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Writing EIAO Correspondence

Course Objectives

• Adopt important “Plain Language” writing principles.

• Use best practices in email writing.

• Write clear, logical, easily understood FSA tool question responses, 

analyses, and executive summaries.

Key Ideas

1. Always have a point that can be expressed in about 10 words or fewer, and 

put that bottom-line up front (BLUF) at the start of paragraphs, analyses, and 

summaries.

2. Write for people who “live outside the neighborhood”— in other words, for 

people unfamiliar with the document and the issue or issues within it.

3. Maintain focus and scope by eliminating irrelevant content.

4. Use shorter sentences (15-20 words) and active voice to enhance your 

reader’s understanding. Shun “tion.”

5. “Chunk” information with headings to enhance your readers’ understanding.
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Desk Tool: Writer’s Process and Checklist

Set Goal

1. Ask and answer: Why am I writing this document? What is the 

outcome I am seeking?

Consider Audience

2. Ask and answer: Who is the audience? What do I know or need to 

know about the audience? 

Consider the audience’s knowledge, values, whether internal or 

external, authority level, anticipated reaction, personal 

preferences, cultural norms, expectations, political or budgetary 

constraints, and priorities.

Optimize Content

3. Ask and answer: Based on the purpose and the target 

audience(s), what content do I need to include? Distinguish 

between must-have and nice-to-have content. What is the best 

format? Create an outline, as appropriate.

Produce Message

4. Write your document. 

5. Let your writing “cool.” Do not review or edit it for at least an hour, 

but longer if possible.

6. Edit and proofread your document. Use MS Word’s spelling and 

grammar check and the Writer’s Checklist to ensure you have 

used clear, succinct language. Revise the document as 

necessary.

Evaluate Success

7. Evaluate the success of your written document. Did you get what 

you were seeking?
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The Writer’s Checklist

Have you done the following?

1. Identified a specific goal and considered the audience before writing?

2. Led with your request or your main idea?

3. Created an outline that logically presents the content?

4. Used “roadmap” sentences and paragraphs to guide readers?

5. Included an introduction in longer documents, with a synopsis and guidance 

on using the document?

6. Used plain, accessible language?

7. Written predominantly short sentences, averaging 15-20 words?

8. Used bullet points and other organizational techniques to break up text?

9. Used verbs in place of nouns, where possible (i.e. “verify” instead of 

“verification”)?

10. Predominantly used active voice, and used passive voice only when 

preferred?

11. Ensured positive or neutral tone in your document?

12. Used linking words and phrases to transition between ideas and paragraphs?

13. Ensured lists are in parallel structure?

14. Ensured consistency in capitalization?

15. Correctly introduced and punctuated initialisms, acronyms, and 

abbreviations?

16. Read the entire message or document for accuracy, clarity, and positive or 

neutral tone? 

17. Included lists of acronyms and defined terms when needed?

18. Ensured graphs and charts have context and clear takeaway messages?

19. Used greetings, closings, pronouns, and complete sentences in email 

messages?

20. Started with a fresh template rather than reusing an existing document when 

appropriate?
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Plain Language Defined

 

President Barack Obama signed the “Plain Writing Act of 2010” on October 13, 

2010. The Act is designed "to improve the effectiveness and accountability of 

Federal agencies to the public by promoting clear Government communication that 

the public can understand and use."

Tips for Using Plain Language

Certain qualities characterize plain language. These include common, everyday 

words, except for necessary technical terms. Other qualities include the use of 

personal pronouns; the active voice; logical organization; and easy-to-read and 

understandable design features, such as bullets and tables.

1. Engage Your Readers.

• First, consider who your readers are.

• Consider what your readers need to know and want to know. Organize 

content to answer their questions.

• Write at a reading level that is appropriate to your intended audience.

2. Write Clearly. Use common, everyday words whenever possible.

Word Choices

• Use common, everyday words but avoid slang.

• Use personal pronouns such as "you."

• Use "must" instead of "shall."

• Avoid using undefined technical terms.

• Use positive rather than negative words.

• Avoid using gender-specific terminology.

• Avoid long strings of nouns.

Verb Forms

• Use active voice.

• Use action verbs.

• Use the present tense whenever you can.

Structure

• Use parallel construction.

• Be direct.

• Avoid unnecessary exceptions.
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3. Display Material Correctly.

Appearance is an important aspect of clear communication. If a document is 

pleasing to the eye, it will be more likely to attract your readers' attention. 

Appearance can also be an aid to readers, improving comprehension and 

retention.

• Organization. Strong, logical organization includes an introduction 

followed by short sentences and paragraphs. Organize messages to 

respond to your readers' interests and concerns.

• Introduction. In lengthier documents, use an introduction and a table of 

contents to help readers understand how a document is organized.

• Short Sentences and Paragraphs. Sentence length should average 15-

20 words. Sentences that are simple, active, affirmative, and declarative 

hold readers' interest. Generally, each paragraph should contain only one 

topic. You may wish to use a series of paragraphs if you need to express 

complex or highly technical information. The more writing deviates from a 

clear and to-the-point structure, the harder it will be for readers to 

understand what you are trying to convey.

• Layout. Layout includes margins, headings, and white space. Provide 

white space between sections to break up text and to make it easier for 

readers to understand. Use headings to guide readers; the question-andanswer format is especially helpful. Try to anticipate your readers' 

questions and pose them as a reader would. 

• Tables. Tables make complex information readily understandable. They 

can help readers see relationships more easily, and they may require 

fewer words than straight text.

• Typography. Typography relates to fonts and typographical elements 

used for emphasis, such as bullets or italics. Limit the number of fonts 

you use. It is usually best to stick to one font for headings and another for 

text. Use typographical elements consistently throughout your document, 

and avoid overusing any one element.
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4. Evaluate Your Document.

To ensure that you are communicating clearly, evaluate the document or, better 

yet, have another person read it and offer suggestions for clarification. 

Look over the document for

• Word choice, verb forms, and structure

• Correct spelling, grammar, and punctuation

• Inclusion of appropriate devices, such as dates, page numbering, and 

consistency

• Visual appeal

• Consistency and effectiveness of layout 

• Line breaks that inadvertently separate part of a name or date in a way 

that reduces clarity

Source: https://www.opm.gov/information-management/plain-language/
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Plain Language Tips

Prefer Active Voice

In passive writing, the "doer" is hidden. Rather than say, "Somebody did 

something," we say, "Something was done by somebody," or we leave off the 

"by somebody" and just say, "Something was done." Passive writing can be 

ambiguous and clunky, but it may be a better choice when you don’t know 

who did something, can’t say who did something, or prefer to focus on what 

happened and not who did it. As a rule, use it less than 20% of the time and 

with intention.

Active 

The manager asked all staff to submit draft accomplishment reports by COB 

Friday.

Passive

All staff were asked to submit draft accomplishment reports by COB Friday 

(by the manager).

Hallmarks of Passive Voice 

• The “true” actor is either not in the sentence or is the object of a 

preposition. (Example: The ball was kicked by the boy.)

• The main verb cannot stand alone—it must always have a helping verb, 

regardless of tense.

• The main verb takes the form of the past participle, again regardless of 

tense. (Example: The ball is being kicked. The ball will be kicked. The ball 

had been kicked.)

• The subject of the sentence would be the direct object if you were to 

reconstruct it in active voice.

Try a Couple 

1. The deadlines were met by the staff.

2. All time and attendance forms should be submitted by COB Friday.
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Set Verbs Free

When a word ends in tion, sion, ance, able, ence, ment, ness, and mant, it is usually 

a “smothered verb”—that is, a verb that has been turned into a noun. 

We did an inspection of the office.

VS.

We inspected the office.

This directive is applicable to all personnel who make use of voicemail.

VS.

This directive applies to all personnel who use voicemail.

Try a Couple 

1. Use that form for the submission of your travel expenses.

2. The team held a meeting to give consideration to the plan.
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Maintain Parallel Structure

Parallel structure means giving equal ideas equal grammatical structure. Notice the 

differences in these two:

The five phases of the interview are as follows:

• Introduction

• Establish Rapport

• Questioning for Information

• Summarizing for Accuracy

• Closing

The five phases of the interview are as follows:

• Introduce Self

• Establish Rapport

• Question for Information

• Summarize for Accuracy

• Close the Interview

A Few Rules to Help You

 

With two phrases or clauses, repeat the introductory word.

Instead of: "It is far better to give than receive." Use: "It is far better to give 

than to receive."

With three phrases or clauses, repeat the introductory word or use it only with the 

first phrase or clause.

Use: "We travel by sea, air, and car." Or: "We travel by sea, by air, and by 

car." But not: "We travel by air, by sea, and car."

With lists, ensure parallel structure.

Instead of: “The coach told the players that they should get a lot of 

sleep, that they should not eat too much, and to do some warm-up 

exercises before the game.”

Use: "The coach told the players that they should get a lot of sleep, not eat too 

much, and do some warm-up exercises before the game."
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Try a Few 

1. The employee expected that he would present his project plan at the 

meeting, that he would have time to show his slide presentation, and that 

questions would be asked by attendees.

2. Staff are to safeguard the security of tissue specimens during preparation, 

storing, packaging, and submission of specimens for pathological or 

diagnostic microbiological evaluation.

3. We are seeking the following outcomes:

• Collaboration with organizations in the community

• Increase attendance at community meetings

• Partner with other Federal agencies to host half-day quarterly 

informational sessions
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Use the MS Word Proofing Tools

If you work in MS Word and Outlook, consider using the proofing tools to evaluate 

how well you are applying Plain Language principles. You can activate these tools 

easily using the instructions for both Word and Outlook that follow on page 4. 

Depending upon which version you are currently using, the steps may vary slightly.

When you review your document and have processed all the feedback on grammar, 

spelling, and usage, both Word and Outlook will give a synopsis of the readability of 

your writing in a dialogue box, like this: 

Notice that the information includes these important details:

• Average words per sentence

• Average characters per word

• Percent of passive voice sentences

• Flesch Reading Ease Score

• Flesch-Kincaid Grade Level Score

While the primary criteria for readability are average sentence and word length, you 

will also want to pay attention to the percentage of passive voice, which also 

impacts reader understanding.
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Ideal Numbers

So what are ideal numbers? It depends on the topic, audience, and document 

complexity. Some writing samples will have lengthy but unavoidable words, for 

example Listeria monocytogenes, and some documents will be extremely long. 

However, these recommended averages can help you evaluate and modify your 

writing.

Average Words per Sentence (15-20) 

This is perhaps the most critical element of making writing digestible. Long 

sentences thwart understanding, so seek an average sentence length of 15-

20 words.

Average Characters per Word (6) 

The average word length in English is estimated to be six characters, so 

seek to maintain an average of six characters per word or less.

Percent of Passive Voice (Less than 20%) 

As a rule, allow no more than 20% of passive voice sentences in your writing 

and generally seek a much lower number. We will discuss in more detail why 

active voice is a stronger expression and the circumstances when passive 

voice may be the better choice.

Flesch Reading Ease Score (RES of 40-70) 

This test rates text on a 100-point scale. The higher the score, the easier it is 

to understand the document. A good goal is to aim for a score of 60-70. This 

can be difficult to attain, so minimally seek to have a score above 40.

Flesch-Kincaid Grade Level Score (GLS under 14) 

This score indicates the number of years of formal education a reader would 

need to understand the writing sample. Traditionally, newspapers have 

attempted to write on the 8th grade level. However, for most government 

writing, a score of 8 can be hard to attain. Try to keep your score below 14.

Important Note: The more complicated the topic, the simpler the writing needs to 

be. Using shorter sentences, shorter words, and predominantly active voice will 

simplify your writing, even when relating complex information.
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Activate Proofing Features in Outlook and Word

 

Outlook 

1. Click File, and then click Options.

2. Click Mail, and then, under Compose Messages, click Spelling and 

AutoCorrect.

3. Click Proofing.

4. Under When correcting spelling in Outlook, select Check grammar 

with spelling.

5. Select Show readability statistics.

After you enable this feature, open a message that you want to review. When 

Outlook finishes checking the spelling and grammar, it displays information about 

the reading level of the document.

Word 

1. Click the File tab, and then click Options.

2. Click Proofing.

3. Under When correcting spelling and grammar in Word, select Check 

grammar with spelling. 

4. Select Show readability statistics.

Important: You have to correct or ignore all spelling errors found in the document 

before the readability statistics will display. If there are still any red squiggles in the 

file, the readability statistics won't display.

(Source, in part, from Office.com support page)
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Important Points about Paragraphs

1. The first paragraph in a document sums up the message and acts as a road 

map for the rest of the letter or analysis. This “summing up” should give the 

result, outcome, or recommendation. 

This letter serves as official notice by the Food Safety and Inspection Service 

(FSIS) of the intent to withhold the marks of inspection and suspend the 

assignment of inspection program personnel for your Raw Non-Intact and Raw 

Intact Hazard Analysis Critical Control Point (HACCP) processes at BERGER 

COLI & Co., Inc., Establishment 01234 M/ P-01234. We are basing this action on 

our determination that your establishment’s HACCP system is inadequate in 

accordance with Title 9 of the Code of Federal Regulations (CFR) part 417.6 (d), 

which states that a HACCP system may be found inadequate if the establishment 

is not adequately maintaining records. This letter provides background information 

on FSIS, explains our findings and basis for action, and gives you information on 

what steps you may take in response to this letter. 

2. Each paragraph should have a topic sentence (or topic sentences) establishing 

a subject, a purpose, and an order.

While statutory regulations require an establishment to have a pest management 

program to prevent the harborage and breeding of pests on grounds and 

facilities, your establishment did not do so. In reviews at your establishment from 

May through October 2008, FSIS inspectors noted the following infestations and 

accompanying NRs.

3. Each paragraph should contain information relevant only to the topic sentence 

(and the topic itself). Notice in the sample below how the underlined sentence 

dramatically changes the meaning and focus of this paragraph.

Copies of the Acts are enclosed for your review. Please note that under section 

23 (a) of the FMIA, and section 15 of the PPIA, the Secretary is authorized to 

exempt from inspection requirements the custom slaughter of livestock and the 

custom preparation of carcasses, and retail store poultry slaughter and 

processing operations. The exemption at any establishment shall be in effect for 

so long as the establishment maintains and operates its facility in a sanitary 

manner and complies with other requirements set forth in the Acts and 

regulations. Based on reports filed with this office, it has been determined that 

you have been unable or unwilling to comply with these provisions.

4. Most paragraphs have three to five sentences, but this can vary.
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Exercise: Evaluate a Paragraph

Read and evaluate this paragraph.

The following information is provided to support this Notice of Intended Enforcement 

(NOIE) at your facility, which is based on repetitive positive findings of Listeria 

monocytogenes on product contact surfaces and intact product samples documented 

through two separate sampling protocols conducted by FSIS on DATE AND DATE, 

respectively. Also, the implementation of your established Listeria species sampling 

program has been shown to be ineffective in identifying potential harborages of this 

pathogen within your processing environment.
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Organizational Styles

As a rule, write your EIAO documentation in the inverted pyramid (deductive) or the 

hourglass styles.

The Inverted Pyramid (Deductive)

The document or letter starts with the purpose in the first paragraph, with all 

remaining paragraphs supporting this main idea. 

The Hourglass (Deductive with Repetition at the End)

The document, letter, or email begins and flows in the same way as the 

deductive approach, but the final paragraph reiterates the main idea. This is 

an excellent approach to use with requests. The format is “what I need or 

want, why and other details, and what I need or want again.” For a letter of 

NOIE, for example, the letter would begin and end with the intended action 

FSIS plans to take.

The Pyramid (Inductive)

The document or letter is written as a narrative argument or chronology that 

ends with a summation. 

Example: Starting on this date, we inspected your establishment and found 

evidence of rodent infestation. On this date, we wrote you... On this date, 

you responded... Therefore, we believe you may have violated FMIA...”
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Exercise: Determining Organizational Style

Determine the style for each paragraph.

