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Milk for Manufacturing Purposes and Its Production and Processing; Requirements Recommended for Adoption by State Regulatory Agencies

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Information about this document as published in the Federal Register.

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Agricultural Marketing Service, USDA.


Notice; request for comments.


This document proposes to amend the recommended manufacturing milk requirements (Recommended Requirements) by providing provisions for sheep milk, adding follow-up procedures used when plant-commingled milk in storage tanks exceeds the maximum allowable bacterial estimate, and providing a definition for heat-treated cream. The Start Printed Page 20731notice to add to the Recommended Requirements was initiated at the request of the Dairy Division of the National Association of State Departments of Agriculture (NASDA) and developed in cooperation with NASDA, the Food and Drug Administration (FDA), dairy trade associations, and producer groups. This document also proposes certain other changes to the Recommended Requirements for clarity and consistency.


Submit written or electronic comments on or before June 20, 2005.


You may use any of the following methods to file comments on this action: By mail: Reginald Pasteur, Marketing Specialist, Standardization Branch, Dairy Programs, STOP 0230 (Room 2746 South Building), Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Washington, DC 20250-0230.

By fax: (202) 720-2643.

By e-mail: or via the electronic process available at the Federal eRulemaking portal at

Comments should reference the docket number and the date and page number of this issue of the Federal Register. Any comments received may be inspected at the above address during regular business hours (8 a.m.—4:30 p.m.) or accessed via the Internet at​dairy/​stand.htm.

The current Recommended Requirements are available either from the above mailing address or by accessing the following internet address:​dairy/​manufmlk.pdf. The proposed changes to the Recommended Requirements are also available from the above mailing address or by accessing the following internet address:​dairy/​dockets.htm.

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Reginald Pasteur, Marketing Specialist, Standardization Branch, Dairy Programs, AMS, USDA, telephone (202) 720-7473 or e-mail

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Under the authority of the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-1627), the U. S. Department of Agriculture maintains a set of model regulations relating to quality and sanitation requirements for the production and processing of manufacturing grade milk. These Recommended Requirements are developed by AMS and recommended for adoption and enforcement by the various States that regulate manufacturing grade milk. The purpose of the model requirements is to promote uniformity in State dairy laws and regulations relating to manufacturing grade milk.

In consultation with representatives from NASDA, State regulatory agencies, FDA, and dairy industry trade associations, the Department prepared the Recommended Requirements to promote uniformity in State dairy laws and regulations for manufacturing grade milk. To accommodate changes that have occurred in the dairy industry, NASDA and various State officials have from time to time requested USDA to update the Recommended Requirements.

During its July 2003 annual meeting, the Dairy Division of NASDA passed resolutions requesting USDA to provide provisions for sheep milk, add follow-up procedures used when plant-commingled milk in storage tanks exceeds the maximum allowable bacterial estimate, and provide a definition for heat-treated cream. AMS reviewed these resolutions and developed a draft that identified the changes associated with this request. This draft was provided to State regulatory officials and dairy trade association representatives for informal discussion prior to publication in the Federal Register. AMS is now soliciting comments on the proposed notice to the Recommended Requirements.

The requirements of Executive Order 13132, Federalism, were considered in developing this notice, and it has been determined that this action does not have federalism implications as defined under the executive order. This action does not have substantial effects on the States (the relationship between the national government and the States or on the distribution of power and responsibilities among the various levels of government). The adoption of the Recommended Requirements by State regulatory agencies is voluntary. States maintain the responsibility to establish dairy regulations and continue to have the option to establish regulations that are different from the Recommended Requirements. A State may choose to have requirements less restrictive or more stringent than the Recommended Requirements. Their decision to have different requirements would not affect the ability of milk producers to market milk or of processing plants to produce dairy products in their state. AMS is publishing this notice with a 60-day comment period to provide a sufficient time for interested persons to comment on the changes.

