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§ 114.80 Processes and controls.
（a） Processing operations. The manufacturer shall employ appropriate quality control procedures to ensure that finished foods do not present a health hazard.
（1） Acidified foods shall be so manufactured, processed, and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. Manufacturing shall be in accordance with the scheduled process. Acidified foods shall be thermally processed to an extent that is sufficient to destroy the vegetative cells of microorganisms of public health significance and those of nonhealth significance capable of reproducing in the food under the conditions in which the food is stored, distributed, retailed and held by the user. Permitted preservatives may be used to inhibit reproduction of microorganisms of nonhealth significance （in lieu of thermal processing）.
（2） Sufficient control, including frequent testing and recording of results, shall be exercised so that the finished equilibrium pH values for acidified foods are not higher than 4.6. Measurement of acidity of foods in-process may be made by potentiometric methods, titratable acidity, or colorimetric methods. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method, and the in-process measurements by titration or colorimetry shall be related to the finished equilibrium pH. If the finished equilibrium pH is 4.0 or below, then the measurement of acidity of the final product may be made by any suitable method. Special care should be taken when food ingredients have been subjected to lye, lime, or similar high pH materials.
（3） Procedures for acidification to attain acceptable equilibrium pH levels in the final food include, but are not limited to, the following:
（i） Blanching of the food ingredients in acidified aqueous solutions.
（ii） Immersion of the blanched food in acid solutions. Although immersion of food in an acid solution is a satisfactory method for acidification, care must be taken to ensure that the acid concentration is properly maintained.
（iii） Direct batch acidification, which can be achieved by adding a known amount of an acid solution to a specified amount of food during acidification.
（iv） Direct addition of a predetermined amount of acid to individual containers during production. Liquid acids are generally more effective than solid or pelleted acids. Care must be taken to ensure that the proper amount of acid is added to each container.
（v） Addition of acid foods to low-acid foods in controlled proportions to conform to specific formulations.
（4） Testing and examinations of containers shall occur often enough to ensure that the container suitably protects the food from leakage or contamination.
（b） Coding. Each container or product shall be marked with an identifying code permanently visible to the naked eye. If the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, as long as the label is securely affixed to the product container. The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed. The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift.
§114.80 加工（殺菌）和控制
（a）加工（殺菌）：制造商必須采用一套有效的質量控制程序以確保食品成品不構成對健康的損害。
（1）酸化食品的制造、殺菌、包裝要使食品在工藝規程規定的時間內，其平衡的pH達到4.6或小于4.6，并在食品成品中保持這一pH。制造必須符合工藝規程。酸化食品必須經過熱殺菌。熱殺菌要足以殺滅對公眾健康有危害的有生長力的微生物細胞，以及對健康雖無影響但在食品貯藏、分銷、零售和消費者存放情況下可能繁殖的微生物細胞。可以使用準許使用的防腐劑，以抑制對健康無害的微生物的繁殖（以替代熱殺菌）。
（2）必須進行適當的控制，包括經常測試和記錄測試結果，以確保酸化食品的最終平衡pH不高于4.6。用電位法可滴定酸度或者比色法測量加工中食品的酸度。如果食品的最終平衡pH高于4.0，用電位法測量最終平衡pH，用滴定法或比色法測量加工中食品的pH。如果最終平衡pH等于或低于4.0，那么可以用任何合適方法測量最終產品的酸度。當食品配料遭受過堿液、石灰或類似的pH高的物質影響時，應特別當心。
（3）在最終食品中獲得需要的平衡pH的酸化方法如下（不僅限于此）：
（i）食品配料在酸化水溶液中熱燙（預煮）。
（ii）熱燙后的食品在酸溶液中浸漬。雖然在酸溶液中浸漬食品是一種理想的酸化方法，但必須注意保持酸的濃度。
（iii）直接分批酸化，即在規定量的食品中加入已知量的某種酸溶液進行酸化。
（iv）在生產中，在單個容器中直接添加事先定量的酸。液態酸一般比固態或粒狀酸更有效。注意在每只容器內加入適量的酸。
（v）以控制好的比例在低酸性食品中添加酸性食品以達到規定的配方。
（4）要經常進行測試和檢驗，以確保容器內食品不滲透、不被污染。
（b）編號：每只容器或每件產品上都必須打上永久性的、肉眼可見的供識別的代號。如果容器上不允許打上凸紋的或印上油墨的代號，則在標簽上用穿孔或其它方式打上這一代號，但要將標簽牢固地黏著在產品容器上。在代號中要識別出產品罐裝和包裝的企業、年、月、日和包裝的時間段。包裝時間段代號要經常改變，使銷售中易于識別批次。這一代號根據下述中一種情況定期改變：間隔4～5h；工作人員換班或者批量生產的一批產品，但不超過一個工作班次內生產的產品。
更多關于美國FDA酸化食品HACCP法規，請詳見美國FDA酸化食品HACCP法規第113和114部分匯總
