(A) Regulated Activities.

1. (1) Persons who engage in any of the following activities shall comply with 105 CMR 500.081 through 500.083, as appropriate, in addition to 105 CMR 500.004 through 500.008.

   1. (a) Manufacturing frozen desserts or frozen dessert mix within Massachusetts;
   2. (b) Manufacturing frozen desserts or frozen dessert mix outside Massachusetts and selling such product(s) within Massachusetts;
   3. (c) Manufacturing butter within Massachusetts for wholesale; or
   4. (d) Manufacturing cheese within Massachusetts for wholesale.
2. (2) Out-of-state Frozen Dessert License Applicants. With its application for a license, an out-of-state applicant for a license to manufacture and sell frozen desserts in Massachusetts shall also submit a copy of its license, permit, or certification received from the out-of-state regulatory agency having jurisdiction.

(B) License. No person shall engage in any activity listed in 105 CMR 500.081(A)(1) without a valid license or in violation of any of the requirements specified in 105 CMR 500.000. The following licenses are required.

1. (1) A person who manufactures frozen desserts or frozen dessert mix within Massachusetts for sale at wholesale or retail must hold a license (which may be called a permit) issued by the board of health pursuant to M.G.L. c. 94, § 65H.
2. (2) A person who manufactures frozen desserts or frozen dessert mix outside Massachusetts and sells such products in Massachusetts must hold a license issued by the Department pursuant to M.G. L. c. 94, § 65H.
3. (3) A person who manufactures butter or cheese in Massachusetts for sale at wholesale in a facility separate from a pasteurization plant (i.e. does not hold a license under M.G.L. c. 94, § 48A) must hold a license issued by the Department pursuant to M.G. L. c. 94, § 305C.

(C) Pasteurization.

1. (1) Manufacturers of frozen desserts, frozen dessert mixes, butter, and cheese shall comply with the relevant sections of the Department's administrative guidelines based on the PMO, except that manufacturers of cheese made from unpasteurized milk shall comply with all relevant sections of the guidelines except the pasteurization requirements.
2. (2) Any milk-based ingredient used in the manufacture of frozen desserts shall be pasteurized in compliance with the guidelines.

(D) Requirements for Ingredients.

1. (1) All raw milk and cream shall be obtained from a farm or facility licensed or permitted by the appropriate governmental authority in the jurisdiction.
2. (2) No milk or cream from a source outside the United States, subject to the Federal Import Milk Act, 21 U.S.C. § 141 et seq., shall be used in the manufacture of frozen desserts, frozen dessert mixes, butter, or cheese unless the importer has documentation to show that the exporter is in compliance with 21 CFR Part 1210: Regulations Under the Federal Import Milk Act. The manufacturer shall maintain adequate documentation of such compliance for at least two years.

3. (3) Manufacturers that receive any milk or milk product in bulk form shall pasteurize it before using it in the manufacturing process, even if it has been previously pasteurized, except that this requirement shall not apply to milk or milk products received in:

   1. (a) A tanker that provides written documentation to the facility that:

      1. 1. The tanker is dedicated to fluid milk products;
      2. 2. The tanker has been properly washed and sanitized; and
      3. 3. The load has been previously pasteurized; or
   2. (b) A single service container of five gallons or less whose contents have been pasteurized; or
   3. (c) Any other container and/or system approved by the Department following submission of a written plan by the facility.
4. (4) Fats and oils other than from milk used in frozen desserts shall conform to the applicable provisions of the United States Food, Drug and Cosmetic Act.
5. (5) Dry whole milk, nonfat dry milk, dry whey, or dry buttermilk, when used as an ingredient in a frozen dessert, shall be USDA Extra Grade or its equivalent.

(E) Reprocessing and Resale.

1. (1) Spilled products and ingredients shall be discarded.
2. (2) Product intended for reprocessing shall be handled in sanitary covered containers and stored at or below 45°F (7.2°C) or shall be piped directly back to vats.
3. (3) Frozen dessert mix that has been strained to remove nuts, fruit, or other ingredients shall be re-pasteurized. If such mix contained a major food allergen, it shall be used only as mix for products that contain the same allergen.
4. (4) Products that have left the possession of the manufacturer shall not be reprocessed.

(F) Daily Cleaning and Sanitizing.

1. (1) Processing and Filling Equipment. Any manufacturer that wishes to operate processing or filling equipment for longer than one production day between cleaning and sanitizing the equipment shall apply to the Department for a variance pursuant to 105 CMR 500.212, and shall explain in the variance application how product safety will be maintained.

2. (2) Silos and Holding Tanks.

   1. (a) Any manufacturer that wishes to use any silo or holding tank containing pasteurized or unpasteurized ingredient or product for longer than the time allowed by the Department's administrative guidelines based on the PMO between cleaning and sanitizing shall apply to the Department for a variance pursuant to 105 CMR 500.212, and shall explain in the variance application how product safety will be maintained.
   2. (b) Any silos or holding tanks put into service after September 26, 2003 shall be equipped with a seven-day temperature recording device.
3. (3) Soft-serve Machines. The operator of any soft-serve machine shall comply with the machine manufacturer's instructions with respect to cleaning and sanitizing.

(G) Temperatures for Raw and Finished Products.

1. (1) All milk and milk products used as ingredients in frozen desserts, frozen dessert mixes, butter, or cheese shall be received, stored, and shipped so as to ensure that the internal temperature does not exceed 45°F (7.2°C).
2. (2) All finished frozen dessert products, excluding products produced in a soft-serve machine, shall be received, stored, and shipped so as to ensure that the internal product temperature does not exceed 10°F.
3. (3) All finished butter and pasteurized cheese products shall be received, stored, and shipped so as to ensure that the internal temperature does not exceed 45ºF (7.2ºC).