[Federal Register Volume 66, Number 156 (Monday, August 13, 2001)]
[Proposed Rules]
[Pages 42458-42464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20189]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 58

[DA-99-04]
RIN 0581-AB59


Grading and Inspection, General Specifications for Approved 
Plants and Standards for Grades of Dairy Products; General 
Specifications for Dairy Plants Approved for USDA Inspection and 
Grading Service

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This document proposes to amend the General Specifications for 
Dairy Plants Approved for USDA Inspection and Grading Service (General 
Specifications) by reducing the maximum allowable bacterial estimate 
and somatic cell count in producer herd milk, by reducing the maximum 
allowable bacterial estimate in commingled milk, and by modifying the 
follow-up procedures when producer herd milk exceeds the maximum 
allowable bacterial estimate. These changes would align the General 
Specifications with model regulations relating to quality and 
sanitation requirements of the production and processing of 
manufacturing grade milk. In addition, this document proposes to revise 
the process by which drug residue test methods are evaluated and 
accepted to provide greater consistency with the Grade A milk program 
and proposes certain other changes to the regulations for clarity and 
consistency.

DATES: Comments must be submitted on or before October 12, 2001.

ADDRESSES: Written comments may be submitted to: Duane R. Spomer, 
Chief, Dairy Standardization Branch, Dairy Programs, Agricultural 
Marketing Service, U.S. Department of Agriculture, Room 2946-S, South 
Building, P.O. Box 96456, Washington, DC 20090-6456. Comments may also 
be faxed to (202) 720-2643 or e-mailed to [email protected].
    Comments should reference the date and page of this issue of the 
Federal Register. All comments received will be available for public 
inspection at the above address during regular business hours (8 a.m.-
4:30 p.m.).
    The current General Specifications for Dairy Plants Approved for 
USDA Inspection and Grading are available either through the above 
address or by accessing AMS' Home Page on the Internet at 
www.ams.usda.gov/dairy/stand.htm.

FOR FURTHER INFORMATION CONTACT: Susan Sausville, Dairy Products 
Marketing Specialist, Dairy Programs, Agricultural Marketing Service, 
U.S. Department of Agriculture, Room 2746, South Building, P.O. Box 
96456, Washington, D.C. 20290-6456, (202) 720-7473, 
[email protected].

SUPPLEMENTARY INFORMATION:

A. Executive Order 12866 and Regulatory Flexibility Act

    This rule has been determined to be not significant for purposes of 
Executive Order 12866 and therefore has not been reviewed by the Office 
of Management and Budget (OMB).
    The proposed rule has been reviewed in accordance with the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), and AMS has 
considered the economic impact of this action on small entities. It is 
determined that its provisions would not have a significant economic 
impact on a substantial number of small entities.
    AMS provides, under the authority of the Agricultural Marketing Act 
of 1946, voluntary, user-fee funded inspection and grading services to 
approximately 400 dairy manufacturing plants. All of the dairy 
manufacturing plants utilizing the program would be considered small 
businesses under the criteria established by the Small Business 
Administration (13 CFR 121.201).
    The proposed amendments would not have a significant economic 
impact because many State regulatory agencies have already incorporated 
these changes into State laws and regulations governing dairy 
manufacturing plants. The proposed changes would more closely align the 
General Specifications with mandatory State regulatory requirements in 
a number of areas including:
     The reduction of producer herd milk somatic cell count,
     The reduction of producer herd milk bacterial estimate,
     The follow-up protocol for producers whose herd milk 
exceeds the permitted bacterial estimate,
     The reduction in the bacterial estimate for commingled 
milk counts,
     The laboratory procedures that determine somatic cell 
content of producer herd milk, and
     The drug residue monitoring program.
    Furthermore, the proposed amendments would not have a significant 
economic impact since participation in the USDA-approved plant program 
is voluntary and the cost

[[Page 42459]]

to those utilizing the program would not increase.

C. Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This action is not intended to have retroactive 
effect. This rule would not preempt any State or local laws, 
regulations or policies, unless they represent an irreconcilable 
conflict with this rule. There are no administrative procedures that 
must be exhausted prior to any judicial challenge to the provisions of 
this rule.

D. Paperwork Reduction Act

    The information collection requirements that appear in Part 58 of 
the regulations have been previously approved by OMB and assigned OMB 
Control Number 0581-0110 under the Paperwork Reduction Act (44 U.S.C. 
chapter 35). This action will not impose any additional reporting or 
recordkeeping requirements on large or small dairy processors.

