Description
The purpose of this document is to provide guidance for FDA staff regarding its enforcement policies for pathogens and indicators of inadequate pasteurization or post-pasteurization contamination of dairy products.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Product category in CPG 527.300
Stakeholders
1Primary authority for follow-up on IMS listed plants
Regulatory Context
Regulatory Activities
2DWPE request in import refusal recommendations
Regulatory action for products meeting specific E. coli criteria
Technical Details
Substances
10species that should not be used in dietary supplements
Pathogen tested in spent sprout irrigation water
Enzyme used as an indicator of pasteurization efficacy; Enzyme used as an indicator of pasteurization efficiency.
Microorganism found in contaminated inks that can cause serious infections
bacteria that causes TSS
Pathogen that may grow in reduced oxygen packaging.; spore-forming bacterium found in soil
Pathogen causing gastroenteritis and reactive arthritis
bacterium responsible for campylobacteriosis
Pathogen found in ready-to-eat produce and cheeses; Emerging microbiological hazard associated with raw pet food.; pathogen that may be introduced during transportation
Pathogen targeted in alfalfa seeds
Processes
1heating procedure used to effectively eliminate L. monocytogenes; historically established process control for milk
Clinical Concepts
1serious complication from EHEC infection
Identified Hazards
Hazards
1Contamination occurring after the heating process
Standards & References
Specifications
4Alkaline phosphatase limit for non-cheese dairy products
Limit for E. coli in two or more subsamples
maximum alkaline phosphatase level for certain cheeses
action level for Staphylococcus aureus and Bacillus cereus
Related CFR Sections (5)
- 21CFR133.152§ 133.152 Limburger cheese.
(a) Description.Read full regulation →
- 21CFR133.188§ 133.188 Semisoft part-skim cheeses.
(a) The cheeses for which definitions and standards of identity are prescribed by this section are semisoft part-skim cheeses for which specifically applicable definitions and standards of identity are not prescribed by other sections of this part. They are made from partly skimmed milk and other inRead full regulation →
- 21CFR133.187§ 133.187 Semisoft cheeses.
(a) The cheeses for which definitions and standards of identity are prescribed by this section are semisoft cheeses for which specifically applicable definitions and standards of identity are not prescribed by other sections of this part. They are made from milk and other ingredients specified in thRead full regulation →
- 21CFR133.108§ 133.108 Brick cheese.
(a) Description.Read full regulation →
- 21CFR133.3§ 133.3 Definitions.
(a) Milk means the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, which may be clarified and may be adjusted by separating part of the fat therefrom; concentrated milk, reconstituted milk, and dry whole milk. Water, in a sufficient qRead full regulation →