Docket Management
Docket: 02N-0278 - Bioterrorism Preparedness; Prior Notice of Imported Food Shipments, Section 307
Comment Number: EC -31

Accepted - Volume 2

Comment Record
Commentor Mr. Kazuhisa Takahashi Date/Time 2002-08-30 16:51:10
Organization Japanese Embassy
Category International

Comments for FDA General
1. General Comments General questions 1. When does FDA reply to our initial comments and questions? Please explain FDAfs working procedures for formulating the regulations after receiving comments and questions from stakeholders. How are our comments and questions treated in the process for formulating regulations? 2. Has FDA already conducted a cost / benefit analysis for implementation of regulations that are aimed at enhancing the security of the U.S. food supply? 3. Which article of the GATT/WTO agreements justify the strengthening of those food safety regulations? 4. Will the U.S. support Japan if Japan decides to introduce the food safety related measures that is similar to those in the Title ‡Vof the Bioterrorism Act? 5. We understand that the regulations will apply to all foods within FDAfs jurisdiction. Do the regulations apply not only to processed food, but also to fresh agricultural products? Please clarify all the foods regulated by title III of the Act. 6. Is it correct to understand that foods within USDAfs jurisdiction, such as meat and eggs are out of the purview of the regulations? If this is correct, please explain why such foods are exempted. 7. Japanese food manufacturers, in many cases, export and sell foods via a trading company or a shipping company, rather than export by themselves. In these cases, who (manufacturers or trading/shipping companies) must comply with obligations under the Act such as gregister food facilitiesh, gmaintain recordsh and gnotice imported food shipmentsh? 8. In case that trading or distributing company exports foods purchased in Japan to the United States, who must comply with obligations under the Act such as gregister food facilitiesh, gmaintain recordsh and gnotice imported food shipmentsh? How should these obligations be met? 9. Are manufacturing or trading companies that deal with foods manufactured, sold and consumed inside a single State within the purview of the Bioterrorism Act? 10. Are any new tasks (such as the issuance of certification, submission of the list of any exporting manufacturers, etc.) required for the government of the exporting country after the enactment of the new regulations? If yes, please explain. IV Questions for individual provisions 1. Section 305 (1) We understand that food facilities will be registered only by notification of the documents and there will be neither standard of registered facilities that need to be met nor a determination on whether such a standard is met by the U.S. government. Is that right? (2) How long will a registration be valid? (3) Please explain the definition of the gagent in charge of a domestic or foreign facilityh in this section that needs to submit a registration to the Secretary. (4) Does FDA include gfacilities of food additivesh in the definition of gfood facilitiesh? 2. Section 306 (1) 21CFR113 requires automatic detention of canned foods, when deviation of thermal processing and sealing is detected because it could be a life threatening problem. Will the Bioterrorism Act also order automatic detention or inspection of records, when deviation of such critical control points is detected? (2) Who is required to establish and maintain the records? gSec.305 Registration of Food Facilities of the Bioterrorism Acth states gLimits foreign facilities to those that manufacture, process, pack, or hold food only if food from such facility is exported to the U.S. without further processing or packaging outside the U.S.h Does this mean that there is an obligation for entities that are outside the United States to establish and maintain records? (3) When FDA accesses the records of the exporting facility relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of the food, will FDA notify the exporting country of its actions? (4) Please clarify the scope of the record that FDA expects the manufacturers to keep. Must the manufacturers keep the record of supplier or importer of all of the ingredients, however, small the quantity may be? 3. Section 307 (1) Will FDA use prior notice in same manner to reject a shipment of foods to be exported to the United States? What circumstances will the prior notice be used to reject a shipment? (2) Who must provide the prior notice to the FDA? Importer, exporter or both? (3) Prior notice is an obligatory measure for import foods. Are there any equivalent measures for foods that are manufactured, distributed and consumed inside the United States? (4) When some article is refused admission under this section, will FDA notify the government of exporting countries of that fact and immediately ask them to provide information related to the articles? (5) Who will keep the articles that is held at the port of entry, quarantine authority of the U.S. or the U.S. importer? Who will be responsible for the maintenance of the quality of such articles? 4. Section 303 (1) Are there any reason other than no registration, no notification and inappropriate records with which the FDA will order the detention of food? If so, please identify such reasons. (2) Please identify the measures or procedures that the importers and exporters may take to seek the repeal of an detention order by FDA. (3) We believe that the condition for detention that gcredible evidence or information indicating the article presents a threat of serious adverse health consequences or death to humans or animalsh is unclear. Please provide us several examples of what would constitute gcredible evidence or informationh. (4) Will FDA plan to establish a list of biological agents that are subject to intense inspection? (5) When some food is detained under this section, will FDA notify the government of exporting country of that fact and seek necessary information? (6) Who will keep the food that is detained under this section at the port of entry, quarantine authority of the U.S., or the U.S. importer? Who will be responsible for the maintenance of the quality of such food?

EC -31