Procedures

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:

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

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

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.
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.

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

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. 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.

STATE RESPONSIBILITIES

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.

Enforcement Ratings

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

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.

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.

Reports to Database

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

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, that in accordance with Conference agreements, the current State certification is being withdrawn until such time as the complaint may be investigated or a new rating made.

b. Complaints From Shipping States and Municipalities

1.) Complaints from shipping States and municipalities shall be made in writing to the Rating Agency of the receiving State(s), with a copy to the appropriate PHS/FDA Regional Office.

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

c. Action to be Taken if the PHS/FDA Check Rating Indicates the Listed Rating is Not Justified.

1.) Producer Dairies (Raw Milk)

A.) Action to be Taken

The following table shall be used to determine action to be taken if the PHS/FDA raw milk sanitation compliance rating from a check rating indicates the listed raw milk rating is not justified:

PRODUCER DAIRIES (RAW MILK)

LISTED RATING	RE-RATING	WITHDRAW CERTIFICATION
100 to 90	84 to 80	79 or less
89 to 84	83 to 80	79 or less
83	82 to 80	79 or less
82	81 to 80	79 or less
81 or less	80	79 or less

B.) Re-Rating

When check rating data indicates that the sanitation compliance rating of a listed shipper's producer dairies requires a re-rating, PHS/ FDA shall formally notify the State Rating Agency that a re-rating of producer dairies will be required within sixty (60) days.

C.) Withdrawal of Certification

When check rating data indicates that the sanitation compliance rating of a listed shipper's producer dairies requires a withdrawal of certification, the State Rating Agency, upon written recommendation of the PHS/FDA, shall immediately withdraw the current certification of the shipper and notify such shipper, PHS/FDA, and all known receiving States thereof, in accordance with Section IV., B., 1.d. In case of withdrawal, a new rating shall be made in not less than thirty (30) days and not to exceed sixty (60) days, unless the State Rating Agency has reason to believe a new rating within a lesser time period, would result in an acceptable rating. The effective date for action shall be determined from the date of the letter of notification by the State Rating Agency. Such letter shall be dated within five (5) working days following the date of the official notification.

2.) Milk Plants, Receiving Stations and/or Transfer Stations

A.) Action to be Taken

The following table shall be used to determine action to be taken if the PHS/FDA sanitation compliance rating from a check rating of a milk plant, receiving station and/or transfer station indicates the listed rating is not justified:

MILK PLANTS, RECEIVING STATIONS AND/OR TRANSFER STATIONS

LISTED RATING	REINSPECTION	WITHDRAW CERTIFICATION
100 to 90	80	79 or less

B.) Reinspection

When check rating data indicates that the sanitation compliance rating of the milk plant, receiving station and/or transfer station requires a reinspection, PHS/FDA shall formally notify the State Rating Agency that a reinspection of the plant, receiving station and/or transfer station will be required within thirty (30) days. If the reinspection indicates a level of sanitation compliance below that of the published rating, the State Rating Agency shall submit such new rating for publication, provided that if the reinspection indicates a level of sanitation compliance equal to or better than the published rating, the PHS/FDA Regional Office shall be so advised by the State Rating Agency and no further action will be necessary.

C.) Withdrawal of Certification

When check rating data indicates that the sanitation compliance rating of a milk plant, receiving station and/or transfer station requires a withdrawal of certification, the State Rating Agency, upon written recommendation of PHS/FDA, shall immediately withdraw the current certification of the shipper and notify such shipper, PHS/FDA, and all known receiving States thereof, in accordance with Section IV., B., 1.d. In case of withdrawal, a new rating shall be made in not less than thirty (30) days and not to exceed sixty (60) days, unless the State Rating Agency has reason to believe a new rating within a lesser time period would result in an acceptable rating. The effective date for action shall be determined from the date of the letter of notification by the State Rating Agency. Such letter shall be dated within five (5) working days following the date of the official notification.

3.) If a Rating Agency fails to take the required action outlined in Section IV., B., 6.c.1.) and 6.c.2.), calling for immediate notification of all known receiving States when current certification of a listed shipper is to be withdrawn as recommended by PHS/ FDA, PHS/FDA after a reasonable lapse of time (not to exceed five (5) days), shall provide all participating States with the check-rating scores. The State which failed to take the required action shall be identified in the next listing of the IMS List as not being in compliance with Section IV., B., 6.c.1.) and 6.c.2.).

4.) Should the Rating Agency indicate that it is not in a position to make a new rating within a sixty (60) day period or a reinspection within thirty (30) days, PHS/FDA shall identify those States in the next listing of the IMS List as not being in compliance with the provisions of this paragraph.

5.) If the Rating Agency informs PHS/FDA that it is unable to make arrangements for PHS/FDA to check rate the sanitation compliance status of listed shippers, PHS/FDA shall identify those States in the next listing of the IMS List as not being in compliance with the provisions of this paragraph.

6.) If a Rating Agency fails to request removal of a milk plant, receiving station and/or transfer station from the IMS List as provided for in Section IV., B., 1.e., PHS/FDA shall, after five (5) days, provide this information to all receiving states.

SECTION V. QUALIFICATIONS AND CERTIFICATIONS

SUPERVISION REQUIREMENTS
1. Supervision of the milk supply, 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.
2. The shipper to be rated shall be under the full-time supervision of a State, Regional or Local Milk Sanitation Control Agency.
3. Sampling procedures and laboratory examinations are a fundamental and basic component of supervision. The surveillance of sample collection procedures shall be conducted as prescribed in the EML. Samples from each dairy farm and each pasteurization plant shall be examined for the prescribed tests at the frequency prescribed in the PHS/FDA recommended Grade "A" PMO.
PROCEDURES FOR REQUESTING A MILK SANITATION RATING

A shipper desiring a rating of their supply for the purpose of interstate certification shall submit a request to the Rating Agency in their own State.
COMPLIANCE AND ENFORCEMENT RATINGS REQUIRED

Ratings to be made on each shipper who desires certification shall include:

Sanitation compliance rating on producer farms, transfer stations, receiving stations, pasteurization plants, condensed and dry milk plants and whey plants.
Enforcement rating of the supervising agency.

MILK SANITATION RATING PERSONNEL

Milk sanitation compliance and enforcement ratings and certification of U.S. manufacturers of containers and closures for milk and milk products shall be made by qualified SRO's who:

Have been standardized by PHS/FDA as a SRO and hold a valid certificate of qualification in one (1) or any combination of the following areas: milk pasteurization plants, dairy farms and transfer/receiving stations. Certification of a SRO shall qualify that SRO to perform ratings in any State, upon the request of that State's Regulatory/Rating Agency as long as the Officer's certification is valid.
Have, during the three (3) year period for which standardized, participated in at least one (1) Regional Milk Seminar and, in addition, attended at least one (1) training course on Special Problems in Milk Protection or other training courses judged by PHS/FDA to be equivalent.
Do not have direct responsibility for the routine inspection and enforcement of the supply to be rated. Directors, administrators, etc. may be certified as SRO's.

