[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- 1 R.W. Brown, Current Concepts of Bovine Mastitis, Washington: National Mastitis Council, 1965, pp. 30-34. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \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. --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- 4 ``Mastitis Cell Count Data'', Newsletters of the International Dairy Federation No. 134, Mastitis Newsletter 18, April 1993. --------------------------------------------------------------------------- 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). --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- 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