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Statement of

Henry Giclas\
Vice President -- Strategic Planning, Science and Technology

Western Growers

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Subcommittee on Horticulture and Organic Agriculture\
Committee on Agriculture\
U.S. House of Representatives

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### July 30, 2008

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Good afternoon Chairman Cardoza and Members of the Subcommittee. I am
Hank Giclas, Vice President for Strategic Planning Science and
Technology at Western Growers. Western Growers is a trade association
representing growers, shippers and handlers of fresh fruits, nuts and
vegetables in California and Arizona. Our 3000 members produce
approximately half of the United States total production of fresh
fruits, nuts and vegetables and are committed to ensuring that these
products are delivered safely to consumers, here in the United States
and abroad.

Western Growers appreciates the opportunity to speak before you on the
salmonella outbreak and its consequences for our tomato growers. We also
want to highlight the status of ongoing efforts within the produce
industry to ensure safe food reaches the American table.

The industry has a decades-long history of implementing food safety
improvements to prevent both deliberate and unintentional contamination
of produce as it makes it way from the field to the retail store or
restaurant. We have a commercial interest in ensuring that only safe
wholesome fresh fruits, nuts and vegetables are delivered to our
customers' tables. As a result, industry is driven to constantly improve
and refine its own food safety programs and food safety defense
capabilities.

In addition, there are historical legal requirements, such as the
Perishable Agricultural Commodities Act and the Bioterrorism Act as well
as new governmental mandates and calls for industry action, for example,
the Produce Safety Action Plan and the more recent Food Protection Plan,
that have spurred industry improvements in the areas of prevention and
trace back; each integral parts of comprehensive food safety programs.
These efforts, conducted in cooperation and consultation with FDA, DHS,
USDA, state departments of health and agriculture and food safety
experts have resulted in greater awareness of potential vulnerabilities,
the creation of more effective prevention programs, and the ability to
respond more quickly to outbreaks of food borne illness.

Despite these ongoing and significant improvements in industry food
safety programs and practices, the U.S. Centers for Disease Control and
the Food and Drug Administration appear to maintain a "guilty until
proven innocent" approach to the regulation of select commodities that
has manifested itself recently in sweeping "consumer advisories" that
confuse consumers and wreak havoc in both domestic and export markets.
The result is significant losses at all levels of the supply chain with
no demonstrable positive impact on consumer food safety. It is very
likely that the public health impact has been just the opposite, as
confused consumers abandon fresh fruits and vegetables in their diet in
response to FDA and CDC alerts.

The June 2008 issuance of a consumer alert relating to red round, roma
and plum tomatoes has cost the California tomato industry an estimated
30 million dollars to date and has precluded industry from accessing
established avenues of recourse such as insurance programs to help with
recovery. In addition, the lack of an effective, timely "all clear"
message from public health authorities, a formalized restorative
campaign for the commodity, and the continuing implication of additional
commodities have eroded consumer confidence such that losses are likely
to increase. Keep in mind that these negative impacts are from growing
regions that have not been implicated at any time during this outbreak.
Nonetheless they have been painted with the same brush by CDC and FDA.

**Need for indemnity and improved regulatory processes**

First let me explain specifically why Western Growers asked for this
hearing. On June 3, 2008 - The Food and Drug Administration alerted
consumers in New Mexico and Texas that a salmonellosis outbreak appeared
to be linked to consumption of certain types of raw red tomatoes and
products containing raw red tomatoes and warned them not to eat certain
types of raw red tomatoes. The bacteria causing the illnesses are
*Salmonella* serotype Saintpaul, a relatively uncommon type of
*Salmonella.* Four days later on June 7, 2008 the Food and Drug
Administration expanded its warning to consumers nationwide that a
salmonellosis outbreak had been linked to consumption of **certain** raw
red plum, red Roma, and red round tomatoes, and products containing
these raw, red tomatoes and warned consumers not to eat these products
unless they could be effectively identified as being from one of several
states or countries that had been excluded as a potential source for the
suspect tomatoes.