DRUG RESIDUE COMPLIANCE

A shipper desiring a rating of their supply shall comply with Appendix N of the Grade "A" PMO.
SAMPLING SURVEILLANCE PERSONNEL

Evaluation of sampling practices shall be made by qualified SRO's, LEO's, and, when necessary, State Regulatory Supervisors. All sampling surveillance personnel shall meet the following requirements:

a. Be standardized and certified by PHS/FDA as SSO's.

b. Hold a valid certificate of qualification for a SRO, LEO, or, in the case of a State Regulatory Supervisor, hold a valid certificate as a SSO.
The SSO may delegate the inspection of bulk milk haulers/samplers, who collect samples of raw milk for pasteurization from individual producers, to other qualified State, Regional or Local Regulatory Agency personnel or certified industry personnel as outlined in Section 5 of the Grade "A" PMO.

The SSO may delegate the inspection of Dairy Plant Samples and Industry Plant Samplers to other qualified State, Regional, or Local Regulatory Agency personnel.

In all cases, documentation of delegation is required and records of individual evaluations must be reported as required by Section 8 of the EML, and a copy kept on file by the appropriate State Agency.

MILK LABORATORY EVALUATION PERSONNEL

Milk laboratory evaluations may be made in any State, upon the request of that State's Regulatory Agency, and shall be made by qualified LEO's who:
1. Have been standardized and approved by PHS/FDA as a LEO.
2. Hold a valid certificate or provisional endorsement of qualification.
3. Must not fail, without cause, to attend the PHS/ FDA Regional Milk Seminar, when offered, and, in addition, attended at least one (1) Milk Laboratory Evaluation Officer's Workshop or other training courses judged by PHS/FDA LQAT to be equivalent.
THE HEARING PROCEDURE FOR REVOKING THE CERTIFICATION OF A SRO, SSO, OR LEO
1. Certification Hearing Panel Members
  
  Representatives from the following organizations will comprise the Certification Hearing Panel
  
  a. The Regional Food and Drug Director or designee.
  
  b. The Director of the DFSR or designee.
  
  c. The Director of the Division of Cooperative Programs or designee.
2. Notification of Intent to Revoke FDA Certification and an Opportunity for a Hearing
  
  If the FDA Standard (Regional Milk Specialist or member of LQAT, respectively) makes an initial determination to revoke certification, FDA will notify the SRO, SSO, or LEO in writing of its intent to revoke his or her certification. The notification shall specify:
  
  a. The facts and the reasons that are the basis for the revocation;
  
  b. Deadline for submitting a request for a hearing;
  
  c. Where to send a request for a hearing; and
  
  d. The date revocation will be effective if a hearing is not requested.
3. Request for a Hearing
  
  The SRO, SSO, or LEO, after being notified of FDA's intent to revoke his or her certification, may request a hearing. This request must be received by the Director of the Division of Cooperative Programs within fifteen (15) days of the date the SRO, SSO, or LEO receives written notification of the intent to revoke certification. The hearing request must identify one or more substantial issues of fact for which a hearing is requested.
  
  Within fifteen (15) days after the receipt of a timely request for a hearing, the Certification Hearing Panel will determine whether the material submitted by the SRO, SSO, or LEO raises any genuine and substantial issues of fact relevant to whether certification should be revoked.
  
  If the Certification Hearing Panel determines that the material submitted by the SRO, SSO, or LEO does not raise any genuine and substantial issue of fact, the request for the hearing will be denied. The Certification Hearing Panel will notify the SRO, SSO, or LEO of the decision in writing, and the revocation of the certification shall be effective immediately. If the Certification Hearing Panel determine that the material submitted by the SRO, SSO, or LEO raises one or more genuine and substantial issues of fact, the Certification Hearing Panel will notify the SRO, SSO, or LEO and the FDA Standard in writing that a hearing will be held.
4. Hearings
  
  The hearing will take place at a time, location and manner (in person or via teleconference) agreed upon by the SRO, SSO, or LEO, the FDA Standard, and the Certification Hearing Panel. If an agreement cannot be reached, the hearing shall take place at a reasonable time, location, and manner as determined by the Certification Hearing Panel.
  
  At a hearing, the FDA Standard will first give a statement of the proposed revocation, including the reasons supporting it, and may present relevant oral or written information. The SRO, SSO, or LEO may then present any oral or written information relevant as to why certification should not be revoked. The hearing is informal in nature, and the rules of evidence do not apply. If either party requests that the proceeding be transcribed, the requesting party will be responsible to cover all cost associated with the request.
  
  The Certification Hearing Panel will have the opportunity to request the FDA Standard, the SRO, SSO, or LEO, and any witnesses.
5. Decision
  
  Any time after a hearing is requested, the Certification Hearing Panel may issue a summary decision on any issue in the hearing if the Certification Hearing Panel determines from material submitted in connection with the hearing or from matters officially noticed, that there is no genuine and substantial issue of fact respecting that issue.
  
  The Certification Hearing Panel will make a written decision whether to revoke the certification of the SRO, SSO, or LEO. All relevant written material presented at the hearing will be attached to the decision. The Certification Hearing Panel may uphold or reverse the initial determination to revoke certification or may resolve the issues presented at the hearing in another manner, such as by developing an action plan with requirements for the SRO, SSO, or LEO to retain certification.
  
  Decisions of the Certification Hearing Panel shall require a simple majority vote of its members. Decisions of the Certification Hearing Panel are FDA's final decision on the matter.
AREA RATINGS
1. Area ratings shall be made at a frequency of not less than once every twenty-four (24) months.
2. If a shipper's supply is included in an area rating which is ninety percent (90%) or more, the shipper may be listed without an individual rating, provided that an individual rating shall be furnished upon request of the receiving State(s) or Local jurisdiction(s).
INDIVIDUAL RATINGS
1. Individual ratings shall be made at a frequency of not less than once every twenty-four (24) months.
2. If an IMS listed shipper scores less than ninety (90), a re-rating shall be conducted after written notification from an authorized representative of the IMS listed shipper to the Rating Agency that the IMS listed shipper is in substantial compliance. A re-rating shall be completed in no more than fifteen (15) days, from the date of receipt of the notification, unless the Rating Agency has a reason to believe a new rating within a lesser time would result in an acceptable rating.
RE-RATINGS

Whenever a rating results in a request for a re-rating, the effective date for the re-rating shall be determined from the date of the letter of notification by the Rating Agency. Such letter is to be dated within five (5) working days following the date of the rating.

DENIAL OF RATINGS

Requests for ratings of shippers, which are not under supervision as described in Section V., A., shall be denied.

