U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

 
 
 
PHS:FDA:CFSAN:OFP:DCP:MSB
 
                         200 C Street, SW
                         Washington, DC  20204
 
                         M-I-93-2
                         (Supplement to M-I-91-1)
 
                         June 1, 1993
 
TO:       All Regional Food and Drug Directors
          Attn:  Regional Milk Specialists
 
FROM:     Milk Safety Branch (HFS-626)
 
SUBJECT:  Questions Regarding Grade "A" Fluid Milk and Cream
          Products, and Grade "A" Anhydrous Milkfat from which Some
          or All of the Cholesterol has been or will be Removed
 
 
There has been an interest in Grade "A" products which contain
butterfat from which some or all of the cholesterol has been
removed.
 
These products are manufactured using roughly the following steps:
 
1.   Cream is separated from milk.
 
2.   Anhydrous milkfat is separated out of the cream by a process
     somewhat similar to the original separation of cream from
     milk.
 
3.   The anhydrous milkfat is normally shipped to another location
     for cholesterol removal.
 
4.   The anhydrous milkfat from which some or all of the
     cholesterol has been removed is then shipped to other milk
     plants where it is blended with various nonfat or very low fat
     products to produce Grade "A" dairy products which have lower
     than normal levels of cholesterol.
 
Because of the physical characteristics of anhydrous milkfat,
several questions have been asked regarding the finished product
and the interim products used to produce that finished product.
The answers to these questions may provide useful information to
states wishing to list or receive these products:
 
Question 1:    What testing is required of Grade "A" anhydrous
               milkfat and Grade "A" cholesterol modified
               anhydrous milkfat from which some or all of the
               cholesterol has been removed?
 
Answer:   Because these products are nearly 100% milkfat, they
          inhibit the growth of bacteria.  Therefore, bacterially
          based tests such as standard plate counts, coliform
          tests, and B. stearothermophilus disk assay tests cannot
          be used.
 
Question 2:    What tests are required on the finished Grade "A"
               products produced by recombining this product with
               other Grade "A" products (i.e., skim milk)?
 
Answer:   Each finished fluid milk product should be sampled
          separately at the plant of final pasteurization and
          packaging (2% milk and 2% milk from which cholesterol has
          been removed would be sampled for separately).
 
Question 3:    Are plastic bags or other direct product contact
               packaging materials used to package anhydrous
               milkfat and anhydrous milkfat from which all or
               part of the cholesterol has been removed required
               to meet PMO requirements for single service
               packaging?
 
Answer:   Yes.
 
Question 4:    Are Grade "A" anhydrous milkfat and Grade "A"
               anhydrous milkfat from which all or part of the
               cholesterol has been removed required to be
               refrigerated during shipment?
 
Answer:   No (see answer to question 1).
 
Question 5:    May Grade "A" anhydrous milkfat be made from
               butter?
 
Answer:   Milk is an emulsion of fat in milk serum; butter an
          emlsuion of milk serum in fat.  Once this phase inversion
          occurs and milkfat has been made into butter it can no
          longer be used as an ingredient in a food which has a
          standard of identity which lists cream (but not butter)
          as an ingredient.
 
Question 6:    Is a particular type of "paper trail" required to
               insure that all of these dairy products are Grade
               "A" and processed only at listed facilities?
 
Answer:   The "Procedures..." Section V.B. specifies how state
          rating agencies may fulfill their responsibilities to
          track and verify this important information.
 
Copies of this informational memorandum are enclosed for
distribution to District Milk Specialists, State Milk Sanitation
Regulatory Agencies, and State Milk Sanitation Rating Officers in
your region.
 
 
 
 
                         Johnnie G. Nichols