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National Environmental Assessment Reporting System (NEARS)

OMB: 0920-0980

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National Environmental Assessment Reporting System (NEARS)

OMB Control No. 0920-0980 (Expiration Date: 08/31/2019)

Revision



Supporting Statement Part B –

Collections of Information Employing Statistical Methods











Program Official: Laura G. Brown, Ph.D.

Title: Lead Behavioral Scientist

Phone: 770-488-4332

Email: [email protected]

Fax: 770-488-7310


Date: May 15, 2019





Part B. Collections of Information Employing Statistical Methods

B.1. Respondent Universe and Sampling Methods



Statistical methods will not be used to select respondents for this data collection. All food safety programs in the United States (U.S.) will be invited to participate; however, participation is voluntary. Programs that participate in NEARS will report data on all outbreaks occurring in their jurisdictions. We expect that program participation will increase over time. However, until all eligible programs are participating, a limitation of our data will be that it applies to only those jurisdictions participating in NEARS.


State, local, tribal, and territorial food safety programs will report data into NEARS. There are approximately 3,000 such food safety programs in the U.S.


Although the data reported through this system are collected by food safety programs, they are not collected on food safety programs or personnel. Instead, they are collected primarily on foodborne illness outbreaks. Specifically, data collected by food safety programs during their investigation of foodborne illness outbreaks will be reported into NEARS. These data will provide information on environmental factors associated with outbreaks.


Data on all outbreaks occurring in the jurisdictions of participating food safety programs (the NEARS ‘catchment area’) will be reported to NEARS. Thus, we will be utilizing a convenience sample of voluntary participating programs and not obtaining a statistical sample. In the future, should a nationally representative program evolve, we may be able to generalize our data. Currently, we will describe the population of outbreaks solely in the NEARS catchment area and the environmental factors associated with them, and we will not generalize the data as nationally representative.

B.2. Procedures for the Collection of Information



Data Collection


Prior to collecting data, all food safety program personnel participating in NEARS will be encouraged to attend training for NEARS. These staff will be encouraged to attend a Skype Meeting (i.e., webinar) training session conducted by CDC staff (Attachment 4). This training is voluntary and will cover identifying environmental factors, logging in and entering data into the web-based NEARS data entry system, and troubleshooting problems. There will be no website, form, or presentation document associated with this training. Instead, CDC personnel will be guiding participants through the NEARS data entry system. Attachment 4 contains a brief description of the training.


Although not a requirement, food safety program personnel participating in NEARS will also be encouraged to complete CDC’s Environmental Assessment Training Series (EATS) (Attachment 5). This e-Learning course provides training on how to use a systems approach in foodborne illness outbreak environmental assessments. Participants acquire in-depth skills and knowledge to investigate foodborne illness outbreaks as a member of a larger outbreak response team, identify an outbreak’s environmental causes, and recommend appropriate control measures. The course is presented in the context of a simulated virtual environment where participants can interact and practice the skills being learned. Attachment 5 contains a brief description of the training.


There are two data collection activities. For the first activity, participating food safety programs will record all their environmental assessment data using pen-and -paper form (Attachment 6) and then enter all their data into the secure NEARS web-based system (Attachment 7). The respondents for this activity are the food safety program personnel participating in NEARS. This activity will be done once for each outbreak.


The second activity is the manager interview that will be conducted at each establishment associated with an outbreak (Attachment 8). The respondents for this activity are the retail food managers of the outbreak establishments. Manager interviews are a routine part of outbreak investigations; however, food safety program personnel participating in NEARS conduct a structured interview, and will thus conduct their interviews slightly differently than they would if they were not participating in NEARS.


Data analysis results will be shared informally with participating sites through annual data summary reports and presentations during NEARS quarterly webinars. Results will also be shared with other stakeholders (e.g., NORS Team) and the food safety and environmental public health community through presentations at meetings and conferences, peer-reviewed publications in scientific journals, and possibly ‘plain language’ summaries on the CDC website. Results will be presented in aggregate form.