Paragraph 1

Seven personnel were listed as having completed training in humane handling 

requirements. Documents indicated that these personnel had received per diem 

reimbursement for attending the training session. Documents also revealed the 

personnel did not attend the humane handling training. Therefore, these seven 

personnel were incorrectly paid per diem reimbursement for training they did not 

attend.

Paragraph 2

Seven personnel were incorrectly paid per diem reimbursement for training they did 

not attend. According to the documents we reviewed, these personnel were 

erroneously listed as having attended humane handling training and were then paid 

per diem reimbursement for travel they did not take.
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Notes on “Person,” Abbreviations, Bullets, and 

Microbial Names

Referring to Yourself in FSA Documentation

You may refer to yourself in the third person or the first person: “EIAO Smith 

noted that...” or “I noted that...” in all entries except the Executive Summary. 

Generally, the Executive Summary will not include references to individuals, 

but if required, use the third person rather than the first person.

Consider using bulleted lists to avoid redundantly using “I,” “EIAO Smith,” or 

passive voice. For example, if you want to share a series of observations, 

start with an introduction, such as “I” (or EIAO Smith) noted the following”

and then proceed with the list of observations as individual bullets (dust and 

debris on the slicing equipment, overflowing trash bins, and so on).

Using Bullets to Break Up Text

When you can break up long narrative passages with bullets, opt to do so. 

Ensure the bulleted items are like items, not merely a series of sentences placed 

behind a bullet. For example, the bulleted list might be a series of observations, 

a series of violations, and so on.

Your response should at a minimum include written sanitation procedures and 

pest control measures you have developed and implemented for your business 

operation on a daily and ongoing basis, including all written records completed 

on a daily basis, employee training, and other food safety measures to ensure 

your establishment meets statutory and regulatory requirements.

VS.

Your response should, at a minimum, include the following:

• Written sanitation procedures and pest control measures you have 

developed and implemented for your business operation on a daily and 

ongoing basis

• All written records completed on a daily basis

• Employee training

• Any other food safety measures to ensure your establishment meets 

statutory and regulatory requirements
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Punctuating Bulleted and Numbered Lists

The guiding principle for using bulleted and numbered lists is to present information 

so it is quickly and easily understood. In the absence of prescribed style rules, 

consider using the following guidance:

• Use a period after every bullet point that is a sentence (as in this example).

• Avoid ending bullets with semicolons unless your in-house style dictates it.

• Ensure each item is a complete thought or a fragment—but not a mix of both.

• Prefer bullets when information is interchangeable and prefer numbering 

when the list indicates priority or order.

• Usually start each bullet with a capital letter.

• Most importantly, in all matters, be consistent.

UsingPossessive and Plural Abbreviations 

Ensure you are using the correct punctuation to convey that an abbreviation is 

singular, plural, and/or possessive. Adding an apostrophe and then “s” to an 

abbreviation conveys possession, as in “FSIS’s policy.” Adding an “s” and then an 

apostrophe conveys plural possession, as in “CSIs’ meeting.” Simply adding an “s” 

makes the abbreviation plural, as in SRMs.

• EIAO is singular (talking about a single EIAO).

• EIAOs is plural (talking about several EIAOs).

• EIAO’s is the singular possessive form (one EIAO owns something, such as 

an EIAO’s report).

• EIAOs’ is the plural, possessive form (EIAOs’ reports).

NOTE: Don’t use an abbreviation without first spelling it out and adding the 

abbreviation in parentheses. Don’t place the abbreviation in parentheses unless 

there will be a second reference. For analyses or summaries, assume the reader 

may not have read other parts of the document and may not know or have seen the

abbreviation or acronym.
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Using Correct Bacterial/Microbial Genus and Species Names

Italicize bacterial and microbial genus and species names, as in Escherichia coli. 

When abbreviating, capitalize the genus name and shorten it with a period after 

the first letter; keep the species name lowercase but do not abbreviate it, as in 

E. coli. Note that one common exception is Listeria monocytogenes, which is 

abbreviated Lm. Serotype is never italicized, but it is capitalized, as in 

Salmonella Hadar. Note that in E. coli O157:H7 what precedes the 157 is the 

letter O, not the number zero. 

Here are some commonly used genus/species names:

• Listeria monocytogenes or Lm

• Escherichia coli or E. coli

• Salmonella

• Salmonella Enteritidis or S. Enteritidis

• Salmonella Hadar or S. Hadar

• Salmonella Typhimurium or S. Typhimurium 

• Campylobacter

• Campylobacter jejuni or C. jejuni

• Shiga toxin-producing E. coli or STEC

Using Numbers and Dates 

For FSAs

• Use numerals throughout (1, 9, 11, 20).

• Don’t repeat numbers in parentheses—five (5).

• Use abbreviated dates if you prefer (12/15/21) but be consistent.

Guidance for Other Writing Forms

• Write out zero to nine; use numerals for 10 and higher. 

• Write out any number at the start of a sentence. 

• Use numerals when referring to time or measurements: 24 months, 6 

weeks, 3 days, 4 feet.

• With ranges above and below 10 in a single sentence, use numerals in all 

cases. 

• Use one date format throughout a document. 
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Writing the PHRE Recommendation

You will document your rationale for, or against, conducting an FSA in PHIS using 

the PHRE Tool.

As specified in Directive 5100.4, review the PHRE Report to look for patterns, 

trends, or specific issues that should be investigated. Additionally, seek out and 

review lab results, consumer complaints, details of previous FSAs, any relevant 

enforcement reports, PFGE results for Lm-positive results, and feedback from the 

FLS and IPP on the report and the establishment’s operating practices.

Next, make one of three recommendations and document that recommendation 

using the PHRE Tool:

1. Conduct an FSA.

A recommendation to conduct an FSA leads to PHRE4, which prompts you 

to complete the assessment plan. The following pages have information on 

what to include in this plan and some sample assessment plans.

2. Do not conduct an FSA but take enforcement action.

If you recommend an enforcement action, no FSA is needed.

3. Do not conduct an FSA.

If you recommend against conducting an FSA, you will write the rationale in 

PHRE3. Guidance on writing this rationale and some sample responses 

follow below.

NOTE: The PHRE is an internal document and therefore is not to be distributed to 

the establishment. During the entrance meeting, the EIAO is to explain the reason 

for the FSA and answer questions about the overall process.
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Completing the PHRE: The FSA Assessment Plan

When an FSA is recommended, you will create an Assessment Plan to ensure the

assessment is thorough, well organized, and efficiently uses limited resources. The 

Assessment Plan should include the following elements:

1. Apparent Violations of the Statutes

Briefly state the apparent or possible food safety issue(s) determined through 

the analysis. The plan is to cite the relevant statutes or regulations and state 

or paraphrase the language of the statutes or regulations—for example, “21 

U.S.C. 453 (g)(4) and 458 (a)(3), improperly stored poultry products, after 

transportation in commerce, under insanitary conditions, causing the 

products to become adulterated.”

2. Scope of the FSA

Briefly state the extent and range of the FSA, such as tools that will initially 

be used, regulatory issues, food safety issues or other matters, and any 

possible public health issues or concerns.

3. Steps of the Assessment

List the steps necessary to develop facts and findings and to collect evidence 

of the apparent or possible food safety issues.

It is important to note that the assessment plan is meant to be a tool that illustrates 

the primary concern or concerns at the establishment that need to be investigated 

and why, along with a brief description of the approach for conducting the FSA. It is 

also an opportunity to seek out additional guidance or expertise. Unless necessary, 

the plan should not be lengthy, nor should it point out each of the customary steps 

involved. Rather, think of this plan as an overview of why the FSA is important to 

complete and what unique steps (and guidance) will be needed for this specific 

FSA.

If during the FSA new information causes the approach to change, the plan does 

not need to be updated as long as this new information is captured in the FSA itself. 
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Example of an FSA Assessment Plan (PHRE4)

The EIAO is recommending an FSA because the establishment had a Class I recall 

associated with a product containing an undeclared allergen. Since the 

establishment shipped product into commerce with an undeclared allergen, its food 

safety system failed. During the assessment, the EIAO’s primary focus will be on 

the establishment’s written allergen control procedures and implementation of any 

procedures to determine compliance with 9 CFR 417.2(a)(1) and 417.5(a)(1). 

Because allergens may affect all products produced within the facility, the EIAO 

plans to complete all parts of each processing FSA tool except the Canning Tool. If 

during the assessment, the EIAO determines that certain tools do not apply, he will 

explain this change in the overall analysis section of the report. 

The noncompliance report data indicate the establishment is 16.67% percent 

noncompliant for meeting general labeling requirements. The EIAO’s scope of 

labeling will focus on ingredient statements to verify if final product labels include all 

non-meat/poultry ingredients, specifically to include allergens. Based on the large 

number of products produced at the establishment, it will not be possible to review 

all labels within the 5-7 days allowed. Because of this, the EIAO’s primary focus will 

be on reviewing the establishment’s decisions related to allergens in the hazard 

analyses, on associated prerequisite programs including supporting documentation,

and on observations made in processing and storage areas. Due to the recall and

the information documented in the MOIs and NRs, the establishment’s ability to 

meet the requirements of FMIA 21 USC 601 (n)(1) is a focus of the assessment. As 

part of the assessment, the EIAO will review the establishment’s corrective action 

and reassessment records associated with the undeclared allergen recall. 

The establishment produces post-lethality exposed RTE product under Alternative 3 

and the last RLm conducted was in 2011. The MOIs and NRs indicate some issues 

with the establishment meeting SPS Requirements, including construction, 

ventilation/condensation, and sanitary operations. The EIAO will conduct an RLm

and pay special attention to the establishment’s sanitation procedures and Listeria

sampling and testing procedures to check compliance with 9 CFR 430, 417.5(a)(1) 

and 416. The EIAO will also review food safety decisions and corresponding 

supporting documents related to the production of post-lethality exposed RTE 

products.

The establishment’s enforcement history includes an NOIE issued on September 

13, 2011, for producing adulterated product as defined by the FMIA in 21 USC 

601(m)(4). The establishment did not meet the requirements of 9 CFR 416.2(d), 

416.13(b), 416.16(a), 417.2(a)(1)(2)(3), 417.2(b)(1), 417.2(c)(1) – (7), 417.4(a)(2), 

417.5, and 430, resulting in an inadequate food safety system, as described in 9 

CFR 417.6(a), (b) and (d). As part of the FSA, the EIAO will be verifying compliance 

with all the regulatory requirements. 
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Completing the PHRE: 

Writing the Rationale for Not Initiating an FSA

When you determine that an FSA is not currently needed and select “no,” you will 

then need to complete the PHRE3 question with your rationale for this decision. 

While the reasons for not initiating an FSA will vary, the basic structure for the 

rationale will include a statement indicating the FSA is not recommended and then 

the reasons for this, drawing upon information from the PHRE Report and the 

EIAO’s review of lab results, consumer complaints, enforcement reports, PFGE 

results, and communication with the relevant FLS and IPP.

Here is an example of a well-written response to PHRE3:

The EIAO determined that an FSA is not needed at this time because a review of 

the findings in the PHRE Report does not show trends that a public health risk 

exists. The EIAO reviewed the PHRE Report and identified no public health related 

noncompliance records, no positive sample results, and no recalls at the 

establishment since the time of the last FSA, performed from 5/18 to 6/10/2013. 

Review of the Consumer Complaint Monitoring System (CCMS) shows there are no 

consumer complaints for this establishment. 

The establishment produces pork rinds and pork cracklings under the Heat-Treated 

Shelf Stable HACCP category. No raw product enters the establishment. The 

source materials are purchased heat treated shelf stable. The establishment deep 

fries the pork rinds and crackling pellets. The frying process dries the product to a 

final water activity of ≤.20. The low water activity of the product will not support the 

growth of Listeria monocytogenes and it will not support the growth or germination 

of Clostridium perfringens spores. Challenge studies conducted at the University of 

Simpsonia on the products the establishment produces support a 1 to 2-log 

reduction of Listeria monocytogenes after one week of storage and a 3 to 4-log 

reduction after 5 weeks of storage. The establishment chose to produce the RTE 

pork rinds and pork cracklings under Alternative 3, sanitation measures only; 

however, with the low water activity of the finished product, Alternative 2 would be 

supported. The establishment has not had any Lm positive samples.

The EIAO spoke with FLS Dr. Julius Hibbert, who revealed no concerns. Dr. Hibbert 

met with the IIC at the establishment who also had no concerns. There have been 

few changes in operations over the past 15 years. Based on the PHRE report, 

previous FSAs, sampling results, and the conversation with the FLS there is no 

need for an FSA at this time.
25

Another Example of a Rationale for Not Initiating an FSA

(PHRE3)

The EIAO is recommending that an FSA not be completed at Patriotic Foods, 

Inc. An assessment of the PHIS PHRE data, previous FSAs, and a discussion 

with in-plant inspection personnel indicates that the establishment has provided a 

sanitary environment, designed an adequate food safety system, and is 

implementing its SSOPs and HACCP plans as designed. 

Patriotic Foods is a small establishment that further processes beef, swine, lamb, 

turkey, and chicken, utilizing raw intact and raw non-intact processing categories. 

Products include ground and fabricated pork products; tenderized beef products; 

and fabricated beef, veal, lamb, chicken, and turkey products.

The establishment has had no consumer complaints, enforcement actions, or 

recalls over the past 12 months.

An analysis of the noncompliance records over the past 6 months revealed 2 

NRs, one for insanitary condition of nonfood contact surfaces during 

preoperational inspection and the other for an employee wearing a frock 

outdoors.

During the previous 5 years, a comprehensive FSA was conducted on 10/13/11 

to satisfy the 4-year assessment cycle (Note: This was a previous requirement.). 

The FSA resulted in a recommendation that the in-plant inspection personnel 

write 2 NRs for HACCP-design issues. A review of the 10/13/11 FSA and a 

discussion with FLS Dr. Ned Flanders and IIC Edna Krabappel indicated that the 

establishment utilizes and maintains adequate support for product temperature 

CCPs to control E. coli O157:H7, Salmonella, and Campylobacter. Additionally, 

the prerequisite programs are designed and implemented to support decisions in 

the hazard analysis that hazards are not reasonably likely to occur.

The prerequisite programs include an allergen control program, temperature 

monitoring systems at product receiving and storage and during processing, a 

BSE policy, product staging and receiving procedures, a returned-product policy, 

and a Sanova system to apply acidified sodium chlorite to beef prior to needle 

tenderization. The establishment has purchase specifications for beef that 

require its suppliers to have at least one validated intervention at slaughter and to 

test carcasses for E. coli O157:H7. In addition, the establishment adequately 

maintains and implements its SSOP, which includes ATP testing and visual 

inspection for metal contamination. 

For all of these reasons, an FSA is not recommended at this time. 
26

Exercise: Evaluating a PHRE3 Response 

Analyze the following response. What is effective? What changes would you 

recommend? Compare this to the two suggested rewrites that follow.