SECTION VI. STANDARDS

POINTS BEYOND THE LIMITS OF THE ROUTINE INSPECTIONS

Milk and milk products from points beyond the limits of the routine inspection shall be acceptable under the principles of reciprocity for sale in the State or Local area concerned, provided they are produced and pasteurized under regulations which are substantially equivalent to the current edition of the Grade "A" PMO and have been awarded an acceptable milk sanitation compliance and enforcement rating by a SRO certified by PHS/FDA.
RECIPROCITY FOR THE PURPOSE OF NCIMS AGREEMENTS

Reciprocity for the purpose of NCIMS agreements shall mean that 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.
PROCEDURES PURPOSE IN THE DISTRICT OF COLUMBIA AND EACH PARTICIPATING U. S. TRUST TERRITORY

For the purpose of these Procedures and NCIMS in total, the District of Columbia and each participating U.S. Trust Territory shall be considered as a State with all the rights, duties, responsibilities, and privileges of a State.
PROCEDURES PURPOSE IN EACH PARTICIPATING NON-U. S. COUNTRY OR POLITICAL SUBDIVISION

For the purpose of these Procedures and NCIMS in total, each participating non-U. S. country or political subdivision thereof shall be considered as a State with all the rights, duties, responsibilities, and privileges of a State, providing the governing regulatory body of such non-U. S. country or political subdivision thereof shall meet the requirements of Part A. of this Section by establishing a MOU with PHS/FDA, which provides an acceptable basis for NCIMS to verify equivalence in the State or Local area concerned.

The determination that a foreign country's public health regulatory program and the government oversight of that program has an equivalent effect on the safety of the regulated milk or milk product is the responsibility of PHS/FDA. PHS/FDA will confer with NCIMS prior to finalizing a determination of equivalence. The foreign government must provide adequate assurance that the level of public health protection provided by the NCIMS program is met. When PHS/FDA determines that a foreign country's milk regulatory program is equivalent, PMO defined milk and milk products from that country are accepted in the IMS program.
MILK SANITATION STANDARDS

The current edition of the Grade "A" PMO shall be used as the basic sanitation standards in making milk sanitation compliance ratings of interstate milk shippers.
RATING PROCEDURES

The procedures outlined in the current edition of the PHS/FDA recommended MMSR shall be used in determining compliance with sanitation provisions and enforcement procedures contained in the applicable Standards specified in A. through E. above.
SAMPLING PROCEDURES

Sampling procedures used to collect milk and milk products of interstate milk shippers, as well as pasteurized milk and milk product containers and closures, shall conform substantially to the procedures in the current edition of SMEDP, published by the American Public Health Association.
LABORATORY EVALUATION AND SAMPLE COLLECTOR PROCEDURES

The procedure outlined in the current edition of the PHS/FDA EML shall be used in determining compliance with the laboratory and sample collector provisions and enforcement procedures contained in the applicable Standards specified in E. above.
LABORATORY PROCEDURES

Laboratory procedures used to examine milk and milk products of interstate milk shippers shall conform to the procedures in the current edition of SMEDP, published by the American Public Health Association, and the OMA. Vitamin testing shall be performed using test methods acceptable to PHS/FDA and other official methodologies that give statistically equivalent results to the PHS/FDA methods.

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

STATE PROGRAM EVALUATIONS

PHS/FDA shall evaluate the inspection, supervisory, and rating work of Regulatory and Rating Agencies triennially to determine whether milk regulations are being interpreted and enforced in accordance with the provisions of the Grade "A" PMO.
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 NCIMS Executive Board will have an opportunity to address the NCIMS 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.

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

PURPOSE AND SCOPE
1. Purpose
  
  Contained in this Section are the Procedures for establishing milk sanitation standards and HACCP listing procedures.
2. Products Covered Under HACCP Listings
  
  Agreements adopted by the NCIMS shall apply to Grade "A" raw milk and milk products 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. Listings made under the voluntary HACCP listing system described in this Section, may be made for milk plants, receiving stations and transfer stations.
3. Supervision Requirements
  
  Supervision of the milk supply, condensed and dry milk products, whey and whey products to be HACCP listed 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.
HACCP DEFINITIONS
In addition to the definitions in Section III the following shall apply to Milk Plants, Receiving Stations and Transfer Stations with HACCP Systems regulated under Appendix K. of the Grade "A" PMO.
1. AUDIT: An evaluation of the entire milk plant, receiving station, or transfer station facility, and HACCP System to ensure compliance with the HACCP System and other NCIMS regulatory requirements.
2. CRITICAL LISTING ELEMENT (CLE): An item on the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT identified with a double star (**). The marking of a CLE by a SRO or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk or milk product safety, or that violate NCIMS requirements regarding drug residue testing and trace back or raw milk sources, whereby a listing may be denied or withdrawn.
3. FDA AUDIT: An evaluation conducted by FDA of the entire milk plant, receiving station, or transfer station facility to ensure compliance with the HACCP System and other NCIMS regulatory requirements.
4. HACCP LISTED SHIPPER: A milk plant, receiving station, or transfer station that has been certified by a SRO. The listing is based on compliance with the NCIMS HACCP Program.
5. HACCP LISTING: An inclusion in the IMS List–Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List) based on a SRO’s evaluation of a milk plant's, receiving station's, and transfer station's NCIMS HACCP program and other applicable NCIMS requirements.
6. LISTING AUDIT: An evaluation conducted by a SRO of the entire milk plant, receiving station or transfer station facility to ensure compliance with the NCIMS HACCP Program and other NCIMS regulatory requirements.

PHS/FDA HACCP RESPONSIBILITIES
1. Standardization of Personnel
  
  PHS/FDA shall standardize at least every three (3) years the HACCP listing 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 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 the PHS/FDA to be equivalent.
  
  4.) FDA personnel responsible for FDA HACCP audits and State Program Evaluations in States participating in the NCIMS HACCP Program shall, at a minimum, be required to meet the same level of training and standardization required for SRO’s who make HACCP listing audits.
  b. SRO’s who comply with E. 4. of this Section.
2. HACCP Training
  
  Section IV.A.2. Training shall apply as written. In addition the following HACCP training requirements shall apply:
  
  a.   HACCP training for industry, Regulatory, SRO's, and FDA personnel will be based on the current Hazard Analysis and Critical Control Point Principles and Application Guidelines of the U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF), the current FDA HACCP recommendations, and the requirements of Appendix K of the Grade "A" PMO.
  
  b.   Regulatory Agency Personnel responsible for the evaluation, licensing and regulatory auditing of facilities using the voluntary NCIMS HACCP Program will have equivalent training to the training required to perform traditional NCIMS functions. They shall also have specialized training in conducting HACCP System audits.
  
  c.   It is recommended that industry, Regulatory, SRO's and FDA personnel be trained together.
  
  d.   Specialized Training for HACCP Auditing and Listing Procedures
  
  1.) FDA shall assist in providing training to Regulatory officials and SRO's in the evaluation, licensing and regulatory concerns of facilities, which choose to bring their processing facility into the voluntary NCIMS HACCP Program.
  
  2.) Training will include procedures for conducting the HACCP listing audit; and providing feedback and guidance to the firm. Others charged by law with the enforcement of NCIMS HACCP regulations, along with representatives of the regulated industry should attend such training.
  
  3.) These individuals should be familiar with the elements of public health protection and the requirements of the Grade "A" PMO from previous training. In addition, they should already be familiar with the principles of HACCP and the requirements for developing, implementing, and maintaining a HACCP Plan.
  
