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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
食品的進料、檢查、運輸、分選、預制、加工、包裝及貯存等所有生產加工環節都必須嚴格按照衛生要求進行控制，必須采用合適的質量管理措施，確保食品適合人類食用，并確保包裝材料安全無害。生產加工企業的整體衛生必須由一名或數名被指定的專職的人員進行監督。必須采取一切合理的預防措施，確保各生產工序不受任何污染物的污染。在必要時，必須采用化學的、微生物的或外來雜質的檢測方法驗證衛生控制的缺陷或可能發生的食品污染。凡是污染已達到條例規定的劣質程度的食品時必須全部召回，或者如果許可時，再經處理或加工以消除其污染。
a.原料及其他輔料
（1） 原料和其他輔料必須經過檢查、分選或用其他方法進行必要的處理，確保其干凈衛生；同時，必須將原料和其他輔料貯存在適當的條件下，使其免受污染并將腐敗變質降低到最小程度，以確保適合食品的生產加工。必要時必須對原料進行清洗以除去泥土或其他污物。用于洗、涮、清洗或輸送原料的水必須安全衛生，并完全符合衛生質量標準。如果用過的水不會增加對原料的污染程度，可以再次用于洗、涮、清洗或輸送食品原料。盛裝原料的容器或運載工具必須進行檢查，確保它們具有良好的衛生狀況，不得因此使原料污染而變質。
（2） 原料和其他輔料中的微生物不得超標，避免使人發生食物中毒或患其他疾病。在加工過程中必須對原料和輔料進行巴氏滅菌或其他方法的處理，確保其中的微生物不得超標，使產品不會成為條例所指的劣質品。原料和其他輔料是否達到了上述要求，可以采用任何有效的方法加以證實，包括依據供應商的擔保或證明書購入原料和其他輔料。
（3） 易受黃曲霉毒素或其他天然毒素污染的食品原料和其他輔料必須符合食品藥物管理局關于各種有毒或有害物質的現行法規、指標和作用水平，只有這樣，才能將其用于生產加工食品。可以通過從有擔保或證明書的供應商處購買原料和其他輔料而達到這一要求，或者通過分析原料和輔料中的黃曲霉毒素及其他天然毒素而證實是否符合這一要求。
（4） 容易受害蟲、有害微生物或外來物質污染的原料、其他輔料及返工品必須符合食品藥物管理局關于天然的或不可避免的缺陷的法規、指標和作用水平。如果制造商利用這些原料生產加工食品時，可以通過任何有效的方法來證實是否符合這一要求，包括根據供應商的擔保或證明書而購入這些原料，或檢驗這些原料的污染情況。
（5） 原料、其他輔料及返工品必須散裝存放，或盛入設計及結構能防止污染的容器中，并且以一定的方式存放在一定的溫度和相對濕度下，以防止食品成為條例所講的劣質制品。返工的原料必須有明確的標識。
（6） 冷凍的原料及其他冷凍輔料必須保存在冷凍狀態。如果在使用前需要解凍，解凍的方式必須能防止原料和輔料成為條例所指的劣質品。
（7） 散裝購進和貯存的液體或固體原料及其他輔料必須注意存放，防止污染。
b.加工生產
（1） 設備、工器具及裝載成品的容器，必須通過適當的清洗和消毒，使其保持良好的衛生狀態。必要時，必須拆卸設備進行徹底清洗。
（2） 所有的食品加工，包括包裝和貯存，都必須在必要的條件和控制下進行，盡量減少微生物生長繁殖的可能性，或盡量防止食品受污染。達到這一要求的一種辦法就是對時間、溫度、水分活度、pH值、壓力、流速等物理因素予以控制，通過對冷凍、脫水、熱加工、酸化及冷藏等加工工序進行監控，確保不因機械故障、時間延緩、溫度波動及其他因素而導致食品的分解或污染。
（3）凡是利于有害微生物，特別是對公眾健康有危害的微生物快速生長繁殖的食品必須注意存放方式，防止其成為條例所指的劣質食品。可以采用下列任何一種有效的方法達到這一要求：
ⅰ 冷藏食品保持在 7.2℃，或特殊的食品保持在 7.2℃以下的適當溫度；
ⅱ 冷凍食品保持在凍結狀態；
ⅲ 熱的食品保持在60℃或60 ℃以上；
ⅳ 當酸性或酸化食品需在常溫下置于密閉的容器中存放時，應對其進行熱處理以消滅嗜熱微生物。