Based on the Recommended Requirements which were published in the Federal Register April 7, 1972 (37 FR 7046) and amended August 27, 1985 (50 FR 34726); May 6, 1993 (58 FR 86); and September 12, 1996 (61 FR 48120), the changes are summarized as follows:

Sheep Milk Definition

The definition of sheep milk will include: Section B2(l)(3)—Sheep milk is the lacteal secretion practically free from colostrums obtained by the complete milking of one or more healthy ewes. Sheep milk shall be produced according to the sanitary standards of this ordinance.

Water Buffalo Milk Definition

The definition of water buffalo milk will include: Section B2(l)(4)—Water buffalo milk is the normal lacteal secretion practically free of colostrums, obtained by the complete milking of one or more healthy water buffalo. Water buffalo milk shall be produced according to the sanitary standards of this ordinance.

Lactating Animals Definition

The definition of lactating animals will include: Section B2(l)(5)—Lactating animals are cows, goats, sheep, and water buffalo producing milk for manufacturing purposes.

Milk Term

The term “milk” will include: Section B2(l)(6)— The word “milk” used herein includes only milk, goat milk, sheep milk, and water buffalo milk for manufacturing purposes.

Somatic Cell Count

The requirements for sheep milk somatic cell count will include: Section C11(e), (e)2, and (f)— 750,000 per ml for sheep milk.

Farm Requirements

The requirements for abnormal sheep milk will include: Section D1(d)— Abnormal milk is milk which is ropy, stringy, clotted, thick, or abnormal in any way. It includes milk containing pesticides, insecticides, or medicinal agents. Regular equipment may be used but not until all other animals are milked.

Milking Facility and Housing

The requirements for a sheep milking facility will include: Section D2(b)— Floors for a sheep milking facility shall be constructed of concrete or equally impervious material maintained free of breaks or depressions. They must be Start Printed Page 20732sloped to drain properly. Joints between the floor and wall shall be watertight.

Ramps and platforms used to elevate the sheep for milking must be constructed of an impervious material such as steel (wooden platforms and ramps are not allowed.) Rubber cow mats may be used as long as they are not placed over a wooden platform. Sheep are generally housed in a loose housing building near the milking parlor. This area should be kept reasonably clean. No excessive accumulation of manure is allowed. Complete separation between the sheep housing area and the sheep milking parlor is required if sheep milker units are stored in the parlor. Hogs and fowl shall not be housed with sheep.

Milking Procedure

The requirements for sheep milking procedures will include: Section D3(d) Milking equipment used for handling abnormal milk must be washed and sanitized after such use.

Section D3(e)— Abnormal milk must not be squirted on the floor, on the platform, or in the producer's hand. Producers should also wash their hands after handling such equipment and handling the teats and udders of animals producing abnormal milk.

Cooling and Storage

The requirements for cooling sheep milk will include:

A. Milk in plastic bags shall be cooled to 40° F or lower within two hours of milking. Sheep milk shall be cooled to 45 degrees Fahrenheit or less within two (2) hours of milking. Cooling water used in bulk tanks in which bags of sheep milk are cooled shall be chlorinated. If milk is cooled by pouring into plastic bags and then floating the bags of milk in cooling water, the process must preclude contamination of the milk by the water. All water must be safe and of sanitary quality in accordance to Section D7.

B. Bags used to store frozen sheep milk shall be constructed of plastic that is listed under the NCIMS Certified Manufacturers of Single-Service Containers and Related Products.

C. Bags may be up to 5 gallons in size.

Each bag shall be numbered, dated, and identified with a patron name or number.

D. Frozen sheep milk should remain frozen at 0° F or less for a period not to exceed 12 months.

Milkhouse or Milkroom

The requirements will include: Section D5(a)(i)— A milkhouse must be provided for storage and cooling of milk and proper cleaning and storage of equipment. The milkhouse area is the area that needs to be modified to meet the peculiar needs of sheep milking operations. The following requirement applies to a milkhouse whether or not a bulk tank is used: milk may not be placed directly in the freezer prior to cooling.

Natural and/or artificial light shall be provided in all working areas for conducting milkhouse operations. At least 20 foot-candles of artificial light are required in a milking parlor. Parlors must be properly ventilated in order to prevent excessive condensation and odors. Light fixtures shall not be installed directly above bulk milk tanks, areas where milk may be strained, or areas where equipment is stored.

