July 8, 2003

Dockets Management Branch (HFA-305)

U.S. Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

To whom it may concern:

The following comments are being submitted in response to the FDA
proposal of May 9, 2003 titled "Establishment and Maintenance of Records
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002", docket number 02N-0277.

e-gatematrix is a technology and service company focused on improving
the airline passenger experience while reducing overall costs. Our
services are based on technology systems and management services
leveraging process efficiencies across the supply chain while enhancing
the passenger experience onboard. Our Customer base includes airlines,
and transportation support caterers. Our Supply Chain includes
manufacturers, transporters (US domestic intrastate and interstate as
well as international importers), warehouse managers, and distributors;
the result is to provide product to point of use at catering locations.

**SUMMARY**

As e-gatematrix activities are closely aligned with airline and catering
requirements we have seen the industry transform since September 11,
2001; and been actively involved in implementing adjustments to the
changing requirements.

FDA and HACCP regulations have always been a central key in ensuring
continual food quality/safety management and response to systemic
failures in the food service industry supply chain. Additional measures
across the airline sector have been implemented under the direction and
oversight of the FAA over the last twenty (20) months. These changes
were implemented to deter intentional contamination and/or destruction
as well as address the overall risks of terrorism for airline support
functions. Our organization recognizes the need and importance of these
changes.

The changes that are proposed in the FDA Actions on New Bioterrorism
Legislation expands the scope of food safety and security, but will also
result in redundancy and extraordinary expansion of airline catering
supply chain administrative requirements for material tracking with
limited return on investment. Section 104 of Public Law 107-188, Public
Health Security and Bioterrorism Preparedness and Response Act of 2002,
states that advisory committees will have assistance from working groups
to provide expert recommendations. The plan presented in the proposal
for material tracking does not indicate a clear recognition of airline
catering supply chain operations or existing controls. These changes
will drive increased complexity to the entire supply chain, which brings
with it increased time, materials and systems. The investments have no
justification due to lack of verified risk and are merely an extension
of controls which are currently well defined in Class I-III product
recall procedures, supply chain responsibilities and forms.

e-gatematrix believes the proposed requirements as published in 21 CFR
parts 1, 11 and 16; Federal Register/Vol. 68, No. 90/May 9,
2003/Proposed Rules are ambiguous in classification of food service
suppliers; redundant in defining processes and tracking requirements
relative to existing FDA regulations; ineffective in disaster avoidance
with focus on reactionary tracking; and are being applied to the airline
catering industry with no fact based rational to support increased
administration by a sector with no history or defined risk. e-gatematrix
strongly urges the Secretary to reconsider this proposal as written,
withdraw the draft for review/revision and include representatives from
the airline and airline catering sector, or significantly modify the
Rules to reflect realistic security control of the broad base food
industry supply chain risks and requirements.

**GENERAL**

[Comment \# 1:]{.underline}

The proposal solicits comments concerning the ambiguity existing within
the authorizing legislation, namely differences between wording in
Sections 306(a) and 414(b). The initial document which specifically used
the phrase "the Secretary **may** by regulation establish recordkeeping
requirements" did not define the criteria for "**may"** to become
"**shall**"; regulation should be associated with quantified risk. There
is no supporting evidence that airline catering requires additional
regulation beyond current controls put in place in the last twenty
months to avoid terrorist intervention or that the risk is higher for
airline caters than restaurants, retail, or railway deli's. Extending
the burden to airline catering arbitrarily is without justification;
there is no specification or quantification associated with the method
for identifying high risk food supply chain members; and no historical
failure rate within the airline catering industry as a result of
bioterrorism; There are no extenuating circumstances relating to food
types, sources, delivery, storage, assembly, packing or delivery that
increase risk in airline catering operations relative to other food
service industries. Airline catering facility security has been
addressed by the FAA, measures have been put in place to ensure facility
security and in under constant surveillance by the FAA Product types and
sources are commonly the same for airline catering as for restaurants
and retailers.

