These regulations are to prescribe the methods of calibrating and operating automated testing equipment authorized to be used to measure the milk fat content of raw, unhomogenized milk. These regulations shall apply to any automated testing equipment used at any time for the purpose of measuring milk fat content in raw, unhomogenized milk when the results are to be used as the basis for payment to milk producers. In accordance with the authority of the Secretary to promulgate regulations to regulate the receiving, weighing, measuring, sampling, and testing of milk or other fluid dairy products when the results are to be used as a basis for payment to the producer of the products as contained in Title 11 of the Agriculture Article of the Annotated Code of Maryland, these regulations are adopted as regulations of the Maryland Department of Agriculture. “Automated testing equipment” means any contrivance, machine, or device manufactured for the purpose of measuring the milk fat content of milk or other fluid milk products within the design of the instrument, and approved by the Association of Official Analytical Chemists (AOAC). “Cooperative” means a corporation or association as defined and construed in the Corporations and Associations Article, §5-501, Annotated Code of Maryland. A cooperative shall be deemed a producer within the provisions of these regulations and shall be entitled to their benefits. “Department” means Maryland Department of Agriculture. “Equipment operator” means a person licensed to operate automated testing equipment in accordance with these regulations. “Person” includes: The State, any county, municipal corporation or other political subdivision of the State, or any of its units; An individual, receiver, trustee, guardian, executor, administrator, fiduciary, or representative of any kind; Any partnership, firm, association, public or private corporation; or Any other entity, unless otherwise provided. “Producer” means any person who owns, controls, or operates a dairy herd for the production of milk to be sold or offered for sale. “Purchaser” means any person who pays the producer or the person who pays a cooperative association representing the producers for the milk or other fluid dairy products. “Reference method” means the method of testing milk for milk fat content that is known as the Babcock Test, provided, that for the purposes of these regulations, all measurements obtained by the Babcock Test shall be read to the nearest .05 percent. “Sample” means that representative portion of the producer's shipment that is drawn and placed into a container approved by the Department and used for an analysis of milk constituent content on which payment to the producer may be based. “Secretary” means Secretary of Agriculture or the Secretary’s designee. “Test” means an official procedure, approved by the Association of Official Analytical Chemists or American Public Health Association as published in the latest edition of their official publication and adopted by the Department, which is used to determine the amount of any milk constituent in any sample of milk or other fluid dairy product. The results of the analysis shall also be referred to as a test. A person may not operate any automated testing equipment for the purposes of determining the milk fat content of milk for payment purposes to the producer unless licensed by this Department. Any person testing milk for the purpose of controlling the accuracy of the automated testing equipment shall also be licensed by the Department to test milk for milk fat content by the reference method. Initial Calibration. Any person seeking to use automated testing equipment for measuring milk fat content in raw, unhomogenized milk as a basis of payment to producers shall first cause the equipment to be calibrated in accordance with these regulations. The Department shall be notified at least 10 State working days before initial calibration is to be conducted. The initial calibration may be performed only after the equipment has been installed and stabilized as approved by the Secretary. The initial calibration shall be performed by the equipment operator under the supervision of the Secretary, in accordance with the procedures approved by the Secretary. Subsequent calibrations shall be performed by the equipment operator in accordance with procedures approved by the Secretary, but need not be under the supervision of the Secretary. Method of Calibration. The equipment operator shall obtain 20 representative samples of natural herd milk which have not been adjusted with skim milk, cream, or any other substance. Each sample shall be a representative mixture of the milk from any herd containing at least 20 cows milking. The collection and handling of the 20 representative samples shall be uniform and in accordance with milk sample handling procedures as set forth in the regulations of the Department. The milk fat content of the samples to be used as the natural herd milk samples shall be distributed within the ranges of 3 percent to 6 percent of milk fat and, if possible, reflect the expected milk fat content of the milk to be tested by the equipment. The samples shall be first tested for milk fat content using the reference method. Each sample shall be tested in triplicate. These samples shall then immediately be tested using the automated testing equipment and shall be tested in triplicate, using the automated testing equipment. All testing of the samples for purposes of calibration shall be completed within 24 hours from the time the samples were collected from the producer. The milk fat content for each sample as measured by the reference method shall be determined by taking the average of the three