
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21556-21558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1904]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Comparing Food Safety 
Knowledge, Attitude and Behavior Among English-Dominant Hispanics, 
Spanish-Dominant Hispanics, and Other Consumers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 12, 
2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910--New and 
title ``Comparing Food Safety Knowledge, Attitude and Behavior Among 
English-dominant Hispanics, Spanish-dominant Hispanics, and Other 
Consumers.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Comparing Food Safety Knowledge, Attitude and Behavior Among English-
Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers--
OMB Control Number 0910--NEW

I. Background

    We conduct research and educational and public information programs 
relating to food safety and nutrition issued in our broad statutory 
authority, set forth in section 1003(b)(2) of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)), to protect the 
public health by ensuring that foods are ``safe, wholesome, sanitary, 
and properly labeled,'' and in section 1003(d)(2)(C) of the FD&C Act 
(21 U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, 
cosmetics, devices and tobacco products.
    Our current food safety education and outreach programs and 
materials generally are developed and provided for the English-speaking 
population in the United States (U.S.) (Ref. 1). To better protect 
public health and to help consumers practice safe food handling, we 
need empirical data on how different population groups understand, 
perceive and practice food safety and food handling. An emerging and 
important demographic trend in the United States is the increase in 
Hispanics. Recent estimates suggest that Hispanics (defined as those 
who identify themselves as of Hispanic or Latino origin) are the 
largest and fastest growing minority group in the nation; the 
proportion of the U.S. population that was Hispanic was 14 percent in 
2005 and is projected to increase to 29 percent in 2050 (Ref. 2).

[[Page 21557]]

