0520-commentC2

U.S. Global Trade Services
3650 Hacks Cross Road
Building E, 3rd Floor
Memphis, TN 38125-7433

Telephone 901.434 .4262
Fax 901 .434.4099

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Express

July 31, 2006
Submitted via: http://www.fda.Qov/dockets/cotnments
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD, 20852
RE:

Docket No. 2006N-0202, 71 FR 30940, May 31, 2006,
Notice for comments on Requirements for Prior Notice for Imported Food

Dear Sirs/Madams :
These comments are submitted by Fedex Express ("FedEx") in response to the FDA
Federal Register notice requesting additional comments on the requirement for Prior
Notice of food imported into the United States . FedEx handles regular shipments
containing food items subject to the Prior Notice requirements, and we have worked
closely with the Food and Drug Administration (FDA) since the inception of the Prior
Notice (PN) rules. FedEx supports the intent of improved security and safety for
America, and we appreciate the opportunity to submit additional comments to the FDA.
FedEx continues to believe that implementation of the PN regulations will require
extended time due to the need to reach and educate the huge number of global vendors
affected by these rules, and to secure required changes in the documentation procedures
and business practices by all members of the global food industry . FedEx commends the
FDA for their judicious use of enforcement discretion while PN is implemented; we
believe it is totally appropriate for implementation of a regulatory change that is so broad
in scope. Clearly, the number of shippers aware of the requirement for PN continues to
increase, and many shippers have begun to incorporate it into their shipping procedures .
However, we also believe there are several sections of the collective PN regulations that
can be improved, without compromise to the safety and security of the United States, as
follows:
I.

FDA Prior Notice System Interface (PNSI) :
a. PNSI is available only in English. PNSI should be made available in other
languages to enable easier global access and improved compliance by
shippers, many of who are not fully conversant in English.

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II.

b. PNSI requires internet access . Internet penetration is 65-70% in the
leading countries, and only 10-20% in developing countries. A regular
alternative must be developed for shippers in countries and regions where
internet access is limited or unavailable .
c . PNSI is not practical for high volume shippers . PNSI requires lengthy
sessions to submit the large volume of required data, rendering it
cumbersome or impractical for high volume users. FDA should develop an
alternative for high volume shippers, i.e. a method to allow "batched" or
consolidated submission for multiple shipments, rather than per-shipment
as presently required. A practical alternative for high volume shippers will
increase the likelihood of timely PN, as the shipper can submit PN earlier
via PNSI than a U.S . broker can by utilizing the CBP Automated Broker
Interface (ABI) process.
PN should be integrated with the Customs and Border Protection (CBP)
Advance Cargo Information (ACI) Program :
PN as currently defined requires far more information than is required by the
Bioterrorism Act of 2002, and far more information than is necessary to
protect the nation's food supply . PN in its current form is a cumbersome
"agency-specific" declaration, and creates an unnecessary additional industry
burden of time and expense to the shipping process. The May 31 Federal
Notice contains an FDA admission that " . . .much of the information collected
for PN is identical the information collected for FDA's importer's entry
notice . . .". In addition, the data elements required by the Bioterrorism Act are
included in the ACI data submitted to CBP . FDA could easily work with CBP
and the importing community to align the PN program with the CBP ACI
program so that PN data required by the Bioterrorism Act could be culled
from ACI and delivered to FDA as necessary for separate PN analysis and risk
assessment .
This point raises an important question : is it necessary for the PN data to be
analyzed and evaluated separately by FDA, or can the pre-arrival security
analysis be integrated into the CBP analysis of the ACI data? Understanding
that FDA works closely with CBP in the analysis and evaluation of pre-arrival
data for determination of risk, it seems reasonable that evaluation could be
incorporated into the CBP ACI automated process, thereby eliminating the
need for separate data submission to FDA, and eliminating the need for
continued support of a separate FDA automated system. This would reduce
costs for administration of the PN program; and potentially speed the process
for review and analysis of all affected shipments. FedEx urges FDA to review
and evaluate this recommendation closely.

III.

