April 4, 2003

Food and Drug Administration

Dockets Management Branch (HFA -- 305)

5630 Fishers Lane

Room 1061

Rockville, M.D. 20852

> **Re: Comments on Proposed Notices of Rulemaking:**
>
> **[Docket Numbers 02N-0276 and 02N--0278]{.underline}**

Dear Sirs:

The following is submitted by the NCBFAA and on behalf of the
organizations set forth in the enclosure hereto, in connection with the
Notices of Proposed Rulemaking, ("NPRM") published in the Federal
Register of February 3, 2003, (68 F.R. 5378) relating to proposed
amendments to 21 C.F.R. Part 1, implementing the relevant provisions of
the P.L. 107-188, the "Public Health Security and Bioterrorism
Preparedness and Response Act of 2002" (hereinafter referred to as the
"Bioterrorism Act" or the "Act").

The NCBFAA is a national organization with regular membership consisting
of licensed customs brokers, international freight forwarders,
non-vessel operating common carriers, and international air cargo
agents.

As set forth in the notice, the FDA believes the proposals will protect
U.S. consumers from food imports that may be adulterated or pose other
health risks. The proposed rules will amend the Food and Drug
Administration ("FDA") regulations to require the prior registration of
all domestic and foreign facilities that process food products and the
submission of a prior notice of an imported food shipment to FDA by noon
of the calendar day before the day of arrival.

The stated purposes of these proposals is to improve the security of the
U.S. food supply by enhancing the FDA's ability to inspect imported food
upon arrival in the U.S., as well as FDA's ability to deter, prepare
for, and respond effectively to bioterrorism and other public health
emergencies that might result from importations of food products.
Additionally, FDA believes that the proposed regulations would
facilitate product tracking for containment, should an outbreak or a
bioterrorism event occur and assist the FDA in determining the source
and cause of problems.

Because the rules set forth in the two dockets are inter-related, the
following comments relate to both dockets.

**[Comments]{.underline}**

At the outset, we wish to express wholehearted support for the intended
aim of the proposed regulations - - the protection of the American
public. However, as currently set forth in the NPRM, we do not believe
that the proposals represent the most appropriate solutions for
achieving the purposes of the Bioterrorism Act. As a practical matter,
in many instances, the proposed rules are unrealistic, unduly
burdensome, and will unnecessarily interdict the normal flow of trade in
food products. Its unintended effect will be to impose impossible
burdens on U.S. importers, as well as entities involved in the
transportation and importation of these products. Therefore, as detailed
below, we must object to the implementation of the proposed regulations.

1\. The Time For Submission Of Prior Notice Disregards Various Factors
That Will Effect The Flow of Trade.

Proposed regulation §1.286 provides that notice "must be submitted by
noon of the calendar day before the day the article of food will arrive
at the border crossing in the port of entry;" with the further
requirement that any amendments to the notice must be received at least
three hours before arrival. The authority cited for this regulation,
section 801(m) of the Act, states that the deadline for prior notice
"shall be no less than the minimum amount of time necessary for the
\[FDA\] to receive, review, and appropriately respond to such
notification." Yet, the "Background" section contains no adequate
explanation or reasons why this unduly long prior notice period is
required, particularly for shipments coming from Canada and Mexico.[^1]

The NPRM also fails to adequately address section 801(m)(2)(A) of the
Act, which provides that the FDA consider "other factors" when deciding
the deadline for prior notice, specifically: its effect on commerce; the
locations of various ports; various modes of transportation; types of
food; and any other consideration. In this regard, the NPRM appears to
take no account of the myriad of business and transportation factors,
such as motor and rail transit times from contiguous countries, that
effect the period between when food products are ready to be shipped to
the United States and their actual arrival at the border. It also
overlooks perishable food products that are loaded aboard the
transportation conveyance at the farm, as well as the possible effect of
local weather conditions on fresh produce, that can adversely impact
transit time. Further, the time frame is also impractical with regard to
the shipment of baked goods, fresh fish and seafood; most often, the
exact variety and quantity of such products cannot be determined by noon
of the prior day. At the least, if the FDA does not address these
concerns and revise the proposed regulations, they will drastically
effect on food shipments arriving from contiguous countries and from the
Caribbean.[^2]