A PHRE evaluation was completed on July 16, 2015, by EIAO Lisa Simpson

using the methodology as described in FSIS Directive 5100.4 Rev. 1. Prior FSA 

reports were reviewed including the most recent performed in June of 2011 that 

included FSIS RLm sampling with no unacceptable sampling results, thus there 

were no PFGE results to request. There was no available enforcement data or 

reports for the previous 12 months. Establishment regulatory compliance history 

including PHIS NRs for the previous 6 months was reviewed. Two NRs were 

issued in the past 3 months. The first documented a ventilation/condensation 

issue in a non-production area. No corrective actions were available for review in 

PHIS, but there was no reoccurrence. The second NR documented insanitary 

conditions of two food contact surfaces during the Pre-Operational Verification 

Tasks. Corrective actions were reviewed in PHIS and met 9 CFR 416.15. There 

were no associated NRs identified. PHIS profile data was reviewed. Weekly 

Meeting/IPP MOIs for the previous 6 months were reviewed and there were no 

food safety concerns identified. The establishment has not conducted a product 

recall within the last 12 months. FSIS conducts RTE product sampling at the 

establishment and there have been no unacceptable results within the last 6 

months, thus there were no PFGE results to request. There was one CCMS-II 

consumer complaint within the last 6 months (06/08/2015) of a consumer 

reporting a hair found on a meat/cheese stick, OPHS conducted a search for 

similar cases apparently finding none and the case was closed out. The 

evaluation of establishment historical data and background information resulted 

in a determination that there were no food safety concerns identified. This, along 

with a telephone conversation with FLS Aristotle Amadopolis, DVM, as well as 

follow-up email communication between the EIAO and IIC Gary Chalmers

resulted in a determination that there were no food safety concerns or continuing 

trends of regulatory noncompliance identified and the establishment is 

implementing adequate corrective actions/preventive measures in response to 

the recent NRs issued by FSIS and a FSA as result of the PHRE performed is 

not warranted at this time as the establishment is operating acceptably at this 

time.
27

Notes Page
28

Exercise: Evaluating a PHRE3 Response with Instructor’s 

Comments

A PHRE evaluation was completed on July 16, 2015, by EIAO Lisa Simpson (1)

using the methodology as described in FSIS Directive 5100.4 Rev. 1. (2) Prior 

FSA reports were reviewed including the most recent performed in June of 2011 

that included FSIS RLm sampling with no unacceptable sampling results, thus 

there were no PFGE results to request. There was (3) no available enforcement 

data or reports for the previous 12 months. Establishment regulatory compliance 

history including PHIS NRs for the previous 6 months was reviewed. Two NRs 

were issued in the past 3 months. The first documented a 

ventilation/condensation issue in a non-production area. No corrective actions 

were available for review in PHIS, but there was no reoccurrence. The second 

NR documented insanitary conditions of two food contact surfaces during the 

Pre-Operational Verification Tasks. Corrective actions were reviewed in PHIS 

and met 9 CFR 416.15. There were no associated NRs identified. (4) PHIS 

profile data was reviewed. Weekly Meeting/IPP MOIs for the previous 6 months 

were reviewed and there were no food safety concerns identified. The 

establishment has not conducted a product recall within the last 12 months. FSIS 

conducts RTE product sampling at the establishment and there have been no 

unacceptable results within the last 6 months, thus there were no PFGE results 

to request. There was one CCMS-II consumer complaint within the last 6 months 

(06/08/2015) of a consumer reporting a hair found on a meat/cheese stick,(5) 

OPHS conducted a search for similar cases apparently finding none and the 

case was closed out. (6) The evaluation of establishment historical data and 

background information resulted in a determination that there were no food 

safety concerns identified. (7) This, along with a telephone conversation with FLS 

Aristotle Amadopolis, DVM, as well as follow-up email communication between 

the EIAO and IIC Gary Chalmers resulted in a determination that there were no 

food safety concerns or continuing trends of regulatory noncompliance identified 

and the establishment is implementing adequate corrective actions/preventive 

measures in response to recent NRs issued by FSIS and a FSA as result of the 

PHRE performed is not warranted at this time as the establishment is operating 

acceptably at this time. (8)
29

Instructor’s Comments

1. There is no need to state that you are following the directive. This is 

assumed.

2. The answer (NO) is not presented until the end. While this is understood 

because the “NO” box is checked, it is still helpful to put the answer early 

and use the deductive writing approach.

3. This one could be negotiable because people often use data in the 

singular sense, but the verb should be “were” because data and reports 

are both plural.

4. The statement that “PHIS profile data was reviewed” is somewhat 

incomplete. The reader is left wondering, “And so what?” This would be a 

good opportunity to check for and confirm that the correct FSIS sample 

tasks or inspection tasks are being performed based on operations at the 

plant. 

5. This sentence should be ended after “stick,” and commas are needed 

around “apparently finding none.”

6. This sentence is more difficult to understand than the others are because 

it has two “sions” and a passive verb. 

7. This last sentence is too long and needs to be broken up into two or three 

sentences.

8. Overall, this writer packed a lot of information into a short writing sample. 

Though the sample has quite a bit of passive voice, many of these 

sentences are OK because we know who the actor is (the EIAO) and the 

thing we are most interested in is the RESULT of the reviews, not in who 

did the reviews. Nonetheless, this response could benefit from a higher 

percentage of active voice.
30

Version 1: Suggested Rewrite of PHRE3 Exercise

EIAO Lisa Simpson completed a PHRE evaluation on July 16, 2015, and 

determined that an FSA is not currently needed. As part of the evaluation, EIAO 

Simpson reviewed previously completed FSA reports and other relevant 

documentation. The most recent FSA, completed in June 2011, included FSIS RLm

sampling with no unacceptable sampling results, and thus there were no PFGE 

results to request.

The establishment had no enforcement data or reports for the previous 12 months. 

EIAO Simpson reviewed the establishment’s regulatory compliance history, 

including PHIS NRs for the previous 6 months, finding two NRs, but no associated 

NRs. Of the two identified NRs, the first documented a ventilation/condensation 

issue in a non-production area. No corrective actions were available for review in 

PHIS, but there was no reoccurrence. The second NR documented insanitary 

conditions of two food contact surfaces during the Pre-Operational Verification 

Tasks. Corrective actions were reviewed in PHIS and met 9 CFR 416.15.

A review of the weekly meeting/IPP MOIs for the previous 6 months identified no 

food safety concerns. The establishment has not conducted a product recall within 

the last 12 months. FSIS conducts RTE product sampling at the establishment and 

there have been no unacceptable results within the last 6 months; thus, there were 

no PFGE results to request. 

One CCMS-II consumer complaint was made on 06/08/2015, with a consumer 

reporting a hair found on a meat/cheese stick. OPHS conducted a search for similar 

cases, revealed no cases, and the case was closed out. A review of establishment 

historical data and background information did not identify any food safety 

concerns.

In communication with EIAO Simpson, neither FLS Aristotle Amadopolis, DVM, nor 

IIC Gary Chalmers cited any food safety concerns or continuing trends of regulatory 

noncompliance. The establishment is implementing adequate corrective actions and 

preventive measures in response to recent NRs issued by FSIS, and an FSA is not 

warranted at this time.
31

Version 2: Suggested Rewrite of PHRE3 Exercise

A PHRE evaluation was completed on July 16, 2015, by EIAO Lisa Simpson. Based 

on this review, the EIAO determined an FSA is not needed at this time. This 

recommendation is based on reviews of the following:

• Prior FSA reports, including the most recent performed in June 2011 

that included FSIS RLm sampling with no unacceptable sampling 

results and thus no PFGE results to request.

• Available enforcement data or reports for the previous 12 months 

indicating no action taken.

• Establishment regulatory compliance history, including PHIS NRs for 

the previous 6 months, with no associated NRs.

• Two issued NRs. (The first documented a ventilation/condensation 

issue in a non-production area. No corrective actions were available 

for review in PHIS, but there was no reoccurrence. The second NR 

documented insanitary conditions of two food contact surfaces during 

the Pre-Operational Verification Tasks. Corrective actions were 

reviewed in PHIS and met 9 CFR 416.15.)

• PHIS profile data with no updates made.

• Weekly Meeting/IPP MOIs for the previous 6 months with no food 

safety concerns identified. 

• No establishment recalls within the last 12 months.

• No unacceptable results from FSIS’s RTE product sampling at the 

establishment in the last 6 months, thus no PFGE results to request. 

• One CCMS-II consumer complaint within the last 6 months 

(06/08/2015) of a consumer reporting a hair found on a meat/cheese 

stick, which led to OPHS searching for similar cases, finding none, 

and closing out the case.

• Establishment historical data and background information indicating 

no food safety concerns identified.

Additionally, the EIAO spoke with FLS Aristotle Amadopolis, DVM, and IIC Gary 

Chalmers to determine if either had any food safety concerns. This communication 

yielded that the establishment is implementing adequate corrective actions and 

preventive measures in response to recent NRs issued by FSIS.
32

General EIAO Documentation Tips

Guidance on Writing the FSA from FSIS Directive 5100.1

• Focus on assessing and analyzing the establishment’s food safety system as 

a whole, with an emphasis on documenting vulnerabilities and 

noncompliance. While noncompliance needs to be noted, this should be but 

one aspect of the overall, big-picture assessment.

• Discuss vulnerabilities, even when there are no instances of noncompliance. 

• Generally, do not make positive editorial findings.

• At the end of each tool, summarize the findings that best support the FSA 

recommendation or any enforcement actions you recommend for the 

establishment’s HACCP system.

• Use the decision-making analysis section of the General Tool to provide an 

analysis of the background, applicable sample results, and observations 

made throughout the FSA to support the recommendation. Ensure the 

recommendation is supported by FSIS statutory and regulatory requirements 

(i.e., the Acts and 9 CFR). 

• Provide a summary of the analysis in the Executive Summary, a synopsis of 

the FSA that should be approximately nine sentences long.

General Guidance for Writing EIAO Documentation

• Write for people “outside the neighborhood.”

• Generally, address the most egregious problems first and then discuss 

remaining issues.

• Clearly describe documents and facts. For example, if a section of the 

HACCP plan is involved, or a CCP is at issue, specify the name of the 

document so the reader understands what document or section is at issue. If 

product is involved, describe the product, the quantity, and its condition, if 

applicable. 

• Associate dates with documents, observations, and issues. For example, if 

the record shows that the plant failed to reassess its HACCP plan as 

required, when documenting the facts that led to this conclusion, make sure

you include the date of the most recent HACCP plan. 

• Identify persons involved by name and title. Clarify whether they are FSIS 

employees or plant personnel. 
33

• Relate the noncompliance to accurate regulatory citations (but not 

“recitations”). Remember that as part of due process, FSIS must provide 

plant officials with information that clearly defines the nature of the 

noncompliance and the related regulatory requirement.

• Think about the bottom-line message you are trying to convey before putting 

it on paper. Ask yourself these questions: What do I want to convey? What 

essential information and facts are most important to discuss?

• Avoid jargon and excessive wordiness. 

• Consider the appearance of the document. Avoid long sentences and 

paragraphs. Put material and information in logical order and in a format that 

is “easy to the eye,” for example by indenting text and using bullets. 

Proofread documents. Check grammar and punctuation. 
34

Key Ideas for Responding to FSA Tool Questions

When responding to the FSA tool follow-up questions, the biggest challenges are 

specifically answering the question, ensuring proper scope, and clearly 

demonstrating the critical thinking and analysis associated with the response. 

Answer the Question

When reading an FSA tool, the reader expects that the answer to a question 

will in fact answer the question. Therefore, when writing your response, be 

sure to answer the question directly and then provide the detail that supports 

the response—not the other way around. Forcing yourself to answer directly 

the question will ensure a deductive approach.

Maintain Proper Scope

Scope in this case means having the right level of detail to answer fully the 

question without adding too much or irrelevant information or leaving out 

contextual information. 

Use Critical Thinking

When making an observation, it is important to relate that observation to the 

criterion, regulatory requirement, document, sample result, or record that 

makes it relevant and important. 
35

Tips for Writing FSA Tool Question Responses

DO

• Support your decision in every response. This means you will explain your 

rationale by citing documentation, observations, sample results, and 

regulations.

• Review the questions in a tool before you start to avoid redundancy. This will 

allow you to plan where various information and observations will go.

• Describe fully what you have seen so that readers have a visual 

understanding, as appropriate.

• Lead with your main idea and be sure you have answered the question.

• Keep your focus on assessing and analyzing the establishment’s food safety 

system.

DO NOT

• Copy and paste responses from one question into another question. Instead, 

refer the reader to fuller response. If possible, give a one or two sentence 

synopsis that answers the question and then refer the reader to the fuller 

response. Example: “The establishment’s practice of XYZ creates a 

vulnerability... Please see M2 for a full description of this vulnerability.”

• Quote long passages from the regulations. Instead, simply cite references. 

For example, you may write, “Per 9 CFR 416.13, this plant is required to 

monitor the implementation of Sanitation SOPs at least once a day. We 

reviewed the plant’s monitoring records, including their clean-up, preoperation, and operational sanitation reports, and observed that the plant is 

monitoring its operations every 48 hours.”

• Use jargon and abbreviations that might confuse the reader. For example, 

instead of using the plant’s “TC program,” write out Temperature Control 

Program.

• Make positive editorial comments, but be sure to support fully a 

recommendation of no further action. 

NOTE: PHIS limits the number of text characters allowed in the follow-up question 

boxes. In most instances, the preferred approach would be no more than 5-10 lines 

of brief narrative. Bullet points are allowed and encouraged where appropriate. 

Some situations—such as numerous findings at the plant or a unique process that 

requires a longer description—will merit a lengthier entry. 
36

Exercise: Critique a Response to a Follow-Up Question

In your team, analyze this response from the General Meat Tool. Make note of at 

least three observations, use a flipchart page to create a good outline, and write a 

new first paragraph. Be prepared to share your work.

G14 (Single Choice) Are there any conditions associated with the structure (Sanitation Performance 

Standards) that would hinder the establishment’s ability to maintain sanitary conditions?

 Yes

G15 Describe the vulnerabilities and cite any noncompliance, and document your analysis on how 

the conditions impact food safety.

The first day of the FSA, 9/8/2015, the establishment was not operating. CSI Jasper 

Beardly, HACCP Manager Kent Brockman, and I toured the facility carefully 

inspecting the structure for soundness. Brockman was highly helpful and made 

certain we had easy access to all parts of the establishment. The slaughter area 

was adequately maintained with a small amount of rust visible on the structure 

stationing plates on the ceiling. The packing room was found acceptable. The 

basement contains a vacuum packaging room which is used occasionally. Across 

one wall there were pallets stacked in a manner that made visibility limited. There 

were used boxes, gloves, and some food wrappers in one corner which had the 

appearance of a collection of trash. Kent Brockman stated that the area had not 

been used for several weeks. On 9/10/2015, this area was again toured. The area 

was not in use that day although the plant had run slaughter and packing operations 

in their usual production areas. Noncompliances were found and documented on 

NR 1-2015-9136 and the insanitary areas were rejected. In the first large storage 

room in the basement, west of the basement stairs, there were 6 freezer racks (not 

in use) with a heavy layer of dust on them. This dust was visible and when wiped 

showed it could be easily transferred. In the same room, a drain coming through the 

ceiling near the east wall had water dripping around the outside of it. A beam in the 

same vicinity was rusted and had water stains indicating a constant problem. In this 

area one ceiling panel was missing. In the vacuum pack room four ceiling panels 

had been taken down and were lying on an unused vacuum pack machine. A drain 

pipe running the length of the ceiling with rubber insulation was only partially 

covered with white plastic. The white plastic cover that was on had a heavy coat of 

dust on the top surface. Rust and dust stains were visible along seam joints on the 

glass board walls. Dust and cobwebs were on an exhaust fan shroud on the west 

wall. Dust, cobwebs, and rust were visible on a table along the north wall holding 

boxes of labels and bags. The noncompliances were shown to HACCP Supervisor 

Kent Brockman. Since these rooms were not in use and not scheduled to be used 

prior to the plant having an extended shut down, Kent Brockman said they would 

correct all the issues with extra cleaning accomplished in this area from 9/23/15 

through 9/26/15 and that the area would not be used until the deficiencies were 

corrected. He also said the rust would be cleaned from the slaughter area. Each 

day of the FSA the production areas of the establishment in use were observed and 

the production rooms in use were well maintained and sound.
37

Notes Page
38

Passive Voice in “Critique a Response to a Follow-Up 

Question”

The first day of the FSA, 9/8/2015, the establishment was not operating. CSI Jasper 

Beardly, HACCP Manager Kent Brockman, and I toured the facility carefully 

inspecting the structure for soundness. Brockman was highly helpful and made 

certain we had easy access to all parts of the establishment. The slaughter area 

was adequately maintained with a small amount of rust visible on the structure 

stationing plates on the ceiling. The packing room was found acceptable. The 

basement contains a vacuum packaging room which is used occasionally. Across 

one wall, there were pallets stacked in a manner that made visibility limited. There 

were used boxes, gloves, and some food wrappers in one corner which had the 

appearance of a collection of trash. Kent Brockman stated that the area had not 

been used for several weeks. On 9/10/2015, this area was again toured. The area 

was not in use that day although the plant had run slaughter and packing operations 

in their usual production areas (run-on). Noncompliances were found and 

documented on NR 1-2015-9136 and the insanitary areas were rejected. In the first 

large storage room in the basement, west of the basement stairs, there were 6 

freezer racks (not in use) with a heavy layer of dust on them. This dust was visible 

and when wiped showed it could be easily transferred. In the same room, a drain 

coming through the ceiling near the east wall had water dripping around the outside 

of it. A beam in the same vicinity was rusted and had water stains indicating a 

constant problem. In this area one ceiling panel was missing. In the vacuum pack 

room, four ceiling panels had been taken down and were lying on an unused 

vacuum pack machine. A drain pipe running the length of the ceiling with rubber 

insulation was only partially covered with white plastic. The white plastic cover that 

was on had a heavy coat of dust on the top surface. Rust and dust stains were 

visible along seam joints on the glass board walls. Dust and cobwebs were on an 

exhaust fan shroud on the west wall. Dust, cobwebs, and rust were visible on a 

table along the north wall holding boxes of labels and bags. The noncompliances 

were shown to HACCP Supervisor Kent Brockman. Since these rooms were not in 

use and not scheduled to be used prior to the plant having an extended shut down, 

Kent Brockman said they would correct all the issues with extra cleaning 

accomplished in this area during 9/23/2015 through 9/26/2015 and that the area 

would not be used until the deficiencies were corrected. He also said the rust would 

be cleaned from the slaughter area. Each day of the FSA, the production areas of 

the establishment in use were observed and the production rooms in use were well 

maintained and sound.
39

Observations on “Critique a Response to a Follow-Up 

Question in the General Tool”

1. This response is confusing. It seems that the author feels the important 

production areas are sound. Yet, the author cites many observations of dirt, 

dust, leaks, trash, rust, and so on. Additionally, the response indicates that 

an NR was issued.