  4.) FDA personnel responsible for HACCP audits shall, at a minimum, be required to meet the same level of training and standardization required for SRO's.
3. State Program Evaluationns
  
  In the event a State has a participating HACCP milk plant, receiving station, or transfer station, FDA shall conduct an evaluation of the State's NCIMS HACCP Program, as a part of the State Program Evaluation.
4. Laboratory Evaluations
  
  Section IV., A. 4. shall apply as written.
5. Electronic Publication of Sanitation Compliance and Enforcement Ratings
  
  Section IV., A. 5. shall apply as written, except for for purposes of this Section:
  
  a. PHS/FDA shall provide an electronic publication of the IMS List on their web site. The HACCP listings contained in the electronic publication are certified by the State Rating Agency to be those established by HACCP audits conducted in accordance with the HACCP audits 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 electronic publication.
  
  Dairy plants, receiving stations, and transfer stations must achieve an acceptable HACCP listing in order to be eligible for a listing in the IMS List.
  
  b. PHS/FDA shall identify listings only from States and/or shippers, which are in substantial compliance with the Procedures.
6. Electronic Publication of Qualified PHS/FDA Regional Milk Specialists and State Personnel
  
  Section IV., A. 6. shall apply as written, except that for purposes of this Section:
  
  PHS/FDA shall publish a list of PHS/FDA Regional Milk Specialists and SRO's whose listing methods and interpretations of the PHS/FDA recommended Grade "A" PMO have been evaluated and certified by PHS/FDA in the IMS List.
7. Interpretations and Editorial Updates
  
  Section IV., A. 7. shall apply as written.
8. FDA Audits of HACCP Listings
  
  a.   PHS/FDA shall conduct, each year, FDA audits of HACCP listed shippers. Within a State conducting the NCIMS HACCP Program, FDA audits will be made of a representative number of IMS HACCP listed shippers. The selection of shippers for auditing 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 audited will be selected in advance and assignments scheduled in each State.
  
  c.   The number of shippers selected for FDA Audit 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-audits or withdrawals of certification) in the State based on the results of previous FDA Audits. This approach will shift attention from States, with demonstrated validity, to problem States, while still preserving an adequate level of monitoring.
  
  d.   Except as provided for in Sections VIII., C. 8. i., VIII., D. 2., and VIII., D. 6. c.2.)A.) an FDA HACCP audit will not be made with greater frequency than the official HACCP listing.
  
  e.   For action to be taken when an FDA audit indicated that a HACCP listing is not justified, refer to Section VIII., D. 6. c. For the purpose of these Procedures and all related forms, the terms “listed/listing”, “official listing” and “published listing” shall mean the most recent listing, which is accompanied by written permission by the shipper to publish, and submitted to the PHS/FDA Regional Office by the State Rating Agency.
  
  f.   Except as provided in Sections VIII., C. 8. i., VIII., D. 2., and VIII., D. 6. c.2.), PHS/FDA shall release the detailed results of its check ratings or FDA HACCP audits of listed individual interstate shippers only to the Rating Agency, which originally certified the shipper for listing, and the State Regulatory Agency.
  
  g.   If dairy farms are listed with a HACCP listed milk plant, receiving station or transfer station, the farms will be check rated in conjunction with the FDA audit.
  
  h.   FDA shall conduct on-site plant, receiving station and transfer station audits of the HACCP compliance status of listed interstate milk shippers. These FDA HACCP audits shall be conducted using the procedures for State HACCP listing audits as described in the MMSR. These audits will be used in the overall State Program Evaluation.
  
  i.   FDA shall review the Regulatory Agency records for the plant, receiving station or transfer station being audited. In the event that there is reason to doubt the safety of any State's milk or milk products that are HACCP listed, FDA shall immediately investigate the State’s Milk Safety Program and may evaluate/audit the plants, receiving stations or transfer stations affected. This applies even if the HACCP listing of the milk plant, receiving station or transfer station being audited is sustained.
  
  Based on this investigation, if there are substantial milk or milk product safety program weaknesses, FDA shall send a notice requiring corrections to the State Regulatory Agency with a copy to the Rating Agency. If after thirty (30) days, FDA determines that the corrections were not made, FDA shall notify the affected industry and receiving States.
  
  If after investigation of HACCP listings in the State, FDA determines that the State is not able to fulfill its obligations under the NCIMS HACCP Program and milk or milk products safety remains in doubt, FDA shall provide written notification to the State specifying the reasons this determination was made.
  
  This notification will specify that the State has 180 days from the date of the notification to show to FDA's satisfaction that the State has made appropriate corrections and is once again able to fulfill its obligations under the NCIMS HACCP Program.
  
  After the 180 days, if the State is still unable to fulfill its obligations under the NCIMS HACCP Program and milk or milk product safety remains in doubt FDA will not accept new HACCP listings from the State and FDA may audit the existing listings as necessary to protect the public health.

STATE HACCP RESPONSIBILITIES
1. State HACCP Listings for Milk Plants, Receiving Stations and Transfer Stations
  
  Section IV., B. 1. shall apply as written, except that for purposes of this Section:
  
  a. The Rating Agency of the shipping State shall certify the results of HACCP listing audits of each interstate milk shipper to the appropriate PHS/FDA Regional Office, which in turn, will transmit the HACCP listing audits to the PHS/FDA Headquarters Office for inclusion in the IMS List. (Refer to Section IV., A., 5.) The HACCP listing audit results, together with other pertinent information, shall be forwarded on an appropriate form (Form FDA 2359i).
  
  c. When the sanitation compliance status of a listed shipper's supply changes as a result of a new listing made within the twenty-four (24) month eligibility period, the most recent listing and the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT and the NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT, 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, change in the sanitation compliance or enforcement rating to less than ninety (90), or a change in HACCP listing status, the shipping State shall immediately notify all known receiving States and the appropriate PHS/FDA Regional Office.
  
  e. When HACCP listing 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.
  
  g. The Rating Agency shall furnish Regulatory Agencies with interpretations of the PHS/FDA recommended Grade "A" PMO and HACCP listing procedures received from PHS/FDA.
  
  h. The Rating Agency shall keep current the HACCP listings of all certified shippers within its State.
2. NCIMS HACCP Enforcement Responsibilities
  
  A NCIMS HACCP System Regulatory Agency review shall be conducted and the NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT shall be completed and provided to FDA as a part of all NCIMS HACCP listings.
  
  Based on this report, if FDA finds there may be reason to doubt the safety of the State's milk or milk products that are NCIMS HACCP listed, FDA shall immediately investigate the State's Milk Safety Program and may evaluate/audit the plants, receiving station or transfer station affected. This applies even if the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT finds that the listing of the milk plant, receiving station or transfer station is satisfactory.
  
  If there are substantial milk or milk product safety program weaknesses, FDA shall send a notice requiring corrections to the State Regulatory Agency with a copy to the State Rating Agency. If after thirty (30) days, FDA determines that the corrections were not made, FDA shall notify the affected industry and receiving States.
  
  If FDA determines that the State is not able to fulfill its obligations under the NCIMS HACCP Program and milk or milk product safety remains in doubt, FDA shall provide written notification to the State specifying the reasons this determination was made.
  
  This notification will specify that the State has 180 days from the date of the notification to show to FDA's satisfaction that the State has made appropriate corrections and is once again able to fulfill its obligations under the NCIMS HACCP Program.
  
