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Procedures Governing the Cooperative State-Public Health Service/
Food and Drug Administration Program of the National Conference on Interstate Milk Shipments

 

 

2005 Revision

 

 

Includes the:

bullet CONSTITUTION AND BYLAWS OF THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS
bulletMEMORANDUM OF UNDERSTANDING BETWEEN THE U.S. FOOD AND DRUG ADMINISTRATION AND THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS
bulletRELATED DOCUMENTS

 

 

 

U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration
and the
National Conference on Interstate Milk Shipments

 

 

PREFACE

The safety of fluid milk and milk products shipped interstate as well as intrastate has been of major importance to both the dairy industry and regulatory agencies for many years. In 1946, the Conference of State and Territorial Health Officers requested the U.S. Public Health Service (PHS) to develop a plan for the certification of interstate milk shippers. Such a plan was developed and submitted to the States; however, at the time, few States were able to undertake the additional responsibilities involved. In 1949, the Association of State and Territorial Health Officers again requested PHS to assist the States with ensuring a safe milk supply. Similar demands were made by State Health Departments and State Agricultural Departments, Local Health Officials and representatives of the milk industry. In December 1949, representatives of several Midwestern States met in Indianapolis, Indiana, for the purpose of discussing the problems and determining whether some plan could be developed to address a more effective and efficient system of regulating the interstate shipment of milk and milk products. As a result, representatives of eleven (11) Midwestern States met in Chicago, Illinois, in February 1950, to investigate the problem and to arrange for a national conference.

This committee requested the Surgeon General of the United States to invite all States to have their representatives attend a National Conference in St. Louis, Missouri, June 1, 1950. Representatives of the dairy industry, State Health Departments and State Agricultural Departments, comprising 22 States and the District of Columbia, attended and participated in the Conference. As a result of the Conference and joint planning, certain basic conclusions and procedures were established to be used in developing and administering a voluntary Interstate Milk Shipper Certification Program that would provide Regulatory Agencies with reliable data on the safety of milk and milk products shipped in interstate commerce.

The procedures accepted by the first Conference in 1950 have been used to advantage by many States in developing sound, and more uniform, milk sanitation programs. They have also led to the development of a greater degree of reciprocity between States on acceptance of inspection and laboratory results. These procedures have also been used by many States as a basis of programs for the supervision and certification of intrastate milk sources.

The National Conference on Interstate Milk Shipments (NCIMS) has served as a model cooperative program between PHS/ Food and Drug Administration (FDA), the States and the dairy industry. It is a shining example of esprit de corps, and reflects the cooperative spirit of all those committed to ensuring a safe and wholesome supply of milk and milk products. A history of the NCIMS is available through the Executive Secretary of the NCIMS.

 

 

TABLE OF CONTENTS

PROCEDURES GOVERNING THE COOPERATIVE STATE-PUBLIC HEALTH SERVICE/FOOD AND DRUG ADMINISTRATION PROGRAM OF THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS

SECTION I.     PURPOSE

SECTION II.    SCOPE

SECTION III.   DEFINITIONS

SECTION IV.   OVERSIGHT AND RESPONSIBILITIES

SECTION V.    QUALIFICATIONS AND CERTIFICATIONS

SECTION VI.   STANDARDS

SECTION VII.  PROCEDURES GOVERNING A STATE's PARTICIPATION IN THE COOPERATIVE PROGRAM FOR CERTIFICATION OF IMS LISTED SHIPPERS

SECTION VIII.  PROCEDURES GOVERNING THE CERTIFICATION OF MILK PLANT, RECEIVING STATION AND TRANSFER STATION NCIMS HACCP SYSTEMS FOR IMS LISTED SHIPPERS 

SECTION IX.  APPLICATION OF CONFERENCE AGREEMENTS

 

ALSO INCLUDES:

CONSTITUTION OF THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS [See CONSTITUTION]

BYLAWS OF THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS
[See BYLAWS]

MEMORANDUM OF UNDERSTANDING BETWEEN THE U. S. FOOD AND DRUG ADMINISTRATION AND THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS

RELATED DOCUMENTS

 

Note:  This is an unofficial copy of the 2005 Revision of the Procedures.  The Constitution and Bylaws can be found elsewhere in this web site and are not actually included herein.  