    Data from the Centers for Disease Control and Prevention (CDC) 
indicate that, in the past two decades, Hispanics were one of the 
population groups that often experienced higher incidence rates (per 
100,000 population) of bacterial causes of foodborne illness than 
Caucasians (Ref. 3). These bacterial causes include Campylobacter, 
Listeria monocytogenes (Listeria), Shigella, and Salmonella. While some 
Hispanics living in the United States use the English language 
exclusively or more often than Spanish (English-dominant Hispanics), 
other U.S. Hispanics predominantly use the Spanish language in their 
daily lives (Spanish-dominant Hispanics) (Ref. 4). Since most U.S. food 
labels, including safe food handling instructions, are in English, 
Spanish-dominant Hispanics' understanding and use of safe food handling 
instructions may differ from that of English-dominant Hispanics and of 
non-Hispanics who use English exclusively. In addition, Hispanics may 
have certain food handling practices that may increase their risk of 
foodborne illness (Ref. 5).
    FDA needs an understanding of how different population groups 
perceive and behave in terms of food safety and food handling to inform 
development of possible measures that we may take to better protect 
public health and to help consumers practice safe food handling. FDA is 
aware of no consumer research on a nationwide level on how different 
population groups understand, perceive and practice food safety and 
food handling. This study is intended to provide initial answers to 
research questions such as whether and how much Spanish-dominant 
Hispanics, English-dominant Hispanics, and English-speaking non-
Hispanics differ in their knowledge, attitude, and behavior toward food 
safety and food handling and the role that demographic and other 
factors may play in any differences.
    The proposed study will use a Web-based instrument to collect 
information from 3,000 adult members in online consumer panels 
maintained by a contractor. The study plans to randomly select 1,000 
panel members in each of three groups: Spanish-dominant Hispanics, 
English-dominant Hispanics, and English-speaking non-Hispanics. Both 
English and Spanish questionnaires will be used, as appropriate. The 
study plans to include topics such as: (1) Food safety knowledge and 
attitude; and (2) food handling and consumption practice. To help us 
understand the data, the study will also collect information on 
respondents' background, including, but not limited to, health status 
and demographic characteristics, such as age, gender, education, and 
income, and degree of acculturation among Hispanic respondents using a 
measure developed by Marin et al. (Ref. 6).
    The study is part of our continuing effort to protect the public 
health. We will not use the results of the study to develop population 
estimates. We plan to use the results of the study to develop follow-up 
quantitative and qualitative research to gauge the prevalence and 
extent of differences in food safety knowledge and behaviors between 
the three mentioned population groups. We plan to use the results of 
the follow-up research to help inform the design of effective education 
and outreach initiatives aimed at helping reduce the risk of foodborne 
illness for the general U.S. population as well as Hispanics.
    In the Federal Register of November 28, 2014 (79 FR 70875), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Cognitive interview screener..              72               1              72  0.083 (5                       6
                                                                                 minutes).
Cognitive interview...........               9               1               9  1.5 (90 minutes)              14
Pretest invitation............           1,440               1           1,440  0.033 (2                      48
                                                                                 minutes).
Pretest.......................             180               1             180  0.25 (15                      45
                                                                                 minutes).
Study invitation..............          24,000               1          24,000  0.033 (2                     792
                                                                                 minutes).
Study.........................           3,000               1           3,000  0.25 (15                     750
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,655
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimates on prior experience with research that is 
similar to this proposed study. We will use a cognitive interview 
screener with 72 individuals to recruit prospective interview 
participants. We estimate that it will take a screener respondent 
approximately 5 minutes (0.083 hours) to complete the cognitive 
interview screener, for a total of 5.976 hours, rounded to 6 hours. We 
will conduct cognitive interviews with nine participants. We estimate 
that it will take a participant approximately 90 minutes to complete 
the interview, for a total of 13.5 hours, rounded to 14 hours. We also 
plan to conduct a pretest to identify and resolve potential survey 
administration problems. We will send a pretest invitation to 1,440 
prospective pretest participants and estimate that it will take a 
respondent approximately 2 minutes (0.033 hours) to complete the 
invitation, for a total of 47.52 hours, rounded to 48 hours. We will 
administer the pretest with 180 participants and estimate that it will 
take a participant 15 minutes (0.25 hours) to complete the pretest, for 
a total of 45 hours. We will send a study invitation to 24,000 
prospective participants and estimate that it will take a respondent 
approximately 2 minutes (0.033 hours) to complete the invitation, for a 
total of 792 hours. We will administer the study with 3,000 
participants and estimate that it will take a participant 15 minutes 
(0.25 hours) to complete the study, for a total of 750 hours. The total 
estimated burden for all the study activities is 1,655 hours; this 
estimate is 9 hours higher than that shown in the 60-day notice due to 
revised hours for cognitive interviews, from 30 minutes (0.5 hours) to 
90 minutes (1.5 hours) each interview.

II. References

    1. U.S. Food and Drug Administration. ``Foodborne Illness & 
Contaminants.'' June 9, 2014. (http://www.fda.gov/Food/FoodborneIllnessContaminants/default.htm).
    2. Passel, J.S. and C. D'Vera. ``U.S. Population Projections: 
2005-2050.'' Pew

[[Page 21558]]

Research Center. February 11, 2008. (http://pewhispanic.org/files/reports/85.pdf).
    3. Quinlan, J.J. ``Foodborne Illness Incidence Rates and Food 
Safety Risks for Populations of Low Socioeconomic Status and 
Minority Race/Ethnicity: A Review of the Literature.'' International 
Journal of Environmental Research and Public Health 10(8): 3634-
3652, 2013.
    4. Taylor, P., M.H. Lopez, J. Mart[iacute]nez and G.Velasco. 
``Language Use Among Latinos.'' Pew Research Center. April 4, 2012. 
(http://www.pewhispanic.org/2012/04/04/iv-language-use-among-latinos/).
    5. Henley, S.C., S.E. Stein and J.J. Quinlan. ``Identification 
of Unique Food Handling Practices That Could Represent Food Safety 
Risks for Minority Consumers.'' Journal of Food Protection 75: 2050-
2054, 2012.
    6. Marin, G., F. Sabogal, B.V. Marin, et al. ``Development of a 
Short Acculturation Scale for Hispanics.'' Hispanic Journal of 
Behavioral Sciences 9(2): 183-205, 1987.


    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08332 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P


