Docket Management
Docket: 02N-0276 - Bioterrorism Preparedness; Registration of Food Facilities, Section 305
Comment Number: EC -27

Accepted - Volume 2

Comment Record
Commentor Mr. Kazuhisa Takahashi Date/Time 2002-08-30 16:45:38
Organization Japanese Embassy
Category International

Comments for FDA General
1. General Comments 1. Section 305 (1) FDA should only require minimum information necessary for registration of food facilities, so that the requirement does not become an undue burden on private businesses. (2) FDA should expeditiously register facilities that have already been manufacturing food in the United States or importing food to the United States in order not to hamper their activities. For the same reason, FDA should also expeditiously process application for registration of facilities from private businesses that apply for registration in order to newly enter into the business after the regulations come into force. (3) In order to ensure (2) above, FDA should give appropriate guidance to the private businesses so that they can apply to FDA for registration smoothly, for example, by showing a model application sheet for registration. (4) Japanese facilities manufacturing low-acid foods and acidified foods have already been registered to FDA according to the requirements provided by 21 CFR Part 113 (Thermally Processed Low-acid Foods packaged in Hermetically Sealed Containers) and Part 114 (Acidified Foods). Facilities manufacturing and processing fishery products exported to the United States have also been registered under 21 CFR Part 123. FDA should approve these facilities as registered facilities under this section and should not require additional registration. (5) According to the arrangements of plant quarantine procedures established by plant quarantine authorities in Japan and the United States, such as working plans etc., new facilities for exporting fresh fruits such as Unshu oranges (Satsuma mandarins), apples and pears are registered to the United States Department of Agriculture before the first shipment to the United States. Such facilities include fresh fruit selecting facilities. The registration of these facilities should be substituted for the registration under this section automatically. (6) Concerning the registration of exporting manufacturers, FDA should approve registration by parent companies as the representative of all their branches and subsidiary companies as an alternative to the registration by each branch and subsidiary of such parent companies. (7) FDA should take proper actions to avoid abuse of registered numbers by terrorists etc. (8) FDA should accept electronic registration and submission of documents by organizations or agents on behalf of facilities that need to be registered in order to ensure smooth and reliable registration procedures. (9) Since FDA will be introducing completely new regulations, unintentional errors or need for correction on application forms should not be punished too severely, such as recalling products already distributed in the market. (10) FDA should approve the registration as valid for sufficient long time, in order to avoid undue burden on activities of private businesses by requiring frequent re-registrations. (11) Facilities of Animal and Plant Quarantine Services of the Government of Japan should not be required to register under this section.

EC -27