Ocean vessels rarely arrive at the time originally scheduled. However,
the person required to file the prior notice does not have access to
that information and, most often, only becomes aware of the vessel's
arrival via notification from the carrier. Requiring estimated date and
time of arrival reporting and/or amendments where the shipment will be
delayed by three hours or arrive one hour earlier necessitates
"24x7x365" operation by importers or their agents (*i.e., C*ustoms
brokers), as well as other service providers in the supply chain,
particularly so on the northern U.S. Border. The strict time periods
provided for notice will also eliminate the current method by which
international overnight air carriers presently conduct business.
Typically, cargo on international flights is loaded and detailed well
after noon of the calendar day prior to its arrival at the destination
port. As such, the exhaustive details required on the prior notice, as
set forth in the proposed regulation are not known by the time provided
for submission. Even assuming that compliance is possible, it will only
happen at great expense to both the shippers and the carriers, who will
have to completely revise their current shipping schedules.

Even in situations where the transit time is longer, cargo scheduled for
a particular trip may not be ready in time for shipment. Since cargo
space is at a premium, carriers need the ability to substitute other
cargo. If this occurs after noon of the calendar day prior to
importation, the regulations preclude this because proposed regulation
section §1.289 only allows amendments concerning the last two digits of
the FDA product code and other product information that provides the
specific identity of the article, such as the brand name or common trade
name. A prior notice may not be amended to completely change the
identity of the article. Instead, the filer must cancel the initial
prior notice and submit a new one. In these instances, to require prior
notice to be filed by noon of the calendar day prior to importation is
impractical and will have the effect of delaying cargo either at the
port of entry or at a secure facility, because valid commercial
considerations make it impossible for the entry filer to timely file the
prior notice.

Equally problematic is the impact of the different time zones involved
in international trade. For any given shipment, with the possibility of
a dozen or more time zone differences in play, the reporting requirement
is silent as to which time zone (*i.e.*, place of shipment or place of
arrival) will govern. If the time at the port of arrival governs, an
importer can be subject to the assessment of penalties and delays in
deliveries, by reason of not timely transmitting the information. This,
in turn, can increase both the shipper's and the importer's inventory
costs, with resultant higher prices for consumers. The regulation should
specify which time zone that applies.

In the present economy, where profit margins have already decreased
considerably, the cost of complying with regulations is a primary
concern by industry. For example, freight forwarders, regardless of the
size of their operation, are \"eating costs\" in order to update their
software and/or facilities to conform to the manifest reporting
requirements already in place pursuant to Customs regulations. To
require the trade industry to invest yet another round of software and
other technical upgrades in order to adhere to additional and differing
reporting requirements from the FDA, creates an unreasonable financial
burden on the industry.

As noted below, to avoid duplication of effort, it is essential the FDA
cooperate with the Bureau of Customs and Border Protection ("Customs")
by sharing the arrival data submitted via the Automated Manifest System
("AMS") or Border Cargo Selectivity ("BCS") systems. Otherwise, it is
likely that the data given to FDA will not be consistent with that given
to Customs.

**2. The NPRM Will Unnecessarily Create A New Electronic Interface For
Importers, With New Requirements.**

Although the NPRM states that the FDA has consulted with Customs prior
to promulgation of this notice, the Commissioner of Customs stated
publicly that he was unaware of the NPRM, or its requirements. It is
essential that FDA and Customs work together with each other and the
trade to arrive at a single system, with realistic requirements.

Customs currently has issued requirements for the filing of a cargo
declaration twenty-four hours prior to *lading* on board an ocean
vessel. Moreover, pursuant to Section 353 of the Trade Act of 2002, and
in conjunction with The Treasury Advisory Committee on Commercial
Operations of the United States Customs Service ("COAC"), Customs is
studying the requirements for other modes of transportation. Customs is
also developing its Automated Commercial Environment (ACE), which will
replace all current systems.[^3]

Through the Automated Commercial System ("ACS") importers and Customs
brokers electronically provide import data to Customs for FDA's
Operational and Administrative System for Import Support ("OASIS").
Section 1.286 would, in essence, require that importers provide a second
"advance entry" over the Internet, to FDA. This will cost the importer
both time and money, will not operate as contemplated, and, given the
Customs requirements, is unnecessary.

