01-9623. 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 proposes to amend the recommended manufacturing milk requirements (Recommended Requirements) by updating the existing drug residue monitoring program. The proposal would provide State regulatory agencies and the dairy industry with updated guidance in carrying out sampling, testing, and monitoring activities relating to drug residues in manufacturing grade milk. The proposal to update the drug residue monitoring program was initiated at the request of the Dairy Division of the National Association of State Departments of Agriculture (NASDA) and developed in cooperation with NASDA, the Food and Drug Administration (FDA), dairy trade associations, and producer groups. This document also proposes certain other changes to the Recommended Requirements for clarity and consistency.

DATES:

Comments must be submitted on or before June 19, 2001.

ADDRESSES:

Written comments may be submitted to Duane R. Spomer, Chief, Dairy Standardization Branch, Dairy Programs, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2746 South Building, Stop 0230, P.O. Box 96456, Washington, DC 20090-6456; faxed to [phone]; or e-mailed to [e-mail].

Comments should reference the date and page number of this issue of the Federal Register. All comments received will be made available for public inspection at the above address during regular business hours (8 a.m.-4:30 p.m) and will be available by accessing AMS' Home Page on the Internet at http://www.ams.usda.gov/​dairy/​stand.htm.

The current Recommended Requirements, along with the proposed changes, are available either from the above address or by accessing the information on the Internet. The Recommended Requirements are located at the following Internet address: http://www.ams.usda.gov/​dairy/​manufmlk.pdf. The proposed changes to the Recommended Requirements can be accessed at the following Internet address: http://www.ams.usda.gov/​dairy/​dockets.htm.

FOR FURTHER INFORMATION CONTACT:

Duane R. Spomer, Chief, Dairy Standardization Branch, AMS/USDA/Dairy Programs, Room 2746 South Building, P.O. Box 96456, Washington, DC 20090-6456, telephone [phone], e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

Under the authority of the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621-1627), the United States 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 developed by AMS and recommended for adoption and enforcement by the various States that regulate manufacturing grade milk. The purpose of the model requirements is to promote uniformity in State dairy laws and regulations relating to manufacturing grade milk.

In consultation with representatives from NASDA, State regulatory agencies, FDA, and dairy industry trade associations, the Department prepared the Recommended Requirements to promote uniformity in State dairy laws and regulations for manufacturing grade milk. To accommodate changes that have occurred in the dairy industry, NASDA and various State officials have from time to time requested USDA to update the Recommended Requirements.

On May 6, 1993, the Agricultural Marketing Service (AMS) updated the existing Recommended Requirements and incorporated an expanded drug residue monitoring program based on drug residue provisions for Grade A milk produced under the cooperative National Conference on Interstate Milk Shipments (NCIMS) program (58 FR 26950). Within the NCIMS program, FDA, State regulatory agencies, consumers, and the dairy industry cooperatively develop and modify model regulations that are used to regulate Grade A milk. Since 1993 several drug residue monitoring changes have occurred in the Grade A milk model program.

During its July 1999 annual meeting, the Dairy Division of NASDA passed a resolution requesting USDA to review the drug residue provisions of Recommended Requirements and update this document to provide greater consistency with the drug residue requirements currently in place for Grade A milk. AMS reviewed these provisions and developed a draft that identified the changes associated with this request. This draft was provided to State regulatory officials and dairy trade association representatives for informal discussion prior to publication in the Federal Register. AMS is now soliciting comments on the proposed amendment to the Recommended Requirements.

The requirements of Executive Order 13132, Federalism, were considered in developing this notice, and it has been determined that this action does not have federalism implications as defined under the executive order. This action does not have substantial effects on the States (the relationship between the national government and the States or on the distribution of power and responsibilities among the various levels of government). The adoption of the Recommended Requirements by State regulatory agencies is voluntary. States maintain the responsibility to establish dairy regulations and continue to have the option to establish regulations that are different from the Recommended Requirements. A State may choose to have requirements less restrictive or more stringent than the Recommended Requirements. Their decision to have different requirements would not affect the ability of milk producers to market milk or of processing plants to produce dairy products in their State.

AMS is proposing to change the term “fieldman” to “fieldperson” wherever it appears in the Recommended Requirements so that gender-neutral designations are used. The term fieldman is currently included in the Definitions section and is used in several instances in the Administrative Procedures section of the document.

In addition to the proposals to update the drug residue monitoring program and to provide gender-neutral language, this document proposes certain other changes for accuracy, clarity, and consistency.

