• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

M-I-93-2: 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

<< Back to Index of Memoranda of Information (M-I) Main Page
 

HHS:PHS:FDA:CFSAN:OC: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>/p>

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 frommilk.
  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 emulsion 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 istribution to District Milk Specialists, State Milk Sanitation Regulatory Agencies, and State Milk Sanitation Rating Officers in your region.
 

Johnnie G. Nichols