The proposal suggests that data transmission could be accomplished with
a simple computer over 56K line. This is a flawed assumption. In view of
the high volume of advance notices which must be filed each day,
transmitting over a website portal is impractical, especially for high
volume importers. Based on experience with Customs transmissions, this
large amount of data would require high-speed batch data processing over
dedicated lines.

The notice also makes unrealistic assumptions regarding the current
state of computer capabilities in the food trade - - many suppliers
simply do not have the equipment and/or expertise to prepare and
transmit the data required under section 1.288. Most important, use of
an Internet website leaves the system open to "hackers" and others that
intend to do harm to our food supply.

Further, this also means that much of the same data will have to be
input twice: once for Customs over ABI and again for FDA over the
Internet. This unnecessary redundancy increases the risk of transmitting
incorrect data through clerical error.

**[3. The Proposed Regulations Will Require New ABI
Software.]{.underline}**

Proposed rule 1.288 requires that the Customs entry number as well as a
detailed line item data be presented on the prior notice. Today, under
the systems in use by every Customs filer, the entry number is generated
at the time the data is input into ABI. Meeting the FDA time requirement
will involve a major redesign of the systems and will lead to
duplications and errors. Moreover, given that ACE will shortly replace
ABI, such expenditures cannot be justified. This is another reason
supporting the use of a single transmission to Customs containing the
information needed by FDA.

**[4. Detaining Cargo At Arrival Terminals Will Congest The
Ports.]{.underline}**

If an import does not meet all prior notice criteria, section 1.278
requires that the cargo be held at the arrival port or at an "approved
storage facility," other than the importer's premises.[^4] Currently,
pending FDA review, examination, sampling, and eventual disposition, an
importer is already obligated under its import bond, to provide for the
transport to and holding intact at its facility, of all FDA regulated
goods. This procedure works well and should not be discontinued, merely
because of a defect in the prior notice.

**[5. Registration of All Facilities With FDA Is
Duplicative.]{.underline}**

Many of the facilities that will become subject to registration under
proposed section 1.225 are already registered with the FDA and/or other
federal regulatory agencies. For example all bonded warehouses have been
assigned facility numbers and/or Facilities Information and Resource
Management System ("FIRMS") code. To facilitate efficiency, minimize
duplicate reporting of information, FDA should, wherever possible, use
the Customs Service FIRMS code, reported on Customs documents and in
Customs entry data transmissions, as the primary location identifier for
imported food items being held in a "secure facility" in accordance with
proposed §1.241(e). Further, to minimize confusion, especially about
which of one facility's multiple registration numbers apply to what
types of activities, we strongly recommend that FDA include, on its food
facility registration form 3537 or electronic equivalent, optional
fields for:

\(1\) Type of other facility registration number, with checkable options
including the above types of registration codes, as well as an option
for an "other" type of code, and

\(2\) The appropriate registration number for each option that is
checked.[^5]

**6. The Proposed Rules Use Terms and Definitions That Are Incompatible
With Their Traditional Meaning In Customs And International Trade**

As set out in proposed section 1.227(c)(9), "*Port of Entry*" is defined
as 'the water, air, or land port at which the article of food is
imported or offered for import into the United States, i.e., the port
where food first arrives in the United States." This definition is
inconsistent with that used by Customs to denote the port where a
Customs entry is lodged, together with, when applicable, FDA data via
ABI to OASIS.[^6] Use of this definition will lead to confusion and
likely result in the incorrect completion of the prior notice. The term
should be changed to "Port of First Arrival," and the definition of
"Port of Entry" should be modified to make it compatible with the term
as it appears in 19 C.F.R. §101.1, and as it is traditionally understood
by the import trade.[^7]

The NPRM does not define "*Submitter*," although it uses that term
frequently throughout the background discussion in the NPRM. At page
5433 of the notice, it states, *"FDA notes that the submitter is the
entity responsible for ensuring the adequacy and accuracy of the prior
notice."* For the reasons noted below, a customs broker often acts as
the agent of the importer but should not be considered liable for
incorrect or inaccurate information.