Background and Proposed Changes

    Under provisions of the Agricultural Marketing Act of 1946, as 
amended (7 U.S.C. 1621-1627), the United States Department of 
Agriculture maintains a set of model regulations relating to quality 
and sanitation requirements for the production and processing of 
manufacturing grade milk. The Recommended Requirements are a separate 
document developed by AMS and recommended for State adoption and 
enforcement by the various States that regulate manufacturing grade 
milk. The purpose of the model requirements is to promote, through 
State adoption and enforcement, uniformity in State dairy laws and 
regulations relating to manufacturing grade milk. The Recommended 
Requirements are available from the Dairy Standardization Branch at the 
address provided in the ADDRESSES Section of this proposal. 
Additionally, the Recommended Requirements are available by accessing 
AMS' Home Page on the Internet at www.ams.usda.gov/dairy/stand.htm.
    On November 12, 1996, AMS reduced the somatic cell count and the 
bacterial estimate provisions in the Recommended Requirements (61 FR 
48120). This reduction was requested by the National Association of 
State Departments of Agriculture (NASDA) and was developed in 
cooperation with NASDA, dairy trade associations, and producer groups. 
Now that State regulatory agencies have had an opportunity to implement 
these new limits and the dairy industry has had time to adapt to this 
new level, the Department is recommending similar changes be made in 
the General Specifications for Dairy Plants Approved for USDA 
Inspection and Grading Service. This alignment is needed in order to 
support the reduced levels of somatic cells and bacteria in the USDA 
Recommended Requirements and to promote improvements in the quality of 
raw milk utilized by USDA approved plants.
    In addition, AMS has also identified additional areas where changes 
can be made to improve the regulations. All of the changes are 
explained in further detail below. AMS is proposing to amend the 
General Specifications as follows:
    1. Reduce the maximum bacterial estimate permitted in producer herd 
milk and modify the follow-up procedures when herd milk exceeds the 
maximum allowable bacterial estimate.
    Current Sec. 58.135 provides for a maximum permissible bacteria 
count in producer herd milk of 1,000,000 per milliliter. We are 
proposing to revise Sec. 58.135 by reducing the maximum bacteria 
estimate permitted in producer herd milk to 500,000 per milliliter for 
the following reasons:
    The number of bacteria present in milk increases when the equipment 
and utensils used to collect and store the milk are improperly cleaned 
and sanitized. This number increases rapidly in milk that is not cooled 
promptly or that is not maintained at refrigerated temperatures 
throughout storage. Enhanced milk quality can be attained when dairy 
equipment is properly cleaned and sanitized and when milk is promptly 
cooled and stored at refrigerated temperatures. Improvements in 
sanitation practices and milk cooling equipment have resulted in 
enhanced milk quality. Therefore, to reflect these improvements in 
enhanced milk quality, this proposal would reduce the maximum 
permissible bacteria count in producer herd milk from 1,000,000 to 
500,000 per ml. This and additional changes to Sec. 58.135 are proposed 
as follows:
    Current Sec. 58.135(a) references ``Standard Methods for the 
Examination of Dairy Products,'' for test methods that may be used to 
determine the bacterial estimate of the milk from individual producers. 
This proposal would identify this reference as a publication of the 
American Public Health Association and provide the following list of 
acceptable methods for determining the bacterial estimate of milk from 
individual producers: Direct Microscopic Clump Count, Standard Plate 
Count, Plate Loop Count, Pectin Gel Plate Count, Petrifilm Aerobic 
Count, Spiral Plate Count, Hydrophobic Grid Membrane Filter Count, 
Impedence/Conductance Count, and Reflectance Calorimetry.
    Current Sec. 58.135(b) provides bacterial estimate classifications 
for milk from individual producers of: No. 1 (Not over 500,000 per 
ml.), No. 2 (Not over 1,000,000 per ml.) and Undergrade (Over 1,000,000 
per ml.). This proposal would lower the maximum allowable bacteria 
estimate in milk from individual producers to a maximum of 500,000 per 
ml., thus eliminating the need to classify milk as No.1, No. 2, or 
Undergrade. Therefore, this proposal would delete all information 
currently contained in Sec. 58.135(b).
    Current Sec. 58.135(c) establishes the frequency at which 
individual producer milk is to be tested for bacterial estimate. This 
proposal maintains the current frequency, adds a provision that the 
samples be analyzed in accordance with State regulations, and 
redesignates this information to Sec. 58.135(b).
    Current Sec. 58.135(d) provides for the acceptance of milk based on 
information previously contained in Sec. 58.135(b). This proposal would 
establish new procedures for individual producer's milk that exceeds 
the maximum allowable bacterial estimate to provide consistency with 
the Recommended Requirements and many State regulations. This new 
procedure would require that the producer be notified of all bacterial 
estimates exceeding the maximum permitted. In addition, when two of the 
last four consecutive bacterial estimates exceed the maximum permitted, 
the appropriate regulatory authority would be notified. The producer 
would be provided a written notice that two of the last four bacterial 
estimates exceed the maximum permitted. When two out of the last four 
bacterial estimates exceed the maximum permitted, the proposal provides 
that an additional sample be taken, the result of which determines the 
acceptability of milk from a producer. These proposed changes will 
provide increased uniformity with producer herd milk bacteria and 
somatic cell follow-up procedures and provide greater adaptability to 
computer-based recordkeeping. This revised section will now appear as 
Sec. 58.135(c). Information contained in proposed Sec. 58.135(b) and 
Sec. 58.135(c) provides the information necessary to determine the 
acceptability of milk for bacterial content. Accordingly, 
Sec. 58.135(d) is no longer needed and is being removed.
    Current Sec. 58.135(e) provides for retests based on information 
previously contained in Sec. 58.135(b) and Sec. 58.135(c). Information 
contained in proposed

