§417.2 危害分析和HACCP计划(Hazard Analysis and HACCP Plan)

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　　 �� 417.2 Hazard Analysis and HACCP Plan.

　　（a� Hazard analysis. �?� Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.

　　�?� A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.

　　�?� Food safety hazards might be expected to arise from the following:

　　（i� Natural toxins;

　　（ii� Microbiological contamination;

　　（iii� Chemical contamination;

　　（iv� Pesticides;

　　（v� Drug residues;

　　（vi� Zoonotic diseases;

　　（vii� Decomposition;

　　（viii� Parasites;

　　（ix� Unapproved use of direct or indirect food or color additives; and

　　（x� Physical hazards.

　　（b� The HACCP plan. �?� Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph （a� of this section, including products in the following processing categories:

　　（i� Slaughter��all species.

　　（ii� Raw product��ground.

　　（iii� Raw product��not ground.

　　（iv� Thermally processed��commercially sterile.

　　（v� Not heat treated��shelf stable.

　　（vi� Heat treated��shelf stable.

　　（vii� Fully cooked��not shelf stable.

　　（viii� Heat treated but not fully cooked��not shelf stable.

　　（ix� Product with secondary inhibitors��not shelf stable.

　　�?� A single HACCP plan may encompass multiple products within a single processing category identified in this paragraph, 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 essentially the same, provided that any required features of the plan that are unique to a specific product are clearly delineated in the plan and are observed in practice.

　　�?� HACCP plans for thermally processed/commercially sterile products do not have to address the food safety hazards associated with microbiological contamination if the product is produced in accordance with the requirements of part 318, subpart G, or part 381, subpart X, of this chapter.

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

　　�?� List the food safety hazards identified in accordance with paragraph （a� of this section, which must be controlled for each process.

　　�?� 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 establishment, and

　　（ii� Critical control points designed to control food safety hazards introduced outside the establishment, including food safety hazards that occur before, during, and after entry into the establishment;

　　�?� List the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met;

　　�?� List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

　　�?� Include all corrective actions that have been developed in accordance with ��417.3（a� of this part, to be followed in response to any deviation from a critical limit at a critical control point; and

　　�?� 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.

　　�?� List the verification procedures, and the frequency with which those procedures will be performed, that the establishment will use in accordance with ��417.4 of this part.

　　（d� Signing and dating the HACCP plan. �?� The HACCP plan shall be signed and dated by the responsible establishment individual. This signature shall signify that the establishment accepts and will implement the HACCP plan.

　　�?� The HACCP plan shall be dated and signed:

　　（i� Upon initial acceptance;

　　（ii� Upon any modification; and

　　（iii� At least annually, upon reassessment, as required under ��417.4（a）（3� of this part.

　　（e� Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an establishment to develop and implement a HACCP plan that complies with this section, or to operate in accordance with the requirements of this part, may render the products produced under those conditions adulterated.

　　[61 FR 38868, July 25, 1996, as amended at 62 FR 61009, Nov. 14, 1997]

　　��417.2 危害分析和HACCP计划

　　（a）危害分枏�/p>

　　�?）每个企业都必须对确定的生产过程中很可能发生的食品安全危害进行或已进行了危害分析，并确立了企业可用于控制这些危害的预防措施。危害分析必须包括进入企业前，在企业中和进入企业后可能发生的食品安全危害。一种可能发生的食品安全危害，因历史上曾发生过，或在加工特殊类型产品中因缺少这些控制存在着将会发生的可能性，对此企业要慎重地进行控制、�/p>

　　�?� 必须制定企业内记述每个加工步骤和产品流向的流程图，还必须确定成品的预期用途或消费、�/p>

　　�?� 食品安全危害可能来自以下方面９�/p>

　　（i）天然毒紟�/p>

　　（ii）微生物污染

　　（iii）化学污柒�/p>

　　（iv）农�?/p>

　　（v）药物残畘�/p>

　　（vi）动物性疾痄�/p>

　　（vii）分解物�?/p>

　　（viii）寄生虫

　　（ix）不允许的直接或间接使用的食品或色素添加剂，咋�/p>

　　（x� 物理危害

　　（b）HACCP计划

　　�?）每个企业必须根据本节（a）段在进行危害分析的基础上制定和实施书面的HACCP计划，包括该企业所生产的每种产品，无论何时一种危害分析显示可能发生的一种或多种食品安全危害，包括下列加工种类的产品９�/p>

　　（i）屠�?-所有产�?/p>

　　（ii）生的产�?-碎的

　　（iii）生的产�?-未碎皃�/p>

　　（iv）热加工�?-商业无菌皃�/p>

　　（v）非加热处理�?-货架期稳定的

　　（vi）加热处理的--货架期稳定的

　　（vii）充分烹制的--货架期不稳定皃�/p>

　　（viii）加热处理但尚未完全熟的--货架期不稳定皃�/p>

　　（ix）带中等抑制剂的产品--货架期不稳定皃�/p>

　　�?）在本段所确定的一个单一加工种类中，一个HACCP计划可能包括多种产品，如果按本节（c）段，所要求确定的食品安全危害，关键控制点、关键限值及程序基本相同，则要提供在该计划中清楚描述并在实施中得以观察的、一种特殊产品所独有的计划任何所要求的特性、�/p>

　　�?）如果热加工或商业的无菌产品是按照本章part 318，subpart G或part 381，subpart

　　X的要求加工的，则该产品的HACCP计划 需提出与微生物污染有关的食品安全危害、�/p>

　　（C）HACCP计划的内容：

　　HACCP计划至少必须９�/p>

　　�?� 列出按照本节（a）段所确定的，对每个加工过程必须得以控制的食品安全危害、�/p>

　　�?� 列出对每个所确定的食品安全危害的关键控制点，可能的话，包括：

　　（i）制定控制可能引入企业的食品安全危害的关键控制点、�/p>

　　（ii）制定控制外部引入企业的食品安全危害的关键控制点，包括进入企业前，在企业中和进入企业后发生的食品安全危害、�/p>

　　�?（�/p>

　　列出必须符合每个关键控制点的关键限值。关键限值的设定必须最低保证FSIS所建立的可应用的目标或实施标准，必须符合本章提出的与特殊加工或产品有关的任何其它要求、�/p>

　　�?� 列出将用于监控每个关键控制点以保证符合关键限值的方法和使用这些方法的频率、�/p>

　　�?� 包括按照本部�?17.3（a），相对于任何偏离关键控制点的关键限值制定的所有纠正措施、�/p>

　　�?� 提供证实监测关键控制点的记录保存系统。该记录必须包括监控期间得到的实际值和观测结果、�/p>

　　�?� 列出按照本部�?17.4 企业将要采用的审核程序及完成这些程序的频率、�/p>

　　（d）HACCP计划的签署和注明日期、�/p>

　　�?� HACCP计划必须由企业负责人签名并注明日期，此签字必须意味着该企业将采用和实施此HACCP计划、�/p>

　　�?� HACCP计划必须注明日期并签名：

　　（i）在开始认可时：�/p>

　　（ii）有任何改变时；

　　（iii）至少每年按本部分（3）的要求再评估时

　　（e）依�?1U S C 608�?21，企业没按本节制定和实施HACCP计划，或没按本部分要求操作，那么可能提供在这种低劣条件下生产的产品、�/p>