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> December 23, 2003

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Electronic: <http://www.fda.gov/dockets/ecomments>

RE: Interim Final Rules

October 10, 2003

Prior Notice and Facilities Registration

Under the Public Health Security and Bioterrorism Preparedness

And Response Act of 2002 ("BTA")

Dockets #02N-0276 and 02N-0278

Gentlemen:

American Trucking Associations, Inc. (ATA), with offices at 2200 Mill
Road, Alexandria, Virginia 22314-4677, is the trade association that
represents the U.S. trucking industry's interests[^1]. ATA is vitally
interested in matters affecting the nation's motor carriers, including
the implementation of security requirements affecting the transportation
of food. For this reason, ATA and its affiliated conference, the
Agricultural and Food Transporters Conference (AFTC), are submitting
these comments in response to the Department of Health and Human
Services' Food and Drug Administration's (FDA) Interim Final Rules (IFR)
for Prior Notice and Registration of Facilities promulgated under the
BTA and published in the *Federal Register* on October 10, 2003[^2].

ATA's Agricultural and Food Transporters Conference, formerly known as
the Agricultural Transporters Conference established in 1995, is the
national organization representing the interests of commercial
transporters of agricultural commodities and foodstuffs. Commercial
agricultural transportation moves a significant percentage of all raw
commodities and food either imported into the Unites States or
transported domestically. More than 90 percent of shipments of
perishables are done by truck. Food grains, liquid bulk shipments of
milk, wine, and flour and other foods are transported by tank carriers.
Commercial operations for transporting perishable foods are vastly
different, with significantly diverse time requirements, from operations
for transporting processed foods.

**Background**

As ATA has stated in prior comments to FDA[^3], the trucking industry is
a critical link in the economic interdependency among the United States,
Canada and Mexico, moving approximately 70 percent of the value of
freight between the United States and Canada, and about 83 percent of
the value of U.S.-Mexico freight[^4]. The increasing trade volumes that
have been generated among the three North American Free Trade Agreement
(NAFTA) partners have not only been good for the economic well being of
our countries, but also have allowed businesses throughout North America
to diversify, expand, improve their asset utilization, and access new
markets for their products.

According to U.S. Customs and Border Protection (CBP), during 2001 6.8
million trucks entered the U.S. from Canada, while 4.4 million entered
from Mexico, resulting in more than 13 million truck crossings a year on
the northern border, and more than 8 million crossings on the U.S.
southern border. NAFTA has generated a large increase in the amount of
trade in the food, beverage and agriculture sectors throughout North
America: U.S.-Canada trade in these goods increased from \$16 billion in
1997 to \$20.4 billion in 2001, while U.S.-Mexico trade for the same
period increased from \$8.1 billion to \$11.6 billion.[^5]

ATA and AFTC continue to have a number of concerns regarding FDA's IFRs,
which are discussed throughout this response. Since our last submission
to FDA in response to the Notice of Proposed Rulemaking to implement the
BTA, ATA and concerned members have attended general meetings and
briefings hosted by FDA. In addition, on December 2, ATA and various
members of our organization met with two representatives of FDA to
exchange information, answer questions and share general concerns.
Briefly, the major concerns expressed at the meeting include:

-   The IFR does not address how motor carriers can ascertain that prior
    notice information has been sent by importers to FDA for clearance
    prior to the truck's arrival at a port of entry.

-   The FDA should work further with CBP, from both system-integration
    and supply chain security standpoints, to enhance and establish
    common targeting and risk assessment systems and timeframes for food
    importation.

-   The IFR's definition of "holder of food" remains excessively broad
    and significantly vague. This definition should be narrowed
    appropriately to exclude incidental sorting operations at truck
    terminals that are conducted in the normal course of business for
    trucking operations.

-   FDA's inclusion of refrigerated trucks that ripen and preserve
    produce within the definition of a "processor" of food is an
    inappropriate interpretation, and these trucks should not be
    required to register.

