0345 Food Safety Survey SSA 2017 Extension

U.S. Food and Drug Administration
Food Safety Survey
OMB Control No. 0910-0345
SUPPORTING STATEMENT Part A: Justification
Terms of Clearance: Respondents should be informed that their responses will be kept ‘secure
to the extent permitted by law’ and that ‘confidentiality’ cannot be assured absent explicit
statutory authority. The agency should ensure that the instruments reflect the current wording.
1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food Safety Survey (FSS), a unique data set on
consumer food handling practices, and food safety-related knowledge and attitudes used in
support of improving consumer health. These objectives are also included as part of Healthy
People 2020 goals, discussed more fully at www.healthpeople.gov. The survey is
administered through telephone interviews using a random sample of approximately 4,000 US
adults (2,400 landline and 1,600 cell phone), including at least 400 Hispanic Americans and at
least 400 African-Americans. Data from the survey will be used in support of FDA’s
regulatory policy in diverse areas dealing with food safety and will support consumer
education by enabling us to track consumer knowledge, attitudes, and practices concerning
food safety. The data will also be used to measure progress on two Healthy People 2020
consumer objectives for food safety: (1) increase the proportion of consumers who follow key
food safety practices: clean, cook, separate, and chill, (Objective FS-5); and (2) one objective
related to food allergies: reduce severe allergic reactions to food among adults (Objective FS4) (Ref.1). Data from this survey will also be used to measure progress toward the USDA
Food Safety Inspection Service’s (FSIS) goal of ensuring that, “Consumers, including
vulnerable and underserved populations, adopt food safety best practices” (Ref. 2).
While previous versions of the Food Safety Survey included only landline telephone numbers,
this version will include cellular telephone numbers. The proposed survey will contain many
of the same questions and topics as previous Food Safety Surveys to facilitate measuring
trends in food safety knowledge, attitudes, and behaviors over time. The survey will also be
updated to explore emerging consumer food safety topics and expand understanding of
previously asked topics. For example, recent papers in both the United States (Ref. 3) and
Europe (Refs. 4 and 5) have pointed to changing epidemiology of listeriosis where adults over
60 years old have the highest rates of the illness. One reason for the increase in listeriosis
rates among those over 60 years old could be increasing host susceptibility due to widened
use of immunocompromising medications. We plan to include questions to document the
proportion of those over 60 years old who self-report taking immunocompromising
medications. In conjunction with established questions about safe food handling and eating
potentially risky foods, additional questions will expand our understanding of listeriosis
among those over 60. Other new topics planned to be included on the survey include:
consumer understanding of mechanically tenderized beef, awareness of foodborne pathogens

such as Toxoplasma gondii, and awareness of the risks associated with eating raw sprouts.
The questionnaire has been updated to reflect current issues for consumers and food safety.
2. Purpose and Use of the Information Collection
Data will be used by staff in the Division of Public Health Informatics and Analytics of the
Center for Food Safety and Applied Nutrition (CFSAN) and staff in FSIS. DPHIA staff will
analyze the data in consultation with other units of the Center including the food safety
educators, risk assessors and risk communicators. Survey questions on food handling
behaviors and food allergies will serve as measures of progress toward two Healthy People
2020 objectives by comparing results to previous surveys. Trend analysis will also be
conducted by demographic characteristics to evaluate disparities in practices and attitudes
over time.
3. Use of Improved Information Technology and Burden Reduction
The computer-assisted telephone interviewing (CATI) methodology proposed for the survey
duplicates the method used for the 1993, 1998, 2001, 2006, and 2010 surveys, with which the
data will be compared. CATI is also the most cost-effective approach to acquiring the needed
information. Telephone interviews are less intrusive than face-to-face interviews and are
considerably less expensive. Self-administered surveys sent by mail are not appropriate for
questionnaires with skip patterns such as used here.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. The FSS is a unique survey instrument
designed to capture information otherwise unavailable. The value of asking the core FSS
questions with the same data collection method as the previous waves of the FSS has
increased substantially, now that five data collections have been completed. The
collaboration between FDA and FSIS avoids duplication that would result from independent
surveys.
5. Impact on Small Businesses or Other Small Entities
Respondents to the collection are randomly selected private individuals.
6. Consequences of Collecting the Information Less Frequently
Without the data collection, national estimates of current knowledge, attitudes, and the safety
of consumer food handling practices will not be available. This is important because the 2010
FSS results most likely do not adequately reflect the current state of consumer knowledge,
attitudes, and practices in regard to food safety.

