South Carolina Code of Regulations
Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL
Subchapter 61-36 - Frozen Desserts
Section 61-36.VII - STANDARDS FOR MANUFACTURED GRADE DAIRY PRODUCTS PLANTS AND MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTION STATIONS

Universal Citation: SC Code Regs 61-36.VII

Current through Register Vol. 48, No. 9, September 27, 2024

A. Temperature, bacteriological and chemical requirements.

1. All frozen dessert MIX shall be produced, processed, and PASTEURIZED, ULTRA-PASTEURIZED, or ASEPTICALLY PROCESSED as specified in the PMO and frozen to conform with the following temperature, bacteriological, and chemical standards and the sanitation requirements of this section:
a. RAW MILK and MILK products obtained by a FROZEN DESSERT manufacturer for future PASTEURIZATION, ULTRA-PASTEURIZATION, or ASEPTIC PROCESSING and use in the production of FROZEN DESSERTS must come from an APPROVED source and must be in compliance with the temperature, bacteriological, and chemical standards in R.61-34, Raw Milk for Human Consumption, or R. 61-34.1, Pasteurized Milk and Milk Products, or the PMO.

b. PASTEURIZED FROZEN DESSERTS and/or Heat-Treated, Bulk-Shipped MILK Products:
(1) Temperature - Cooled to 45°F (7°C) or less and maintained thereat.

(2) Bacterial limits* - 30,000 per mL.

(3) Coliform - Not to exceed 10 per mL: provided that, in the case of bulk MILK transport tank shipments, where contents are to be repasteurized, shall not exceed 100 per mL.

(4) Phosphatase** - Less than 500 milliunits/L by the Fluorometer or Clarion ALP or equivalent.

(5) DRUGS - No positive results on DRUG residue detection methods as referenced in Section 6 - Laboratory Techniques, FDA Grade "A" PMO as amended.

c. ASEPTICALLY PROCESSED MIX:
(1) Temperature - None.

(2) Bacterial limits - No growth by test specified in Section VI.

(3) DRUGS - No positive results on DRUG residue detection methods as referenced in Section 6 - Laboratory Techniques, FDA Grade "A" PMO as amended.

*Not applicable to cultured products.

**Not applicable to bulk shipped heat-treated products.

2. Each type of CHEESE shall conform to the sanitation requirements of this section and be produced and processed and PASTEURIZED, ULTRA-PASTEURIZED, and ASEPTICALLY PROCESSED to conform with the temperature, bacteriological, and chemical standards that are outlined below:
a. Except as provided in paragraph A.2.b. below, all MILK and MILK products used in the production of CHEESE shall meet the requirements in either (1) or (2) below:
(1) Be PASTEURIZED or subjected to equivalent heat treatment by the CHEESE manufacturer in accordance with the applicable specifications under the definition of PASTEURIZATION in Section I of this regulation.
a. PASTEURIZATION achieved by methods other than those described in the current PMO must be achieved in accordance with a written procedure that has been APPROVED by the DEPARTMENT; and

b. has been proven by a phosphatase test to achieve PASTEURIZATION.

(2) Be made from PASTEURIZED MILK products or from MILK products which have been subjected to equivalent heat treatment as outlined in Section I of this regulation.

b. If made from RAW MILK (CHEESE labeled as "heat treated", "unPASTEURIZED", "RAW MILK", or "for manufacturing"), CHEESE must be aged for no less than sixty (60) days at a temperature greater than or equal to 35°F (1.7°C) in order to control microbial PATHOGENS.

c. RAW MILK and MILK products obtained by a CHEESE manufacturer for future PASTEURIZATION, ULTRA-PASTEURIZATION, or ASEPTIC PROCESSING and use in the production of CHEESE must come from an APPROVED source and be in compliance with the temperature, bacteriological, and chemical standards in R.61-34, Raw Milk for Human Consumption, or R. 61-34.1, Pasteurized Milk and Milk Products., or the PMO.

d. All CHEESE shall be made from ingredients that conform to the quality specifications for raw materials outlined in 21 CFR 58.430 through 58.437, as amended.

e. Each type of CHEESE must meet the specific standards and limits applicable to it under Subpart B of 21 CFR Part 133, as amended.

3. All BUTTERS shall conform to the sanitation requirements of 21 CFR 117.80 and be produced, processed, and PASTEURIZED, ULTRA-PASTEURIZED, or ASEPTICALLY PROCESSED to conform with the temperature, bacteriological, and chemical standards that are outlined below:
a. All BUTTERS shall be manufactured from MILK or MILK products that have been PASTEURIZED or subjected to equivalent heat treatment in accordance with the applicable specifications under the definition of PASTEURIZATION in Section I of this regulation and shall not be made from RAW MILK or RAW MILK products.
(1) PASTEURIZATION achieved by methods other than those described in the current PMO must be achieved in accordance with a written procedure that has been APPROVED by the DEPARTMENT; and

(2) has been proven by a phosphatase test to achieve PASTEURIZATION.

b. All BUTTERS shall be made from ingredients that conform to the quality specifications for raw materials outlined in 7 CFR 58.322 through 58.331, as amended.

c. BUTTER specifications:
(1) Proteolytic count - Not more than 100 per gram.

(2) Yeast and mold count - Not more than 20 per gram.

(3) Coliform count - Not more than 10 per gram.

(4) Enterococci - Not more than 10 per gram.

4. No process or manipulation other than PASTEURIZATION, ULTRA-PASTEURIZATION or ASEPTIC PROCESSING, freezing, processing methods integral therewith, and appropriate refrigeration (freezing) shall be applied to MANUFACTURED GRADE DAIRY PRODUCTS for the purpose of removing or deactivating MICROORGANISMS.

