From: Omni [mail@omnipacific.net]
Sent: Wednesday, June 02, 2004 7:17 PM
To: 'fdadockets@oc.fda.gov'
Subject: Docket No. 1998N-0583 Department of Health and Human Services - F ood and Drug Administration

Subject: Comments on Docket No. 1998N-0583
Export notification and recordkeeping. 

To: Department of Health and Human Services / Food and Drug Administration.

Good morning. Brett Roberts here, President of Omni Pacific Co., Inc. A food and beverage wholesale and export corporation in good standing, located in Walnut Creek, CA. 

With all the many changes in Federal Law since the Patriot Act and the confusing reorganizing of most governmental departments. I will admit to ingnorance as to the legality or not of the FDA jurisdication over export shipments. I do feel that having to submit multiple forms now to multiple beauracracies is overly time consuming. Especially when we have time sensitive food products that need to ship out on schedule to our overseas customers. While being a good US corporate and tax paying citizen employees who support the war on terrorists, we agree some checking of cargos to see that they are not going to the wrong people or places is valid. But this function is being properly addressed by US Customs services. All USA produced products that we export are already being inspected at the plant origin under USDA services. Having to certify that all goods being shipped to foreign countries meet their foreign regulations is difficult enough, without having to also certify to our own FDA the appropriate manufacturer registration numbers, which are difficult to obtain most times. Especially in light of the fact the FDA will not allow us into their database to easily get the appropriate FDA registration numbers for the 34,000 products we export to 46 countries. Some of our mixed grocery load containers have over 1000 different items in the container. For which they want all the FDA registration numbers is just a crazy waste of our and the government's time. I am betting no one at the FDA reviews even 1% of this mountain of useless data. 

Our firm plays fair and we have nothing to hide from the FDA or any other government agency. How ever I do not see the need or waste of government resources and our tax payer dollars to have the FDA get involved in legitimate export shipments of already US government inspected food and beverage products being exported. It appears to be a huge boon doggle and power grabbing ploy by the FDA to us. Although we are none the less subject to this needless wasted expense in labor and time involved in complying with this new, one of many new directives and regulations the past couple of years. 

Please do not hesitate to contact me if I can answer any questions you may have on this or any issue. 

Sincerely yours,


Brett Roberts
President
Omni Pacific Co., Inc. 
2499 North Main St. Ste#250
Walnut Creek, CA. 94597 USA
Ph# 925-933-0695