[[Page 42460]]

Sec. 58.135(b) and Sec. 58.135(c) provides the information necessary to 
determine the acceptability of milk for bacterial content. Accordingly, 
Sec. 58.135(e) is no longer needed and is being removed.
    2. Reduce the maximum somatic cell count permitted in producer herd 
milk and delete the laboratory screening tests for somatic cells (no 
changes are being proposed for goat milk).
    Current Sec. 58.133(b)(5), Sec. 58.133(b)(5)(ii) and 
Sec. 58.133(b)(6) provides for a maximum somatic cell count in producer 
herd milk of 1,000,000 per milliliter. We are proposing to revise these 
sections by reducing the maximum allowable somatic cell count in 
producer herd cow's milk to 750,000 per milliliter for the following 
reasons:
    The number of leukocytes (somatic cells) present in milk increases 
as a result of mammary gland infection (mastitis) and provides 
information regarding the health of the dairy herd. Through effective 
herd management, dairy farmers have reduced the number of somatic cells 
present in raw milk. Identification and treatment of infected animals 
and improved milking techniques are two examples of herd management 
tools being used to reduce somatic cell counts. Therefore, to reflect 
these improvements in enhanced milk quality, this proposal would reduce 
the maximum permissible somatic cells in producer herd milk from 
1,000,000 to 750,000 per ml. Because the number of somatic cells found 
in milk produced from healthy goats is normally higher than the number 
found in cow's milk, similar reductions are not being proposed for goat 
milk. Research indicates that physiological and microbiological 
differences exist in goat and cow milk independent of disease status 
which justify different standards between the two species.\1\
    Current Sec. 58.133(b)(2) lists the California Mastitis Test (CMT) 
and the Wisconsin Mastitis Test (WMT) as acceptable screening tests for 
somatic cells in producer herd milk samples. We are proposing to revise 
Sec. 58.133(b)(2) by limiting the California Mastitis Test (CMT) and 
Wisconsin Mastitis Test (WMT) as screening tests for somatic cells in 
goat herd milk samples for the following reasons:
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    \1\ G.F. Haenlein, L.S. Hinckley, ``Goat Milk Somatic Cell Count 
Situation in the United States'', Goat Management: (http://bluehen.ags.udel.edu/deces/goatmgt/gm-11.htm).
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    The CMT and the WMT are used as screening tests for somatic cells. 
However, these screening tests are reliable for samples containing 
1,000,000 or more somatic cells per milliliter. Since this action would 
reduce the maximum somatic cell count in cow's milk to 750,000 per ml., 
the CMT and WMT tests are not accurate enough to screen cow milk at the 
reduced level. Since the maximum somatic cell count for goat milk 
remains at 1,000,000 per ml., the CMT and WMT tests may continue to be 
used to screen goat milk. Since screening tests would no longer apply 
to cow's milk, the proposed changes would revise Sec. 58.133(b)(3) to 
indicate that the listed tests are only considered confirmatory when 
performed on goat's milk. The proposal lists in Sec. 58.133(b)(3), the 
Direct Microscopic Somatic Cell Count, the Electronic Somatic Cell 
Count (particle counter), and the Electronic Somatic Cell Count 
(fluorescent dye) as tests that may be used to determine somatic cell 
count. In addition, this proposal provides for additional methods that 
may later be included in the latest edition of ``Standard Methods for 
the Examination of Dairy Products,'' a publication of the American 
Public Health Association. A copy of this document is available from 
the American Public Health Association, 1015 Fifteenth Street, NW., 
Washington, DC 20005.
