[Federal Register Volume 70, Number 76 (Thursday, April 21, 2005)]
[Notices]
[Pages 20730-20733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8029]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

[No. DA-03-07]


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice; request for comments.

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SUMMARY: 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

[[Page 20731]]

notice 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.

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

ADDRESSES: 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: [email protected] or via the electronic process 
available at the Federal eRulemaking portal at http://www.regulations.gov.
    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 http://www.ams.usda.gov/dairy/stand.htm.
    The current Recommended Requirements are available either from the 
above mailing address or by accessing the following internet address: 
http://www.ams.usda.gov/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: http://www.ams.usda.gov/dairy/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Reginald Pasteur, Marketing 
Specialist, Standardization Branch, Dairy Programs, AMS, USDA, 
telephone (202) 720-7473 or e-mail [email protected].

SUPPLEMENTARY INFORMATION: 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

[[Page 20732]]

sloped 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[deg] 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[deg] 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

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million 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.

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

    Dated: April 15, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 05-8029 Filed 4-20-05; 8:45 am]
BILLING CODE 3410-02-P