§ 58.133   Methods for quality and wholesomeness determination.

　　（a） Appearance and odor. The appearance of acceptable raw milk shall be normal and free of excessive coarse sediment when examined visually or by an acceptable test procedure. The milk shall not show any abnormal condition （including, but not limited to, curdled, ropy, bloody or mastitic condition）, as indicated by sight or other test procedures. The odor shall be fresh and sweet. The milk shall be free from objectionable feed and other off-odors that adversely affect the finished product.

　　（b） Somatic cell count. （1） A laboratory examination to determine the level of somatic cells shall be made at least four times in each 6-month period at irregular intervals on milk received from each patron.

　　（2） A screening test may be conducted on goat herd milk. When a goat herd screening sample test exceeds either of the following results, a confirmatory test identified in paragraph （b）（3） of this section shall be conducted.

　　（3） Milk shall be tested for somatic cell content by using one of the following procedures or by any other method approved by Standard Methods for the Examination of Dairy Products （confirmatory test for somatic cells in goat milk）:

　　（i） Direct Microscopic Somatic Cell Count （Single Strip Procedure）. Pyronin Y-methyl green stain or “New York” modification shall be used as the confirmatory test for goat's milk.

　　（ii） Electronic Somatic Cell Count （particle counter）.

　　（iii） Electronic Somatic Cell Count （fluorescent dye）.

　　（4） The somatic cell test identified in paragraph （b）（3） of this section shall be considered as the official results.

　　（5） Whenever the official test indicates the presence of more than 750,000 somatic cells per ml. （1,000,000 per ml. for goat milk）, the following procedures shall be applied:

　　（i） The producer shall be notified with a warning of the excessive somatic cell count.

　　（ii） Whenever two out of the last four consecutive somatic cell counts exceed 750,000 per ml. （1,000,000 per ml. for goat milk）, the appropriate State regulatory authority shall be notified and a written notice given to the producer. This notice shall be in effect as long as two of the last four consecutive samples exceed 750,000 per ml. （1,000,000 per ml. for goat milk）.

　　（6） An additional sample shall be taken after a lapse of 3 days but within 21 days of the notice required in paragraph （b）（5）（ii） of this section. If this sample also exceeds 750,000 per ml. （1,000,000 per ml. for goat milk）, subsequent milkings shall not be accepted for market until satisfactory compliance is obtained. Shipment may be resumed and a temporary status assigned to the producer by the appropriate State regulatory agency when an additional sample of herd milk is tested and found satisfactory. The producer may be assigned a full reinstatement status when three out of four consecutive somatic cell count tests do not exceed 750,000 per ml. （1,000,000 per ml. for goat milk）. The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.

　　（c） Drug residue level. （1） USDA-approved plants shall not accept for processing any milk testing positive for drug residue. All milk received at USDA-approved plants shall be sampled and tested prior to processing for beta lactam drug residue. When directed by the regulatory agency, additional testing for other drug residues shall be performed. Samples shall be analyzed for beta lactams and other drug residues by methods that have been independently evaluated or evaluated by the Food and Drug Administration （FDA） and that have been accepted by the （FDA） as effective to detect drug residues at current safe or tolerance levels. Safe and tolerance levels for particular drugs are established by the FDA and can be obtained from the U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, 200 C Street SW., Washington, DC 20204.

　　（2） Individual producer milk samples for beta lactam drug residue testing shall be obtained from each milk shipment as follows:

　　（i） Milk in farm bulk tanks. A sample shall be taken at each farm and shall include milk from each farm bulk tank.

　　（ii） Milk in cans. A sample shall be formed separately at the receiving plant for each can milk producer included in a delivery, and shall be representative of all milk received from the producer.

　　（3） Load milk samples for beta lactam drug residue testing shall be obtained from each milk shipment as follows:

　　（i） Milk in bulk milk pickup tankers. A sample shall be taken from the bulk milk pickup tanker after its arrival at the plant and prior to further commingling.

　　（ii） Milk in cans. A sample representing all of the milk received on a shipment shall be formed at the plant, using a sampling procedure that includes milk from every can on the vehicle.

　　（4） Follow-up to positive-testing samples. （i） When a load sample tests positive for drug residue, the appropriate State regulatory agency shall be notified immediately of the positive test result and of the intended disposition of the shipment of milk containing the drug residue.

　　（ii） Each individual producer sample represented in the positive-testing load sample shall be singly tested to determine the producer of the milk sample testing positive for drug residue. Identification of the producer responsible for producing the milk testing positive for drug residue, and details of the final disposition of the shipment of milk containing the drug residue, shall be reported immediately to the appropriate agency.

　　（iii） Milk shipment from the producer identified as the source of milk testing positive for drug residue shall cease immediately and may resume only after a sample from a subsequent milking does not test positive for drug residue.

　　[50 FR 34672, Aug. 27, 1985, as amended at 58 FR 26912, May 6, 1993; 67 FR 48975, July 29, 2002]

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