§123.6 危害分析和危害分析关健控制点（HACCP）计划(Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan)

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　   　§ 123.6   Hazard analysis and Hazard Analysis Critical Control Point （HACCP） plan.

　　（a） Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed by that processor and to identify the preventive measures that the processor can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment, including food safety hazards that can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent processor would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that it will occur in the particular type of fish or fishery product being processed in the absence of those controls.

　　（b） The HACCP plan. Every processor shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, as described in paragraph （a） of this section. A HACCP plan shall be specific to:

　　（1） Each location where fish and fishery products are processed by that processor; and

　　（2） Each kind of fish and fishery product processed by the processor. The plan may group kinds of fish and fishery products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in paragraph （c） of this section are identical for all fish and fishery products so grouped or for all production methods so grouped.

　　（c） The contents of the HACCP plan. The HACCP plan shall, at a minimum:

　　（1） List the food safety hazards that are reasonably likely to occur, as identified in accordance with paragraph （a） of this section, and that thus must be controlled for each fish and fishery product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:

　　（i） Natural toxins;

　　（ii） Microbiological contamination;

　　（iii） Chemical contamination;

　　（iv） Pesticides;

　　（v） Drug residues;

　　（vi） Decomposition in scombroid toxin-forming species or in any other species where a food safety hazard has been associated with decomposition;

　　（vii） Parasites, where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so consumed;

　　（viii） Unapproved use of direct or indirect food or color additives; and

　　（ix） Physical hazards;

　　（2） List the critical control points for each of the identified food safety hazards, including as appropriate:

　　（i） Critical control points designed to control food safety hazards that could be introduced in the processing plant environment; and

　　（ii） Critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest;

　　（3） List the critical limits that must be met at each of the critical control points;

　　（4） List the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

　　（5） Include any corrective action plans that have been developed in accordance with §123.7（b）, to be followed in response to deviations from critical limits at critical control points;

　　（6） List the verification procedures, and frequency thereof, that the processor will use in accordance with §123.8（a）;

　　（7） Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

　　（d） Signing and dating the HACCP plan. （1） The HACCP plan shall be signed and dated, either by the most responsible individual onsite at the processing facility or by a higher level official of the processor. This signature shall signify that the HACCP plan has been accepted for implementation by the firm.

　　（2） The HACCP plan shall be dated and signed:

　　（i） Upon initial acceptance;

　　（ii） Upon any modification; and

　　（iii） Upon verification of the plan in accordance with §123.8（a）（1）.

　　（e） Products subject to other regulations. For fish and fishery products that are subject to the requirements of part 113 or 114 of this chapter, the HACCP plan need not list the food safety hazard associated with the formation of Clostridium botulinum toxin in the finished, hermetically sealed container, nor list the controls to prevent that food safety hazard. A HACCP plan for such fish and fishery products shall address any other food safety hazards that are reasonably likely to occur.

　　（f） Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with §123.11（b） they need not be included in the HACCP plan, and vice versa.

　　（g） Legal basis. Failure of a processor to have and implement a HACCP plan that complies with this section whenever a HACCP plan is necessary, otherwise operate in accordance with the requirements of this part, shall render the fish or fishery products of that processor adulterated under section 402（a）（4） of the act. Whether a processor's actions are consistent with ensuring the safety of food will be determined through an evaluation of the processors overall implementation of its HACCP plan, if one is required.

　　§123.6 危害分析和危害分析关健控制点（HACCP）计划

　　（a）危害分析。每个加工者必须进行或业已进行危害分析，以确定每种水产及水产品在接受加工者的加工时是否有理由且有可能产生食品安全危害，并确定加工者所能采用的控制危害的预防措施。这些危害可以从加工场所的内外环境引入，包括在捕捞的前、中、后发生的危害。有理由且有可工过程在缺乏控制的情况下，这些危害的产生是有理由，而且是有可能的，谨慎的加工者应对此实施控制。

　　（b）HACCP计划。当本节（a）段所述的危害分析表明有理由且有可能产生一种或多种食品安全危害时，每个加工者必须拥有并执行一个已成文的HACCP计划。一份HACCP计划须列明：

　　（1）加工者加工水产及水产品的每处地点；

　　（2）加工者所加工的水产及水产品种类。如果本节（c）段所要求确定和实施的食品安全危害、关键控制点、关键限值和程序与某些水产及水产品相同，计划可以将这些水产和水产品的加工方法合并归类。

　　（c）HACCP计划的内容。HACCP计划必须至少包括以下内容：

　　（1）要列明按照本节（a）段确定的。有理由且有可能发生，并且在水产及水产品中必须加以控制的食品安全危害，要考虑到是否由于下列原因，食品安全危害有理由且有可能发生：

　　（i）天然毒素

　　（ii）微生物污染

　　（iii）化学污染

　　（iv）杀虫剂

　　（v）农药残留

　　（vi）产鲭鱼毒素品种的腐败，或者与食品安全危害有关的其它种类水产品的腐败。

　　（vii）寄生虫。加工者必须对那些携带有寄生虫的水产及水产品可能会在未经足以杀灭寄生虫的加工处理的情况下被食用具备经验和知识，或者加工者要对这样食用的产品做出说

　　（viii）违规直接或间接使用食品添加剂或色素。

　　（ix）物理危害

　　（2）列出每个已经识别的食品安全危害的关键控制点，要相应的包括：

　　（i）控制加工厂内部环境危害食品安全的关键控制点。

　　（ii）用于控制来自工厂外部环境（包括捕捞前、中、后）的食品安全危害的关键控制点

　　（3）列明在每个关键控制点必须达到的关键限值。

　　（4）列明为保证符合关键限值，监测各关键控制点需采用的监测程序和监测次数；

　　（5）包括、针对关键控制点上关键限值的偏离需要采取的，按照§123.7（b）制订的各种纠正措施计划。

　　（6）列明加工者按照§123.8（a）将采用的验证程序和验证次数。

　　（7）规定记录各关键控制点监测情况的记录保持制度，记录须包含监测过程中所获取的实际数值和观察情况。

　　（d）HACCP计划的签署

　　（1）HACCP计划要由工厂在职的最高负责人，或厂方较高级别的职员签字和注明日期。签署必须注明生产商已同意实施该HACCP计划。

　　（i）首次同意

　　（ii）在任何修改时

　　（iii）计划按§123.8（a）（1）所制定的计划验证时

　　（e）受其它法规约束的产品。

　　受本章113或114部分约束的水产及水产品。其HACCP计划不需要把与在的控制方法。这部分水产及水产品的HACCP计划要列出其它各种有理由且有可能产生的食品安全危害。

　　（f）卫生。

　　卫生控制措施可以列入HACCP计划。然而，按照§123.11（b）实施监控的那些范围不必列入HACCP计划，反之亦然。

　　（g）法律依据。

　　当HACCP是必需的时候，对于没有和未执行一个符合本节要求的HACCP计划，未按本部分的要求进行操作的加工者，其水产和水产品将依照本法402条款（a）（4）被视为伪劣食品。加工者的操作是否能持续保障食品的安全，必要时，将通过对加工者实施HACCP计划的情况进行-次评估来作出判断。

　　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。