ADMINISTRATIVE ENFORCEMENT REPORTING (AER) SYSTEM

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From: TSS ()
Subject: ADMINISTRATIVE ENFORCEMENT REPORTING (AER) SYSTEM
Date: November 1, 2005 at 7:15 am PST

UNITED STATES DEPARTMENT OF AGRICULTURE

FOOD SAFETY AND INSPECTION SERVICE

FSIS DIRECTIVE 5100.3 10/26/05

WASHINGTON, DC

ADMINISTRATIVE ENFORCEMENT REPORTING (AER) SYSTEM

I. PURPOSE

The purpose of this directive is to issue FSIS Form 5400-9, Administrative

Enforcement Report, explain when and how the form is used, and set out the exhibits

that Enforcement Investigative Analysis Officers (EIAOs) are to compile to support the

different actions covered by the AER.

II. RESERVED

III. RESERVED

IV. REFERENCES

9 CFR part 313, 416, 417, and 500

FSIS Directive 8410.1, 8080.1, Revision 4, 5000.1, Revision 1, 5100.2, 5420.1,

Revision 2, 6500.1, and 6500.2

V. BACKGROUND

A. To ensure that all administrative actions are fully supported and based on the

relevant facts, the Acts, and the applicable regulations, FSIS instituted the AER system

and the AER form, FSIS Form 5400-9. The system provides for the proper and

accurate maintenance of documents produced by the Agency related to various

administrative actions.

B. OFO personnel carry out administrative enforcement actions under the Rules

of Practice regulations (9 CFR part 500) when a Federal establishment is not meeting

provisions of the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act

(PPIA), or the Egg Products Inspection Act (EPIA). When OFO decides to pursue an

enforcement action under 9 CFR 500.3, Withholding action or suspension without prior

notification or under 9 CFR 500.4, Withholding action or suspension with prior

notification (i.e., Notice of Intended Enforcement Action (NOIE), the Case Specialist or

designee begins FSIS Form 5000-9, and all supporting documentation will be

DISTRIBUTION: Inspection Offices; T/A Inspectors; OPI: OPPED

Plant Mgt; T/A Plant Mgt; TRA; ABB; TSC; Import

Offices

attached exhibits to the AER form.

C. OFO personnel also carry out other administrative activities for which an FSIS

Form 5000-9 is started, and all supporting documentation will be attached exhibits.

Such administrative activities include:

1. Reviews of the sanitary conditions at custom exempt operations, and,

when necessary, the preparation of written recommendations along with evidence to the

Office of Program Evaluation, Enforcement, and Review (OPEER).

2. Detention of product as set out in FSIS Directive 8410.1,

3. Recall Effectiveness Checks as set out in FSIS Directive 8080.1, Revision

4, Recall of Meat and Poultry Products, and FSIS Directive 5100.2, Enforcement,

Investigations, and Analysis Officers (EIAO) Responsibilities Related to Recalls and

Consumer Complaints,

4. Investigations of prohibited activities as set out in the FMIA, section 10,

the PPIA, section 9 and 10, and the EPIA section 8, such as adulterated product

deliberately distributed into commerce,

5. Investigating illness outbreaks such as an illness outbreak related to a

recall, and

NOTE: Illness outbreak investigations related to the Consumer Complaint Monitoring

System are documented under the CCMS system, not the AER system).

6. Non-Routine Incident investigations addressed in FSIS Directive 6500.1,

Emergency Management Committee, and FSIS Directive 6500.2, Incident Investigation

Teams.

D. Under the AER system, OFO personnel at all phases of an administrative

enforcement action are to develop and compile supporting documents for the decision

reached. Supporting documents include Noncompliance Records (NRs) (FSIS Form

5400-5), EIAO assessment reports, District Veterinary Medical Specialist (DVMS)

reports, laboratory findings, agency letters, corrective and preventive measures

provided by an establishment that have been determined to be unacceptable,

photographs, and memoranda of interview. The supporting documents and evidence

should be referenced on and attached to the AER in a manner that makes it clear why a

particular action is justified. These documents should address the "who, what, when,

where, and how" of the alleged violation. For enforcement actions, the documents are

to link the alleged violations to the FMIA, PPIA, or EPIA. The documents are to be

written in a manner that someone unfamiliar with the facts will be able to understand

what has occurred, and why what has occurred violates the Acts.

