Testing Requirements; Enforcement

(A) Raw Milk to be Used in Frozen Desserts, Frozen Dessert Mixes, Butter, or Cheese. (1) Drug Residues. (a) All manufacturers shall test for drug residues, or have evidence of a previous test for drug residues, on all incoming unpasteurized milk and milk products received for processing into frozen desserts, frozen dessert mixes, butter, or cheese. (b) Drug residue tests shall be performed as required by the Department's administrative guidelines based on the PMO. (c) The manufacturer shall not use any item tested until it receives a negative test result, provided that when drug residues have been found in a second sample of raw milk or a raw milk product, the manufacturer shall destroy such milk or milk product. (d) Any positive drug residue test shall be reported to the Department of Agricultural Resources. (e) Whenever a drug residue test is confirmed positive, the manufacturer shall investigate to determine the cause, and shall correct the cause in accordance with the guidelines. (2) Pesticide Residues. (a) Pesticide residue tests are performed by federal agencies on a non-routine basis. (b) Whenever a pesticide residue test is positive, the manufacturer shall investigate to determine the cause, and shall correct the cause. No product shall be offered for sale until it is shown by a subsequent sample to be free of pesticide residues or below the levels established by law for such residues. (B) Finished Products Testing Requirements for Manufacturers of Frozen Desserts. (1) Phosphatase. (a) Phosphatase tests are performed by the Department on samples that are collected routinely. (b) Whenever a phosphatase test is positive, the manufacturer shall investigate to determine the cause. Where the cause is improper pasteurization, it shall be corrected and any product involved shall not be offered for sale. (2) All manufacturers manufacturing finished frozen dessert products by means other than a soft-serve machine shall have the tests specified in 105 CMR 500.083(F) performed by a laboratory approved by the Department of each of the following categories of finished products at least once a month: (a) Plain frozen dessert (vanilla, chocolate, coffee, etc.); (b) Fruits and variegated (strawberry, frozen pudding, raspberry royale, etc.); (c) Nuts and candy (maple walnut, butter crunch, etc.); (d) Sherbet; (e) Novelties (spumoni, dixies, sandwiches, etc.); (f) Seasonal products (products manufactured during only part of the year); and (g) Frozen yogurt, except that if live cultures have been added to the product after pasteurization, the test for bacterial limit shall not be required. If the flavors listed in each of these categories can be practically rotated, the tests shall be made on that basis. (3) New Products. Any new frozen dessert product, including a new flavor of any frozen dessert, shall be placed in the appropriate category specified in 105 CMR 500.082(B)(2) and shall have priority for testing. (4) All manufacturers of frozen desserts produced in a soft-serve machine shall have the tests of its finished product specified in 105 CMR 500.083(F) performed by a laboratory approved by the Department at least once a month. (5) Copies to be Submitted by In-state Manufacturers. The manufacturer shall ensure that copies of all test results for required tests are submitted directly to the board of health by the laboratory within three business days of completion of the tests. (6) Notification Regarding Laboratory. Each manufacturer of a frozen dessert or frozen dessert mix shall notify the board of health in writing of the name and address of the laboratory where the tests required by 105 CMR 500.083 are done. When the manufacturer ceases to use a particular laboratory, he or she shall immediately notify the board of health in writing of the name and address of the new laboratory that is to be used. (C) Sampling and Testing after a Bacterial Violation is Found: Frozen Desserts Produced by Means Other than a Soft-Serve Machine. Whenever any sample tested pursuant to 105 CMR 500.082(B)(1), (2) or (3) is found to be in violation of the bacterial limit or coliform standard in 105 CMR 500.083(F), the manufacturer shall re-sample and retest each subsequent production run of the finished product originally found in violation (e.g. vanilla, chocolate, etc.) until three consecutive non-violative samples are obtained. (D) Enforcement of Bacterial Standards: Frozen Desserts and Frozen Dessert Mixes. (1) Whenever two of the last four consecutive tests for bacterial limit counts or coliform determinations (except those for aseptically processed products), taken on separate days (different production days), exceed the limit of the standard specified in 105 CMR 500.083(D), (E), or (F), the board of health or the Department, as appropriate, shall send a written notice thereof to the licensee. This notice shall also inform the licensee of the provisions of 105 CMR 500.082(D)(2), and shall remain in effect as long as two of the last four consecutive samples exceed the limit of the standard. (2) Whenever a standard specified in 105 CMR 500.083(D), (E), or (F) has been violated by three of the last five consecutive tests for bacterial limit or coliform determinations (except those for aseptically processed products), taken on separate days (different production days), the board of health or the Department, as appropriate, shall immediately suspend the license or one or more particular operations, or the sale of one or more particular products, without prior notice or hearing, in accordance with 105 CMR 500.207(B). (3) When the license or operation(s) are suspended as provided in 105 CMR 500.082(D)(2), the following procedures shall be followed. (a) The manufacturer shall provide to the board of health and the Department documentation showing: 1. The cause of the violative condition; and 2. The plan of correction used to correct the violative condition. (b) After receipt of the documentation specified in 105 CMR 500.082(D)(3)(a): 1. The Department shall collect samples and conduct laboratory analyses to determine if the conditions(s) have been corrected, and 2. An inspection shall be made. If it is determined that the condition(s) responsible for the violation(s) has been corrected, the board of health or Department shall reinstate the license, or allow the resumption of operation(s), or the sale of suspended product(s). (E) Violation of Standards: Soft-serve Machines. Whenever any sample from a soft-serve machine tested pursuant to 105 CMR 500.082(B)(2)(a) is found to be in violation of the bacterial limit or coliform standard in 105 CMR 500.083(F), the machine operator shall thoroughly clean, rinse, and sanitize the machine and shall test the first product produced by the machine after cleaning. The machine may be operated until the result of the confirmatory test is received. If such test shows a violation, production must stop and further cleaning, sanitizing, and testing must be done. No product may be sold or distributed in any way until the result of the subsequent test meets the standards in 105 CMR 500.083(F).