CPG Sec. 527.300 Dairy Products - Microbial 
Contaminants and Alkaline Phosphatase Activity 
 
You may submit either electronic or written comments regarding this guidance at any time. 
Submit electronic comments to http://www.regulations.gov. Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket 
number listed in the notice of availability that publishes in the Federal Register.  
U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Food Safety and Applied Nutrition  
Office of Regulatory Affairs  
December 2010  
 
This guidance represents 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 telephone number listed on the title page of this guidance.  
Table of Contents  
I. Introduction  
II. Background  
III. Policy  
IV. Regulatory Action Guidance  
V. Specimen Charges  
 
I. Introduction:   *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.  
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  
3 Contains Nonbinding Recommendations  
dairy animals themselves. Contamination of the udder and teats by the feces may in turn 
contaminate raw milk. Insanitary practices by milk handlers may contribute to the contamination. 
Insanitary or inadequate processing conditions also may contaminate the raw milk dairy product. 
Pasteurization of raw milk is lethal to pathogens. Thus, the presence of pathogens in a dairy 
product made from milk that was subjected to a pasteurization process indicates inadequate 
pasteurization or post-pasteurization contamination.  
Salmonella - Salmonella is a pathogen that, when consumed, can cause an infection. A dose of 
as little as 15-20 organisms can cause illness. The symptoms of infection include gastroenteritis. 
Salmonella is shed in the feces of infected animals and can contaminate pasture land and milking 
parlors.  
EHEC O157:H7 and other enterohemorrhagic Escherichia coli - The infectious dose of 
EHEC 0157:H7 is estimated to be between 10-100 organisms. When food contaminated with the 
EHEC O157:H7 is consumed, the pathogen colonizes the intestinal tract where it produces a  toxin and causes haemorrhagic colitis that can progress to more serious complications such as 
haemolytic uraemic syndrome or thrombotic thrombocytopenic purpura. EHEC O157:H7 is the 
predominant EHEC strain that has caused illness worldwide. However, other EHEC serotypes 
have also been implicated in illness and are of public health concern.  
Campylobacter jejuni - A dose of 400-500 organisms of Campylobacter jejuni can cause 
infection. Symptoms of infection include abdominal pain, fever, diarrhea, and vomiting. 
Campylobacter jejuni can either be shed in feces or in milk from an infected udder of a dairy 
animal. Most human outbreaks of infection of Campylobacter jejuni that are associated with 
dairy products have been linked to raw milk or inadequately pasteurized milk.  
Yersinia enterocolitica - Yersinia enterocolitica is a pathogen which causes infection. Symptoms 
of infection include gastroenteritis, fever, diarrhea, bloody stools, rash, joint pain, nausea, 
vomiting, headache, and malaise. Infection by Yersinia enterocolitica is also considered a cause 
of reactive arthritis. Yersinia enterocolitica has been found in many different animals and is shed 
in feces.  
Clostridium botulinum - Clostridium botulinum produces a neurotoxin. A few nanograms (ng) 
of the neurotoxin can cause illness. Symptoms include lassitude, weakness, vertigo, double-
vision, difficulty speaking, and difficulty swallowing. Symptoms can progress to difficulty of 
breathing, weakness of other muscles, abdominal distention, and constipation. The incidence of 
this disease is low, but the mortality rate is high if not treated immediately and properly. 
Although the neurotoxin is heat labile and can be destroyed when exposed to a minimum of 80 
oC for 10 minutes, the time and temperature reached in pasteurization do not destroy the 
neurotoxin.  
Enterotoxigenic Staphylococcus  Some species of Staphylococcus produce an enterotoxin that 
is extremely heat stable and is not inactivated at pasteurization  
4 Contains Nonbinding Recommendations  
temperatures. When ingested, the enterotoxin may rapidly produce symptoms including nausea, 
vomiting, retching, abdominal cramps, muscle cramping, headache, and transient changes in 
blood pressure and pulse rate. The presence of any Staphylococcus enterotoxin in a dairy product 
is of public health concern.  
A dairy cow with mastitis may be the source of enterotoxigenic Staphylococcus in raw milk, 
which may subsequently be commingled with other milk. Also, at any point from the milk 
collection process to the packaging of the finished product, enterotoxigenic Staphylococcus 
species can be introduced by an infected human, inadequate employee hygienic practices, such 
as inadequate hand washing, equipment and utensils that are not cleaned and sanitized, or 
contaminated raw material.   Staphylococcus aureus has traditionally been used as a microbiological indicator of insanitation 
during processing. Because of environmental factors, low levels of Staphylococcus aureus may 
be found in raw milk, even when produced using good manufacturing practices (GMPs). 
However, excessive numbers of Staphylococcus aureus organisms in raw milk or other dairy 
products, i.e., greater than or equal to 104 cfu/g, indicate that the product was produced under 
insanitary conditions.  
Bacillus cereus - Bacillus cereus can cause illness when 106 cfu/g or more are consumed in 
food. There have been two enterotoxins produced by Bacillus cereus identified as causing 