The results will be used to develop recommendations for food safety and environmental public health programs and the retail food industry. For example, if data collection identifies specific environmental antecedents are associated with certain foodborne outbreaks, CDC can develop recommendations that address these unsafe polices and/or practices and disseminate the information to environmental public health programs and the retail food industry.


Quality Control Procedures


CDC personnel will periodically review the data from each site, and perform quality assurance procedures to check for data entry errors. They will provide reports to each program about the quality of their data. CDC personnel will use these reports to highlight weaknesses in data and recommend ways to improve the quality of the data.


Potential Biases


The act of observing workers during environmental assessments may influence their performance and behavior on work-related tasks. In other words, the workers may not respond naturally when they know they are being observed. However, for the most part, those collecting these data will be experienced and will take measures (such as remaining unobtrusive and engaging in activities that will place workers more at ease) to minimize this bias when possible.


The manager interview data may be influenced by social desirability bias - the tendency for people to report greater levels of socially desirable behavior (such as safe food preparation practices) than they actually engage in, or to report their best behavior rather than their typical or worst behavior.


Any presentation of these data will acknowledge these potential biases and include a discussion of how they impact data interpretation.

B.3. Methods to Maximize Response Rates and Deal with No Response


Program Response

We have been and will continue to engage in activities to promote and encourage food safety program participation in NEARS. We have presented at multiple conferences attended by those responsible for outbreak investigation (e.g., National Environmental Health Association, Council to Improve Foodborne Outbreak Response, etc.). We will hold informational conference calls with programs interested in NEARS. During these calls, we will attempt to identify barriers to NEARS participation and address those barriers. Our goal is to achieve close to 100% participation in NEARS.

B.4. Test of Procedures or Methods to be Undertaken



Development of Revisions

A work group of experienced foodborne outbreak investigators and NEARS participants developed the proposed revisions to the instrument, after extensive discussion. Thus, the revisions and discussions were based on the collective experience and expertise of these investigators. For example, added questions were ones that these investigators have regularly used in the course of their investigations, and many of the clarification revisions were ones investigators have had to regularly make in the field to obtain the desired data. Thus, although these revisions were not formally cognitively tested, we feel confident that the revisions will lead to improved flow and comprehension, and higher quality data. Nevertheless, we will regularly obtain feedback from NEARS users on the data collection instrument and experience, and routinely assess data quality, and will respond to any identified issues.

Future Revisions

The data collection instrument to be used for the NEARS was previously developed by the Environmental Health Specialists Network (EHS-Net) (See Attachments 6, 7, and 8). As food safety programs beyond the EHS-Net participants continue using the instrument, we expect that they will identify some components of the instrument that need revision. We expect these revisions to be minor. We plan to review respondents’ revision comments and questions on an annual basis to determine the nature and scope of requested revisions. Annual review of data may also reveal minor needed changes. Should we identify the need for changes to the data collection instruments, we will submit a nonmaterial or non-substantive change request to OMB for approval. For major changes to the instruments or methods, a full revision information collection request (ICR) will be submitted for Paperwork Reduction Act (PRA) clearance.

Data Analysis Plan

The three main goals of this data collection are to:

  1. Describe foodborne illness outbreaks and outbreak responses.

  2. Describe environmental factors (environmental antecedents and contributing factors) associated with outbreaks.

  3. Describe the associations between environmental antecedents and contributing factors to outbreaks.

To address the first goal of this data collection, describe foodborne illness outbreaks and outbreak responses, we will conduct descriptive analyses (frequencies, means, etc.) to describe:

  • outbreaks (Table B.4.1 contains the variables included in these descriptive analyses)

  • outbreak responses (Table B.4.2 contains the variables included in these descriptive analyses).

Table B.4.1. Variables included in descriptive analyses of outbreaks

Question

Number

Question

Justification

I_1

Did the exposure(s) take place in a single or multiple locations?

Describe where the outbreak took place.

I_2

Did the exposure(s) occur in a single state or multiple states?

I_3

Did the exposure(s) happen in a single county/township/parish or multiple counties/ townships/parishes?

