2002N-0276 - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Reopening of Comment Period
FDA Comment Number : EC375
Submitter : Mr. Patrick Donoho Date & Time: 05/19/2004 09:05:52
Organization : International Bottled Water AAssociation
Food Association
Category :
Issue Areas/Comments
May 14, 2004

Re: Interim Final Regulations of PL 107-188:
Food Facility Registration ? Docket No. 02N-0276

Dear Sir or Madam:
The International Bottled Water Association (IBWA) appreciates the opportunity to submit additional comments to the U.S. Food and Drug Administration (FDA) on the interim final regulations on food facility registration and prior notice of food importation that implement the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. No. 107-188).
IBWA is dedicated to helping ensure the safety and quality of bottled water. IBWA is committed to preventing potential adverse events, both natural and man-made, through monitoring and testing, risk assessment, risk management, appropriate controls and procedures, and due diligence. Prior to the December 12, 2003, interim regulations? effective date, IBWA conducted a series of eight seminars that were three and one half hour long in six regions of the country to educate bottlers, distributors, and bottled water suppliers on the interim final regulations and the requirements for compliance with the regulations by the bottled water industry. IBWA also produced a CD ROM for seminar participants, and for other IBWA members at a nominal charge, that contained the IBWA presentation and materials, the interim final regulations, and FDA?s supporting materials.
In addition, IBWA has continued this education process through 2004 by conducting additional seminars at five state and regional bottled water associations meetings. IBWA has also publicized the interim final regulations in the Association?s newsletter and bimonthly publication.

IBWA sincerely appreciates this opportunity to provide FDA with additional input on the areas of the interim final regulations that need further clarification and/or modification, and the experience with the workability of the regulation since they became effective.
IBWA commends FDA on the timely implementation of the Federal Unified Registration and Licensing System (FURLS), the online system for food facility registration. This is a prime example of excellence from the agency. With only a few technical difficulties, this system has been relatively simple for bottlers, distributors, and suppliers to use to register their food facilities, according to reports from IBWA members. This has been true for initial registrations and also for the updating of facility information. As a user friendly and secure system, it is impressive that FDA has had as few technical difficulties with the system.
Docket No. 02N-0276 - Registration of Food Facilities
IBWA Comments
IBWA commends FDA on the attention and resources the Agency devoted to developing FURLS. The feedback received by IBWA from our membership is that the system is user friendly and sufficiently flexible to adapt to the variety of corporate configurations and situations. Those who have used it update their registration information indicate that it was a very simple process.
Food Categories
One area of confusion with the current system is the food category section of the registration. This section appears to need further refinement. There are a number of various ingredients and processing aids, such as chlorine dioxide or carbon dioxide, that do not neatly fit the broad general categories within the regulations, although they are stored and used in bottling plants and thus subject to the regulations. Either further clarification of the current categories or the addition of categories would be helpful in maintaining facility registrations.
IBWA urges FDA to continually review the categories to further refine them to include more descriptive definitions and possibly add categories to cover such food products as processing aids that do not neatly fit the current categories.
IBWA urges FDA to continue the outreach effort and improve the communication with affected industry.