    3. Reduce the maximum permitted bacterial estimate in commingled 
milk.
    Current Sec. 58.143(b) provides for a maximum allowable bacterial 
estimate in commingled milk in storage tanks of 3,000,000 per 
milliliter. This proposal would revise Sec. 58.143(b) by reducing the 
maximum allowable bacterial estimate in commingled milk in storage 
tanks to 1,000,000 per milliliter for the following reasons:
    Commingled milk is the combined milk from more than one producer. 
Farm improvements in sanitation practices and milk cooling equipment 
have resulted in enhanced milk quality. Therefore, to reflect these 
improvements and the resulting improvements of enhanced commingled milk 
quality, this proposal would reduce the maximum permissible bacterial 
estimate in commingled milk from 3,000,000 to 1,000,000 per milliliter.
    4. Update procedures for excluding milk.
    Current Sec. 58.137(b) provides for the exclusion of milk that has 
been classified as Undergrade for bacterial estimate for more than four 
successive weeks. Proposed changes to Sec. 58.135 would eliminate the 
bacterial based classification of milk (No.1, No.2, or Undergrade). 
Therefore, we are proposing to revise Sec. 58.137(b) to follow the 
protocol proposed in Sec. 58.135(c)(3) and exclude milk when three of 
the last five milk samples have exceeded the maximum bacterial estimate 
of 500,000 per ml.
    Current Sec. 58.137(c) provides for milk to be excluded when three 
out of the last five milk samples have exceeded the maximum somatic 
cell count level of 1,000,000 per ml. This proposal would lower the 
maximum somatic cell count level to 750,000 per ml. Therefore, we are 
proposing to revise Sec. 58.137(c) to exclude milk when three out of 
the last five milk samples have exceeded the maximum somatic cell count 
level of 750,000 per ml.
    5. Update the Drug Residue Testing Program.
    We are proposing to revise Sec. 58.133(c) to provide greater 
consistency with current Grade A milk requirements. When the General 
Specifications were revised in 1993, provisions detailing a drug 
residue testing program were added. At that time, those provisions were 
consistent with the drug residue program developed by the National 
Conference for Interstate Milk Shipment and used to monitor drug 
residues in Grade A milk. When the Grade A milk drug residue monitoring 
program was developed, the program allowed for the approval of test 
methods by the Virginia Polytechnic Institute and State University. 
Since that time, the Grade A milk program has changed to allow further 
independent evaluations and not specifically limited to the Virginia 
Polytechnic Institute and State University. The proposed changes would 
revise Sec. 58.133(c) to provide greater consistency in the methods 
used to analyze samples for drug residues, and test methods would now 
be independently evaluated or evaluated by the Food and Drug 
Administration (FDA) and accepted by FDA as effective to detect drug 
residues at current safe or tolerance levels.
    6. Update of 3-A Sanitary Standards References.
    This proposal would update the 3-A Sanitary Standard references in 
Sec. 58.131(a)(2) to properly reflect the title of the two standards 
for dairy farm cooling and storage tanks. Therefore, we are proposing 
to revise Sec. 58.131(a)(2) to reference the 3-A Sanitary Standard for 
Farm Cooling and Holding Tanks and the 3-A Sanitary Standard for Farm 
Milk Storage Tanks. In addition, this proposal would reflect a change 
in the title of the document detailing methods to produce culinary 
steam in Sec. 58.127(d). The current title is the 3-A Accepted 
Practices for a Method of Producing Steam of Culinary Quality. Copies 
of each of these documents are available from the International 
Association for Food Protection, 6200