ATA strongly reiterates that within the trucking industry itself exist
several sectors with very distinct operations, and we believe these
sectors have not been given independent consideration by FDA in
developing the IFR. Operations by truckload carriers,
less-than-truckload carriers, small package carriers, tank-truck
operators, agricultural transporters vary significantly in terms of time
frames, methods of handling freight, and types of terminals or
facilities used in their business. ATA wants to work jointly with FDA to
ensure that each particular segment of our industry is given careful
consideration on the potential short and long term impacts of the rule.

Following are ATA's and AFTC's comments regarding both the requirements
established for Prior Notice and for the Registration of Facilities.

**I. PRIOR NOTICE**

The IFR specifies that pre-notification must be submitted by the
"purchaser or importer of an article of food (or their agent) who
resides or maintains a place of business in the U.S." two hours prior to
the time the truck with FDA-regulated freight arrives at a U.S. port of
entry. In addition, the IFR states that no amendments to the prior
notice may be made. The required entry-level information will be
forwarded to FDA through the CBP ACS system by importers or their agents
-- which could include the shipper and/or the customs broker.
Acknowledgement of receipt of the required prior notice information will
be sent to the filer.

A major concern regarding the IFR is that trucking companies picking up
FDA-regulated freight in Canada or Mexico bound for the U.S. cannot
ascertain that the importer, shipper, or customs broker has indeed filed
the appropriate prior notice. In the past, FDA has suggested that motor
carriers require proof of pre-filing from customers. What form of proof
will the FDA (or other border regulatory agencies) consider acceptable
in order to release the motor carrier from responsibility if the prior
notice was not filed appropriately. It is not clear whether FDA would
supply an official document that the importer, shipper, or customs
broker would issue to the motor carrier to assure the carrier that prior
notice has been filed.

In an LTL environment, where on average a trailer contains about 40
shipments, there is a potentially serious impact on several parties when
a single shipment is not filed in a timely fashion. Holding a trailer at
a port of entry would affect not only the motor carrier's operations,
but also all of the shippers, importers, and consignees whose goods are
on board.

The possibility that trucks might be turned back or held for clearance
at a port of entry because an importer failed to file prior notice, or
failed to file in a timely manner is unacceptable. The motor carrier's
potential loss of productivity from having equipment tied up when a
shipment has been denied entry or is being held, is a serious negative
impact on the bottom line of cross-border trucking operators. In
addition, this kind of down time would have a serious negative impact on
truck drivers' compensation, when they are paid based on miles driven,
and greatly reduce the number of allowable hours a driver is allowed to
operate under Federal Motor Carrier Safety regulations.

Accordingly, ATA and AFTC recognize the joint efforts that FDA and CBP
have undertaken to ensure that the implementation of the Prior Notice
rule does not have a negative impact on our commercial operations. The
joint Compliance Policy Guide for FDA and CBP staff is an excellent
document for assisting personnel staffing the ports of entry so that the
movement of legal and safe foodstuffs is not hampered. The document does
a commendable job in establishing a soft enforcement period for the rule
and ensuring that efforts will be undertaken to both educate the trade
community and allow CBP personnel to become better acquainted with the
rule. We congratulate FDA and CBP in putting this document together.

**FDA Should Continue to Coordinate with CBP Efforts**

ATA believes there are three specific areas where FDA could benefit by
working closely with CBP, the agency that is today our nation's primary
enforcement agency at ports of entry:

1.  [Import System Integration]{.underline}: ATA congratulates FDA for
    coordinating with CBP to allow transmission of FDA-required
    information through the Automated Broker Interface (ABI) to CBP's
    Automated Customs Suystem (ACS), instead of requiring submission
    through an FDA parallel stand-alone system. ATA is a strong
    supporter of modernizing and improving systems for import cargo
    reporting information. Although the implementation of the Automated
    Customs Environment (ACE) and the International Trade Data System
    (ITDS) continues to face delays, ATA strongly supports such system
    consolidation efforts and encourages other federal agencies to
    participate in these systems.

2.  [Supply Chain Security]{.underline}: FDA should consider utilizing
    and benefiting from CBP's Customs Trade Partnership Against
    Terrorism (C-TPAT) and the Free and Secure Trade (FAST) programs.
    When undertaking risk assessments on imported foods transported by
    these motor carriers, FDA could consider providing special treatment
    to those accepted into the programs.

