食品设施登记(Federal Food, Drug, and Cosmetic Act Sec. 350d - Registration of food facilities)

　　Sec. 415. [21 USC §350d] Registration of Food Facilities

　　（a） Registration.—

　　（1） Regulations.— In general.--The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered--

　　（A） for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and

　　（B） for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.

　　（2） Registration.—An entity （referred to in this section as the `registrant'） shall submit a registration under paragraph （1） to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through guidance, the general food category （as identified under section 170.3 of title 21, Code of Federal Regulations） of any food manufactured, processed, packed, or held at such facility. The registrant shall notify the Secretary in a timely manner of changes to such information.

　　（3） Notification.—Upon receipt of a completed registration described in paragraph （1）, the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility.

　　（4） Records.—The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. Such list and any registration documents submitted pursuant to this subsection shall not be subject to disclosure under section 552 of title 5, United States Code. Information derived from such list or registration documents shall not be subject to disclosure under section 552 of title 5, United States Code, to the extent that it discloses the identity or location of a specific registered person.

　　（b） Facility.—For purposes of this section:

　　（1） The term `facility' includes any factory, warehouse, or establishment （including a factory, warehouse, or establishment of an importer） that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels （except such vessels engaged in processing as defined in section 123.3（k） of title 21, Code of Federal Regulations）.

　　（2） The term `domestic facility' means a facility located in any of the States or Territories.

　　（3）（A） The term `foreign facility' means a facility that manufacturers, processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.

　　（B） A food may not be considered to have undergone further processing or packaging for purposes of subparagraph （A） solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food.

　　（c） Rule of Construction.—Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process.

更多有关《联邦食品、药品和化妆品法》的内容，请点击《联邦食品、药品和化妆品法》第II章及第IV章食品法规汇总。