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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關(guān)健控制點(diǎn)（HACCP）計(jì)劃
（a）危害分析。每個(gè)加工者必須進(jìn)行或業(yè)已進(jìn)行危害分析，以確定每種水產(chǎn)及水產(chǎn)品在接受加工者的加工時(shí)是否有理由且有可能產(chǎn)生食品安全危害，并確定加工者所能采用的控制危害的預(yù)防措施。這些危害可以從加工場(chǎng)所的內(nèi)外環(huán)境引入，包括在捕撈的前、中、后發(fā)生的危害。有理由且有可工過(guò)程在缺乏控制的情況下，這些危害的產(chǎn)生是有理由，而且是有可能的，謹(jǐn)慎的加工者應(yīng)對(duì)此實(shí)施控制。
（b）HACCP計(jì)劃。當(dāng)本節(jié)（a）段所述的危害分析表明有理由且有可能產(chǎn)生一種或多種食品安全危害時(shí)，每個(gè)加工者必須擁有并執(zhí)行一個(gè)已成文的HACCP計(jì)劃。一份HACCP計(jì)劃須列明：
（1）加工者加工水產(chǎn)及水產(chǎn)品的每處地點(diǎn)；
（2）加工者所加工的水產(chǎn)及水產(chǎn)品種類。如果本節(jié)（c）段所要求確定和實(shí)施的食品安全危害、關(guān)鍵控制點(diǎn)、關(guān)鍵限值和程序與某些水產(chǎn)及水產(chǎn)品相同，計(jì)劃可以將這些水產(chǎn)和水產(chǎn)品的加工方法合并歸類。
（c）HACCP計(jì)劃的內(nèi)容。HACCP計(jì)劃必須至少包括以下內(nèi)容：
（1）要列明按照本節(jié)（a）段確定的。有理由且有可能發(fā)生，并且在水產(chǎn)及水產(chǎn)品中必須加以控制的食品安全危害，要考慮到是否由于下列原因，食品安全危害有理由且有可能發(fā)生：
（i）天然毒素
（ii）微生物污染
（iii）化學(xué)污染
（iv）殺蟲劑
（v）農(nóng)藥殘留
（vi）產(chǎn)鯖魚毒素品種的腐敗，或者與食品安全危害有關(guān)的其它種類水產(chǎn)品的腐敗。
（vii）寄生蟲。加工者必須對(duì)那些攜帶有寄生蟲的水產(chǎn)及水產(chǎn)品可能會(huì)在未經(jīng)足以殺滅寄生蟲的加工處理的情況下被食用具備經(jīng)驗(yàn)和知識(shí)，或者加工者要對(duì)這樣食用的產(chǎn)品做出說(shuō)
（viii）違規(guī)直接或間接使用食品添加劑或色素。
（ix）物理危害
（2）列出每個(gè)已經(jīng)識(shí)別的食品安全危害的關(guān)鍵控制點(diǎn)，要相應(yīng)的包括：
（i）控制加工廠內(nèi)部環(huán)境危害食品安全的關(guān)鍵控制點(diǎn)。
（ii）用于控制來(lái)自工廠外部環(huán)境（包括捕撈前、中、后）的食品安全危害的關(guān)鍵控制點(diǎn)
（3）列明在每個(gè)關(guān)鍵控制點(diǎn)必須達(dá)到的關(guān)鍵限值。
（4）列明為保證符合關(guān)鍵限值，監(jiān)測(cè)各關(guān)鍵控制點(diǎn)需采用的監(jiān)測(cè)程序和監(jiān)測(cè)次數(shù)；
（5）包括、針對(duì)關(guān)鍵控制點(diǎn)上關(guān)鍵限值的偏離需要采取的，按照§123.7（b）制訂的各種糾正措施計(jì)劃。
（6）列明加工者按照§123.8（a）將采用的驗(yàn)證程序和驗(yàn)證次數(shù)。
（7）規(guī)定記錄各關(guān)鍵控制點(diǎn)監(jiān)測(cè)情況的記錄保持制度，記錄須包含監(jiān)測(cè)過(guò)程中所獲取的實(shí)際數(shù)值和觀察情況。
（d）HACCP計(jì)劃的簽署
（1）HACCP計(jì)劃要由工廠在職的最高負(fù)責(zé)人，或廠方較高級(jí)別的職員簽字和注明日期。簽署必須注明生產(chǎn)商已同意實(shí)施該HACCP計(jì)劃。
（i）首次同意
（ii）在任何修改時(shí)
（iii）計(jì)劃按§123.8（a）（1）所制定的計(jì)劃驗(yàn)證時(shí)
（e）受其它法規(guī)約束的產(chǎn)品。
受本章113或114部分約束的水產(chǎn)及水產(chǎn)品。其HACCP計(jì)劃不需要把與在的控制方法。這部分水產(chǎn)及水產(chǎn)品的HACCP計(jì)劃要列出其它各種有理由且有可能產(chǎn)生的食品安全危害。
（f）衛(wèi)生。
衛(wèi)生控制措施可以列入HACCP計(jì)劃。然而，按照§123.11（b）實(shí)施監(jiān)控的那些范圍不必列入HACCP計(jì)劃，反之亦然。
（g）法律依據(jù)。
當(dāng)HACCP是必需的時(shí)候，對(duì)于沒有和未執(zhí)行一個(gè)符合本節(jié)要求的HACCP計(jì)劃，未按本部分的要求進(jìn)行操作的加工者，其水產(chǎn)和水產(chǎn)品將依照本法402條款（a）（4）被視為偽劣食品。加工者的操作是否能持續(xù)保障食品的安全，必要時(shí)，將通過(guò)對(duì)加工者實(shí)施HACCP計(jì)劃的情況進(jìn)行-次評(píng)估來(lái)作出判斷。
更多有關(guān)美國(guó)FDA水產(chǎn)品HACCP法規(guī)內(nèi)容，請(qǐng)點(diǎn)擊美國(guó)FDA水產(chǎn)品HACCP法規(guī)匯總。