3.  [Prior Notice Timeframes]{.underline}: CBP recently promulgated
    Final Rules for the Advance Presentation of Electronic Cargo
    Information as required under the Trade Act of 2002. Although ATA
    still believes that CBP's timeframes for undertaking risk analysis
    could be reduced to 15 minutes prior to arrival for C-TPAT trucks
    moving CTPAT cargo with FAST drivers, the final CBP requirements
    established 30 minutes for such trucks, and one hour prior to
    arrival for non-C-TPAT freight/motor carriers. These timeframes,
    however, are far better than the two hours required in FDA's rule.
    For freight to qualify as C-TPAT, both the motor carrier and the
    importer of record must be enrolled in the C-TPAT program. ATA
    suggests that FDA harmonize its timeframes with CBP's to ensure that
    the rules for importation and exportation of food do not conflict
    with CBP requirements.

**II. REGISTRATION OF FACILITIES**

**Definition of Truck Terminals as Holders of Food**

The FDA's overly broad definition for "holders of food" as written
inappropriately includes truck terminals. FDA should redefine "holders
of food" in keeping with the intent of the law and the realities of the
trucking industry's business practices. The IFR exempts "a transporter
that holds food only in the normal course of doing business." However,
FDA appears to believe that only a carrier that transports cargo from
the point of origin to the point of destination falls under that
definition. Truckload carriers rarely handle freight at their terminals,
but less-than-truckload carriers and small package carriers routinely
sort freight for delivery at one or more cross-docking facilities. FDA
fails to consider that not all trucking companies' operations are
similar even though they all fall under the "normal course of business"
definition.

This is a critical operational issue for LTL motor carriers, whose
productivity is based on keeping freight in motion and whose customers
expect shipments to be delivered in a timely manner. For small package
carriers, this is an especially big concern. These carriers may have
thousands of overnight or expedited shipments on one trailer.

During ATA's meeting with FDA on December 2, FDA and ATA representatives
agreed that as long as the FDA regulated cargo is not loaded/unloaded
from the trailer during a visit to the motor carrier's facility/terminal
(e.g. the truck comes to the terminal only for fueling the truck or for
repairs to the vehicle) such a facility will not be subject to FDA's BTA
facilities registration requirements. This scenario applies to any type
of truck operation, including tank-truck, LTL, truckload, flatbed, etc.
At the meeting, FDA representatives stated that a terminal or motor
carrier facility will have to register only if FDA regulated cargo is
loaded/unloaded at a specific facility.

In the LTL environment motor carriers consolidate loads from various
shippers in a single trailer. That trailer then arrives at a
facility/terminal where the shipments are unloaded and sorted for
loading onto a different trailer for delivery to its final destination.
This is basically a "hub and spoke" system, which is used for both
domestic and international cargo movements.

ATA and AFTC's position continues to be that trucking companies that do
not store or warehouse FDA regulated cargo should not be required to
register under the Facilities Registration regulations. Further
supporting this position is the fact that LTL carriers and associated
cross-dock operations are considered to be transportation operations
within the Standard Industrial Code Classification System (SIC #4213-
"Trucking Except Local"), and not SIC 4225 -- "General Warehousing and
Storage".

We recommend that the FDA consider SIC classifications as a guide in
defining facilities that "hold" food under SIC #4213. Again, FDA needs
to differentiate between "storing and warehousing," and "sorting"
freight, which generally takes a few hours, is done under supervision in
a secure facility and performed in the usual course of business. Motor
carriers have no contractual agreements with their customers to store
freight. Rather, the entire thrust of trucking operations is to get
freight from one point to another as rapidly as possible in order to be
paid for services. If a motor carrier enters into a contractual
agreement to store or warehouse freight for a shipper, then such a
facility should be registered with FDA.