  After the 180 days, if the State is still unable to fulfill its obligations under the NCIMS HACCP Program and milk or milk product safety remains in doubt FDA will not accept new HACCP gs from the State and necessary to protect the public health.
3. Challenges and Remedies
  
  a. Complaints from Receiving States and Municipalitie
  
  Section IV., B. 6. a. shall apply as written, except that for purposes of this Section:
  
  1.) Complaints as to the sanitary quality of milk or milk products being received and challenges of the validity of certified HACCP listing audits 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.
  
  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:
  
  C.) Make a new listing audit within sixty (60) days and, with the written permission of the shipper, forward the new listing audit and a copy of the shipper's written permission to the appropriate PHS/FDA Regional Office for publication 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 listing called for in 6.a.4.) above, it shall:
  
  B.) Notify the shipper involved, and any other interested parties, that in accordance with Conference agreements, the current State certification is being withdrawn until such time as the complaint may be investigated or a new listing audit is made.
  
  b.   Complaints from Shipping States and Municipalities
  
  1.) Complaints from shipping States and municipalities shall be made in writing to the Rating Agency of the receiving State(s), with a copy to the appropriate PHS/FDA Regional Office.
  
  2.) The Rating Agency of the receiving State(s) will make a preliminary investigation of the complaint(s) within fifteen (15) days and notify the shipping State in writing of the action being taken, with a copy to the appropriate PHS/FDA Regional Office.
  
  c.   Action to be Taken if the PHS/FDA HACCP Audit Indicates the Listing is Not Justified:
  
  1.) Producer Dairies (Raw Milk)
  
  Section IV., B. 6.c.1. shall apply as written.
  
  2.) Milk Plants, Receiving Stations and/or Transfer Stations
  
  A.) Action to be Taken
  
  Should a milk plant, receiving station or transfer station's HACCP System be found to be either invalid or improperly verified, FDA shall request that the State initiate regulatory action. In addition, FDA may request a re-audit or withdrawal of certification. When milk or milk product safety is in doubt, based on Regulatory Agency practices or concerns, FDA shall immediately investigate and may audit other milk plants, receiving stations and transfer stations affected.
  
  Based on this investigation, if there are substantial milk or milk product safety program weaknesses, FDA shall send a notice requiring corrections to the Regulatory Agency with a copy to the Rating Agency. If after thirty (30) days, FDA determines that the corrections were not made, FDA shall notify the affected industry and receiving States.
  
  If FDA determines that the State is not able to fulfill its obligations under the NCIMS HACCP Program and milk or milk product safety remains in doubt, FDA shall provide written notification to the State specifying the reasons this determination was made.
  
  This notification will specify that the State has 180 days from the date of the notification to show to FDA's satisfaction that the State has made appropriate corrections and is once again able to fulfill its obligations under the NCIMS HACCP Program.
  
  After the 180 days, if the State is still unable to fulfill its obligations under the NCIMS HACCP Program and milk or milk product safety remains in doubt, FDA will not accept new HACCP listings from the State and FDA may audit the existing listings as necessary to protect the public health.
  
  B.) Re-Audit
  
  If deficiencies or non-conformities are significant to the point that timely correction is necessary, but do not require an immediate withdrawal of certification, the deficiencies or non-conformities shall be corrected and the correction confirmed by a re-audit by an appropriate listing official. The period of time allowed to correct the HACCP System deficiencies or non-conformities shall be specified by the FDA Regional Milk Specialist in writing to the State. No re-audit is required if the deficiencies or non-conformities are immediately corrected, or are minor and can be corrected within a time period, which will neither present a risk to the public health nor result in milk or milk product adulteration.
  
  If after notice, as specified by FDA, the HACCP System deficiencies or non-conformities have not been corrected, the milk plant's, receiving station's or transfer station's listing shall be withdrawn by the State.
  
  If the HACCP System deficiencies or non-conformities have been corrected, the Rating Agency shall notify the Regional office of FDA and no further action will be necessary.
  
  C.) Withdrawal of Certification
  
  i.) A HACCP listing shall be requested to be withdrawn when CLE's have been noted indicating that the milk plant, receiving station or transfer station has failed to recognize or correct a deficiency(ies) or nonconformity(ies) indicating:
  
  1.) A major HACCP System dysfunction that is reasonably likely to result in a milk or milk product safety hazard or an adverse health consequence;
  
  NOTE: A milk or milk product safety hazard that is reasonably likely to occur is one for which a prudent milk plant, receiving station or transfer station operator would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable likelihood that, in the absence of those controls, the milk or milk product hazard will occur in the particular type of milk or milk product being processed.
  
  2.) Series of observations that lead to a finding of a potential HACCP System failure that is likely to result in a compromise to milk or milk product safety;
  
  3.) Drug residue testing and trace back requirements are not met; or
  
  4.) Milk is received from a supply other than a NCIMS listed source or from a listed source with a sanitation rating score below 90.
  
  ii.) Significant deficiencies involving one (1) or more CLEs constitute grounds for withdrawal of a HACCP listing. Observations of CLE related concerns and anomalies that do not meet these criteria should be discussed with the milk plant, receiving station or transfer station being audited and/or the Regulatory Agency but not marked on the audit report as a CLE or used to justify the removal of a listing. In this case, professional judgment should be exercised to allow the milk plant, receiving station or transfer station to retain its listing and benefit from the observation by making the necessary corrections to their system.
  
  NOTE: CLEs are noted on the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT with a double Star (**) and cover the following areas of the NCIMS HACCP Program:
  
  1.   HAZARD ANALYSIS: Flow Diagram and Hazard Analysis conducted and written for each kind or group of milk or milk products processed.
  
  2.   HACCP PLAN: HACCP Plan prepared for each kind or group of milk or milk products processed.
  
  3.   HACCP PLAN CRITICAL LIMITS (CLs): CLs are adequate to control the hazard identified.
  
  4.   HACCP PLAN CORRECTIVE ACTION: Corrective action taken for milk or milk products produced during a deviation from CLs defined in the HACCP Plan.
  
  5.   HACCP PLAN VERIFICATION AND VALIDATION: Calibration of Critical Control Point (CCP) process monitoring instruments performed as required and at the frequency defined in the HACCP Plan.
  
  6.   HACCP PLAN RECORDS: Information on HACCP records not falsified.
  
  7.   OTHER NCIMS REQUIREMENTS:   Including a milk supply from a NCIMS listed source(s) with a sanitation compliance rating score(s) of 90 or better and drug residue control program implemented.
  
