
[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70875-70876]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28088]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. Under the Paperwork Reduction Act of 1995 (the PRA), 
Federal Agencies must publish a notice in the Federal Register 
concerning each proposed collection of information and allow 60 days 
for public comment. This notice invites comments on the proposed data 
collection entitled ``Comparing Food Safety Knowledge, Attitude, and 
Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, 
and Other Consumers.''

DATES: Submit either electronic or written comments on the collection 
of information by January 27, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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:

I. Background

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal Agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information before submitting 
the collection to OMB for approval. To comply with this requirement, we 
are publishing this notice of the proposed collection of information 
set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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

    We conduct research and educational and public information programs 
relating to food safety and nutrition under our broad statutory 
authority, set forth in section 903(b)(2) of the Federal Food, Drug, 
and Cosmetic Act (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 903(d)(2)(C) of the FD&C Act (21 
U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, 
cosmetics, and devices.
    Our current food safety education and outreach programs and 
materials generally are developed and provided for the English-speaking 
population in the United States (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).
    Data from the Centers for Disease Control and Prevention 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, 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 
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 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 among the three population groups, 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

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from 3,000 adult members in online consumer panels maintained by a 
contractor. The study plans to randomly select 800 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 will use the results of the study to develop followup 
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 will use the results of the 
followup 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.
    We estimate 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  0.5 (30 minutes)               5
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.....................  ..............  ..............  ..............  ................           1,646
----------------------------------------------------------------------------------------------------------------
\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 30 minutes to complete 
the interview, for a total of 4.5 hours, rounded to 5 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 1,646 hours.

II. References

1. FDA. ``Foodborne Illness & Contaminants.'' June 9, 2014. 
Available at http://www.fda.gov/Food/FoodborneIllnessContaminants/default.htm.
2. Passel, J. S. and D'V. Cohn. ``U.S. Population Projections: 2005-
2050.'' Pew Research Center. Washington, DC February 11, 2008. 
Available at 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. Washington, DC 
April 4, 2012. Available at 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: November 21, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28088 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P