The airline industry has, under the direction of the FAA, implemented
security controls across all airline related activities in the last
twenty months. Changes in airline catering operations that have been
implemented include:

-   Background checks on all new and exiting employees

-   Secured facilities requiring authorization and accompaniment of
    non-employees

-   Security checks and sealing of all equipment and transportation
    vehicles prior to departure to aircraft by third-party security
    company

-   Security check and release of sealed upon arrival at aircraft by
    third party security company

[Comment \# 2]{.underline}:

According to Section 1.327 (b) and (d), both restaurants and retailers
have been excluded. Restaurants are excluded "to keep records of each
individual recipient consumer would be too burdensome and not necessary
in order to address credible threats of serious health consequences or
death to human or animals". The additional administration required for
airline caterers to track and supply information on every product to the
raw material by flight is as well burdensome.

An example is a mid-size airline catering unit that would prepare an
average of 10,000 meals per day for four airlines. There are two to
three classes (First, Business, Coach) of services which get different
meals; long haul flights have two services per class. There is an
average of twelve seats in first class, 24 seats in business and 130
seats in coach. For each meal there is an average of four components
plus assorted bulk boarded products (food and beverage) for all
passengers. For each component there are recipes that contain an average
of four ingredients, all of which can be multiple lot numbers of product
from a single source on the same flight as well as sub-components from
multiple sources. The components and sub-components can also be from the
same lot number and source for multiple airlines. The meals are prepared
and delivered to the aircraft for consumption; passengers receive meals
randomly, dependent on how the flight attendant pulls product from
carts, carriers or ovens. In addition to the standard meal loading
passengers are able to order special meals which are placed within 24
hours of departure and may contain totally different components from
other passenger meals.

The complexity of these processes and the variance in food sources, lots
and customers at a minimum reflects the uncontrollable variance of
restaurant operations; meals provided to passengers are as random as
sales to individual consumers in a restaurant.

[Comment \# 3:]{.underline}

The initial publication of information, Public Law 107-188 (Public
Health Security and Bioterrorism Preparedness and Response Act of 2002)
published June 12, 2002, indicated a study would be performed to
determine high risk areas and implement procedures to monitor and
control these as a priority. There is no incorporation into the Act of
study results indicating airline catering is neither at greater risk
than restaurants nor includes recognition of controls put in place by
the FAA to maintain secure airline catering operations and onboard
loading.

In the Agency's proposal discussion the term "catering facilities" there
is a distinction between a snack bar on a train selling sandwiches to
consumers for immediate consumption (considered an exempted restaurant)
and a facility that provides the sandwiches to an airplane under
controlled transfer conditions for later consumption (considered a
covered processing establishment). This is an arbitrary distinction not
reflective of actual activities associated with the service and products
provided. The risk associated with the sandwich is the same for the two
facilities; both obtain product, assemble into components and randomly
provide to customers. The FDA has, under the Public Health Service Act,
historically inspected the facilities providing food to interstate
conveyances, but the rules under the proposed act are changing and are
not equally addressing risk. If the product for airline catering is at
risk, what additional control is being added to the existing FDA
inspection criteria? If audit criteria are enhanced for one facility
type, could that criteria not apply to both in the form of an audit? An
audit would be inspection to verify adequate controls are in place;
additional administrative record keeping would only result in redundant
information for tracking when there is a failure. Airline catering
facilities continue to be responsible for meeting safe food handling
techniques through the application of HACCP requirements, internal
quality control processes, and customer specified quality assurance
procedures; this is constantly assessed and evaluated through internal,
customer and third-party audits.