I_4

How many food service establishment locations within your jurisdiction were associated with this outbreak?

I_5

How many environmental assessments conducted at foodservice establishments in your jurisdiction as part of this outbreak?

Describe whether environmental assessments were conducted.

I_5a

Why were no environmental assessments conducted in your jurisdiction as a part of this outbreak?

Describe barriers to conducting environmental assessments.

I_6

How many non-food service establishments within your jurisdiction were associated with this outbreak?

Describe whether any non-food service establishments were associated with the outbreak.

I_6a

How many environmental assessments were conducted at non-food service establishments in your jurisdiction as part of this outbreak?

Describe how many environmental assessments were conducted in non food service establishments.

I_7

Was a primary agent identified (suspected or confirmed) in this outbreak?

Describe the agent and serotype.

I_7a

What was the identified agent?


I_7b

Was a serotype identified for this outbreak?

I_7c

What was the identified serotype?

I_8

Was this outbreak reported to a state or local Communicable Disease Surveillance Program?

This information will be used to help connect the NEARS data to existing epidemiological and laboratory data reported to the state.

I_8a

Select the state or local surveillance system(s) where this outbreak was reported.

I_9

Was this outbreak reported to a national surveillance system?

This information will be used to help connect the NEARS data to existing epidemiological and laboratory data reported to other national surveillance systems.

I_9a

Select the national surveillance system(s) where this outbreak was reported and record the corresponding reporting number.

I_10

Was a specific ingredient or multi-ingredient food suspected or confirmed in this outbreak?

Describe ingredients and foods associated with the outbreak.

I_10a

If an ingredient/food was not suspected or confirmed, explain why this outbreak was considered foodborne.

I_11

Provide any comments that would help describe the foods involved in this outbreak.

Va_1

What is the name of the suspected or confirmed ingredient / food vehicle?

Va_2

Is this food a single specific ingredient or multi-ingredient?

I_11

Were any contributing factors identified in this outbreak?

Describe contributing factors to the outbreak.

VII_1

Which contributing factors was identified?

VII_2

In your judgment, was this the primary contributing factor to this outbreak?

VII_3

Briefly explain why this is a contributing factor in this outbreak.

VII_4

When did this factor most likely occur?

Va_3

Select the reason that best describes how this single specific ingredient or multi ingredient food was implicated in the outbreak.

Describes the type of information used to determine the food associated with the outbreak.

Va_4

Which best describes the food preparation process used for this specific ingredient or multi-ingredient food before consumption?

Describe the preparation of the suspected ingredient/food associated with the outbreak.

Va_5

During the likely time the ingredient/food was prepared, were any events noted that appeared to be different from the ordinary operating circumstances or procedures, as described by managers and/or workers?

Describe the circumstances of the outbreak.

Va_5a

How would those differing events best be characterized?

V1_1

Describe the agent found in the sample.

Describe sample agents.

VI_2

Where was the sample taken?

VI_3

Provide any other information about the sample.



Table B.4.2 Variables included in descriptive analyses of outbreak responses

Question Number

Question

Justification

I_12

What activities were conducted during the outbreak investigation to try to identify the contributing factors?

Describe outbreak investigation activities.

I_13

Please rate the quality of communication between the food regulatory program and the communicable disease control program during this outbreak investigation.

Describe communication during the outbreak investigation.

I_16

Were any immediate control measures implemented for this outbreak?

Describe outcomes of the outbreak investigation.

I_16a

If control measures were implemented, briefly describe this measures.

Describe outcomes of the outbreak investigation.

II_1

Date the establishment was identified for an environmental assessment

Describe how long it takes to respond to outbreaks with an environmental assessment.

II_2

Date of first contact with establishment management

II_3

Number of visits to the establishment to complete this environmental assessment

Describe environmental assessment responses.

II_4

Number of contacts with the establishment other than visits to complete this environmental assessment

II_7

Was a translator needed to communicate with the kitchen manager during the environmental assessment?

