[Federal Register Volume 61, Number 178 (Thursday, September 12, 1996)]
[Notices]
[Pages 48120-48124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23319]


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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[DA-93-06]


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice.

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SUMMARY: This document amends the recommended manufacturing milk 
requirements (Recommended Requirements) by reducing the maximum 
allowable bacterial estimate and somatic cell count in producer herd 
milk and by reducing the maximum allowable bacterial estimate in 
commingled milk. In addition, this amendment modifies the follow-up 
procedures when producer herd milk exceeds the maximum allowable 
bacterial estimate. The amendment to reduce somatic cell count and 
bacterial estimate was initiated at the request of the National 
Association of State Departments of Agriculture (NASDA) and was 
developed in cooperation with NASDA, dairy trade associations, and 
producer groups.

EFFECTIVE DATE: November 12, 1996.

FOR FURTHER INFORMATION CONTACT: Roland S. Golden, Dairy Products 
Marketing Specialist, Dairy Standardization Branch, USDA/AMS/Dairy 
Division, Room 2750-S, P.O. Box 96456, Washington, DC 20090-6456, 
(202)720-7473.

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 available for adoption by the various States. 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.
    On July 22, 1992, the Dairy Division of NASDA passed a resolution 
recommending that certain milk quality requirements be tightened. The 
Dairy Division of NASDA requested that the maximum allowable bacterial 
estimate in producer herd milk be reduced from 1,000,000 per ml. to 
500,000 per ml. and that the maximum allowable somatic cell count in 
producer herd milk be

[[Page 48121]]

reduced from 1,000,000 per ml. to 750,000 per ml. (The changes for 
somatic cell count only apply to milk from cows, not milk from goats.) 
The Dairy Division of NASDA also requested that the maximum allowable 
bacterial estimate in commingled milk be reduced from 3,000,000 per ml. 
to 1,000,000 per ml.
    Their desire to have these changes were further reinforced in a 
resolution passed on July 18, 1994. In this resolution, the Dairy 
Division of NASDA requested that USDA expedite the printing of this 
amendment.
    In addition, certain State regulatory agencies have requested 
modifications to the follow-up procedures when producer herd milk 
exceeds the maximum allowable bacterial estimate. Changes are made that 
increase uniformity with producer herd milk bacteria and somatic cell 
follow-up procedures. This modified follow-up program is more adaptable 
to computer-based recordkeeping.
    In order to align the bacterial estimate and somatic cell count 
requirements contained in the Recommended Requirements with the 
resolution passed by NASDA, USDA is amending this document as follows:
    1. Reduce the maximum somatic cell count permitted in producer herd 
milk (no change for goat milk). 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. The National Mastitis Council (NMC) is an organization that 
promotes research and provides educational materials to help dairy 
producers reduce the incidence of mastitis and thus enhance milk 
quality. In their publication entitled Current Concepts of Bovine 
Mastitis 1, the NMC states that ``Presence of more than 500,000 
leukocytes per milliliter of mixed herd milk suggests a significant 
incidence of mastitis in a given herd.'' Changes in the Recommended 
Requirements will reduce the maximum somatic cell count permitted in 
producer herd milk (cows milk only) from 1,000,000 to 750,000 per ml. 
Through effective herd management, many dairy farmers have reduced the 
number of somatic cells well below this maximum limit. Since the number 
of somatic cells found in milk produced from healthy goats is normally 
higher than the number found in cows milk, similar reductions have not 
been made for goat milk.
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     1 R.W. Brown, Current Concepts of Bovine Mastitis, 
Washington: National Mastitis Council, 1965, pp. 30-34.
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    2. Delete the laboratory screening tests for somatic cells in 
producer herd milk samples (no change for goat milk). The California 
Mastitis Test (CMT) and the Wisconsin Mastitis Test (WMT) were used as 
screening tests for somatic cells. These screening tests are accurate 
for samples containing 1,000,000 or more somatic cells per ml. Since 
this action reduces maximum somatic cell count 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. This amendment identifies those tests that 
may be used for somatic cell counting and makes provisions for 
additional methods that may later be added to the latest edition of 
``Standard Methods for the Examination of Dairy Products.''
    3. Reduce the maximum bacterial estimate permitted in producer herd 
milk. 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 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 has 
resulted in enhanced milk quality. Changes in the Recommended 
Requirements reduce the maximum permissible bacteria count in producer 
herd milk from 1,000,000 to 500,000 per ml.
    4. Modify the follow-up procedures when producer herd milk exceeds 
the maximum allowable bacterial estimate. Changes have been made that 
modify the follow-up procedures when producer herd milk exceeds the 
maximum permitted bacterial estimate. These changes now require dairy 
plant personnel to notify the appropriate State regulatory authority 
when two of the last four consecutive bacterial estimates exceed the 
maximum permitted. The State regulatory authority would then send a 
written warning letter to the producer. After 3 days but within 21 
days, an additional sample of herd milk is tested. If this sample also 
exceeds the maximum permitted, that producer's herd milk is excluded 
from the market until satisfactory compliance is obtained.
    These changes increase uniformity with producer herd milk bacteria 
and somatic cell follow-up procedures and provide greater adaptability 
to computer-based recordkeeping.
    5. Reduce the maximum permitted bacterial estimate in commingled 
milk. Commingled milk is the combined milk from more than one producer. 
Reductions in the maximum bacterial estimate for producer herd milk 
should result in improved commingled milk quality. Changes in the 
Recommended Requirements are made to reflect this improved milk quality 
by reducing the maximum permissible bacterial estimate in commingled 
milk from 3,000,000 to 1,000,000 per ml.
    6. In order to provide consistency throughout the Recommended 
Requirements, changes in terminology and formatting have been made. The 
amendment: (a) Revises the definitions for ``acceptable milk'' and 
``probational milk'' by deleting the reference to bacterial estimate; 
(b) revises the requirements for ``excluded milk'' by incorporating 
provisions for milk with a history of excessive bacteria counts; (c) 
revises the terms of quality testing of milk from producers by 
including bacterial requirements; and (d) instructs dairy plant 
management to provide field assistance to farmers concerning excessive 
bacteria counts.

