1,500,000 somatic cells per ml., the following procedures shall be applied:

(i) A notice shall be sent to the producer warning him of the excessive somatic cell count.

(ii) Whenever two of the last four consecutive somatic cell counts exceed 1,500,000 cells per ml. the appropriate regulatory authority shall be notified and a written notice given to the producer. This notice shall be in effect so long as two of the last four consecutive samples exceed 1,500,000 cells per ml. In addition to the written notice an inspection shall be made of the farm facility.

(4) A third milk sample shall be taken after a lapse of 3 days and within 14 days of the inspection required under (2) above. If this sample also indicates a high somatic cell count, the patron's milk shall be rejected until satisfactory compliance is obtained.

(c) Antibiotics. At least 4 times in 6 months, at irregular intervals, a separate or commingled sample of each producer's milk shall be tested for antibiotic residues. When a producer's milk shows a positive test the milk shall be immediately rejected from all markets and shall not be accepted until a subsequent test is negative.

§ 58.134 Sediment content.

(a) Method of testing. Methods for determining sediment content of milk shall be those described in the latest edition of Standard Methods for the Examination of Dairy Products. For the testing of milk in cans, the off-the-bottom method shall be used. For testing bulk milk, a mixed one-pint sample shall be tested. Sediment content shall be based on comparison with applicable charts of Sediment Standards described in Subpart T 58.2728 through 58.2731_of this part.

(b) Sediment content classification of discs. Milk in cans and in farm bulk tanks shall be classified for sediment content as follows:

(2) Sediment (mixed sample): (0.40 inch diameter disc).

No. 1-USDA Sediment Standard (not to exceed) 0.0625 mg. (0.50 mg. equiv.) (Acceptable).

No. 2-USDA Sediment Standard (not to exceed) 0.1875 mg. (1.50 mg. equiv.) (Acceptable).

No. 3-USDA Sediment Standard (not to exceed) 0.3125 mg. (2.50 mg. equiv.) (Probational) not over 10 days.

No. 4 USDA Sediment Standard (over) 0.3125 mg. (2.50 mg. equiv.) (Reject).

(c) Frequency of tests. At least once each month, at irregular intervals, the milk from each producer shall be tested as follows:

(1) Milk in cans. One or more cans of milk selected at random from each producer.

(2) Milk in farm bulk tanks. A sample shall be taken from each farm bulk tank.

(d) Acceptance or rejection of milk. If the sediment disc is classified as No. 1, No. 2, or No. 3 the producer's milk may be accepted. If the sediment disc is classified No. 4 the milk shall be rejected: Provided that if the shipment of milk is commingled with other milk in a transport tank the next shipment shall not be accepted until its quality has been determined before being picked up; however, if the person making the test is unable to get to the farm before the next shipment it may be accepted but no further shipments shall be accepted unless the milk meets the requirements of No. 3 or better. In the case of milk classified as No. 3 or No. 4, if in cans, all cans shall be tested. Producers of No. 3 or No. 4 milk (cans or bulk) shall be notified immediately and shall be furnished applicable sediment discs and the next shipment shall be tested.

(e) Retests. On test of the next shipment (if in cans, all cans shall be tested) milk classified as No. 1, No. 2, or No. 3 may be accepted, but No. 4 milk shall be rejected. Retests of bulk milk classified as No. 4 shall be made before pickup. The producers of No. 3 or No. 4 milk shall be notified immediately, furnished applicable sediment discs and the next shipment tested.

This procedure of retesting successive shipments and accepting probational (No. 3) milk and rejecting No. 4 milk may be continued for not more than 10 calendar days. If at the end of this time all of the producer's milk does not meet the acceptable sediment content classification (No. 1 or No. 2), it shall be rejected.

(c) Frequency of tests. At least once each month, at irregular intervals, a mixed sample of each producer's milk shall be tested.

(d) Acceptance of milk. If the sample of milk is classifled as No. 1 or No. 2 the producer's milk may be accepted without qualification. If the sample is classified as "Undergrade" (probational) the producer's milk may be accepted for a temporary period of four weeks. The producer of "Undergrade" milk shall be notified immediately.