**Concerns From Tank Truck Operators**

Following are a number of scenarios that another ATA affiliated
organization, the National Tank Truck Carriers (NTTC), presented to FDA
for clarification. Guidance on the following scenarios would be
appreciated:

-   FDA Tank Lines operates food grade trailers in College Park MD. An
    FDA driver takes his unit to Baltimore Syrups where it is loaded
    with sweeteners. He then drives to Boston where he makes a delivery.
    He then returns to his truck terminal where his truck is washed,
    serviced and parked awaiting the next load. Does this facility need
    to register? Our interpretation is that the motor carrier need not
    register the facility. (Does the fact that a transporter operates a
    terminal at which trailers used to haul food are based/parked
    require that facility to register?)

-   FDA Tank Lines operates a trucking terminal at which it also has a
    rail siding with 4 rail tank cars of bulk sweeteners belonging to a
    customer. When an order is received, an FDA driver loads his trailer
    from the railcar and makes his delivery. Does this facility need to
    register?

-   FDA Tank Lines sends a trailer with a pre-load driver to Baltimore
    Syrups. The driver loads his trailer and returns to the College Park
    terminal. (This is done to schedule drivers so they have sufficient
    hours to drive long trips or to allow the food shipper to better
    schedule loadings.) A long-haul driver then takes that trailer and
    proceeds to make a delivery in Chicago. Does that truck terminal
    have to register because a loaded trailer/transport vehicle returned
    to it prior to completing a delivery? This now appears to be a gray
    area. The food never leaves the transport vehicle and is not "held"
    at the terminal. However, the terminal could be seen to "support"
    the efforts required to complete the delivery. Guidance is
    especially needed in this area.

-   Is FDA considering making time-limit distinctions if a loaded truck
    waits at the terminal for one hour, 5 hours or 12 hours? (The final
    rule does not consider hold time.)

ATA and NTTC would appreciate specific guidance regarding the above
scenarios to pass this information to our members.

**Definition of Refrigerated Trucks as Processors of Food**

FDA's requirement that refrigerated trucks that ripen or preserve fruit
in-transit register as "processors of food" extends beyond the limits of
what ATA believes the BTA mandates. ATA reinforces that such equipment
should be excluded from the requirement to register as "holders of food"
until the FDA provides a more detailed definition as to what constitutes
a refrigerated truck being a "processor of food." ATA believes that in
large measure refrigerated trucks simply transport perishable cargo and
"conserve" such cargo rather than "treat" it or "process" it.

FDA's own revisions to 19 CFR 1.277(b)(6) in fact would not seem to
include refrigerated trucks that ripen fruit, and so this requirement
seems to be in conflict with the agency's regulations. We suggest to the
agency that these vehicles also fall under the description provided by
FDA regarding commercial vehicles not required to register, i.e.
"transport vehicles if they hold food only in the usual course of
business".

**The Purpose of Registration**

The trucking industry is confused about the ultimate purpose or use of
the FDA's truck terminal registration information. The information seems
to be non-dynamic, relegated to an inert status somewhere in the
agency's database, apparently for tracking purposes. Any freight
tracking information the FDA needs will be readily available from a
motor carrier's bill of lading and internal business systems. A motor
carrier's internal tracking system is likely to be more effective in
mapping out the path of a load from point of pick up to point of
delivery. Further, many motor carriers websites offer access to detailed
information about terminals and company information.

ATA requests that FDA provide greater clarity as to the ultimate
objective for developing such a registration process and what the
assumed benefits for the agency will be in garnering such a collection
of information.

Furthermore, although FDA has published a "Compliance Policy Guide" for
FDA and CBP staff for Prior Notice of Imported Food, no similar document
has been issued for the enforcement of the rules referring to the
Registration of Facilities. Many motor carriers and other sectors of
industry are under the impression that the soft enforcement for Prior
Notice also applies to the Registration of Facilities. FDA needs to
either issue such a policy guidance document for registration, state
that the policy guide for Prior Notice applies to registration, or
clarify what the situation is for enforcement of the registration rule.