Public Comment

    On October 6, 1994, the Department published (59 FR 50894) a notice 
of intent to amend the ``Milk for Manufacturing Purposes and Its 
Production and Processing; Recommended Requirements for Adoption by 
State Regulatory Agencies.'' The public comment period closed December 
5, 1994. Comments were received from 52 commenters: 27 manufacturing 
grade milk producers, 12 dairy plant personnel, 6 State regulatory 
agencies, 2 private individuals, 1 national dairy trade associations, 1 
national association representing State regulatory agencies, 1 
veterinary association, 1 national goat association, 1 goat research 
center, 1 county commissioner office, and 1 State dairy association.

Discussion of Comments

1. Fifteen Commenters Stated That Current Somatic Cell Counts Do Not 
Pose a Public Health Hazard

    Milk is defined in 21 CFR 131.110 as ``* * * the lacteal secretion, 
practically free from colostrum, obtained by the complete milking of 
one or more healthy cows.'' Somatic cell levels in some milking herds 
(cattle) have been

[[Page 48122]]

maintained at or below 200,000. These levels indicate a healthy milking 
herd. Research by the National Mastitis Council (NMC) states somatic 
cell levels above 500,000 generally indicate the presence of mastitis 
in the milking herd. Mastitis is caused by an infection of the milk-
producing tissue in the udder.
    Somatic cell counts are a measure of the health of the lactating 
dairy animal and provide an indirect measure of the public health 
safety of the raw milk. The level at which somatic cells pose a public 
health hazard is not known. While the previous level of 1,000,000 
somatic cells per ml. is not considered to be a public health concern, 
a lower level is readily obtainable and improves the milk production of 
the dairy cow and the quality of the dairy products.

2. Fourteen Commenters Felt That Milk Containing 1,000,000 Somatic 
Cells Does Not Affect Product Quality

    Research published by National Mastitis Council 2 and the 
Journal of Dairy Science 3 has shown that milk protein content and 
cheese yield are reduced as somatic cell counts increase. Studies in 
these two publications also showed a corresponding increase in the 
frequency of quality defects in Cheddar cheese with somatic cell counts 
over 500,000. Research indicates that higher somatic cell counts affect 
product quality.
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    \2\ ``Udder Topics'', National Mastitis Council Newsletter, 
Volume 17, No. 4, August 1994.
    \3\ R.J. Verdi, D.M. Barbano, Journal of Dairy Science, ``Effect 
of coagulants, somatic cell enzymes, and extracellular bacterial 
enzymes on plasminogen activation'', American Dairy Science 
Association, March 1991, v. 74 (3) p. 772-782.
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3. Twenty-Seven Commenters Expressed Concern That the Reduction in the 
Somatic Cell Count Requirement Would Cost the Producer More for 
Rejected Milk, Medication Costs and Veterinarian Fees

