Reports and guidance documents; availability, etc.: Milk for manufacturing purposes and its production and processing; requirements adoption by State regulatory agencies,
[Federal Register: April 20, 2001 (Volume 66, Number 77)]
[Notices]
[Page 20226-20231]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ap01-25]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[DA-00-10A]
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 Duane.Spomer@usda.gov.
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 Duane.Spomer@usda.gov.
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
[[Page 20227]]
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
B--Definitions
We propose to update the name and B2. Terms defined
B2. Terms defined
address of the Association of (t) Official methods. Official
(t) Official methods. ``Official Official Analytical Chemists Methods of Analysis of the
Methods of Analysis of the
International. Association of Official
Association of Official Analytical Agricultural Chemists, a
Chemists'' (AOAC), a publication of publication of the Association of the Association of Official Official Analytical Chemists, Box Analytical Chemists International, 540, Benjamin Franklin Station, 481 North Frederick Avenue, Suite Washington, DC
500, Gaithersburg, MD 20877-2417 B--Definitions
B--Definitions
We propose to update the address of B2. Terms defined
B2. Terms defined
the American Public Health (u) Standard methods. Standard
(u) Standard methods. ``Standard Association. Methods for the Examination of
Methods for the Examination of Dairy Products, a publication of Dairy Products'', a publication of the American Public Health
the American Public Health Association, 1790 Broadway, New Association, 1015 Fifteenth Street, York, NY
NW, Washington, DC 20005 B--Definitions
B--Definitions
We propose adding ``and accepted B2. Terms defined
B2. Terms defined
practices'' to the definition and (v) 3-A Sanitary Standards. The (v) 3-A Sanitary Standards. The
include both standards and accepted latest standards for dairy
latest standards for dairy
practices formulated by the 3-A equipment formulated by the 3-A equipment and accepted practices Sanitary Standards Committees. Sanitary Standards Committees
formulated by the 3-A Sanitary
Also, we propose to update the name representing the International
Standards Committees representing and address of the International Association of Milk, Food and
the International Association of Association for Food Protection and Environmental Sanitarians, the U.S. Food Protection, the Federal Food specifically identify the Federal Public Health Service, and the
and Drug Administration, and the Food and Drug Administration as a Dairy Industry Committee. Published Dairy Industry Committee. These participant in the development of by the International Association of standards are published by the
equipment standards and accepted Milk, Food and Environmental
International Association for Food practices established by the 3-A Sanitarians, Box 437, Shelbyville, Protection, 6200 Aurora Avenue, Sanitary Standards Committees. IN 46176
Suite 200W, Des Moines, IA 50322- 2863 B--Definitions
B--Definitions
We propose to modify the definition B2. Terms defined
B2. Terms defined
of sanitizing treatment to more (y) Sanitizing treatment.
(y) Sanitizing treatment. Subjection clearly and accurately define this Application of any effective method of a clean surface to steam, hot term and to provide greater or sanitizing agent to clean
water, hot air, or an acceptable consistency with the definition for surface for the destruction of
sanitizing solution for the
this term in other related pathogens and other organisms as destruction of most human pathogens documents. far as is practicable. The
and other vegetative microorganisms sanitizing agents used shall comply to a level considered safe for with the Federal Food, Drug, and product production. Such treatment Cosmetic Act
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
[[Page 20228]]
C--Quality Requirements for Milk for C--Quality Requirements for Milk for Since the last revision of the Manufacturing Purposes
Manufacturing Purposes
Recommended Requirements, the C3. Sediment Content Classification C3. Sediment Content Classification Department has decided to remove (a) Method of testing. Methods for (a) Method of testing. Methods for certain standards from the Code of determining the sediment content of determining the sediment content of Federal Regulations. The current the milk of individual producers the milk of individual producers wording in this document references shall be those described in the shall be those described in the the Code of Federal Regulations as latest edition of Standard Methods latest edition of Standard Methods the source for sediment standard for Examination of Dairy Products. for Examination of Dairy Products. information. We propose to correct Sediment content shall be based on Sediment content shall be based on this citation by providing current comparison with applicable charts comparison with applicable charts information where sediment of the United States Sediment
of the United States Sediment
standards can be obtained. Standards for Milk and Milk
Standards for Milk and Milk Products, 7 CFR Part 58, Subpart T, Products. These charts are Sec. 58.2728 through 58.2732
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 C--Quality Requirements for Milk for
A change in the model requirements Manufacturing Purposes
for Grade A milk no longer requires C7. Excluded Milk
a producer to review the ``Milk and (f) The producer is delinquent in
Dairy Beef Quality Assurance completing a review of the ``Milk
Program'' with a licensed and Dairy Beef Quality Assurance
veterinarian. We propose to delete Program'' with a licensed
this provision that results in the veterinarian following an
exclusion of milk from an occurrence of shipping milk testing
individual producer that has not positive for drug residue (sec.
