[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62810-62812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-26131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0263]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Experiment To 
Evaluate Risk Perceptions of Produce Growers, Food Retailers, and 
Consumers After a Food Recall Resulting From a Foodborne Illness 
Outbreak

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 (the PRA).

DATES: Fax written comments on the collection of information by 
November 10, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Experiment to Evaluate Risk Perceptions of Produce Growers, 
Food Retailers, and Consumers After a Food Recall Resulting From a 
Foodborne Illness Outbreak.'' Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., 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.

Experiment To Evaluate Risk Perceptions of Produce Growers, Food 
Retailers, and Consumers After a Food Recall Resulting From a Foodborne 
Illness Outbreak--(OMB Control Number 0910--NEW)

I. Background

    This proposed collection of information entitled ``Experiment to 
Evaluate Risk Perceptions of Produce Growers, Food Retailers, and 
Consumers After a Food Recall Resulting From a Foodborne Illness 
Outbreak'' 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 (CRCR) 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 CRCR will 
design and administer the study.
    FDA is requesting OMB approval under the PRA for the CRCR to 
conduct research with produce growers, food retailers, and consumers to 
gain information about these groups' risk perceptions associated with 
produce that has recently been subject to a food recall resulting from 
a foodborne illness outbreak. The purpose of this research is to help 
FDA better understand whether the magnitude and duration of the decline 
in commodity consumption following food recalls can be partly explained 
by grower and retailer speculations and projections about consumers' 
attitudes toward food recalls resulting from foodborne illness 
outbreaks. This research will be used to assess how grower, retailer, 
and consumer perceptions, attitudes, knowledge, and beliefs affect 
market recovery after a hypothetical fresh spinach recall.
    Epidemiologists define foodborne illness outbreaks as two or more 
cases of a similar illness resulting from the ingestion of a common 
food (Ref. 1). Because many foodborne illness cases are mild, most 
outbreaks are never

[[Page 62811]]

