Document ID: FDA-2008-N-0354-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-03-24T04:00Z

[Federal Register: March 24, 2009 (Volume 74, Number 55)]
[Notices]               
[Page 12364-12365]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr09-74]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0354]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Mental Models Study 
of Farmers' Understanding and Implementation of Good Agricultural 
Practices

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 April 
23, 2009.

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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title, ``Mental Models Study of Farmers' Understanding and 
Implementation of Good Agricultural Practices.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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.

Mental Models Study of Farmers' Understanding and Implementation of 
Good Agricultural Practices

    The proposed information collection will help FDA protect the 
public from foodborne illness by increasing the agency's understanding 
of how farmers and growers use Good Agricultural Practices (GAPs) to 
address common risk factors in their operations and thereby minimize 
food safety hazards potentially associated with fresh produce. Fresh 
fruits and vegetables are those that are likely to be sold to consumers 
in an unprocessed or minimally processed (i.e., raw) form and that are 
reasonably likely to be consumed raw. Under section 903(b)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393 (b)(2)), FDA is 
authorized to conduct research relating to foods and to conduct 
educational and public information programs relating to the safety of 
the Nation's food supply. Under Title 42 of the Public Health Service 
Act (1944), FDA has authority to act to protect the public health.
    In 1998, FDA issued a guidance document entitled ``Guide to 
Minimize

[[Page 12365]]

Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' 
available at http://www.cfsan.fda.gov/~dms/prodguid.html. The guidance 
addresses microbial food safety hazards and good agricultural and good 
management practices common to the growing, harvesting, washing, 
sorting, packing, and transporting of most fruits and vegetables sold 
to consumers in an unprocessed or minimally processed (raw) form.
    There is evidence that growers have not fully implemented the GAPs 
to reduce production risks, despite intensive GAPS training programs. 
FDA is planning to conduct a study to determine growers' decision-
making processes with regard to understanding and implementing GAPs on 
the farm, to more fully understand the barriers and constraints 
associated with GAPs implementation.
    The project will use ``mental modeling,'' a qualitative research 
method wherein the decision-making processes of a group of respondents 
(described below) concerning the implementation of GAPs on the farm are 
modeled and compared to a model based on expert knowledge and 
experience in the implementation of GAPs. The information will be 
collected via a telephone interview concerning the factors that 
influence the perceptions and motivations related to the implementation 
of GAPs. A comparison between expert and consumer models based on the 
collected information may identify ``consequential knowledge gaps'' 
that can be redressed through information campaigns designed by FDA.

Description of respondents:

    Respondents will be farmers or growers, GAPs trainers, and retail 
buyer and/or grower association representatives.
    In the Federal Register of July 1, 2008 (73 FR 37464), FDA 
published a 60-day notice requesting public comment on the proposed 
information collection. FDA received one letter in response to the 
notice, containing one or more comments. One comment recommended that 
FDA increase the sample size and ensure that key subsets of the produce 
industry are surveyed. FDA responds that the proposed study is 
qualitative in nature. FDA does not intend the results of this study to 
be a quantitative estimate of the prevalence of the use of GAPs across 
the produce industry. The proposed sample size is sufficient to enable 
FDA to construct mental models of the barriers and constraints related 
to GAPs implementation. FDA agrees with the recommendation to ensure 
key subsets of the industry are included in the study.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR Section               No. of      Frequency  per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Screener                                      80               1              80            0.02               2
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Pre-tests/ Cognitive Interviews                9               1               9             .75            6.75
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Farmers/ Growers                              24               1              24             .75              18
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GAPs Trainers                                 24               1              24             .75              18
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Retail Buyers/ Growers                        12               1              12             .75               9
 Association Representatives
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Total                             ..............  ..............  ..............  ..............           53.75
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the 60-day notice published on July 1, 2008, FDA estimated the 
total burden hours to be 51.75. FDA has made changes to its burden 
estimate, reflected in table 1 of this document. FDA added a screener 
and listed the participants separately in the table. The new total 
burden hours are estimated to be 53.75 and are described in the 
following paragraphs.
    Approximately 80 respondents will be screened. We estimate that it 
will take a respondent 1.2 minutes (0.02 hours) to complete the 
screening questions, for a total of 1.6 hours (rounded to 2). FDA will 
conduct 9 pretests; we estimate that it will take respondents 45 
minutes (0.75 hours) to complete the pretest, for a total of 6.75 
hours. Sixty respondents will complete the interview. We estimate that 
it will take respondents 45 minutes (0.75 hours) to complete the entire 
interview, for a total of 45 hours. Thus, the total estimated burden is 
53.75 hours. FDA's burden estimate is based on prior experience with 
mental models research that is similar to this proposed study.
    The study will involve approximately 60 respondents, including 24 
farmers or growers of fruits and vegetables, 24 GAPs trainers, and 12 
retail buyer or grower association representatives. FDA estimates that 
each respondent will take 45 minutes (0.75 hours) to complete the 
interview for the study (60 respondents x 0.75 hours = 45 hours).
    Thus, the total annual burden for this one-time collection of 
information is 53.75 hours (2 hours + 6.75 hours + 45 hours = 53.75 
hours). These estimates are based on FDA's experience with consumer 
research.

    Dated: March 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6393 Filed 3-23-09; 8:45 am]

BILLING CODE 4160-01-S