This nuanced message was largely lost on consumers and to a certain
extent industry buyers who instead avoided purchasing all raw red, red
Roma and red plum tomatoes. As a result, growers on the okayed list
experienced severe restrictions in demand and depressed pricing.

One of our members, a Central California tomato grower, lost \$1.4
million in revenue due to lower market prices related to poor demand.
Other members including Central Valley and Central Coast tomato growers
have reported losses ranging from \$400,000 to \$1.5 million. And
suffering perhaps the greatest damage among our membership, another
Central California member has sustained losses of nearly \$3.4 million.
In addition to revenue losses in the market, several of our members have
had to disc up their tomato acreage because there are simply no buyers.

To date, our members have experienced nearly \$13 million in losses at
the farm gate related to the FDA advisory on tomatoes. It's important to
note that this \$13M figure reflects only early season losses. The
growing season for tomatoes in California doesn't peak until late July
and August. As indicated earlier, the losses are expected to increase.
It is also important to note that these numbers are calculated at the
grower level, and do not include economic losses sustained at other
points along the supply chain, including shippers, packers, processors,
and retailers and food service.

In addition, two consumer polls were conducted recently surveying
attitudes about food safety and the potential to avoid commodities that
have been implicated in recent media stories. The first was a Produce
Marketing Association survey, conducted June 13 to 19, which found that
while 88 percent of those surveyed indicated they were regular consumers
of fresh tomatoes, two-thirds of consumers had stopped purchasing
tomatoes. Remember, at this time only a few production areas in Florida
and Mexico had been implicated by FDA. But in the market, it didn't
matter that most of the country's tomatoes were deemed safe to eat. The
second survey, which has implications well beyond tomatoes, was an
Associated Press-Ipsos poll, conducted July 10 to 14, which found that
46 percent of people surveyed were worried they might get sick from
eating tainted products, such as tomatoes. In fact, these consumers have
changed their eating and buying habits over the past six months because
they are afraid they could get sick by eating contaminated food.

Grower losses and waning consumer confidence underlie our principal
rationale for being here today. We have stated publicly that these
sweeping generalizations and speculations in the public arena cannot go
unquestioned and that the protocol for making a decision to implicate an
entire commodity generically must become transparent to the public and
subjected to fair and balanced scrutiny. When FDA takes action to issue
a broad consumer warning it is for all intents and purposes an
international recall for that commodity, regardless of production area,
or variety. A recall that calls into question the offerings of all
producers, handlers, retailers and food service providers causes
immediate and long-term damage to the marketplace.

Western Growers asks that the impacted growers be made whole, and for
changes to be made in the way FDA and CDC investigate outbreaks and
communicate outbreaks to consumers. The FDA and CDC have an entire
industry army at the ready to assist with any food borne illness
outbreak, but we are left largely out of the process. We have a common
goal: safety of the food supply.

To advance this common goal it is imperative that both industry and
government work together. True reforms, improvements and enhanced
protection of both public health and industry cannot occur in a silo-ed
fashion or by pointing fingers of blame. We must talk openly and
candidly about the declaration of outbreaks, the management of
traceback, and the communication with industry and the public including
examining CDC criteria for connecting a food source to an outbreak (as
well as the criteria for clearing it), FDA operating procedures,
internal policies, experience in tracing product in the fresh produce
industry, and the desperate need for improved messaging to industry and
consumers.

We are here today, a full two months after the outbreak began, with no
definitive idea as to what food item(s) is (are) responsible for the
illnesses. FDA has speculated in calls with the media that the outbreak
"could be" attributed to tomatoes [or]{.underline} "foods commonly
served with tomatoes" "such as" jalapeno and serrano peppers, cilantro,
onions [or]{.underline} "foods where these are common ingredients" like
salsa, pico de gallo, guacamole. For every speculation there is a
negative marketplace reaction.