Section D5(b)(i)— A double compartment wash sink with hot and cold running water plumbed to the sink is required. Each compartment must be large enough to accommodate the largest piece of equipment. Hot water heaters or hot water supply systems for use in the milkhouse or milk room shall have a capacity of at least 30 gallons for the manual washing of equipment. CIP washing of pipelines, units, and bulk tanks requires the capacity of 75 gallons. Water under pressure must be piped into the milk house to perform cleaning of the equipment. Walls and ceilings must be reasonably smooth and be painted or whitewashed or have other acceptable finish; it shall be kept in good repair and surfaces shall be finished whenever wear or discoloration is evident. Ceilings must be dust tight. Hay or straw chutes must have dust-tight doors that must be kept closed during milking.

Utensils and Equipment

Requirements will include: Section D6(a)(i)—Milk contact surfaces shall be made of stainless steel of the 300 series, equally corrosion-resistant non-toxic metals or heat-resistant glass. Plastic or rubber-like material must be relatively inert and resistant to scoring, chipping, or decomposition, and it must be non-toxic and not impair flavor or odor of the product. All milk contact material must be easily cleaned and must be cleaned after each use. Sanitizers must be an approved type with full label directions. Syringes and bolus guns shall be stored in a manner to preclude any contamination of milk or milk contact surfaces.

All containers and utensils must be free from breaks and corrosion, and points must be free from pits or cracks. Bulk tank and freezer thermometers should be accurate within +/−2 degrees Fahrenheit.

All milk containers and equipment, including milking machine vacuum hoses, must be stored in the milkhouse. Milking equipment must be stored to assure complete drainage. Filters and single-service plastic bags shall be stored in the original container inside a protective box. Bags for milk storage must be stored in a manner which protects them from contamination. It is recommended they be stored in an enclosed cabinet.

Commingled Milk

Requirements will include:

Section E1.8 Raw Product Storage

A. All milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration. Drip milk from can washers or 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 degrees Fahrenheit 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.

B. The bacterial estimate of commingled milk in plant storage tanks shall be 1 million per ml or lower.

C. During any consecutive 6 months, at least four samples of commingled raw milk for processing shall be taken by the regulatory agency from each plant.

D. A laboratory test of these samples to determine the bacterial estimate shall be performed at a laboratory approved by the regulatory agency.

E. Whenever a bacterial estimate of commingled milk in a plant indicates the presence of more than 1 million per ml, the following procedures shall be applied:

1. The regulatory agency shall notify plant management with a warning of excessive bacterial estimate and recommend that appropriate action be taken to eliminate the bacterial problem.

2. Whenever two of the last four consecutive commingled milk bacterial estimates exceed 1 million per ml, the regulatory agency shall notify plant management with a written warning notice. The notice shall be in effect so long as two of the last four consecutive samples exceed 1 million per ml. Plant management should continue to work to eliminate the bacterial problem.

3. An additional sample shall be taken by the regulatory agency after a lapse of 3 days but within 21 days of the notice required in paragraph (e)(1) of this section. If this sample also exceeds 1 Start Printed Page 20733million per ml, the plant license shall be suspended. A temporary status may be assigned to the plant by the appropriate regulatory agency when an additional sample of commingled milk is tested and found satisfactory. The plant shall be assigned a full reinstatement status when three out of four consecutive commingled bacterial estimates do not exceed 1 million per ml. The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.

Heat-Treated Cream Definition

The definition of heat-treated cream will be added to include:

E 1.9(i) Heat-treated cream—Heat-treated cream is cream in which the product may be heated to less than 160 degrees Fahrenheit in a continuing heating process and immediately cooled to 45 degrees Fahrenheit or less for a functional reason.

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(Authority: 7 U.S.C. 1621-1627)

Dated: April 15, 2005.

Kenneth C. Clayton,

Acting Administrator, Agricultural Marketing Service.

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[FR Doc. 05-8029 Filed 4-20-05; 8:45 am]