2. Generally, the emphasis should be on vulnerabilities and noncompliance—

not on what is OK and sound. This response could be shortened significantly 

and be more on point by eliminating the positive commentary, including the 

positive comment about Brockman’s helpfulness.

3. A rewrite should include a better topic sentence and organization, as well as 

some simple formatting. If all of the content is left in, it needs to be two or 

three paragraphs, and the observations should be presented as bulleted lists.

4. If the establishment made corrections to relevant findings during the FSA, 

this could be noted. Ideally, if the findings are relevant to the outcome of the 

FSA, for example enforcement, then it is best to indicate if the corrective 

actions will address the concern raised in the FSA. However, a blanket 

statement about every NR issued and whether the establishment has 

addressed corrective actions is not necessary. Items G12 and G13 allow the 

EIAO to indicate if an NR requires follow up.

If the establishment has not made corrective actions before the end of the 

FSA, and if the NR is significant or complex, the 5100.1 directive allows for 

the EIAO to follow-up after the FSA is completed. In that case, the EIAO 

should mention it in the FSA tools questions. Additionally, when the 

noncompliance is part of a larger enforcement action, the NR may not 

actually be written at the time, but rather folded into the enforcement action 

recommended by the FSA.

5. The author has done a good job of describing what he saw, so the reader is 

easily able to envision the issues. However, the writing suffers from too much 

passive voice, and there are some shifts in tense.

6. Finally, the writing sample is missing several commas after introductory 

phrases and before “which” statements. (Alternately, “which” could be 

replaced with “that.”)
40

Suggested Rewrite of “Critique a Response to a Follow-Up 

Question”

G14 (Single Choice) Are there any conditions associated with the structure (Sanitation Performance 

Standards) that would hinder the establishment’s ability to maintain sanitary conditions?

 Yes

G15 Describe the vulnerabilities and cite any noncompliance, and document your analysis on how 

the conditions impact food safety.

On 9/8/2015 and 9/10/2015, I (or EIAO Blank) toured the facility with CSI Jasper 

Beardly and HACCP Manager Kent Brockman and identified multiple sanitation 

noncompliances in the vacuum packaging room and a large storage room in the 

basement area. The specific concerns are outlined below. Please note that the 

storage room is a nonproduction area, and the vacuum packaging room was not in 

use at the time but is used occasionally. The IPP rejected the insanitary areas and 

documented the noncompliance on NR 1-2015-9136. The establishment has 

scheduled complete cleaning of the areas the week of 9/23. I (or EIAO Blank) 

recommend the areas remain rejected until the establishment restores sanitary 

measures.

The specific concerns in the vacuum packaging room and the storage area were as 

follows:

Vacuum Packaging Room

• Across one wall, a stack of pallets limited visibility.

• Boxes, gloves, and some food wrappers in one corner appeared to be a pile 

of trash. 

• Four ceiling panels had been removed and were lying on an unused vacuum 

pack machine.

• An approximate 6-foot portion of rubber insulation was missing on a 14-foot 

drainpipe. The portion of insulation that remained had a heavy coating of 

dust.

• Rust and dust stains were visible along seam joints on the glass board walls. 

• Dust and cobwebs were visible on an exhaust fan shroud on the west wall. 

• Dust, cobwebs, and rust were visible on a table along the north wall holding 

boxes of labels and bags. 

Large Storage Room (located west of basement stairs)

• Six freezer racks, not in use, had a heavy layer of dust on them. This dust 

was visible and when wiped was transferred easily.

• A drain coming through the ceiling near the east wall had water dripping 

around the outside of it.

• A beam close to this same drain was rusted and had water stains indicating 

an active leak.

• A ceiling panel was missing.
41

Writing a Tool Summary

• Use the summary question at the end of each tool to focus on the most 

significant noncompliance(s) or vulnerabilities that can affect an 

establishment’s ability to produce safe, wholesome, and unadulterated 

product.

• Present these findings as 3-5 bullet points.

• If a bulleted finding needs a narrative explanation, follow the bullet with an 

explanation.

• Write the summaries carefully and ensure they fully capture the critical 

findings.

• Use information from the tool summary (or summaries if more than one tool 

is completed) to write the Decision-Making Analysis and the Executive 

Summary.

• Be aware that this summary should capture the essence of the information 

collected using that tool. It should not be lengthy, nor should it be a 

chronology of the FSA. 

• Do not reference other tool questions within the summary because the 

summary should be considered a stand-alone entry.
42

Example of a Tool Summary (NRTE Tool)

• The deviation from the critical limit on June 20, 2015, during the FSA showed 

that monitoring procedures performed at the filling step were vulnerable and 

may not be preventing pathogen growth and therefore may have an impact 

on the establishment’s ability to produce safe, wholesome, unadulterated 

NRTE products for the consumer. The establishment failed to meet the 

requirements of 9 CFR 417.5(a)(2) and 417.2(c)(4), with documentation 

occurring at the time of the event by IPP on NR # XXXXX. Specifically,, the 

food preparation process results in the product being exposed to room 

temperatures for potentially extended periods. The EIAO requested that the 

establishment take a product temperature of the product that was staged on 

the racks. The product’s temperature was 62°F, which was above the 

establishment’s critical limit of ≤ 45°F. 

• The EIAO is recommending that IPP issue an NR for regulatory noncompliance with the verification and recordkeeping requirements in 9 CFR 

417.4(a)(2)(i)(ii)(iii) and 417.5(c). Even though the establishment conducted 

monitoring activities at the described frequency, the establishment failed to 

do the following: conduct verification activities to ensure the thermometers 

were functioning properly; verify process control with a direct observation of 

the monitoring procedures; review generated records; and conduct a preshipment review to ensure completeness for all products produced. Failure to 

complete these actions may create a vulnerability in the establishment’s food 

safety system for their HTNFCNSS process. The failure to conduct 

verification activities does not ensure that the establishment is maintaining 

process control and could allow the production of misbranded or adulterated 

products.

• The establishment lacks validated cooking instructions for the items par fried 

after filling. Review of the FSIS product labels for the Yummy Bites product 

found that they state: “Heat oil to 350 degrees Fahrenheit and cook for 1 1⁄2 to 

2 minutes. Or until golden brown.” Therefore, the establishment’s lack of 

validated cooking instruction does not support the decisions made in the 

hazard analysis for the Yummy Snacks or support the cooking instructions 

printed on the label for NRTE products that have the appearance of being 

RTE. This is not compliant with the requirements of 9 CFR 417.5(a)(1) and

could affect the establishment’s ability to produce safe, wholesome, and 

unadulterated product for the consumer. The EIAO is recommending an NR 

be documented by IPP to address this noncompliance.
43

Exercise: Critique and Rewrite a Meat Tool Summary

Read, critique, and rewrite this Meat Tool Summary. Also, underline each passive 

voice construction.

Bouvier Fine Meats produces various intact and non-intact meat products. Some

meat products are processed from boxed beef received and others are processed 

from carcasses received. The Hazard Analysis concluded that there are no 

pathogens, including E. coli O157:H7, reasonably likely to occur on received 

products. Pathogen growth was deemed likely to occur and a HACCP plan was 

created to ensure room temperatures were controlled to prevent outgrowth of 

pathogens. 

The Hazard Analysis, HACCP plan and accompanying required documentation 

failed to meet regulatory requirements as set forth in 9 CFR 417 for the following 

issues. 

 

Incoming intact boxed beef intended for needle tenderization and the carcasses 

intended for further processing into trim for grinding lack support for the decision 

made that E. coli O157:H7 is unlikely to occur at receiving. According to Bouvier 

Fine Meats, E. coli O157:H7 is unlikely to occur because supporting scientific 

articles supplied say there is an extremely low prevalence that exists and that 

products they receive are subjected to at least one validated intervention to reduce 

to an undetectable level pathogens of concern at the supplying plants as indicated 

in yearly Letters of Guarantee and third party audits. In the unlikely case that E. coli

O157:H7 did contaminate a carcass or boxed beef intended for non-intact use, they 

have proposed (and initiated by the end of the FSA) a program that sprays 

carcasses with acidified sodium chlorite (ASC), using a hand sprayer. Boxed beef 

intended for tenderization is run through a spray cabinet. Both the carcass spray 

and spray cabinet utilize ASC to reduce E. coli O157:H7 to undetectable levels. The 

ASC is validated to reduce E.coli O157:H7 by 1 to 2 logs. The carcass spray is 

instituted, but there is no data at this time to verify the efficacy of the program. Trim 

created from the boxed beef is labeled “for cooking only” and is sent to 

establishments that cook it to lethality.

 

When conducting the Hazard Analysis, an establishment needs to consider food 

safety hazards that are reasonably likely to occur before, during, and after entry. In 

this case, Bouvier Fine Meats failed to support their decision that E. coli O157:H7 is 

unlikely to occur in received boxed beef and carcasses. Under HACCP regulations, 

the receiving establishment must perform on-going activities to verify that its 

HACCP plan is being effectively implemented and maintain documents that support 

those activities, and the frequency with which it performs them, are appropriate to 

accomplish their intended purpose. 
44

Receiving a yearly LOG or third-party audit from suppliers does not constitute 

ongoing verification activities. There is no evidence provided of communication 

between Bouvier and its suppliers on an ongoing basis that demonstrates there are 

consistent and effective controls in place to ensure E. coli O157:H7 is not present at 

a detectable level in product being received at the establishment. According to 9 

CFR 417.2 (a), “a food safety hazard that is reasonably likely to occur is one for 

which a prudent establishment establishes controls because it historically has 

occurred....” E. coli O157:H7 has been shown to occur in recent recalls, and human 

illness has been associated with ground beef and cuts intended for non-intact use 

(tenderized subprimals) from other establishments. This further indicates that 

reliance on scientific articles and yearly LOG from other establishments is not 

enough to conclude that incoming product has undetectable levels of E. coli

O157:H7. E. coli O157:H7 is considered an adulterant in beef products intended for 

non-intact use. This includes subprimals that are tenderized.

The approved supplier program also calls for all beef products intended for grinding 

to be accompanied by a Certificate of Analysis (COA) indicating a negative test for 

E. coli 0157:H7 using an approved testing methodology. Incoming carcasses that 

are further fabricated have the trim ground. They are not received with COAs.
45

Notes Page
46

Meat Tool Summary: Passive Voice Identified

Bouvier Fine Meats produces various intact and non-intact meat products. Some

meat products are processed from boxed beef received and others are processed

from carcasses received. The Hazard Analysis concluded that there are no 

pathogens, including E. coli O157:H7, reasonably likely to occur on received 

products. Pathogen growth was deemed likely to occur and a HACCP plan was 

created to ensure room temperatures were controlled to prevent outgrowth of 

pathogens. 

The Hazard Analysis, HACCP plan and accompanying required documentation 

failed to meet regulatory requirements as set forth in 9 CFR 417 for the following 

issues. 

 

Incoming intact boxed beef intended for needle tenderization and the carcasses 

intended for further processing into trim for grinding lack support for the decision 

made that E. coli O157:H7 is unlikely to occur at receiving. According to Bouvier

Fine Meats, E. coli O157:H7 is unlikely to occur because supporting scientific 

articles supplied say there is an extremely low prevalence that exists and that 

products they receive are subjected to at least one validated intervention to reduce 

to an undetectable level pathogens of concern at the supplying plants as indicated 

in yearly Letters of Guarantee and third party audits. In the unlikely case that E. coli

O157:H7 did contaminate a carcass or boxed beef intended for non-intact use, they 

have proposed (and initiated by the end of the FSA) a program that sprays 

carcasses with acidified sodium chlorite (ASC), using a hand sprayer. Boxed beef 

intended for tenderization is run through a spray cabinet. Both the carcass spray 

and spray cabinet utilize ASC to reduce E. coli O157:H7 to undetectable levels. The 

ASC is validated to reduce E.coli O157:H7 by 1 to 2 logs. The carcass spray is 

instituted, but there is no data at this time to verify the efficacy of the program. Trim 

created from the boxed beef is labeled “for cooking only” and is sent to 

establishments that cook it to lethality.

 

When conducting the Hazard Analysis, an establishment needs to consider food

safety hazards that are reasonably likely to occur before, during, and after entry. In 

this case, Bouvier Fine Meats failed to support their decision that E. coli O157:H7 is

unlikely to occur in received boxed beef and carcasses. Under HACCP regulations, 

the receiving establishment must perform on-going activities to verify that its 

HACCP plan is being effectively implemented and maintain documents that support 

those activities, and the frequency with which it performs them, are appropriate to 

accomplish their intended purpose. 

Receiving a yearly LOG or third-party audit from suppliers does not constitute 

ongoing verification activities. There is no evidence provided of communication 

between Bouvier and its suppliers on an ongoing basis that demonstrates there are
47

consistent and effective controls in place to ensure E. coli O157:H7 is not present at 

a detectable level in product being received at the establishment. According to 9 

CFR 417.2 (a), “a food safety hazard that is reasonably likely to occur is one for 

which a prudent establishment establishes controls because it historically has 

occurred....” E. coli O157:H7 has been shown to occur in recent recalls, and human 

illness has been associated with ground beef and cuts intended for non-intact use 

(tenderized subprimals) from other establishments. This further indicates that 

reliance on scientific articles and yearly LOG from other establishments is not 

enough to conclude that incoming product has undetectable levels of E. coli

O157:H7. E. coli O157:H7 is considered an adulterant in beef products intended for 

non-intact use. This includes subprimals that are tenderized.

The approved supplier program also calls for all beef products intended for grinding 

to be accompanied by a Certificate of Analysis (COA) indicating a negative test for 

E. coli 0157:H7 using an approved testing methodology. Incoming carcasses that 

are further fabricated have the trim ground. They are not received with COAs.
48

Observations on “Critique and Rewrite Meat Tool 

Summary”

This is a good start. It is fairly well organized, and it clearly states that the 

establishment is noncompliant and is failing to meet regulatory requirements. 