（4） 為消滅或防止有害微生物，尤其是對公眾健康有害的微生物的生長繁殖而采取的各種措施，如消毒、輻射、巴氏殺菌、冷凍、冷藏、控制pH值或控制水分活度，必須確保符合加工、運輸和銷售的條件要求，以防止食品成為條例所指的劣質品。
（5） 正在進行的操作必須認真仔細，防止污染。
（6） 必須采取有效措施防止成品食品受到原料、其他輔料或廢料的污染。當原料、其他輔料或廢料未得到保護時，如果它們在收繳、裝卸或運輸、加工中會污染食品，那么必須加以防護。必須采取必要的措施防止用傳送帶輸送的食品受污染。
（7） 用來傳送、放置或貯存原料、半成品、返工品或食品的設備、容器及工器具，在加工和貯藏中必須結構合理，便于操作，易于維護以防止污染。
（8） 必須采取有效措施防止金屬或其他外來物質摻入食品。可通過篩網、捕捉器、磁體、電子金屬探測器或其他適當的有效手段達到這一要求。
（9） 在處理條例所指的劣質食品、原料及其他輔料時必須避免其他食品受到污染。如果劣質的食品能再處理，必須用切實有效的方法進行處理，或者必須再檢驗，證實它不是條例所指的劣質食品時才能加入其他食品。
（10） 進行清洗、剝皮、修邊、切割、分選以及檢驗、搗碎、脫脂、成形等機械加工步驟時必須防止食品污染。可以通過物理防護手段防止食品受滴入、排入或吸入食品的污染物的污染，從而達到上述要求。防護手段包括對一切食品接觸面進行徹底的清洗和消毒，以及在每個加工步驟及各步驟間進行時間和溫度的控制。
（11） 制備食品需要熱漂燙時，應該將食品加熱到一定的溫度，并在此溫度下維持一定時間，然后或快速冷卻或立即送往下一加工步驟。應當通過足夠的操作溫度和定期的清洗將漂燙機中耐熱微生物的生長繁殖及污染降低到最小程度。在罐裝前對漂燙食品的清洗用水必須安全衛生，而且完全符合衛生質量的要求。
（12） 面糊、面包糖、調味汁、澆汁、調料及其他預制物必須以適當的方式處理和維護，防止污染。采用下列一種或數種有效的方法即可達到這一要求：
ⅰ使用未受污染的輔料；
ⅱ凡是可行的工序均采用充分加熱的方法；
ⅲ采用準確的時間和溫度控制措施；
ⅳ采取充分有效的物理防護手段防止各種食品成分免受滴入、排入或吸入的污染物的污染；
ⅴ在加工過程中將食品冷卻至適當的溫度；
ⅵ每隔一段時間將面糊清除一次，以防止微生物的生長繁殖。
（13） 必須以適當的方式進行裝填、配套、包裝以及其他生產加工，防止食品受污染。采用下列任何一種有效手段即可達到這一要求：
在加工過程中對已確定的所有關鍵控制點加以控制；
ⅰ徹底清洗和消毒食品接觸面和食品容器；
ⅱ采用本章130.3（d）規定的安全適用性材料作為食品容器和食品包裝材料；
ⅲ采用物理防護措施防止污染，特別是空氣污染；
ⅳ采用良好的衛生操作方法。
（14） 以下食品，但不僅限于這些食品，如干燥的混合料、堅果、中等水分食品、脫水食品，以及其他同類通過控制水分活度（aw）以防止有害微生物生長繁殖的食品，必須加工至保持安全的水分含量，采用下列一種或多種有效措施即可達到這一要求：
ⅰ 監測食品的水分活度（aw）；
ⅱ 控制成品食品中可溶性固形物與水的比例；
ⅲ 采用密封隔絕水分或其他手段防止食品吸收水分，使其水分活度（aw）達到安全水平。
（15） 以下食品，但不僅限于這些食品，如酸性及酸化食品（它們主要通過控制pH值防止有害微生物的生長繁殖）必須監測pH值并使其保持在4.6或4.6以下。采用下列一種或數種有效的辦法即可達到這一要求：
ⅰ 對原料、正在加工的食品以及成品食品的pH值進行監測。
ⅱ 控制加入低酸食品中的酸性或酸化食品的數量。
（16） 食品在生產、存放過程中需與冰接觸時，制冰用水必須安全衛生，并且完全符合衛生質量標準。只有按照前述的現行良好操作規范制成的冰才能與食品接觸。
（17） 為保障供人類食用食品免受污染，不得使用供人類食用食品的加工區域和設備生產加工動物飼料或非食用性產品。
更多關于美國FDA 21 CFR 第110部分的內容，請詳見美國FDA 21 CFR 第110部分關于食品生產企業現行良好操作規范（GMP）法規匯總
