# 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 (202) 720-2643; or e-mailed to *[email protected].*
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 (202) 720-7473, e-mail *[email protected].*
**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.
| Current Requirement | Proposed | Discussion |
| --- | --- | --- |
| B—Definitions | B—Definitions | We propose to update the name and address of the Association of Official Analytical Chemists International. |
| B—Definitions | B—Definitions | We propose to update the address of the American Public Health Association. |
| B—Definitions | B—Definitions | 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 | B—Definitions | 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 | C—Quality Requirements for Milk for Manufacturing Purposes | 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 | | 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 | C. Quality Requirements for Milk for Manufacturing Purposes | 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 | C. Quality Requirements for Milk for Manufacturing Purposes | 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 | C—Quality Requirements for Milk for Manufacturing Purposes | 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 | 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 | C—Quality Requirements for Milk for Manufacturing Purposes | 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 | C—Quality Requirements for Milk for Manufacturing Purposes | 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 | 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 | 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 | C—Quality Requirements for Milk for Manufacturing Purposes | We propose that the paragraph designation be changed without changing the information. |
| C—Quality Requirements for Milk for Manufacturing Purposes | C—Quality Requirements for Milk for Manufacturing Purposes | 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 | C—Quality Requirements for Milk for Manufacturing Purposes | We propose that the paragraph designation be changed without changing the information. |
| E—Requirements for Licensed Dairy Plants | E—Requirements for Licensed Dairy Plants | 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 | 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.