[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21379-21381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to

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publish notice in the Federal Register concerning each proposed 
collection of information and to allow 60 days for public comment in 
response to the notice. This notice solicits comments on ``Experiment 
to Evaluate Risk Perceptions of Produce Growers, Food Retailers, and 
Consumers After a Food Recall Resulting From a Foodborne Illness 
Outbreak.''

DATES: Submit either electronic or written comments on the collection 
of information by June 14, 2011.

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

SUPPLEMENTARY INFORMATION: 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, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's 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.

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)

    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 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 over-attribution 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

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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 (0.033 hours) to complete, for a total of 24 hours (11 + 11 = 
22). Twenty-four participants (20 consumers, 2 growers, 2 retailers) 
will complete the pre-test. Each pre-test will take 10 minutes (0.17 
hours) for a total of 5 hours for the pre-test 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 215 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden  per
        Portion of study            respondents    responses per     responses     response (in     Total hours
                                                    respondent                      hours) \2\
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Cognitive Interview Recruitment.              25               1              25            5/60               2
Cognitive Interviews............              10               1              10               1              10
Consumer Panel Screener.........             800               1             800            2/60              24
Grower Screener.................             360               1             360            2/60              11
Retailer Screener...............             360               1             360            2/60              11
Pre-tests.......................              24               1              24           10/60               5
Experiment......................             900               1             900           10/60             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.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

II. References

11. Olsen, S., L. MacKinon, et al., ``Surveillance for Foodborne 
Disease Outbreaks--United States, 1993 to1997,'' Morbidity and 
Mortality Weekly Report 49(SS01), pp. 1 through 51, 2000.
2. FDA 101: Product Recalls--From First Alert to Effectiveness 
Checks, Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm.
3. Calvin, L., ``Outbreak Linked to Spinach Forces Reassessment of 
Food Safety Practices,'' Amber Waves 5(3), pp. 24 through 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: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9155 Filed 4-14-11; 8:45 am]
BILLING CODE 4160-01-P