§110.80 食品生产加工及控制(Processes and controls)

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　　    § 110.80   Processes and controls.

　　All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permissible, treated or processed to eliminate the contamination.

　　（a） Raw materials and other ingredients. （1） Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.

　　（2） Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.

　　（3） Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or may be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.

　　（4） Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination.

　　（5） Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the act. Material scheduled for rework shall be identified as such.

　　（6） Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the act.

　　（7） Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.

　　（b） Manufacturing operations. （1） Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.

　　（2） All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. One way to comply with this requirement is careful monitoring of physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.

　　（3） Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated within the meaning of the act. Compliance with this requirement may be accomplished by any effective means, including:

　　（i） Maintaining refrigerated foods at 45 °F （7.2 °C） or below as appropriate for the particular food involved.

　　（ii） Maintaining frozen foods in a frozen state.

　　（iii） Maintaining hot foods at 140 °F （60 °C） or above.

　　（iv） Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.

　　（4） Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling awthat are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act.

　　（5） Work-in-process shall be handled in a manner that protects against contamination.

　　（6） Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary.

　　（7） Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

　　（8） Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.

　　（9） Food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and found not to be adulterated within the meaning of the act before being incorporated into other food.

　　（10） Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.

　　（11） Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of adequate sanitary quality.

　　（12） Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following:

　　（i） Using ingredients free of contamination.

　　（ii） Employing adequate heat processes where applicable.

　　（iii） Using adequate time and temperature controls.

　　（iv） Providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them.

　　（v） Cooling to an adequate temperature during manufacturing.

　　（vi） Disposing of batters at appropriate intervals to protect against the growth of microorganisms.

　　（13） Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:

　　（i） Use of a quality control operation in which the critical control points are identified and controlled during manufacturing.

　　（ii） Adequate cleaning and sanitizing of all food-contact surfaces and food containers.

　　（iii） Using materials for food containers and food- packaging materials that are safe and suitable, as defined in §130.3（d） of this chapter.

　　（iv） Providing physical protection from contamination, particularly airborne contamination.

　　（v） Using sanitary handling procedures.

　　（14） Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of awfor preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

　　（i） Monitoring the awof food.

　　（ii） Controlling the soluble solids-water ratio in finished food.

　　（iii） Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the awof the food does not increase to an unsafe level.

　　（15） Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

　　（i） Monitoring the pH of raw materials, food in process, and finished food.

　　（ii） Controlling the amount of acid or acidified food added to low-acid food.

　　（16） When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.

　　（17） Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.

　　[51 FR 24475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]

　　110.80 加工及控制

　　食品的进料、检查、运输、分选、预制、加工、包装及贮存等所有生产加工环节都必须严格按照卫生要求进行控制，必须采用合适的质量管理措施，确保食品适合人类食用，并确保包装材料安全无害。生产加工企业的整体卫生必须由一名或数名被指定的专职的人员进行监督。必须采取一切合理的预防措施，确保各生产工序不受任何污染物的污染。在必要时，必须采用化学的、微生物的或外来杂质的检测方法验证卫生控制的缺陷或可能发生的食品污染。凡是污染已达到条例规定的劣质程度的食品时必须全部召回，或者如果许可时，再经处理或加工以消除其污染。

　　a.原料及其他辅料

　　（1） 原料和其他辅料必须经过检查、分选或用其他方法进行必要的处理，确保其干净卫生；同时，必须将原料和其他辅料贮存在适当的条件下，使其免受污染并将腐败变质降低到最小程度，以确保适合食品的生产加工。必要时必须对原料进行清洗以除去泥土或其他污物。用于洗、涮、清洗或输送原料的水必须安全卫生，并完全符合卫生质量标准。如果用过的水不会增加对原料的污染程度，可以再次用于洗、涮、清洗或输送食品原料。盛装原料的容器或运载工具必须进行检查，确保它们具有良好的卫生状况，不得因此使原料污染而变质。

