EIAO Recommendations 

Tool Summaries 

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• EIAO recommendations from FSAs vary:

• No action necessary

• NRs issued by in-plant inspectors (500.1)

• NOIE with or without NRs (500.4)

• Notice of Suspension (NOS) (500.3)

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• Summarize findings at the end of each tool.

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Decision Making Analysis- General Tool 

Analysis -

Questions to help the analysis process 

Analysis and Recommendations 

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• Length is 1 to 2 pages

• Provide an overall analysis of findings and the thought process used to arrive at the recommendation

• Support the recommendation with: 

• sampling results

• PHRE

• in-plant observations

• HACCP system design and implementation

• Show how the findings impact establishment’s ability to produce safe product

• Show how recommendation is supported by FSIS statutory and regulatory requirements

• Summarize the analysis in an Executive Summary

• State whether follow up is necessary

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• Is there a relationship between past and current noncompliances?

• Do the current findings indicate that repetitive, sustained, or

persistent food safety problems continue?

• Is supporting documentation adequate to support decisions in the

hazard analysis?

• Has additional information arisen that calls hazard analysis decisions

into question?

• Are there flaws in system design or implementation?

• Does the HACCP system prevent the production of adulterated, 

unsafe products?

• Is there a correlation between test results and findings related to

sanitary practices?

• Once analysis has been performed and a

supportable recommendation determined

• EIAO formulates and documents a regulatory

rationale to supportthe recommendation

• Example

• The establishment’s Raw Non-Intact process is

inadequate under 9 CFR 417.6 because the

establishment cannot support the decision in its

hazard analysis that E. coli O157:H7 is not likely to

occur.

• Discuss significant findings and what lead to this

conclusion using the regulations and statutes

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Analysis and Recommendations 

Analysis and Recommendations 

Analysis and Recommendations 

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• FSA report must describe in detail so reader has a clear

understanding of the information considered and how

that supports the recommendation.

• Identify all documents that had a bearing on the

recommendation.

• Describe in detail how past noncompliances relate to any

present noncompliances

• Describe the public health significance

• If an enforcement action is recommended without evidence of

multiple recurring noncompliances clearly document the

findings which indicate serious threat to public health

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• Many establishments will address noncompliances as they

are identified during the FSA

• EIAO will still document those in the FSA and recommend NRs

and/or enforcement actions as warranted

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Analysis and Recommendations 

Analysis and Recommendations 

Analysis and Recommendations 

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• Additional points when writing analysis

• Directives, Notices, and Guides are not support

for enforcement

• Analysis is not a simple repeating or listing of

individual findings

• Analysis is an explanation of the rationale and

support for the enforcement based upon

regulations, statutes, and public health

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• Items to include in the analysis

• For the recommendation of no further action

• Describe facts that indicate compliance and that no food safety concerns

exist

• For the recommendation of NRs written

• Describe noncompliance(s) and why this recommendation is being made. 

NRs issued if not in support of NOIE

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• Items to include in the analysis

• For the recommendation of NOIE

• Clearly describe noncompliances that meet one of the provisions of 9 CFR

500.4

• Describe how noncompliances resulted in adulterated product or created

insanitary conditions

• Clearly describe the analysis and regulatory thought process that lead to

the determination

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Analysis and Recommendations 

Executive Summary 

Executive Summary 

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• Items to include in the analysis

• Recommendation of Notice of Suspension without prior notice

• Clearly describe noncompliances that meet one of the provisions of 9

CFR 500.3

• Describe how noncompliances resulted in an imminent threat to public

health

• Clearly describe the analysis and regulatory thought process that lead

to the determination

• Emphasize the recommendation - include only the essential

or most significant supporting information

• Show how you arrived at the recommendation.

• Make the summary concise 

• Do not duplicate the Decision Making Analysis. Use the summary question from each tool to construct the executive summary. 

• TIP FOR SUCCESS: imagine that the Executive Summary is

the only part of the FSA that anyone can see - Does this

summary adequately explain and support the

recommendation?

• Good Executive Summary contains:

• 1-2 sentences describing establishment/products

• 1-2 sentences describing compliance history

• 2 sentences describing findings leading to recommendation

• 2 sentences discussing analysis of findings and their significance

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Executive Summary 

Executive Summary 

Executive Summary 

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• Emphasizes recommendation and essential support for it

• Organized in coherent manner

• No more than 350 words in most cases

• Up to 500 words for complex cases

• First and last sentence of Analysis section often contains

key information

• Review summary and remove unnecessary words or

sentences

• Do not introduce any “new” information not contained in

the FSA Report.

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• How can an EIAO know that enough information has been

included?

• Imagine that the summary is the only part of the FSA report that

anyone can see and then ask the question:

• Does this summary adequately explain and support the

recommendation?

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