[Comment \# 4:]{.underline}

As part of the justification for the proposed regulation, FDA states
that "it is critically important for FDA to have the ability to trace
back and trace forward quickly in the event of a terrorist event or
other food-related emergency...." e-gatematrix recognizes the importance
of maintaining this capability, but this capability is in effect today.
Each supply chain member is responsible for maintaining tracking and
control information on sources, handling, processing, packing, and
storage as applicable and next point of delivery. Section 1.337(a)(6)
deals with the record keeping on the firm that delivers (transports) the
food to the covered facility. In the case of a systemic failure the
specific supply chain member is responsible for providing supporting
documentation of product control, identification and movement. This
information is currently accessible and used to identify the location
and isolate product when a recall is issued. The potential events
identified the revised regulations are seeking to address rare
occurrences and do not warrant restructuring of the existing
traceability process as it has proven to be effective in many business
sectors.

[Comment \# 5:]{.underline}

Title III indicates that product tracking information should be
available for presentation within four to eight hours of identification
of a potential risk product. The current FDA recall procedure requires
initial steps to be identification of product location, isolation, and
segregation. As isolation is the most critical factor, followed by
determining product routing; the focus should be on isolating product
within the first four hours rather than identifying the path of the
product. Standard operating procedure is to isolate product beyond the
specific lot number to ensure controlled evaluation. As there are
documented processes and forms for FDA recalls Levels I-II, enhanced
control would be better served to use the existing process and
procedures with an additional level if required for product isolation
due to terrorism, Level I+. The process has proven effective across many
industries, in both food and non-food recalls.

[Comment \# 6:]{.underline}

Section 1.337(a)(6) deals with the record keeping on the firm that
delivers (transports) the food to the covered facility. That
transporting firm must have a record of the previous firm and therefore,
there is no reason for the receiving entity to have or keep duplicative
records on the shipping firm. Should FDA need to trace product the
receipt documenting the date received, lot number, quantity and
transporter should provide sufficient information to go to the previous
product handling source in the supply chain. Section 1.337(a)(1) is then
unnecessary as the responsibility of documentation control and
maintenance is at the point of influence. Total product handling
information at all points is redundant.

[Comment \# 7]{.underline}:

The Agency sought comment on whether the "responsible individual" within
the meaning of this regulation should be the operator of the transport
vehicle or someone in the corporation with responsibility for the
vehicle and the food.

A "responsible individual" by the standard quality definition is a
management representative responsible for providing product traceability
information; this is typically a quality assurance representative or
designee at a management level sufficient to make decisions and
represent a company position. This requirement applies not only to
transportation, but is a requirement of all supply chain members. HACCP
clearly defines responsibility and ownership. Supply chain member should
be able to designate the individual(s) responsible for tracking the
incoming and outgoing products. The government need not regulate how
firms do business internally. e-gatematrix recommends that a definition
of "responsible individual" be added to 1.328 and that it clearly
delineate that the facility must identify a "responsible individual" to
fulfill any obligations under this regulation.

**CONCLUSION**

e-gatematrix firmly supports all enhancements required to ensure the
safe handling of products and protection of the consumer. We feel that
it is critical that before implementing changes, particularly
unilaterally through legislation, that it is important to quantify risk,
develop improvement plans that result in improved controls without
unnecessarily compounding work requirements. The issues identified above
as well as the concerns of the applicability of the standards as is
currently drafted relative to the airline catering industry prompt
e-gatematrix to request a change in direction from implementation to
review. We request that the reassessment include representatives from
our industry that will provide valuable direction resulting in achieving
a common goal of protection from bioterrorism.

Regards,

Lisa Woody

Director of Supply Chain Operations and Performance

e-gatematrix llc

4751 Best Road, Suite 480

Atlanta, Georgia 30337 USA

Telephone: +1 404 765 6630

Telefax: +1 404 761 1324

[[lwoody@e-gat](mailto:your email here@e-gatematrix.com)ematrix.com]{.underline}

[[www.e-gatematrix.com]{.underline}](http://www.e-gatematrix.com/)

A member of the Gate Gourmet Group.

[[www.gategourmet.com]{.underline}](http://www.gategourmet.com/)