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U.S. Department of Health and Human Services

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Report on Growers' Understanding and Implementation of FDA's GAPS Guidance

Mental Models Research Report

FINAL REPORT

June 2010

 

Full Report available in PDF (252KB).

 

Prepared for FDA:

Linda Verrill, Ph.D., Project Officer

 

By Decision Partners:

Sara Eggers, Ph.D., Steve Ackerlund, Sarah Thorne and Gordon Butte

 

Executive Summary

Introduction, Background and Method

Decision Partners was asked to conduct research that will support FDA in improving its communications related to the 1998 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables1 (updated in 20082 and hereafter referred to as the FDA GAPs Guide, or Guidance, or the Guide). The goals of this research were to: 1) gain an understanding of Growers’ awareness and knowledge of, and attitude toward, “good agricultural practices (GAPs)” in general and the FDA Guide in particular; 2) understand whether, how, and why growers are currently implementing GAPs using the FDA GAPs Guide; and 3) identify opportunities to facilitate Growers’ adoption of the FDA GAPs Guide.

The researchers conducted confidential, in-depth telephone interviews with: 22 Growers: individuals who serve in a management capacity on farms where tomatoes (Florida) or leafy greens (primarily California and Arizona) are grown, with annual revenues over $250,000 and distribution in multiple states; 19 Trainers and Auditors: individuals who provide training on food safety and to produce growers, packers or handlers, or who are actively engaged in auditing farm food safety practices; and 4 Buyers: individuals who serve in a management capacity for organizations that purchase produce from growers. Data analysis consisted of content analysis of the interviews and assigning codes (according to an expert model developed in advance of the analysis) to discrete segments of the transcribed interviews. Coded segments of each interview were then combined into a database and analyzed to: assess key themes corresponding to the codes in the expert model, explore relationships among themes and to identify other emerging themes not anticipated in the expert model. See Appendix A for background on the methodology.

The researchers experienced significant recruitment challenges, specifically, getting people to agree to, or follow through with, the telephone interview. Given the geographic sample frame (Growers in Florida and California), as well as the volume of non-response, the sample of Growers interviewed may not be representative of produce growers across the nation. The sample is mainly comprised of Growers who already have established GAPs programs on their farms and who may be more supportive of GAPs, GAPs standardization, and GAPs regulation than their non-participating counterparts.

This project was built upon similar research conducted with small-, medium- and large-scale produce growers in 2007– 2008.3 Relevant findings from that study are also included in this Report.

 

Results

Awareness and Understanding of the FDA GAPs Guide

This research identified substantial differences among Growers in terms of awareness and knowledge of the FDA GAPs Guide. Most of the Growers interviewed for this study were familiar with and apply some kind of GAPs, but not necessarily those of the FDA GAPs Guide. Some Growers confused FDA’s authorship of the Guide with that of USDA, and a few said they were unfamiliar with it. Growers were generally aware that the federal government (FDA and/or USDA) are promoting GAPs; however, they believed that the key drivers of GAPs development and adoption are large-scale produce buyers, state governments and industry associations, all of whom tend to have their own GAPs standards and guidelines.

When Growers were asked to identify their primary source of information related to GAPs, none spontaneously mentioned FDA or the Guide. Growers said that they prefer to seek information and support on GAPs adoption through agricultural extension agents and university experts (primarily for Florida Tomato Growers), private auditors and consultants, professional or trade associations, and/or commodity groups. Results from the Trainers and Auditors interviews, as well as from previous research, suggest that smaller growers: a) have less familiarity with formalized GAPs; b) are generally less proactive in seeking information on GAPs; and c) rely heavily on the agricultural extension agencies for information on food safety.

Trainers and Auditors had a detailed understanding and appreciation of the FDA GAPs Guide. However, they said that they generally rely on and communicate GAPs information from other sources (Cornell University, for example), preferring a format that they feel is more accessible and relevant to growers. Trainers and Auditors believed FDA’s role is to focus on scientifically-supported GAPs development; their own role is to find ways to effectively communicate that information to growers and support growers’ adoption of GAPs.

Buyers generally had detailed understanding of the FDA GAPs Guide. However, they believed that FDA’s Guidance lacks specificity, accessibility and relevance to farming operations and broad stakeholder buy-in that they felt was necessary to make GAPs adoption practical, relevant and aligned with their own food safety needs. Buyers cited other programs, such as the California Leafy Greens Marketing Agreement (LGMA), as an appropriate model for future development of produce-specific guidance because it is a broadly accepted GAPs program.