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7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The collection fully complies with 5 CFR 1320.5(d) (2). There are no special circumstances
associated with this information collection. The study will not require respondents to: report
the information more often than quarterly; provide a written response in less than 30 days;
submit more than one original plus 2 copies of the information; or, retain records for more
than 3 years. The design of the statistical survey will not produce results that cannot be
generalized to the universe of study. The study will not use statistical data that has not yet
been reviewed or approved by OMB. The study will not include a pledge of confidentiality
that is (1) not supported by authority established in statute or regulation; (2) not supported by
disclosure and data security policies that are consistent with the pledge; or (3) which
unnecessarily impedes sharing of data with other agencies for compatible confidential use.
Finally, the study does not involve the submission of trade secrets, proprietary information or
other confidential information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice in the Federal Register
of July 3, 2017 (82 FR 30871) soliciting public comment on the information collection.
While two comments were received, they were beyond the scope of the information topics
solicited. After evaluating the comments we did not revise the information collection.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts will be offered to respondents. If cell phone respondents request money
to offset the cost to them of paying for the phone minutes needed to take the survey, a ten
dollar incentive will be offered.
10. Assurance of Confidentiality Provided to Respondents
Confidential information is protected from disclosure under the Freedom of Information Act
(FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the
agency’s regulations (21 CFR part 20). Identifying information will not be included in the
data files delivered by contractors to the agency. Information will be kept private to the
extent permitted by law.
All data will be maintained in a manner that is consistent with the Department of Health and
Human Services ADP Systems Security Policy as described in DHHS ADP Systems Manual,
Part 6, chapters 6-30 and 6-35. All data will be maintained in consistency with the FDA
Privacy Act System of Records #09-10-0009 (Special Studies and Surveys on FDA Regulated
Products).
11. Justification for Sensitive Questions
The study does not include any questions that are of a sensitive nature.

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12. Estimates of Annualized Burden Hours and Costs
FDA estimates the burden of this collection of information as follows:
12a. Annualized Hourly Burden
Table 1 – Estimated Annual Reporting Burden1

Cognitive interview
screener
Cognitive interview

75

No. of
Responses per
Respondent
1

9

1

9

Pretest screener

45

1

45

Pretest

18

1

18

Survey screener

10,000

1

10,000

Survey

4,000

1

4,000

Non-response survey
screener
Non-response survey

125

1

125

50

1

50

Activity

No. of
Respondents

Total
1

Total
Annual
Responses
75

Avg. Burden
per Response

Total
Hours

0.083
(5 min.)
1
(60 min.)
0.0167
(1 min.)
0.33
(20 min.)
0.0167
(1 min.)
0.33
(20 min.)
0.0167
(1 min.)
0.167
(10 min.)