Describe whether language and communication are issues in collecting information for environmental assessments.

II_7a

Was a translator used to communicate with the kitchen manager?

II_8

Was a translator needed to communicate with the food workers during the environmental assessment?

II_8a

Was a translator used to communicate with the food workers?

II_13

Were any samples taken in the establishment?

Describe sampling practices

II_13a

Where were they taken?

II_13b

What foods or ingredients were sampled?

III_1a

How long was the interview?


III_1

Date the manager interview was initiated

Describe the time from identification/contact until specific environmental assessment activities are conducted.

IV_1a

How long was the observation?

IV_1

Date the observation was initiated



To address the second goal of this data collection, describe environmental factors associated with outbreaks, we will conduct descriptive analyses (frequencies, means, etc.) to describe

  • environmental antecedents (see Table B.4.3 for the variables included in these descriptive analyses and their environmental antecedent classifications [economics, equipment, food, people, processes])

  • contributing factors (examined by category: contamination, proliferation, and survival; see Table B.4.4 for the variables included in these descriptive analyses).

The list and descriptions of all contributing factors can be found in Attachment 3.

NEARS collects data on a number of environmental antecedent variables. These variables were chosen for inclusion in NEARS because existing hypotheses, theories or data suggest that they may be related to food safety and/or foodborne illness outbreaks.

Table B.4.3. Variables included in descriptive analyses of environmental antecedents

Question Number

Question

Justification

Classification

I_14

What were the environmental antecedents of this outbreak?

Describe the underlying causes of the outbreak.


Economics, Equipment, Food People, Processes


I_15

Briefly describe any other information about the underlying causes of the outbreak

II_5

Facility type

Describe facility type.

Process

II_6

How many critical violations/priority foundation items were noted during the last routine inspection?

Describe critical violations.

Equipment, People, Process

II_9

Establishment type

Describe establishment type.

Process

II_10

Do customers have direct access to unpackaged food such as a buffet line or salad bar in this establishment?

Describe customer access to unpackaged food.

People

II_11

Does the establishment serve raw or undercooked animal products (example, oysters or raw shell eggs) in any menu item?

Describe whether this food safety risk exists and whether customers are notified of this risk.

Food, Process

II_11a

Is a consumer advisory regarding the risk of consuming raw or undercooked animal products provided?

People

II_11a1

Where is the consumer advisory located?

People

II_12

Which one of the options best describes the menu for this establishment?

Describe the establishment menu.

Food, Process

III_2

Is this an independent establishment or a chain establishment?

Describe establishment ownership.

People, Process

III_3

Approximately how many meals are served here daily?

Describe volume of business.

Economics, People, Process

III_4

What is the establishment’s busiest day, in terms of number of meals served?

III_5

Are any foods prepared or partially prepared at a commissary or other location?

Describe whether foods are prepared at commissaries.

Process

III_6

Other than daily specials, when was the last time food items were added to your menu(s)?

Describe whether food items have been added to the menu.

Food, People, Process

III_7

Approximately how long have you been employed as a kitchen manager in this establishment?

Describe manager experience.


People, Process

III_8

Approximately how long have you worked as a kitchen manager?

III_9

How many kitchen managers, including you, are currently employed in this establishment?

Describe ratio of managers to workers (measure of worker supervision).

People

III_10

What language(s) do you and other managers in this establishment speak fluently?

Describe manager/worker communication/language barriers.


People

III_11

What languages do you and other managers speak at work?

III_12

In your opinion, how well do you communicate verbally with your food workers, very well, somewhat well or not well at all?

III_13

Do any kitchen managers receive food safety training?

Describe manager food safety training.

People

III_13a

How many kitchen managers have had food safety training?

III_13b

What type of food safety training do kitchen managers (you) receive?

III_14

Does this establishment require that kitchen managers have a food safety certification?

Describe food safety certification.

People

III_15

Are any kitchen managers, including you, food safety certified?

III_15a

How many kitchen managers in this establishment, including yourself, are food safety certified by an ANSI accredited program such as ServSafe National Registry of Food Safety Professionals/Environmental Health Testing or Thomson Prometric?

