From: BFloyd7192@aol.com Sent: Friday, June 25, 2004 1:04 PM To: fdadockets@oc.fda.gov Cc: BFloyd7192@aol.com Subject: Docket No: 2002N-0278];[FR Doc: 04-11247];[Page 28060-28061]; Public Health Secu Docket 2002N-0278 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Interim final rule. I am Bruce Floyd, the owner of the small business Process Systems Consulting, Iowa City, Iowa. I provide consulting services both within the US and to other countries. The majority of my foreign clients are in developing countries. I assist companies with raw material sourcing, product development, designing and implementing processing systems, quality control and food safety issues. My service not only includes finding raw material sources but in monitoring the quality of raw materials provided. The majority of my clients either use or process dairy derived materials. To provide this service for the foreign clients, I secured a United States Veterinary Permit for the importation and Transportation of Controlled Materials and Organisms and Vectors in 1998. I have renewed the permit each year since. My permit number is 45319. This program is administered by the USDA Animal and Plant Health Inspection Service, Veterinary Services, Riverdale, Maryland. Under the program each sample from outside the US is reviewed by the USDA/APHIS for proper packaging and permit number before being allowed to proceed to my registered location. When bring samples into the US, I furnish a list of samples along with a copy of the permit. The USDA/APHIS inspector examines the samples for labeling, permit authority and proper packaging. The approved location is subject to audits and record keeping reviews. I have been audited. The samples do not enter the neither the human nor animal food supply of the United States. How the material is to be disposed is listed in the permit. Before Prior Notice, this was a fairly good system and good business. My clients could send samples to me from various locations via FedEx, DHL or other services or I could bring them back from other countries with me. All that was required was a copy of the Permit along with a packing list. Many of these samples originated from suppliers in the US; but lacking the original packaging container, this can not be verified so the Permit system eliminated the problem of returning samples to the US for review. Since Prior Notice has begun, this business has all but disappeared. At present in order to send samples to me, the client has to register with the FDA even if they do not do any business in the US. Their suppliers from countries other than the US have to be registered with the FDA in order to send me samples directly. To bring samples in when returning to the US requires hours on line to make a Prior Notice due to the very slow response time of the FDA server. In some areas this is extremely expensive due to local telephone rates. There is the other problem that the system does not recognize US goods returned. Many times the samples taken of US goods are due to quality problems. My clients must have a FDA registration number in order to complain about poor quality US origin materials. If they have a registration number, the carriers are requiring that customs’ brokers process the Prior Notices before they will take the samples. This adds cost to s system that previously only involved a freight charge and a copy of the USDA/APHIS permit. If they do not have a registration number, the samples are rejected. Without samples to justify a claim and a third party opinion of these samples, the developing world company is at the mercy of the vendor. Poor quality materials arriving in the developing world from the US and Europe are a very big problem and an impediment to improving the quality and safety of the domestic food supply in many areas of the world. Since Prior Notification has begun, most of my clients have stopped shipping samples to the US. Many are buying raw materials without the benefit of prior sample approval and are receiving, at times, ingredients of poor quality. The recourse for local companies once the material has arrived is limited. I believe that samples that are brought into the US under the supervision of the USDA/APHIS and controlled through their Permit system should be exempt from the Prior Notification requirements of the act. This is a duplication of effort that does not bring any more control than what already existed. The samples are being recorded twice. Prior Notification in this instance puts an undue burden on the foreign company that wishes to use US expertise. Bruce Floyd Process Systems Consulting Bfloyd7192@aol.com 319-351-8352 1809 Hafor Drive Iowa City, IA 52246