[[Page 42461]]

Aurora Ave., Suite 200 W, Des Moines, Iowa 50322-2863.
    7. Inclusion of USDA Equipment Guidelines.
    The proposed change would reference the ``USDA Guidelines for the 
Sanitary Design and Fabrication of Dairy Processing Equipment'' in 
Sec. 58.128(o). The Guidelines address design and fabrication 
requirements for dairy processing equipment not covered by an existing 
3-A Sanitary Standard.
    8. Increase the Keeping Quality Test Temperature of Whipped Butter.
    Currently, Sec. 58.346(b)(1) provides for a keeping quality test 
temperature for whipped butter of 70 deg. F. We are proposing to revise 
Sec. 58.346(b)(1) by raising the keeping quality test temperature of 
whipped butter from 70 deg. F to 72 deg. F. This proposal would provide 
consistent keeping quality test temperature requirements for butter and 
whipped butter. Agricultural Marketing Service graders have confirmed 
that accurate keeping quality results can be achieved for both butter 
and whipped butter when using 72 deg. F. Alignment of this temperature 
requirement would allow the storage of both butter and whipped butter 
samples in the same temperature controlled keeping quality cabinet.
    9. Addition of Reduced Fat, Light, and Fat Free Cottage Cheese and 
Ice Cream.
    Current Sec. 58.505(b)(3) provides for the term lowfat cottage 
cheese. We are proposing to revise Sec. 58.505(b)(3) by including terms 
consistent with FDA labeling requirements such as ``reduced fat,'' 
``light,'' and ``fat free'' cottage cheese.
    Current Sec. 58.605(c) provides for the term ice milk. We are 
proposing to revise Sec. 58.605(c) by replacing the term ice milk with 
terms consistent with FDA labeling requirements such as ``reduced 
fat,'' ``light,'' and ``fat free'' ice cream. The proposed changes 
would also add the following CFR references to the General 
Specifications: ``Nutrient content claims for fat, fatty acid, and 
cholesterol content of foods,'' (21 CFR 101.62), and ``Requirements for 
foods named by use of a nutrient content claim and a standardized 
term,'' (21 CFR 130.10).
    10. Other Changes.
     The proposed changes would correct Sec. 58.124 by revising 
(j) and adding (k). These errors were inadvertent and occurred when the 
section was printed in the Federal Register and reproduced in the Code 
of Federal Regulations. A portion of the information in paragraphs (j) 
and (k) was inadvertently dropped from the CFR. Section 58.124(j) 
incorrectly contains the following wording: ``(j) proper storage 
conditions for ingrpackaging methods and materials.'' This proposal 
would correct this error by revising the information to read ``(j) 
proper storage conditions for ingredients and dairy products, or (k) 
suitable and effective packaging methods and materials.''
     The proposed changes would update citations made to CFR 
references in Sec. 58.101(e), Sec. 58.405(a), Sec. 58.505, Sec. 58.605, 
Sec. 58.705(a), Sec. 58.905, Sec. 58.915, and Sec. 58.938 to provide 
accurate information.
     The proposed changes would update Dairy Division to Dairy 
Programs in Sec. 58.245 and Sec. 58.812 and would update AMS Science 
Division to AMS Science and Technology Programs in 
Sec. 58.126(e)(5)(ii) to reflect the name changes.
     The proposed changes would update the compositional 
standards in Sec. 58.905 for evaporated milk, concentrated milk, and 
sweetened condensed milk to reflect compositional changes in the FDA 
Standards of Identity for evaporated milk (21 CFR 131.130), 
concentrated milk (21 CFR 131.115), and sweetened condensed milk (21 
CFR 131.120).
     The proposed changes would update the association names 
and addresses in Sec. 58.101 for the Association of Official Analytical 
Chemists, the American Public Health Association, and the International 
Association for Food Protection.
     The proposed changes would improve the current definition 
of a sanitizing treatment in Sec. 58.101(e) and provide a definition 
consistent with terminology currently used in the dairy industry.
     The proposed changes in Sec. 58.134(a) would provide 
information on how to obtain sediment standards.
     The proposed changes in Sec. 58.245 would include DA 
Instruction 918-RL as a reference for methods of laboratory analysis 
and delete DA Instructions 918-103, 918-109-1, and 918-109-3. These DA 
instructions have been combined into 918-RL and no longer exist.
    AMS is publishing this proposed rule with a 60-day comment period 
in order to provide sufficient time for interested persons to comment 
on the revisions.

List of Subjects in 7 CFR Part 58

    Dairy Products, Food grades and standards, Food labeling, Reporting 
and recordkeeping requirements.

    For the reasons set forth in the preamble, it is proposed that 7 
CFR part 58, Subpart B, be amended to read as follows:

PART 58--[AMENDED]

    1. The authority citation for 7 CFR part 58, Subpart B, continues 
to read as follows:

    Authority: Agricultural Marketing Act of 1946, 7 U.S.C. 1621-
1627.

    2. Amend Sec. 58.101 by revising paragraphs (e), (m), (v), and (w) 
to read as follows:


Sec. 58.101  Meaning of words.

* * * * *
    (e) Sanitizing treatment. Subjection of a clean product contact 
surface to steam, hot water, hot air, or an acceptable sanitizing 
solution for the destruction of most human pathogens and other 
vegetative microorganisms to a level considered safe for product 
production. Such treatment shall not adversely affect the equipment, 
the milk or the milk product, or the health of consumers. Sanitizing 
solutions shall comply with 21 CFR 178.1010.
* * * * *
    (m) Official Methods of Analysis of the Association of Official 
Analytical Chemists. ``Official Methods of Analysis of the Association 
of Official Analytical Chemists,'' a publication of the Association of 
Official Analytical Chemists International, 481 North Frederick Avenue, 
Suite 500, Gaithersburg, MD 20877-2417.
* * * * *
    (v) Standard Methods for the Examination of Dairy Products. 
``Standard Methods for the Examination of Dairy Products,'' a 
publication of the American Public Health Association, 1015 Fifteenth 
Street, NW., Washington, DC 20005.
    (w) 3-A Sanitary Standards and Accepted Practice. The latest 
standards for dairy equipment and accepted practices formulated by the 
3-A Sanitary Standards Committees representing the International 
Association for Food Protection, the Food and Drug Administration, and 
the Dairy Industry Committee. Published by the International 
Association for Food Protection, 6200 Aurora Avenue, Suite 200 W, Des 
Moines, Iowa 50322-2863.
* * * * *
    3. Amend Sec. 58.124 by revising (j) and adding (k) to read as 
follows:


Sec. 58.124  Denial or suspension of plant approval.