    The effort to lower somatic cell levels in a dairy herd is 
primarily one of management, not cost. Some management practices which 
have been found effective in reducing somatic cell count include:

--proper nutrition
--maintaining a clean and safe housing and milking environment
--proper udder preparation prior to milking
--post-milking teat dipping
--maintenance, cleaning and sanitizing of milking equipment
--a regular individual cow monitoring program which includes dry cow 
treatment.

    Better management will reduce the cost of medication, veterinarian 
fees, and rejected milk and will increase production because overall 
herd health will improve. In addition, lower somatic cell counts can 
also translate into price incentives for the dairy producer from the 
buyer of the milk. While there may be added costs to maintain a dairy 
herd's somatic cell count below 750,00 per ml., an increase in 
production and price incentives should more than offset the additional 
expense.

4. Eleven Commenters Expressed Dissatisfaction With the Same Somatic 
Cell Count Regulations for Manufacturing Grade Milk as Are Required for 
Higher-Priced Grade A Milk

    The definition of milk in 21 CFR 131.110 does not distinguish 
between different grades of milk. It requires that all milk offered for 
sale must be obtained from ``* * * the milking of one or more healthy 
cows.'' Somatic cell counts are one measure of the health status of a 
lactating dairy animal. A healthy cow should be the basis for the 
production of all grades of milk. Somatic cell levels of 1,000,000 for 
a dairy herd indicate production of milk is originating from one or 
more animals with mastitis.
    Somatic cell levels in international markets for products which use 
manufacturing grade milk influence our ability to effectively compete. 
The International Dairy Federation (IDF) published information from 23 
countries 4 which showed the average dairy herd somatic cell count 
at less than 500,000 per ml. In order to have access to these 
international markets, it will be necessary for the United States dairy 
industry to establish somatic cell counts which, through effective 
dairy herd management, are readily attainable.
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     4 ``Mastitis Cell Count Data'', Newsletters of the 
International Dairy Federation No. 134, Mastitis Newsletter 18, 
April 1993.
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5. Four Commenters Felt That Extremely Cold Weather Results in 
Increased Incidence of Mastitis

    The increase in somatic cell counts tends to increase under any 
type of stress, including environmental stress. Temperature extremes, 
both hot and cold, may increase somatic cell counts. Cold weather 
conditions require adequate housing for the milking herd and an 
increased management focus on environmental cleanliness. Freezing of 
teat ends caused by cold weather and injury to teat ends caused by 
close confinement need special management attention. Inadequate housing 
and lack of attention to the special needs of the dairy herd during 
cold weather periods can result in increased incidence of mastitis.

6. One Commenter Suggested the Reduction in the Bacteria Count for 
Producer Herd Milk Be Reduced to 750,000 per ml., Instead of 500,000 
per ml.

    The Department feels that a bacterial level of 500,000 per ml. is 
representative of the manufacturing milk produced today utilizing good 
management practices, adequate milking equipment, and proper cooling of 
the milk at the farm. A single failure to maintain bacterial levels 
below 500,000 per ml. will not result in regulatory action against a 
producer. Only after bacterial counts exceed 500,000 per ml. for three 
of the last five samples, does the regulatory agency begin action to 
exclude that milk from the market. This approach allows the dairy 
producer time to trouble shoot the problem and begin corrective action.

7. Three Commenters Recommended that the Implementation of These 
Revisions be Delayed

    Twenty-three States have already established State laws to meet the 
bacterial and somatic cell levels proposed in this amendment. The 
Department understands that those States that have not already approved 
these changes will need some time to modify their rules, regulations, 
State laws and testing procedures (somatic cell count). Time will also 
be required by State regulatory agencies and the dairy industry to 
become familiar with the new requirements. Some dairy producers may 
need time to adapt their management practices to these new levels. For 
these reasons, the Department has selected the effective date for the 
amended manufacturing milk requirements to be 60 days after publication 
in the Federal Register.