6
9
1
6
167
1,320
2
8
1519

There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA plans to conduct cognitive interviews by screening 75 potential respondents in
order to obtain 9 respondents in the interviews. Each screening is expected to take 5 minutes
(0.083 hour) and each cognitive interview is expected to take one hour. The total for
cognitive interview activities is 15 hours (6 hours + 9 hours). Subsequently, we plan to
conduct pretests of the questionnaire before it is administered in the study. We expect that 45
adults will need to be screened, each taking 1 minute (0.0167 hours), in order to get 18 of
them to complete a 20-minute (0.33 hours) pretest. The total for the pretest activities is 7
hours (1 hour + 6 hours). For the survey, we estimate that 10,000 adults will need to be
screened, each taking 1 minutes (0.0167 hours), to have 4,000 of them complete a 20-minute
(0.33 hours) questionnaire. The total for the survey activities is 1,487 hours (167 hours +
1,320 hours). Additionally, for the survey non-response analysis, we estimate that 125 adults
will need to be screened, each taking 1 minute (0.0167), to have 50 of them complete a 10
minute (0.167 hours) non-response survey. The total time for the non-response survey is 10
hours (2 hours + 8 hours). Thus, the total estimated burden is 1,519 hours.
12b. Annualized Cost Burden Estimate
The annualized cost to all respondents for the hour burden for the collection of
information is $30,380 (1,519 x $20) at the 2017 median wage rate for Clinical Processing
Clerks, in the United States (rounded from $19.61).
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The annualized cost to all respondents for the hour burden for the collection of information is
$27,053.39 (1,519 x $20.00) at the 2017 median wage rate in the United States.1
Activity
Responding to
Survey

Total Burden
Hours
1,519

Hourly Wage Rate
$20.00

Total Respondent
Costs
$30,380.00

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, operating, or maintenance costs associated with this data collection.
14. Annualized Cost to the Federal Government
Costs for the information collection are estimated at $650,000 and include costs paid to the
contractor to draw the sample, collect the survey data, create a database of the data, tabulate
and summarize the survey data, and prepare a final report. This estimate also includes FDA
staff time to manage the study.
15. Explanation for Program Changes or Adjustments
There is no change in the estimated burden for this collection.
16. Plans for Tabulation and Publication and Project Time Schedule
Activities associated with the outcomes of this research will primarily consist of a top-line
report summarizing the survey findings posted on the FDA Web site, articles published in
peer reviewed journals, and presentations at national conferences on food safety and public
health. The planned schedule for project activities is shown in Table 3.
Table 3. Project Schedule
Date
Within 3 days after receipt
of OMB approval of
collection of information
Within 150 days after
notification to contractor
Within 180 days after
notification to contractor
Within 6 months after
receipt of final data files

1

Activity
Notification to the contractor to proceed
with data collection activities

Audience
Not applicable

Completion of data collection

Not applicable

Delivery by the contractor of final data files

Not applicable

Posting of top-line report to FDA Web site.

FDA

http://www.bls.gov/oes/current/oes_nat.htm, accessed October, 2017.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of OMB Expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
REFERENCES:
1. U.S. Department of Health and Human Services, “Health People 2020 - Improving the
Lives of Americans,” July 30, 2013. Available
http://www.healthypeople.gov/2020/default.aspx.
2. U.S. Department of Agriculture, Food Safety Inspection Service, “Strategic Plan FY
2011-2016,” April 6, 2012. Available at
http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/strategic-planning/fy2011-2016-strategic-plan/ct_index.
3. Pouillot, R., Hoelzer, K., Jackson, K.A., Henao, O.L. and Silk, B.J. “Relative Risk of
Listeriosis in Foodborne Diseases Active Surveillance Network (FoodNet) Sites
According to Age, Pregnancy, and Ethnicity,” Clinical Infectious Diseases, 54(S5):
S401-410, 2012.
4. Goulet, V., Hedberg, C., Le Monnier A. and de Valk, H. “Increasing Incidence of
Listeriosis in France and other European Countries,” Emerging Infectious Diseases,
14(5): 734-740, 2008.
5. Muñoz, P., Rojas, L., Bunsow, E., Saez, E., Sánchez-Cambronero, L., Alcalá, L.,
Rogríguez-Creixems, M. and Bouza, E. “Listeriosis: An Emerging Public Health
Problem Especially Among the Elderly,” Journal of Infection, 64: 19-33, 2012.

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