Proposed §1.277(c)(2), FDA adds a new definition for the "*origin*" of
imported goods as the "country from which the article of food was
shipped defined as loaded aboard the conveyance that brings it into the
United States." This definition fails to take into account what
frequently occurs in the international transportation industry. Both
ocean and air carriers routinely use "feeder" vessels/aircraft to move
cargo from the country of origin to a "gateway," for transfer to a
larger vessel or aircraft, that will transport the cargo to its final
destination. The importer/submitter does not necessarily know when and
where this may occur. Moreover, ocean vessels frequently discharge
containers destined for the U.S. in Canada, where they are transferred
to a motor carrier for transport to the U.S.[^8]

The proposed definition requires that the submitter reflect the "origin"
of the goods as the place it was put on the conveyance to the U.S. We
fail to understand what possible use this information can be to the FDA
and/or how it will impact on determining if the product has been
adulterated. Certainly, the rule will confuse importers and require them
to (needlessly) attempt to obtain the cargo routing from the master
carriers. We believe that the requirement should be changed to reflect
the country where the product originated and or was last stored.

Finally, proposed section 1.286(a) requires that prior notice be
submitted by noon of the day before the article of food will arrive at
the *"border crossing in the port of entry."* That term may be clear
when used with regard to goods imported through a port on the Mexican
and Canadian border, however, with regard to ocean vessels, the Customs'
definition of "date of importation" is defined in 19 C.F.R. §101.1 as
"the date on which the vessel arrives within the limits of a port on the
United States with the intent then and there to unlade." That term has a
clear and definite meaning. Unless FDA intends that a different meaning
should apply, the regulations should adopt the Customs definition.

**[7. The Prior Notice Information Required Is Unduly
Burdensome]{.underline}**

The FDA notes that over 4.7 million entry lines of food were entered
during the 2001 fiscal year. FDA now proposes to increase this already
overwhelming amount of data by requiring the reporting of more product
code breakouts than ever before. Showing of brand name and lot
information for canned goods, requiring grower data for produce, and
demanding size breakout for seafood, translates into a vast number of
additional lines of reporting and creates an unreasonable burden on the
importer. We also question whether FDA has the resources to assimilate
and react to this increase in data.

FDA is also of the belief that information about a sale is always known
at time an order for merchandise is placed. Many transactions are
confirmed for a quantity that is to be shipped over a period of time.
With fresh produce, it is not uncommon for substitution to be made in
the growing fields, during picking process. (For example, an importer
may order 40 crates of green lettuce, but the supplier ships 20 crates
of red and 20 crates of green.) In some industries, such as seafood,
quantities are always subject to change, based upon the day's catch.

Under the proposed regulations, any change in product breakouts or
different line numbers would require that a new prior notice process, as
well as new customs entry, must be transmitted. This is an inordinate
burden upon submitters and entry filers. It will certainly lead to
delays in the export of shipments.

Further, in view of the increased number of entry lines proposed, it is
impractical to limit the number of amendments to one, (Section 1.290(b))
and require that they be made not later than two hours prior to arrival
of goods in the U.S. In light of the volume and variety of data FDA
seeks, and the small window of opportunity to obtain and present such
data, it is an unrealistic limitation. The proposed regulations must
allow for the correction of routine clerical error and/or registration
information without limitation, so long as it is received in time for
the FDA to react to the new information.

Of equal importance is the fact that the regulations do not require the
transmission by FDA of an acknowledgement of a prior notice and/or the
fact that it is complete - - the importer will only determine this after
arrival, when the cargo is accepted or refused by FDA. To avoid
substantial economic harm to importers and the industry at large, this
oversight should be corrected.

8\. The Responsibilities and Liabilities Of An "Agent" Should
Specifically Exclude Licensed Customs Brokers.