However, it has a few areas that need work. These include the following:

1. The last sentence in the first paragraph (Pathogen growth was deemed likely 

to occur and a HACCP plan was created to ensure room temperatures were 

controlled to prevent outgrowth of pathogens) does not add to the analysis 

and, in fact, distracts from the matter at hand.

2. The final paragraph about the COAs is vague. Does this mean they have 

never received COAs? This would need to be clarified and contain more 

specific information about how often and when, if ever, the establishment 

received COAs.

3. Two of the sentences are very long. Specifically, see the second sentence in 

the third paragraph, which is 64 words long. Additionally, look at the third 

sentence in the fourth paragraph, which is 42 words long.

4. This analysis is 50% passive voice, which “fogs up” the writing significantly.
49

Suggested Rewrite of Meat Tool Summary

The establishment cannot support the decision that E. coli O157:H7 is NRLTO in 

accordance with 9 CFR 417.5(a)(1) and 417.2(a)(1). Specific examples of Bouvier’s 

inadequate support include the following:

• Scientific articles Bouvier provided said there is an extremely low prevalence of 

E. coli O157:H7. While establishments are commended for staying abreast of 

scientific research associated with food safety, these articles do not specifically 

correlate with the products produced by Bouvier and do not provide the 

necessary validation to support the decision that the pathogen is NRLTO.

• Bouvier proffered annual Letters of Guarantee (LOG) and third-party audits and 

stated that products they receive have had at least one validated intervention 

applied by the supplying establishments to reduce pathogens of concern to an 

undetectable level. However, annual LOG or third-party audits do not constitute 

ongoing communication between Bouvier and its suppliers on an ongoing basis 

that demonstrates consistent or effective controls to reduce E. coli O157:H7 to 

undetectable levels. 

• Bouvier failed to follow the “Approved Supplier Program,” which requires beef 

products intended for grinding to be accompanied by a Certificate of Analysis 

(COA) with negative test results for E. coli O157:H7 or to be held until tested for 

E. coli O157:H7. Bouvier neither receives COAs from their supplier nor performs 

tests for the pathogen.

• During the Food Safety Assessment (FSA), Bouvier proposed and initiated a 

program that sprays carcasses (using a hand sprayer) and boxed beef (in a 

spray cabinet) with acidified sodium chlorite (ASC). ASC is validated to reduce 

E. coli O157:H7 by 1 to 2 logs, and although Bouvier has implemented the ASC 

spray program, there is no data available to verify the efficacy of the program. 
50

Writing the Decision-Making Analysis (DMA) in the 

General Tool

You will write your overall recommendation and the rationale for it in the decisionmaking analysis (DMA) section (G5) of the General Tool. The DMA is an especially 

important part of the FSA because it captures the recommendation and the support 

for this recommendation.

Within the DMA, you will include relevant findings and interpret these findings and 

their impact on the establishment’s ability to produce safe, wholesome, and 

unadulterated product. In doing so, you will provide context and support for your

recommendation.

• Write the DMA using the findings in the tool summaries, including the 

General Tool Summary (G54).

• Additionally, use the DMA to share information on relevant results from RLm, 

IVT, or IIT sampling, PHRE, and in-plant observations.

• Note that the text box in PHIS allows for up to 20,000 characters; however, 

the ideal DMA will be one to two pages, far less than 20,000 characters.

• Consider the “puzzle pieces” before you begin writing the DMA. Review the 

tool summaries and any other content you feel is important, including 

sampling data, PHRE, observations, and so on.

• As appropriate, clearly identify what is noncompliance and what is a 

vulnerability.

• Be sure to lead with the recommendation(s) and an overview of the findings. 

If desired, give brief information about the facility and process.

• Consider using small headers to separate content. For example, if your DMA 

needs to address sampling, sanitation, and HACCP design—and if these can 

and should be addressed separately—use headers to guide the reader.

• If desired, use the “hourglass” structure and repeat the recommendation(s) at 

the end of the DMA.
51

• Create a simple outline to guide you as you begin. One approach does not 

work all of the time, so use critical thinking to help you. 

Example: are there two distinct and separate findings? If so, then lead 

with the recommendation and the fact that there are two findings. 

Then follow this initial paragraph with a paragraph on each of the 

findings and their impact on food safety.

Example: is there a single finding of noncompliance and two potential 

vulnerabilities that are not violations? If so, state this in the opening 

paragraph (along with the recommendation, of course), and then 

follow with information on each of these three items.

Example: is there a recommendation of no further action but NRs by 

in-plant personnel? State this in the first paragraph, give a very brief 

overview of the fact that the establishment is meeting regulatory 

requirements, and then expand on why each NR needs to be written.
52

Sample DMA in Outline

Recommendation in 1-2 sentences

EIAO Blank is recommending issuance of an NR by IPP because the 

establishment failed to conduct sampling at the location described in the 

written program for process control organisms at post-chill and failed to 

support the selection of Enterobacteriaceae as the indicator organism, 

leading to a failure to meet 9 CFR 381.65(g). Additionally, the establishment 

does not have a written recall procedure as required by 9 CFR 418.3.

Analysis and Explanation

Issuance of an NR for these noncompliances is appropriate because (detail 

here on your thought process and the impact on the establishment’s ability to 

produce safe, wholesome, and unadulterated product)...

Additional Information on Reason for FSA and Other Relevant 

Findings

EIAO Blank conducted this FSA for cause at the request of the Frontline 

Supervisor and IPP. A review of the PHRE report indicates that the 

establishment maintains records as required, has not had an enforcement 

action in the past 12 months, has not conducted any product recall, and had 

no positive samples for Salmonella, Campylobactor, or residue in the past 12 

months. 

Reiterate Recommendation

In summary, the establishment has failed to design, implement, and maintain 

a sampling program to demonstrate process control and has not developed 

written recall procedures. Thus, EIAO Blank is recommending the issuance 

of NRs by IPP with a follow-up in 30 days by an EIAO to ensure that a 

scientifically supported sampling plan along with sample results for either the 

pathogens of concerns (Salmonella or Campylobactor) or an indicator 

organism are in place as required by the New Poultry Slaughter Inspection’s 

final rules.
53

Exercise: Comparing a DMA “Before” and “After” 

Read the DMA below and then read the DMA on pages 73-74. What changes do 

you notice? Please make note of at least three significant differences.

BEFORE

This FSA was conducted to evaluate the establishment’s food safety system due to 

potential changes in the HACCP plans because of the recent change in ownership. 

All HACCP systems, SSOPs, recall program, and general food defense program 

were evaluated during the FSA. in addition to discussions with IIC Lenny Leonard.

Montgomery Burn’s Foods USA is a small establishment producing Raw Intact, Raw 

Non-Intact, and Fully Cooked – Not Shelf Stable products. Products include 

fabricated raw and RTE beef, pork, chicken, and turkey products. All RTE post 

lethality exposed products are produced under Alternative 3. 

Review of the establishment’s HACCP systems indicated that all hazards 

associated with the products produced and production processes were identified 

and addressed; providing measures for the prevention or control of potential 

hazards. The establishment identified product temperature during processing as a 

hazard RLTO in raw products and product cooking and stabilization temperatures 

as RLTO in RTE products; for which CCPs were developed. Management provided 

reliable supportable documentation for decisions made in the hazard analysis and in 

the development of CCPs. CCPs for monitoring raw product’s temperatures during 

processing were supported by FDA’s Food Code, Section: 3-5 Limitation of Growth 

of Organisms of Public Health; while RTE product’s temperatures during cooking 

and stabilization were supported by FSIS’s Appendix A: Compliance Guidelines for 

Meeting Lethality Performance Standards for Certain Meat and Poultry Products. 

The establishment is implementing controls as described in the support documents 

with the exception of not monitoring the oven’s relative humidity during product 

cooking. An establishment relying on FSIS’ Appendix A for cooking RTE products is 

required to meet all the parameters of the process schedule, including the relative 

humidity of the ovens. The time-temperature table in Appendix A is based on wetheat. Without humidity, the product will dry, and the bacteria may become more 

heat resistant (Goepfert, 1970; Goodfellow and Brown, 1978; Faith, N.G. et al. 

1998). Failure to achieve the required levels of pathogen lethality during the cooking 

process may allow for viable pathogens on products which may render then 

injurious to health. As described, the establishment failed to support the adequacy 

of the CCP in controlling the hazard (pathogen lethality during the cooking cycle). 

This failure to meet the requirements of 9 CFR Part 417.5(a)(2) for design of the 

HACCP system was documented on a NR issued by IPP during the FSA. 
54

Reviews and observations of the implementation of the HACCP 

systems and associated records (prerequisite records, HACCP 

records, test results, FSIS’s MOIs, and FSIS’sNR) demonstrated that 

management is implementing the HACCP plans as described. No 

noncompliances related to the implementation of the HACCP systems 

were identified by the EIAO; however, vulnerabilities associated with 

the food safety system were identified. 

The establishment adds non-meat ingredients to raw products and to RTE products 

after the lethality step. Management addressed hazards associated with these upon 

receiving and during storage and determined that non-meat ingredients are a 

hazard NRLTO based on prerequisite programs for allergen control, suitability of 

ingredients, and manufacturer pathogen controls (COAs from manufacturer that 

these have been subject to pathogen controls, shelf stability, etc.). However, dry 

non-meat ingredients, such as spices and breadcrumbs, added to raw products and 

RTE products after the lethality step, are removed from their original containers and 

placed in bins for their dispensing and storage between uses. Even though 

ingredients are covered while stored in these bins, they are stored in a high humidity 

area (room is washed daily). These storage bins are not sealed; allowing for 

moisture to come in in contact with the ingredients. The establishment has not 

addressed the potential for changes in ingredient’s moisture levels during long 

storage periods, which may allow for pathogen, mold, and / or yeast growth. During 

the FSA, the EIAO did not observe that ingredients had become contaminated or 

that these were stored under insanitary conditions that may cause products to

become adulterated. No evidence of mold or yeast growth were observed in nonmeat ingredients; however, there is a concern that if storage conditions are not 

monitored, insanitary conditions could develop causing product to become 

adulterated. 

This establishment operates under dual jurisdiction (FSIS/FDA); however, 

management does not make any distinction between SSOP procedures for 

FSIS or FDA products. FSIS requirements are being following for all 

processes. Facilities, grounds, equipment, and utensils were observed to be 

well maintained preventing the creation of insanitary conditions that may 

adulterate product. SSOP procedures were observed to be implemented as 

described. The establishment is meeting the requirements of 9 CFR Parts 

416.1-416.4 for facilities and equipment, as well as, Parts 416.11-416.16 for 

the development and implementation of SSIOPs. 
55

Analysis/Recommendation: 

The noncompliance identified during the assessment indicate a failure by the 

establishment to support the design of the HACCP plan, as required by 9 CFR Part 

417.5(a)(2). Actual in-plant observation of monitoring activities support the absence 

of any immediate food safety concern, yet the establishment has a responsibility to 

support the adequacy of the design of their food safety system and maintain 

documentation to demonstrate the proper implementation and effectiveness of that 

design, as required by 9 CFR Part 417.5. There were no issues identified, including 

identified vulnerabilities associated with non-meat ingredient storage or product 

traceability, which demonstrate the creation of insanitary conditions which may 

render product adulterated.

The noncompliance was addressed on a NR issued by IPP during the FSA. 

Vulnerabilities identified were discussed by plant management. There were no 

issues of noncompliance creating an imminent threat to food safety that warranted a 

recommendation for an enforcement action in accordance with the Rules of 

Practice. The EIAO recommends that the FLS be contacted in 30 days or the EIAO 

visit the establishment to verify that the establishment has implemented actions to 

meet Part 417.4.
56

Notes Page
57

AFTER

EIAO Blank’s review of all HACCP systems, SSOPs, the recall program, and the 

general food defense program, as well as consultations with FSIS IIC Lenny 

Leonard, lead to a recommendation of no further enforcement action. However,

during the FSA, IPP issued one NR related to the establishment’s failure to monitor 

oven humidity, a violation of 9 CFR Part 417.5(a)(2). Additionally, the EIAO noted a 

vulnerability related to the storage of non-meat ingredients. Because of this NR and 

the noted vulnerability, the EIAO is recommending follow up within 30 days to 

confirm the establishment has implemented actions to meet Part 417.5. Follow-up 

can be through the FLS or through a visit from the EIAO.

This FSA was conducted to evaluate the establishment’s food safety system due to 

potential changes in the HACCP plans because of a recent change in ownership.

Montgomery Burn’s Foods USA is a small establishment producing Raw Intact, Raw

Non-Intact, and Fully Cooked Not Shelf Stable products. Products include fabricated 

raw and RTE beef, pork, chicken, and turkey products. All RTE post-lethality 

exposed products are produced under Alternative 3.

Review of the establishment’s HACCP systems indicated that the establishment has 

identified and addressed all hazards associated with the products produced and its 

production processes. Except for the NR that was issued and the cited vulnerability, 

the EIAO noted that the establishment is implementing controls as described in the 

support documents. There were no additional issues of noncompliance creating an 

imminent threat to food safety that warranted recommending an enforcement action 

in accordance with the Rules of Practice.

Details on the NR and the cited vulnerability follow below. 

NR #123456

An NR was issued as a result of the establishment’s failure to meet the 

requirements of 9 CFR Part 417.5(a)(2). Specifically, the establishment 

identified product temperature during processing as a hazard RLTO in raw 

products and product cooking and stabilization temperatures as RLTO in 

RTE product, for which CCPs were developed. Management provided 

reliable supportable documentation for decisions made in the hazard analysis 

and in the development of CCPs. The establishment is implementing controls 

as described in the support documents with the exception of not monitoring 

the oven’s relative humidity during product cooking. An establishment relying 

on FSIS’s Appendix A for cooking RTE products is required to meet all the 

parameters of the process schedule, including the relative humidity of the 

ovens. The time-temperature table in Appendix A is based on wet-heat. 
58

Without humidity, the product will dry, and the bacteria may become more 

heat resistant (Goepfert, 1970; Goodfellow and Brown, 1978; Faith, N.G. et 

al. 1998). Failure to achieve the required levels of pathogen lethality during 

the cooking process may allow for viable pathogens on products, which may 

render them injurious to health. As described, the establishment failed to 

support the adequacy of the CCP in controlling the hazard (pathogen lethality 

during the cooking cycle). 

Food Safety System Vulnerability

A vulnerability with the food safety system was also identified. The 

establishment adds non-meat ingredients to raw products and to RTE 

products after the lethality step. Management addressed hazards associated 

with these upon receiving and during storage and determined that non-meat 

ingredients are a hazard NRLTO based on prerequisite programs for allergen 

control, suitability of ingredients, and manufacturer pathogen controls (COAs 

from manufacturer that these have been subject to pathogen controls, shelf 

stability, etc.). However, dry non-meat ingredients, such as spices and 

breadcrumbs, added to raw products and RTE products after the lethality 

step, are removed from their original containers and placed in bins for their 

dispensing and storage between uses. Even though ingredients are covered 

while stored in these bins, they are stored in a high humidity area (room is 

washed daily). These storage bins are not sealed, allowing for moisture to 

come into contact with the ingredients. The establishment has not addressed 

the potential for changes in ingredients’ moisture levels during long storage 

periods, which may allow for pathogen, mold, and/or yeast growth. During 

the FSA, the EIAO did not observe that ingredients had become 

contaminated or that these were stored under insanitary conditions that may 

cause products to become adulterated. No evidence of mold or yeast growth 

were observed in non-meat ingredients; however, there is a concern that if 

storage conditions are not monitored, insanitary conditions could develop 

causing product to become adulterated. 

