Examination of Milk and Milk Products for Vitamin and Mineral Fortification

(A) Sampling. Each pasteurization plant that adds vitamins or minerals to milk or milk products shall have at least two assays made per year, at approximately six month intervals. It shall be the responsibility of the pasteurization plant to provide for the submission and shipment of samples and payment for testing to a laboratory approved by the Department pursuant to 105 CMR 500.062(C). (B) Approved Methods for Laboratory Testing. Samples for assay shall be analyzed at a laboratory approved by the Department using methods prescribed by administrative guidelines of the Department based on the Association of Official Analytical Chemists' Official Methods of Analysis, or by such modified methods as may be approved by the Department. Results of all assays conducted on milk and milk products and Grade A dry milk products for the purpose of meeting the requirements set forth in 105 CMR 500.062(A) shall be forwarded to the Department by the laboratory within ten days of obtaining test results. In addition, results of all assays conducted to determine if deficiencies in fortification procedures have been corrected shall be forwarded to the Department by such laboratory within ten days of obtaining test results. (C) Approval of Milk Laboratories. Any person who desires to have his or her laboratory approved by the Department as a milk laboratory shall first satisfy the Department that tests to be made in such laboratory will be conducted by persons qualified by training and/or experience to make such tests accurately and that the tests will be conducted in accordance with administrative guidelines of the Department based on methods prescribed by the Association of Official Analytical Chemists' Official Methods of Analysis, or by such modified methods as may be approved by the Department. Laboratories operated and maintained by those persons who thus satisfy the Department shall be designated "Approved Laboratories". (D) Enforcement. (1) Whenever vitamin or mineral assay results indicate that fortification levels are not within the fortification levels required by 21 CFR § 131.110: Milk, the pasteurization plant shall investigate its fortification procedures to determine the cause, and the cause shall be corrected. Additional samples of milk or milk products shall be taken and shall be resubmitted by the pasteurization plant to the approved laboratory for analysis within 30 days of notification of the original assay results. It shall be the responsibility of the pasteurization plant to provide for the submission and shipment of samples and payment for testing to the approved laboratory. Results of these tests shall also be forwarded to the Department by the laboratory within ten days of obtaining test results. (2) Whenever the pasteurization plant fails to comply with requirements set forth in 105 CMR 500.062(D)(1), the Department may initiate proceedings to suspend or revoke the license.