Except for the gender changes identified earlier in this Notice, the following outline details the remaining proposed changes in the Recommended Requirements. For the reasons set forth, AMS is publishing this notice with a 60-day comment period to provide a sufficient time for interested persons to comment on the changes.

Milk for Manufacturing Purposes and Its Production and Processing

Current Requirement	Proposed	Discussion
B—Definitions B2. Terms defined (t) Official methods. Official Methods of Analysis of the Association of Official Agricultural Chemists, a publication of the Association of Official Analytical Chemists, Box 540, Benjamin Franklin Station, Washington, DC	B—Definitions B2. Terms defined (t) Official methods. “Official Methods of Analysis of the Association of Official Analytical Chemists” (AOAC), a publication of the Association of Official Analytical Chemists International, 481 North Frederick Avenue, Suite 500, Gaithersburg, MD 20877-2417	We propose to update the name and address of the Association of Official Analytical Chemists International.
B—Definitions B2. Terms defined (u) Standard methods. Standard Methods for the Examination of Dairy Products, a publication of the American Public Health Association, 1790 Broadway, New York, NY	B—Definitions B2. Terms defined (u) Standard methods. “Standard Methods for the Examination of Dairy Products”, a publication of the American Public Health Association, 1015 Fifteenth Street, NW, Washington, DC 20005	We propose to update the address of the American Public Health Association.
B—Definitions B2. Terms defined (v) 3-A Sanitary Standards. The latest standards for dairy equipment formulated by the 3-A Sanitary Standards Committees representing the International Association of Milk, Food and Environmental Sanitarians, the U.S. Public Health Service, and the Dairy Industry Committee. Published by the International Association of Milk, Food and Environmental Sanitarians, Box 437, Shelbyville, IN 46176	B—Definitions B2. Terms defined (v) 3-A Sanitary Standards. The latest standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committees representing the International Association of Food Protection, the Federal Food and Drug Administration, and the Dairy Industry Committee. These standards are published by the International Association for Food Protection, 6200 Aurora Avenue, Suite 200W, Des Moines, IA 50322-2863	We propose adding “and accepted practices” to the definition and include both standards and accepted practices formulated by the 3-A Sanitary Standards Committees. Also, we propose to update the name and address of the International Association for Food Protection and specifically identify the Federal Food and Drug Administration as a participant in the development of equipment standards and accepted practices established by the 3-A Sanitary Standards Committees.
B—Definitions B2. Terms defined (y) Sanitizing treatment. Application of any effective method or sanitizing agent to clean surface for the destruction of pathogens and other organisms as far as is practicable. The sanitizing agents used shall comply with the Federal Food, Drug, and Cosmetic Act	B—Definitions B2. Terms defined (y) Sanitizing treatment. Subjection of a clean surface to steam, hot water, hot air, or an acceptable sanitizing solution for the destruction of most human pathogens and other vegetative microorganisms to a level considered safe for product production. Such treatment shall not adversely affect the equipment, the milk, the milk product or the health of consumers. Sanitizing solutions shall comply with 21 CFR 178.1010	We propose to modify the definition of sanitizing treatment to more clearly and accurately define this term and to provide greater consistency with the definition for this term in other related documents.
C—Quality Requirements for Milk for Manufacturing Purposes C3. Sediment Content Classification (a) Method of testing. Methods for determining the sediment content of the milk of individual producers shall be those described in the latest edition of Standard Methods for Examination of Dairy Products. Sediment content shall be based on comparison with applicable charts of the United States Sediment Standards for Milk and Milk Products, 7 CFR Part 58, Subpart T, § 58.2728 through 58.2732	C—Quality Requirements for Milk for Manufacturing Purposes C3. Sediment Content Classification (a) Method of testing. Methods for determining the sediment content of the milk of individual producers shall be those described in the latest edition of Standard Methods for Examination of Dairy Products. Sediment content shall be based on comparison with applicable charts of the United States Sediment Standards for Milk and Milk Products. These charts are available from the Dairy Standardization Branch, Dairy Programs, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2746-South, P.O. Box 96456, Washington, DC 20090-6456	Since the last revision of the Recommended Requirements, the Department has decided to remove certain standards from the Code of Federal Regulations. The current wording in this document references the Code of Federal Regulations as the source for sediment standard information. We propose to correct this citation by providing current information where sediment standards can be obtained.
C—Quality Requirements for Milk for Manufacturing Purposes C7. Excluded Milk (f) The producer is delinquent in completing a review of the “Milk and Dairy Beef Quality Assurance Program” with a licensed veterinarian following an occurrence of shipping milk testing positive for drug residue (sec. C12.)		A change in the model requirements for Grade A milk no longer requires a producer to review the “Milk and Dairy Beef Quality Assurance Program” with a licensed veterinarian. We propose to delete this provision that results in the exclusion of milk from an individual producer that has not completed this review. However, the Department recognizes the educational benefits this program provides and proposes to include provisions for voluntary participation under Section C10.
