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§ 123.9 Records.
(a) General requirements. All records required by this part shall include:
?。?) The name and location of the processor or importer;
?。?) The date and time of the activity that the record reflects;
?。?) The signature or initials of the person performing the operation; and
?。?) Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.
?。╞) Record retention. (1) All records required by this part shall be retained at the processing facility or importer's place of business in the United States for at least 1 year after the date they were prepared in the case of refrigerated products and for at least 2 years after the date they were prepared in the case of frozen, preserved, or shelf-stable products.
?。?) Records that relate to the general adequacy of equipment or processes being used by a processor, including the results of scientific studies and evaluations, shall be retained at the processing facility or the importer's place of business in the United States for at least 2 years after their applicability to the product being produced at the facility.
(3) If the processing facility is closed for a prolonged period between seasonal packs, or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal pack but shall be immediately returned for official review upon demand.
?。╟) Official review. All records required by this part and all plans and procedures required by this part shall be available for official review and copying at reasonable times.
?。╠) Public disclosure. (1) Subject to the limitations in paragraph (d)(2) of this section, all plans and records required by this part are not available for public disclosure unless they have been previously disclosed to the public as defined in §20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in §20.61 of this chapter.
(2) However, these records and plans may be subject to disclosure to the extent that they are otherwise publicly available, or that disclosure could not reasonably be expected to cause a competitive hardship, such as generic-type HACCP plans that reflect standard industry practices.
?。╡) Tags. Tags as defined in §123.3(t) are not subject to the requirements of this section unless they are used to fulfill the requirements of §123.28(c).
?。╢) Records maintained on computers. The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.
§123.9記錄
(a)一般要求,本部分所要求的所有記錄須包括:
?。?)本部分所要求的所有記錄必須保存在加工廠,或進口商在美國的商務處,冷藏品的記錄至少要保存一年,冷凍、腌制或貨架期穩定的產品至少要保存兩年。
?。?)所記錄活動的日期和時間
(3)操作執行者的簽名或者首寫字母,以及
?。?)必要時,對產品和生產編號的識別。加工和其它信息在觀察時要及時記錄。
(b)記錄的保存
?。?)本部分所要求的所有記錄必須保存在加工廠,或進口商在美國的商務處,冷藏品的記錄至少要保存一年,冷凍、腌制或貨架期穩定的產品至少要保存兩年。
?。?)加工者正在使用的,與設備和工藝的適用性有關的記錄,包括科學研究和評估結果,必須在加工廠或進口商在美國的商務處保存兩年以上。
?。?)如果加工廠要在生產季節的間隔期停產一段時間,或者在加工船上存放記錄的位置有限,或者是在一個偏遠的加工點,記錄可以在季節生產結束時轉送到其他適當的地點,但在官方需要審查時,必須能立即取回。
(c)官方復查:本部分要的所有記錄、計劃和加工工序在適當時候,必須能提供給官方復查和復制。
(d)資料的公開
(1)由于本條款(d)段(2)的限制,本部分所要求的計劃和記錄不許對外公開,除非按照本章§120.81的規定,原先已對外公開,或者它們與業已淘汰的產品和配方有關,或者它們已不再是本章§120.61所定義的貿易機密、商業秘密或金融情報。
(2)然而,對于公眾可通過其它途徑獲得,或外傳后不會導致競爭上的不利,如反映標準工廠規范的HACCP計劃樣板,這些記錄可以公開。
?。╡)標簽。123.3(t)定義的標簽除非完全符合§123.28(c)的要求;否則不運用本部分要求。
?。╢)電腦存儲的記錄。可以使用電腦保存記錄,但必須采取相應的控制措施,以保證電子數據和簽名的完整性。
更多有關美國FDA水產品HACCP法規內容,請點擊美國FDA水產品HACCP法規匯總。