under the heading.  Investigators are not to include any other information on the continuation page.

D. ROI Headings Format – Investigators are to prepare the ROI headings and any subheadings using the following format:

1. Headings are to be in uppercase, underlined, and aligned over each section on the left side of the page (e.g., PREDICATION).  Investigators are to ensure that headings do not start at the bottom of a page.
2. Sub-headings may be used to organize sections of the ROI and to aid the reader’s comprehension.  When used, sub-headings are to be formatted in title case and underlined (e.g., ABC Sold Misbranded Product).

E. ROI Headings – Investigators are to prepare the ROI text to include the following components as headings:

1. Predication – A brief statement that identifies when and how the program area (e.g., OIEA) became aware of and involved in the issue;
2. Objective – A brief statement that identifies the purpose (one or more objectives) of the investigation or inquiry;
3. Summary – A brief statement of the investigation or inquiry with respect to the objectives, presented in the same order as the objectives, to answer whether the findings sustain or do not sustain the respective objectives;
4. Background – A brief statement that identifies relevant background information about the subject of the investigation (e.g., nature of business operations, organization, responsible officials).  When necessary, Investigators also are to use the background to:
   1. Explain any unusual, confusing, or complex regulatory provisions or other issues (e.g., issues concerning Specified Risk Material (SRM), humane handling, or voluntary inspection under the Agricultural Marketing Act); and
   2. Provide a brief statement regarding the Agency’s statutory authority, and if applicable, the regulatory requirements, if the case is more complex or may be referred to EOS in accordance with FSIS Directive 8010.5, Case Referral and Disposition
5. Findings – Organization and content of the findings are critical to the ROI.  Under this heading, Investigators are to:
   1.  Include a paragraph that identifies the elements of the statutory, and, if applicable, regulatory violations, for each violator;
      
      NOTE:  In some cases, a ROI is necessary to show a completed inquiry, but the ROI may not involve violations (e.g., USDA Office of Inspector General (OIG) Hotline Complaint with no violation).
       
   2. Cite the relevant section of the statutes and, if applicable, the regulations; quote or paraphrase the relevant language (e.g., TITLE 21 UNITED STATES CODE § 610 (a) and (c)), and link to the appropriate violator;
   3. Present the findings and evidence collected for each element of the violation or factual situation.  For example, if the Investigator identified violations of 21 U.S.C. § 610 (c), then the findings and evidence are to support each element charged in 21 U.S.C. § 610 (c) (e.g., individual support for the sale, transportation, offer for sale, and offer for transportation);
   4. Provide a specific reference to the supporting evidence in exhibits for each finding; and
   5. Relate the findings back to the objective;
6. Product Disposition – A brief, specific statement of the product’s disposition, if applicable, including whether the Investigator witnessed the disposition actions; and
7. Compliance History – The relevant compliance history for the subjects of the ROI, to include any known violations of the FMIA, PPIA, EPIA, or HMSA; administrative enforcement actions; or violations of other Federal or State laws.  Include the file number (e.g., ANet Investigation Number, ANet Enforcement Number), type of case (e.g., Criminal – Adulterated – Food Safety), closing action (e.g., Notice of Warning, Injunction), and date closed.  If none, state “No record of past violations.”

NOTE:  When a subject, witness, or firm is mentioned more than once in the ROI, Investigators are to write the full name of the person or firm the first time it is used in the ROI; thereafter, they are to use uppercase letters to abbreviate and reference names of those persons and firms (e.g., John Smith (SMITH); Clyde’s Meat Company (CLYDES)).  Investigators are not to use this abbreviation method for Federal, State, and local government employees.

F. List of Exhibits – The list of evidence included as exhibits in the ROI.  Investigators are to include in the “List of Exhibits” all evidence that supports the investigative findings in the ROI and other evidence relevant to disposition decisions, including any enforcement actions that may be taken based on the investigation, the ROI, and the case evidence.

1. The list of exhibits is auto-populated with information entered by the Investigator into ANet and is generated by and printed from ANet;
2. Exhibits are to be presented in an order that facilitates an understanding of the findings and the evidence in the ROI.  Exhibits may be placed in the order referenced in the text of the ROI or organized by exhibit type (e.g., statements, invoices);
3. All exhibits used in the ROI are to have an evidence collection date, as required by FSIS Directive 8010.3, Procedures for Evidence Collection, Safeguarding and Disposal.  The evidence collection date is the date the Investigator obtained the evidence.  For organizational structures, flow charts, summary tables, and other demonstrative or informational documents created by Investigators, the evidence collection date is the date the Investigator collected the information from an individual, firm, or government entity to support creating the document, not the date the document was created; and
4. The exhibits may be ordered in various ways.  One example of a possible exhibit order is:
   1. A flow chart with a graphic representation of the step-by-step progression of the alleged violation;
   2. Memorandum of Interview, a statement, or a Shipper’s or Receiver’s Certification (FSIS Form 8050-2) from the subject of the investigation;
   3. Relevant photographs, which are to be entered on FSIS Form 8000-7B, Photographic Report, and FSIS Form 8000-15, Photographic Log (see FSIS Directive 8010.3);
   4. Relevant business records (e.g., invoices, bills of lading, pest control records, storage temperature charts, or formulation records);
   5. Relevant Agency records (e.g., FSIS Laboratory Sample Forms, Notice of Detention, Termination of Detention, voluntary disposition forms, Grant of Inspection, and other Federal, State, or local agency records);
   6. temperature charts, or formulation records);
   7. The legal structure of each alleged violator's business or organization (e.g., sole proprietorship, partnership, corporation, limited liability company (LLC)), if relevant.  If the firm is a corporation, the company structure information is to be included as evidence.  The company information is generally available on the website of the State where the business entity is registered.

