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

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