[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Pages 20990-20992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0267]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Survey on Consumers' 
Emotional and Cognitive Reactions to Food Recalls

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 16, 
2011.

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 e-mailed to <a href="/cdn-cgi/l/email-protection#f49b9d8695ab878196999d87879d9b9ab49b9996da919b84da939b82"><span class="__cf_email__" data-cfemail="37585e4556684442555a5e44445e585977585a551952584719505841">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-new and 
``Survey on Consumers' Emotional and Cognitive Reactions to Food 
Recalls.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3793.

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.

Survey on Consumers' Emotional and Cognitive Reactions to Food 
Recalls--21 U.S.C. 393(d)(2)(C) (OMB Control Number 0910-NEW)

I. Background

    The proposed ``Survey on Consumers' Emotional and Cognitive 
Reactions to Food Recalls'' will be conducted under a cooperative 
agreement between the Joint Institute for Food Safety and Applied 
Nutrition (JIFSAN) and the Center for Risk Communication Research at 
the University of Maryland. JIFSAN was established in 1996 and is a 
public and private partnership between FDA and the University of 
Maryland. The Center for Risk Communication Research will design and 
administer the study.
    The proposed study will assess consumers' emotional and cognitive 
recollection of certain food recalls and gauge how these recollections 
affect their current perceptions about food recalls and their 
inclination to adhere to future recommended food recall behaviors. 
Existing data show that many consumers do not take appropriate 
protective actions during a foodborne illness outbreak or food recall 
(Refs. 1 and 2). For example, 41 percent of U.S. consumers say they 
have never looked for any recalled product in their home (Ref. 2). 
Conversely, some consumers overreact to the announcement of a foodborne 
illness outbreak or food recall. In response to the 2006 fresh, bagged 
spinach recall which followed a

[[Page 20991]]

multistate outbreak of Escherichia coli O157: H7 infections (Ref. 3), 
18 percent of consumers said they stopped buying other bagged, fresh 
produce because of the spinach recall (Ref. 1).
    Research shows that emotion plays a large role in decisionmaking, 
and that individuals may not be conscious of its effects on their 
behavior (Ref. 4). For example, when people are angry they are likely 
to place blame, take action, and want justice to be served (Ref. 5). If 
a particular food recall engenders widespread anger and the anger is 
coupled with behavior that is less than desirable from a food safety or 
nutritional standpoint, it is possible that anger will be the lens 
through which future food recall situations are viewed, thus resulting 
in similar undesirable behaviors. Findings from this study will help 
FDA understand the emotional response to food recalls. This will help 
FDA to design more effective consumer food recall messages during and 
after a recall.
    FDA conducts research and educational and public information 
programs relating to food safety under its broad statutory authority, 
set forth in section 903(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 903(d)(2)(C), to conduct research relating to 
foods, drugs, cosmetics, and devices in carrying out the FD&C Act.
    FDA plans to survey U.S. consumers using a web-based panel of U.S. 
households to collect information on consumers' cognitive and emotional 
reaction to food recalls. The survey will query consumers on their 
recollection of food recalls within the past 5 years; attitude toward 
recalled foods; knowledge about particular food recalls; behavior 
during the food recall; and assessment and appraisals of 
susceptibility, severity, satisfaction, and self-efficacy.
    The data will be collected using an online survey. A pool of 10,000 
consumers from a Web-based consumer panel will be screened for 
eligibility based on age (18+ years) and familiarity with recent food 
recalls. One thousand of eligible consumers will be randomly selected 
to participate in the survey. The results of the survey will not be 
used to generate population estimates.
    The estimated total hour burden of the collection of information is 
354 hours (table 1 of this document). To help design and refine the 
questionnaire, the Center for Risk Communication Research will conduct 
cognitive interviews by screening 25 adult consumers in order to obtain 
8 respondents for the cognitive interviews. Each screening is expected 
to take 5 minutes (0.083 hours) and each cognitive interview is 
expected to take 1 hour. The total for cognitive interview activities 
is 10 hours (2 hours + 8 hours). Subsequently, we will conduct pretests 
of the study questionnaire before it is administered. We expect that 
100 invitations, each taking 2 minutes (0.033 hours), will need to be 
sent to adult members of the online consumer panel to have 40 of them 
complete a 10 minute (0.167 hours) pretest. The total for the pretest 
activities is 10 hours (3 hours + 7 hours). We estimate sending 10,000 
survey screeners, each taking 1 minute (0.017 hours), to adult members 
of the online consumer panel to have 1,000 of them complete a 10 minute 
(0.167 hours) survey. The total for the survey activities is 337 hours 
(170 hours + 167 hours).
    The burden estimate for this study published in the Federal 
Register of June 18, 2010 (75 FR 34745), has increased from 234 hours 
to 357 hours. The increase in burden hours represents the addition of 
cognitive interviews to the study design and correction of a math 
error.
    In the Federal Register of June 18, 2010 (75 FR 34745), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two letters containing multiple 
comments in response to the notice. One letter contained comments 
outside the scope of the four collection of information topics on which 
the notice solicits comments and, thus, will not be addressed here.
    (Comment) One comment suggested that the survey should include 
consumers whose pets were sickened or had died because of mycotoxins in 
pet food that resulted in the 2004 pet food recall.
    (Response) FDA agrees that consumers who were affected by the 2004 
pet food recall should be included as survey respondents. These 
consumers will be included if they are members of the online consumer 
panel from which the survey sample will be drawn and they are randomly 
selected from the panel. FDA does not believe that the affected 
population should be target-sampled because the study focuses on human 
food recalls rather than pet food recalls.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                Annual
             Portion of study                  Number of     frequency per   Total annual    Hours per    Total
                                              respondents      response        responses      response    hours
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Cognitive interview screener..............              25               1              25         5/60        2
Cognitive interview.......................               8               1               8         1/60        8
Pretest screener..........................             100               1             100         2/60        3
Pretest...................................              40               1              40        10/60        7
Screener..................................          10,000               1          10,000         1/60      170
Survey....................................           1,000               1           1,000        10/60      167
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     Total................................  ..............  ..............  ..............  ...........      357
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Cuite, C., Condry, S., Nucci, M., and Hallman, W., ``Public 
Response to the Contaminated Spinach Recall of 2006,'' Publication 
number RR-0107-013. New Brunswick, New Jersey: Rutgers, the State 
University of New Jersey, Food Policy Institute, 2007.
    2. Hallman, W., Cuite, C., and Hooker, N., ``Consumer Responses to 
Food Recalls: 2009 National Survey Report,'' Publication number RR-
0109-018. New Brunswick, New Jersey: Rutgers, the

[[Page 20992]]

State University of New Jersey, Food Policy Institute, 2009.
    3. Acheson, D., ``Outbreak of Escherichia coli 0157 Infections 
Associated with Fresh Spinach--United States, August-September 2006,'' 
2007. Available at http://first.fda.gov/cafdas/documents/Acheson_Spinach_Outbreak_2006_FDA_pres.ppt.
    4. Han, S., Lerner, J.S., and Keltner, D., ``Feelings and Consumer 
Decision Making: The Appraisal-Tendency Framework,'' Journal of 
Consumer Psychology, 17(3), 158-168, 2007.
    5. Lazurus, R.S., Emotion and Adaptation. New York: Oxford 
University Press, 1991.

    Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8936 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P


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