PROCEDURES GOVERNING THE COOPERATIVE STATE-PUBLIC HEALTH SERVICE/FOOD AND DRUG ADMINISTRATION PROGRAM OF THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS

SECTION I.  PURPOSE
 

The Procedures document was established to develop a more uniform milk sanitation program. It establishes the criteria governing the Cooperative Program of the National Conference on Interstate Milk Shipments (NCIMS). As a result of these Procedures, there is a greater degree of reciprocity between States on acceptance of inspection and laboratory results.

Contained in this document are the Procedures for establishing milk sanitation standards, rating procedures, sampling procedures, laboratory procedures, laboratory evaluation and sample collector procedures. It also contains the Constitution of the NCIMS, the Bylaws of the NCIMS, the Memorandum of Understanding (MOU) Between the U. S. Food and Drug Administration and the NCIMS, and Related Documents.

This Procedures is the governing document of the NCIMS and contains the information necessary to maintain a national program that is both uniform and acceptable to the States, U. S. Public Health Service/Food and Drug Administration (PHS/FDA) and the dairy industry. It helps all concerned parties to assure a safe supply of milk and milk products to consumers.

SECTION II.  SCOPE
 
  1. PRODUCTS COVERED

    Agreements adopted by the NCIMS shall apply to Grade "A" raw milk for pasteurization, heat-treated products, pasteurized, ultra-pasteurized, and aseptically processed milk and milk products, condensed and dry milk products, and whey and whey products produced under the NCIMS program.
     

  2. SUPERVISION REQUIREMENTS

    Supervision of the milk supply, condensed and dry milk products, whey and whey products to be rated for interstate certification shall be based on the criteria and procedures for Grade "A" standards set forth in Section VI., and procedures for Grade "A" standards set forth in Section VI., E., or regulations pertaining to supervision substantially equivalent thereto.

    If a powdered blend is to be used as an ingredient in the production of a Grade "A" product from an IMS listed plant, the blend must be labeled Grade "A" and the plants where the Grade "A" dairy powder are manufactured and the facility where the powder is blended and packaged must each have an IMS listing.

     

SECTION III.  DEFINITIONS
 

Terms used in this document, not specifically defined herein, are those within Title 21, Code of Federal Regulations (CFR) and/or the Federal Food, Drug, and Cosmetic Act (FFD&CA) as amended.

  1. ADVERSE ACTION:  A re-inspection, re-rating or withdrawal of certification of an individual IMS listed shipper.

  2. AREA RATING:  An area rating, if used, shall apply to raw milk for pasteurization only. An area rating consists of more than one (1) producer group operating under the supervision of a single Regulatory Agency and which is rated as a single entity.

  3. BULK TANK UNIT (BTU):  A dairy farm or group of dairy farms from which raw milk for pasteurization is collected under the routine supervision of one (1) Regulatory Agency and rated as a single entity and given a sanitation compliance and enforcement rating.

  4. CERTIFIED MILK SANITATION RATING OFFICER (SRO):  A State employee who has been standardized by PHS/FDA, has a valid certificate of qualification, and does not have direct responsibility for the routine inspection and enforcement of the shipper to be rated. Directors, administrators, etc. may be certified as SRO's.

  5. CHECK RATING: The designated PHS/FDA and NCIMS Procedures method to ensure that the published State rating of a milk shipper on the IMS LIST -- Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) is valid and maintained during the interval between State ratings.

  6. DAIRY FARM:  A dairy farm is any place or premises where one (1) or more lactating animals (cows, goats, sheep, water buffalo, or other hooved mammal) are kept for milking purposes, and from which a part or all of the milk or milk product(s) is provided, sold or offered for sale to a milk plant, receiving station, or transfer station.

  7. ENFORCEMENT RATING: This is a measure of the degree to which enforcement provisions of the Grade "A" Pasteurized Milk Ordinance (Grade "A" PMO) are being applied by the Regulatory Agency.

  8. IMS LISTED SHIPPER: An interstate milk shipper (BTU, receiving station, transfer station, or milk plant) which has been certified by the State Milk Sanitation Rating Authorities as having attained the milk sanitation compliance and enforcement ratings necessary for inclusion in the IMS List. The ratings are based on compliance with the requirements of the Grade "A" PMO and were made in accordance with the procedures set forth in the Methods of Making Sanitation Ratings of Milk Supplies (MMSR).

  9. INDIVIDUAL RATING: An individual rating is the rating of a single producer group, receiving station, transfer station and/or milk plant under the supervision of a single Regulatory Agency.

