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, 21379-21381 [2011-9155]
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21379
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
Request for Designation as Country Not
Subject to the Restrictions Applicable to
Human Food and Cosmetics
Manufactured From, Processed With, or
Otherwise Containing, Material From
Cattle—21 CFR 189.5 and 700.27 (OMB
Control Number 0910–0623—Extension)
Section 801(a) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 381(a)) provides requirements
with regard to imported food and
cosmetics and provides for refusal of
admission into the United States of
human food and cosmetics that appear
to be adulterated. Section 701(b) of the
FD&C Act (21 U.S.C. 371(b)) authorizes
the Secretaries of Treasury and Health
and Human Services to jointly prescribe
regulations for the efficient enforcement
of section 801 of the FD&C Act. To
address the potential risk of BSE in
human food and cosmetics, FDA
regulations in §§ 189.5 and 700.27 (21
CFR 189.5 and 700.27) designate certain
materials from cattle as ‘‘prohibited
cattle materials,’’ including specified
risk materials, the small intestine of
cattle not otherwise excluded from
being a prohibited cattle material,
material from nonambulatory disabled
cattle, and mechanically separated (MS)
(Beef). Under the regulations no human
food or cosmetic may be manufactured
from, processed with, or otherwise
contain prohibited cattle materials.
However, the Agency may designate a
country from which cattle materials
inspected and passed for human
consumption are not considered
prohibited cattle materials and their use
does not render a human food or
cosmetic adulterated.
Sections 189.5(e) and 700.27(e)
provide that a country seeking to be so
designated must send a written request
to the Director, Center for Food Safety
and Applied Nutrition (CFSAN). The
information the country is required to
submit includes information about a
country’s BSE case history, risk factors,
measures to prevent the introduction
and transmission of BSE, and other
information relevant to determining
whether specified risk materials, the
small intestine of cattle not otherwise
excluded from being a prohibited cattle
material, material from nonambulatory
disabled cattle, or MS (Beef) from the
country seeking designation should be
considered prohibited cattle materials.
FDA uses the information to determine
whether to grant a request for
designation, and whether to impose
conditions if a request is granted.
Sections 189.5 and 700.27 further
state that countries that have been
designated under §§ 189.5(e) and
700.27(e) will be subject to future
review by FDA to determine whether
designation remains appropriate. As
part of this process, FDA may ask
designated countries to confirm that
their BSE situation and the information
submitted by them in support of their
original application remain unchanged.
FDA may revoke a country’s designation
if FDA determines that it is no longer
appropriate. Therefore, designated
countries may respond to periodic
requests by FDA by submitting
information to confirm that their
designation remains appropriate. FDA
uses the information to ensure that their
designation remains appropriate.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Total annual
responses
Average burden
per response
Total hours
§§ 189.5 and 700.27— request for designation
§§ 189.5(e) and 700.27(e)—response to request for review by FDA ..............................
1
1
1
80
80
1
1
1
26
26
Total ..........................................................
............................
............................
............................
............................
106
srobinson on DSKHWCL6B1PROD with NOTICES
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA’s
experience and the average number of
requests for designation under §§ 189.5
and 700.27 received in the past 3 years.
FDA received one request for
designation in 2009 and one in 2010.
Based on this experience, FDA estimates
the annual number of new requests for
designation will be 1. FDA estimates
that preparing the information required
by §§ 189.5 and 700.27 and submitting
it to the Agency in the form of a written
request to the Director, CFSAN will
require a burden of approximately 80
hours per request. Thus, the annual
burden for new requests for designation
is estimated to be 80 hours, as shown in
table 1, row 1 of this document.
Under §§ 189.5(e) and 700.27(e),
designated countries are subject to
future review by FDA and may respond
to periodic requests by FDA by
submitting information to confirm that
their designation remains appropriate.
In the last 3 years, FDA has not
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16:58 Apr 14, 2011
Jkt 223001
requested any reviews. Thus, the
Agency estimates that one or fewer will
occur annually in the future. We
estimate that the designated country
undergoing a review in the future will
need one third the time it took
preparing its request for designation to
respond to FDA’s request for review, or
26 hours (80 hours x 0.33 = 26.4 hours,
rounded to 26). The annual burden for
reviews is estimated to be 26 hours, as
shown in table 1, row 2 of this
document. The total annual burden for
this information collection is estimated
to be 106 hours.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
HHS.
[FR Doc. 2011–9154 Filed 4–14–11; 8:45 am]
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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:
ACTION:
Food and Drug Administration,
Notice.
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
SUMMARY:
E:\FR\FM\15APN1.SGM
15APN1
srobinson on DSKHWCL6B1PROD with NOTICES
21380
Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
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 https://
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
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16:58 Apr 14, 2011
Jkt 223001
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
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Fmt 4703
Sfmt 4703
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
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Federal Register / Vol. 76, No. 73 / Friday, April 15, 2011 / Notices
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
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
(in hours) 2
Total hours
Cognitive Interview Recruitment ..........................................
Cognitive Interviews .............................................................
Consumer Panel Screener ..................................................
Grower Screener ..................................................................
Retailer Screener .................................................................
Pre-tests ...............................................................................
Experiment ...........................................................................
25
10
800
360
360
24
900
1
1
1
1
1
1
1
25
10
800
360
360
24
900
5/60
1
2/60
2/60
2/60
10/60
10/60
2
10
24
11
11
5
153
Total ..............................................................................
........................
........................
........................
........................
216
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
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 https://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
[Docket No. FDA–2009–E–0241]
21, 2011, the following correction is
made:
1. On page 15323, in the first column,
in the Docket No. heading, ‘‘[Docket No.
FDA–2010–E–0241]’’ is corrected to read
‘‘[Docket No. FDA–2009–E–0241]’’.
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ATRYN; Correction
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2011–9153 Filed 4–14–11; 8:45 am]
AGENCY:
Food and Drug Administration,
BILLING CODE 4160–01–P
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of March 21, 2011 (76 FR
15323). The document announced the
determination of the regulatory review
period for ATRYN. The document was
published with an incorrect docket
number. This document corrects that
error.
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
srobinson on DSKHWCL6B1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Planning
and Budget, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3208, Silver Spring,
MD 20993–0002, 301–796–9138.
SUPPLEMENTARY INFORMATION: In FR Doc.
2011–6509, appearing on page 15323, in
the Federal Register of Monday, March
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ACTION:
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
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]]>Agencies
[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21379-21381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9155]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 21380]]
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 https://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
[[Page 21381]]
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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Portion of study respondents responses per responses response (in Total hours
respondent hours) \2\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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 https://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