　　（2） 原料和其他辅料中的微生物不得超标，避免使人发生食物中毒或患其他疾病。在加工过程中必须对原料和辅料进行巴氏灭菌或其他方法的处理，确保其中的微生物不得超标，使产品不会成为条例所指的劣质品。原料和其他辅料是否达到了上述要求，可以采用任何有效的方法加以证实，包括依据供应商的担保或证明书购入原料和其他辅料。

　　（3） 易受黄曲霉毒素或其他天然毒素污染的食品原料和其他辅料必须符合食品药物管理局关于各种有毒或有害物质的现行法规、指标和作用水平，只有这样，才能将其用于生产加工食品。可以通过从有担保或证明书的供应商处购买原料和其他辅料而达到这一要求，或者通过分析原料和辅料中的黄曲霉毒素及其他天然毒素而证实是否符合这一要求。

　　（4） 容易受害虫、有害微生物或外来物质污染的原料、其他辅料及返工品必须符合食品药物管理局关于天然的或不可避免的缺陷的法规、指标和作用水平。如果制造商利用这些原料生产加工食品时，可以通过任何有效的方法来证实是否符合这一要求，包括根据供应商的担保或证明书而购入这些原料，或检验这些原料的污染情况。

　　（5） 原料、其他辅料及返工品必须散装存放，或盛入设计及结构能防止污染的容器中，并且以一定的方式存放在一定的温度和相对湿度下，以防止食品成为条例所讲的劣质制品。返工的原料必须有明确的标识。

　　（6） 冷冻的原料及其他冷冻辅料必须保存在冷冻状态。如果在使用前需要解冻，解冻的方式必须能防止原料和辅料成为条例所指的劣质品。

　　（7） 散装购进和贮存的液体或固体原料及其他辅料必须注意存放，防止污染。

　　b.加工生产

　　（1） 设备、工器具及装载成品的容器，必须通过适当的清洗和消毒，使其保持良好的卫生状态。必要时，必须拆卸设备进行彻底清洗。

　　（2） 所有的食品加工，包括包装和贮存，都必须在必要的条件和控制下进行，尽量减少微生物生长繁殖的可能性，或尽量防止食品受污染。达到这一要求的一种办法就是对时间、温度、水分活度、pH值、压力、流速等物理因素予以控制，通过对冷冻、脱水、热加工、酸化及冷藏等加工工序进行监控，确保不因机械故障、时间延缓、温度波动及其他因素而导致食品的分解或污染。

　　（3）凡是利于有害微生物，特别是对公众健康有危害的微生物快速生长繁殖的食品必须注意存放方式，防止其成为条例所指的劣质食品。可以采用下列任何一种有效的方法达到这一要求：

　　ⅰ 冷藏食品保持在 7.2℃，或特殊的食品保持在 7.2℃以下的适当温度；

　　ⅱ 冷冻食品保持在冻结状态；

　　ⅲ 热的食品保持在60℃或60 ℃以上；

　　ⅳ 当酸性或酸化食品需在常温下置于密闭的容器中存放时，应对其进行热处理以消灭嗜热微生物。

　　（4） 为消灭或防止有害微生物，尤其是对公众健康有害的微生物的生长繁殖而采取的各种措施，如消毒、辐射、巴氏杀菌、冷冻、冷藏、控制pH值或控制水分活度，必须确保符合加工、运输和销售的条件要求，以防止食品成为条例所指的劣质品。

　　（5） 正在进行的操作必须认真仔细，防止污染。

　　（6） 必须采取有效措施防止成品食品受到原料、其他辅料或废料的污染。当原料、其他辅料或废料未得到保护时，如果它们在收缴、装卸或运输、加工中会污染食品，那么必须加以防护。必须采取必要的措施防止用传送带输送的食品受污染。

