Flying Food Group

179-17 149^th^ Avenue

Jamaica, New York 11434

July 8, 2003

Dockets Management Branch (HFA-305)

U.S. Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852 Re:

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.

Flying Food Group (FFG) began operations in 1983 at Chicago's Midway
Airport. Sue Ling Gin, Chairman and CEO founded the Company to provide
catering services for the original Midway Airlines, an airline that was
known at that time for its fresh, innovative in-flight service. From
that small beginning, the Company has grown to include eight in-flight
kitchens in the United States and one in-flight kitchen in China. In
addition to airline catering, the Company supplies prepared snacks,
salads, and meals for major grocery chains and retailers; plus produces
frozen specialty items for these same grocery chains and retailers.
Flying Food Group has become a \$100,000,000 Company and is proud to
serve over 85 major airlines plus more than 15 major grocery chains and
retailers from its ten airport locations.

FFG is dedicated to the standards of quality, sanitation, and safety
within the on-board food service industry.

GENERAL

The passenger airlines and railways have been the industries most
directly affected by the terrorist attack on September 11, 2001. Despite
the economic situation since that tragic day, The in-flight food
services industry has responded by voluntarily taking unprecedented
steps to assure the safety of the food we prepare and serve to the
traveling public. We have hired food security professionals and
consultants; we have taken steps to safeguard our premises; and we are
carefully screening both our current employees and new hires. We are
more careful about our sources of incoming products and now take special
steps to assure the integrity of the carts of food boarded on aircraft.

Now FDA is proposing a record keeping requirement that will bury our
industry in a mountain of either paper or electronic data. Please
reconsider the ramifications of these regulations on our industry.

The following is a reasonable scenario for food service aboard an
interstate conveyance. An airplane with 300 people is to leave the East
Coast and fly about 6 hours to the West Coast. The caterer has loaded on
board sufficient beverages, snacks and meals for the passengers and
crew. There is a choice of meals in first class and 2 different meals in
coach. Five passengers have requested special meals -- 2 lacto-ovo
vegetarian meals, 2 kosher meals and 1 low-sodium meal.

The beverage service includes ice, 20 varieties of bottled/canned
drinks, juices, coffee and tea. There are lemon, sugar, sweeteners and
creamers available. All except the coffee and tea are prepared by
inspected processors and simply "passed through" by the caterer.
Nonetheless, these items come from many different suppliers and have
arrived at the caterer at different times. Some have been stored for
weeks or months. Along with the beverage service, the flight attendants
pass out packaged snacks. These are also "pass through" foods and may
represent several different deliveries and different suppliers.

Now comes the food service. The trays are prepared in the catering
kitchen. Each tray may have 5 to 7 different foods (bread, butter,
salad, dressing, entrée, vegetable, dessert, condiments). Each salad may
have 4 or 5 components from different suppliers. Each entrée may have 10
or 15 ingredients from many suppliers. For example, lasagna will include
pasta, several varieties of cheese, tomato sauce, tomato paste, 4 or 5
spices and ground beef. Even a simple sandwich would include bread,
meat, cheese, mayonnaise, lettuce and sliced tomato.

Now about those special meals!

So one flight is likely to include hundreds of individual foods from
scores of different sources, representing many suppliers. And there are
thousands of flights every day from hundreds of airports across the
country. Tomorrow's meal service will be quite different, as will the
food on the return flight.

What this proposal does is create a nightmare for our industry in the
name of making food more secure. Please remember that the situations
that this proposal is attempting to prevent are hypothetical and have
never occurred in the first 100 years of flight. FFG believes this
proposal must be modified to be significantly less burdensome or to
exempt the catering business altogether.

The following are some more specific comments regarding the subject
proposal:

COMMENT #1

The proposal solicits comments concerning the ambiguity existing within
the authorizing legislation, namely differences between wording in
Sections 306(a) and 414(b). IFSA believes that Congress specifically
used the phrase "the Secretary **may** by regulation establish
recordkeeping requirements" because it recognized that such
recordkeeping regulations might be unnecessary or be so onerous as to be
unworkable. The word "may" implies that the Secretary also "may not" as
he/she so determines..

COMMENT #2

FDA has "tentatively concluded" that it is "burdensome" and
"unnecessary" to require retail facilities to keep records of each
individual recipient consumer. The draft proposal, therefore, excludes
retail facilities from its requirements in Section 1.327(d)(1). IFSA
believes that a reasonable case can be made for including caterers in
this "retail" exemption.

Like retailers and restaurants (also exempted), caterers supplying
interstate conveyances are preparing meals for direct consumption by the
consumer. To regulate even-handedly, the maker of a sandwich whether it
is to be served in a restaurant, is to be offered for sale in a vending
machine, is to be delivered as carry-out, is to be on a hospital
patient's tray, or is to be served on a train or airplane must be
subject to the same set of rules. If restaurants and retailers are to be
exempt, caterers should also be exempt.

Past FDA Commissioners have spoken out boldly about "level playing
fields." In this case, exemption of conveyance caterers is the only way
to regulate even-handedly.

COMMENT #3

As part of the justification for the promulgation of this 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...." While IFSA agrees
with this concept, we believe the Agency can perform such traces today,
using records now available, without requiring the onerous record
keeping specified in this regulation. The potential events these
regulations are seeking to address are rare occurrences and should not
be used to justify enormous mandatory changes to current business
practices.

COMMENT #4

The Agency requested comment regarding the application of these
requirements to intra-corporate transfers of food. IFSA feels that this
regulation should not cover such transfers so long as they involve only
company owned/controlled transport vehicles. Moving food from site to
site aboard company vehicles is standard operating procedure and lacks
sufficient risk to address in a food security regulation. In fact, this
is not significantly different than transporting food from one location
to another within a single large establishment. Such a record keeping
requirement would impose unnecessary burdens on firms regarding an
everyday practice already under the control of management.

COMMENT #5

In the Agency's discussion of the term "catering facilities" in the
proposal, it makes a distinction between a snack bar on the train
selling sandwiches to consumers for immediate consumption (considered an
exempted restaurant) and the facility that provides the sandwiches to an
airplane for later consumption (considered a covered processing
establishment.) This is an arbitrary and illogical distinction. In what
way is the risk associated with that sandwich different in the two
facilities? Just because the FDA has, under the Public Health Service
Act, historically inspected the facilities providing food to interstate
conveyances, doesn't mean these facilities should be considered
processors under this security regulation.

COMMENT #6

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 back a food, the
receipt documenting the date received and the transporter should provide
sufficient information to the Agency to guide it back stepwise along the
distribution chain. Section 1.337(a)(1) is then unnecessary.

COMMENT #7

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.

IFSA assumes again that this requirement pertains only to transportation
between locations and not within a single, large location. In such a
case, IFSA feels that, as with HACCP, the company should be able to
designate the individual(s) responsible for tracking the incoming foods
and the outgoing foods. The government need not intrusively regulate how
firms do business internally. FFG suggests 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.

In summary, FFG believes these proposed requirements are onerous,
unnecessary and are unfairly being applied to our industry. FFG strongly
urges the Secretary to reconsider this proposal as written, and withdraw
or significantly modify it.

Sincerely,

Carol Heaver-Norton

Corporate Director, Quality Assurance

Flying Food Group