  10. MEMORANDUM OF CONFERENCE ACTIONS (IMS-a):  A memorandum issued by PHS/FDA providing the transmittal of information related to the actions taken at NCIMS Conferences and between PHS/FDA and the NCIMS Executive Board.

  11. MEMORANDUM OF INFORMATION (M-I):  A memorandum issued by PHS/FDA providing the transmittal of administrative and miscellaneous information by PHS/FDA to PHS/FDA Regional staff and State agencies.

  12. MEMORANDUM OF INTERPRETATION (M-a):  A memorandum issued by PHS/FDA following the Procedures document, providing clarification of the intent or meaning of wording related to the Grade "A" PMO and the Evaluation of Milk Laboratories (EML).

  13. MEMORANDUM OF MILK ORDINANCE EQUIPMENT COMPLIANCE (M-b):  A memorandum issued by PHS/FDA that provides a notice of PHS/FDA's review of equipment related to compliance with the Grade "A" PMO.

  14. MILK PLANT: A milk plant is any place, premises, or establishment where milk or milk products are collected, handled, processed, stored, pasteurized, aseptically processed, packaged, or prepared for distribution.

  15. RECEIVING STATION: A receiving station is any place, premises, or establishment where raw milk is received, collected, handled, stored or cooled and prepared for further transporting.

  16. RECIPROCITY: For the purpose of the NCIMS agreements, reciprocity shall mean no action or requirements on the part of any Regulatory Agency will cause or require any action in excess of the requirements of the current edition of the Grade "A" PMO and related documents of the NCIMS agreements.

  17. REGULATORY AGENCY: A Regulatory Agency shall mean an agency which has adopted an ordinance, rule or regulation in substantial compliance with the current edition of the Grade "A" PMO or two (2) agencies which have mutually agreed to share the responsibilities for the enforcement of an ordinance, rule or regulation in substantial compliance with the Grade "A" PMO for a listed interstate milk shipper. The mutual agreement shall specify the details of how the rating will be made so long as the details do not conflict with the basic intent of this document.

  18. STATE PROGRAM EVALUATION: An evaluation of a State program by PHS/FDA. This shall include check ratings of IMS Listed Shippers, an assessment of State administrative procedures and records, adoption of the Grade "A" PMO (or equivalent laws and regulations), and compliance with NCIMS Procedures.

  19. TRANSFER STATION: A transfer station is any place, premises, or establishment where milk or milk products are transferred directly from one (1) milk tank truck to another.

SECTION IV.  OVERSIGHT AND RESPONSIBILITIES
 
  1. PHS/FDA RESPONSIBILITIES

    1. Standardization of Personnel

      PHS/FDA shall standardize at least every three (3) years the rating procedures of:

      a.  PHS/FDA Regional personnel who:

      1.)  Meet the qualification requirements of the PHS/FDA Milk Safety Program;

      2.)  Comply with the directives of the PHS/FDA Milk Safety Program as administered by the Milk Safety Team (MST): and

      3.)  Must not fail, without cause, to attend the FDA Regional Milk Seminar when offered, the PHS/FDA Regional Milk Specialists Conference, and attended at least one (1) training course on Special Problems in Milk Protection or other training courses judged by PHS/FDA to be equivalent.

      b.  SRO's who comply with Section V., D.

      c.  PHS/FDA shall standardize the evaluation procedures of State Milk Laboratory Evaluation Officers (LEO's) and State Sampling Surveillance Officers (SSO's).

    2. Training

      a.  The PHS/FDA shall extend to State Regulatory Agencies and educational institutions assistance in the training of representatives of State, Regional and Local Governmental Units, including Milk Sanitation Rating, Milk Laboratory Evaluation, Sampling Surveillance Officers and dairy industry personnel.

      b.  In order to coordinate ratings and evaluation procedures and interpretations, PHS/FDA shall sponsor seminars annually or biennially for the state milk rating and milk laboratory personnel in each of its regions. The content and agenda of the seminar shall be mutually concurred with by MST and appropriate PHS/FDA Regional milk personnel. Each seminar shall be open to representatives of State, Regional and Local Government Units, including SRO's, LEO's and SSO's. Dairy industry personnel should be permitted to attend appropriate sessions of such seminars.

      c.  PHS/FDA should provide consultation and training in order to correct any deficiency in State programs. Reasonable action must be taken to resolve any dispute between PHS/FDA and the State over interpretations and implementation of any program components.

