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M-I-13-5: IMS Listing “Product Codes” Clarification For Aseptic and Ultra-Pasteurized Milk and Milk Products

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HHS:PHS:FDA:CFSAN:OFS:DPDFS:DEB:MST

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-13-5

July 26, 2013

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Dairy and Egg Branch (HFS-316)

SUBJECT: IMS Listing “Product Codes” Clarification For Aseptic and Ultra-Pasteurized Milk and Milk Products

This M-I is being issued to clarify recent changes made to the Product Code listings used to complete Block 6-Product Code #s on FORM FDA 2359i-Interstate Milk Shipper’s Report and what Product Codes will be included on the Interstate Milk Shippers (IMS) List on the FDA website.  With the Aseptic Pilot Program becoming a permanent part of the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk Safety Program, changes are warranted to more clearly define what Grade “A” aseptically processed and packaged milk and milk products are being produced in an IMS listed Grade “A” aseptic milk plant.

Under the Grade “A” Aseptic Program, an aseptic milk plant or portion of a Grade “A” milk plant that produces Grade “A” aseptically processed and packaged milk and/or milk products shall be rated and IMS listed separately from pasteurized and/or ultra-pasteurized (UP) milk and/or milk products. For aseptic milk plant IMS listings, Product Code #6-Aseptic Milk and Milk Products (Including Flavored) and/or #36-Aseptic Goat Milk and Milk Products shall continue to be recorded in Block 6 on FORM FDA 2359i.  These new changes will require that when Product Codes #6 and/or #36 is selected that at least one (1) Sub-Product Code, respectively, to be selected for the submission of FORM FDA 2359i to FDA for inclusion on the IMS list.

Selection of Product Codes:

For an aseptic milk plant IMS listing, Product Code #6-Aseptic Milk and Milk Products (Including Flavored) will be selected and only the following Product Codes will be allowed to be selected in addition to Product Code #6 for inclusion in Block 6 of FORM FDA 2359i:

Product Codes:

  • 1-Raw Milk for Pasteurization (May Include Lowfat, Skim or Cream);
  • 3-Heat-Treated (May Include Reduced Fat, Lowfat, Skim or Cream);
  • 31-Raw Goat Milk for Pasteurization; and/or
  • 36-Aseptic Goat Milk and Milk Products.

NOTE: When Product Code #6 is selected, the submitter may not select any additional Product Codes other than Product Codes #1, #3, #31 and/or #36.  If the submitter only selects Product Code #36, then they may only select additional Product Code #31.

When Product Code #6 and/or #36 is selected, the submitter shall select at least one (1) of the following Sub-Product Codes to be included with Product Codes #6 and/or #36 for inclusion on the IMS list:

Sub-Product Codes:

  • 2-Milk, Reduced Fat, Lowfat, Skim;
  • 4-Half & Half, Coffee Cream, Creams;
  • 8-Cultured or Acidified Milk and Milk Products;
  • 9-Yogurt (Including Lowfat or Skim);
  • 10-Sour Cream Products (Acidified or Cultured);
  • 18-Eggnog;
  • 19-Lactose Reduced Milk and Milk Products:
  • 20-Low-Sodium Milk and Milk Products;
  • 21-Milk and Milk Products with Added Safe and Suitable Microbial Organisms (Such as Lactobacillus acidophilus); and/or
  • 25-Chlosterol Modified Fluid Milk Products.

NOTE: On the IMS list, the system shall display the Product Code, a hyphen and then the Sub-Product Code(s).  For Example: 6-2, 6-4, 6-18, etc.

Additional Changes:

  1. When Product Code #5-Ultra-Pasteurized Milk and Milk Products and/or #35-Ultra-Pasteurized Goat Milk and Milk Products, respectively is selected, the submitter shall select at least one (1) of the following Sub-Product Codes to be included with those Product Codes:
    • 2-Milk, Reduced Fat, Lowfat, Skim;
    • 4-Half & Half, Coffee Cream, Creams;
    • 8-Cultured or Acidified Milk and Milk Products;
    • 9-Yogurt (Including Lowfat or Skim);
    • 10-Sour Cream Products (Acidified or Cultured);
    • 18-Eggnog;
    • 19-Lactose Reduced Milk and Milk Products:
    • 20-Low-Sodium Milk and Milk Products;
    • 21-Milk and Milk Products with Added Safe and Suitable Microbial Organisms (Such as Lactobacillus acidophilus); and/or
    • 25-Chlosterol Modified Fluid Milk Products.

NOTE: When either Product Code #5 or #35 is selected, the submitter may not select Product Codes #6 or #36. On the IMS list, the system shall display the Product Code, a hyphen and then the Sub-Product Code(s).  For Example: 5-2, 5-8, 35-2, etc.

  1. The following changes have also been made to the Product Codes:

PREVIOUS PRODUCT CODES:

  1. Raw Sheep Milk for Pasteurization
  2. Cultured Sheep Milk and Milk Products
  3. Concentrated Raw Milk Products for Pasteurization
  4. Concentrated Pasteurized Milk Products
  5. Ultrafiltered Permeate from Milk
  6. Ultrafiltered Permeate from Whey
  7. Raw Water Buffalo Milk for Pasteurization
  8. Cultured Water Buffalo Milk and Milk Products

NEW AND RENUMBERED PRODUCT CODES:

  1. Raw Sheep Milk for Pasteurization
  2. Pasteurized Sheep Milk and Milk Products (NEW)
  3. Cultured Sheep Milk and Milk Products
  4. Concentrated Raw Milk Products for Pasteurization
  5. Concentrated Pasteurized Milk Products
  6. Ultrafiltered Permeate from Milk
  7. Ultrafiltered Permeate from Whey
  8. Raw Water Buffalo Milk for Pasteurization
  9. Pasteurized Water Buffalo Milk and Milk Products (NEW)
  10. Cultured Water Buffalo Milk and Milk Products
  11. Raw Camel Milk for Pasteurization (NEW)
  12. Pasteurized Camel Milk and Milk Products (NEW)
  13. Cultured Camel Milk and Milk Products (NEW)

NOTE: Existing IMS listings that include these Product Codes at the time that these changes were made were automatically corrected and updated on the IMS list.  Page 2 of Form FDA 2359i will be revised to indicate these Product Code changes within the 10/13 version of this Form.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, Milk Regulatory and Rating Agencies and Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and will also be available on the FDA Web Site at http://www.fda.gov at a later date.

If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to robert.hennes@fda.hhs.gov.
 

/s/

Robert F. Hennes, RS, MPH
CAPT U.S. Public Health Service
Dairy and Egg Branch