tests by that method. The three tests conducted using the automated testing equipment shall be averaged for each sample to determine its milk fat content as measured by that method. All averages shall be computed to the nearest 0.01 percent. Any sample, in which the fat content as measured by either method varies more than 0.10 percent during the course of being tested three times, may not be used in calculating the standard deviation of difference (Sd). The standard deviation of difference (Sd) shall be computed by using the averages of at least 18 of the 20 samples tested and applying the (Sd) formula used by the AOAC. The maximum allowable average difference (D) and the standard deviation of difference (Sd) between the results obtained by using the reference method and the results obtained by using the automated testing equipment may not exceed those established by the AOAC for the make and model of automated testing equipment used. Only automated testing equipment meeting these standards may be used to measure the milk fat in milk as a basis of determining the payment to producers. Once the automated testing equipment has been calibrated in accordance with the initial calibration procedures provided in these regulations, it may be used to determine the milk fat content of raw unhomogenized milk, provided it is operated in compliance with the following procedures: Control Milk Samples. Milk samples to be used as control milk samples shall be prepared in accordance with the following procedures: Eight samples of natural herd milk shall be prepared in accordance with Regulation .06. These eight samples shall be tested three times by the reference method. The milk fat content of each sample shall be determined by averaging the results of the three tests to the nearest 0.01 percent. They shall contain a milk fat content within the range being tested by the equipment. The samples shall then be tested immediately by the automated equipment. The results of the three tests for each sample shall be averaged as provided in §A(2), above. If the standard deviation of difference between the average of the results obtained using the two methods does not exceed 0.06 percent, the equipment may continue to be used. If the (Sd) exceeds 0.06 percent, the equipment shall cease being used and be inspected to determine why the (Sd) exceeds this limit, be repaired, if necessary. and then recalibrated in accordance with the initial calibration procedures as set forth in Regulation .06 of this chapter. The Department need not be notified as to this recalibration. All control milk samples prepared shall be stored at temperatures between 35 degrees—40 degrees F. A control milk sample may not be used beyond 7 days from the date of its preparation. Daily Performance Checks. At the beginning of each day in which the automated testing equipment is to be used, the following tests shall be conducted: Upon proper zero adjustment, a performance check shall be made by measuring a control milk sample four times in the automated testing equipment. The results of the first two tests shall be disregarded and the results of the last two tests shall be averaged to the nearest 0.01 percent. If in the performance check the difference between the milk fat content of the control milk sample and the averaged results of the two tests conducted using the automated testing equipment (D) is greater than 0.06 percent milk fat, the determination shall be repeated using three additional control milk samples, each of which shall be tested in duplicate. If the difference (D) of any of the three additional samples is again greater than 0.06 percent milk fat, then the equipment shall be recalibrated according to the procedures provided for initial calibration as provided in Regulation .06. When the automated testing equipment is being used to determine the milk fat content of milk as a basis of payment to producers, a control milk sample will be tested by the automated testing equipment once every hour of its operation or once every 50 samples tested, whichever occurs first. If the difference between the milk fat content as measured by the equipment and the milk fat content of the control milk is 0.06 percent or less, the equipment may be continued in use as a basis of measuring milk fat content to determine payments to producers. If the difference is greater than 0.06 percent, the equipment shall cease being used for this purpose and shall be checked in accordance with Regulation .07, above. All test results obtained from the equipment subsequent to the last acceptable check as provided by this regulation as well as all payments to producers based on these tests shall be void. The equipment may not be used for determining payments to producers until it shall have been checked and calibrated, if necessary, in accordance with Regulation .07, above. Required Records. When automated testing equipment is used to determine payments to producers, the following records shall be maintained on file for a period of 12 months, at the facility where the instrument is operated: Initial and subsequent calibrations, including the worksheet used in computing the standard deviation; Results of tests used as a basis of payment to producers; Control milk test results required by Regulation .07A, above; Daily performance checks; Machine adjustments; Major maintenance reports; Other procedural records required by the Department; Records of the preparation of control milk samples as required by Regulation .03. All automated testing equipment and required records shall be available for examination by the Department during any business hours. Agriculture Article, §11-402, Annotated Code of Maryland Effective date: November 15, 1973