    3. State Program Evaluations

      a.  A PHS/FDA Regional Milk Specialist shall conduct a triennial written program evaluation of the IMS program administered by each member State. This triennial written program evaluation will be submitted to the State Milk Regulatory Agency, the State Milk Rating Agency, if applicable, and MST and the Division of Federal-State Relations (DFSR).  The evaluation shall concentrate on the following areas:

      1.) The organizational structure or a review of the organizational changes, which may have occurred since the last triennial evaluation.

      2.) Identification of regulatory responsibilities:

      A.) Inspection procedures and follow-up,
      B.) Sample procedures and follow-up, and
      C.) Enforcement procedures.

      3.) State laws and regulations to include a review of State laws and regulations with an explanation of any areas not compatible with the Grade "A" PMO.

      4.) Identification of IMS responsibilities:

      A.) SRO's,
      B.) LEO's,
      C.) Sampling surveillance and SSO's,
      D.) Adherence to the Grade "A" PMO and attendant documents,
      E.) Reciprocity,
      F.) A summary and review of ratings and check ratings conducted within the triennial evaluation period, and
      G.) Summary and Conclusions.

      5.) Regulatory compliance with Appendix N of the Grade "A" PMO will be determined by the PHS/FDA Milk Specialist through check ratings or the triennial evaluation and will be reported as part of the written triennial evaluation. The review shall include:

      A.) Adequate proof of disposition of contaminated loads.

      A report signed by the Regulatory Agency or responsible industry person would be acceptable. The report shall include the following:

      1.) Name of the plant,
      2.) Date,
      3.) Tanker identification,
      4.) Test method used,
      5.) Time,
      6.) Results including clearing samples,
      7.) Disposition of milk,
      8.) Producer identification,
      9.) Confirmatory method and location,
      10.) Tester or supervisor identification, and
      11.) Signature of responsible person.

      B.) Adequate proof of producer follow-up and penalty shall be determined by:

      1.) A procedure to check for repeated violations within a twelve (12) month period,
      2.) Confirmation of action if two (2) or three (3) violations occur within a twelve (12) month period, and
      3.) Assessment of penalties should be determined by a review of documents produced in the normal course of business.

      6.) Regulatory compliance with Appendix B. and other Grade "A" PMO milk sampling, hauling, and transportation requirements will be determined by PHS/FDA and will be reported as part of the written triennial evaluation. This portion of the evaluation shall include a review of:

      A.) Milk Sampling:

      1.) SSO certifications,
      2.) Delegation of sampling surveillance authority,
      3.) Sampler training program,
      4.) Sampler evaluations (adequacy and frequency),
      5.) Observed sampling practices,
      6.) Sampling permit issuance and suspensions, and
      7.) Associated records.

      B.) Milk Hauling and Transportation:

      1.) The issuing of milk tank truck permits,
      2.) Milk tank truck inspection (adequacy and frequency),
      3.) Actions taken against those milk tank trucks or milk transportation companies not in compliance,
      4.) Forwarding results of milk tank truck inspections, performed on milk tank trucks permitted by another Regulatory Agency, to that Regulatory Agency in a timely manner,
      5.) Follow-up actions taken when a violative milk tank truck inspection report is received from another Regulatory Agency regarding a milk tank truck permitted by this Regulatory Agency,
      6.) Inspection, enforcement and permitting program for unattached milk tank truck cleaning facilities, and
      7.) Adequacy of associated records.

      b.  Any State in substantial non-compliance as determined by PHS/FDA will be referred to the NCIMS Executive Board for determination of listing on a separate page in the IMS List. The State, upon notification of PHS/FDA and the Executive Board will have an opportunity to address the Executive Board to explain why they believe they should not be so listed. If such listing is required, annual evaluations shall be conducted until substantial compliance, as determined by PHS/FDA, is achieved. Any State not in substantial compliance a second consecutive year will be notified by PHS/FDA and provided an opportunity for a hearing by the NCIMS Executive Board. The NCIMS Executive Board, as a result of the hearing, may determine that the State should not be an active participant in future NCIMS Conferences until substantial compliance is achieved.