It borders on reckless for CDC and FDA to operate seemingly without
clear definitive criteria for when they can and cannot name or intimate
a commodity as a public health risk. We firmly believe that a structured
problem analysis must occur to quickly identify what is and is not
implicated by the epidemiology and that levels of confidence must be
established prior to impugning an entire commodity. While CDC and FDA
may conduct this analysis today, the analytical process has not been
effectively communicated to industry or others who could possibly review
and refine the approach. There must also be a specific timeframe
established to communicate at each stage of the analysis such that it is
clear at what stages information is released and or shared with all
parties. FDA has access to industry expertise that can help guide the
agency through the complexities of the produce supply chain quickly and
efficiently. It's imperative for FDA to establish an incident command
process---an outbreak team, if you will---that includes industry experts
and would be formally engaged from the very beginning to help the agency
in its investigations.

In protecting public health it is important to ensure FDA is able to
respond from a relevant position. World class manufacturing
organizations turn their inventories over 18 to 25 times a year. Produce
companies turn their inventories over 100s of times per year. In the
time it takes the system to identify an outbreak (up to two weeks)
growers may have turned their inventory over dozens of times. This lag
time coupled with the rapid movement of industry product puts FDA in an
"after the fact" or "reactionary" position. We must look at the entire
system with an eye towards reducing this lag in order to improve the
overall ability of all parties to respond.

**Industry Activity and Capability**

**Good Agricultural Practices (GAPs)**

The fresh produce industry has a long history of activity in the area of
food safety. Much of the activity has centered on the development and
dissemination of guidelines to prevent contamination from the field
throughout the supply chain to the consumer. This work has been and
continues to be critical to the first element of FDA's integrated
strategy to protect the food supply (as outlined in the Food Protection
Plan of 2007) which is to "prevent" contamination in the supply chain.

Western Growers has been integrally involved since our lead in the
development of the first ever "good agricultural practices" document in
the mid 90's. This landmark industry work laid the foundation for FDA
and USDA to develop and publish in 1998 the "Guide to Minimize Microbial
Food Safety Hazards for Fresh Fruits and Vegetables"" which today
remains the benchmark utilized by FDA and USDA in gauging the adequacy
of prevention programs employed by the fresh produce industry.

That benchmark, while effective for most fresh produce commodities, has
evolved significantly for select commodities that have been deemed a
higher risk because of their continuing association with key pathogens.
In the last few years, beginning as a response to the Produce Safety
Action Plan issued by FDA in 2004, industry has developed much more
specific guidance for several commodities that continue to be identified
by FDA as higher risk including tomatoes, leafy greens and cantaloupes.

These newer more specific sets of good agricultural practices have again
been widely disseminated and closely adhered to by producers of these
commodities. Adherence has typically been overseen by the marketplace in
the form of buyers who will not purchase from parties that have not been
rigorously audited to ensure they meet or exceed the benchmark.

Driven by more recent outbreaks, both the tomato and leafy greens
industries have moved beyond the commodity specific guidelines to more
prescriptive sets of best practices. In close collaboration with the FDA
CFSAN and CDC scientists and with other public health and academic
partners, newer specific guidelines were developed driving the adoption
of more rigorous best practices by the industry to reduce or mitigate
potential risks.

With regard to leafy greens in particular, California and Arizona have
established uniform GAPs and a corresponding verification program that
requires implementation of food safety measures developed with the FDA,
CDC, state health authorities and private sector experts. Compliance
with the requirements is verified by government inspectors.

As a result of these newer generation guidelines, risk assessment
procedures, sampling and analysis of inputs, safety response measures
and requirements for documentation can now be verified in the field.
These guidelines have become the foundation for formalized verification
programs in which government inspectors audit production and handling
practices for compliance. They are a food safety lynchpin, for helping
FDA and industry advance efforts to prevent contamination.

**Traceability**

While efforts to improve our abilities to prevent contamination have
long been the focal point of industry activity, it is also clearly
evident that efforts to "intervene" and "respond" in the event of food
borne illness or positive identification of a contaminated product are
critical to protecting public health as well as important to improving
food safety systems. One element of key importance is traceability. It
is critical that producers, handlers and others within the supply chain
be able to quickly and efficiently identify where product was sourced
and to whom it was delivered so as to limit the scope of any event.