Interviewees in all cohorts commented that they would like FDA to conduct further research that will lead to more produce-specific and scientifically-supported GAPs. While they viewed FDA Guidance as providing a technically sound basis for GAPs, they believed that universities, extension offices, and private companies have the long-standing, in-depth relationships with growers that are needed to motivate, communicate and support growers in their GAPs adoption.

 

Attitudes Regarding Food Safety and Risk Prevention

This research suggests that Growers’ current food safety goals and activities are driven primarily by customer expectations and buyer requirements and, to a lesser degree, by regulations, concern for legal or financial liability resulting from a contamination event, and moral obligation to protect people’s health. The research, however, also suggests that the food industry (including growers and buyers) is interested in promoting a broader and more integrated “food safety culture,” by encouraging more proactive food safety attitudes and behavior among growers.

Large-scale Growers recognized the value of adopting GAPs programs (generally and not specifically the FDA’s GAPs Guidance). However, they believed that certain GAPs and related audits are onerous and/or unproductive, and they did not always see the value of GAPs in terms of real risk reduction on the farm. They were frustrated by the inconsistency in the GAPs Guidance and other standards across government and industry. They believed these guidelines should extend to other players in the food system, including retailers and suppliers. They would likemore uniform and specific standards of performance than what the current guidelines contain, and specifics on how GAPs should be implemented.

The research suggests that smaller-scale Growers may not see the value in adopting GAPs, largely because they do not see the public health need to change “what they’ve always been doing.”

 

Opportunities to Facilitate Adoption of GAPs

Most of the Growers interviewed in this study were motivated to implement GAPs in order to meet customers’ expectations and to protect their own financial interests. For these Growers, the transition to GAPs as a legal requirement appears to be largely achievable and even welcomed because they want all Growers to share in the costs of providing safe food and because an outbreak caused by one grower affects the entire industry.

However, results of this research and previous research suggest that a regulatory requirement to implement GAPs will present a real or perceived financial challenge for smaller-scale Growers. Trainers indicated that growers struggle in the early stages of GAPs awareness and implementation. They believed that growers on farms without formalized GAPs programs need training to help them recognize the need for GAPs programs and to become more knowledgeable about specific GAPs practices. Once they understand what they need to do, they believed the growers will need support in developing and initially implementing GAPs programs specific to their farms. The research suggests that once implemented, GAPs programs can become accepted and embraced on the farm.

Over the course of the interviews, Growers, Trainers and Auditors, and Buyers, suggested a number of potential opportunities for FDA to help implement the adoption of the FDA GAPs Guidance. These opportunities included:

    • Clarifying FDA’s role and responsibilities in promoting food safety, including its relationship with other regulatory partners at the federal (e.g., USDA) and state level.
    • Continue to better understand and recognize the complexity of the produce industry, and the “food safety system” more broadly when developing and communicating GAPs. Coordinate with stakeholders in the development of GAPs policies, standards and communications.
    • Facilitate stakeholder dialogue to clarify stakeholder roles and responsibilities, as well as their priorities and objectives for food safety. Promote the design and adoption of common food safety standards across the industry.
    • Facilitate scientific research needed to advance GAPs development and implementation across the industry, with an emphasis on developing produce-specific, simple standards that growers can understand and implement.
    • Partner with and support trainers, auditors and others in the industry to better support growers. Use existing communication networks and channels to support GAPs adoptions.
    • Promote the value of the FDA GAPs Guidance to consumers, emphasizing the value of food grown by growers adopting GAPs.
    • Gain further insight into other key stakeholders’ decision-making processes and information needs. Other stakeholders may include small growers, large growers in states without established GAP programs; suppliers of goods and services to growers; packers and handlers; and consumers.

 


1 See http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
ProduceandPlanProducts/ucm064574.htm

2 See http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
ProduceandPlanProducts/ucm064458.htm

3 That research supported a U.S. Department of Agriculture (USDA) National Integrated Food Safety Initiative special emphasis grant on microbial risks to fresh and fresh-cut produce. For more information, contact Sarah Thorne (sthorne@decisionpartners.com).