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　　    § 123.3   Definitions.

　　The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act （the act） and in part 110 of this chapter are applicable to such terms when used in this part, except where they are herein redefined. The following definitions shall also apply:

　　（a） Certification number means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish processor.

　　（b） Critical control point means a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.

　　（c） Critical limit means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

　　（d） Fish means fresh or saltwater finfish, crustaceans, other forms of aquatic animal life （including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals） other than birds or mammals, and all mollusks, where such animal life is intended for human consumption.

　　（e） Fishery product means any human food product in which fish is a characterizing ingredient.

　　（f） Food safety hazard means any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

　　（g） Importer means either the U.S. owner or consignee at the time of entry into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States, who is responsible for ensuring that goods being offered for entry into the United States are in compliance with all laws affecting the importation. For the purposes of this definition, ordinarily the importer is not the custom house broker, the freight forwarder, the carrier, or the steamship representative.

　　（h） Molluscan shellfish means any edible species of fresh or frozen oysters, clams, mussels, or scallops, or edible portions of such species, except when the product consists entirely of the shucked adductor muscle.

　　（i） Preventive measure means physical, chemical, or other factors that can be used to control an identified food safety hazard.

　　（j） Process-monitoring instrument means an instrument or device used to indicate conditions during processing at a critical control point.

　　（k）（1） Processing means, with respect to fish or fishery products: Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding.

　　（2） The regulations in this part do not apply to:

　　（i） Harvesting or transporting fish or fishery products, without otherwise engaging in processing.

　　（ii） Practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel.

　　（iii） The operation of a retail establishment.

　　（l） Processor means any person engaged in commercial, custom, or institutional processing of fish or fishery products, either in the United States or in a foreign country. A processing includes any person engaged in the production of foods that are to be used in market or consumer tests.

　　（m） Scombroid toxin-forming species means tuna, bluefish, mahi mahi, and other species, whether or not in the family Scombridae, in which significant levels of histamine may be produced in the fish flesh by decarboxylation of free histidine as a result of exposure of the fish after capture to temperatures that permit the growth of mesophilic bacteria.

　　（n） Shall is used to state mandatory requirements.

　　（o） Shellfish control authority means a Federal, State, or foreign agency, or sovereign tribal government, legally responsible for the administration of a program that includes activities such as classification of molluscan shellfish growing areas, enforcement of molluscan shellfish harvesting controls, and certification of molluscan shellfish processors.

　　（p） Shellstock means raw, in-shell molluscan shellfish.

　　（q） Should is used to state recommended or advisory procedures or to identify recommended equipment.

　　（r） Shucked shellfish means molluscan shellfish that have one or both shells removed.

　　（s） Smoked or smoke-flavored fishery products means the finished food prepared by:

　　（1） Treating fish with salt （sodium chloride）, and

　　（2） Subjecting it to the direct action of smoke from burning wood, sawdust, or similar material and/or imparting to it the flavor of smoke by a means such as immersing it in a solution of wood smoke.

　　（t） Tag means a record of harvesting information attached to a container of shellstock by the harvester or processor.

　　§123.3定義

　　聯邦食品、藥品及化妝品法）201條款及本章101部分對術語的定義和解釋除非重新定義、否則均適用本部分，以下定義也將適用：

　　（a）認證編號：貝類控制當局授予軟體貝類加工者的一個特定的文字與數字的組合。

　　（b）關鍵控制點：可實施控制的食品加工的一個點、工序或過程。它能防止、消除食品安全危害或使危害減少至可接受的水平。

　　（c）關鍵限值：為防止、消除已確認的食品安全危害的發生、或使危害減少至可接受的水平。必須在關健控制點加以控制的一個物理、生物或化學參數的最大或最小值。

　　（d）水產品：淡水或海水中供人類食用的，除鳥類、哺乳類以外的有鰭類、甲殼類和其他類型的水產生物、包括，但不限于鱷魚、蛙類、龜類、海蟄、海參、海膽及此類動物的卵、以及所有軟體動物。

　　（e）水產加工品：以水產為主要組分的人類食品

　　（f）食品安全危害：任何會使食品對人類消費安全構成威脅的生物、化學或物理因素。

　　（g）進口商：商品進入美國后，其在美國的貨主或受貨人，或是國外貨主或受貨人在美國的代理人或代表、此人負責確保獲準進入美國的貨物符合一切有關進口的法律。為此，通常進口商不能是海關代理人、發貨人、承運人或輪船代理人。

　　（h）軟體貝類：指新鮮或冷凍牡蠣、蛤、貽貝、扇貝的可食種類或它們的可食部分。完全由閉殼肌制成的產品除外。

　　（i）預防措施：用于控制已確定的食品安全危害的物理、化學或其他要素。

　　（j）加工監控裝置：加工過程中顯示關鍵控制點狀態的儀器或設備。

　　（k）（1）加工：對于水產及水產品的整理、貯存、預處理、去頭、去臟、去殼、冷凍，加工成不同的商品形式，以及加工、保鮮、包裝、貼標、卸貨或暫寸。

　　（2）本部分規定不適用于：

　　（）在捕撈或運輸過程中未經加工的水產及水產品。

　　（）在捕撈船上僅為水產保鮮而做的，例如去頭、去臟或去殼處理。

　　（）為零售而規定的操作。

　　（l）加工者：任何在美國或外國從事水產品商業性的、通關的或普通加工的人。加工者包括那些從事生產供銷售或消費者檢驗用食品的人員。

　　（m）產鯖魚毒素的品種：金槍魚、深藍色魚（bluefish）mahi-mahi，以及其它不論是否屬鯖魚亞目的種類，這種魚被捕撈后處于嗜溫菌可繁殖的溫度條件下，其肉中的組氨酸被分解，產生游離的組胺，并可達到一個顯著的水平。

　　（n）必須：用以表述強制性的要求。

　　（o）貝類控制當局：指一個聯邦、州或國外機構、或是君主部落的政府，其依法從事包括諸如：

　　軟體貝類生長區分類，實施貝類捕撈管制及對軟體貝類加工者進行認證等活動。

　　（o）貝類原料：生的帶殼軟體貝類

　　（q）應該：用于表述推薦或建議的步驟或明確所推薦的設備。

　　（r）去殼貝類：指軟體貝類的一側或兩側貝殼已被去掉。

　　（s）煙熏或有煙熏味的水產品：指用以下方式制成的食品：

　　（1）水產經鹽（NaCl）處理

　　（2）用木頭、木屑或類似物質燃燒產生的煙直接熏制，或是通過諸如將其浸入有木煙味的溶液中，將煙味傳給它。

　　（t）貝類標簽：捕撈者或加工者附在貝類原料容器上的捕撈情況記錄。

　　更多有關美國FDA水產品HACCP法規內容，請點擊美國FDA水產品HACCP法規匯總。