C. Quality Requirements for Milk for Manufacturing Purposes 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 of as necessary to assist and encourage the production of high-quality milk	C. Quality Requirements for Milk for Manufacturing Purposes 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 to eliminate any potential cause of drug residue. A review of the “Milk and Dairy Beef Quality Assurance Program” is one method that can be used to educate the producer in practices that are effective in eliminating the occurrence of drug residues in the milk. A representative of the plant should routinely visit each producer as often as necessary to assist and encourage the production of high-quality milk	A change in the model requirements for Grade A milk no longer requires a producer to review the “Milk and Dairy Beef Quality Assurance Program” with a licensed veterinarian. Previously the Recommended Requirements mandated that a producer review this program under certain circumstances detailed in Section C7. The Department recognizes the educational benefits this program provides and proposes to include provisions for voluntary participation under Section C10.
C. Quality Reqirements for Milk for Manufacturing Purposes C12. Drug residue level (a) Industry responsibilities (1) Sampling and testing program. (ii) When so specified by the U.S. Food and Drug Administration (FDA), all milk shipped for processing, or intended to be processed on the farm where it was produced, shall be sampled and tested prior to processing, for other drug residues under a random drug sampling program. The random drug sampling program shall include at least four samples collected in at least 4 separate months during any 6-month period	C. Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (a) Industry responsibilities (1) Sampling and testing program. (ii) When so specified by the U.S. Food and Drug Administration (FDA), all milk shipped for processing, or intended to be processed on the farm where it was produced, shall be sampled and tested prior to processing, for other drug residues under a random drug sampling program. The random drug sampling program shall include at least four samples collected in at least 4 separate months during any consecutive 6-month period	We propose to include the word “consecutive” in the final sentence in this paragraph. This would clearly indicate that the random sampling for drug residues other than beta lactam are to be performed on at least four samples collected during a consecutive 6-month period. This change would provide greater consistency with Grade A provisions.
C. Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (a) Industry responsibilities (1) Sampling and testing program. (iv) The dairy industry shall analyze samples for beta lactams and other drug residues by methods evaluated by the Association of Official Analytical Chemists (AOAC) and accepted by the FDA as effective in determining compliance with established “safe levels” or tolerances. “Safe levels” and tolerances for particular drugs are established and amended by the FDA. The industry may employ on a temporary basis other test methods evaluated by the Virginia Polytechnic Institute and State University, or by other institutions using equivalent evaluation procedures, and determined to demonstrate accurate compliance results. These test methods may be used until they are evaluated by the AOAC and accepted or rejected by the FDA	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (a) Industry responsibilities (1) Sampling and testing program. (iv) The dairy industry shall analyze samples for beta lactams and other drug residues by methods which have been independently evaluated or evaluated by FDA and accepted by FDA as effective to detect drug residues at current safe or tolerance levels. Safe and tolerance levels for particular drugs are established by the FDA.	When the drug residue provision of the Recommended Requirements were initially included, the Grade A milk program allowed for the approval of test methods by the Virginia Polytechnic Institute and State University. Since that time this method of approval is no longer specified. The proposed changes would provide greater consistency with information included in the Grade A milk program.
	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (1) Sampling and testing program. (v) All sample test results for milk that does not test positive shall be recorded, and test result records shall be retained for a period of six months	We propose to include a provision that all test results that do not test positive for drug residues be retained for a period of 6 months. Currently Section C12(a)(4) of the Recommended Requirements stipulate that all test results be maintained for a period of 12 months. This change would provide greater consistency with Grade A requirements.
C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (a) Industry responsibility (4) Sample and record retention. A load sample that tests positive for drug residue shall be retained for a period of not less than 12 months	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (a) Industry responsibility (4) Sample and record retention. A load sample that tests positive for drug residue shall be retained according to guidelines established by the appropriate State regulatory agency. The records of all positive sample test results shall be retained for a period of not less than 12 months	We propose to include the word “positive” prior to “sample” in the second sentence of this paragraph. This change would relax the requirement that all test results be maintained for 12 months while ensuring that all positive test results are retained for a period of 12 months. The 12-month retention for positive results is necessary in order to address producers that repetitively violate the drug residue provisions. This change would provide greater consistency with Grade A requirements.