(e) Retests. Additional samples shall be tested and classified at least weekly and the producer notified immediately of the results. This procedure of testing at least weekly and accepting "Undergrade" milk may be continued for a time period not exceeding four weeks. If at the end of this time the producer's milk does not meet the acceptable bacterial estimate requirements (No. 1 or No. 2), it shall not be accepted.

§ 58.136 Rejected milk.

A plant shall reject specific milk from a producer if it fails to meet the requirements for appearance and odor (section 58.133(a)) or if it is classified No. 4 for sediment content (section 58.134). Such milk shall be identified with a reject tag.

§ 58.137 Excluded milk.

A plant shall not accept milk from a producer for use in products:

(a) If a new producer's milk does not meet the requirements for appearance and odor (§ 58.133 (a)) or sediment content (§ 58.134); or

(b) If the milk has been in a probational (No. 3) sediment content classification for more than ten calendar days (§ 58.134); or

(c) If the milk has been classified "Undergrade" for bacterial estimate for more than four successive weeks (section 58.135).

(d) If the milk has been classified as having a high somantic cell count (§ 58.133 (b) (4)) or having a positive test for antibiotics (§ 58.133 (c)).

§ 58.138 Quality testing of milk from new producers.

An examination shall be made on the first shipment of milk from producers shipping milk to a plant for the first time or after a period of nonshipment. The milk shall meet the requirements for "acceptable milk” (§§ 58.133, 58.134, and 58.135). Thereafter, the milk shall be tested in accordance with the procedure established for regular shippers. § 58.139 Record of tests.

Accurate records, listing the results of quality tests of each producer, shall be kept on file at the receiving plant where performed and shall be available for examination by the inspector. § 58.140 Field service.

A representative of the plant should arrange to promptly visit each producer shipping milk which does not meet the requirements for acceptable milk, for the purpose of inspecting the equipment, utensils and facilities at the farm and to offer constructive assistance for improvement in the quality of the milk. A representative of the plant should visit each producer as often as practicable to assist in and encourage the production of high quality milk. § 58.141

gram.

Alternate quality control pro

When a plant has in operation an acceptable quality program, at the producer level, which is approved by the Administrator as being effective in obtaining results comparable to or higher

than the quality program as outlined above for milk or cream, then such a program may be accepted in lieu of the program herein prescribed.

OPERATIONS AND OPERATING PROCEDURES § 58.142

Product quality and stability.

The receiving, holding and processing of milk and cream and the manufacturing, handling, packaging, storing and delivery of dairy products shall be in accordance with clean and sanitary methods, consistent with good commercial practices to promote the production of the highest quality of finished product and improve product stability. Milk should not be more than three days old when picked up from the producer and delivered to the plant, receiving station or transfer station. § 58.143 Raw product storage.

All milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration. Drip milk from can washers and any other source shall not be used for the manufacture of dairy products. Bulk milk in storage tanks within the dairy plant shall be handled in such a manner as to minimize bacterial increase and shall be maintained at 45° F. or lower until processing begins. This does not preclude holding milk at higher temperatures for a period of time, where applicable to particular manufacturing or processing practices.

The bacteriological quality of commingled milk in storage tanks shall not exceed 3,000,000/ml.

§ 58.144 Pasteurization or

teurization.

ultra-pas

When pasteurization or ultra-pasteurization is intended or required, or when a product is designated "pasteurized" or "ultra-pasteurized" every particle of the product shall be subjected to such temperatures and holding periods in approved systems as will assure proper pasteurization or ultrapasteurization of the product. The heat treatment by either process shall be sufficient to insure public health safety and to assure adequate keeping quality, yet retaining the most desirable flavor and body characteristics of the finished product.

§ 58.145 Composition and wholesome

ness.

All necessary precautions shall be taken to prevent contamination or adulteration of the milk or dairy products during manufacturing. All substances and ingredients used in the processing or manufacuring of any dairy product shall be subject to inspection and shall be wholesome and practically free from impurities. The finished products shall comply with the requirements of the Federal Food, Drug, and Cosmetic Act as to their composition and wholesomeness. § 58.146 Cleaning and sanitizing treat

ment.

