[Federal Register Volume 59, Number 193 (Thursday, October 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-24778]


[[Page Unknown]]

[Federal Register: October 6, 1994]


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DEPARTMENT OF AGRICULTURE

Agriculture 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 of intent to amend.

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SUMMARY: This document proposes to amend 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 proposal would modify the follow-up 
procedures when producer herd milk exceeds the maximum allowable 
bacterial estimate. The proposal 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.

DATES: Comments should be filed by December 5, 1994.

ADDRESSES: Comments should be sent to: Director, Dairy Division, 
Agricultural Marketing Service, U.S. Department of Agriculture, room 
2968-S, P.O. Box 96456, Washington, DC 20090-6456. They will be made 
available for public inspection at the Dairy Division in room 2750-S 
during regular business hours.

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, 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.
    In July 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 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 in July 1994. In this resolution, the Dairy Division 
of NASDA requested that USDA expedite the printing of this proposal.
    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 being 
proposed that will provide uniformity with producer herd milk bacteria 
and somatic cell follow-up procedures. The modified follow-up program 
is also 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, this document proposes the following 
changes:
    1. Reduce the maximum somatic cell count 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). The number of 
somatic cells present in milk provides information regarding the health 
of the dairy herd. The National Mastitis Council (NMC) is an 
organization that promotes research and provides education to help 
dairy producers reduce the incidence of mastitis and thus enhance milk 
quality. In their publication entitled Current Concepts of Bovine 
Mastitis, 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 are being proposed that would 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 the 
maximum limit being considered. 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 are not being proposed for goat 
milk.
    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) are used as screening tests for somatic cells. These screening 
tests are accurate for samples containing 1,000,000 or more somatic 
cells per ml. When the maximum somatic cell count is reduced to 750,000 
per ml., the CMT and WMT screening tests are not accurate. Since the 
maximum somatic cell count for goat milk remains at 1,000,000 per ml., 
the CMT and WMT tests can still be used to screen goat milk. The 
proposal identifies those tests which may be used for cow milk somatic 
cell counting. The appropriate tests are those listed in this document 
or other methods identified in 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 is 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 are being proposed 
that would 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 are being proposed that will modify the follow-up 
procedures when producer herd milk exceeds the maximum permitted 
bacteria estimate. These changes would require the dairy plant to 
notify the producer with a warning whenever an excessive bacterial 
estimate is found. When two of the last four consecutive bacterial 
estimates exceed the maximum permitted, the dairy plant would be 
required to notify the appropriate State regulatory authority. 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 would provide uniformity with producer herd milk 
bacteria and somatic cell follow-up procedures. The modified follow-up 
program is also more adaptable 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. 
Proposed reductions in the maximum bacterial estimate for producer herd 
milk should result in improved commingled milk quality. Changes in the 
Recommended Requirements are being proposed that reduce 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 are being proposed.
    The proposal would: (a) Amend the definitions for ``acceptable 
milk'' and ``probational milk'' by deleting the reference to bacterial 
estimate; (b) amend the requirements for ``excluded milk'' by 
incorporating provisions for milk with a history of excessive bacteria 
counts; (c) amend the bacterial requirements under the terms of quality 
testing of milk from producers; and (d) instruct plants to provide 
field assistance to farmers concerning excessive bacteria counts.
    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 proposed to be 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.
    (a) 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:
    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 bacterial estimate by using one of the 
following methods or by any other method approved by Standard Methods 
for the Examination of Dairy Products:
    (d) 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.
    (e) The results of the confirmatory test on goat milk for somatic 
cells shall be the official results.
    (f) 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).
    (g) 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.

    Dated: October 3, 1994.
Kenneth C. Clayton,
Deputy Administrator, Marketing Programs.
[FR Doc. 94-24778 Filed 10-5-94; 8:45 am]
BILLING CODE 3410-02-P