Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -29

Accepted - Volume 2

Comment Record
Commentor Mr. joel friedman Date/Time 2002-08-31 00:06:30
Organization MIKAWAYA
Category Food Industry

Comments for FDA General
Questions
1. General Comments I attended your seminar known as Food Security and Recalls Workshop. At this seminar I learned that the FDA is about to write the regulations for the, Public Health Security and Bioterrorism Preparedness and Response Act of 2002. We were told that public input was request and encouraged. I am therefore writing you to concerning certain provisions of this act. DOCKET No. 02N-0276 The area of my concern relates to imported food. Our company has been in business in Los Angeles for 92 years. The company is a family owned and operated business. We specialize in the manufacture and sale of traditional Japanese pastries. We have 5 retail locations where we sell the products we make as well as products we import from Japan. Additionally, due to the unique nature of our business, we are forced to purchase many raw ingredients from Japan that go into the making of our products. It is my understanding, based on what I believe I have learned, that part of the plan is to insist that all manufacturers of finished food as well as ingredients will be required to register with FDA. While I agree with the concept, it is the details that concern me. As an example, we purchase many different items from Japan and although I would like say that we buy big quantities, it is not the case. We purchase our items from a wholesaler in Japan. We do this via a shipping agent that consolidates the shipments into one container and then sends it to us. Many of the companies, who's products we purchase actually do not sell to the United States or do not know they are selling to the United States. Most of these companies do not speak English and would have a difficult time registering. While the dollar volume is not large, eliminating these items from the United States would in some small measure disenfranchise many good and decent people most of whom do not speak much English. They have no idea of how they would interact with the government to make their needs and wants known. As a suggestion, would it be possible to have the distributor register with the FDA and therefore by using the distributors' registration the different manufacturers would be able to send their products to the United States? Much like today, the name and address of all the manufacturers would be listed, and through this list as well as the other shipping documents, it would be possible to do a traceback should it be necessary. I also believe that it would be possible to require that the manufacturers give to the distributor some type of lot number so that the ability to traceback would be easier and more concise. In conclusion, regarding this area, what I am requesting would be somewhat like the small business exemption to the nutritional labeling law. , But unlike the nutritional labeling law the manufacturers would not be completely exempted only that it be modified to allow small businesses and small minorities to continue to enjoy foods of their culture.




EC -29