SSA_NEARS_20190515 final

Goal of the study: The goal of this information collection request is to continue to improve public health practice by providing a standardized, detailed reporting system for food safety programs, to collect foodborne outbreak environmental assessment data, and to establish a sound epidemiological basis for disease prevention activities.

Intended use of the resulting data: The foodborne outbreak environmental assessment data reported to NEARS will be used to characterize data on food vehicles and monitor trends; identify contributing factors and their environmental antecedents; generate hypotheses, guide planning, and implementation; evaluate food safety programs; and ultimately assist to prevent future outbreaks.

Methods to be used to collect: Foodborne outbreak environmental assessment data will be collected through retail food service establishment observations by the state and local food safety programs currently registered to report data to NEARS, and through manager interviews or pen-and-paper assessments in retail food service establishments.

Subpopulation to be studied: Foodborne outbreak environmental assessment data collected in retail food service establishments from state and local food safety programs, and from the kitchen managers and food workers in those establishments.

How data will be analyzed: Descriptive analyses (frequencies, means, etc.), tests for association, and logistic regression models.

Part A. Justification

A.1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC) requests a three-year Paperwork Reduction Act (PRA) clearance for the National Environmental Assessment Reporting System (NEARS), OMB Control No. 0920-0980, Expiration Date: 08/31/2019. This is a revision of a previously approved information collection request (ICR). Requested revisions include the following:

Reducing the total burden from 2,125 hours to 1,350 hours, due to a reduction in the estimated number of respondents that need to take the training.
Changes to data collection forms. These changes were based on feedback from NEARS users and analysis of data, and include the following:
- 22 questions were removed.
- 21 questions were added.
- 10 questions were revised.
- 10 questions were moved to a different section of the data collection instrument to streamline and improve the data collection process.
- 7 questions that were asked for every environmental sample taken are now only asked for positive samples.

Foodborne illness is a significant problem in the United States (U.S.)—an estimated 47.8 million foodborne illnesses occur annually in the U.S., resulting in 127,839 hospitalizations, and 3,037 deaths annually (Scallan, Hoekstra et al., 2011; Scallan, Griffin et al., 2011). Many of these illnesses result from foodborne illness outbreaks—an average of 823 foodborne illness outbreaks occur in the U.S. every year (Dewey-Mattia, Manikonda, Hall, Wise, Crowe (2018)).

Reducing the number of outbreaks requires identification and understanding of the etiology of outbreaks. We need to know the pathogen, food, and the pattern of illness associated with each outbreak. We also need to identify the environmental factors associated with each outbreak; in other words, we need to know how and why the food became contaminated with pathogens and how and why these pathogens were not eliminated before ingestion.

Foodborne Illness Outbreak Environmental Factors. Environmental health specialists in environmental health or food safety programs (hereafter referred to as food safety programs) focus on collecting detailed environmental factor data during foodborne illness outbreak investigations. These data identify how and why the food became contaminated with pathogens, and how and why these pathogens were not eliminated before ingestion. To identify these environmental factors, environmental health specialists conduct environmental assessments, which involve a thorough assessment of the environment in which the outbreak occurred. When this information is reported to CDC, it provides an opportunity for CDC to systematically monitor and evaluate environmental factors of foodborne illness, which can then be used to develop effective foodborne illness outbreak response and preventative controls.

Foodborne Illness Outbreak Surveillance. Many surveillance systems are used in the U.S. to provide information about the occurrence of foodborne disease. Most of CDC’s surveillance systems rely on data from state and local food safety programs. Some focus on specific pathogens likely to be transmitted through food and have been used extensively for decades. For example, Foodborne Diseases Active Surveillance Network, referred to as FoodNet, is the principal foodborne disease component of CDC's Emerging Infections Program (EIP). It is a sentinel surveillance system that collects information from one site in each of 10 states—covering 15% of the U.S. population, or 48 million Americans—about diseases that are caused by any of seven bacteria and two parasites commonly transmitted through food. The system has been in operation since 1995. Investigators actively seek out laboratory confirmed cases of illness in an attempt to detect every person in the 10 EIP sites who went to a doctor's office, had a sample tested, and was diagnosed with one of these infections (https://www.cdc.gov/ncezid/dpei/eip/).