III_15b

How often is there a certified kitchen manager present during hours of operation?

III_16

How many food workers do you have?

Describe staff size.

People, Process

III_16a

What language(s) do food workers in this establishment speak fluently?

Describe manager/worker communication/language barriers.


People

III_16b

What languages do food workers speak at work?


III_16c

Do any food workers receive food safety training?

Describe food worker food safety training.

People

III_16c1

How many food workers have had food safety training?

III_16c2

What type of food safety training do food workers receive?

III_17

Does this establishment have a policy or schedule for

Describe cleaning and glove use policies.

Process


III_17a

Cleaning cutting boards?

III_17b

Cleaning food slicers?

III_17c

Cleaning food preparation tables?

III_17d

After a worker or customer vomits and/or has diarrhea in the establishment?

III_17e

Frequently touched customer surfaces?

III_17f

Are any of these policies written?

III_17f1

Which ones?

III_18

Does this establishment have a policy for disposable glove use?

III_18a

Does the glove use policy require that food workers wear gloves?

III_18a1

When they have cuts or other injuries?

III_18a2

When handling ready-to-eat foods?

III_18a3

When handling raw meat or poultry?

III_18a4

At all times while working in the kitchen?

III_18b

Is the policy written?



III_19

Does this establishment have a policy to take the temperature of any incoming food products?

Describe temperature taking policies.

Process

III_20

Excluding incoming products, does this establishment have a policy to take food temperatures?

III_21

When food workers say they are ill, do you typically ask if they are experiencing certain symptoms?

Describe ill worker and sick leave policies.

Process, People

III_22

Does this establishment have a policy or procedures that requires food workers to tell a manager when they are ill?

III_22a

Is this policy in writing?

III_22b

Does this policy require ill workers to tell managers what their symptoms are?

III_22c

Does this policy specify certain symptoms that ill workers are required to tell managers about?

III_25c1

What are those symptoms?

III_23

Does this establishment have a policy or procedure to restrict or exclude ill workers from working?

III_23a

Is this policy in writing?

III_23b

Does this policy specify the specific symptoms that would prompt excluding or restricting ill workers from working?

III_23b1

What are those symptoms?

III_24

Do any kitchen managers (including you) ever get paid when they miss work because they are ill?

III_24a

How many kitchen managers get paid when they miss work because they are ill?

III_25

Do any food workers ever get paid when work is missed because they are ill?

III_25a

How many food workers get paid when they miss work because they are ill?

IV_2

How many hand sinks are in the employee restrooms?

Describe availability of handwashing sinks, supplies and equipment, and handwashing and handwashing behavior

Equipment, People


IV_2a

Is warm water (minimum 100°F) available at all employee restroom hand sinks?


IV_2b

Is soap available at (or near) all employee restroom hand sinks?


IV_2c

Are paper or cloth drying towels or electric hand dryers available at (or near) all employee restroom hand sinks?


IV_3

How many hand sinks are located in the work area?


IV_3a

Is warm water (minimum 100°F) available at all hand sinks in the work area?


IV_3b

Is soap available at (or near) all employee restroom hand sinks in the work area?


IV_3c

Are paper or cloth drying towels or electric hand dryers available at (or near) all hand sinks in the work area?


IV_4

If workers are observed washing hands, do the hand washes include water, hand cleanser, appropriate drying methods and are they for the appropriate length of time (approximately)?





IV_5

How many cold storage units are in the establishment?

Describe cold storage units and their temperatures.

Equipment




IV_5a

Which types of units did you observe?






IV_6

Were any foods observed in cold holding?




IV_6a

Were the temperatures of all foods measured in cold holding at 41°F or below?




IV_7

Are any food workers using gloves while handling food?

Describe glove practices.

Equipment, People




IV_8

Is there a supply of disposable gloves available in the establishment?

Describe glove availability.

Economics, Equipment




IV_9

Are food workers using any methods besides gloves to prevent bare hand contact with ready-to-eat food?

