Famers MM GAPS comment-Western Growers 9-1-08

September 1, 2008
Division of Dockets Management (HFA–305),
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
[Docket No. FDA–2008–N–0354]

Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models
Study of Farmers’ Understanding and Implementation of Good Agricultural Practices

Western Growers is a trade association that represents growers and handlers of fresh fruits, nuts and vegetables
produced in California and Arizona. Our 3000 members grow and handle almost half of the United States total output
of fresh produce. As such, our organization and members are fundamentally interested in the development of
information that can be utilized to improve food safety in the fresh produce sector and are generally supportive of the
Agency’s efforts to develop “mental models” that will provide information on the “usability” of good agricultural
practices in fresh produce operations. Western Growers has been a vanguard in the development and extension of good
agricultural practices having been engaged for decades in writing, refinement and training associated with GAPs. We
have done this in close collaboration with the public health community as part of our commitment to work with them to
achieve the common goals of reducing food borne illness associated with fresh produce commodities. During this
decades long collaboration key questions that have consistently been raised by public health partners such as “What is
the depth and breadth voluntary GAPs implementation?” and “What barriers might exist that would prevent or provide
disincentive to implement good agricultural practices?” have gone largely unanswered. Western Growers believes that
the vast majority of our members employ strong food safety programs including good agricultural practices at the
production, harvest, packing and transportation levels and that the current marketplace makes it difficult for any firm to
introduce product into commerce that has not been produced utilizing strong gaps and audited as a means of verifying
to receivers that this is in fact the case. We hope that this information collection activity will assist in confirming this is
the case and we will collaborate with FDA in every way to help facilitate the proposed collection. In the event barriers
to implementation of GAPs are identified by models or through the collection of information we additionally will
support efforts to break down those barriers and encourage FDA to work directly with us and other produce trade
associations committed to improving industry performance.
While the preceding comments are general in nature, we offer the following input on the specific topics raised in the
federal register notice on this initiative:
(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;
Western Growers believes that the collection of this information will assist both FDA and industry in the development
of information on the breadth and depth of the use of voluntary good agricultural practices in the produce industry. The
information collected and resulting modeling may also provide information on the “usability” of GAPs including the
perceived effectiveness, efficiency and satisfaction on the part of users. This information in turn can be utilized to
develop strategies and tactics to assist in greater adoption of voluntary GAPs. The project will have practical utility if
there is any increased subscription or implementation of GAPs programs on the part of industry resulting from
information developed.
(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;
Western Growers perceives that the small scale nature of this project will not place any undue burden on individuals or
firms participating in information gathering. We are concerned however that the small sample sizes proposed will not
provide sufficient baseline information for model development or use by industry. Limited sampling will provide little
information to fill in knowledge gaps necessary to develop strategies for redress as proposed by FDA.

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
Recognizing that the small sample sizes being proposed will limit the utility of the data and hence the quality of any
associated model parameters and/or any qualitative assumptions Western Growers suggests that FDA collaborate with
industry organizations to further develop data that can be utilized. Direct coordination with Western Growers, for
example, could provide access to a large portion of the produce industry which in turn could be surveyed under FDA
supervision utilizing the proposed telephonic method as well as electronically using email and web-based formats
routinely utilized by the association to solicit feedback from members. The increased sample size would provide added
strength, utility and enhance the overall quality of data gathered. Because the data would be of value to the industry in
terms of analyzing the breadth and scope of education and extension efforts on GAPs these initiatives could be carried
out by industry under supervision of FDA investigators.
Western Growers anticipates that our membership and most produce operators affiliated with an organization like WG
are largely implementing GAPs under either a market based or regulatory structure. We are concerned however those
smaller operators and those in other areas of the country may not be as engaged in food safety related good agricultural
practice programs as operators in major produce shipping areas. These smaller entities and regions are now taking on
increased importance as buyers look to source closer to the point of service and to reduce transportation costs. This
study must sample a diverse set of growers and others to truly determine the breadth and depth of the national
implementation of voluntary good agricultural practices. Western Growers strongly recommends that the sample size
be increased and that key sub-sets be surveyed to ensure that there is definitive information on the wide diversity of
produce operations.
(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.
As mentioned above, collaborating with key trade associations across the country to develop and disseminate electronic
surveys utilizing email and/or web based technology could expand the scope of the survey and the sample size
dramatically without much cost to FDA. Industry collaborators who are interested in developing information on their
own members would likely willingly collaborate to facilitate contact with their members in exchange for access to data
points associated with their membership. Western Growers encourage FDA to expand the scope and sample size in this
fashion and would volunteer to work with FDA to develop mechanisms to develop data on WG members that would
prove useful to the Agency and the Association.
In summary, Western Growers supports the proposed project to collect information for mental models that will enhance
our understanding of the implementation of good agricultural practices in the fresh produce industry. We do not
perceive that this project would cause undue burden on the Agency or industry but we are concerned that the limited
scope of information being developed will not provide sufficient data to correctly characterize the industry or assist
with model development. WG suggests that FDA collaborate with industry to expand the scope of collection efforts
and volunteers to assist in any way feasible to improve the efforts and to achieve the desired outcomes.

Sincerely,

Hank Giclas, Vice President
Strategic Planning, Science and Technology
Western Growers
17620 Fitch Street
Irvine CA, 992614
949-885-2205 direct line
949-809-6205 fax
hgiclas@wga.com