**III. CONCLUSION**

ATA and the trucking industry share the FDA's and our entire nation's
concern for securing our national and economic security. In addition to
reactive measures our industry has taken to comply and work with various
proposals by Congress and regulatory agencies, the trucking industry has
also initiated a number of proactive measures regarding the security of
our operations after, and even well before, the terrorist attacks of
September 11.

For many years, motor carriers have faced the challenge posed by
organized groups involved in cargo theft. After September 11, ATA
expanded our industry's efforts to ensure that a commercial vehicle not
by used to transport a weapon of mass destruction or that it be used as
a weapon itself. This effort resulted in the creation of an American
trucking industry Anti-Terrorism Action Plan (ATAP). ATAP has allowed
trucking industry representatives to present a solid front to stem the
possibility of a terrorist attack on our transportation industry and
infrastructure. ATA has closely coordinated many of ATAP's principal
initiatives with state and federal government agencies to help monitor
our transportation modes and our nation's highways. Currently, the AFTC
is working under a contract with the U.S. Department of Agriculture to
create a *Guide for Security Practices in the Transportation of
Agricultural Commodities*.

In addition to coordinating with various segments of the transportation
industry, ATA also interacts with a large number of government agencies
developing separate security initiatives that could have an impact on
trucking operations. ATA believes it is essential that all agencies
planning or developing security initiatives impacting international
trade coordinate closely with agencies within DHS, such as CBP and the
Transportation Security Administration (TSA) in order to avoid
duplication of efforts and programs.

In summary, ATA urges that the following issues be taken into
consideration by FDA when modifying the IFR:

-   FDA must understand that there are various types of operations
    within various sectors of the trucking industry, and the operational
    requirements of each segment must be considered when developing
    motor carriers requirements.

-   FDA must clarify how motor carriers will be notified that the prior
    notice has been filed by the importer, before to sending a truck to
    the border, and what system will FDA and/or CBP develop to notify
    the motor carrier to proceed to a port of entry.

-   FDA must narrow the definition of "holder of food" so it does not
    include motor carrier terminals. ATA encourages FDA to use the SIC
    codes related to storage and warehousing as a basis for such a
    definition, which should not include truck terminals used for
    "sorting" cargo in the normal course of business. In addition, FDA
    needs to clarify what purpose will be served by registering
    terminals.

-   FDA must reconsider the classification of refrigerated carriers that
    ripen and preserve fruit as "processors of food" and eliminate any
    requirement that for registration under this rule.

-   FDA should hold ongoing meetings with the trucking industry in order
    to more fully understand the operational issues involved with
    changes required by the BTA and its implementation.

-   Lastly, FDA must take advantage of existing border security programs
    such as C-TPAT and FAST and recognize and understand how these
    programs ensure the security of the entire supply chain. Such
    programs provide a way to improve resource utilization by targeting
    unknown entities and providing preferential treatment to known and
    trusted trade entities.

ATA appreciates the opportunity to comment on this important Interim
Final Rule, and we look forward to working with FDA and other government
agencies in ensuring our national and economic security. If you have any
questions related to these comments, please call Martin Rojas at (703)
838-7950 or Fletcher Hall at (703) 838-7999.

Sincerely,

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Martin Rojas Fletcher R. Hall

Director Executive Director

> Office of Customs, Immigration & Cross Agricultural & Food
> Transporters
>
> Border Operations Conference

[^1]: Through our affiliated trucking associations, and their over
    30,000 motor carrier members, affiliated conferences, and other
    organizations, ATA represents every type and class of motor carrier.

[^2]: (68 *Federal Register* 58974 & 58894)

[^3]: American Trucking Associations; Comments to FDA Notice of Proposed
    Rulemaking, Published in *Federal* Register on February3, 2003 on
    Registration of Food Facilities under Bioterrorism Preparedness and
    Response Act of 2002 (vol 68, No. 22, pp. 5378-5427); Alexandria,
    VA; April 4, 2003.

[^4]: Bureau of Transportation Statistics, U.S. Department of
    Transportation

[^5]: Trade and Economy: Data Analysis, International Trade
    Administration, U.S. Department of Commerce,
    http://www.ita.doc.gov/td/industry/otea/usfth/top80cty/top80cty.html