  8.   HACCP SYSTEM AUDIT FOLLOW-UP ACTIONS:   A series of observations that lead to a finding of a potential HACCP System failure that is likely to result in a compromise to milk or milk product safety.
  
  iii.) When FDA audit data indicates that the milk plant, receiving station and/or transfer station requires a withdrawal of certification, the Rating Agency, upon written recommendation of the PHS/FDA, shall immediately withdraw the current certification of the shipper and notify such shipper, PHS/FDA, and all known receiving States thereof. In case of withdrawal, a new listing shall be made in not less than thirty (30) days and not to exceed sixty (60) days, unless the Rating Agency has reason to believe a new listing within a lesser time period would result in an acceptable listing. The effective date for action shall be determined from the date of the letter of notification by the Rating Agency. Such letter shall be dated within five (5) working days following the date of the official notification.
  
  iv.) If a Rating Agency fails to immediately notify all known receiving States when current certification of a listed shipper is to be withdrawn as recommended by PHS/FDA, the PHS/FDA, after a reasonable lapse of time, not to exceed five (5) days, shall provide all participating States with the FDA audit conclusion. The State, which failed to take the required action, shall be identified in the next listing of the IMS List as not being in compliance with this paragraph.
  
  v.) If the Rating Agency informs PHS/FDA that it is unable to make arrangements for PHS/FDA to audit HACCP listed shippers, PHS/FDA shall identify those States in the next listing of the IMS List as not being in compliance with this paragraph.
  
  vi.) If a Rating Agency fails to request removal of a milk plant, receiving station and/or transfer station from the IMS List as provided for in this Section, PHS/FDA shall, after five (5) days, provide this information to all receiving States.
  
  D.) Imminent Health Hazard
  
  i.) When an imminent health hazard is observed, PHS/FDA shall request the Regulatory Agency to take immediate action to prevent any further movement of such milk or milk products until such hazard(s) has been eliminated. If such a violation results in a milk or milk product that presents a public health risk, the Regulatory Agency shall take immediate action against all milk and milk products produced and/or processed that have already entered the distribution system.
  
  ii.) The Regulatory Agency shall report in writing to PHS/FDA concerning actions taken within five (5) working days.
  
  iii.) If the Regulatory Agency fails to take immediate appropriate corrective action, PHS/FDA shall take any action necessary to protect the public health.
  
  iv.) If the Regulatory Agency fails to take immediate action to correct the identified hazard(s), or fails to notify PHS/FDA concerning actions taken within five (5) working days, PHS/FDA shall provide this information to all receiving States.

Qualifications and Certifications
1. Supervision Requirements
  
  Section V., A. shall apply as written, except that for purposes of this Section:
  
  a. Supervision of the milk supply, condensed and dry milk products, whey and whey products to be audited 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.
  
  b. The shipper to be audited shall be under the full-time supervision of a State, Regional or Local Milk Regulatory Agency.
2. Procedures for requesting a HACCP Listing
  
  A shipper desiring a HACCP listing of their supply for the purpose of interstate certification shall submit a request to the State Milk Rating/Rating Agency in their own State.
3. HACCP Listing
  
  a. An acceptable HACCP listing shall be substituted for an acceptable sanitation and enforcement rating for a milk plant, receiving station or transfer station participating in the voluntary NCIMS HACCP Program. A MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT and a NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT shall be completed as a part of all milk plant, receiving station or transfer station HACCP listing audits.
  
  b. Milk plants, receiving stations or transfer stations participating in the NCIMS HACCP Program shall receive dairy ingredients, including raw milk and milk products, for use in listed products only from IMS listed sources that have been awarded an acceptable HACCP listing or acceptable sanitation compliance and enforcement ratings.
4. HACCP Listing Personnel
  
  HACCP listings shall be made by qualified SRO's who:
  
  a. Have been standardized by PHS/FDA as a SRO and hold a valid SRO qualification to perform HACCP listing audits.
  b. Have attended at least one (1) training course in the auditing of dairy plant HACCP Systems and NCIMS listing for the period of qualification.
  
  c. Have, during the three (3) year period for which standardized, participated in at least one (1) Regional Milk Seminar and, in addition, attended at least one (1) training course on Special Problems in Milk Protection or other training course judged by the PHS/FDA to be equivalent.
  
  d. Do not have direct responsibility for the routine regulatory audits of the shipper to be listed.
5. Drug Residue Compliance
  
  A shipper desiring a listing audit of their supply shall comply with Appendix N. of the Grade “A” PMO.
6. Certification Procedure for SRO's Who Will Conduct HACCP Listing Audits
  
  a. Candidate Background
  
  1.) Training and Experience
  
  A.) The Candidate shall provide a statement describing their background and experience that qualifies them to perform this work.
  B.) Candidates are encouraged to gain practical milk plant experience in the application of HACCP and in conducting milk plant NCIMS HACCP audits by working with SRO's that are certified to perform NCIMS HACCP Listings audits whenever practical.
  C.) The Candidate shall complete a basic HACCP training course that is acceptable to the NCIMS and FDA; NCIMS HACCP Orientation; as well as training in general auditing requirements for the auditing of milk plants, receiving stations and transfer stations under the NCIMS HACCP Program.br D.) Candidate shall be a certified SRO for milk plants.
  
  b. Original Certification Process
  
  1.)   Knowledge of HACCP and NCIMS HACCP Auditing Standards and Requirements
  
  A standardized FDA Regional Milk Specialist (RMS), qualified to conduct HACCP Audits, will accompany the Candidate during the course of one (1) mock-listing audit conducted separate from an official HACCP listing audit. The candidate may be certified to conduct HACCP listings after successfully completing one (1) mock-listing audit, with the certification valid for three (3) years. In the case of an original HACCP certification, the date of expiration of the other SRO certification shall be automatically extended to correspond with the original HACCP certification expiration date.
  
  2.) Knowledge of HACCP and NCIMS HACCP Auditing Standards and Requirements
  
  The RMS shall accompany the Candidate during the mock-listing audit and shall evaluate the Candidate's HACCP knowledge and NCIMS HACCP auditing skills. Particular attention shall be given to the Candidate's observations, evaluation and decision making skills related to planning and conducting the mock-listing audit, identifying and recording the findings, communicating with industry representatives, and arriving at a listing audit determination. The RMS will categorize the Candidate's HACCP knowledge and NCIMS HACCP auditing skills into one (1) of the following three (3) categories:
  
  A.) The Candidate's work is acceptable; or
  B.) The Candidate's work is acceptable with written recommendations identifying areas that need improvement; or
  C.) The Candidate is not certified.
  
  NOTE: The cause shall be documented and provided to the candidate and the State Rating Agency.
  
  c.   Continuous Certification
  
  After the initial successful Conditional HACCP Certification, subsequent certification of a SRO to make NCIMS HACCP Listing Audits will be valid for three (3) years unless revoked for cause.
  
  1.)   Milk Plant Technical Knowledge
  
  The Candidate shall continue to meet the requirements for certification of a SRO for milk plants.
  
  During the three (3) year certification period, the SRO, certified to conduct NCIMS HACCP listings, will complete the minimum training requirements established to maintain proficiency regarding the NCIMS HACCP Program.
  
  Small group training with practical exercises and other appropriate training that may include written examinations will be used to evaluate the SRO's technical knowledge for continuing certification.
  