The term "U.S. Agent," as described in proposed §1.227(c)(12) clearly
includes customs brokers as parties authorized to submit prior notice.
However, the proposals also extend liability for the accuracy of the
information submitted in the prior notice, to parties that did not
provide the information.

Customs brokers will very likely be called upon to serve as the U.S.
agent of the importer under the proposed rule, in that this authority
already exists under the Customs Regulations. Pursuant to 19 CFR 141.36,
a customs broker is required to obtain a power of attorney to conduct
"customs business" and accept service of process, on behalf of a
nonresident principal. However, as an agent of the importer, Customs
recognizes that the broker is not responsible for the accuracy of the
invoice information upon which it relies, in preparing the entry.

Contrary to the above, proposed section 1.278 appears to create
liability on the part of the customs broker for the accuracy and
timeliness of submissions by non-resident principals. Only the entity
supplying the data or a party-in-interest in the transaction should be
held liable for the accuracy of the information submitted. In order to
permit the continuation of importations by foreign importers,
particularly on the Northern U.S. border, FDA must revise the rule to
reflect that the customs brokers is merely an agent for the *filing* of
information *submitted* by importers, and is not responsible for either
the adequacy or accuracy of the data submitted, other than to exercise
reasonable care to present the information provided by its client in
correct form.

9\. Limiting Authorized Parties Submitting Prior Notice To U.S. Agents
Is Discriminatory.

While, the proposed regulations do not specifically require foreign
facilities to designate a

U.S. agent, section 1.225(c) implies that all foreign facilities must
have U.S. agents, designated as "agent in charge". Section 1.232(f)
requires that the foreign facility list U.S. contact information. Under
proposed section 1.285(a), the purchaser or importer residing in the
U.S. is the party responsible for submitting notice. These proposed
regulations fail to take into account the fact that certain types of
products, such as coffee, is sold in transit or after release by FDA and
Customs. Therefore, the actual consignee information is simply not
available at the time the prior notice must be submitted. This could
result in a "refusal" by FDA simply because the prior notice information
is incomplete. FDA must allow for the foreign shipper to appear as
consignee on the prior notice.

10\. The Requirements of the NPRM Will Cause Economic Harm To The
Importer and Carrier Without A Commensurate Increase In Security.

There are many instances where the geographic distance and subsequent
transit time between the foreign port of lading and the U.S. port of
discharge is minimal.[^9] If the proposed regulations are implemented as
presently drafted, they would impose significant additional costs on the
trade industry. Carriers would effectively be barred from loading last
minute cargo, resulting in significantly lower revenue. It will also
interdict the importers ability to employ a "just in time" inventory
system and will increase storage costs.

Exporters would have to deliver merchandise to the carrier sooner than
previously required, resulting in increased internal and inventory
costs, because additional personnel would be necessary in order to
process the advance cargo declarations. Containers delivered to a
carrier without sufficient time to comply with the new prior notice
requirements would remain on the dock or terminal. This would only serve
to allow additional time for our enemies to insert a biological/chemical
weapon either directly on the food product or inside the container
housing the food.

11\. The List Of Facilities Subject To Registration Will Not Achieve The
FDA's Desired Goal Of Product Tracking

The number of facilities potentially subject to registration under
proposed §1.225(a) is reflected in Tables 1 through 6 of the NPRM.
However, the tables take into account only the types of facilities that
are now regarded as being "food storage or handling" locations and
overlook many other facilities that a literal reading of the provision,
would have to be registered. These facilities include, but are not
limited to:

(a) Rail yards -- where many types of shipments, including containerized
    (whether or not on rail cars at the time), boxcar (both dry carton
    and refrigerated/frozen), hopper car (typically grain), and bulk
    liquid (*e.g.*, milk) may be held for extended periods in the course
    of their through transit;

\(b\) Container yards -- at marine terminals, off-dock holding yards,
truck terminals, rail terminals, etc.;

\(c\) LTL truck terminals -- where cargo is staged, consolidated,
loaded, re-handled, and held for on forwarding, pick-up, or delivery;

(d) FTL truck terminals -- including relay points and "drop lots" where
    previously loaded trailers are staged or held for pick-up or for
    exchange to a new power unit;

\(e\) Customs bonded Container Freight Stations (CFS facilities) where
containerized cargo is often held for Customs clearance (and/or other
agency release), and/or trans-loaded from international to domestic
transportation equipment;

\(f\) Air cargo handling agents; and

\(g\) Air, ocean, and truck break-bulk terminals.

