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

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:

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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