Clarification of definition in the Interim Final Rule :
Country from which the article is shipped (1 .276(b)(3)) : The definition in the
interim rule states this means ". . .the country in which the article of food is
loaded onto the conveyance that brings it to the United States . . .". This
definition fails to consider the normal and regular intermodal handling of

shipments by multiple modes of transportation, under which a shipment that
actually originates in one country is commonly moved by one mode, e.g.
truck, to another country, where it is loaded to another mode of transport, e.g.
air, for movement to the United States . Thus, a more accurate term would be
"exporting country" as currently used and defined by Customs and Border
Protection . CBP defines "exporting country" as "that country from which the
merchandise was shipped to the United States having last been a part of the
commerce of the country and without contingency of diversion." FedEx
recommends that FDA adopt the term and definition of "exporting country" to
replace the current term "country from which the article is shipped" .
IV.

Exemptions :
FedEx recommends that the final rule for Prior Notice include exemptions for
the following situations :
a. Low value shipments, commercial or non-commercial : FedEx
recommends that shipments valued not over USD200 be exempted from
the requirements for Prior Notice .
b. Non-commercial (personal use) shipments: FedEx recommends that FDA
fully exempt all non-commercial food shipments from Prior Notice. Noncommercial shipments would include manufactured and/or purchased food
items for the personal use and consumption by an individual purchaser or
consignee.
c. Shipments transiting the U.S . to a non-U.S. destination : all suck shipments
should be fully exempted from PN, whether or not the shipment is
exported directly from the port of arrival. The double standard now
utilized for transiting shipments creates confusion on the part of foreign
shippers and causes confusion for carrier operations in the U.S . Further,
and perhaps more importantly, this requirement creates additional security
risk through forced revealing of a carrier's routing through the U.S ., which
the Transportation Safety Administration (TSA) has advised is undesirable
from a security perspective. That is, TSA recommends that air carriers do
not disclose details of their flight routings to minimize risk of hazardous,
undeclared items on those flights. Therefore, in order to ensure maximized
security, a foreign shipper sending a food item to a non-U.S. destination
should not be concerned with having to determine if the shipment will
transfer multiple U.S . ports; the shipper should have no concern at all over
U.S . transit. PN requirements for some transit shipments and not others is
unpractical and burdensome for a foreign shipper who is likely unfamiliar
and inexperienced with making declarations to U.S. regulatory agencies .
d. Food that is not for human or animal consumption: The FDA Compliance
Policy Guide (November 2005) describes certain situations under which
FDA and CBP would "typically consider not taking any regulatory
action", one situation of which is food for testing and not for consumption .
FedEx recommends that food items imported for testing and analysis and
not intended for human or animal consumption should be fully exempted
from Prior Notice . Some restrictions would be reasonable, e.g. a weight

and value limit, statement on the shipper documents, and labeling on the
items.
V.
Estimated Annual Reporting Burden:
The information provided in this Federal Register notice regarding the number and
costs of PN submitted by FDA's Prior Notice System Interface (PNST) and Customs
and Border Protection's Automated Broker System (ABI) is interesting and revealing.
The data shows that PNSI has more than 30 times the number of users than ABI
(214,400 vs . 6500), and an average length of time for PN submission that is more
than double that for ABI (23 minutes vs . 10 minutes) . These numbers represent the
difference between PNSI use by foreign shippers and ABI use by U.S . Customs
Brokers and entry filers, and demonstrate the slower performance of PNSI .
If PNSI performance were improved to capture half of the 13 minutes difference
between PNSI and ABI, the 214,400 PNSI users would reduce the time spent on PN
submission by 192,781 hours (214,400 shippers x 8.3 per shipper annually x 6 .5
minutes = 11,566,880 minutes, or 192,781 hours) .
FDA admits that much of the PN data is "identical" to the importer's entry notice, and
the "burden hour" tabulation for PN submitted by ABI should therefore be reduced to
avoid double counting, as the data is simultaneously captured for PN and the import
declaration. However, no details are stated regarding the adjustment in the burden
hour analysis . We are therefore unable to determine the accuracy of this theoretical
adjustment .
FedEx would like to reiterate our support to the FDA for the implementation of the
various aspects of the Bioterrorism Act, and we applaud the FDA efforts to implement
the regulations with prudence and discretion so that this industry is not unduly disrupted.
We appreciate the opportunity to submit these additional comments .
Sincerely,

Robby eau, Managing Director
Global Trade Services
FedEx Express
3650 Hacks Cross Road
Building E, Third Floor
Memphis, TN, 38125