Because a single domestic U.S. transportation company, regardless of
their size, may have literally dozens or hundreds of such locations, the
separate registration of each of these as an individual facility,
through which imported food products might occasionally pass, will be a
huge and unreasonable burden on many such firms.

We recommend that the FDA only require registration of facilities which
are generally or regularly used for the storage and handling of food
products. We accordingly suggest that proposed §1.226 be amended by
adding the following exemption:

> \(g\) Transportation facilities at which a shipment of food may be
> temporarily stored during the course of its transportation. This would
> include temporary storage at marine, truck, rail, or air carrier
> terminals, container yards, container freight stations, and similar
> types of locations but does not include a transportation facility that
> is used for the storage of food, other than in the ordinary course of
> transportation or pursuant to §1.241(e) of this part.

12\. Registration Of Facilities Under The Proposed Regulations Must Be
Verifiable.

Verification of the registration of a facility cannot be verified in
that proposed rule 1.243(a) makes the information exempt from public
disclosure. Therefore, importers and other "submitters" of the prior
notice have no way of verifying if a packer, shipper, warehouse, etc.,
is properly registered. This could lead to refusal or delay of the
shipment by the FDA, for reasons beyond the submitter's control. In
addition, NVOCCs, motor freight carriers with less-than-truckload
shipments, and carriers of consolidated shipments, would also encounter
delays if they have to segregate a refused food shipment from other
cargo.

We believe it unreasonable for submitters not to be able to confirm that
a facility is registered until after the cargo arrives. By that time,
the importer runs the risk of refusal, possible demurrage or other
storage costs, and/or "General Order" charges. It should be incumbent on
FDA to timely reject a prior notice that contains an erroneous facility
registration number.

**[13. The Regulations Place An Unreasonable Burden on
Carriers.]{.underline}**

For imported food products that will merely be transiting the United
States in-bond, section 1.286(b) provides that the arriving or in-bond
carrier may submit the prior notice. Simply stated, the carriers do not
have access to this information or the expertise to prepare and submit
the prior notice. It will expose them to the assessment of sanctions for
possible submission of a false notice and/or liability to the consignee
if the shipment is detained. We suggest that this provision be deleted
and "in transit" merchandise be exempted from the rule.

**[14. The NPRM does not comply with the requirements of the Regulatory
Flexibility Act and E.O. 12866.]{.underline}**

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires federal
agencies to consider the effects of their regulatory actions on small
businesses and other small entities and to minimize

undue disproportionate burdens on particular business sectors. Many
brokers and other participants in the trade industry located in the U.S.
have gross incomes under 18 million dollars per year and are considered
"small businesses," as defined in the statute. Contrary to the statement
contained in the NPRM, as noted above, the proposed regulations will
have a significant impact upon these small entities and subject them to
potentially crippling losses of revenue. This, coupled with the
increased possibility for monetary penalties for non-compliance, will
place the continued existence of the many customs brokers that
specialize in food products, at risk.

In addition, we challenge the calculation of one hour as the time
required to comply with the proposed regulations. Taking into account
the many variables, which includes obtaining an entry number,
determining the last port the cargo was shipped from, ascertaining the
facility registration numbers, obtaining the names, addresses, etc. of
contacts, determining the correct product code, etc., will take far
longer than one hour. If prepared by the importer, we estimate that the
time required to acquire and verify the information will take from four
to six hours, and possibly longer.

**[Conclusion]{.underline}**

The NCBFAA is anxious to see that regulations are put in place that will
help insure against bio-terrorist attacks on our food supplies. However,
it appears that the proposed regulations go too far in trying to reach
that goal and will have the effect of interdicting the smooth flow of
legitimate commerce and economically disadvantage importers, customs
brokers, transportation companies and various other entities involved in
the supply chain. Further, while security can be measurably enhanced
through the transmission of advance import shipment data, the FDA should
not strike out to achieve this.