In today's business environment, there are many requirements for record
keeping that facilitate tracing product from its point of service to its
origin. The legal requirements of the Perishable Agricultural
Commodities Act, the Bioterrorism Act and state standardization and
marketing laws all require documentation about the entity to whom the
product was sold, and from whom the product was received.

These documents can be maintained in a variety of formats but when
handlers are asked to identify from where they sourced product and to
where they shipped product they can readily provide that information
today. Current industry approaches employed by shippers and processors,
associate a product with a number that conveys information on harvest
date, harvest crew, field location and grower, in other words, traceback
to the field.

In the recent investigation of tomatoes we have been repeatedly told
that industry's traceback capabilities have made it difficult for
investigators to follow the trail from a point of service to a
production field but we have received no information on where this trace
back breaks down. Is it a function of some entity not maintaining
required records? Are the records in a format that cannot be utilized by
FDA? Is FDA actually getting back to the handler level before
traceability is lost? Western Growers is firmly committed to leading the
industry to improving our own and FDA's ability to intervene and respond
but we must understand the challenges faced by FDA in this arena.

During the current salmonella outbreak, we have asked repeatedly for
this information, first when the investigation was focused on tomatoes,
and now, as the investigation has shifted to jalapenos.

Please don't misunderstand our frustration. We are not saying that the
industry could not improve its timeline for traceback. In fact, we are
participating in such an initiative underway that will be based on a
common language and uniform data requirements. But we have no evidence
that delayed traceback is to blame for the ongoing outbreak.

**Conclusion**

The industry adopts measures constantly to improve the safety of our
produce for the protection of our consumers. But what about our
protection? To exclude the industry from investigative procedures
ignores knowledge and expertise that only industry can bring to bear to
help bring outbreak to swifter conclusion. Instead, our industry is left
in ruin. We cannot sit by any longer. We must be made whole, and a new,
more transparent, more participatory communications and investigative
process must emerge from the FDA and CDC.

**Henry L. (Hank) Giclas** has worked for Western Growers Association
for over 15 years. He began his career in the Phoenix office as the
Director of Public Affairs where he was responsible for implementing
WGA's government affairs and public relations agendas in Arizona. While
in that office Hank developed an expertise in ag chemical and
environmental issues and led the association in becoming more actively
engaged in the science and technical aspects of agriculture and
agricultural policy in California and Arizona. The Science and
Technology focus allowed WG to take on managerial responsibilities for
the Certified Crop Advisor programs in both California and Arizona, the
Arizona Crop Protection Association and has led to WG being a lead trade
association in many of the issues related to the production of specialty
crops in Arizona and California.

Hank served a brief stint as Vice-President of Science and Government
Affairs for WGA in their Sacramento office. There he oversaw the
activities of the division in both Arizona and California including the
legislative and regulatory advocacy programs, political action efforts,
technical and registration projects as well as the management of a
various local trade associations and other programs.

In July of 2002 he was asked by the WGA Board of Directors to return to
the Phoenix office and help the association start a new division that
would focus on the science and technological issues facing our industry.
That division now has oversight on food safety programs, pesticide and
chemical registration and policy issues, environmental programs
including water and air quality issues and a host of other issue areas
where sound science must drive agricultures involvement and government
policy. In August of 2003 Hank took on strategic planning for WG in
addition to the science and technology duties. Today Hank serves as Vice
President Strategic Planning, Science and Technology for Western Growers
and is actively developing association leadership in the areas of food
safety, food security, crop production and protection as well as
assisting in the implementation of the strategic plan.

Before coming to WGA Hank was a vocational agriculture instructor in
Phoenix Arizona. He received his B.S. in Agricultural Education from the
University of Arizona and is pursuing a M.S. in Agribusiness from
Arizona State University.