~ Food Safety and lns~lon Service 

iiia U£ llEPARThENf Of AGROJ..T\M 

Objectives 

• 

lSD.IFS6 

nlorccmcnt 

nvcst~ation 

nalvsis 

llicer 

Major Sections of Enforcement Letter 

• 

EIAO Training 3/29/16

1

Upon completion of this module, you will be

able to:

•Describe the purpose of an NOIE letter

•Identify required contents of an NOIE letter

•State how long an establishment has to

answer an NOIE letter

2

2

•Opening Paragraph

•Background/Authority

•Findings and Basis for Actions

•Notification, Appeal, Hearing Rights

3

3

1
 

 

 

 

 

 

 

 

 

 

 

 

Opening Paragraph 

• 

Background/ Authority 

• 

Background/ Authority 

• 

EIAO Training 3/29/16

•Clearly describe the letter’s purpose

•Intent to take enforcement action (NOIE)

• FSIS has withheld the marks of inspection or

suspended assignment of inspectors

4

4

•Describe in clear language what sections of the

FMIA, PPIA, or EPIA give us the authority to

initiate this enforcement action under the Rules

of Practice

•Be sure that you read the sections in each Act and

understand why the action is being taken

5

5

•Statutory provisions cited should be well thought

out and consistent with the strategy used to

develop the enforcement action

• You should understand.......

• Under what authority our inspection personnel

acted

• Under what authority you acted

• Provisions of the Act the establishment violated

6

6

2
 

 

 

 

 

 

 

 

 

Findings and Basis for Action 

• 

Findings and Basis for Action 

• 

Findings and Basis for Action 

2 u. I I 

• 

EIAO Training 3/29/16

•Describe the findings and facts that serve to

support that violations of the Act and

regulations exist.

7

7

•Cite the title and the specific section of the

applicable regulatory requirementfor each

violation that is supported by the evidence

•Example: 9 CFR 417.5(a)(1)

8

8

•Cite the title or the specific section and

paragraph of the statute

•Example: 21 U.S.C. 601(m)(1)

9

9

3
 

 

 

 

 

 

 

 

 

 

 

 

Findings and Basis for Action 

• 

Findings and Basis for Action 

• 

Findings and Basis for Action 

• 

EIAO Training 3/29/16

•This section should describe:

• Establishment processes that are the source of the

violation

• What is objectionable

• What the public health significance is

• Why the plant’s actions to address the problem

are inadequate

• Why this inadequacy results in the product being

adulterated or other violation

10

10

•Describe conditions or evidence that

demonstrates adulteration under the

provisions of:

• 21 U.S.C. 601(m)(1), (m)(3), or (m)(4), of the FMIA

• 21 U.S.C. 451(g)(1), (g)(3), or (g)(4) of the PPIA

•Other applicable provisions

11

11

•Describe events which formed the factual

basis for the case

•These facts must be supported by

documentation

•Describe why documentation demonstrates

noncompliance

12

12

4
 

 

 

 

 

 

Notification/ Appeal/Hearing Rights 

72 urs 

• 

Notification/ Appeal/Hearing Rights 

• 

Notification/ Appeal/Hearing Rights 

• 

EIAO Training 3/29/16

•The NOIE should notify the plant that is has

72 hours or 3 business days to respond in

writing

• FSIS will determine further action based on

the establishment’s response

13

13

•Establishment may contest the basis for the

NOIE

14

NOIE

14

•Withholding or Suspension

•Rules of Practice provide establishments a

right to appeal the matter and to request a

hearing

15

15

5
 

 

 

 

 

 

 

 

 

 

 

Notification/ Appeal/Hearing Rights 

• 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

EIAO Training 3/29/16

•Advise the establishment of the right to

appeal the matter to EARO, Field

Operations

•Advise the establishment of the right to

request a hearing by contacting the

Director, Enforcement Operations Staff, 

OIEA

16

16

17

Determining Sufficiency of an Establishment’s

Response to a NOIE or Suspension

EIAO Training

17

• EIAOs will review and evaluate the sufficiency

of establishment’s corrective actions

submitted in response to:

• An enforcement action

• Data generated during abeyance or deferral

18

18

6
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

EIAO Training 3/29/16

•Due Process under the Rules of Practice

•Establishment has 72 hours to respond to

NOIE (Suspension letter indefinite time)

•Once response is received by District Office, 

FSIS must promptly review and evaluate the

response

• FSIS must sustain communication with the

establishment during the period of review of

the plant’s response

19

19

•Work under the direction of the District

Office to review the response

•Engage the IIC to confirm and obtain any

additional information to evaluate the

proposed corrective actions

•Maintain communication with the FLS

regarding the ongoing evaluation

20

20

•Read and review the issues addressed in the NOIE

or Suspension letter

•Review the FSA report and decision document

that was the basis for the action

• Formulate a list of questions that are critical to

evaluate the sufficiency of the response

21

21

7
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

EIAO Training 3/29/16

•What noncompliance served as the basis for the

action?

•What are the significant issues identified related

to the establishment’s food safety systems?

•What information do you need to determine

whether the establishment has addressed the

food safety issues?

•What information do you need to assess what

may be missing?

22

22

•Determine whether the submitted response is

complete – For example:

• Are the hazard analysis and supporting

documentation included?

• Are the revised HACCP plan and SSOP included?

• Are the revised prerequisite programs, SOPs, or

GMPS discussed in the hazard analysis included?

•Is otherrelevant data necessary to completely

evaluate the submitted response?

23

23

•Has the establishment proffered anything

new?

•Has the establishmentreassessed their HACCP

plan

•Does the establishment have data to support

the decisions they are making?

24

24

8
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

EIAO Training 3/29/16

•Continue your review to identify the issues

that will need to be discussed with subject

matter experts

•Determine the types of expertise you will need

to assist in the review

• Are there microbiological issues?

• Are there slaughterinspection issues?

• Are there RTE processing issues – lethality, 

cooling, stabilization?

25

25

•If necessary, contact OPPD to obtain the

experts’ opinions

•If experts from OPHS are needed, work with

the OPPD staff to arrange for their

involvement

•Provide the OPPD and OPHS experts with

copies of the establishment’s submission

26

26

•As needed, conduct daily discussions with the

experts during the review process

•Include the IIC by phone in these discussions

•Maintain daily contact with the DDM and FLS

about the progress of the review and issues

that emerge

27

27

9
 

 

 

 

 

 

 

 

 

 

 

 

 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

EIAO Training 3/29/16

•If the corrective actions are deemed insufficient,

prepare a decision document that:

• Describes each issue raised in the NOIE or Suspension

letter

• For each issue, explain why the response is not

adequate

• Includes an analysis of the sufficiency of the response

and a recommendation for acceptance or denial of the

establishment’s corrective actions

• Submit this draft to the DDM and wait for guidance

28

28

•If the corrective actions are acceptable this will be

the substance of:

•Deferral Letter

• Abeyance Letter

29

29

•If the corrective actions are acceptable, work

with the FLS, IIC, and in-plant inspection

personnel to develop the verification plan

that will accompany the deferral or

abeyance letter

30

30

10
 

 

 

 

 

 

 

 

 

 

 

Evaluating an Establishment's Response 

• 

Evaluating an Establishment's Response 

• 

WORKSHOP 

• 

EIAO Training 3/29/16

•If the corrective actions are incomplete, draft a

response to the establishment that describes the

documents that are needed

•Assist the DO in communicating verbally with the

establishment to inform them of the additional

documentation that is needed for the agency’s

evaluation

31

31

•The DM will decide whether to:

•Issue letterto initiate a suspension (from NOIE)

• Sustain the suspension or

• Engage in further correspondence with the

establishmentto reach a successfulresolution

to move to a deferral or abeyance

32

32

33

33

11