Fed Regist. 2008 Nov 7;73(217):66293-410.
The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled "Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002."
美国食品药品监督管理局（FDA）正在发布一项最终规定，要求向FDA提交进口或拟进口至美国的食品（包括动物饲料）的预先通知。最终规则实施了2002年《公共卫生安全与生物恐怖主义防范与应对法案》（《生物恐怖主义法案》），该法案要求自2003年12月12日起对进口食品进行预先通报。最终规则要求通过自动商业系统（ACS）的美国海关与边境保护局（CBP或海关）自动报关行接口（ABI）或FDA预先通知系统接口（FDA PNSI）以电子方式向FDA提交预先通知。必须在食品抵达入境口岸前至少8小时（对于通过水路抵达的食品）、4小时（对于通过空运或陆运/铁路抵达的食品）和2小时（对于通过陆路/公路抵达的食品）以电子方式提交并由FDA确认信息表面完整以供审查。未提供充分预先通知而进口或拟进口的食品可能会被拒收，若被拒收，则必须予以扣留。在本期《联邦公报》的其他地方，FDA宣布提供一份合规政策指南（CPG）草案，标题为“2002年《公共卫生安全与生物恐怖主义防范与应对法案》下进口食品的第110.310条预先通知”。