Describe other bare hand contact prevention practices.

Equipment, people




IV_9a

If methods besides gloves are used: What methods?




IV_10

Are any food workers handling ready-to-eat foods with bare hands?

Describe bare hand contact practices.

People




IV_12

Are there records to indicate that the temperatures of incoming ingredients are being taken and recorded?

Describe temperature taking and recording practices.

People




IV_13

Are there records to indicate that the temperatures of foods, excluding incoming ingredients, are being taken and recorded?




IV_13

Is there any evidence of direct cross contamination of raw animal products with ready to eat foods?

Describe practices that could lead to cross contamination.

People, Process




IV_13a

Describe cross contamination evidence.




IV_14

Were any hot foods observed in cooling?

Describe food cooling practices.

Process




IV_14a

What cooling method(s) are used?




IV_14b

Were the cooling methods properly implemented?




IV_15

Were any foods observed in hot holding?

Describe food holding and cooking practices.

People, Process



IV_15a

Were the temperatures of all foods measured in hot holding at 135°F or above?



IV_16

Were any foods observed during cooking?



IV_16a

Were the temperatures of all foods measured during cooking at or above the recommended temperatures?



IV_17

Were any thermometers observed in food preparation areas to measure food temperatures?



IV_17a

Were any thermometers observed being used?



IV_18

Were any of these materials observed for cleaning/sanitizing food contact surfaces and in-place equipment?

Describe cleaning practices.

People, Process



IV_18a

Are all wet wiping cloths stored in sanitizer solution between uses?



IV_18b

Pick one sanitizer bucket (or bottle) and test sanitizer concentration. Is it in the proper range?



IV_19

What does the establishment use to clean dishes, utensils, or other food equipment that is not cleaned in place?

Describe dishwashing practices.

Equipment, Process



IV_19a

Does the wash cycle reach the temperatures recommended for the mechanical washing machine?



IV_19b

How is sanitization achieved?



IV_191

Does the sanitizing cycle reach the temperatures recommended for sanitization?



IV_19b2

Does the chemical sanitizing cycle have the required levels of chemical sanitizer recommended for the machine?



IV_19c

What type of sink is used for manual washing?



IV_19d

Are dishes, utensils, etc. washed, rinsed, and sanitized (either with heat or chemical) properly?



IV_19d1

Is a santitizing method properly implemented?



IV_20

Did you observe signs and instructions posted in the establishment?

Describe signs.


People, Process



IV_20a

Did any use pictures or symbols to communicate a message?



IV_20b

What languages did you observe on signs or instructions posted for food workers?


IV_21

Did you observe any of these items for responding to vomit and/or diarrheal incidents?

Describe equipment for cleaning after vomiting/diarrheal incidents

Equipment

IV_21a

Were any of these things located together?

IV_24

Is a certified manager present at the time of data collection?

Describe manager training

People

IV_25

Does the written employee health policy or procedure….

Describe employee health policy

Process

Va_1

What is the name of the suspected or confirmed ingredient/food vehicle?

Describe and classify food ingredients linked with the outbreak.


Food

Va_2

Is this food a single specific ingredient or multi-ingredient?

Va_3

Select the reason that best describes how this single specific ingredient or multi-ingredient food was implicated in the outbreak.

Va_4

Which of the following best describes the food preparation process used for this specific ingredient or multi-ingredient food before consumption?

Describe and classify the food prep processes that the establishment used to prepare the suspected/confirmed vehicle.

Food, Process

Va_5

During the likely time the ingredient/food was prepared, were any events noted that appeared to be different from the ordinary operating circumstances or procedures, as described by managers and/or workers?

Out-of-the ordinary events can lead to potential food safety risks. These data will identify and describe these events.

Economics, Equipment, Food People, Processes


Va_5a

How would these events best be characterized?

Vb_1

Name of ingredient

Describe and classify food ingredients linked with the outbreak.


Food, Process

Vb_2

If any information is present that shows this ingredient is an important food item or from an unapproved source or recall, describe.