completed this review. However, the C12.)
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 C. Quality Requirements for Milk for A change in the model requirements Manufacturing Purposes
Manufacturing Purposes
for Grade A milk no longer requires C10. Field Service
C10. Field Service
a producer to review the ``Milk and A representative of the plant shall A representative of the plant shall Dairy Beef Quality Assurance arrange to promptly visit the farm arrange to promptly visit the farm Program'' with a licensed of each producer whose milk tests of each producer whose milk tests veterinarian. Previously the positive for drug residue, exceeds positive for drug residue, exceeds Recommended Requirements mandated the maximum somatic cell count
the maximum somatic cell count
that a producer review this program level, exceeds the maximum
level, exceeds the maximum
under certain circumstances bacterial estimate, or does not bacterial estimate, or does not detailed in Section C7. The meet the requirements for
meet the requirements for
Department recognizes the acceptable milk. The purpose of the acceptable milk. The purpose of the educational benefits this program visit shall be to inspect the
visit shall be to inspect the
provides and proposes to include milking equipment and facilities, milking equipment and facilities, provisions for voluntary to offer assistance to improve the to offer assistance to improve the participation under Section C10. quality of the producer's milk, and quality of the producer's milk, and eliminate any potential cause of to eliminate any potential cause of drug residue. A representative of drug residue. A review of the the plant should routinely visit ``Milk and Dairy Beef Quality each producer as often of as
Assurance Program'' is one method necessary to assist and encourage that can be used to educate the the production of high-quality milk 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 C. Quality Reqirements for Milk for C. Quality Requirements for Milk for We propose to include the word Manufacturing Purposes
Manufacturing Purposes
``consecutive'' in the final C12. Drug residue level
C12. Drug residue level
sentence in this paragraph. This (a) Industry responsibilities
(a) Industry responsibilities
would clearly indicate that the (1) Sampling and testing program. (1) Sampling and testing program. random sampling for drug residues (ii) When so specified by the U.S. (ii) When so specified by the U.S. other than beta lactam are to be Food and Drug Administration (FDA), Food and Drug Administration (FDA), performed on at least four samples all milk shipped for processing, or all milk shipped for processing, or collected during a consecutive 6- intended to be processed on the intended to be processed on the month period. This change would farm where it was produced, shall farm where it was produced, shall provide greater consistency with be sampled and tested prior to
be sampled and tested prior to
Grade A provisions. processing, for other drug residues processing, for other drug residues under a random drug sampling
under a random drug sampling program. The random drug sampling program. The random drug sampling program shall include at least four program shall include at least four samples collected in at least 4 samples collected in at least 4 separate months during any 6-month separate months during any period
consecutive 6-month period
[[Page 20229]]
-
Quality Requirements for Milk for C--Quality Requirements for Milk for When the drug residue provision of Manufacturing Purposes
Manufacturing Purposes
the Recommended Requirements were C12. Drug residue level
C12. Drug residue level
initially included, the Grade A (a) Industry responsibilities
(a) Industry responsibilities
milk program allowed for the (1) Sampling and testing program. (1) Sampling and testing program. approval of test methods by the (iv) The dairy industry shall
(iv) The dairy industry shall
Virginia Polytechnic Institute and analyze samples for beta lactams analyze samples for beta lactams State University. Since that time and other drug residues by methods and other drug residues by methods this method of approval is no evaluated by the Association of which have been independently
longer specified. The proposed Official Analytical Chemists (AOAC) evaluated or evaluated by FDA and changes would provide greater and accepted by the FDA as
accepted by FDA as effective to consistency with information effective in determining compliance detect drug residues at current included in the Grade A milk with established ``safe levels'' or safe or tolerance levels. Safe and program. tolerances. ``Safe levels'' and tolerance levels for particular tolerances for particular drugs are drugs are established by the FDA. 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 We propose to include a provision Manufacturing Purposes