This is certainly not the time for federal agencies to fight "turf
wars," at the expense of the public. Rather, FDA should partner with
Customs in an effort to find one system that will satisfy the needs of
both agencies, at minimum cost to the public. To that end, we believe
the NPRMs should be withdrawn, pending substantive discussions between
FDA and Customs.

We thank you for the opportunity to submit these comments.

Sincerely,

Federico C. Zuniga,

President

> Harvey A. Isaacs
>
> General Counsel

/jov

cc: NCBFAA Board of Directors

### ENCLOSURE

# LIST OF ORGANIZATIONS ENDORSING THE NCBFAA COMMENTS

**Baltimore Customs Broker & Forwarders Association**

**Charleston Brokers and Freight Forwarders Association, Inc.**

**Customs Brokers ANC**

**CB&IFFA of Virginia**

**Columbia River Customs Brokers and Forwarders**

**Customs Brokers and Foreign Freight Forwarders Association of
Chicago**

**Customs Brokers and Forwarders Association of Northern California**

**Detroit Customs Brokers & Freight Forwarders Association**

**International Freight Forwarders and Customs Brokers Association of
Charlotte, NC**

**International Freight Forwarders and Customs House Brokers of Atlanta,
GA**

**International Freight Forwarders and Customs Brokers Association of
New Orleans**

**Laredo Licensed U.S. Customs Brokers Assn., Inc.**

**Los Angeles Customs Brokers and Freight Forwarders Association**

**Northern Border Customs Brokers Association, Inc.**

**Philadelphia Customs Brokers & Forwarders Association**

**Rio Grande Valley Customs Brokers Association**

**San Diego Customs Brokers Association**

**UPS Supply Chain Solutions, Inc.**

[^1]: The fact that FDA does not have employees at every port of entry
    is not justification for imposing this requirement on shipments from
    Mexico and Canada.

[^2]: For example, if coffee is sent by vessel from Honduras on a
    Friday, the shipper does not receive his copy of the bill of lading
    until Monday, which will be after the vessel has arrived in Miami;
    this will mean that every such shipment will be refused by FDA
    because of an incomplete prior notice.

[^3]: Use of the International Trade Data System ("ITDS") should be
    seriously considered as the means to obtain the data; that is the
    only way to eliminate confusion and insure the highest compliance
    percentages, while, at the same time, affording the least disruption
    to trade.

[^4]: This presents an insurmountable problem in the case of merchandise
    that is intended for "immediate exportation" or "transportation and
    exportation:" in these situations, the obligations default to the
    carrier, who does not have the requisite knowledge either to file an
    adequate prior notice and/or correct a defect.

[^5]: The FDA food facility registration number should be cross-linked
    in the FDA database with each other type of facility registration
    number (if any) that also applies to that facility.

[^6]: Specifically, 19 C.F.R. 101.1 defines "Port of Entry" as "any
    place designated by Executive Order of the President, by order of
    the Secretary of the Treasury, or by Act of Congress, at which a
    Customs officer is authorized to accept entries of merchandise to
    collect duties, and to enforce the various provisions of the Customs
    and navigation laws."

[^7]: Further, as noted above, requiring that the importation be held at
    the port of first arrival, will seriously interdict the ability of
    carriers to arrange the in-bond transportation of merchandise,
    destined for entry at inland ports and will place importers of goods
    intended to move in-bond in the position where they may have to
    arrange storage at ports where they do not do business and do not
    employ a customs broker.

[^8]: In other instances, a shipment may contain goods with a country or
    origin of Belgium, that was placed in an ocean container and
    tendered to the carrier in Brussels; it may then be transported by
    motor or rail carrier to Rotterdam where it is laden on board an
    ocean vessel that discharged them in Montreal, from where it is then
    taken by motor or rail carrier to the U.S., through one of the
    numerous U.S./Canada border crossings.

[^9]: Such is the case with shipments between Vancouver, Canada and
    Bellingham, Everett, Seattle and Tacoma.