![](media/image1.png){width="3.1131944444444444in"
height="1.0347222222222223in"}6309 Beachway Drive

Falls Church, Virginia 22044

703.998.7121

703.998.7123 (f)

www.expressassociation.org

**Comments of the Express Delivery & Logistics Association**

**On FDA's Comprehensive Food Protection Plan**

**Docket No. FDA-2008-N-0188**

**Submitted to FDA July 30, 2008**

These comments are submitted by the Express Delivery & Logistics
Association (XLA) in response to the notice published by the Food and
Drug Administration (FDA) in the *Federal Register* of April 2, 2008,
soliciting comments on its Food Protection Plan ("the Plan") (73 Fed.
Reg. 17987). XLA is the trade association representing the express
delivery services industry; our members include large firms with global
delivery networks, such as DHL, FedEx, Purolator, TNT and UPS, as well
as smaller businesses with strong regional delivery networks, such as
International Bonded Couriers and Midnite Express. Together, our members
employ approximately 700,000 American workers. Worldwide, XLA members
have operations in over 200 countries and territories; move more than 20
million packages each day; employ more than 1 million people; operate
1,200 aircraft; and earn revenues in excess of \$80 billion annually.

The Plan, published in November, 2007, has three core elements
consistent with the overall approach of the Inter-agency Working Group
on Import Safety: prevention, intervention and response. XLA believes
this is a sound conceptual framework, and shares FDA's desire to ensure
the safety of the U.S. food supply. XLA also believes that it is
important to pursue this mission in a manner that is minimally
disruptive to the flow of commerce. We commend FDA for reaching out to
stakeholders for input on the Plan and, as detailed below, have several
general and specific comments on it.

***General comments***

Whenever possible, FDA should utilize existing statutory or regulatory
authority, rather than seeking new mandates. In particular, when
conducting its prevention, intervention and response activities, FDA
should look first to existing data already provided by carriers and
importers to U.S. government agencies such as U.S. Customs and Border
Protection (CBP). Rather than requiring duplicative or new data, which
would place a significant burden on the trade, FDA should first evaluate
these data elements. Regarding submission of any data, it will be
especially important for FDA to participate fully in the ongoing
development of the International Trade Data System (ITDS), intended to
be the single window for U.S. import data, and to coordinate data
submission timelines with existing trade practices. Through careful
review of existing data, e.g. Prior Notice, facility registration,
OASIS, etc., FDA may determine that it is sufficient to support
prevention and pre-arrival risk assessment, even if the timing of data
submission may change. This will minimize disruption to the food supply
chain.

XLA believes that new agreements with origin countries resulting in the
development and maintenance of quality standards that meet U.S.
standards, and placement of FDA personnel in origin countries, would
provide the greatest enhancement to current safety practices. This would
help reduce the need for selection and examination of product upon its
arrival in the United States, thereby speeding the supply chain and
reducing costs to importers and consumers. It would also allow data
collection and targeting to serve as a second line of defense in FDA's
screening process. Inspection and testing should be a third (and even
less frequently used) layer of safety, in line with modern risk
assessment practices. In conducting any examination or sampling, it is
critical that FDA utilize technologies that deliver results in minutes,
rather than hours or days, in order to meet the narrow timelines of
today's expedited supply chains. This is an especially critical matter
for express consignment operators, who function with the narrowest
timelines of any mode of carriage.

Finally, in seeking any new legislation or developing any new
regulations to address food safety, FDA should work in conjunction with
the trade, by soliciting industry's input prior to the drafting of any
new measures.

***Specific issues***

The Plan is quite general in nature. It would be helpful for FDA to
articulate specific actions and the timelines for their implementation.

The plan embraces a risk management approach to food protection, and XLA
commends FDA for doing so. However, it is unclear from the Plan what
constitutes "high risk" and what the primary risk factors for food are.
It would be helpful for FDA to provide details in this regard.
Furthermore, in establishing risk, FDA should consider supply chain
members' participation in the Customs-Trade Partnership Against
Terrorism (C-TPAT) and other relevant programs as significant risk
reduction factors. Participating companies have invested significant
resources to meet the standards of programs such as C-TPAT, which have
been established by the U.S. government to enhance supply chain
security, and FDA should take this into account when evaluating risk.

On a related issue, the Plan indicates that electronic import
certificates may be required for "high risk products". Again, high risk
should be defined. Furthermore, FDA should specify that any such
certifications be submitted through ITDS and coordinated with existing
practices for import declarations. FDA should also explain how
electronic certifications would relate to prior notice requirements,
OASIS, and entry/release procedures by CBP.

Finally, the Plan mentions a "unique identifier" that would "more
accurately identify firms" and "eliminate duplicate records".
Consideration of such a concept should be reviewed carefully with CBP in
order to prevent different numbering schemes for different regulatory
agencies. CBP has an existing scheme for importer numbers, and FDA
already requires registration data for certain food production firms. If
FDA develops another numbering scheme, it should do so carefully and in
a manner that is not burdensome to the trade.

***Conclusion***

XLA appreciates the opportunity to comment on FDA's Food Protection Plan
and looks forward to working with FDA as it refines its approach to
ensuring the safety and security of the U.S. food supply chain. Please
feel free to contact us for any additional information that may be
helpful in this regard.