8. Three Commenters Expressed Concern that if this Amendment is put 
into Effect, State Laws will have Tighter Requirements than USDA in the 
Approved Plant Program

    The USDA approved plant program is a voluntary plant inspection 
program that establishes minimum standards in order for a plant to 
qualify. The changes made in this action affect the recommended 
requirements that state regulatory agencies utilize to regulate 
manufacturing grade raw milk. This action will improve the quality of 
manufacturing grade milk throughout the country and result in milk 
quality which exceeds the requirements for voluntary USDA-approved 
plants. Once

[[Page 48123]]

the dairy industry adapts to this new level, the Department may 
initiate similar changes in the USDA-approved plant program.

9. One Commenter Suggested that the Specific Testing Protocols for 
Bacteria were not Listed in Section C11(c) of the Proposed Amendment

    An inadvertent error was made in the printing of the notice of 
intent to amend the recommended requirements. This action has corrected 
that printing error.

10. One Commenter Suggested that the Direct Microscopic Clump Count be 
Deleted as a Method to Determine Bacterial Estimate

    The direct microscopic clump count is officially recognized and 
published in Standard Methods for the Examination of Dairy Products, 
16th Edition.5 As such, it is an acceptable test for evaluating 
the bacterial count along with all other tests listed in Section C4(b).
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     5 Standard Methods For The Examination Of Dairy Products, 
16th Edition, 1992, published by American Public Health Association, 
1015 Fifteenth Street, NW, Washington, DC 20005.
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11. One Commenter Requested that all States Adopt the Current 
Recommended Manufacturing Milk Requirements

    The USDA Recommended Manufacturing Milk Requirements were 
established as minimum standards for adoption by States. The Department 
and the National Association of State Departments of Agriculture 
(NASDA) encourages all States with manufacturing grade milk production 
and/or processing to adopt these requirements into State law or 
regulation. There has been good cooperation in State adoption of past 
changes in the manufacturing milk requirements.
    For the reasons set forth in the preamble, the Recommended 
Requirements which were published in the Federal Register issued April 
7, 1972 (37 FR 7046) and amended August 27, 1985 (50 FR 34726) and May 
6, 1993 (58 FR 86) are amended as follows:
    1. Sec. B2. is amended by revising paragraphs (n) and (o) to read 
as follows:
* * * * *
    (n) Acceptable milk. Milk that qualifies under sec. C2. as to sight 
and odor and that is classified No. 1 or No. 2 for sediment content 
(sec. C3.).
    (o) Probational milk. Milk classified No. 3 for sediment content 
that may be accepted by plants for not over 10 days (sec. C3.).
* * * * *
    2. Sec. C4. is revised to read as follows:

Sec. C4. Bacterial estimate classification

    (a) A laboratory examination to determine the bacterial estimate 
shall be made on each producer's milk at least once each month at 
irregular intervals. Samples shall be analyzed at a laboratory approved 
by the State regulatory agency.
    (b) Milk shall be tested for bacterial estimate by using 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) PetrifilmTM aerobic count
    (6) Spiral plate count
    (7) Hydrophobic grid membrane filter count
    (8) Impedance/conductance count
    (c) Whenever the bacterial estimate indicates the presence of more 
than 500,000 bacteria per ml., the following procedures shall be 
applied:
    (1) 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 of the last four consecutive samples 
exceed 500,000 per ml.
    (d) 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 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 shall be assigned a full reinstatement 
status when three out of four consecutive bacterial estimates do not 
exceed 500,000 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.
    3. Sec. C7. is amended by revising paragraphs (a), (c) and (d) to 
read as follows:

Sec. C7. Excluded milk

     A plant shall not accept milk from a producer if:
    (a) The producer's initial milk shipment to a plant is classified 
as No. 3 for sediment content;
    (b) * * *
    (c) Three of the last five milk samples have exceeded the maximum 
bacterial estimate of 500,000 per ml. (sec. C4.);
    (d) 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. C11.);
* * * * *
    4. Sec. C8. is amended by: revising paragraph (a)(1)(i), adding a 
new paragraph (a)(1)(ii), and redesignating present paragraphs 
(a)(1)(ii) and (iii) as (a)(1)(iii) and (iv); revising paragraph 
(b)(1)(i), adding a new paragraph (b)(1)(ii), and redesignating present 
paragraphs (b)(1)(ii) and (iii) as (b)(1)(iii) and (iv); and revising 
paragraph (b)(3)(i), adding a new paragraph (b)(3)(ii),and 
redesignating present paragraphs (b)(3)(ii), (iii), and (iv) as 
(b)(3)(iii), (iv) and (v) as follows:

Sec. C8. Quality testing of milk from producers

New Producers.