    1. Laboratory Evaluations

      a.  PHS/FDA shall evaluate and approve the laboratory facilities and procedures of State laboratory approval agencies to assure compliance with FDA-2400 series evaluation forms and, where appropriate, the current edition of Standard Methods for the Examination of Dairy Products (SMEDP) and Official Methods of Analysis of the AOAC INTERNATIONAL (OMA).

      b.  PHS/FDA shall periodically evaluate milk laboratories of participating States to assure compliance with FDA-2400 series evaluation forms, and where appropriate, the current edition of SMEDP and OMA.  Evaluations conducted during the recertification of LEO's shall be submitted, but it shall be the option of the LEO as to whether or not the evaluation is submitted for official action regarding laboratory status.
       
    2. Electronic Publication of Sanitation Compliance and Enforcement Ratings

      a.  PHS/FDA shall provide an electronic publication of the IMS List on their web site.  The electronic IMS List is available at http://www.cfsan.fda.gov/~ear/ims-toc.html.  The sanitation compliance and enforcement ratings of Regulatory Agencies contained in the electronic publication are certified by the State Rating Agency to be those established by ratings conducted in accordance with the MMSR by certified SRO's when the Form FDA 2359i-INTERSTATE MILK SHIPPER's REPORT is signed and submitted to the PHS/FDA Regional Office for publication.

      Transfer stations, receiving stations and dairy plants must achieve a sanitation compliance rating of 90 or better in order to be eligible for a listing in the IMS List.  Sanitation compliance rating scores for transfer and receiving stations and dairy plants will not be printed in the IMS List

      PHS/FDA shall update the IMS List not less than monthly.

      b.  PHS/FDA shall list ratings only from States and/or shippers, which are in substantial compliance with the Procedures.

      c.  The IMS List shall identify those shippers located in States where complete reciprocity as defined in Sections VI., A. and B., is not recognized by the State, Regional and/or Local Regulatory Agency.

      d.  PHS/FDA shall identify in the IMS List milk laboratories approved by PHS/FDA Laboratory Quality Assurance Team  (LQAT) or State Milk Laboratory Control Agencies to perform official examinations of Grade "A" raw milk and milk products, condensed and dry milk products, and whey and whey products; as well as milk containers and closures.

    3. Electronic Publication of Qualified PHS/FDA Milk Specialists and State Personnel

      a.  PHS/FDA shall provide a list of PHS/FDA Regonal Milk Specialists and SRO's whose rating methods and interpretations of the PHS/FDA recommended Grade "A" PMO have been evaluated and certified by PHS/FDA in the IMS List.

      b.  PHS/FDA shall provide a list of LEO's whose competence in interpreting and evaluating milk laboratory methods have been evaluated and certified by the PHS/FDA LQAT in the IMS List.

      c.  PHS/FDA shall provide a list of SSO's whose competence in interpreting and evaluating the sample collection and hauling procedures and practices of sample collectors have been evaluated and certified by PHS/FDA in the IMS List.


    4. Interpretations and Editorial Updates

      a. Interpretations of the PHS/FDA recommended Grade "A" PMO and related documents as referenced in Section VI. of these Procedures shall be issued to the State Milk Regulatory and Rating Agencies in accordance with the following procedure: 

      Procedure for Issuing Interpretations of the Grade "A" PMO and Related Documents

      1. PHS/FDA is requested or determines the necessity to issue an M-a.
      2. PHS/FDA develops the M-a, with a proposed implementation date, after seeking input from appropriate sources.
      sources.

    5. 3. PHS/FDA Division of Federal-State Relations (DFSR) disseminates the M-a to all State Milk Regulatory and Rating Agencies and the Executive Board with provisions for a thirty (30) day written comment period from the date of dissemination.
      4. All comments shall be submitted to the Executive Secretary, NCIMS Executive Board.
      5. The Executive Secretary shall forward comments to PHS/FDA, MST, and the Executive Board within thirty (30) days of the end of the comment period.
      6. The NCIMS Executive Board may, within sixty (60) days of the dissemination of the M-a, with the majority of the Board consenting, request PHS/FDA to consider modifying the M-a.
      7. Within ninety (90) days of the dissemination of the M-a, PHS/FDA shall provide to the NCIMS Executive Secretary sufficient copies of each M-a for submission to the NCIMS voting delegates for their approval or disapproval.  After receipt from PHS/FDA of the M-a, the NCIMS Executive Secretary shall forward within thirty (30) days a copy of the M-a to the current NCIMS voting delegates, along with a ballot and instructions for returning their vote.  The Executive Secretary shall include a copy of the comments and the minutes covering the discussion between PHS/FDA and the Executive Board.  All ballots shall contain a date thirty (30) days from the date the ballot was mailed or sent (if by other means) by which time, the ballot must be received by the NCIMS Executive Secretary to be counted.
      8. The NCIMS Executive Secretary may use any available method for delivering copies of each M-a and the voting ballots including, but not limited to: (i) the mail; (ii) private carriers; (iii) facsimile; (iv) email; or (v) other electronic means.  The Executive Secretary has fifteen (15) days from the end of the voting period to forward the results (votes per State) to PHS/FDA.
      9. No M-a shall become effective unless it receives the approval from a simple majority of the returned ballots of the NCIMS voting delegates.
      10. PHS/FDA shall, at the next duly convened Conference, submit a Proposal, incorporating the requirements of any M-a, issued between Conferences, into the appropriate document(s).