More recently, new surveillance methods have emerged which improve the quality, quantity, and timeliness of data (e.g., sentinel surveillance systems and national laboratory networks). The CDC sponsors the National Outbreak Reporting System (NORS), which is maintained by the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) under the National Disease Surveillance Program II - Disease Summaries (OMB Control Number: 0920-0004, expiration date October 31, 2020). NORS is a mature passive surveillance system into which food safety programs (i.e. each state epidemiologist) voluntarily report epidemiological and clinical information about foodborne outbreaks. There is no mandatory requirement for food safety programs to report data to CDC through NORS. Currently all 50 states report outbreak data to NORS. Based on existing NORS data, it is estimated that a minimum of 800 foodborne illness outbreaks will occur in the U.S. annually (see Table A.1.1).

Table A.1.1. Outbreaks Reported to NORS

Year

2012

2013

2014

2015

2016

2017

Total number of outbreaks

834

829

877

924

849

839

The NORS Dashboard allows the general public direct access to information on foodborne outbreaks reported to CDC (https://wwwn.cdc.gov/norsdashboard/). Most outbreaks are reported to NORS by the state, local, territorial, or tribal health department that conducted the outbreak investigation. Multi-state outbreaks are generally reported to NORS by CDC. Data available via the NORS Dashboard originate from a dynamic outbreak surveillance database. Reporting agencies (state, local, territorial, and tribal health departments, and CDC) can modify their NORS reports at any time, even months or years after an outbreak. Therefore, results from the NORS Dashboard Search Tool are subject to change.

Data obtained through foodborne illness outbreak investigations, such as the number of ill people associated with individual outbreaks and the pathogen involved, are collected and reported by communicable disease control programs to NORS. Environmental factor data are not frequently reported to this system. The names of contributing factors identified in outbreak investigations are reported, but no details on these contributing factors are reported (e.g., when the factor occurred, how it was identified, etc.), nor is any other information obtained from environmental assessments (e.g., environmental antecedents) reported.

Although CDC’s long-term goal is to have one foodborne illness outbreak surveillance system that will collect these two sets of data, it is currently not feasible. The consolidation to one foodborne illness surveillance system will be a long-term process, and environmental factor data are a priority now. The collection of environmental factor data and efforts to improve coordination and communication across communicable disease control programs that report to NORS and food safety control programs that report to NEARS will continue to occur simultaneously. When linked, both NORS and NEARS data are critical to food safety efforts. The original anticipated timeline for the merger of NORS and NEARS systems was December 2018. This timeline has been revised to December 2019, and will include extensive project planning amongst NORS and NEARS teams and information technology (IT) developers. This will be followed by design, development and review of the integrated system which will be led by IT developers. Lastly, CDC and its partners will thoroughly conduct testing of the system to ensure user acceptance prior to release.

National Food Safety Context

President Obama established the Federal Food Safety Working Group (FSWG) in 2009 to strengthen federal efforts and establish short-term and long-term strategies to improve food safety. FSWG recommended a new, public health-focused approach to food safety based on several core principles, one of which is strengthening surveillance and enforcement. FSWG also recommended the development of a national surveillance system to collect environmental data related to foodborne illness outbreaks. Additionally, the Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011, recognizes that robust foodborne illness surveillance data are needed to inform targeted prevention interventions. FSMA directed CDC, with its expertise in surveillance, to expand national food safety surveillance systems and increase state and local participation in these systems.

NEARS addresses the above-stated goals of the FSWG and FSMA. NEARS collects environmental data on foodborne illness outbreaks on a national level, and expands the current national food safety surveillance from collection of epidemiological and clinical data through NORS to collection of environmental data. NEARS also increases state and local participation in food safety surveillance, as this system is designed for use by local, state, federal, territorial, and tribal food safety programs. NEARS continues to support the U.S. Department of Health and Human Services’ Healthy People 2020 Goal to, “Improve food safety and reduce foodborne illnesses.”