foodborne illness. Illness is characterized by abdominal pain and diarrhea or nausea and 
vomiting. Bacillus cereus is commonly found in soil, on vegetables, and in many raw and 
processed foods, including milk and cheese.  
Additional information about foodborne pathogens and associated diseases can be found in the 
Bad Bug Book.  
B. Nontoxigenic Escherichia coli  
Escherichia coli has traditionally been used as a microbiological indicator of insanitation during 
processing. Escherichia coli are not inherently present in the milk of a dairy animal. Escherichia 
coli in milk and dairy products generally originate from animal or human feces. Thus, the 
presence of Escherichia coli in milk or other dairy product means that the milk or dairy product 
was exposed either directly or indirectly to feces.  
Because of the close association of raw milk with the animal environment, low levels of 
Escherichia coli may be present in raw milk or products made from raw milk, even when 
properly produced using GMPs. Insanitary conditions, including poor employee hygiene 
practices, improperly sanitized utensils and equipment, or contaminated raw materials, may also 
be a source of Escherichia coli in milk and other dairy products.  
C. Alkaline phosphatase  
Alkaline phosphatase is an enzyme that is naturally found in milk. Although the alkaline 
phosphatase in milk is more thermal resistant than nonsporeforming microorganisms, it is 
denatured by pasteurization temperatures. Therefore, the presence of alkaline phosphatase 
indicates the milk was not properly pasteurized. The alkaline phosphatase  
5 Contains Nonbinding Recommendations  
level should be negligible in dairy products, other than certain cheese and cheese products.  
For some dairy products such as certain cheeses, microorganisms used during production 
produce alkaline phosphatase. For some cheeses, the maximum level of alkaline is established in 
the standard of identity for the cheese (21 CFR part 133). For other cheese and related cheese  products required to be made from pasteurized milk, the alkaline phosphatase level should not be 
greater than 3 g/0.25 g (12 micrograms phenol equivalents per gram).  
III. Policy:  
FDA will review the available evidence on a case-by-case basis to determine whether a dairy 
product is adulterated and, in doing so, will be guided but not bound by the following general 
statements of policy relating to the presence in those products of pathogens, nontoxigenic 
Escherichia coli, or alkaline phosphatase.  
A. Pathogens  
Salmonella species, EHEC O157:H7 and other enterohemorrhagic Escherichia coli, 
Campylobacter jejuni, Yersinia enterocolitica, vegetative cells of Clostridium botulinum, 
Clostridium botulinum toxin, Staphylococcus enterotoxin, or Bacillus cereus enterotoxin  
Dairy products may be considered adulterated within the meaning of section 402(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342 (a)(1)) in that they bear or 
contain a poisonous or deleterious substance which may render them injurious to health when 
Salmonella species, EHEC O157:H7 and other enterohemorrhagic Escherichia coli, 
Campylobacter jejuni, Yersinia enterocolitica, vegetative cells of Clostridium botulinum, 
Clostridium botulinim toxin, Staphylococcus enterotoxin, or Bacillus cereus enterotoxin are 
present.  
Staphylococcus aureus  
Dairy products may be considered adulterated within the meaning of section 402(a)(4) of the Act 
(21 U.S.C. 342(a)(4)), in that they have been prepared, packed, or held under insanitary 
conditions whereby they may have been rendered injurious to health when Staphylococcus 
aureus are present at levels greater than or equal to 104 cfu/g.  
Bacillus cereus  
Dairy products may be considered adulterated within the meaning of section 402(a)(4) of the Act 
(21 U.S.C. 342(a)(4)), in that they have been prepared, packed, or held under insanitary 
conditions whereby they may have been rendered injurious to health when Bacillus cereus are 
present at levels greater than or equal to 104 cfu/g.  
B. Nontoxigenic Escherichia coli  
Dairy products may be considered adulterated within the meaning of section 402(a)(4) of the Act 
(21 U.S.C. 342(a)(4)), in that they have been prepared, packed, or held under insanitary 
conditions whereby they may have become contaminated with filth when  
6 Contains Nonbinding Recommendations   Escherichia coli is found at levels greater than 10 MPN per gram in two or more subsamples or 
greater than 100 MPN per gram in one or more subsamples.  
C. Alkaline phosphatase  
Dairy products made from bovine milk may be considered adulterated within the meaning of 
section 402(a)(4) of the Act (21 U.S.C. 342 (a)(4)) when:  
 For cheese and related cheese products required to be made from pasteurized milk (21 CFR 
part 133), alkaline phosphatase levels are:  
o Greater than 5 g/0.25 g (20 micrograms phenol equivalents per gram) in one or more 
subsamples for brick (21 CFR 133.108), semisoft (21 CFR 133.187), and semisoft part-skim 
cheeses (21 CFR 133.188);  
o Greater than 4 g/0.25g (16 micrograms phenol equivalents per gram) in one or more 
subsamples for Limburger cheese (21 CFR 133.152); or  
o Greater than 3 g/0.25 g (12 micrograms phenol equivalents per gram) in one or more 
subsamples for all other cheese and related cheese products.  
 For dairy products other than cheese and related cheese products, alkaline phosphatase level is 
greater than or equal to 2.0 micrograms phenol equivalents per gram in one or more subsamples.  
 
