原文后附帶中文翻譯，由食品伙伴網(wǎng)食品論壇網(wǎng)友gaoketian提供，食品伙伴網(wǎng)在此表示感謝！
§ 417.2 Hazard Analysis and HACCP Plan.
?。╝） Hazard analysis. （1） 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.
（2） 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;
?。╥i） Microbiological contamination;
?。╥ii） Chemical contamination;
（iv） Pesticides;
（v） Drug residues;
?。╲i） Zoonotic diseases;
（vii） Decomposition;
?。╲iii） Parasites;
（ix） Unapproved use of direct or indirect food or color additives; and
?。▁） Physical hazards.
?。╞） The HACCP plan. （1） 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:
?。╥） Slaughter—all species.
（ii） Raw product—ground.
?。╥ii） Raw product—not ground.
（iv） Thermally processed—commercially sterile.
?。╲） Not heat treated—shelf stable.
（vi） Heat treated—shelf stable.
?。╲ii） Fully cooked—not shelf stable.
?。╲iii） Heat treated but not fully cooked—not shelf stable.
?。╥x） Product with secondary inhibitors—not shelf stable.
（2） 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.
（2） List the critical control points for each of the identified food safety hazards, including, as appropriate:
?。╥） Critical control points designed to control food safety hazards that could be introduced in the establishment, and
?。╥i） 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;
（5） 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.
?。╠） Signing and dating the HACCP plan. （1） The HACCP plan shall be signed and dated by the responsible establishment inpidual. 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;
?。╥i） Upon any modification; and
（iii） At least annually, upon reassessment, as required under §417.4（a）（3） of this part.
?。╡） 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計劃
（a）危害分析
?。?）每個企業(yè)都必須對確定的生產(chǎn)過程中很可能發(fā)生的食品安全危害進行或已進行了危害分析，并確立了企業(yè)可用于控制這些危害的預(yù)防措施。危害分析必須包括進入企業(yè)前，在企業(yè)中和進入企業(yè)后可能發(fā)生的食品安全危害。一種可能發(fā)生的食品安全危害，因歷史上曾發(fā)生過，或在加工特殊類型產(chǎn)品中因缺少這些控制存在著將會發(fā)生的可能性，對此企業(yè)要慎重地進行控制。
（2） 必須制定企業(yè)內(nèi)記述每個加工步驟和產(chǎn)品流向的流程圖，還必須確定成品的預(yù)期用途或消費。
（3） 食品安全危害可能來自以下方面：
?。╥）天然毒素
?。╥i）微生物污染
?。╥ii）化學(xué)污染
?。╥v）農(nóng)藥
?。╲）藥物殘留
（vi）動物性疾病
?。╲ii）分解物質(zhì)
?。╲iii）寄生蟲
?。╥x）不允許的直接或間接使用的食品或色素添加劑，和
?。▁） 物理危害
（b）HACCP計劃
?。?）每個企業(yè)必須根據(jù)本節(jié)（a）段在進行危害分析的基礎(chǔ)上制定和實施書面的HACCP計劃，包括該企業(yè)所生產(chǎn)的每種產(chǎn)品，無論何時一種危害分析顯示可能發(fā)生的一種或多種食品安全危害，包括下列加工種類的產(chǎn)品：
（i）屠宰--所有產(chǎn)品
?。╥i）生的產(chǎn)品--碎的
?。╥ii）生的產(chǎn)品--未碎的
?。╥v）熱加工的--商業(yè)無菌的
?。╲）非加熱處理的--貨架期穩(wěn)定的
（vi）加熱處理的--貨架期穩(wěn)定的
?。╲ii）充分烹制的--貨架期不穩(wěn)定的
?。╲iii）加熱處理但尚未完全熟的--貨架期不穩(wěn)定的
?。╥x）帶中等抑制劑的產(chǎn)品--貨架期不穩(wěn)定的
?。?）在本段所確定的一個單一加工種類中，一個HACCP計劃可能包括多種產(chǎn)品，如果按本節(jié)（c）段，所要求確定的食品安全危害，關(guān)鍵控制點、關(guān)鍵限值及程序基本相同，則要提供在該計劃中清楚描述并在實施中得以觀察的、一種特殊產(chǎn)品所獨有的計劃任何所要求的特性。
?。?）如果熱加工或商業(yè)的無菌產(chǎn)品是按照本章part 318，subpart G或part 381，subpart
X的要求加工的，則該產(chǎn)品的HACCP計劃 需提出與微生物污染有關(guān)的食品安全危害。
（C）HACCP計劃的內(nèi)容：
HACCP計劃至少必須：
?。?） 列出按照本節(jié)（a）段所確定的，對每個加工過程必須得以控制的食品安全危害。
（2） 列出對每個所確定的食品安全危害的關(guān)鍵控制點，可能的話，包括：
?。╥）制定控制可能引入企業(yè)的食品安全危害的關(guān)鍵控制點。
?。╥i）制定控制外部引入企業(yè)的食品安全危害的關(guān)鍵控制點，包括進入企業(yè)前，在企業(yè)中和進入企業(yè)后發(fā)生的食品安全危害。
（3）
列出必須符合每個關(guān)鍵控制點的關(guān)鍵限值。關(guān)鍵限值的設(shè)定必須最低保證FSIS所建立的可應(yīng)用的目標(biāo)或?qū)嵤?biāo)準(zhǔn)，必須符合本章提出的與特殊加工或產(chǎn)品有關(guān)的任何其它要求。
（4） 列出將用于監(jiān)控每個關(guān)鍵控制點以保證符合關(guān)鍵限值的方法和使用這些方法的頻率。
（5） 包括按照本部分417.3（a），相對于任何偏離關(guān)鍵控制點的關(guān)鍵限值制定的所有糾正措施。
?。?） 提供證實監(jiān)測關(guān)鍵控制點的記錄保存系統(tǒng)。該記錄必須包括監(jiān)控期間得到的實際值和觀測結(jié)果。
（7） 列出按照本部分417.4 企業(yè)將要采用的審核程序及完成這些程序的頻率。
?。╠）HACCP計劃的簽署和注明日期。
?。?） HACCP計劃必須由企業(yè)負(fù)責(zé)人簽名并注明日期，此簽字必須意味著該企業(yè)將采用和實施此HACCP計劃。
?。?） HACCP計劃必須注明日期并簽名：
?。╥）在開始認(rèn)可時；
（ii）有任何改變時；
（iii）至少每年按本部分（3）的要求再評估時
?。╡）依據(jù)21U S C 608和621，企業(yè)沒按本節(jié)制定和實施HACCP計劃，或沒按本部分要求操作，那么可能提供在這種低劣條件下生產(chǎn)的產(chǎn)品。
更多國外法規(guī)翻譯，請聯(lián)系食品翻譯中心
編輯：foodfagui