This data collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. § 241) (Attachment 1A) and Section 205 of the Food Safety Modernization Act (FSMA) (21 U.S.C § 2201) (Attachment 1B).

The 60-day Federal Register Notice was published on 03/06/2019 (Attachment 2) and is further discussed in Section A.8.

A.2. Purpose and Use of the Information Collection

The information collected through NEARS is primarily used by the CDC to identify and understand environmental factors (contributing factors and environmental antecedents) associated with foodborne illness outbreaks.

Data collected through NEARS will also be used to:

Describe outbreaks and outbreak responses. NEARS collects detailed descriptive data on outbreaks and outbreak responses (e.g., number of locations associated with the outbreak, number of establishments involved, number of environmental assessments conducted, etc.).
Describe environmental factors associated with outbreaks. NEARS collects detailed information on environmental antecedents (economics, equipment, food, people, processes) and contributing factors (contamination, proliferation, survival) associated with outbreaks (Attachment 3).

Describe the associations between environmental antecedents and specific contributing factors. NEARS collects data that will allow us to understand the associations between environmental antecedents and specific contributing factors associated with outbreaks. For example, an analysis may reveal that the environmental antecedent of lack of paid sick leave was associated with the contributing factor of an ill worker contaminating food.
Describe outbreaks reported to NORS and describe characteristics of outbreaks not reported to NORS. NEARS collects data that will allow us to understand the characteristics of outbreaks reported to NEARS but, not reported to NORS. For example, an analysis may reveal that outbreaks reported to NEARS, but not reported to NORS, are more likely to be single location outbreaks. Outbreaks reported to NORS typically involve multi-locations (i.e. multi-states). This analysis may also reveal information on the number of outbreaks that NORS reporting misses.

Experience to Date

Currently, there are 31 local and state food safety programs registered to report outbreaks to NEARS. Table A.2.1. provides a snapshot of data on outbreaks reported to NEARS between 2014 and 2017. Reporting data to NEARS is not mandatory for local and state food safety programs; however, Table A.2.1. shows that the number of outbreaks reported to NEARS is increasing each year.

Table A.2.1. Outbreaks Reported to NEARS

2014

2015

2016

2017

Total

111

112

168

217

In 2017, CDC held a NEARS User Meeting; a representative from each participating NEARS site attended. At this meeting, users discussed their experiences with NEARS and provided CDC with feedback on how to improve NEARS. We have revised the NEARS instrument based on this feedback, and on analysis of NEARS data. Specifically, we:
- Removed 22 questions that users said did not work in the field or were unnecessary.
- Added 21 questions that users felt were important to understanding foodborne outbreaks. Most of these were focused on food safety issues related to norovirus prevention, given that the majority of outbreaks reported to NEARS were caused by norovirus.
- Revised 10 questions to improve their clarity.
- Moved 10 questions to a different section of the data collection instrument to streamline the data collection process.
- Changed the data collection protocol so that seven questions that were asked for every environmental sample taken are now only asked for positive samples.

NORS collects de-identified outbreak data on the epidemiologic and clinical laboratory data from outbreaks. NORS and NEARS data are linked using outbreak ID numbers (unique system-generated numbers given to each outbreak in each system upon data entry). When data for the same outbreak are reported to both NORS and NEARS, these data can be linked. When NORS and NEARS data are linked, it provides opportunities to strengthen the robustness of outbreak data reported to CDC. Collectively, these data play a vital role in improving the food safety system. In 2018, CDC merged NEARS and NORS data for 2014-2016. We were able to match records across the two databases for 85% of outbreaks reported to NEARS. CDC is currently working with sites to understand why the remaining 15% of NEARS outbreaks failed to match.

Over half (58%) of outbreaks reported to NEARS had identified contributing factors. Contributing factors are determinants that directly or indirectly cause an outbreak, and they describe how the outbreak occurred. When data are available to understand how outbreaks occur, they can be used to assist in the development of outbreak prevention efforts. Identifying contributing factors is a key component of understanding the causes of outbreaks and preventing future ones. It is a significant accomplishment that the majority of NEARS outbreaks had an identified contributing factor, since, historically these data were not available at a national level.