* * * * *
    (j) proper storage conditions for ingredients and dairy products, 
or (k) suitable and effective packaging methods and material.
    4. Amend Sec. 58.126 by revising paragraph (e)(5)(ii) to read as 
follows:

[[Page 42462]]

Sec. 58.126  Buildings.

* * * * *
    (e) * * *
    (5) * * *
    (ii) Approved laboratories shall be supervised by the USDA resident 
inspector in all aspects of official testing and in reporting results. 
Plant laboratory personnel in such plants may be authorized by USDA to 
perform official duties. The AMS Science and Technology Programs will 
provide independent auditing of laboratory analysis functions.
* * * * *
    5. Amend Sec. 58.127 by revising paragraph (d) to read as follows:


Sec. 58.127  Facilities.

* * * * *
    (d) Steam. Steam shall be supplied in sufficient volume and 
pressure for satisfactory operation of each applicable piece of 
equipment. Culinary steam used in direct contact with milk or dairy 
products shall be free from harmful substances or extraneous material 
and only those boiler water additives that meet the requirements of 21 
CFR 173.310 shall be used, or a secondary steam generator shall be used 
in which soft water is converted to steam and no boiler compounds are 
used. Steam traps, strainers, and condensate traps shall be used 
wherever applicable to insure a satisfactory and safe steam supply. 
Culinary steam shall comply with the 
3-A Accepted Practices for a Method of Producing Steam of Culinary 
Quality, number 609. This document is available from the International 
Association for Food Protection, 6200 Aurora Avenue, Suite 200 W, Des 
Moines, Iowa 50322-2863.
* * * * *
    6. Amend Sec. 58.128 by revising paragraph (o) to read as follows:


Sec. 58.128  Equipment and utensils.

* * * * *
    (o) New replacement or modified equipment, processing system, or 
utensils. All new, replacement or modified equipment and all processing 
systems, cleaning systems, utensils, or replacement parts shall comply 
with the most current, appropriate 3-A Sanitary Standards or 3-A 
Accepted Practices. If 3-A Sanitary Standards or 3-A Accepted Practices 
are not available, such equipment and replacements shall meet the 
general criteria of this section and the USDA Guidelines for the 
Sanitary Design and Fabrication of Dairy Processing Equipment available 
from USDA, Agricultural Marketing Service, Dairy Programs, Dairy 
Grading Branch, or by accessing the Internet at www.ams.gov/dairy/grade.htm.
* * * * *
    7. Amend Sec. 58.131 by revising the first sentence of paragraph 
(a)(2) to read as follows:


Sec. 58.131  Equipment and facilities.

* * * * *
    (a)(2) Farm bulk tanks. Farm bulk tanks shall comply with 3-A 
Sanitary Standards for Farm Cooling and Holding Tanks or 3-A Sanitary 
Standards for Farm Milk Storage Tanks, as applicable. * * *
* * * * *
    8. Amend Sec. 58.133 by revising paragraphs (b)(2), (b)(3), (b)(4), 
(b)(5) introductory text, (b)(5)(ii), (b)(6), and (c)(1) to read as 
follows:
* * * * *


Sec. 58.133  Methods for quality and wholesomeness determination.

* * * * *
    (b) * * *
    (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) * * *
    (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 which have been independently evaluated or 
evaluated by the Food and Drug Administration (FDA) and 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.
* * * * *
    9. Amend Sec. 58.134 by revising paragraph (a) to read as follows:


Sec. 58.134  Sediment content.

    (a) Method of testing. Methods for determining the sediment content 
of the milk of individual producers shall be those described in the 
latest edition of Standard Methods for the Examination of Dairy 
Products. Sediment content shall be based on comparison with applicable 
charts of the United States Sediment Standards for Milk and Milk 
Products, available from USDA, AMS, Dairy Programs, Dairy 
Standardization Branch.
* * * * *
    10. Revise Sec. 58.135 to read as follows:


Sec. 58.135  Bacterial estimate.