While the noncompliance identified during the assessment indicates a failure by the 

establishment to support the design of the HACCP plan, as required by 9 CFR Part 

417.5(a)(2), actual in-plant observation of monitoring activities supports the absence 

of any immediate food safety concern at present. However, the establishment has a 

responsibility to support the adequacy of the design of their food safety system and 

maintain documents that demonstrate the proper implementation and effectiveness 

of that design, as required by 9 CFR Part 417.5. 
59

Writing the Executive Summary

The executive summary, documented in the General Tool, should give readers a 

brief overview of the FSA’s recommendations and support. You should write this 

after you have made a recommendation and completed the decision-making

analysis. The executive summary should not exceed 350 words.

The purpose of the executive summary is to lay out concisely the principal findings 

of the FSA report in relation to the focus and execution of the assessment plan 

developed under FSIS Directive 5100.4. After reading the executive summary, the 

reader should understand the main regulatory findings that support any 

conclusion(s) that the establishment is not meeting specific sections of the Acts. 

A good executive summary contains the following: 

1. A sentence or two that describes the establishment and its processes, including 

the major types of products it produces

2. A sentence or two that describes the establishment’s compliance history

3. A sentence that describes the sampling results, if applicable

4. A couple of sentences that describe the major findings leading to the 

recommendation

5. A couple of sentences that discuss the EIAO’s analysis of the significance of 

those findings under the regulations that result in not meeting the requirements 

of the Acts, and what they show about the establishment’s ability to produce 

safe products

The executive summary is to emphasize your recommendation and include only the 

essential or most significant information to support that recommendation. You will 

draw content from the decision-making analysis section and each of the tool 

summaries to help you write the summary.

It should NOT be a reiteration of the decision-making analysis, nor should it 

introduce any information that is not contained in the FSA report. 

A Good Method for Measuring the Effectiveness of Your Executive Summary

Imagine that the executive summary is the only part of the FSA report that anyone 

can see and then ask the question: Does the summary adequately explain and 

support the recommendation?
60

An Executive Summary Dissected

A Sentence or Two that Describes the Establishment and Its Processes

Shaw Foods, Inc., is a large establishment utilizing pork slaughter, raw nonintact, raw intact, heat treated shelf stable, fully cooked not shelf stable, and 

heat treated not fully cooked processes. Products include fabricated raw 

pork, pork trimmings, textured pork, lard, sliced cooked ham and Canadian 

bacon, and bacon. The establishment produces post-lethality exposed readyto-eat products using Alternatives 2 (potassium lactate/sodium diacetate) and 

3.

A Sentence or Two That Describes the Establishment’s Compliance History

The establishment had no enforcement actions over the past 12 months. Our 

analysis of the 7 sanitation noncompliance reports (NR) over the previous 6 

months revealed no trend of noncompliance. 

A Sentence that Describes Sampling Results, If Applicable

No positives for FSIS verification sampling for Listeria monocytogenes have 

been identified in the past 12 months. Additionally, the plant is in Category 1 

for Salmonella sample sets.

 

A Couple of Sentences that Describe Major Findings Leading to the 

Recommendation

Our thorough analysis of the FSA findings supports a recommendation of 

NRs written by in-plant inspection personnel. The establishment did not have 

a procedure within the fully-cooked not shelf-stable HACCP plan to 

document the results of CCP 2B (cooking) and CCP 3B (chilling) as required 

by 9 CFR 417. The establishment was documenting the results as part of a 

program outside the HACCP plan corresponding to 417.2(c) (4) and 417.2(c) 

(6) noncompliances (NR #XXXX-XXXX-XXXX). The establishment was 

following the program, and the program was adequately supported (direct 

observation, discussion with establishment personnel, and document 

review), so there were no food safety concerns.

A Couple of Sentences Analyzing Findings and Their Significance

With the exception of the noncompliance discussed above, the operational 

and preoperational observations, as well as records reviewed during the 

assessment for all HACCP plans, indicate the establishment is implementing 
61

its food safety system according to its written procedures. The establishment 

based these programs on determinations it made after conducting hazard 

analyses to determine the food safety hazards reasonably likely to occur in 

each respective production process. The establishment has developed 

measures to control all hazards identified as reasonably likely to occur. The 

CCPs, including the critical limits, are fully supported and validated. These 

data, in total, demonstrate that the establishment is in compliance at present, 

with the exception of the recommended NRs cited above.

NOTE: If noncompliance had an effect on food safety—for example, the possibility 

that contaminated product was shipped—this would be added to the final portion of 

the executive summary.
62

Example of an Executive Summary

Montgomery Burn’s Foods USA is a small establishment producing Raw Intact, Raw 

Non-Intact, and Fully Cooked–Not Shelf Stable products. Products include 

fabricated raw and RTE beef, pork, chicken, and turkey products. All RTE post 

lethality exposed products are produced under Alternative 3.

This FSA was conducted to assess changes that may have occurred in the food 

safety system due to the change in ownership of the establishment. The 

establishment has had no enforcement actions since the change in ownership 

(01/09/15). Analysis of the 3 noncompliance reports (NRs) over the previous 5 

months indicated no trend of noncompliance.

The food safety assessment included review of all HACCP plans, SSOPs, facilities, 

Recall Program, and Food Defense Plan. Analysis of the RTE HACCP plan 

indicated failure by the establishment to support the design of the HACCP plan, 

therefore failing to meet the requirements of Part 417.5(a)(2).The following 

vulnerabilities associated with the production process were identified. Once nonmeat ingredients (spices, breadcrumbs, etc.) are removed from the dry storage 

area, they are placed in bins for dispensing, exposing these ingredients to high 

moisture levels. The establishment has not addressed the potential for changes in 

ingredients’ moisture levels during long storage periods, which may allow for 

pathogen, mold, and/or yeast growth.

The findings noted during the assessment indicate failures by the establishment to 

support the design of the food safety system. Review of FSIS’s and the 

establishment’s test results, HACCP, and SSOP records did not indicate an 

immediate threat to product safety. Actual in-plant observation of monitoring and 

verification activities support the absence of immediate food safety concerns, yet 

the establishment has a responsibility to support the adequacy of the design of their 

food safety system and maintain documentation to demonstrate the proper 

implementation and effectiveness of that design as required by Part 417.5. There 

were no issues of noncompliance creating an imminent threat to food safety that 

warranted a recommendation for an enforcement action in accordance with the 

Rules of Practice. No further action is recommended.

(334 words; 2,222 characters with spaces)
63

Exercise: Executive Summary Critique and Rewrite

Read and critique this executive summary. What works well? What changes might 

you make? Critique and then rewrite this executive summary as you believe it

should be written. Be prepared to share your rewrite.

Meat and poultry products are an important part of the Nation’s supply of food. They 

are consumed throughout the nation and the major portion thereof moves in 

interstate or foreign commerce. It is essential in the public interest that the health 

and welfare of the consumers be protected by assuring that meat and poultry 

products distributed to them are wholesome, not adulterated, and properly marked, 

labeled, and packaged. (21 U.S.C. 602).

To meet this objective, Enforcement Investigation Analysis Officers (EIAOs) verify 

the sanitary conditions of such establishments by performing Food Safety 

Assessments, 21 U.S.C. 608, which states, “The Secretary shall cause to be made, 

by experts in sanitation or by other competent inspectors, such inspection of all 

slaughtering, meat-canning, salting, packing, rendering, or similar establishments in 

which cattle, sheep, swine, goats, horses, mules and other equines are slaughtered 

and the meat and meat food products thereof are prepared for commerce as may 

be necessary to inform himself concerning the sanitary conditions of the same, and 

to prescribe the rules and regulations of sanitation under which such establishments 

shall be maintained; and where the sanitary conditions of any such establishment 

are such that the meat or meat food products are rendered adulterated, he shall 

refuse to allow said meat or meat food products to be labeled, marked, stamped, or 

tagged as “inspected and passed”.

The Federal Meat Inspection Act, 21 U.S.C. 608 and Poultry Products Inspection 

Act (PPIA) (21 U.S.C. 451 et seq.) gives the Secretary the authority to prescribe 

rules and regulations (CFR 416 and 417), requiring sanitary practices in official 

establishments. 21 U.S.C. 608 also gives the Secretary the authority to refuse 

inspection to any establishment who fails to meet the requirements 21 U.S.C. 

601(m)(4) and 21 U.S.C. 453 Section 4(g)(4) describes product as adulterated if it 

has been produced, packed, or held under insanitary conditions whereby it may 

have been rendered injurious to health.

B. Gumble’s, Establishment #ABC123, is a very small red meat slaughter facility. 

The establishment slaughters multiple species (beef, goats, lamb, and hogs) for 

distribution to restaurants and supermarket sales using the Raw-Red Meat 

Slaughter HACCP category. The establishment’s predominant species is goat. All 

products are sold as whole carcasses and the establishment does not process 

bench trim, raw-intact or raw-non intact products at this time. The establishment had 

no enforcement actions within the last year. The establishment’s grant of inspection 

was issued April 2, 2014. This is the first Food Safety Assessment being performed 

at this establishment.
64

The establishment has a written SSOP plan in accordance with the regulatory 

requirements of 9 CFR Part 416.11. Direct observations of the facility and 

equipment showed that the establishment is maintained clean and sanitary. There 

was no evidence during this FSA of any deficiencies that would cause a public 

health concern.

Direct observations and a complete review of the establishment’s Red Meat 

Slaughter HACCP plan and records by the EIAO showed that the establishment’s 

Red Meat Slaughter HACCP plan meets the basic regulatory requirements of 9 

CFR Part 417 at this time. The establishment is implementing their humane 

handling and sanitary dressing procedures as their programs and FSIS regulatory 

requirement state. However, the establishment is not testing and documenting the 

acetic acid mixture concentration being used as an antimicrobial agent. This could 

be a weakness in the establishment’s HACCP system. An NR is recommended to 

address this non-compliance.

The establishment is sampling their goat carcasses for generic E. coli by the 

surface swab method. The establishment has had no positive test results for 

antibiotic residues and all E. coli sample results are negative. Direct observations 

and records reviewed showed that the establishment is addressing SRM removal as 

per regulatory requirements. Direct observations and complete review of the 

establishment’s Red Meat Slaughter HACCP plan and records showed that the 

establishment’s HACCP plan with the one exception noted meets the regulatory 

requirements of 9 CFR Part 417 at this time.

The overall assessment of the establishment and the food safety plans in operation 

is one that operates in compliance. There were no HACCP deviations documented 

by FSIS in-plant inspection personnel. There was one HACCP deviation observed 

in the HACCP records for CCP#2 by the EIAO during this assessment. The 

establishment’s SSOPs, SOPs, E. coli control, Sanitary Dressing and SRM 

programs along with the HACCP plan meets the regulatory requirements of 9 CFR 

Parts 416, 417, and 310 at this time. Direct observations and records reviewed of 

the establishment’s food safety systems in operation at this time; provide the basic 

environmental conditions for the production of safe, wholesome food and no issues 

affecting public health were observed. The final recommendation is that an NR be 

issued with a follow up visit in 30 days to assure that the possible titration weakness 

at CCP#2 be corrected.

The follow-up visit will be conducted with the FLS in approximately 30 days.

Corrective actions for the non-compliance are to be implemented by June 29, 2015. 
65

Notes Page
66

Suggested Response for Executive Summary Rewrite

B. Gumble’s, Establishment #ABC123, is a very small establishment that slaughters 

multiple species (beef, goats, lamb, and hogs) for distribution to restaurants and 

supermarket sales using the Slaughter HACCP category. The establishment’s 

predominant species is goat. All products are sold as whole carcasses and the 

establishment does not process bench trim, raw-intact or raw-nonintact products at 

this time. The establishment had no enforcement actions within the last year. The 

establishment’s grant of inspection was issued April 2, 2014. This is the first Food 

Safety Assessment being performed at this establishment.

The establishment has a written SSOP plan in accordance with the regulatory 

requirements of 9 CFR Part 416.11. Direct observations of the facility and 

equipment showed that the establishment is maintained clean and sanitary. There 

was no evidence during this FSA of any deficiencies that would cause a public 

health concern.

Direct observations and a complete review of the establishment’s Red Meat 

Slaughter HACCP plan and records by the EIAO showed that the establishment’s 

Red Meat Slaughter HACCP plan meets the basic regulatory requirements of 9 

CFR Part 417 at this time. The establishment is implementing their humane 

handling and sanitary dressing procedures as designed. The establishment collects 

surface swab samples from their goat carcasses and tests for generic E. coli. The 

establishment has had no positive test results for antibiotic residues and all E. coli

sample results were negative. Direct observations and records reviewed showed 

that the establishment is addressing SRM removal, per regulatory requirements

Based upon this food safety assessment, one NR is recommended for a HACCP 

deviation that was observed in the HACCP records for CCP#2, Antimicrobial Spray 

Application. Specifically, the establishment is not testing and documenting the 

acetic acid mixture concentration being used as an antimicrobial agent. This could 

be a weakness in the establishment’s HACCP system, and an NR by IPP is 

recommended to address this non-compliance, with a planned follow-up in 30 days 

by the FLS.

(348 words)
67

Exercise: Evaluate and Rewrite an Executive Summary

Please read, evaluate, and then rewrite the following executive summary.

Bouvier Fine Meats Inc. is a small establishment utilizing Raw Non-Intact meat, 

Raw Intact meat and poultry, Retail exempt and Custom Exempt processes. Raw 

Non-Intact products include ground beef, pork, lamb, sausage, and buffalo. Raw 

Intact products include beef, pork, lamb, veal cuts, poultry, and buffalo. This Food 

Safety Assessment (FSA) for cause due to a request by the Frontline Supervisor for

changes in the food safety system. The establishment has not had any 

enforcement actions or complaints over the past 12 months. Analysis of 1 (one) 

sanitation performance standard (SPS) and one (1) sanitation standard operating 

procedures (Sanitation SOP) noncompliance records (NRs) over the previous 6 

months revealed no trend of noncompliance. There have been no positives for FSIS 

verification sampling. 

A thorough analysis of the FSA findings supports a recommendation that a Notice of 

Intended Enforcement be issued. The establishment conducted a Hazard Analysis 

that failed to support the decision that E. coli O157:H7 is not reasonably likely to 

occur for both the Raw Non-Intact and the Raw Intact process categories per 9 CFR 

417.2 (a) (1). 

 

Bouvier Fine Meats receives raw beef products (boxed beef and carcasses) 

intended for non-intact uses of grinding and needle tenderization. Bouvier Fine 

Meats has determined in the hazard analysis that the pathogen E. coli O157:H7 is 

not reasonably likely to occur at receiving. They support this decision by citing 

several research papers that have outlined that E. coli O157:H7 has a low 

prevalence in these types of products. Letters of Guarantee and third-party audits 

received on a yearly basis from suppliers constitute additional support for their 

decision.

 

E. coli O157:H7 is considered an adulterant in non-intact beef. On January19, 1999, 

FSIS published a policy statement, “Beef Products Contaminated with E. coli

O157:H7” (64 FR 2803). This document reiterated that ground beef is adulterated if 

contaminated with E. coli O157:H7. It also stated beef products mechanically 

tenderized are adulterated if contaminated with E. coli O157:H7. 

Recent documented recalls and human illness for non-intact beef products 

contaminated with E. coli O157:H7 provides historical evidence that adulteration of 

product occurs. Because it has historically occurred for the types of products they 

produce, Bouvier has failed to meet 9 CFR 417.2 (a) (1) which states, “A food safety 

hazard that is reasonably likely to occur is one for which a prudent establishment 

would establish controls because it historically has occurred...”
68

Bouvier has also failed to meet nine CFR 417.4 (a). They have failed to perform 

meaningful, on-going, activities to verify that the HACCP plan is being effectively 

implemented. The LOG and third-party audits are received from supplying 

establishments on a yearly basis. Bouvier is relying on the information provided in 

the LOG and audits to support the decision that E. coli O157:H7 is unlikely to occur. 

The LOG state that suppliers are applying interventions to reduce E. coli O157:H7 

to undetectable levels. The sporadic low-level occurrence of E. coli O157:H7 

requires frequent verification to provide assurance that the pathogen is being 

successfully prevented. Bouvier does not conduct frequent on-going 

communications with suppliers that would give them the information and assurance 

the interventions and controls in place are effective reducing E. coli O157:H7 to a 

non-detectable level.