Analysis of NEARS data identified some key investigation activities related to identifying outbreak contributing factors. These include conducting timely and comprehensive environmental assessments (Brown, Hoover, Selman, Coleman, Schurz Rogers, 2017). These analyses provide valuable information about how to improve outbreak investigations.

Participation of food safety programs in NEARS is voluntary and a convenience sample; therefore, the information collected is not designed to contribute to generalizable knowledge applicable to all foodborne illness outbreaks. Data collected in NEARS will be invaluable in determining and understanding the ultimate causes of outbreaks, and are critically important to outbreak response and prevention efforts, because they answer how and why questions about the causes of outbreaks. Over time, CDC will use data from NEARS to develop recommendations specific to individual food safety programs and those that are broadly applicable to other NEARS participants engaged in foodborne illness outbreak response and prevention. For example, if data analysis reveals that the lack of policies requiring workers to tell managers when they are ill is associated with the contributing factor of workers working while ill, CDC can develop interventions designed to increase the food safety programs’ implementation of such policies. Other public health agencies (FDA, USDA, state and local food safety programs, industry) may also use the data in this way.

Without these data, it will be difficult for CDC to identify the environmental factors associated with contributing factors and foodborne illness outbreaks, and without this information, it will be difficult to reduce outbreaks and consequently reduce illness associated with them.

In the future, should a nationally representative program evolve, we may be able to generalize our data. 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.

A.3. Use of Improved Information Technology and Burden Reduction

Participating food safety programs will record all their information on pen and paper (Attachments 6 and 8) and then enter all their data into a secured web-based system (Attachment 7) designed to make data entry easy for respondents. This eliminates the need to copy data collection forms or to mail or fax forms to CDC.

In the future, CDC plans to develop a mobile web application (contingent on receiving additional funding) that will extend the functionality of the current system. When available, CDC will seek PRA clearance for the approved use of this application. The proposed mobile web application will support the storing and reporting of environmental assessment data. By enhancing the current system to allow mobile data importing into NEARS, this will allow greater productivity in the field as data collectors are no longer confined to an office infrastructure to electronically capture and enter data.

A.4. Efforts to Identify Duplication and Use of Similar Information

Through examination of the activities of other organizations, such as FDA, and organizations within CDC, such as NCEZID, we have confirmed that no local, state, federal, territorial, or tribal surveillance system for reporting of information about environmental factors associated with foodborne illness outbreaks presently exists. However, epidemiological and clinical information on foodborne illness outbreaks is currently reported in other national surveillance systems, such as NORS. So that data from other systems and NEARS can be linked when appropriate, NEARS collects information related to whether epidemiological or laboratory information has been reported to other surveillance systems and the reporting numbers associated with those systems for each outbreak.

Additionally, both NORS and NEARS collect the names of identified contributing factors; however, NEARS also collects several important additional details about the contributing factors, such as when the contributing factors occurred and how they were identified. Once NEARS is an established reporting system for food safety programs, the contributing factor data points will be dropped from NORS, eliminating this overlap.

As noted earlier, the implementation of NEARS resulted in two foodborne illness outbreak surveillance systems at CDC—NORS and NEARS. NORS and NEARS will collect different and complementary sets of data on foodborne illness outbreaks; both data sets are critical to food safety efforts. Although CDC’s long-term goal is to have one foodborne illness outbreak surveillance system that will collect these two data sets, it is currently not feasible, given coordination and communication issues at the local, state, federal, territorial, or tribal level. CDC will be working to improve coordination and communication between these two types of programs so that we can eventually meet the goal of one foodborne illness outbreak surveillance system.