Vb_3a

Select poultry type

Vb_3b

Select seafood type

Vb_3c

Select beef, pork, lamb, other meat type

Vb_3d

Poultry, seafood, beef, pork, lamb, other meat, Select best description of product upon arrival at the food service establishment

Vb_3e

Dairy, Select best description of product upon arrival at the food service establishment

Vb_3f

Eggs, Select best description of product upon arrival at the food service establishment

Vb_3g

Plant or plant product, Select type

Vb_3h

Produce, Select produce type

Vb_3i

Plant or plant product, Select best description of product upon arrival at the food service establishment

Vb_3j

Describe other ingredient



To address the third goal of this data collection, describe the associations between environmental antecedents and contributing factors, we will conduct tests for association and logistic regression models.

Analysis will involve bivariate tests for association between individual environmental antecedent (explanatory) variables and the contributing factor (outcome) variables. Odds ratios will be calculated to assess the strength and direction of the bivariate relationships. For those bivariate associations found to be statistically significant at p<.30, the environmental antecedent variables will be used as candidate “predictors” to examine their multivariate relationships with the contributing factor variables. Multivariable logistic regression will be used to model for the effects that these environmental antecedent variables have in explaining the variations observed in the contributing factor variables. This type of analysis allows us to determine which environmental antecedents contribute to the presence of the contributing factor, and the relative degree of impact that each environmental antecedent has in the presence of that contributing factor. A separate model will be developed for each contributing factor analyzed.

Table B.4.5 describes the study questions designed to address this third goal of this data collection and the data collection variables designed to answer those questions. Note that we will likely create composite environmental antecedent variables based on the individual variables listed in the table.

Table B.4.5. Study questions and the data collection variables designed to answer those questions

Study Question

Environmental Antecedent Variables

Contributing Factors

How are specific environmental antecedents related to contamination contributing factors?

II_5, II_6, II_7 (a), II_8 (a), II_9, II_10, II_12, III_2, III_3, III_4, III_5, III_6, III_7, III_8, III_9, III_10, III_11, III_12, III_13 (a, b), III_14, III_15 (a, b), III_16 (a, b, c, c1, c2), III_17 (a, b, c, d, e, f, f1), III_18 (a, b), III_21, III_22 (a, b, c, c1), III_23 (a, b, b1), III_24 (a), III_25 (a), III_26 (a), IV_2 (a, b, c), IV_3 (a, b, c), IV_4, IV_7, IV_8, IV_9 (a), IV_10, IV_13 (a), IV_17 (a, b), IV_18 (a, b), IV_19 (a, b, b1, b2, c, d, d1), IV_20 (a, b), IV_21, IV_22 (a), IV_23, IV_24, IV_25

C1-C15


How are specific environmental antecedents related to proliferation contributing factors?

II_5, II_6, II_7 (a), II_8 (a), II_9, II_11, II_12, III_2, III_3, III_4, III_5, III_6, III_7, III_8, III_9, III_10, III_11, III_12, III_13 (a, b), III_14, III_15 (a, b), III_16 (a, b, c, c1, c2), III_17 (a, b, c, d, e, f, f1), III_19, III_20, IV_5 (a), IV_6 (a), IV_11, IV_12, IV_14 (a, b), IV_15 (a), IV_16 (a), IV_17 (a)

P1-P12

How are specific environmental antecedents related to survival contributing factors?

II_5, II_6, II_7 (a), II_8 (a), II_9, II_11 (a, a1), II_12, III_2, III_3, III_4, III_5, III_6, III_7, III_8, III_9, III_10, III_11, III_12, III_13 (a, b), III_14, III_15 (a, b), III_16 (a, b, c, c1, c2), III_17, III_18, III_20, III_26 (a), IV_16 (a), IV_17 (a), IV_22 (a), IV_23

S1-S5



Table B.4.6 is a table shell that illustrates how we might analyze and present the data examining the bivariate relationships between specific environmental antecedents and the contributing factor of bare-hand contact with ready-to-eat food by a food worker who is suspected to be infectious (contributing factor C10).