that all test results that do not C12. Drug residue level
test positive for drug residues be (1) Sampling and testing program. retained for a period of 6 months. (v) All sample test results for Currently Section C12(a)(4) of the milk that does not test positive Recommended Requirements stipulate shall be recorded, and test result that all test results be maintained records shall be retained for a for a period of 12 months. This period of six months
change would provide greater consistency with Grade A requirements. C--Quality Requirements for Milk for C--Quality Requirements for Milk for We propose to include the word Manufacturing Purposes
Manufacturing Purposes
``positive'' prior to ``sample'' in C12. Drug residue level
C12. Drug residue level
the second sentence of this (a) Industry responsibility
(a) Industry responsibility
paragraph. This change would relax (4) Sample and record retention. A (4) Sample and record retention. A the requirement that all test load sample that tests positive for load sample that tests positive for results be maintained for 12 months drug residue shall be retained for drug residue shall be retained
while ensuring that all positive a period of not less than 12 months according to guidelines established test results are retained for a by the appropriate State regulatory period of 12 months. The 12-month agency. The records of all positive retention for positive results is sample test results shall be
necessary in order to address retained for a period of not less producers that repetitively violate than 12 months
the drug residue provisions. This change would provide greater consistency with Grade A requirements. C--Quality Requirements for Milk for C--Quality Requirements for Milk for The proposed changes would provide Manufacturing Purposes
Manufacturing Purposes
greater consistency with C12. Drug residue level
C12. Drug residue level
information currently used in the (b) Regulatory agency responsibility (b) Regulatory agency responsibility Grade A milk program to analyze (1) Monitoring and surveillance. (i) (1) Monitoring and surveillance. (i) samples for drug residues by Each producer is included in a
Each producer is included in a
providing for test methods accepted routine, effective drug residue routine, effective drug residue by FDA as effective to detect drug milk monitoring program utilizing milk monitoring program utilizing residues at current safe or AOAC-evaluated and FDA-approved methods evaluated and found
tolerance levels. methods to test samples for the acceptable by FDA to test samples presence of drug residue
for the presence of drug residue C--Quality Requirements for Milk for We propose to incorporate Manufacturing Purposes
information that would support the C12. Drug residue level
requirements currently contained in (b) Regulatory agency responsibility section C12(a)(5)(iii) and direct (2) Enforcement. (i) Any time milk the regulatory agency to is found to test positive for drug immediately suspend the producer's residue, the regulatory agency
milk shipping privileges when a shall immediately take action to sample of milk tests positive. This suspend the producer's milk
change would provide greater shipping privileges to prevent the consistency with Grade A sale of milk from the producer
requirements. shipping milk testing positive for drug residue
[[Page 20230]]
C--Quality Requirements for Milk for We propose to incorporate Manufacturing Purposes
information that would support the C12. Drug residue level
requirements currently contained in (b) Regulatory agency responsibility section C12(a)(5)(iii) and provide (2) Enforcement. (ii) The producer's requirements to be met in order for milk shipping privileges may be a producer to resume shipping milk. reinstated when a representative This change would provide greater sample taken from the producer's consistency with Grade A milk, prior to commingling with any requirements. other milk, is no longer positive for drug residue C--Quality Requirement for Milk for C--Quality Requirements for Milk for We propose that the paragraph Manufacturing Purposes
Manufacturing Purposes
designation be changed without C12. Drug residue level
C12. Drug residue level
changing the information. (b) Regulatory agency responsibility (b) Regulatory agency responsibility (2) Enforcement. (i) A penalty
(2) Enforcement. (iii) A penalty sanctioned by the State regulatory sanctioned by the State regulatory agency shall be imposed on the
agency shall be imposed on the producer for each occurrence of producer for each occurrence of shipping milk testing positive for shipping milk testing positive for drug residue.