    (1) * * *
    (i) ``Acceptable milk'' (sec. C2. and C3.);
    (ii) Bacterial estimate (sec. C4.);
    (iii) Somatic cell count (sec. C11.); and
    (iv) Drug residue level (sec. C12.).
    (2) * * *

(b) Transfer producers.

    (1) * * *
    (i) ``Acceptable milk'' (sec. C2. and C3.);
    (ii) Bacterial estimate (sec. C4.);
    (iii) Somatic cell count (sec. C11.); and
    (iv) Drug residue level (sec. C12.).
    (2) * * *
    (3) * * *
    (i) The milk is currently classified ``acceptable'' for sediment;
    (ii) Three of the last five consecutive milk samples do not exceed 
the maximum bacterial estimate;
    (iii) Three of the last five consecutive milk samples do not exceed 
the maximum somatic cell count level requirements;
    (iv) The last shipment of milk received from the producer by the 
former plant did not test positive for drug residue; and
    (v) Milk shipments currently are not excluded from the market due 
to a positive drug residue test.
* * * * *
    5. Sec. C10. is revised to read as follows:

[[Page 48124]]

Sec. C10. Field service

    A representative of the plant shall arrange to promptly visit the 
farm of each producer whose milk tests positive for drug residue, 
exceeds the maximum somatic cell count level, exceeds the maximum 
bacterial estimate, or does not meet the requirements for acceptable 
milk. The purpose of the visit shall be to inspect the milking 
equipment and facilities, to offer assistance to improve the quality of 
the producer's milk, and eliminate any potential cause of drug residue. 
A representative of the plant should routinely visit each producer as 
often as necessary to assist and encourage the production of high 
quality milk.
    6. Sec. C11. is revised to read as follows:
    (a) A laboratory examination to determine the level of somatic 
cells shall be made on each producer's milk at least four times in each 
6-month period at irregular intervals. Samples shall be analyzed at a 
laboratory approved by the State regulatory agency.
    (b) A screening test may be conducted on goat herd milk. When a 
goat herd screening sample exceeds either of the following screening 
test results, a confirmatory test shall be conducted.
    (1) California Mastitis Test--Weak Positive (CMT 1).
    (2) Wisconsin Mastitis Test--WMT value of 18 mm.
    (c) Milk shall be tested for somatic cell content by using one of 
the following procedures (confirmatory test for somatic cells in goat 
milk):
    (1) Direct Microscopic Somatic Cell Count (Single Strip Procedure). 
Pyronin Y-Methyl green stain or ``New York'' modification shall be used 
for goat milk.
    (2) Electronic Somatic Cell Count.
    (3) Flow Cytometry/Opto-Electronic Somatic Cell Count.
    (4) Membrane Filter DNA Somatic Cell Count.
    (d) The results of the confirmatory test on goat milk for somatic 
cells shall be the official results.
    (e) Whenever the official test indicates the presence of more than 
750,000 somatic cells per ml. (1,000,000 somatic cell per ml. for goat 
milk), the following procedures shall be applied:
    (1) The producer shall be notified with a warning of the excessive 
somatic cell count.
    (2) Whenever two of the last four consecutive somatic cell counts 
exceed 750,000 per ml. (1,000,000 per ml. for goat milk), 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 of the last four consecutive samples exceed 750,000 per ml. 
(1,000,000 per ml. for goat milk).
    (f) An additional sample shall be taken after a lapse of 3 days but 
within 21 days of the notice required in paragraph (e) (2) of this 
section. If this sample also exceeds 750,000 per ml. (1,000,000 per ml. 
for goat milk), subsequent milkings shall be excluded from the 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 shall 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.
    7. Sec. E1.8 is amended by revising paragraph (b) to read as 
follows:

Sec.  E1.8 Raw Product Storage.

    (a) * * *
    (b) The bacteriological estimate of commingled milk in storage 
tanks shall be 1 million per ml. or lower.

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

    Dated: September 6, 1996.
Lon Hatamiya,
Administrator.
[FR Doc. 96-23319 Filed 9-11-96; 8:45 am]
BILLING CODE 3410-02-P