[Federal Register Volume 66, Number 77 (Friday, April 20, 2001)]
[Notices]
[Pages 20226-20231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9623]


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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.

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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

[[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
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         Current Requirement                        Proposed                             Discussion
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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]]

 
C. 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. 01-9623 Filed 4-19-01; 8:45 am]
BILLING CODE 3410-02-P