C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (1) Monitoring and surveillance. (i) Each producer is included in a routine, effective drug residue milk monitoring program utilizing AOAC-evaluated and FDA-approved methods to test samples for the presence of drug residue	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (1) Monitoring and surveillance. (i) Each producer is included in a routine, effective drug residue milk monitoring program utilizing methods evaluated and found acceptable by FDA to test samples for the presence of drug residue	The proposed changes would provide greater consistency with information currently used in the Grade A milk program to analyze samples for drug residues by providing for test methods accepted by FDA as effective to detect drug residues at current safe or tolerance levels.
	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (i) Any time milk is found to test positive for drug residue, the regulatory agency shall immediately take action to suspend the producer's milk shipping privileges to prevent the sale of milk from the producer shipping milk testing positive for drug residue	We propose to incorporate information that would support the requirements currently contained in section C12(a)(5)(iii) and direct the regulatory agency to immediately suspend the producer's milk shipping privileges when a sample of milk tests positive. This change would provide greater consistency with Grade A requirements.
	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (ii) The producer's milk shipping privileges may be reinstated when a representative sample taken from the producer's milk, prior to commingling with any other milk, is no longer positive for drug residue	We propose to incorporate information that would support the requirements currently contained in section C12(a)(5)(iii) and provide requirements to be met in order for a producer to resume shipping milk. This change would provide greater consistency with Grade A requirements.
C—Quality Requirement for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (i) A penalty sanctioned by the State regulatory agency shall be imposed on the producer for each occurrence of shipping milk testing positive for drug residue.	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (iii) A penalty sanctioned by the State regulatory agency shall be imposed on the producer for each occurrence of shipping milk testing positive for drug residue	We propose that the paragraph designation be changed without changing the information.
C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (ii) The producer shall review the “Milk and Dairy Beef Quality Assurance Program” with a licensed veterinarian within 30 days after each occurrence of shipping milk testing positive for drug residue. A certificate confirming that the “Quality Assurance Program” has been reviewed shall be signed by the responsible producer and a licensed veterinarian. The appropriate State regulatory agency shall be notified after the program has been reviewed	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (iv) Whenever a drug residue test is positive, an investigation shall be made to determine the cause. Action shall be taken to prevent future occurrences	We propose that the mandatory review of the “Milk and Dairy Beef Quality Assurance Program” be deleted and that the information in this paragraph be modified to require an investigation be made to determine the cause of the positive drug residue test and that preventative measures be taken to prevent future occurrences. The Department recognizes the educational benefits this program provides in educating milk producers and proposes to include provisions for voluntary participation under Section C10.
C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (iii) If a producer ships milk testing positive for drug residue three times within a 12-month period, the appropriate State agency shall initiate administrative procedures to suspend the producer's milk shipping privileges, according to State policy	C—Quality Requirements for Milk for Manufacturing Purposes C12. Drug residue level (b) Regulatory agency responsibility (2) Enforcement. (v) If a producer ships milk testing positive for drug residue three times within a 12-month period, the appropriate State agency shall initiate administrative procedures to suspend the producer's milk shipping privileges according to State policy	We propose that the paragraph designation be changed without changing the information.
E—Requirements for Licensed Dairy Plants E1. General Requirements E 1.13 Plant records (a) Sediment and bacterial test results on raw milk from each producer: Retain for 12 months. (1) Routine tests and monthly summary of all producers showing number and percent of total in each class, (2) Retests, if initial test places milk in a probationary status, (3) Rejections of raw milk over No. 3 in quality	E—Requirements for Licensed Dairy Plants E1. General Requirements E 1.13 Plant records (a) Sediment, drug residue, and bacterial test results on raw milk from each producer: Retain for 12 months. (1) Routine tests and monthly summary of all producers showing number and percent of total in each class, (2) Retests, if initial test places milk in a probationary status, (3) Rejections of raw milk over No. 3 in quality, (4) Positive drug residue tests	We propose to update the information in this section to provide consistency with the proposed drug residue record keeping provisions of Section C12(a)(4).
	E—Requirements for Licensed Dairy Plants E1. General Requirements E 1.13 Plant records (e) Drug residue test results for milk samples that do not test positive: Retain for 6 months	We propose to update the information in this section to provide consistency with the proposed drug residue record keeping provisions of Section C12(a)(1)(v).

Authority: (7 U.S.C. 1621-1627)

Dated: April 3, 2001.

Kenneth C. Clayton,

Acting Administrator, Agricultural Marketing Service.