E9-6393. 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.

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: [phone], or e-mailed to [e-mail]. 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 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 Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Screener	80	1	80	0.02	2
Pre-tests/ Cognitive Interviews	9	1	9	.75	6.75
Farmers/ Growers	24	1	24	.75	18
GAPs Trainers	24	1	24	.75	18
Retail Buyers/ Growers Association Representatives	12	1	12	.75	9
Total					53.75
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.