(a) Equipment and utensils. The equipment, sanitary piping and utensils used in receiving and processing of the milk, and manufacturing and handling of the product shall be maintained in a sanitary condition. Sanitary seal assemblies shall be removable on all agitators, pumps, and vats and shall be inspected at regular intervals and kept clean. Unless other provisions are recommended in the following supplement sections, all equipment not designed for C.I.P. cleaning or mechanical cleaning shall be disassembled after each day's use for thorough cleaning. Dairy cleaners, detergents, wetting agents or sanitizing agents, or other similar materials which will not contaminate or adversely affect the products may be used. Steel wool or metal sponges shall not be used in the cleaning of any dairy equipment or utensils.

Product contact surfaces shall be subjected to an effective sanitizing treatment prior to use, except where dry cleaning is permitted. Utensils and portable equipment used in processing and manufacturing operations shall be stored above the floor in clean, dry locations and in a self draining position on racks constructed of impervious corrosionresistant material.

C.I.P. cleaning or mechanical cleaning systems shall be used only on equipment and pipeline systems which have been designed, engineered and installed for that purpose. When such cleaning is used, careful attention shall be given to the proper procedures to assure satisfactory cleaning. All C.I.P. installations and cleaning procedures shall be in accordance with 3-A Suggested Method for the

Installation and Cleaning of Cleaned-InPlace Sanitary Milk Pipelines for Milk and Milk Products Plants. Because of the possibilities of corrosion, the recommendations of the cleaning compound manufacturer should be followed with respect to time, temperature and concentration of specific acid or alkaline solutions and bactericides. Such cleaning operation should be preceded by a thorough rinse at approximately 110-115° F. continuously discarding the water. Following the circulation of the cleaning solution the equipment and lines shall be thoroughly rinsed with lukewarm water and checks should be made for effectiveness of cleaning. All caps, plugs, special fittings, valve seats, cross ends, pumps, and tee ends shall be opened or removed and brushed clean. All non-pasteurized product contact surfaces should be sanitized. Immediately prior to starting the product flow, the pasteurized product contact surfaces shall be given sanitizing treatment.

(b) Milk cans and can washers. Milk cans and lids shall be cleaned, sanitized and dried before returning to producers. Inspection, repair or replacement of cans and lids shall be adequate to substantially exclude from use cans and lids showing open seams, cracks, rust condition, milkstone or any unsanitary condition.

Washers shall be maintained in a clean and satisfactory operating condition and kept free from accumulation of scale or debris which will adversely affect the efficiency of the washer. Only washing compounds which are compatible with the water for effective cleaning, should be used. The can washer should be checked regularly during the run for proper operation. At the end of the day, the wash and rinse tanks should be drained and cleaned, jets and strainers cleaned, air filters checked and changed or cleaned if needed, and checks should be made for proper adjustment and condition of mechanical parts.

(c) Milk transport tanks. A covered or enclosed wash dock and cleaning and sanitizing facilities shall be available to all plants that receive or ship milk in tanks. Milk transport tanks, sanitary piping, fittings, and pumps shall be cleaned and sanitized at least once each day after use: provided that, if they are not to be used immediately after emptying a load of milk, they shall be washed promptly after use and given bactericidal treatment immediately before use. After

being washed and sanitized, each tank should be identified by a tag attached to the outlet valve, bearing the following information: plant and specific location where cleaned, date and time of day of washing and sanitizing, and name of person who washed and name of person who sanitized the tank. The tag shall not be removed until the tank is again washed and sanitized.

(d) Building. All windows, glass, partitions, and skylights should be washed as often as necessary to keep them clean. Cracked or broken glass shall be replaced promptly. The walls, ceilings and doors should be washed periodically and kept free from soil and unsightly conditions. The shelves and ledges should be wiped or vacuumed as often as necessary to keep them free from dust and debris. The material picked up by the vacuum cleaners shall be disposed of in sealed containers which will prevent contamination or insect infestation from the waste material.

§ 58.147 Insect and rodent control pro

gram.

