FDA CPG Sec 527.300 (Draft) Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity

标准简介

CPG Sec 527.300 (Draft) Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity[附网盘链接]是Food And Drug Administration于不久前发布的FDA标准,适用于U.S。

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CPG Sec 527.300 (Draft) Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity[附网盘链接]
CPG Sec 527.300 (Draft) Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity[附网盘链接](截图)

 

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Draft — Not for Implementation Guidance for FDA Staff Compliance Policy Guide Sec. 527.300 Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity (CPG 7106.08) This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance. I. Introduction: The purpose of this document is to provide guidance for FDA staff regarding FDA’s current thinking on its enforcement policies for pathogens and indicators of inadequate pasteurization or post-pasteurization contamination of dairy products. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background: *Significant outbreaks of illness associated with dairy products include salmonellosis (including infections with some multi-drug resistant Salmonella), enterohemorrhagic Escherichia coli (EHEC) O157:H7 infections, listeriosis, staphylococcal food poisoning, botulism, and Yersinia enterocolitica infection. (A Federal Register notice of availability for draft CPG Sec. 555.320 Listeria monocytogenes was published on February 7, 2008 (73 FR 7293)). Symptoms of illnesses from pathogens may include anything from mild discomfort to headaches, nausea, vomiting, watery or bloody diarrhea, cramps, and hemolytic uremic syndrome. In some cases, death may result. A. Pathogens The presence of pathogens in dairy products is an indicator of poor sanitation, temperature abuse, inadequate pasteurization (21 CFR 133.3(d)), fermentation failure, or obtaining milk from diseased animals. Many pathogens originate from the feces of the

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