    (a) Methods of testing. Milk shall be tested for bacterial estimate 
by using

[[Page 42463]]

one of the following methods or by any other method approved by 
Standard Methods for the Examination of Dairy Products.
    (1) Direct microscopic clump count;
    (2) Standard plate count;
    (3) Plate loop count;
    (4) Pectin gel plate count;
    (5) Petrifilm aerobic count;
    (6) Spiral plate count;
    (7) Hydrophobic grid membrane filter count;
    (8) Impedance/conductance count;
    (9) Reflectance calorimetry.
    (b) Frequency of testing. A laboratory examination to determine the 
bacterial estimate shall be made on a representative sample of each 
producer's milk at least once each month at irregular intervals. 
Samples shall be analyzed at a laboratory in accordance with State 
regulations.
    (c) Acceptance of milk. The following procedures shall be applied 
with respect to bacterial estimates:
    (1) Whenever the bacterial estimate indicates the presence of more 
than 500,000 bacteria per ml., the producer shall be notified with a 
warning of the excessive bacterial estimate.
    (2) Whenever two of the last four consecutive bacterial estimates 
exceed 500,000 per ml., the appropriate regulatory authority shall be 
notified and a written warning notice given to the producer. The notice 
shall be in effect so long as two out of the last four consecutive 
samples exceed 500,000 per ml.
    (3) An additional sample shall be taken after a lapse of 3 days but 
within 21 days of the notice required in paragraph (c) (2) of this 
section. If this sample also exceeds 500,000 per ml., subsequent 
milkings shall be excluded from the market until satisfactory 
compliance is obtained. Shipment may be resumed when an additional 
sample of herd milk is tested and found satisfactory.
    11. Amend Sec. 58.137 by revising paragraphs (b) and (c) to read as 
follows:


Sec. 58.137  Excluded milk.

* * * * *
    (b) Three of the last five milk samples have exceeded the maximum 
bacterial estimate of 500,000 per ml. (Sec. 58.135 (c)(3)).
    (c) Three of the last five milk samples have exceeded the maximum 
somatic cell count level of 750,000 per ml. (1,000,000 per ml. for goat 
milk) (Sec. 58.133 (b)(6)); or
* * * * *
    12. Amend Sec. 58.143 by revising paragraph (b) to read as follows:


Sec. 58.143  Raw product storage.

* * * * *
    (b) The bacteriological quality of commingled milk in storage tanks 
shall not exceed 1,000,000/ml.
    13. Revise Sec. 58.245 to read as follows:


Sec. 58.245  Method of sample analysis.

    Samples shall be tested according to the applicable methods of 
laboratory analysis contained in either DA Instruction 918-RL as issued 
by the USDA, Agricultural Marketing Service, Dairy Programs, or 
Official Methods of Analysis of the Association of Analytical Chemists 
or Standard Methods for the Examination of Dairy Products.
    14. Amend Sec. 58.346 by revising paragraph (b)(1) to read as 
follows:


Sec. 58.346  Whipped butter.

* * * * *
    (b) * *  *
    (1) Proteolytic count, not more than 50 per gram; yeast and mold 
count, not more than 10 per gram; coliform count, not more than 10 per 
gram; and keeping-quality test, satisfactory after 7 days at 72 deg. F.
* * * * *
    15. Amend Sec. 58.405 by revising paragraph (a) to read as follows:


Sec. 58.405  Meaning of words.

* * * * *
    (a) Cheese. The fresh or matured product obtained by draining after 
coagulation of milk, cream, skimmed, or partly skimmed milk or a 
combination of some or all of these products and including any cheese 
that conforms to the requirements of the Food and Drug Administration 
for cheeses and related cheese products (21 CFR part 133).
* * * * *
    16. Amend Sec. 58.505 by revising paragraphs (b), (c), and (d), and 
the last sentence of paragraph (f) to read as follows:


Sec. 58.505  Meaning of Words.

* * * * *
    (b) Cottage cheese. (1) Cottage cheese dry curd. The soft uncured 
cheese meeting the requirements of the Food and Drug Administration for 
dry curd cottage cheese (21 CFR 133.129).
    (2) Cottage cheese. The soft uncured cheese meeting the 
requirements of the Food and Drug Administration for cottage cheese (21 
CFR 133.128).
    (3) Reduced Fat, Light, and Fat Free Cottage cheese. The products 
conforming to all applicable Federal Regulations including ``Cottage 
cheese,'' Food and Drug Administration (21 CFR 133.128), ``Dry curd 
cottage cheese,'' Food and Drug Administration (21 CFR 133.129), 
``Nutrient content claims for fat, fatty acid, and cholesterol content 
of foods,'' Food and Drug Administration (21 CFR 101.62), and 
``Requirements for foods named by use of a nutrient content claim and a 
standardized term,'' Food and Drug Administration (21 CFR 130.10).
    (c) Direct acidification. The production of cottage cheese, without 
the use of bacterial starter cultures, through the use of approved food 
grade acids. This product shall be labeled according to the 
requirements of the Food and Drug Administration, 21 CFR 133.128 or 
133.129, as appropriate.
    (d) Cottage cheese with fruits, nuts, chives, or other vegetables. 
Shall consist of cottage cheese to which has been added fruits, nuts, 
chives and other vegetables. The finished cheese shall comply with the 
requirements of the Food and Drug Administration for cottage cheese (21 
CFR 133.128).
    (e) * * *
    (f) * * * The creaming mixture in its final form may or may not be 
homogenized and shall conform to the requirements of the Food and Drug 
Administration (21 CFR 133.128(b)).
    17. Amend Sec. 58.605 by revising paragraphs (a), (b), (c), (d) and 
(e).


