**Comments on Docket Number O1D-0583**

**67 Federal Register 1224**

**United Fresh Fruit and Vegetable Association**

The United Fresh Fruit & Vegetable Association is pleased to provide
comments on the Food and Drug Administration's guidance documents and
specific questions contained in Docket Number O1D-0583 67 Federal
Register 1224. United is a national trade association representing
member growers, shippers, packers, processors, marketers and
distributors of fresh produce in the United States.

The terrorist attacks of September 11, 2001 have had a dramatic impact
on almost every aspect of American life. In addition to the devastating
human toll caused by the attacks themselves, the fear of future
terrorist incidents has undermined the individual sense of safety and
security that many Americans long have taken for granted. The financial
fallout also has been severe and has resulted in increased pressure on
the economy and risk to private enterprise from both real and imagined
threats.

The dramatic impact of these events has led to a new focus in public
policy aimed at promoting greater safety and security and preventing
terrorist action. As our members provide over 1,000 different fresh
fruits and vegetables to American consumers from both domestic growers
and around the world, we take seriously our responsibility for
prevention, detection, and all necessary actions to protect consumers
from intentional contamination of our products.

We commend the FDA for its leadership in working with the private
sector, including our industry, to ensure that appropriate steps are in
place to minimize the potential of terrorist action to contaminate
foods. The guidance documents published by FDA offer generally wise
advice to industry, and a clear sense of the scrutiny all food producers
and handlers must apply to our systems for food security.

However, we must continue to stress that industry and government efforts
can only reduce the risk of intentional contamination, not eliminate all
risk. In any risk management system, one reaches a point of diminishing
returns in reducing risk, versus increasing costs or taking steps
unacceptable to society at large. For example, grounding all commercial
aircraft after the 9-11 attacks virtually eliminated the risk that such
aircraft could be used as missiles in an attack. Yet, society has chosen
more appropriate risk mitigation steps such as careful passenger
screening and bolted cockpit doors.

In this regard, we comment first on FDA's two questions raised in the
Federal Register.

**[The Use of Tamper-Evident Packaging]{.underline}**

As an industry that markets highly perishable and living, breathing
products, tamper-evident packaging would not be feasible for the vast
majority of produce products available in the marketplace.
Tamper-evident packaging would also dramatically alter how consumers
select produce, which remains a sensory experience of touch and smell.
The fresh fruit and vegetable industry and the retail supermarket
industry have found that bulk fresh produce displays are an integral
component in helping consumers choose sufficient produce items to
fulfill 5 A Day health and nutrition goals.

Today, many produce items are being offered in convenience packaging,
such as salads in a bag or pre-cut small vegetables. Cut fruits are also
being offered in plastic cups or other molded packaging. For these
products, the packaging is intended for the consumer's convenience and
is uniquely designed to meet the quality control needs of the fruit or
vegetable it contains. The design of current packaging materials for
fresh fruits and vegetables allows for proper cooling, ventilation, and
product integrity, but cannot be considered tamper-evident packaging.
The unique shape, size and form in which fresh produce comes does not
lend itself to tamper evident packaging. More importantly fresh produce
is a living product with various respiration rates that would require
various types of packaging materials. Confining the respiratory gases
within the package can have a very negative impact upon produce quality.
More importantly it could also have a very negative affect on the
product safety. Current packaging technology does not afford any
enhancements that the product does not currently have in its natural
form.

For foodservice applications, such as salad bars in either restaurants
or grocery stores, tamper-evident packaging is clearly not feasible.
Fundamentally, as fresh fruits and vegetables are marketed directly to
consumers at retail and restaurant level, the industry and government
must recognize that requiring tamper-evident packaging would be
commensurate with grounding commercial aircraft. It would have
significant impact on the *fresh* produce business. Rather, the produce
industry and our retail partners will continue to increase our vigilance
and risk mitigation systems to prevent isolated tampering incidents at
retail level.

**[The Use of Procedures and Records for
Traceback-Traceforward]{.underline}**

With highly perishable products that move quickly through distribution
systems and are consumed quickly, the fresh produce industry believes
government's most important investment in either food safety or food
security is in *prevention*, not tracking records after the fact. Unlike
many processed food products, a certain lot of fresh produce is likely
gone from the food distribution pipeline before public health
authorities even learn of an illness to start a traceback investigation.

We believe current carton or bulk package labeling which contains the
name and address of the food marketer is effective in allowing
investigators to identify the sources of the product, and then look into
the general agricultural and handling *practices* of the grower-shipper
to further enhance *prevention* should systemic problems be identified.
In the potential case of intentional contamination occurring at the
producer level, if such tampering is not caught through the distribution
chain until a consumer is affected, such carton labeling could still
quickly identify the source of the product.