G. List of Evidence Not Included – A list of evidence and any non-evidentiary materials obtained in the investigation but not included as exhibits in the ROI.  The list of evidence not included is also generated by and printed from ANet.

H. Exhibits – Exhibits supplement and support findings.  Each ROI is to include exhibits that are relevant and necessary to facilitate an understanding of the findings and evidence.

1. All exhibits (i.e., evidence) included in the ROI are to be identified under an Exhibit Cover Sheet, FSIS Form 8000-7.  ANet will generate an Exhibit Cover Sheet for each exhibit, based on information entered by the Investigator into the investigative record in ANet.
2. Each Exhibit Cover Sheet is to include:
   1. A description of the evidence (copy or original);
   2. Name and address of the person, entity, or place (e.g., where digital photographs were taken) from whom or from which the evidence was obtained;
   3. Name, title, and badge number of the Investigator who obtained the evidence (or took the photographs);
   4. Date the evidence was obtained;
   5. Location of the original evidence; and
   6. The appropriate sequential exhibit number.
3. Exhibit Legibility – Exhibits are to be legible.  When a document is not legible, the Investigator is to copy or reproduce the document, make the copy legible by writing in the information or by otherwise reproducing the information, and include both the original document and the legible copy or reproduction with the exhibit.  When a signed statement, or Shipper’s or Receiver’s Certification, is handwritten, the Investigator is to include a verbatim, typed copy as part of the exhibit.

I. Witness List – A witness list needs to be compiled only when a case is referred for prosecution consideration.  At that time, EOS, OGC, or the United States Attorney’s Office may request that the Investigator prepare and provide a list of all witnesses with knowledge of the case.  When requested, the witness list is to include the following:

1. Identity of each witness (name, title);

2. Residence address, if known (street, apt. number, city, state, zip code);

3. Business address (street, suite number, city, state, zip code);

4. Telephone number and e-mail address, if known;

5. Short summary of what the witness can attest to; and

6. Any information that could bear on the credibility of the witness.

VI. ROI SUBMITTAL AND REVIEW

CID personnel are to use the following process for review and submittal of the ROI in ANet:

1. Investigators are to submit the ROI in ANet within 10 business days of the last piece of evidence being collected.

2. The Supervisory Investigator (SI) is to review and evaluate the ROI, as necessary, to ensure that it has been prepared in accordance with this directive.  CID has established management controls and performance measures for the SI and RD, or designee, related to review of the ROI.

3. The SI is to return the ROI to the Investigator if changes are needed.  If no changes are necessary, or after revisions are received, the SI is to submit the ROI in ANet to the RD, or designee, with their recommended action.

4. Based on the findings and evidence in the ROI, the RD, or designee, is to make a determination (e.g., issue a Notice of Warning; refer the ROI to another authority; refer the ROI to EOS for administrative, civil or criminal prosecution consideration; or close with no action) in accordance with the criteria in FSIS Directive 8010.5, and enter the action in ANet.

VII. REFERRAL AND TRANSFER OF ROI

A. At times, it is necessary to transfer a ROI to another Regional Office for completion or refer a completed ROI to another authority (e.g., State Meat and Poultry Inspection (MPI) program). 
 
B. When the ROI is transferred between Regional Offices, the Regional Office responsible for completing the ROI is to complete the following steps:

1. Complete the ROI and ensure it satisfies all parts of this directive;

2. Ensure that only the completed ROI is included with the final investigative record; 

3. Determine the proper order of the exhibits and prepare the list of exhibits; and 

4. Sign the ROI Title Page by checking the RD Review signature approval box in ANet.

C. When the ROI is referred to another authority, the Regional Office is to:

1. Complete a referral letter as described in FSIS Directive 8010.5, and attach the letter to the investigative record in ANet; and 

2. Refer the ROI through ANet to the authority for further investigation or enforcement. 

NOTE:  When it is not practical to make an electronic referral in ANet, the RD or designee is to scan all relevant case documents and forward to appropriate parties via secure e-mail, an Agency approved service for express and ground delivery (e.g., UPS), Certified Mail, or hand delivery.

VIII. QUESTIONS

Refer questions regarding this directive through supervisory channels.

Assistant Administrator
Office of Policy and Program Development