IV. Regulatory Action Guidance:  
Interstate Milk Shippers  
Dairy products produced in an Interstate Milk Shippers (IMS) listed plant that may be considered 
adulterated under the Act should first be referred to the appropriate State regulatory agency for 
follow-up. This includes a non-IMS product manufactured in an IMS-listed plant for which the 
State is providing a regulatory program to address these issues. If the State is unable to take 
appropriate action, the appropriate program field office should proceed to initiate FDA action as 
indicated below.  
Direct Reference  
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, for direct reference import detention by the appropriate 
division within the Human and Animal Food Program, and for direct reference requests for 
detention without physical examination (DWPE) to ORA, Office of Enforcement and Import 
Operations (OEIO) *:   Analysis of the dairy product demonstrates that one or more subsamples is positive for 
Salmonella species, Campylobacter jejuni, Yersinia enterocolitica, Staphylococcus enterotoxin, 
or Bacillus cereus enterotoxin.  
Recommendations  
The following represent criteria for recommending seizure, import detention, or DWPE to 
CFSAN/Office of Compliance/Division of Enforcement (HFS-605):  
1.  For all dairy products:  
 
7 Contains Nonbinding Recommendations  
 
.  EHEC O157:H7 or other enterohemorrhagic Escherichia coli, or vegetative cells of 
Clostridium botulinum, or Clostridium botulinum toxin found in one or more subsamples; or  
.  Escherichia coli found at levels greater than 10 MPN per gram in two or more 
subsamples or greater than 100 MPN per gram in one or more subsamples; or  
.  Staphylococcus aureus found at levels greater than or equal to 104 cfu/g in one or more 
subsamples; or  
.  Bacillus cereus found at levels greater than or equal to 104 cfu/g in one or more 
subsamples.  
.  2. For cheese and related cheese products made from pasteurized bovine milk:  
.   Alkaline phosphatase level in:  
.  o Brick, semisoft, and semisoft part-skim cheeses - greater than 5 g/0.25 g (20 
micrograms phenol equivalent per gram) in one or more subsamples;  
.  o Limburger cheese - greater than 4 g/0.25g (16 micrograms phenol equivalent per 
gram) in one or more subsamples for Limburger cheese;  
.  o All other cheese and related cheese products - greater than 3 g/0.25g (12 micrograms 
phenol equivalent per gram) in one or more subsamples.  
 