recognized or brought to the attention of public health authorities. 
When the outbreaks are large in scale or cause hospitalization, serious 
illness, or death, public health officials will inform the public in 
order to try to stop the spread of disease. A food recall can occur 
when a particular food in the marketplace is found to have a known 
contaminant because either people have become sickened by it or 
pathogen testing has revealed contamination (Ref. 2). The purpose of a 
food recall is to rid retail establishments of the product and to 
inform consumers that they should discard the product if they have it 
in their homes. Although the purpose of a food recall is to keep 
consumers from becoming ill, food recalls can be costly to all sectors 
of the food distribution chain (Ref. 3). The goal of the proposed 
project is to test, by experimental study, whether the psychological 
tendency called ``attribution error,'' contributes to unnecessarily 
prolonging the economic effects of a food recall. ``Attribution error'' 
is the tendency people have of overestimating others' negative response 
to situations compared to their own response. If industry 
decisionmakers' measures of consumer response are biased by 
``attribution error,'' industry could be contributing to its own slow 
recovery after a food recall.
    When a widespread foodborne illness outbreak results in a food 
recall, the product can be out of the marketplace for an extended 
period of time; this occurred when fresh, bagged spinach was recalled 
in 2006 (Ref. 3). Tomatoes were also less available following the 
Salmonella Saintpaul outbreak in 2008 (Ref. 4). Although growers and 
retailers want to provide safe foods, decisions surrounding production, 
wholesale, and retail sales forecasting in response to a food recall 
affects how quickly the food is again available for consumption. We 
hypothesize that industry's overattribution of consumers' fear of the 
food after such a food recall would result in the food being kept off 
of the market longer than necessary.
    The CRCR plans to conduct an experiment using a Web-based 
questionnaire. The center will use a convenience sample of 900 
participants (180 growers, 180 retailers, 540 consumers) drawn from 
industry networks (for the growers and retailers), and a Web-based 
panel of U.S. households (for the consumers). Participation in the 
study is voluntary.
    This study will help FDA better understand the reasons for the time 
between a food recall resulting from a foodborne illness outbreak and 
market recovery. In order to understand the complexities of market 
recovery process, the CRCR will compare understandings and reactions of 
growers, retailers, and consumers to a hypothetical food recall 
resulting from a hypothetical foodborne illness outbreak. To make this 
comparison, individuals in each group will be assigned to one of the 
following experimental conditions (consisting of vignettes in the form 
of news articles on a hypothetical food recall): An ``anger'' scenario, 
a ``fear'' scenario, or a ``control'' scenario. After reading the news 
article, participants will complete a questionnaire assessing their 
emotional response; appraisals; attribution of responsibility; 
perceptions about the safety of the affected produce; intentions to 
grow, sell, or buy the affected produce; perceived probability of a 
repeat event; and a measure of their innate ability to effectively 
respond to the information in the article.
    To help design and refine the questionnaire, we will recruit 25 
participants in order to conduct 10 cognitive interviews. We estimate 
cognitive interview recruitment will take 5 minutes (0.083 hours), for 
a total of 2 hours. The cognitive interviews are estimated at 1 hour 
per response for a total of 10 hours for the cognitive interview 
activities. We expect to send screeners to 800 members of a consumer 
panel, each taking 2 minutes (0.03 hours) to complete, for a total of 
24 hours for the consumer panel screener activity. We also expect to 
administer 360 screeners to growers and retailers, each taking 2 
minutes (0.03 hours) to complete, for a total of 22 hours (11 + 11 = 
22). Twenty-four participants (20 consumers, 2 growers, 2 retailers) 
will complete the pretest. Each pretest will take 10 minutes (0.17 
hours) for a total of 5 hours for the pretest activity. We estimate 
that 900 individuals (540 consumers, 180 growers, and 180 retailers) 
will complete the questionnaire for the experiment, each taking 10 
minutes (0.17 hours) for a total of 153 hours for the experimental 
study activities. The estimated total hour burden of the collection of 
information is 216 hours.
    In the Federal Register of April 15, 2011 (76 FR 21379), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The Agency received two comments. The 
comments, and the Agency's responses, are discussed in the following 
paragraphs.
    (Comment 1) One comment suggested that FDA should include the 
foodservice distributor community in the study.
    (Response) FDA disagrees. FDA is not including the foodservice 
distributor community as a study sample because the foodservice 
distributor community is responsive to retail's demands for product. 
The retail sector is included in the study.
    (Comment 2) One comment questioned the need for FDA to apply 
government resources toward the research question, which was 
characterized in the comment as a survey of consumers' reactions to 
food recalls.
    (Response) FDA disagrees that the research data are not needed. The 
proposed study utilizes an experimental design to assess how well 
industry predicts consumer reaction to a food recall. This information 
will help FDA in their risk management role during and following a food 
recall. Risk management involves communicating both with industry and 
consumers about the important health and economic consequences related 
to the recall.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                  Number of
           Activity               Number of     responses per   Total annual    Average  burden     Total hours
                                 respondents     respondent       responses       per response
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Cognitive Interview                        25               1              25  0.08 (5 min.)....               2
 Recruitment.
Cognitive Interviews.........              10               1              10  1 (60 min.)......              10
Consumer Panel Screener......             800               1             800  0.03 (2 min.)....              24
Grower Screener..............             360               1             360  0.03 (2 min.)....              11
Retailer Screener............             360               1             360  0.03 (2 min.)....              11
Pretests.....................              24               1              24  0.17 (10 min.)...               5

[[Page 62812]]

 
    Experiment...............             900               1             900  0.17 (10 min.)...             153
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    Total....................  ..............  ..............  ..............  .................             216
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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 (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

1. Olsen, S., L. MacKinnon, J.S. Goulding, et al., ``Surveillance for 
Foodborne Disease Outbreaks--United States, 1993 to 1997,'' Morbidity 
and Mortality Weekly Report, vol. 49, pp. 1-51, 2000.
2. ``FDA 101: Product Recalls--From First Alert to Effectiveness 
Checks,'' (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm).
3. Calvin, L., ``Outbreak Linked to Spinach Forces Reassessment of Food 
Safety Practices,'' Amber Waves, vol. 5, pp. 24-31, 2007.
4. Lucier, G. and R. Dettmann, ``Vegetables and Melons Outlook: A 
Report From the United States Department of Agriculture, Economic 
Research Service,'' VGS-327, June 26, 2008.

    Dated: October 4, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-26131 Filed 10-7-11; 8:45 am]
BILLING CODE 4160-01-P