In addition to any commercial pest control service, if one is utilized, a specially designated employee should be made responsible for the performance of a regularly scheduled insect and rodent control program. Poisonous substances shall be properly labeled, and shall be handled, stored and used in such a manner as considered satisfactory by the Environmental Protection Agency..

§ 58.148 Plant records.

Adequate plant records shall be maintained of all required tests and analyses performed in the laboratory or throughout the plant during storage, processing and manufacturing, on all raw milk receipts and dairy products. Such records shall be available for examination at all reasonable times by the inspector. The following are the records which shall be maintained for examination at the plant or receiving station where performed.

(a) Sediment and bacterial test results on raw milk from each producer. Retain for 12 months.

(1) Routine tests and monthly summary of all producers showing number and percent of total in each class.

(2) Retests, if initial test places milk in probationary status.

(3) Rejections of raw milk over No. 3 in quality.

(b) Pasteurization recorder charts. Retain for 3 months.

(c) Water supply test certificate. Retain current copy for 6 months. (d) Cooling and heating charts. Retain for 3 months.

§ 58.149

recorder

Alternate quality control programs for dairy products.

(a) When a plant has in operation an acceptable quality control program which is approved by the Administrator as being effective in obtaining results comparable to or higher than the quality control program as outlined in this subpart, then such a program may be accepted in lieu of the program herein prescribed.

(b) Where a minimum number of samples per batch of product, or per unit of time on continuous production runs are not specified, the phrase "as many samples shall be taken as is necessary to assure compliance to specific quality requirements" is used. Acceptable performance of this would be any method approved by the Administrator as meeting sound statistical methods of selecting samples and determining the number of samples to be taken.

PACKAGING AND GENERAL IDENTIFICATION § 58.150 Containers.

The size, style, and type of packaging used for dairy products shall be commercially acceptable containers and packaging materials which will satisfactorily cover and protect the quality of the contents during storage and regular channels of trade and under normal conditions of handling.

Packaging materials for dairy products shall be selected which will provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation. In addition, the wrapper should be resistant to puncturing, tearing, cracking or breaking under normal conditions of handling, shipping and storage. When special type packaging is used, the instructions of the manufacturer shall be followed closely as to its application and methods of closure.

§ 58.151 Packaging and repackaging.

Packaging dairy products or cutting and repackaging all styles of dairy products shall be conducted under rigid sanitary conditions. The atmosphere of the packaging rooms, the equipment and

packaging materials shall be practically free from mold and bacterial contamination. Methods for checking the level of contamination shall be as prescribed by the latest edition of Standard Methods or by other satisfactory methods approved by the Administrator.

When officially graded bulk dairy products are to be repackaged into consumer type packages with official grade labels or other official identification, a supervisor of packaging shall be required, see Subpart A of this part. (Title 7, §§ 58.2 and 58.53 of the Code of Federal Regutions). If the packaging or repackaging is done in a plant other than the one in which the dairy product is manufactured, the plant, equipment, facilities and personnel shall meet the same requirements as outlined in this subpart. § 58.152 General identification.

All commercial bulk packages or consumer packaged product containing dairy products manufactured under the provisions of this subpart shall comply with the applicable regulation of the Food and Drug Administration.

STORAGE OF FINISHED PRODUCT § 58.153 Dry storage.

The product should be stored at least 18 inches from the wall in aisles, rows, or sections and lots, in such a manner as to be orderly and easily accessible for inspection. Rooms should be cleaned regularly. It is recommended that dunnage or pallets be used when practical. Care shall be taken in the storage of any other product foreign to dairy products in the same room, in order to prevent impairment or damage to the dairy product from mold, absorbed odors, or vermin or insect infestation. Control of humidity and temperature shall be maintained at all times, consistent with good commercial practices, to prevent conditions detrimental to the product and container.

§ 58.154 Refrigerated storage.

Finished product in containers subject to such conditions that will affect its useability shall be placed on shelves, dunnage or pallets and properly identified. It shall be stored under temperatures that will best maintain the initial quality. The product shall not be exposed to anything from which it might absorb any foreign odors or be contaminated by drippage or condensation.