E. When an establishment appeals an administrative enforcement action or

decision, the appeal will be decided on the basis of the establishment's appeal and the

FSIS Directive 5100.3

AER supporting the action or decision. Once the appeal is decided, the decision and

any supporting documentation are to be included as an exhibit in the supporting AER.

VI. FSIS FORM 5400-9 AND AER NUMBERING SYSTEM

A. FSIS Form 5400-9 is available on outlook at: Public Folders\All Public

Folders\Agency Issuances\Forms\FSIS 5,000 SERIES.

B. To number the AER, the first number is the DO number and the second

number is the fiscal year. The lettering identifies the report type. The last numbers

enable FSIS to determine how many reports of this nature have been completed in a

given District. For example, AER 65-05-N003, the N indicates the issuance of an NOIE

in Albany (65) in fiscal year 2005 (05). The last numbers, 003, mean the NOIE is the 3rd

NOIE issued in Albany in the fiscal year.

AER Report Type

1) NOIE (N)

2) Suspension (S)

3) Reinstatement (R)

4) Withholding of Labels (WL)

5) Custom (C)

(Request to withdraw the custom exemption)

6) Recall Effectiveness Check (REC)

Report Number

65-05-N003

65-05-S001

65-05-R001

65-05-WL001

65-05-C001

65-05-REC001

NOTE: When completed for recall effectiveness checks, insert in block 11 of the FSIS

5400-9, the FSIS Recall Number, (e.g., FSIS-REC-XXX-200X). The FSIS recall

numbering system is based on calendar years, while the AER numbering system is by

fiscal years.

7) Detention (D) 65-05-D002

8) Prohibited Act (PA) 65-05-PA001

9) Outbreak of Illnesses Investigation (OI) 65-05-OI001

11) Non-routine incident report (NRI) 65-05-NRI001

12) Withdraw of Inspection (W) 65-05-W001

NOTE: This would be specified under OTHER in block 11.

13) Complaint for Suspension (CS) 65-05-CS001

NOTE: This would be specified under OTHER in block 11.

14) Other 65-05-O001

C. For incidents involving assistance from multiple Districts, there would be one

District assigned overall responsibility for completing the AER. For example, for recalls

involving multiple Districts, the District Recall Officer would be responsible for ensuring

that the AER includes recall effectiveness check information collected by the assisting

Districts and there would be only one AER.

D. For incidents that have individual AERs and that are related (e.g., a situation

where in the course of a recall there has been a prohibited act), Block 15 for each FSIS

Form 5400-9 should list the related AER report number (e.g., the AER form for the recall

would list AER number under which the prohibited act was recorded and AER for the

prohibited act would list the AER number under which the recall was recorded).

VII. PHOTOGRAPHS AND DOCUMENTS

A. Photographic Evidence

1. OFO personnel may take photographs as part of their inspections at

establishments. Since photographs are one of the most effective and useful forms of

evidence, each photograph should be taken for a purpose. Photographs should be

related to insanitary conditions contributing to, or likely to contribute to, the adulteration

of product or to practices likely to render product injurious to health or otherwise

violative.

2. The purpose of photographic evidence is to:

a. provide a visual documentation of the facts, conditions, or the sequence of

events; and to

b. provide visual support that there was a problem or violation of the law.

3. Examples of documents, conditions, or practices effectively documented by

photographs include:

a. whenever possible, any document list in paragraph VII. B.

b. evidence of rodents or insect infestation, faulty construction or

maintenance, or other failure of Sanitation Performance Standard conditions which

contribute to insanitary conditions;

FSIS Directive 5100.3

c. routes of, as well as, actual contamination of raw materials or finished

products;

d. condition of raw materials or finished products;

e. employee practices contributing to adulteration of product or to violative

conditions;

f. manufacturing processes;

g. effluent contamination of water systems; and

h. labeling.

B. Documents

1. Documents include all FSIS Forms (e.g., NRs, and the Food Safety

Assessment). Documents also include:

a. letters to an establishment related to enforcement actions such as an

NOIE, Deferral of an NOIE, institution of a suspension, or holding a suspension in

Abeyance,

b. letters to an establishment related to other administrative actions such

as notification that a recall was ineffective, or notification that the establishment failed to

notify all customers of a recall.

c. decision documents that render an FSIS opinion about a matter,

memoranda from District Managers (DM) to Office of Field Operations (OFO)

Headquarters management, or memoranda between Assistant Administrator offices.

d. memoranda of interview that report the discussions that Agency

personnel have with members of the public such as establishment management,

consumers, or custom exempt operators. Such memoranda are to:

i. identify all participants present at the meeting;

ii. explain all facts that provide the basis for the meeting;

iii. fully describe the meeting; and

iv. be written in a concise and clear manner.