Table B.4.6. Example Table Shell: Environmental antecedent variables associated with the outcome variable of whether the contributing factor of bare-hand contact with ready-to-eat food by an infectious food worker was identified, bivariate analyses

Environmental antecedent variables

Bare hand contact with food by infectious food worker (C10) identified as a contributing factor


OR (95% CI)

P

Number of meals served daily (III_3)



<300

x.xx (ref)

.xxx

>300

x.xx


Food worker training provided (III_20)



No

x.xx (ref)

.xxx

Yes

x.xx


Paid sick leave provided (III_28)



No

x.xx (ref)

.xxx

Yes

x.xx


Establishment has ill worker policy (III_26)



No

x.xx (ref)

.xxx

Yes

x.xx


Disposable gloves are available in establishment (IV_8)



No

x.xx (ref)

.xxx

Yes

x.xx


Hand sink is available in work area (IV_2)



No

x.xx (ref)

.xxx

Yes

x.xx


OR=Odds Ratio, P=probability level

Below is an example figure demonstrating results from a multivariate analysis of the associations between environmental antecedents and the contributing factor of bare-hand contact with ready-to-eat food by an infectious food worker. This type of analysis allows us to determine the relationships among environmental antecedents and between environmental antecedents and contributing factors. It allows us to determine the direct and indirect effects of each environmental antecedent on the contributing factor. A separate model would be developed for each contributing factor analyzed.

Figure B.4.1. Example Figure - Environmental antecedent variables associated with the outcome variable of whether the contributing factor of bare-hand contact with ready-to-eat food by an infectious worker was identified, multivariate analyses

Shape1

























B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data


The following persons were primarily responsible for designing the instrument; however, Laura Brown and Adam Kramer will be primarily responsible for analyzing data.


Data Collection Designers and Analysts


Laura Green Brown, Ph.D.

Behavioral Scientist

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Environmental Health Science and Practice

Water, Food, and Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-4332

[email protected]


Carol Selman, MPH (Retired)

Senior Public Health Advisor

Centers for Disease Control and Prevention

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Environmental Health Science and Practice

Water, Food, and Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-4352

[email protected]


Erik W. Coleman, MPH

Health Scientist (Informatics)

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Environmental Health Science and Practice

Water, Food, and Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-3438

[email protected]


Adam Kramer, ScD

Environmental Science Officer

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Environmental Health Science and Practice

Water, Food, and Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-3438

[email protected]

References



Brown, L, Hoover, E, Selman, C, Coleman, E, Schurz Rogers, H. Outbreak characteristics associated with identification of contributing factors to foodborne illness outbreaks. Epi Infect. 2017;1:1-9.


Dewey-Mattia D, Manikonda K, Hall AJ, Wise ME, Crowe SJ. Surveillance for Foodborne Disease Outbreaks — United States, 2009–2015. MMWR Surveill Summ 2018;67(No. SS-10):1–11.


Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, Roy SL, et al. Foodborne illness acquired in the United States—major pathogens. Emerg Infect Dis. 2011; 17:7–15.


Scallan E, Griffin PM, Angulo FJ, Tauxe RV, Hoekstra RM. Foodborne illness acquired in the United States—unspecified agents. Emerg Infect Dis. 2011; 17:16–22.

Attachments



Attachment 1A. Authorizing Legislation 42 U.S.C. § 241

Attachment 1B. Authorizing Legislation 21 U.S.C § 2201

Attachment 2. 60-day Federal Register Notice

Attachment 3. Definition of Contributing Factors to Foodborne Illness Outbreaks

Attachment 4. NEARS Food Safety Program Training Webinar

Attachment 5. NEARS e-Learning on Environmental Assessment Foodborne Illness Outbreaks (screenshots)

Attachment 6. NEARS Data Recording Instrument Word

Attachment 7. NEARS Data Recording and Manager Interview Web Entry (screenshots)

Attachment 8. NEARS Manager Interview

Attachment 9. Research Determination Form





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