Public Health Security and Bioterrorism Preparedness and Response Act of 2002From: Juan Carlos Hollenstein [jchollenstein@flyingfood.com]
Sent: Friday, July 04, 2003 1:20 PM
To: 'fdadockets@oc.fda.gov'
Cc: Carol Heaver-Norton; John Long
Subject: Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Juan Carlos Hollenstein 
General Manager 
Flying Food Group JFK New York City 
147 - 17 Guy Brewer Boulevard 
Jamaica, NY 11434 
(718) 917 - 7782 ext. 177 
(718) 917-8624 fax 
jchollenstein@flyingfood.com <mailto:jchollenstein@flyingfood.com> 

                                                                        July 4th, 2003 

Attn: 
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 Bio terrorism 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, entre, vegetable, dessert, condiments).  Each salad may have 4 or 5 components from different suppliers.  Each entre 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 record keeping requirements" because it recognized that such record keeping 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,          

Juan Carlos Hollenstein 
General Manager 
Flying Food Group - JFK New York City