Bouvier does test on a random basis product from two suppliers per month for 

indicator organisms, not E. coli O157:H7. They are using this data to confirm 

sanitary conditions of the suppliers and not as a reason that E. coli O157:H7 is 

unlikely to occur. One of the Suppliers of Carcasses performs E. coli O157:H7 

testing consisting of 300cm2 swab on everyone 1 out of 300 carcasses. There is no 

evidence that this is considered robust testing or if it is representative of the lots of 

beef sent to Bouvier. 

Bouvier has a program to spray intact beef (Box beef subprimals and carcasses) 

intended for non-intact use (tenderization and grinding). This program utilizes an 

acidified sodium chlorite (ASC) spray cabinet for subprimals and hand sprayer for 

carcasses that is validated to provide 1 to 2 log reductions in E. coli O157:H7. It is 

utilized as a processing aid only and not to control E. coli O157:H7 except in the 

unlikely chance it has contaminated product. The establishment recognizes that 

there is a possibility incoming raw beef products can be contaminated with the 

adulterant E. coli O157:H7 but considers the likelihood small enough to consider it 

unlikely to occur. When the CFSA started the establishment had not been spraying 

carcasses. By the end of the CFSA they indicated they were going to start the 

carcass spray. The ASC spray cabinet lacked support for the overlapping of 

subprimals on the conveyor and the subsequent observation that not all the surface 

was being contacted with ASC as required by the supporting documentation as per 

417.5 (a) (1). Support was also lacking in regard for a lack of a written program and 

records designed to confirm LOG are on file for shipments received. Bouvier also 

failed to follow the supporting program “Approved Supplier program” which requires 

beef products intended for grinding to be accompanied by a COA (negative test 

results for E. coli O157:H7) or be held until tested for E. coli O157:H7. Carcasses 

received and further processed for grinding are not received with COA’s or held for 

E. coli O157:H7 testing.
69

Bouvier Fine Meats, Inc. has an inadequate HACCP system per 417.6 (a). They 

consider E. coli O157:H7 unlikely to occur for non-intact beef products and have 

failed to support that decision. Bouvier Fine Meats relies on scientific articles, yearly 

LOG, and third-party audits to lend support to their decision. Historical evidence has 

shown the types of products produced at Bouvier Fine Meats have been implicated 

in recalls and human illness associated with E. coli O157:H7 adulteration. E. coli

O157:H7 contamination of product may occur at a sporadic and low level but that 

only indicates frequent verification is necessary to provide assurance the pathogen 

is being successfully prevented. Bouvier lacks evidence that frequent on-going 

communication with suppliers is occurring. Other than yearly LOG and third party 

audits there is no significant communication or data between Bouvier and its 

suppliers that would lend assurance that consistent and effective controls are in 

place to ensure E. coli O157:H7 is not present at a detectable level in product being 

received. Additionally, supporting documentation is lacking that LOG are confirmed 

for incoming products and the ASC spray cabinet being operated outside the 

parameters of supporting documentation. (1116 words)
70

Notes Page
71

Suggested Rewrite of “Evaluate and Rewrite an Executive 

Summary” Exercise

Bouvier Fine Meats, Inc. is a small establishment utilizing Raw Non-Intact, Raw 

Intact and Poultry, Retail Exempt, and Custom Exempt processes. Its Raw NonIntact products include ground beef, pork, lamb, sausage, and buffalo. Its Raw 

Intact products include beef, pork, lamb, veal cuts, poultry, and buffalo. FSIS 

performed this Food Safety Assessment (FSA) for cause based on a request by the 

Frontline Supervisor because of changes in the food safety system. The 

establishment has had no enforcement actions or complaints over the past 12 

months. Our review of two noncompliance reports (NRs)—one for sanitation 

performance standard (SPS) and one related to its sanitation standard operating 

procedures (SSOP)—over the previous 6 months revealed no trend of 

noncompliance. There have been no positives for FSIS verification sampling. 

The FSA findings support a recommendation that a Notice of Intended Enforcement 

be issued. The establishment conducted a hazard analysis that failed to support the 

decision that E. coli O157:H7 is unlikely to occur for both the Raw Non-Intact and 

Raw Intact processes per 9 CFR 417.5(a)(1) and 417.2(a)(1).

Bouvier Fine Meats, Inc. Food Safety System would be characterized as an 

inadequate HACCP system per 417.6 (a). They consider E. coli O157:H7 unlikely to 

occur for non-intact beef products and have failed to support that decision. The 

establishment relies on scientific articles, yearly Letters of Guarantee (LOG), and 

third-party audits to support its decision. However, Bouvier lacks evidence of 

frequent on-going communication with suppliers. Other than yearly LOG and thirdparty audits, there is no significant communication or data between Bouvier and its 

suppliers to ensure consistent and effective controls are in place, thus ensuring E. 

coli O157:H7 is not present at a detectable level in received product.

Bouvier also failed to follow the “Approved Supplier Program,” which requires beef 

products intended for grinding to be accompanied by a Certificate of Analysis (COA) 

with negative test results for E. coli O157:H7 or to be held until tested for E. coli

O157:H7. Carcasses received and further processed for grinding are not received 

with COAs or held for E. coli O157:H7 testing by Bouvier. Because of these 

findings, we recommend the issuance of a Notice of Intended Enforcement as 

described in 9 CFR 500.4(a). Therefore, the inadequate design of the Food Safety 

System may result in the production of adulterated product as described in The 

Federal Meat Inspection Act (FMIA) 21 United States Code (USC) 601, Section 

1(m)(4).

Information on Writing Sample Above:

• 354 words, 20.8 words per sentence, 4.2 sentences per paragraph

• 5% passive voice, 13.1 Grade Level Score, 37.5 Reading-Ease Score
72

Format for Writing Notice of Intended Enforcement (NOIE) 

and Suspension Letters

First Paragraph: What Action FSIS is Taking

Clearly state the purpose of the letter, either FSIS’s intent to take 

enforcement action or that FSIS is withholding the marks of inspection and 

suspending the assignment of inspectors. Keep this paragraph short. Do not 

include detailed regulatory language in this paragraph. If you wish, include a 

“roadmap” sentence that tells the reader what to expect section by section, 

including the fact that action is required.

Second Paragraph: FSIS’s Authority to Take Action

This paragraph (or paragraphs, if needed) outlines the applicable sections of 

the FMIA, PPIA, or EPIA that give FSIS the authority to initiate this 

enforcement action under the Rules of Practice. Be certain that the cited 

provisions reflect the findings outlined in the letter.

Third Paragraph: Findings and Basis for Action

This section describes the reason for the violation. It should include 

references to establishment documentation, processes, the public health 

significance of the violation, and why the establishment’s actions to address 

the violation are inadequate. Be sure to cite the specific title of the applicable 

regulatory requirement (such as 9 CFR 416.3) for each violation, as well as 

the specific title of the USC and applicable paragraph of the statute.

When there are multiple findings, organize this section using sub-heads. 

Likewise, use bullet points for lists of related material, such as multiple NRs.

Fourth Paragraph: Alleged Violator’s Next Steps and Appeal/Hearing Rights

This final section spells out to the alleged violator what rights he or she has 

and what actions he or she can take to respond to the NOIE or suspension 

letter.
73

Example of a Notice of Suspension

Dear Mr. DENT:

This letter serves as official notice that the Food Safety and Inspection Service (FSIS) 

is withholding the marks of inspection and suspending the assignment of inspection 

program personnel at your establishment, Est. 0000 R. O. DENT Co. Incorporated. 

The following letter provides information on FSIS’s statutory authority, our findings, 

and next steps you may take.

Statutory Authority

The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and Poultry Products 

Inspection Act (PPIA) (21 U.S.C. 454 et seq.) provides that it is essential for the public 

interest that the health and welfare of consumers be protected by assuring that meat 

products distributed to them are wholesome, not adulterated, and properly marked, 

labeled and packaged. These Acts give FSIS the authority, as designated by the 

Secretary of the Department of Agriculture, to prescribe rules and regulations 

describing sanitation requirements for inspected establishments. They also provide 

FSIS program personnel the authority to refuse to allow meat or meat food products 

to be labeled, marked, stamped, or tagged as “inspected and passed” and to prevent 

the entry of products into commerce when the sanitary conditions of any such 

establishment are such that products are adulterated. Furthermore, the Acts provide 

FSIS the authority to appoint inspectors from time to time to examine and inspect 

products, including the sanitary conditions of facilities. They also give FSIS program 

personnel the right to examine and inspect all carcasses and parts of carcasses that 

are further treated and prepared and the right to access and examine establishment 

records. When the sanitary conditions of a facility are not properly maintained, FSIS 

can refuse inspection and indefinitely withdraw inspection from an establishment 

provided the establishment is afforded the right to an administrative hearing. 

Under the authorities of these Acts, FSIS has prescribed rules and regulations 

required for establishments producing meat products, including the requirements 

pertaining to Sanitation Standard Operating Procedures (SANITATION SSOP) and 

Sanitation Performance Standards (SPS) (9 CFR Part 416), and other matters.

FSIS has also developed Rules of Practice regarding enforcement (9 CFR Part 500). 

The Rules of Practice describe the types of enforcement action that FSIS may take 

and include procedures for taking a withholding action and/or suspension, with or 

without prior notification and for filing a complaint to withdraw a Grant of Federal 

Inspection. FMIA and PPIA contain similar language FMIA 21 U.S.C 601, Title 1, 

Section 1(m)(4), which defines adulteration as “If it has been prepared, packed, or 

held under unsanitary conditions, whereby, it may have become contaminated with 

filth, or whereby, it may have been rendered injurious to health.” PPIA 21 USC 454 
74

Section 4 (g)(4) defines adulteration if it has been prepared, packed or held under 

insanitary conditions whereby it may have been rendered injurious to health.

Findings and Basis for Action

FSIS is basing this decision on findings of rodent infestation and insanitary conditions 

at your establishment. FSIS is presenting this notification as authorized by the Rules 

of Practice in accordance with 9 CFR 500.3 (a) (4).

The following outlines FSIS’s findings at your establishment, including multiple noncompliance records.

• NR 0015-2006-9999, June 23, 2006: FSIS personnel observed several rodent 

droppings in the chemical storage room, in the mechanical room adjacent to 

the main processing room, and on a pallet containing packaging materials.

FSIS inspection personnel rejected the affected packaging materials and 

detained the product. The inspector took regulatory control action on the entire 

facility due to the insanitary conditions created by the rodent infestation as 

follows: storage rooms using US-Reject tags # B-11111 and B-2222, 

packaging material using US- Reject tag # B-3333, mechanical room using 

US- Reject tag # B-4444, and chemical room using US- Reject tag # B-5555. 

• NR 0014-2006-9999, June 20, 2006: FSIS observed a small rodent running 

across a production room floor. There were no affected products or packaging 

material. Personnel rejected the room with US-reject tag B-123456.NR

• 0013-2006-9999, June 09, 2006: FSIS observed rodent droppings in the dry 

storage room underneath an unused packing machine and rejected the room 

with US-Reject tag # B-457689.

• NR 0011-2006-9999, May 20, 2006: FSIS observed rodent droppings in the 

storage room in contact with two stacks of packaging boxes. FSIS rejected the 

chemical room using US-Reject tag # B-7891011, the packaging material with

US-Reject tag # B-987654, and the dry storage areas with US-Reject tag # B8765432 and US-Reject tag # B-678912.

• NR 0009-2006-9999, May 4, 2006: FSIS observed rodent droppings on top of 

packaging materials in the storage room. FSIS personnel rejected the storage 

room using US-Reject tag # B-876543, as well as rejected the effected 

packaging materials. A large gap was identified underneath the roll-down gate 

to the outside of the facility.
75

Steps You May Take

This suspension of inspection will remain in effect until you provide adequate written 

corrective and preventive measures that will ensure your meat and poultry products 

are produced in accordance with the FMIA, PPIA, and the regulations promulgated 

thereunder. 

For inspection to resume at your establishment, you must submit to my attention 

corrective actions that include the following. 

1. Procedures to ensure appropriate disposition of the products that may be 

contaminated and to ensure no product that is injurious to health or otherwise 

adulterated as a result of the rodent infestation enters commerce.

2. A detailed assessment of the Sanitation SOP and a review of other sanitation 

failures at your plant.

3. Specific changes to be made to your SPS.

4. Monitoring activities you will take to ensure your changes are effective.

You are reminded that as an operator of a federally inspected plant you are expected 

to comply with FSIS regulations and to take appropriate corrective actions to prevent 

the production of adulterated products at your establishment. Please be advised you 

have the right to appeal this matter. If you wish to appeal, you should contact:

Executive for Regulatory Operations

USDA/FSIS/OFO

1400 Independence Avenue S.W.

Room 3157, South Building

Washington, DC 20250-3700

Telephone: (202) 720-3697

Fax: (202) 690-3287

In accordance with 9 CFR 500.5(d), you may request a hearing concerning this action 

by contacting:

Director

Evaluation and Enforcement Division

Office of Program Evaluation, Enforcement and Review

Food Safety and Inspection Service

United States Department of Agriculture

Congressional Quarterly Building Room 300

Washington, DC 20250-3700

Telephone: (202) 418-8872

Fax: (202) 418-8896

If you have any questions regarding this matter, please feel free to contact XXX.
76

All about Email

Interesting Statistics

• Over a messaging system’s lifetime—estimated at 3.5 years—the permessage cost for desktop users is 54 cents. Source: Creative Networks

• The cost of acquiring, deploying, managing, administering, and using a 

messaging system is about $4,200 per user per year. Source: Creative 

Networks

• About 130 million workers in the US send 2.8 billion email messages a day, 

and 50% report receiving racist, sexist, pornographic, or otherwise 

inappropriate email at work. Source: “The e-Policy Handbook,” by Nancy 

Flynn

• Twenty-seven percent of Fortune 500 companies have defended themselves 

against claims of sexual harassment stemming from inappropriate email. 

Source: “The e-Policy Handbook,” by Nancy Flynn

• “Cyber loitering” is on the rise. Workers with access to the Internet spend the 

equivalent of 21 working days a year web surfing. About 64% of that time is 

used for "non-work related entertainment." Source: Georgia Tech College 

study

• A study by Atlassian, the developer of team collaboration software, found 

that professional workers receive an average of 304 emails a week and 

check email 36 times an hour.

• A study on interruptions in the workplace found the following:

o People spend about 20 seconds concentrating on a single item before 

moving on to another. 

o On average, workers have eight screens open on their computers—for 

example, email messages, Web pages, Word documents, or 

PowerPoint files. 

o Many people do not return to the work they were doing and, if they do, 

it can take up to 15 minutes to refocus.

Source: Mary Czerwinski, scientist at the Microsoft Research Lab and a 

leading expert in “Interruption Science”
77

Deciding When to Use and When Not to Use Email

Situations where email makes the best sense:

• You need to get announcements to a set group of people.

• You need an informal written record.

• You need to communicate across time zones.

Others?

Situations where email does not make the best sense:

• You need privacy.

• You need to watch the other person’s body language.

• You are concerned that the message might be misunderstood or 

misconstrued.

• You have anything negative to say.

“Best Practices” for Writing Email

1. Write the email, and then let it “cool.” Do not yet complete the “To” line.

2. Review the email. Did you include a greeting and a closing? Is the purpose 

and/or request obvious? Does the text need formatting? Are there typos? 

Use the spelling and grammar-checking function.

