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M-a-97: Specified Microbial Inhibitors and/or Preservatives Accepted By FDA For Use In The Production Of Cottage Cheese That Will Be Filled At 13C (55F) Or Less, Cooled To 10C (50F) Or Less Within Twenty-Four (24) Hours Of Filling, And Cooled To 7C (45F) Or Less Within Seventy-Two (72) Hours Of Filling

<< Back to Index of Memoranda of Interpretation (M-a)
 

June 7, 2011

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

FROM: Dairy and Egg Branch (HFS-316)  

SUBJECT: Specified Microbial Inhibitors and/or Preservatives Accepted By FDA For Use In The Production Of Cottage Cheese That Will Be Filled At 13°C (55°F) Or Less, Cooled To 10°C (50°F) Or Less Within Twenty-Four (24) Hours Of Filling, And Cooled To 7°C (45°F) Or Less Within Seventy-Two (72) Hours Of Filling

This is the accompanying document as referenced in IMS-a-45 (Supplement 2)-Additional Action from the 2005 National Conference on Interstate Milk Shipments (NCIMS) Related to Proposal 126, dated June 7, 2011, with an effective/implementation date of June 15, 2011 as passed in Proposal 117 from the 2011 NCIMS Conference.

The 30th National Conference on Interstate Milk Shipments was held in Columbus, Ohio, May 12-17, 2005. FDA responded in writing to the NCIMS Conference Chair on September 2, 2005 and met with the NCIMS Executive Board on September 27, 2005 concerning all of the Proposals passed during the 2005 Conference. FDA did not concur with Proposals 126, 127 and 128 relating to Item 17p-Cooling of Milk and Milk Products of the Grade “A” PMO. FDA and the Executive Board mutually concurred with all of the other Proposals and changes cited in IMS-a-45, which was issued October 1, 2005.

Since the September 27, 2005 NCIMS Executive Board meeting, the Dairy Industry has submitted scientific data to FDA addressing Proposal 126 (Cold Filled Cottage Cheese with a pH of 5.3 or below, packaged at a temperature of 13ºC (55ºF) or less and cooled to a temperature of 7ºC (45ºF) or less within seventy-two (72) hours of packaging).

FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) staff has reviewed the Dairy Industry’s submitted scientific data and has reached the following conclusions based on the specific scientific data submitted. Those conclusions are identified by the specific criteria and parameters cited below. They address the appropriate changes to be incorporated into Item 17p-Cooling of Milk and Milk Products within the 2011 Grade “A” Pasteurized Milk Ordinance (Grade “A” PMO), which are warranted to address FDA’s consensus conclusions from their review of the specific scientific data submitted.

Following are CFSAN’s conclusions based on the specific scientific data submitted for review and the specific criteria and parameters for the cold filled packaging of cottage cheese at a temperature of 13ºC (55 ºF) or less; cooled to 10ºC (50°F) or less within twenty-four (24) hours of filling; and cooled to a temperature of 7ºC (45ºF) or less within seventy-two (72) hours of filling as cited in the Grade “A” PMO:

“ITEM 17p. COOLING OF MILK AND MILK PRODUCTS

All pasteurized milk and milk products, except the following, shall be stored at a temperature of 7ºC (45ºF) or less and maintained there at following filling or until further processed:

5. Cultured cottage cheese at all milkfat levels with a pH of 5.2 or below* and: …

c. The addition of potassium sorbate at a minimum concentration of 0.06% and filled at 13ºC (55°F) or less*; cooled to 10ºC (50°F) or less within twenty-four (24) hours of filling**; and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling **; or

d. The addition of one (1) of the specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97; filled at 13ºC (55°F) or less*; cooled to 10ºC (50°F) or less with twenty-four (24) hours of filling**; and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling**.

*Critical factors including, but not limited to, pH, filling temperature, cooling times and temperatures, and potassium sorbate concentration or specified microbial inhibitors and/or preservatives, at the specified concentration as addressed in M-a-97, if applicable, shall be monitored and documented by the processing facility for verification by the Regulatory Agency. pH limit with a pH variance of + 0.05 units to account for reproducibility and inaccuracies in pH measurements. Formulation or processing changes that affect critical factors shall be communicated to the Regulatory Agency.

NOTE: Microbial inhibitors and/or preservatives and all of their individual components shall have GRAS status; and pathogen inhibition shall be supported by documented challenge study results that are acceptable to the Regulatory Agency and FDA.

** Cooling temperatures monitored at the slowest cooling portion, i.e., in the middle of the container, of the slowest cooling container, i.e., in the middle of the pallet.”

The following Table includes the FDA accepted specified microbial inhibitors and/or preservatives, at the specified concentration, for use in the production of cottage cheese that will be cold filled packaged at 13ºC (55°F) or less; cooled to 10ºC (50°F) or less within twenty-four (24) hours of filling; and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling at the time of the issuance of this M-a:

 

PRODUCT BRAND NAMEFOOD INGREDIENTSSPECIFIED CONCENTRATION
to be used
MANUFACTURER
Sea-i®Glucose (common name is corn sugar, also call D-glucose), Glucose Oxidase, Whey (Lactperoxidase, Lactose, and Casein)0.03% Bioactive Protein I
Or
0.04% Bioactive Protein I
Bienca Products
MicroGARD 430Cultured Skim Milk Blend, NFDM and Maltodextrin0.15% Fermentate DDanisco
DURAFresh™ 5015
And
DURAFresh™ 5015
+
Fargo 763
Cultured Skim Milk and Skim Milk Powder, Cultured Skim Milk and Skim Milk Powder and, Lactic Acid Starter Culture, or Starter Culture0.1% Fermentate E,
0.1% Fermentate E
+
0.1% Culture
Kerry Ingredients & Flavours
Pura Q™ Safe-RS20PCultured Whey
and
Calcium Lactate
0.15%
To
0.5% Fermentate
Purac

 

NOTE:Proposal 117 as passed at the 2011 NCIMS Conference provided for the issuance of IMS-a-45 (Supplement 2) and accompanying M-a-97 with an effective/ implementation date of June 15, 2011. It also provided that future updates to M-a-97 that add, delete or revise the listing of FDA acceptable specified microbial inhibitors and/or preservatives for use in the production of cottage cheese that will be filled at 13ºC (55°F) or less; cooled to 10ºC (50°F) or less within twenty-four (24) hours of filling; and cooled to 7°C (45°F) or less within seventy-two (72) hours of filling will not require a public comment period or follow the protocol established in the Procedures document for the issuance of M-a’s. FDA has concurred with Proposal 117 and this M-a was unanimously approved by the NCIMS Executive Board on June 7, 2011.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation 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