drug residue C--Quality Requirements for Milk for C--Quality Requirements for Milk for We propose that the mandatory review Manufacturing Purposes
Manufacturing Purposes
of the ``Milk and Dairy Beef C12. Drug residue level
C12. Drug residue level
Quality Assurance Program'' be (b) Regulatory agency responsibility (b) Regulatory agency responsibility deleted and that the information in (2) Enforcement. (ii) The producer (2) Enforcement. (iv) Whenever a this paragraph be modified to shall review the ``Milk and Dairy drug residue test is positive, an require an investigation be made to Beef Quality Assurance Program'' investigation shall be made to
determine the cause of the positive with a licensed veterinarian within determine the cause. Action shall drug residue test and that 30 days after each occurrence of be taken to prevent future
preventative measures be taken to shipping milk testing positive for occurrences
prevent future occurrences. The drug residue. A certificate
Department recognizes the confirming that the ``Quality
educational benefits this program Assurance Program'' has been
provides in educating milk reviewed shall be signed by the
producers and proposes to include responsible producer and a licensed
provisions for voluntary veterinarian. The appropriate State
participation under Section C10. regulatory agency shall be notified after the program has been reviewed C--Quality Requirements for Milk for C--Quality Requirements for Milk for We propose that the paragraph Manufacturing Purposes
Manufacturing Purposes
designation be changed without C12. Drug residue level
C12. Drug residue level
changing the information. (b) Regulatory agency responsibility (b) Regulatory agency responsibility (2) Enforcement. (iii) If a producer (2) Enforcement. (v) If a producer ships milk testing positive for ships milk testing positive for drug residue three times within a drug residue three times within a 12-month period, the appropriate 12-month period, the appropriate State agency shall initiate
State agency shall initiate administrative procedures to
administrative procedures to suspend the producer's milk
suspend the producer's milk shipping privileges, according to shipping privileges according to State policy
State policy E--Requirements for Licensed Dairy E--Requirements for Licensed Dairy We propose to update the information Plants
Plants
in this section to provide E1. General Requirements
E1. General Requirements
consistency with the proposed drug E 1.13 Plant records
E 1.13 Plant records
residue record keeping provisions (a) Sediment and bacterial test (a) Sediment, drug residue, and
of Section C12(a)(4). results on raw milk from each
bacterial test results on raw milk producer: Retain for 12 months. (1) from each producer: Retain for 12 Routine tests and monthly summary months. (1) Routine tests and of all producers showing number and monthly summary of all producers percent of total in each class, (2) showing number and percent of total Retests, if initial test places in each class, (2) Retests, if milk in a probationary status, (3) initial test places milk in a Rejections of raw milk over No. 3 probationary status, (3) Rejections in quality
of raw milk over No. 3 in quality, (4) Positive drug residue tests E--Requirements for Licensed Dairy We propose to update the information Plants
in this section to provide E1. General Requirements
consistency with the proposed drug E 1.13 Plant records
residue record keeping provisions (e) Drug residue test results for of Section C12(a)(1)(v). milk samples that do not test positive: Retain for 6 months
[[Page 20231]]
Authority: (7 U.S.C. 1621-1627)
Dated: April 3, 2001. Kenneth C. Clayton, Acting Administrator, Agricultural Marketing Service.
[FR Doc. 01-9623Filed4-19-01; 8:45 am]
BILLING CODE 3410-02-P