Sec. 58.605  Meaning of words.

* * * * *
    (a) Ice cream. The product conforming to the requirements of the 
Food and Drug Administration for ice cream (21 CFR 135.110).
    (b) Frozen custard. The product conforming to the requirements of 
the Food and Drug Administration for frozen custard (21 CFR 135.110).
    (c) Reduced Fat, Light, or Fat Free ice cream. The products 
conforming to all applicable Federal Regulations including ``Ice cream 
and frozen custard,'' Food and Drug Administration (21 CFR 135.110), 
``Nutrient content claims for fat, fatty acid, and cholesterol content 
of foods,'' Food and Drug Administration (21 CFR 101.62), and 
``Requirements for foods named by use of a nutrient content claim and a 
standardized term,'' Food and Drug Administration (21 CFR 130.10).
    (d) Sherbet. The product conforming to the requirements of the Food 
and Drug Administration for sherbet (21 CFR 135.140).
    (e) Mellorine. The product conforming to the requirements of the 
Food and Drug Administration for mellorine (21 CFR 135.130).
* * * * *
    18. Remove and reserve Sec. 58.651.
    19. Amend Sec. 58.705 by revising paragraph (a) to read as follows:


Sec. 58.705  Meaning of words.

    (a) Pasteurized process cheese and related products. Pasteurized 
process

[[Page 42464]]

cheese and related products are the foods which conform to the 
applicable requirements of the Food and Drug Administration for cheeses 
and related cheese products (21 CFR part 133).
* * * * *
    20. Amend Sec. 58.812 to read as follows:


Sec. 58.812  Methods of sample analysis.

    Samples shall be tested according to the applicable methods of 
laboratory analysis contained in either DA Instruction 918-RL, as 
issued by the USDA, Agricultural Marketing Service, Dairy Programs, or 
the Official Methods of Analysis of the Association of Official 
Analytical Chemists, or Standard Methods for the Examination of Dairy 
Products.
* * * * *
    21. Amend Sec. 58.905 by revising paragraphs (a), (b), and (c) to 
read as follows:


Sec. 58.905  Meaning of words.

* * * * *
    (a) Evaporated milk. The liquid food made by evaporating sweet milk 
to such point that it contains not less than 6.5 percent of milkfat and 
not less than 16.5 percent of the total milk solids. The finished 
product shall conform to the requirements of the Food and Drug 
Administration for evaporated milk (21 CFR 131.130).
    (b) Concentrated milk, plain condensed milk. The product which 
conforms to the standard of identity for evaporated milk except that it 
is not processed by heat to prevent spoilage. The container may be 
unsealed, and stabilizing ingredients are not used. The finished 
product shall conform to the requirements of the Food and Drug 
Administration for concentrated milk (21 CFR 131.115).
    (c) Sweetened condensed milk. The liquid or semi-liquid food made 
by evaporating a mixture of sweet milk and refined sugar (sucrose) or 
any combination of refined sugar (sucrose) and refined corn sugar 
(dextrose) to such point that the finished sweetened condensed milk 
contains not less than 28.0 percent of total milk solids and not less 
than 8.0 percent of milkfat. The quantity of sugar used is sufficient 
to prevent spoilage. The finished product shall conform to the 
requirements of the Food and Drug Administration for sweetened 
condensed milk (21 CFR 131.120).
* * * * *
    22. Revise Sec. 58.915 to read as follows:


Sec. 58.915  Batch or continuous in-container thermal processing 
equipment.

    Batch or continuous in-container thermal processing equipment shall 
meet the requirements of the Food and Drug Administration for thermally 
processed low-acid foods packaged in hermetically sealed containers (21 
CFR part 113). The equipment shall be maintained in such a manner as to 
assure control of the length of processing and to minimize the number 
of damaged containers.
    23. Amend Sec. 58.938 by revising paragraph (g) to read as follows:


Sec. 58.938  Physical requirements and microbiological limits for 
sweetened condensed milk

* * * * *
    (g) Composition. Shall meet the minimum requirements of the Food 
and Drug Administration for sweetened condensed milk (21 CFR 131.120). 
In addition, the quantity of refined sugar used shall be sufficient to 
give a sugar-in-water ratio of not less than 61.5 percent.
* * * * *

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

    Dated: August 7, 2001.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 01-20189 Filed 8-10-01; 8:45 am]
BILLING CODE 3410-02-P