　　（7） 用来传送、放置或贮存原料、半成品、返工品或食品的设备、容器及工器具，在加工和贮藏中必须结构合理，便于操作，易于维护以防止污染。

　　（8） 必须采取有效措施防止金属或其他外来物质掺入食品。可通过筛网、捕捉器、磁体、电子金属探测器或其他适当的有效手段达到这一要求。

　　（9） 在处理条例所指的劣质食品、原料及其他辅料时必须避免其他食品受到污染。如果劣质的食品能再处理，必须用切实有效的方法进行处理，或者必须再检验，证实它不是条例所指的劣质食品时才能加入其他食品。

　　（10） 进行清洗、剥皮、修边、切割、分选以及检验、捣碎、脱脂、成形等机械加工步骤时必须防止食品污染。可以通过物理防护手段防止食品受滴入、排入或吸入食品的污染物的污染，从而达到上述要求。防护手段包括对一切食品接触面进行彻底的清洗和消毒，以及在每个加工步骤及各步骤间进行时间和温度的控制。

　　（11） 制备食品需要热漂烫时，应该将食品加热到一定的温度，并在此温度下维持一定时间，然后或快速冷却或立即送往下一加工步骤。应当通过足够的操作温度和定期的清洗将漂烫机中耐热微生物的生长繁殖及污染降低到最小程度。在罐装前对漂烫食品的清洗用水必须安全卫生，而且完全符合卫生质量的要求。

　　（12） 面糊、面包糖、调味汁、浇汁、调料及其他预制物必须以适当的方式处理和维护，防止污染。采用下列一种或数种有效的方法即可达到这一要求：

　　ⅰ使用未受污染的辅料；

　　ⅱ凡是可行的工序均采用充分加热的方法；

　　ⅲ采用准确的时间和温度控制措施；

　　ⅳ采取充分有效的物理防护手段防止各种食品成分免受滴入、排入或吸入的污染物的污染；

　　ⅴ在加工过程中将食品冷却至适当的温度；

　　ⅵ每隔一段时间将面糊清除一次，以防止微生物的生长繁殖。

　　（13） 必须以适当的方式进行装填、配套、包装以及其他生产加工，防止食品受污染。采用下列任何一种有效手段即可达到这一要求：

　　在加工过程中对已确定的所有关键控制点加以控制；

　　ⅰ彻底清洗和消毒食品接触面和食品容器；

　　ⅱ采用本章130.3（d）规定的安全适用性材料作为食品容器和食品包装材料；

　　ⅲ采用物理防护措施防止污染，特别是空气污染；

　　ⅳ采用良好的卫生操作方法。

　　（14） 以下食品，但不仅限于这些食品，如干燥的混合料、坚果、中等水分食品、脱水食品，以及其他同类通过控制水分活度（aw）以防止有害微生物生长繁殖的食品，必须加工至保持安全的水分含量，采用下列一种或多种有效措施即可达到这一要求：

　　ⅰ 监测食品的水分活度（aw）；

　　ⅱ 控制成品食品中可溶性固形物与水的比例；

　　ⅲ 采用密封隔绝水分或其他手段防止食品吸收水分，使其水分活度（aw）达到安全水平。

　　（15） 以下食品，但不仅限于这些食品，如酸性及酸化食品（它们主要通过控制pH值防止有害微生物的生长繁殖）必须监测pH值并使其保持在4.6或4.6以下。采用下列一种或数种有效的办法即可达到这一要求：

　　ⅰ 对原料、正在加工的食品以及成品食品的pH值进行监测。

　　ⅱ 控制加入低酸食品中的酸性或酸化食品的数量。

　　（16） 食品在生产、存放过程中需与冰接触时，制冰用水必须安全卫生，并且完全符合卫生质量标准。只有按照前述的现行良好操作规范制成的冰才能与食品接触。

　　（17） 为保障供人类食用食品免受污染，不得使用供人类食用食品的加工区域和设备生产加工动物饲料或非食用性产品。

　　更多关于美国FDA 21 CFR 第110部分的内容，请详见美国FDA 21 CFR 第110部分关于食品生产企业现行良好操作规范（GMP）法规汇总