3. Check for attachments. Do you need to add any?

4. Finally, send the email, ensuring it is headed to the correct person.

Bottom Line: 

All email should pass the “Washington Post” test, regardless of whether it is sent via 

your work or home computer or via a smartphone. Simply put, to pass the 

“Washington Post” test (or your preferred national news source), you would be 

willing to have anything in your email on the cover of the newspaper or on the 

webpage of a major news source.
78

What Should Never Go in an Email

• Criticism

• Chain Letters

• Profanity

• Religious Messages

• Political Information

• Anything of a Sexual/Pornographic Nature

• Jokes (unless they are completely non-discriminatory)

• Discriminatory Comments

• Sales or Marketing Materials from Outside Businesses

Email Management Tips

• Get to know the Microsoft Outlook system and all its features. 

• Call or visit instead of sending an email, especially if you don’t want or need 

a paper trail, the matter is simple, or the recipient is within proximity.

• Generally, choose to reply without attachments but with the original message 

to create a thread of meaning.

• Provide context by replying with the original sender’s message and by using 

key words from the original message.

• Send and reply only to those who MUST get the email message.

• Use simple formatting to upgrade your email.

• Make an effort to respond to emails within 24 hours, if possible. If you will be 

out of the office, use the “Out of Office” reply option.

• Plan your day around small periods of writing and responding to email. 

• Consider turning off pop-up notification if you find it distracting. 

• If possible, “touch” each email just once. Here are some ways of coping with 

each piece of email:

▪ Read it and delete it.

▪ File it in the appropriate folder (by project, person, event, and so on).

▪ Act on the “softballs.”

▪ Forward and delegate the action, as required.

▪ Print a hard copy and file it if considered a record.
79

“AHA!” and Goals Page
80

APPENDICES

A. Confusing Words, pages 81-85

B. Transition Words and Phrases, page 86

C. Say It Simply, page 87

D. Punctuation Review, pages 88-91

E. Helpful Resources, page 92
81

Appendix A: Confusing Words

1. The others will (accept, except) your invitation only if you serve lunch.

2. Please give me some good (advice, advise).

3. Her charm had its intended (affect, effect); she's now wearing a huge diamond ring.

4. It is (apt, liable, likely) that she will charge him for hitting her car.

5. This (coarse, course) is tough to travel on a bike.

6. A thin mint is the perfect (complement, compliment) to a hearty meal.

7. Al met with the (consul, council, counsel) to discuss the best strategies for 

improving the trade imbalance with Japan.

8. (Because of, Due to) the Big, Bad Wolf, we cannot hike through the woods.

9. I am (anxious, eager) to get home and eat my favorite dessert.

10. She wants to (farther, further) her education so she can go (further, farther) in life.

11. Tommy has (fewer, less) teeth than Zachary.

12. Always read the (forward, foreword) or you may miss something vital about a book.

13. David's cheap car and ragged clothes are a/an (allusion, delusion, illusion); he is 

really a very wealthy person.

14. Lucy makes those subtle, little comments to (infer, imply) that I am a hussy.

15. (It's, Its) not fair that you got the last piece of pizza.

16. He was not feeling well so he (lay, laid) down.

17. Do not (lose, loose) that key or we will have to call for a spare.

18. People always say it is the (principal, principle) of the matter, but they are actually 

worried about losing money.

19. Placing first, second, and third were Tim, Allan, and Sam (respectfully, respectively).

20. Do not just (set, sit) there; (set, sit) that tray down and we can dance!

21. She was shocked at the expense of the (stationary, stationery).

22. I was (to, too) elated to care about the dent in my car.

23. The person (who, which, that) called me last night is a complete fool.

24. Pat dances (well, good), but she is not a (good, well) singer.

25. Norma is (sure, surely) a successful lawyer.

26. Hugh was (real, really) pleased to win the contest.

27. The pressures of college are different (from, than) the pressures of work life.

28. I will (bring, take) it with me when I go.

29. If you bring the teacher (a, an) ukulele, he is likely to give you a good grade.
82

30. If you finished your homework (already, all ready), then we can get the van 

(already, all ready) to go on our vacation.

31. Maury said the answers were (alright, all right).

32. (Alot, A lot) of people crowded the food truck at noon.

33. We traveled (altogether, all together) to the White House and were (altogether, all 

together) pleased when we saw the President wave to us.

34. She told me that I should use (anyway, any way) possible to get to the concert even 

though I did not want to go (anyway, any way).

35. A letter takes an (attachment, enclosure) and a memorandum takes an 

(attachment, enclosure).

36. I sat (between, among) two handsome triathletes while my sister stood (between, 

among) eight rugged rugby players.

37. I (can, may) do this assignment today, but (can, may) I submit it online?

38. The data (is, are) available tomorrow.

39. I will (try and, try to) meet you at the cafeteria at noon.

40. She (would have, would of) printed her paper if the power was on.
83

Confusing Words Defined

1. accept: to take or to agree to

except: to omit or exclude

2. advice: information or suggestion (noun)

advise: to offer an opinion or to counsel (verb)

3. affect: to influence (verb); behavior or mood (noun/psychological term)

effect: a result, or outcome (noun); to bring about (verb)

4. apt: appropriate or pertinent

liable: exposed to damage; responsible

likely: probable

5. coarse: rough

course: path

6. complement: to complete

compliment: expression of respect or praise

7. consul: officer residing in a foreign country to promote his/her own country's 

interests

counsel: an exchange of opinion; one who advises; to give advice

council: an assembly of persons

8. due to: payable to; owed

because of: by reason of

9. eager: enthusiastic

anxious: apprehensive; nervous

10. farther: a greater distance

further: an extension of time or degree

11. fewer: smaller in number; things you can count

less: smaller in size or bulk; things you cannot count

12. foreword: a preface or explanation at the beginning of a book or report

forward: situated near the front; to advance (verb)
84

13. illusion: deceptive appearance

allusion: a casual reference

delusion: deceit

14. imply: to insinuate or express indirectly

infer: to conclude from what was said (The speaker implies; the hearer infers.)

15. its: possessive form of pronoun "it"

it's: contraction of words "it" and "is"

16. lie: intransitive verb (takes no object) meaning to recline one's body; lie/lay/lain

lay: transitive verb (takes an object); lay/laid/laid

17. lose: to fail to keep

loose: not rigidly fastened

18. principal: occupying the first rank

principle: fundamental truth or doctrine

19. respectfully: with respect

respectively: singly considered, in this specific order

20. sit: intransitive verb meaning to put your bottom down

set: transitive verb meaning to put an item someplace

21. stationary: fixed in place

stationery: paper and other writing materials

22. to: preposition of direction

too: adverb that describes the degree or amount

23. who: refers to people, that--refers to people, animals, or things

which: refers to animals or things

24. good: describes nouns (adjective)

well: describes verbs (adverb)

25 sure: an adjective meaning to be certain

surely: an adverb meaning certainly

26. real: an adjective meaning genuine

really: an adverb meaning extremely, usually modifies an adjective
85

27. different from: the correct usage for comparing different things. 

28. bring: indicates movement toward speaker. 

take: indicates movement away from the speaker

29. a: used in front of words with a consonant sound such as snake

an: used in front of words with a vowel sound such as hour or apple

30. all ready: to be fully prepared

already: having already occurred

31. all right: in satisfactory order (alright is the incorrect form)

32. a lot: a significant amount (alot is the incorrect form)

33. altogether: completely or thoroughly

all together: in a group, in unison

34. anyway: regardless, nonetheless (anyways is not a word)

any way: using whatever means possible

35. attachment: additional information included with a memorandum

enclosure: additional information included with a letter

36. between: used with to people or things

among: used with more than two people or things

37. can: expresses ability

may: expresses permission

38. data: plural noun meaning a group of facts; use are not is

39. try to: this is the correct form; do not use try and

40. would have: this is the correct form; do not use would of
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Appendix B: Transition Words and Phrases

Common 

Transitions

CAUSE EFFECT CHOICE

Because As a result Or

Since Therefore Alternatively

As Consequently Instead

For Thus Either...or

Due to Accordingly Neither...nor

Thus So...that

On account of Such a...that

ADDITION CONTRAST COMPARISON

And But Similarly

Also However Likewise

Too Instead In the same way

As well as Yet Just as...so

Besides Otherwise

In addition Nevertheless

Moreover Except for

Furthermore In spite of

Including Despite

ILLUSTRATION SEQUENCE TIME

For example First Now

Specifically Next Then

For instance After Later

In other words Ultimately Currently

In particular Before Meanwhile

That is Finally Earlier

PLACE CONDITION DURATION

Here If To some extent

There Even if To some degree

At this point Although To date

Below Unless Up to now

Next to Supposing that So far

In front of Given that Until

Alongside Assuming that
87

Appendix C: Say It Simply

DIFFICULT SIMPLE

Additional More

Aforementioned Cited

Allocate Give, divide

As per According to

Assistance Help

Cease Stop

Deem Consider

Employ Use

Endeavor Try

Facilitate Help

Furnish Give

Herein Here

Heretofore Until now

Implement Carry out

Indicate Show

In lieu of Instead of

In the event that If

Issue Give

Necessitate Require

Notification Notice

On behalf of For

Per annum A year

Possess Have

Prior to Before

Proceed Go ahead

Procure Get

Provided that If (or change sentence)

Pursuant to Under

Regarding About

Represents Is

Retain Keep

Submit Send

Subsequent to After

Terminate End

To the extent that If, when

Transmit Send, give

Utilize Use

With regard/respect to For
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Appendix D: Punctuation Review

Apostrophe (‘)

1. Use (or the apostrophe and s) to indicate possession. 

To form the possessive case of a singular or plural noun not ending in s, add an 

apostrophe and s, as in the Administrator’s meeting. 

To form the possessive case of a singular or plural noun ending in s or with an s 

sound, add an apostrophe only, as in James’ coat (one person’s coat) or the 

girls’ lockers (many girls with lockers). 

Be cautious with irregular plural forms not ending in s, as in men’s room or 

children’s party.

2. Use to indicate omitted letters in contractions, shortened words, and abbreviated 

dates.

Is Tom a Class of '67 graduate?

3. Use to indicate the plural of uppercase and lowercase letters only when leaving 

it off would confuse the reader.

I wish she would cross her t's and dot her i's.

4. Do not use the apostrophe with possessive pronouns.

The children are theirs, not ours. (Not: The children are their's, not ours’.)

Brackets: [ ]

Use brackets to indicate language that is not part of the original quote, to show a 

correction, to clarify or explain information, or to guide the reader.

The report contains data on this phenomenon [see pages 12-15].

Colon (:)

1. Use after a complete sentence to introduce a list.

The investigators brought the following items to document the investigation: 

pencils, notepads, cameras, tape recorders, and a video camera.

2. Use after a complete sentence to introduce a quotation, summary, or 

explanation.

The investigators followed the manual guidelines: “At the beginning of this 

section, cite the section of the relevant statute that was allegedly violated.”
89

3. Use to separate the hour and minutes in clock time.

6:30 a.m. to 5:00 p.m.

2 p.m., 3 p.m., 6 p.m. but 3:15 p.m. and 5 p.m.

4. Use after the salutation in a formal business letter.

Dear Dr. Fox: or To Whom It May Concern:

Comma (,)

1. Use to separate main clauses when linked by a coordinating conjunction.

I was unsuccessful in reaching Mr. Banks on the telephone or via email, so I 

drove to his business to interview him.

2. Use to separate words or phrases in a series. Use a comma before the 

conjunction with a series of three or more.

We interviewed the facility manager, night-shift manager, and day-shift manager.

3. Use with adjectives that can be interchanged (or where you can use and in the 

middle without affecting the meaning).

This must be a thorough, impartial report.

4. Use to set off an introductory clause or interjection.

Oh, you are right. If snow falls, the drive will be slow.

5. Use in pairs to set off nonessential information—information that if left off would 

not affect the meaning of the sentence. This includes appositives and which 

statements.

We interviewed Mr. Thomas Banks, the facility owner, at his office.

6. Use with phrases that begin with terms like as well as and in addition to.

He had reviewed the market research reports, as well as the export reports.

7. Use commas in pairs to set off degrees and titles.

William Brown, Ph.D., is the guest speaker.

8. Use to set off dates, places, and addresses. Do not use a comma with just the 

name of a city, state, or country. Do not use a comma with just the month and 

year. (January 2017).

Forward his mail to 2973 Main Street, Tallahassee, Florida, until January 28, 

2009.

9. Use to set off a tag question.

You do like my gift, correct?

10. Use to set off the words said in a direct quotation.

Sam said, "It's about time you got a job."

11. Use to separate two identical words or two sets of figures. 

Curtis had lost it, it seemed.

We told you, you might regret doing that.

Buy me 20, 34¢ stamps and 10, 55¢ stamps.
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12. Use to set off words or phrases expressing contrast. 

I want my children to be independent thinkers, not little monsters.

Lucy always wanted a lucrative position, but never with so many duties attached. 

13. Use with direct address.

Paul, I do not agree with your approach.

Dashes (--)

To use this punctuation mark, hit the hyphen mark twice and do not include a space 

before, between, or after the hyphens marks. A dash is twice as long as a hyphen 

and sits lower.

 

1. Use to mark a sudden break or an afterthought.

He said––and no one contradicted him––“The battle is lost.” 

2. Use to indicate more emphasis.

Many components of the rule—for example, the introductory summary—are 

written before the regulation text.

I want my children to be independent thinkers—not little monsters.

3. Use in place of commas or parentheses if the meaning is clarified by the dash.

These are shore deposits––gravel, sand, and clay––but marine sediment is 

beneath them.

4. Use to precede a credit line or signature.

This statement is open to question.––Gerald H. Forsythe

Ellipses (...) 

1. Use to show that words or sentences are missing from a quoted passage. 

During the past five years...we have noticed a change in the use of this code.

2. Use to indicate a pause or interruption.

We can go to the play...if you want to go. 

Exclamation Point (!)

Use to indicate the end of a complete thought that expresses surprise, incredulity, 

enthusiasm, or other strong emotion.

I am extremely upset right now! 
91

Hyphen (-)

Use it if a pair of words forms an adjective that comes before the noun. The 

general rule is to use a hyphen between words if the words by themselves would 

make no sense in connection with the following noun.

third-party witness, FSIS-regulated products

Quotation Marks

1. Use to enclose a direct quotation. Begin a direct quote with an uppercase letter.

Mr. Sacks stated, “I ordered this product and had it labeled as required.”

2. Use to enclose any words following terms such as “labeled,” "entitled," "marked," 

or "referred to." 

The product was labeled “Not for Human Consumption.”

3. Use to enclose the titles of short works like magazine articles, short stories, 

essays, poems, songs, and book chapters.

The jukebox was playing the Beatles' song "Yesterday."

4. Use to enclose misnomers, slang expressions, nicknames, coined words, or 

words used in an unusual way.

My "best friend" had an affair with my husband.

Place commas and periods within quotations. Place colons or semicolons outside 

quotations unless it is part of the quote.

The water buffalo’s name was "Big Bad Bubba." 

I am reading an article called, "Getting Dates"; you ought to read it, too.

Semicolon (;)

1. Use it to connect two related sentences.

The owner was not present for the interview; therefore, I interviewed the 

manager.

2. Use it to connect elements in a list when the list has many commas.

Our training sites include Philadelphia, Pennsylvania; Sacramento, California; 

and Omaha, Nebraska.
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Appendix E: Helpful Resources

Bailey, Edward P., Jr. (1990) The Plain English Approach to Business Writing

New York: Oxford University Press

Bivins, Thomas (1996). Handbook for Public Relations Writing

Chicago, IL: NTC Business Books

Brereton, John C. and Margaret A. Mansfield (1997). Writing on the Job

New York, NY: W.W. Norton and Company

Davidson, Wilma, Ed. D. (1994) Business Writing: What Works, What Won’t

New York: St. Martin’s Griffin

Lauchman, Richard (1993) Plain Style

New York: AMACOM

Pearsall, Thomas E. and Donald H. Cunningham (1994) How to Write for the World of Work

New York: Harcourt Brace College Publishers

Rubens, Philip (1992 Science and Technical Writing: A Manual of Style

New York: Henry Holt and Company

Zinsser, William (2006) On Writing Well, 30th Anniversary Edition

New York, NY: Harper & Row, Publishers