[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