      NOTE:  In the event of a public health emergency, PHS/FDA shall exercise its authority to protect the public health under the provisions of the FFD&CA and the Public Health Service Act.  Federal regulations that impact the regulation of the Grade "A" dairy industry are not subject to this "Procedure for Issuing Interpretations".

      b. After each Conference and/or request by the NCIMS Executive Board, PHS/FDA shall incorporate editorial updates into the Grade "A" PMO, the MMSR, the Procedures, and the EML in accordance with the guidelines to be developed jointly by PHS/FDA and the NCIMS Executive Board.
    6. Check Ratings of the Sanitation Compliance Status of Listed Interstate Shippers

      a. PHS/FDA shall conduct, each year, check ratings of the sanitation compliance status of listed interstate milk shippers.  Within a State, check ratings will be made of a representative number of IMS Listed shippers.  The selection of shippers for check rating in a given State will be made randomly.

      b. In order to make effective use of Regional Office personnel, the random selection of shippers to be check rated will be selected in advance and assignments scheduled in each State.  Selection of farms will be made from records provided at the time of the check rating.

      c. The number of shippers selected for check rating will be based on consideration of the number of shippers in the State as well as the demonstrated validity of the State program. Validity will be measured by estimating the number of adverse actions (re-inspections, re-ratings, or withdrawals of certification) in the States based on the results of previous check ratings. This approach will shift attention from States with demonstrated validity to problem States while still preserving an adequate level of monitoring.

      d. In no case can a check rating be made with greater frequency than the official rating.

      e. For action to be taken if the PHS/FDA check rating indicates the listed rating is not justified, refer to Section IV., B., 6.c. For the purpose of these Procedures and all related forms, the terms "listed rating", "official rating" and "published rating" shall mean the most recent rating, which is accompanied by written permission by the shipper to publish, and submitted to the PHS/FDA Regional Office by the State Milk Sanitation Rating Agency.

      f. Except as provided in Section IV., B., 6.c., the PHS/FDA shall release the detailed results of its check ratings of listed individual interstate shippers only to the State Milk Sanitation Rating Agency which originally certified the shipper for listing and the State Regulatory Agency.

      g. Enforcement ratings will be made as part of check ratings.

  1. STATE RESPONSIBILITIES

    1. State Ratings

      a.  The State Rating Agency of the shipping State shall certify the results of ratings of each interstate milk shipper to the appropriate PHS/FDA Regional Office which, in turn, will transmit the ratings to the PHS/ FDA Headquarters Office for inclusion in the IMS List.  (Refer to Section IV., A., 5.)  The rating results, together with other pertinent information, shall be forwarded on an appropriate form (Form FD 2359i).

      b.  If both an area and individual rating are available on an individual supply of milk, the most recent rating of the two (2) shall be reported.  The Rating Agency shall immediately send a completed copy of Form FDA 2359i to the State Regulatory Agency upon completion of any milk sanitation rating.

      c.  When the sanitation compliance status of a listed shipper's supply changes as a result of a new rating made within the twenty-four (24) month eligibility period, the most recent rating, including enforcement rating, shall apply and shall be submitted to PHS/FDA.

      d.  When a certified interstate milk shipper's supply, raw or pasteurized, changes status because of degrading, permit revocation, significant change in number of producers, or change in the sanitation compliance or enforcement rating to less than ninety (90), the shipping State shall immediately notify all known receiving States and the appropriate PHS/FDA Regional Office.

      e.  When an existing rating is no longer valid because a listed milk plant, receiving station and/or transfer station's permit is revoked, the State shall within five (5) days request PHS/FDA to remove the listing.