5. All IMITATION MILK, IMITATION MILK PRODUCTS, AND PRODUCTS MADE IN SEMBLANCE OF MILK AND MILK PRODUCTS shall meet the minimum standards for the MILK or MILK product which it imitates or resembles, including those for fat and solids not fat. To each quart of IMITATION MILK, imitation low-fat MILK, imitation skim MILK, and products made in semblance of these products, 400 U.S.P. units of Vitamin D and 2000 U.S.P. units of Vitamin A shall be added.

B. Post-PASTEURIZATION ingredients.

Only the following flavoring ingredients and other ingredients which have been found to be safe and suitable may be added to a MANUFACTURED GRADE DAIRY PRODUCT after PASTEURIZATION:

1. Fresh fruits and vegetables, provided the resultant equilibrium pH level (4.6 or below when measured at 75°F (24°C)) of the finished product is reached without undue delay and is maintained during the shelf life of the product;

2. Ingredients subjected to prior heating or other technology that has been demonstrated to the FDA to be sufficient to destroy or remove PATHOGENIC MICROORGANISMS;

3. Ingredients having a water activity of 0.85% or less;

4. Ingredients having a high acid content (pH level of 4.6 or below when measured at 75°F (24°C)) or high alkalinity (pH level greater than 11 when measured at 75°F (24°C));

5. Roasted nuts;

6. Dry sugars and salts;

7. Safe and suitable bacterial cultures and enzymes;

8. Alcohol;

9. Ingredients that have been found to be safe and suitable by the FDA.

All such additions shall be made in a sanitary manner that prevents the contamination of the added ingredient or the MANUFACTURED GRADE DAIRY PRODUCT.

C. Sanitation of MANUFACTURED GRADE DAIRY PRODUCTS PLANTS and MANUFACTURED GRADE DAIRY PRODUCTS DISTRIBUTION STATIONS.

1. All MANUFACTURED GRADE DAIRY PRODUCTS MANUFACTURERS and DISTRIBUTORS, regardless of exemption status, shall comply with the requirements of 21 CFR Part 117, Subpart A - General Provisions, Subpart B - Current Good Manufacturing Practice, and Subpart F - Requirements Applying to Records That Must Be Established and Maintained, as amended.
a. In addition to the requirements in Section VII(C)(1) above, BUTTER plants, BUTTER manufacturers, BUTTER distribution stations, and BUTTER distributors shall comply with 7 CFR 58.311 through 58.321, as amended, and 7 CFR 58.332 through 58.344, as amended.

b. In addition to the requirements in Section, VII(C)(1) above, CHEESE plants, CHEESE manufacturers, CHEESE distribution stations, and CHEESE distributors shall comply with 7 CFR 58.406 through 58.429, as amended, and 7 CFR 58.438 through 58.445, as amended.

2. MANUFACTURED GRADE DAIRY PRODUCTS PLANTS and DISTRIBUTION STATIONS that have been granted a Qualified Facility Exemption by the FDA or that are solely engaged in the storage of refrigerated UNEXPOSED PACKAGED FOODS when temperature controls are necessary to prevent PATHOGEN growth shall comply with the requirements of 21 CFR Part 117, Subpart A - General Provisions, Subpart B - Current Good Manufacturing Practice, Subpart D - Modified Requirements, and Subpart F - Requirements Applying to Records That Must Be Established and Maintained, and be familiar with Subpart E - Withdrawal of a Qualified Facility Exemption, as amended.

3. All MANUFACTURED GRADE DAIRY PRODUCTS PLANTS and DISTRIBUTION STATIONS that have not been granted a Qualified Facility Exemption by the FDA shall comply with the requirements of 21 CFR Part 117, Subpart A - General Provisions, Subpart B - Current Good Manufacturing Practice, Subpart C - Hazard Analysis and Risk-Based Preventive Controls, and Subpart F - Requirements Applying to Records That Must Be Established and Maintained, as amended.

4. MANUFACTURED GRADE DAIRY PRODUCTS PLANTS and DISTRIBUTION STATIONS that are requiring a withdrawal of their Qualified Facility Exemption from the FDA shall be subject to the requirements of 21 CFR Part 117, Subpart E - Withdrawal of a Qualified Facility Exemption, as amended.

5. MANUFACTURED GRADE DAIRY PLANTS and DISTRIBUTION STATIONS that have not been granted a Qualified Facility Exemption by the FDA and have identified a hazard requiring a supply-chain applied control shall comply with the requirements of 21 CFR Part 117, Subpart G - Supply-Chain Program, as amended.

6. There shall be separate rooms for processing and packaging of different types of MANUFACTURED GRADE DAIRY PRODUCTS as determined by the DEPARTMENT.

7. Water Supply.
a. Water used for MANUFACTURED GRADE DAIRY PRODUCTS PLANT purposes shall be from a supply properly located, protected, and operated, and shall be easily accessible, adequate, and of a safe, sanitary quality. Any water used as an ingredient must be obtained from an APPROVED public water system as defined in R.61-58. Water for MANUFACTURED GRADE DAIRY PLANTS that have not been granted a Qualified Facility Exemption by the FDA must be from an APPROVED public water supply.

b. Firms that have been granted a Qualified Facility Exemption by the FDA shall have their water supply tested. Samples for bacteriological testing of individual water supplies may be taken by the DEPARTMENT or by other APPROVED individuals with the results to be submitted to the DEPARTMENT upon the initial approval of the physical structure, annually thereafter, and when any repair or alteration of the water supply system has been made. Examinations shall be conducted in an OFFICIAL LABORATORY at the MANUFACTURED GRADE DAIRY PRODUCT PLANT'S expense. The plant must maintain records of the tested samples.

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