3. For all other dairy products made from bovine milk, except cheese and related cheese 
products:   .  Alkaline phosphatase level is greater than or equal to 2.0 micrograms phenol equivalents 
per gram in one or more subsamples.  
 
Other Considerations  
This guidance does not establish acceptable levels of pathogens, nontoxigenic Escherichia coli, 
or alkaline phosphatase in dairy products. FDA may choose to take action against adulterated 
food that does not meet the criteria under this Section.  
V. Specimen Charges:  
Domestic Seizure  
A. Pathogens  
Salmonella species, EHEC O157:H7 or other enterohemorrhagic Escherichia coli, 
Campylobacter jejuni, Yersinia enterocolitica, vegetative cells of Clostridium botulinum, 
Clostridium botulinum toxin, Staphylococcus enterotoxin, Bacillus cereus enterotoxin  
The article of food was adulterated when introduced into and while in interstate commerce and is 
adulterated while held for sale after shipment in interstate commerce, within the meaning of the 
Act, 21 U.S.C. 342(a)(1), in that it bears and contains a poisonous or deleterious substance, 
namely ________, which may render it injurious to health.  
8 Contains Nonbinding Recommendations  
Staphylococcus aureus  
The article of food was adulterated when introduced into and while in interstate commerce and is 
adulterated while held for sale after shipment in interstate commerce, within the meaning of the 
Act, 21 U.S.C. 342(a)(4), in that it has been prepared, packed, and held under insanitary 
conditions whereby it may have been rendered injurious to health.  
Bacillus cereus  
The article of food was adulterated when introduced into and while in interstate commerce and is 
adulterated while held for sale after shipment in interstate commerce, within the meaning of the 
Act, 21 U.S.C. 342(a)(4), in that it has been prepared, packed, and held under insanitary 
conditions whereby it may have been rendered injurious to health.  
B. Nontoxigenic Escherichia coli  
The article of food was adulterated when introduced into and while in interstate commerce and is 
adulterated while held for sale after shipment in interstate commerce, within the meaning of the  Act, 21 U.S.C. 342(a)(4), in that it has been prepared, packed, and held under insanitary 
conditions whereby it may have become contaminated with filth.  
C. Alkaline phosphatase  
The article of food was adulterated when introduced into and while in interstate commerce and is 
adulterated while held for sale after shipment in interstate commerce, within the meaning of the 
Act, 21 U.S.C. 342(a)(4), in that it has been prepared, packed, and held under insanitary 
conditions whereby it may have been rendered injurious to health.  
Import Detention  
A. Pathogens  
Salmonella species, EHEC O157:H7 or other enterohemorrhagic Escherichia coli, 
Campylobacter jejuni, Yersinia enterocolitica, vegetative cells of Clostridium botulinum, 
Clostridium botulinum toxin, Staphylococcus enterotoxin, Bacillus cereus enterotoxin  
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(1) of the FD&C Act 
in that it bears and contains a poisonous and deleterious substance, namely , which may render it 
injurious to health.  
Staphylococcus aureus  
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(4) of the FD&C Act 
in that it has been prepared, packed, and held under insanitary conditions whereby it may have 
been rendered injurious to health.  
9 Contains Nonbinding Recommendations 10  
Bacillus cereus  
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(4) of the FD&C Act 
in that it has been prepared, packed, and held under insanitary conditions whereby it may have 
been rendered injurious to health.  
B. Nontoxigenic Escherichia coli  
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(4) of the FD&C Act 
in that it has been prepared, packed, and held under insanitary conditions whereby it may have 
become contaminated with filth.   C. Alkaline phosphatase  
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C 
Act in that it appears to be adulterated within the meaning of section 402(a)(4) of the FD&C Act 
in that it has been prepared, packed, and held under insanitary conditions whereby it may have 
been rendered injurious to health.*  
*Material between asterisks is new or revised.*  
Issued: 10/1/80 Revised: 7/1/83, 8/1/86, 3/95, 8/96, 12/2010