VIII. EXHIBITS

The following sets out the typical exhibits that are to be a part of the AER file for

the action as listed in block 11:

A. Enforcement Actions

For enforcement actions pursuant to 9 CFR part 500, the exhibits would be:

a. FSIS Form 5000-8 and accompanying exhibit list (e.g., all relevant NRs);

b. Food Safety Assessment reports that served as the basis for taking

enforcement;

c. Memoranda of interview;

d. Conversation records documenting discussions with the Technical Service

Center; other parts of the Office of Policy, Program, and Employee Development; or

Office of Public Health Science;

e. Any relevant laboratory results;

f. Any relevant photographs of product conditions or plant conditions;

g. The NOIE and establishment response;

h. Communications regarding deferral actions and establishment response, if

applicable;

i. Communications regarding withholding or suspension actions and

establishment response;

j. Communications regarding abeyance actions and establishment response,

if applicable; and

k. Communications regarding the withholding of labels.

B. Custom Exempt Reviews

For a review of custom exempt operations before referral to OPEER, the

exhibits may include:

a. Review forms;

b. Photographic evidence of the condition of product, as well as conditions

under which the product is produced;

FSIS Directive 5100.3

c. Memoranda of interview with facility management regarding the situation;

d. Letters of warning issued by the DO; and

e. Decision memoranda for various enforcement actions up to

recommendation of removal of exemption privilege.

C. Detentions

For detention actions as described in FSIS Directive 8410.1, Detention and

Seizure, the exhibits may include:

a. Evidence such as laboratory reports;

b. Photographic evidence of the adulterated or misbranded product and the

condition under which it was being packaged and held;

c. Memoranda of interview with the responsible officials;

d. Photograph of the "US Detain Tag";

e. FSIS Form 8080-1, Notice of Detention;

f. FSIS Form 8080-4, Voluntary Destruction Notice;

g. Evidence that the product was destroyed (e.g., a renderer’s record);

h. Communications regarding approval of extended detention procedures;

i. Paperwork surrounding court seizure; and

j. FSIS Form 8400-1, Notice of Termination or Destruction.

D. Recalls

For a recall as set out in FSIS Directive 8080.1, Revision 4, Recall of Meat and

Poultry Products, and effectiveness checks as set out in FSIS Directive 5100.2,

Enforcement, Investigations, and Analysis Officer (EIAO) Responsibilities Related to

Recalls, and Consumer Complaints, the exhibits may include:

a. Recall worksheets;

b. Memoranda of interview with producing establishment management;

c. Conversation records with inspection program personnel over critical issues;

d. Decision memoranda to request voluntary recall;

e. Laboratory reports (internal and external);

f. CCMS or consumer documentation;

g. Notification by recalling firm of consignees;

h. Company press release;

i. USDA press release;

j. Recall notification report;

k. Official notification by establishment of intent to voluntarily recall and the

name of the coordinators; and

l. FSIS Form 8400-4, Report of Recall Effectiveness

E. Prohibited Activities

For prohibited activities (e.g., adulterated product deliberately distributed into

commerce), the exhibits may include:

a. Memoranda of interview with responsible officials;

b. Photographic evidence;

c. FSIS decision memorandum;

d. Information of how the product was shipped or received; and

e. Any other information that supports the action.

F. Illness Outbreak

For an illness outbreak, the exhibits may include:

a. Information supplied by FSIS or by other public health stakeholders;

b. Memoranda of interview with effected parties;

c. Description of the sample taken;

d. Photographic evidence;

FSIS Directive 5100.3

e. Laboratory results; and

f. FSIS decision memorandum.

G. Non-Routine Incidents

For a non-routine incident report completed by the Case Specialist or District

Staff in situations related to such activities as disposition of products or verification that

contamination concerns have been addressed, the exhibits may include:

a. Investigative files of non-routine incidents;

b. Photographic evidence;

c. Memoranda of interview; and

d. Memoranda describing incidents of adulteration.

H. OTHER

For any letters sent by FSIS that are not addressed in the above categories

such as concerns related to recordkeeping requirements.

