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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定义
联邦食品、药品及化妆品法）201条款及本章101部分对术语的定义和解释除非重新定义、否则均适用本部分，以下定义也将适用：
（a）认证编号：贝类控制当局授予软体贝类加工者的一个特定的文字与数字的组合。
（b）关键控制点：可实施控制的食品加工的一个点、工序或过程。它能防止、消除食品安全危害或使危害减少至可接受的水平。
（c）关键限值：为防止、消除已确认的食品安全危害的发生、或使危害减少至可接受的水平。必须在关健控制点加以控制的一个物理、生物或化学参数的最大或最小值。
（d）水产品：淡水或海水中供人类食用的，除鸟类、哺乳类以外的有鳍类、甲壳类和其他类型的水产生物、包括，但不限于鳄鱼、蛙类、龟类、海蛰、海参、海胆及此类动物的卵、以及所有软体动物。
（e）水产加工品：以水产为主要组分的人类食品
（f）食品安全危害：任何会使食品对人类消费安全构成威胁的生物、化学或物理因素。
（g）进口商：商品进入美国后，其在美国的货主或受货人，或是国外货主或受货人在美国的代理人或代表、此人负责确保获准进入美国的货物符合一切有关进口的法律。为此，通常进口商不能是海关代理人、发货人、承运人或轮船代理人。
（h）软体贝类：指新鲜或冷冻牡蛎、蛤、贻贝、扇贝的可食种类或它们的可食部分。完全由闭壳肌制成的产品除外。
（i）预防措施：用于控制已确定的食品安全危害的物理、化学或其他要素。
（j）加工监控装置：加工过程中显示关键控制点状态的仪器或设备。
（k）（1）加工：对于水产及水产品的整理、贮存、预处理、去头、去脏、去壳、冷冻，加工成不同的商品形式，以及加工、保鲜、包装、贴标、卸货或暂寸。
（2）本部分规定不适用于：
（ⅰ）在捕捞或运输过程中未经加工的水产及水产品。
（ⅱ）在捕捞船上仅为水产保鲜而做的，例如去头、去脏或去壳处理。
（ⅲ）为零售而规定的操作。
（l）加工者：任何在美国或外国从事水产品商业性的、通关的或普通加工的人。加工者包括那些从事生产供销售或消费者检验用食品的人员。
（m）产鲭鱼毒素的品种：金枪鱼、深蓝色鱼（bluefish）mahi-mahi，以及其它不论是否属鲭鱼亚目的种类，这种鱼被捕捞后处于嗜温菌可繁殖的温度条件下，其肉中的组氨酸被分解，产生游离的组胺，并可达到一个显著的水平。
（n）必须：用以表述强制性的要求。
（o）贝类控制当局：指一个联邦、州或国外机构、或是君主部落的政府，其依法从事包括诸如：
软体贝类生长区分类，实施贝类捕捞管制及对软体贝类加工者进行认证等活动。
（o）贝类原料：生的带壳软体贝类
（q）应该：用于表述推荐或建议的步骤或明确所推荐的设备。
（r）去壳贝类：指软体贝类的一侧或两侧贝壳已被去掉。
（s）烟熏或有烟熏味的水产品：指用以下方式制成的食品：
（1）水产经盐（NaCl）处理
（2）用木头、木屑或类似物质燃烧产生的烟直接熏制，或是通过诸如将其浸入有木烟味的溶液中，将烟味传给它。
（t）贝类标签：捕捞者或加工者附在贝类原料容器上的捕捞情况记录。
更多有关美国FDA水产品HACCP法规内容，请点击美国FDA水产品HACCP法规汇总。
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