  2.)   Knowledge of HACCP and NCIMS HACCP Auditing Standards and Requirements
  
  During the three (3) year certification period, a RMS will accompany the SRO during the course of at least one (1) recertification listing audit. The recertification listing audit can be done independent as a mock-listing audit or as part of an official HACCP listing audit, at the discretion of the RMS and SRO. This decision will be made prior to the beginning of the recertification listing audit. In the absence of an agreement, the recertification listing audit shall be conducted during a mock listing audit. The standardizing official (RMS) shall accompany as a "silent observer" during this recertification listing audit. The RMS shall evaluate the SRO's HACCP knowledge and NCIMS HACCP auditing skills. Particular attention shall be given to the SRO's observations, evaluation, and decision making skills related to planning and conducting the listing or mock-listing audit, identifying and recording the findings, communicating with industry representatives, and arriving at an audit listing or mock-listing audit determination. The RMS will categorize the SRO's HACCP knowledge and NCIMS HACCP auditing skills into one (1) of the following three (3) categories:
  
  A.) The SRO is recertified to conduct NCIMS HACCP Listing Audits; or
  B.) The SRO is recertified with written recommendations identifying areas that need improvement; or
  C.) The SRO is not recertified.
  
  NOTE: The cause shall be documented and provided to the SRO and the State Rating Agency.
  
  d.   Paperwork Review
  
  The MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP AUDIT REPORT, with attachments, the NCIMS HACCP SYSTEM REGULATORY AGENCY REVIEW REPORT, and the PERMISSION FOR THE PUBLICATION OF AN INTERSTATE MILK SHIPPER's LISTING shall be submitted with Form FDA 2359i for each NCIMS HACCP Listing Audit to the FDA Regional Office for quality assurance review.
  
  These reviews will be used to enhance uniformity and strengthen each individual's skills and will be used to assist in identifying needs for future training.
7. Sampling Surveillance Personnel
  
  Section V., F shall apply as written.
8. Milk Laboratory Evaluation Personnel
  
  Section V., G shall apply as written.
9. Milk Plant, Receiving Station and Transfer Station HACCP Listings
  
  a. Individual milk plants, receiving stations or transfer stations participating in the NCIMS HACCP listing process shall be audited for listing at a frequency of not less than once every twenty-four (24) months.
  
  b. If an audit for a HACCP listing is unsatisfactory, another audit shall be conducted after written notification from an authorized representative of the IMS Listed shipper to the State Rating Agency that the IMS Listed shipper is in substantial compliance. The audit shall be completed in no more than fifteen (15) days from the date of receipt of the notification, unless the Rating Agency has a reason to believe a new listing within a lesser time would result in an acceptable listing.
10. Re-Audits
  
  Whenever a listing audit results in a request for a re-audit, the effective date for the re-audit shall be determined from the date of the letter of notification by the Rating Agency. Such letter is to be dated within five (5) working days following the date of the listing audit.
11. Denial of Listings
  
  Requests for HACCP listings of shippers, which are not under supervision as described in E. 1. of this Section, shall be denied.
STANDARDS TO BE USED FOR THE NCIMS HACCP PROGRAM

Section VI. shall apply as written, except that for purposes of this Section:
1. Points Beyond the Limits of Routine Inspection
  
  Milk and milk products from points beyond the limits of the routine inspection shall be acceptable under the principles of reciprocity for sale in the State or Local area concerned, provided they are produced and pasteurized under regulations which are substantially equivalent to the current edition of the Grade “A” PMO and have been awarded an acceptable HACCP listing by a SRO certified by PHS/FDA.
1. Milk Sanitation Standards
  
  The current edition of the Grade “A” PMO shall be used as the basic sanitation standards in making listing audits of interstate milk shippers.
2. HACCP Listing Audit Procedures
  
  The procedures outlined in the current edition of the PHS/FDA recommended MMSR shall be used in determining compliance with sanitation provisions and enforcement procedures contained in the applicable Standards specified in 1. through 5. above.
PROCEDURES GOVERNING A STATE's PARTICIPATION IN THE NCIMS HACCP PROGRAM FOR CERTIFICATION OF IMS LISTED SHIPPERS

Section VII. shall apply as written, except that for purposes of this Section:

1. State Program Evaluations

a. PHS/FDA shall evaluate the inspection, supervisory, and listing work of Regulatory and Rating Agencies triennially to determine whether milk regulations are being interpreted and enforced in accordance with the provisions of the Grade "A" PMO.

SECTION IX. APPLICATION OF CONFERENCE AGREEMENTS

IMPLEMENTATION OF CHANGES

Unless explicitly specified otherwise by a vote of the voting delegates, changes in the Procedures and recommended changes in Standards, found in Section VI., shall be implemented in accordance with the following schedule:

1. The transcript of the second voting day shall be forwarded to PHS/FDA within forty-five (45) days of the close of the Conference.

2. PHS/FDA will review the transcript and within ninety (90) days of receipt, notify the Conference Chair of those issues with which they do or do not concur. The changes involved, that have been concurred with, shall be effective within one (1) year of the electronic publication of the affected documents or notification to the States by IMS-a, following the Conference at which the changes were approved.

3. Those issues with which PHS/FDA does not concur will be referred to the NCIMS Executive Board for further discussion (within thirty (30) days if possible). If mutual concurrence is obtained, the changes shall be effective within one (1) year of the electronic publication of the affected documents or notification to the States by IMS-a, following the Conference at which the changes were approved, unless otherwise mutually agreed upon by PHS/FDA and the NCIMS Executive Board.

4. If mutual concurrence cannot be reached, the matter will be referred to the next Conference for further discussion. In the interim period between the PHS/FDA-NCIMS Executive Board Meeting (referred to in 3. above) and the next NCIMS Conference, PHS/FDA will consider additional information that becomes available concerning Proposals for which there was not mutual concurrence. If review of this additional information causes PHS/FDA to reconsider its position, PHS/FDA may bring Proposals back to the NCIMS Executive Board for reconsideration and the establishment of an alternative effective date.

EDITORIAL CHANGES TO NCIMS CONFERENCE DOCUMENTS

Editorial changes may be made to the Procedures and other NCIMS conference documents (excluding the Constitution and Bylaws) for the purposes of:

Incorporating language from Proposals adopted by the voting delegates into their respective documents.
Incorporating language from any Proposal that does not include the exact language to be incorporated but does provide some direction for determining the text to be incorporated in the document (for example: Section IV. A. 6. shall apply as written except that, for purposes of this Section, the word "rating" shall be replaced with "listing");
Correcting misspelled words;
Correcting capitalization of words;
Correcting the use of punctuation within documents;
Correcting paragraph or section numbering schemes;
Correcting incorrect citations or other references within a document;
Correcting the incorrect use of terms used in any Proposal (for example: using the term "rating" instead of "listing");
Correcting the inconsistent use of defined terms when referencing facilities, persons or equipment subject to any requirement contained in any of the documents (for example: adding "receiving station and transfer station" after "milk plant" if the Sections requirements were intended to be applicable to all three);
Changing incomplete sentences into complete sentences without changing the meaning or intent of the original language;
Consistently using acronyms within documents after they have been cited where the term or phrase first occurs in each document;
Deleting or changing references within NCIMS conference documents if a document is deleted or combined with another document to ensure accurate references;
Deleting any language that would extend the regulatory oversight to products outside the scope of the Grade "A" NCIMS Program;
Modifying any definition that is in conflict with a previously established definition in any NCIMS document to be consistent with the established definition and limited to the extent that the editorial changes do not alter the meaning or intent of the original language passed by the voting delegates; or
Providing consistent references to Document Titles, Committee Names, Agency Names, Agency Identifications, Position Names, Reporting Forms, citations of Documents and citations of Sections within Documents.