Some produce and retail companies are adopting various case or pallet
coding schemes to allow tracking of product movement for logistics
efficiency. However, such logistics systems are not intended to scan and
permanently record all data at every stage of a product's movement in
order to facilitate a computer search of records to identify the pathway
of the product some weeks later. These systems are designed for
warehousing, restocking and ordering efficiency, not food security.
Tracking and storing the huge volumes of information that FDA
contemplates would be a massive imposition of costs and operational
burden for industry, with little real benefit in food security or food
safety. We ask the agency to refocus its efforts on true risk mitigation
-- how can industry and government collectively prevent intentional acts
of terrorism that result in food contamination? That must be our supreme
goal.

**[General Guidance]{.underline}**

As for the general guidance documents, we applaud FDA's timely and
thoughtful advice to the broad food industry on these important issues.
We are encouraged that the agency has issued these documents as "Level
1" guidance, allowing flexibility for food industry operators to use a
"tool box" approach with recommendations that best fit their operations.
With the produce industry's diversity of products and complexity of
global production and distribution, flexibility is critical in that many
prescriptive recommendations would be inappropriate or not applicable to
our industry.

Because FDA has issued broad general guidance, rather than regulatory
prescription, our industry supports the intent of FDA to stimulate the
careful review and assessment of a wide range of security measures. This
is precisely the process our organization and our members have
undertaken and will continue. However, we have reservations about
certain provisions of these documents that are clearly not appropriate
for the produce industry, and that, regardless of intentions, could
become "de facto" regulation due to market and liability pressures.

Therefore, we want to include for the record some examples of where
specific comments are inappropriate for our industry. This is meant for
illustrative purposes, and is not comprehensive. Should FDA contemplate
proposing new regulations in this regard, United would want the
opportunity to comment specifically on the entire slate of
recommendations in much more detail.

Specific recommendations that illustrate this point include:

1\. Management of food security

-   Supervision: Suggesting that daily security checks of the premises
    be conducted is too prescriptive, particularly in primary production
    environments. Firms should determine the frequency of security
    checks that best suits their own individual needs.

-   Mail/packages: It is not relevant for all segments of the produce
    industry to visually inspect or x-ray all incoming mail and
    packages.

2\. Physical facility

-   Due to the growing and packing environments, it is inappropriate to
    suggest that perimeter fencing and metal-clad doors be viable
    options for securing primary production areas found in the fruit and
    vegetable industry. Access can be controlled without these specific
    measures.

3\. Employees

-   Pre-hiring screening: While verifying work references, addresses,
    and phone numbers of new employees are effective screening measures,
    performing criminal background checks and verifying immigration
    status beyond that called for in current law could be an enormous
    cost with little benefit. The produce industry relies heavily on
    seasonal, temporary, and contract labor and these measures could
    negatively impact the supply and cost of fresh fruits and
    vegetables. In addition, many state and local worker privacy laws
    prohibit such checks.

4\. Raw materials and packaging

-   It is inappropriate to suggest that suppliers, transporters,
    warehouses, and vehicles be *audited* to ensure implementation of
    food security measures, as there are no government guidelines for
    such measures and thus no system that address audit standards. In
    the case of Good Agricultural Practices, our industry has worked
    closely with FDA to implement, educate and audit to a specific set
    of practices. The more appropriate advice in food security is that
    business partners address mutual interests in food security measures
    with their customers and suppliers.

5\. Finished products

-   Requesting vehicles, containers, and/or railcars be locked and
    sealed throughout distribution may appear initially to be sound
    advice for most manufactured goods. However, due to the
    perishability of fresh produce and the complexity of the produce
    distribution chain, this request would present significant
    challenges to the marketability of fresh fruits and vegetables. For
    example, a sealed refrigerated truck must still allow air
    circulation into the interior load for cooling, thus negating the
    perceived benefit of the door seal.

6\. Operations

-   Security of water: "To the extent possible" should be applied to the
    section concerning the security of water sources as well as the air
    circulation systems. Due to the scarcity of water supplies in many
    primary production areas across the U.S. and abroad, the security
    and access of water sources may be out of the control of many
    producers.

The produce industry is committed to ensuring the security of its
products. The industry is proud of the contribution it makes to the
health of Americans by providing wholesome foods essential for good
health. It is important to always consider that increasing the
consumption of fresh fruits and vegetables is a critical component of
public health, and that risk management steps are properly weighed with
the public health impact on the cost and availability of fresh produce.

The produce industry strongly supports guidance based on sound
scientific results that can help the industry enhance the safety and
security of produce, enhance consumer confidence, and increase the
consumption of fresh fruits and vegetables.

Since September, United Fresh Fruit & Vegetable Association and its
members have been actively assisting the FDA in better understanding the
production, packing, processing and distribution of fresh produce and
potential supply chain vulnerabilities. United formed its own Food
Security Task Force in September to address food security issues from
farm to table and continues to address produce-specific issues for our
industry. In the coming months, we also will be joining with the Food
Marketing Institute in a new Food Industry Information Sharing and
Analysis Center (ISAC) to work with the FBI and other government
agencies. The new ISAC will provide information and analysis that will
enable the food industry to report, identify and reduce its
vulnerabilities to malicious attack, and to recover from any attacks as
quickly as possible.

Thank you for the opportunity to comment. We look forward to continuing
to work together with the FDA on these important matters.