A.5. Impact on Small Businesses or Other Small Entities

Local, state, federal, territorial, and tribal food safety program officials are the primary respondents for this data collection. As indicated earlier, the foodborne illness outbreak investigation data reported into NEARS by these officials is reported to CDC as a part of routine public health practice (Attachment 6). Food safety programs do vary in size; some of them are small, with few staff (estimate: 30%). Reporting to NEARS may be difficult for some of these small programs. However, reporting into NEARS is voluntary; and small entities will be encouraged to delay their participation until they can do so relatively easily.

Retail food managers of establishments in which outbreak investigations occur are respondents to the manager interview (Attachment 8). Some of these establishments will be small (estimate: 30%). However, it is important to note that this interview will only be conducted in establishments in which a routine public health activity—an outbreak investigation—is already occurring, and this manager interview is a part of that investigation.

A.6. Consequences of Collecting the Information Less Frequently

Each respondent is asked to provide information once per outbreak. Programs that voluntarily participate in NEARS are expected to report data on all outbreaks occurring in their jurisdictions. All food safety programs in the U.S. are invited to participate.

If this information is not collected, a major gap in overall foodborne illness surveillance will remain, hampering efforts to develop effective prevention measures. Thus, it would also be difficult for CDC to fully address CDC’s research agenda goal of decreasing health risks from environmental exposures.

There are no legal obstacles to reduce the burden.

A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.

A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A 60-day Federal Register Notice was published in the Federal Register on March 6, 2019, Vol. 84 No. 44, pp. 8101-8103 (Attachment 2). CDC did not receive public comments related to this notice.

The data collection instrument was developed by the Environmental Health Specialists Network (EHS-Net), a collaborative network of federal, state, and local epidemiologists and environmental health specialists. This network developed the instrument in 2004 and 2005 and revised and tested it extensively from 2006 through 2009. We also revised the instrument in 2018; these revisions were based on feedback from NEARS users. Federal and state consultants are listed in Table A.8.1.

Table A.8.1. 2016 ATSDR External Consultations

Federal Consultants

Jack Guzewich, RS, MPH (Retired)

Director-Emergency Coordination & Response

U.S. Food and Drug Administration

Center for Food Safety and Applied Nutrition

MS HFS-600 Bld. CPK1

College Park, MD 20740

301-436-1608

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Food safety program personnel	NEARS Food Safety Program Training	50	1	2	100
	NEARS e-Learning (screenshots)	50	1	10	500
	NEARS Data Recording (paper form)	300	1	30/60	150
	NEARS Data reporting and manager’s interview (web entry)	300	1	40/60	200
Retail food personnel	NEARS Manager Interview	1200	1	20/60	400
Total					1,350

Category	Number of staff	% effort	Average Yearly Salary	Total Costs
Environmental Health Specialists Network (EHS-Net)-Practice based research to improve food safety RFA-EH-15-001	N/A	N/A	N/A	1,425,000
NEARS related activities funding	N/A	N/A	N/A	115,000
CDC fellow	1	100%	$50,000	$50,000
IT Contractor (maintains the system)	1	50%	$50,000	$50,000
CDC FTE	1	50%	$65,000	$65,000
Total				$1,705,000

Activity- Data collection and cleaning	Time Frame
6^th year (2019) data collection	2019
6^th year (2019) data verification and correction	Completed May 2020
7^th year (2020) data collection	2020
7^th year (2020) data verification and correction	completed May 2021
8^th year (2021) data collection	2021
8^th year (2021) verification and correction	completed May 2022
9^th year (2022) data collection	2022
9^th year (2022) data verification and correction	completed May 2023
Activity- Data analysis and publication
4^th year (2017) data analysis and annual report	completed Dec. 2019
5^th year (2018) data analysis and annual report	completed Dec.2020
6^th year (2019) data analysis and annual report	completed Dec.2021
4^th-6^th year (2017-2019) aggregate data analysis and report publication	completed Dec.2022
7^th year (2020) data analysis and annual report	completed Dec.2022
8^th year (2021) data analysis and annual report	completed Dec.2023
9^th year (2022) data analysis and annual report	completed Dec.2024
7^th-9^th year (2020-2022) aggregate data analysis and report publication	completed Dec.2025

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SSA_NEARS_20190515 final