      f.  Receiving States shall notify shipping States of any irregularities in the supply received. (Refer to Section IV., B., 6.).

      g.  The Rating Agency shall furnish Regulatory Agencies with interpretations of the PHS/FDA recommended Grade "A" PMO and rating procedures received from PHS/FDA.

      h.  The Rating Agency shall keep current the ratings of all certified shippers within its State.

      i.  The Rating Agency shall certify U. S. manufacturers of containers and closures in accordance with Appendix J. STARDARDS FOR THE FABRICATION OF SINGLE-SERVICE CONTAINERS AND CLOSURES FOR MILK AND MILK PRODUCTS in the Grade "A" PMO for inclusion in the IMS List.

    2. Enforcement Ratings

      Enforcement ratings shall be conducted as part of milk sanitation ratings.

    3. Lab Evaluation

      a.  If written split sample results of the laboratories/Certified Industry Supervisor (CIS) used by certified interstate milk shippers are not received by PHS/FDA LQAT within sixteen (16) months of the last previous split sample date, PHS/FDA LQAT will notify the appropriate PHS/FDA Regional Office in writing to send a written withdrawal of the accreditation of the laboratory(ies) concerned. A copy of the PHS/FDA Regional Office notice to the State Milk Laboratory Control Agency to withdraw accreditation shall be sent to the State Regulatory and/or Rating Agency. The State Milk Laboratory Control Agency shall then inform the laboratory(ies) and the Regulatory Agency and/or Rating Agency in writing of the action.

      b.  If written results of the official evaluations are not received by PHS/FDA LQAT within twenty-six (26) months of the previous evaluation date, PHS/FDA LQAT will notify the appropriate PHS/FDA Regional Office, in writing, to inform the State Milk Laboratory Control Agency to send a written withdrawal of accreditation of the laboratory(ies) concerned. A copy of the PHS/FDA Regional Office notice to the State Milk Laboratory Control Agency to withdraw accreditation shall be sent to the Regulatory Agency and/or Rating Agency. The State Milk Laboratory Control Agency shall then inform the laboratory(ies) and the Regulatory Agency, and/or Rating Agency, in writing, of the action.

    4. Response to State Program Evaluations

      The State shall cooperate with PHS/FDA in order to correct any deficiencies in State programs, including regulatory, rating and laboratory.

    5. Reports to Database

      State Regulatory or Rating Agencies shall submit drug residue summary data to a third party database.

    6. Challenges and Remedies

      a.  Complaints from Receiving States and Municipalities

      1.) Complaints as to the sanitary quality of milk being received and challenges of validity of certified ratings shall be made in writing by the receiving State or municipality to the Rating Agency of the shipping State, with a copy to the appropriate PHS/FDA Regional Office.

      2.) The written complaint or challenge shall provide specific and factual information, such as violation of bacterial counts and cooling temperature, adulteration, improper heat treatment, or non-conformance with other requirements, changes in sanitation status of supply, etc. The written complaint shall specifically verify that all sampling and testing procedures, used in the determination of changes in sanitation status of the supply, have been conducted in accordance with the laboratory procedures specified in Section VI., G. and I.

      3.) The Rating Agency of the shipping State shall make a preliminary investigation of the complaints within fifteen (15) days and notify the receiving State in writing of the action being taken, with a copy to the appropriate PHS/FDA Regional Office.

      4.)  After an investigation, and based on the facts disclosed, the shipping State shall:

      A.) Notify the receiving State(s) and appropriate PHS/FDA Regional Office that the complaint was resolved.

      B.) Withdraw the certification of the shipper and notify the receiving State(s) and appropriate PHS/FDA Regional Office of such action; or

      C.) Make a new rating within sixty (60) days and, with the written permission of the shipper, forward the new rating and a copy of the shipper's written permission to the appropriate PHS/FDA Regional Office for listing in the  IMS List. The receiving State(s) shall also be notified of the action being taken by the shipping State.

      5.)  If the Rating Agency of the shipping State for any reason cannot make a prompt investigation called for in 6.a.3.) above, or the new rating called for in 6.a.4.) above, it shall:

      A.) Notify PHS/FDA and the State making the complaint. Such notification shall be considered by PHS/FDA as tantamount to withdrawal of the present State certification of the interstate shipper involved.

      B.) Notify the shipper involved, and any other interested parties,