REVIEW AND APPROVAL OF EDITORIAL CHANGES

After receipt of the transcript of the second voting day PHS/FDA shall prepare an IMS-a document detailing the actions of the NCIMS Conference and shall incorporate the language from all Proposals passed by the voting delegates into the appropriate NCIMS conference documents.
PHS/FDA shall prepare an electronic version of each IMS-a and NCIMS conference document detailing the actions of the NCIMS Conference for review by the NCIMS Documents Review Committee that strikes out text to be deleted and underlines text to be inserted. The NCIMS Documents Review Committee shall have a minimum of ten (10) business days to review the changes and respond back to PHS/FDA with any concerns. Review of each IMS-a and NCIMS conference document detailing the actions of the NCIMS Conference shall continue until both the NCIMS Documents Review Committee and PHS/FDA concur on the IMS-a and NCIMS conference document or concurrence cannot be reached.
Those issues on which the NCIMS Documents Review Committee and PHS/FDA do not concur shall be referred to the NCIMS Executive Board for further discussion. If the NCIMS Executive Board and PHS/FDA reach agreement on a proposed solution, the IMS-a or NCIMS conference document being considered shall require approval by a minimum of two-thirds (2/3) affirmative vote of the NCIMS Executive Board members before being released for publication.
The NCIMS Executive Board shall review and approve all editorial changes to NCIMS conference documents by a minimum of two-thirds (2/3) affirmative vote of the NCIMS Executive Board members. Editorial changes that did not raise any concerns of the NCIMS Documents Review Committee may be combined and voted on as one (1) motion by the NCIMS Executive Board.

TRAINING COURSE DEVELOPMENT

NCIMS and/or PHS/FDA may determine the need to develop and conduct training courses for regulatory and industry personnel.

CONSTITUTION OF THE
NATIONAL CONFERENCE
ON INTERSTATE MILK SHIPMENTS

Constitution and Bylaws

BYLAWS OF THE
NATIONAL CONFERENCE
ON INTERSTATE MILK SHIPMENTS
Constitution and Bylaws

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

BACKGROUND

The Food and Drug Administration (FDA) is the federal agency responsible for enforcing the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq. Included within the FDA's responsibilities under the Act is the responsibility for regulation of foods shipped in interstate commerce, including milk and milk products.

The National Conference on Interstate Milk Shipments (NCIMS) is a voluntary organization directed and controlled by the member States and open to all persons interested in its objective of promoting the availability of a high quality milk supply. It is governed by an Executive Board whose members include representatives from state departments of health and agriculture, the FDA, the U.S. Department of Agriculture, and industry.

Through their collaborative efforts, the FDA and the NCIMS have developed a cooperative, federal-state program (the Interstate Milk Shipper Program) to ensure the sanitary quality of milk and milk products shipped interstate. The Program is operated primarily by the States, with FDA providing varying degrees of scientific, technical and inspection assistance as provided by FDA Publication No. 72-2022, Procedures Governing the Cooperative Federal-State Program for Certification of Interstate Milk Shippers ("Procedures Manual")*. The result has been the establishment of a viable and effective certification and enforcement program, which has been of significant benefit to consumers.

The Interstate Milk Shippers Program relies upon the Grade "A" Pasteurized Milk Ordinance and related technical documents referred to in the Procedures Manual for the sanitary standards, requirements and procedures it follows to ensure the safety and wholesomeness of Grade "A" milk and milk products. FDA considers these standards, requirements, and procedures to be adequate for the protection of the health and safety of the consumer. Sources of Grade "A" milk and milk products intended for use on interstate conveyances and subject to the Interstate Conveyance Sanitation Regulations (21 CFR 1250 et seq.) promulgated pursuant to the Public Health Service Act (42 U.S.C. 264) are considered approved sources for purposes of 21 CFR 1250.26 if they have a State or local permit, are under the routine inspection of a State or local regulatory agency and meet the provisions of the Procedures Manual.

PURPOSE

The purpose of this Memorandum is to strengthen the Interstate Milk Shippers Program by stating the responsibilities of the FDA and the NCIMS for execution of the Program, the means for resolving questions of interpretation that may arise in the execution of the Program, and the means for making modifications in the Program.

AGREEMENT

The FDA and the NCIMS have agreed upon the following principles:

The Interstate Milk Shippers Program shall be governed by the provisions of the current FDA Publication No. 72-2022, Procedures Governing the Cooperative Federal-State Program for Certification of Interstate Milk Shippers, and by the documents referenced therein. Copies of all governing documents are available for review in the office of the Food and Drug Administration, Hearing Clerk.

The responsibilities of the NCIMS, the participating States, and FDA for execution of the Interstate Milk Shippers Program shall be as stated in the above referenced Procedures Manual.

Failure on the part of any certified state milk sanitation rating officer, state milk laboratory survey officer, or state sampling surveillance officer to comply with the provisions of this Memorandum or the Procedures Manual shall be sufficient cause for FDA to proceed to a hearing to provide said rating officer, laboratory survey officer, or sampling surveillance officer an opportunity to show cause why his/her certification or approval should not be revoked.

It shall be the right of the NCIMS and each participating State to request and receive consultation with the appropriate representative of the FDA to discuss the provisions of this Memorandum or problems encountered in the execution of the provisions of the Procedures Manual. The initial contact office at FDA for all inquiries pertaining to the Program is the Bureau of Foods (HFF-415)**, FDA, 200 C Street, S.W., Washington, D.C. 20204.

It shall be the right of the FDA to request and receive consultation with appropriate officials of the NCIMS or any of its member States to discuss the provisions of this Memorandum or problems encountered in the execution of the provisions of the Procedures Manual. The Executive Board of NCIMS can be contacted by FDA personnel through the Bureau of Foods (HFF-415)** at the address indicated in paragraph D, above.

Problems of interpretation regarding provisions of the Procedures Manual and the documents referenced therein, or their application, shall be subject to resolution by mutual agreement of the parties.

Changes in the provisions of the Procedures Manual and the documents referred to therein shall be mutually concurred in by NCIMS and FDA.

This Memorandum of Understanding may be modified by mutual consent of the parties and may be terminated by either party upon a thirty (30) day advance written notice to the other. Any modification or notice of termination will be published in the Federal Register.

For the FDA.

Dated: August 5, 1977.

Donald Kennedy,
Commissioner of
Food and Drugs.

For the NCIMS.

Dated: June 28, 1977.

H. H. Vaux,
Chairman, NCIMS

Effective date: This Memorandum of Understanding became effective August 5, 1977.

Dated: September 12, 1977.

Joseph P. Hile
Associate Commissioner
for Compliance.

(FR Doc. 77-27071 Filed 9-19-77; 8:45 am)

* Current document is titled: Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments

**Note: HFF-415 mail symbol for Dairy and Lipid Technology Branch, DFT, Bureau of Foods, is now HFS-626, Center for Food Safety and Applied Nutrition, Milk Safety Team, 5100 Paint Branch Parkway, College Park, MD 20740.
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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