[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