X. CASE FILE SCAN AND DOCUMENT MANAGEMENT PROCESS

A. The physical copies of FSIS Form 5400-9 and the supporting documentation

are maintained at the appropriate District Office. Additionally, cases will be added to

SmeadLink Express via processing images through a software called Kofax Ascent

Capture. The Case Specialist or District Staff will scan the cases into a file two days

after receiving the form and supporting documentation for administrative activities or

within 24 hours of initiation of an Administrative Enforcement Action by the District

Office. The Case Specialist or District Staff will need to send the TIFF file to the

Financial Processing Center (FPC) for processing and create a PDF file that can be put

onto a CD. Kofax Ascent Capture is used at the FPC to process the images to create

indexes that can be searched through SmeadLink. The following are the general

procedures for the electronic case files.

B. Two days from receipt, the Case Specialist or District Staff will scan the FSIS

Form 5400-9 so that Kofax can read data (all fields on form) for importing into Smead to

provide search capabilities. The image files will be located on an FPC server so that

the FPC IT Staff can retrieve the images for processing through Kofax and into Smead.

C. A record will be established within Smead for each AER and will be considered

the main record linking each related exhibit by case number. The Case Specialist or

District Staff will scan an exhibit cover sheet for each exhibit. The cover sheets provide

a record within Smead for each exhibit.

D. If the exhibit contents are in paper format, the paper will follow the exhibit cover

sheet during the physical scanning. If the exhibit is physically scanned, the images will

be displayed in Smead as pages; each page will be displayed as a thumbnail.

E. If the exhibit contents are in electronic file format, the electronic files will be

attached to the exhibit record within Smead. This process will be manually completed

by the Case Specialist or District Staff and will occur after the FPC IT Staff processes

the physically scanned TIFF images through Kofax and into Smead.

F. If the exhibit is created by attaching electronic files, the images will be displayed

as icons rather than thumbnails of the actual pages. To view the electronically attached

files, the user must click on the icon to open the file. The user must also have the

software of the attached file on the computer he or she is using to view the file in its

format. Example: If a file is attached as a Word document, the user must have Word or

the Word viewer installed on the computer to view the document.

G. The process to attach electronic files to records in Smead is briefly described

below:

1. Exhibit record must be established in Smead as explained above,

2. Select and then right click on exhibit record that will house attached files,

3. Select "Attach PC File",

4. Look in: Navigate to the path,

5. File name: Select file, and

6. Click on Open

H. The above steps must be completed for each electronic file attachment. Multiple

files cannot be selected at one time.

I. If additional exhibits are created after the original case file is scanned and created

in Smead, the FSIS Form 5400-9 will be modified by the Case Specialist or District Staff

to add the additional exhibit to the "List of Exhibits" and the FSIS Form 5400-9 will be

physically scanned along with the additional exhibit coversheet.

J. For recall effectiveness checks, the District Office for the establishment conducting

the recall will input all information for recall effectiveness check information received

from other Districts into Smead. District Offices that supply recall effectiveness

information are to scan the information and may dispose of paper copies.

FSIS Directive 5100.3

Key fields identified by OFO to be indexed in Smead for search capabilities (these

are on the FSIS Form 5400-9):

V Report Number

V Establishment Number

V Non-Compliance type

V Name of establishment

V Non-federally inspected business type

V Plant size

V HACCP processing categories

V Product type

V Laboratory findings

V Report type and date of actions

V Comprehensive assessment of the execution and design of an establishment’s

food safety systems

V Other special review

V Additional information

V Completed dates

The Smeadlink Express District Office User Training Guide can be found at:

Public Folders\All Public Folders\OM\FMD\FPC\USDA DO User Trng Guide.pdf.

Assistant Administrator

Office of Policy, Program, and Employee Development

http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/5100.3.pdf

O.K. so, where is the update on the recent violations of the USA ruminant to ruminant feed ban? i suppose everyone is in compliance since the fda et al seems to have stopped posting these violations in a timely manner to the public;

June 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE (June 20, 2005)

March 2005 Update on Feed Enforcement Activities to Limit the Spread of BSE (March 17, 2005)

November 2004 Update on Ruminant Feed (BSE) Enforcement Activities (November 23, 2004)

snip...

http://www.fda.gov/cvm/bse_updates.htm

day late and dollar short. they should have implemented this on 8/4/97, along with the TSE/BSE feed ban, as _mandatory_. they would not have to be doing now what they claimed they had been doing for the last 5+ years.