U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Division of HACCP Programs
May 2001

These proposals requested the formation of a NCIMS HACCP committee which would address how a voluntary HACCP system should be implemented, evaluated, monitored, and enforced under the NCIMS.

This document contains the provisions for a voluntary NCIMS HACCP Pilot Program as developed by the NCIMS HACCP Committee.

The committee wishes to express its gratitude to those individuals and past members who contributed their time and ideas to the betterment of the NCIMS HACCP Pilot Program.

NCIMS HACCP COMMITTEE MISSION STATEMENT:

To address how a voluntary HACCP System should be implemented, evaluated, monitored and enforced under the National Conference on Interstate Milk Shipments (NCIMS) as an alternative to the traditional Inspection/Rating/Check Rating System. This program will:

• Utilize current National Advisory Committee on Microbiological Criteria for Foods (NACMCF) HACCP principles consistent with current Food and Drug Administration (FDA) HACCP recommendations.

• Continue to assure at least the same level of milk safety provided by the traditional Inspection/Rating/Check Rating System.

• Continue to provide uniformity and reciprocity under the HACCP alternative to the traditional Inspection/ Rating/Check Rating System.

To report to the voting delegates of the National Conference on Interstate Milk Shipments (NCIMS).

HACCP is a science-based system used to ensure that food safety hazards are controlled to prevent unsafe food from reaching the consumer. In the United States, meat and poultry are regulated under HACCP by the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) program. The seafood industry is regulated under HACCP by the Food and Drug Administration (FDA) and final juice HACCP regulations were published in the Federal Register by FDA on January 19, 2001. In addition, FDA also has an Advance Notice of Proposed Rule Making (ANPRM) published for HACCP for the rest of the food industry. The proposed program follows the above precedents as closely as possible and is harmonized with the current recommendations of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF).

This proposal recommends a voluntary pilot study to test the implementation, evaluation, monitoring and enforcement of the proposed HACCP program under the NCIMS as an alternative to the traditional Inspection/Rating/Check Rating System.

HACCP places more responsibility on the food processor to identify and control hazards and to document the effectiveness of the system. In addition, it requires constant verification that the system is working. The regulatory agency retains its authority and responsibility to verify that food is manufactured and handled in such a way that safety is enhanced. Food safety will be enhanced by a proactive approach of continuous monitoring of food safety controls and documentation of results and corrective actions, since this monitoring takes place in "real time" rather than in a reactive after-the-fact approach. This will allow greater regulatory flexibility to direct resources to plants and to situations of greatest need. The program follows the recommendations of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and FDA for establishing the plant's HACCP system. These recommendations are tried, tested and represent the best current thinking on establishing a HACCP system.

While following current HACCP regulations and guidelines left the committee little concern for the safety of milk and milk products, the committee encountered more challenges with finding a model for incorporating the program into a regulatory format. This HACCP Pilot Program has been harmonized with the traditional requirements of the NCIMS in terms of reciprocity and oversight.

Properly trained individuals must produce the HACCP plan and verify monitoring, corrective actions, and records. The committee has appointed a subcommittee to address training issues. State regulators responsible for the evaluation, licensing and regulatory concerns of facilities using the HACCP alternative will have equivalent training to the training required to perform traditional NCIMS functions. They will also need specialized training in conducting HACCP system audits. State listing officers are to be accepted by the state listing agency and FDA, based on specialized training, qualification, and standardization. The training subcommittee is working with FDA, universities and key regulatory and industry personnel on ways to provide the necessary training.

As noted previously, regulatory authority and responsibility for oversight in the safety of food has not changed, but implementing HACCP under this program allows more flexibility to use resources wisely. It gives the regulator a continuous picture of the food safety controls applied and documentation of corrective actions taken by the industry. FDA's role in this alternative program is similar to the traditional system, providing oversight and technical assistance.

The committee sees the need for the regulatory authority to verify that the HACCP system is working through the auditing function. Deficiencies and non-conformities to the HACCP system are identified on the Audit Report and must be corrected within the time period indicated. Obviously, an imminent threat to public health will trigger immediate regulatory action.

In-plant audits and record review audits are a necessary part of regulatory oversight. The processing plant is responsible for conducting and documenting regular pasteurization equipment checks as a part of its HACCP program. Also, the plant will be required to verify that these checks and controls work. The regulatory authority will be responsible to be physically present during certain equipment checks.

The Pasteurized Milk Ordinance (PMO) represents the cumulative wisdom and knowledge for producing safe dairy products. The expectation of the committee is that food safety controls addressed in the PMO are also addressed in this HACCP program providing an equivalent margin of safety to the consumer. The committee is recommending the pilot program in order to determine if an alternative voluntary HACCP program could potentially be placed in the PMO as an appendix.

HACCP Principles

The following are the seven (7) HACCP principles.

Principle 1. Conduct a hazard analysis.
Principle 2. Determine the critical control points.
Principle 3. Establish critical limits.
Principle 4. Establish monitoring procedures.
Principle 5. Establish corrective actions.
Principle 6. Establish verification procedures.
Principle 7. Establish record-keeping and documentation procedures.

Prerequisite Programs

Prior to the implementation of a HACCP plan, there is a requirement for dairy plants to develop, document and implement written prerequisite programs. Prerequisite programs provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in Federal, State and Local regulations and guidelines.

Prerequisite programs address public health concerns such as those identified in 21 CFR part 7, Recalls, part 110, Good Manufacturing Practices (GMPs), part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, part 131, Milk and Cream, the Pasteurized Milk Ordinance (PMO) and the current edition of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) Hazard Analysis and Critical Control Point Principles and Application Guidelines.

Adulterated: See the Federal Food, Drug, and Cosmetic Act, section 402.

Audit: An evaluation of the entire milk plant, receiving station, transfer station facility, and HACCP system to ensure compliance with the HACCP system and other NCIMS regulatory requirements.

Centralized Deviation Log: A centralized log or file identifying data detailing any deviation of critical limits and the corrective actions taken as required by this document.

Control: (a) To manage the conditions of an operation to maintain compliance with established criteria. (b) The state where correct procedures are being followed and criteria are being met.

Control Measure: Any action or activity that can be used to prevent, eliminate, or reduce a significant hazard.

Control Point: Any step at which biological, chemical, or physical factors can be controlled.

Corrective Action: Procedures followed when a deviation occurs.

Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit: A maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a food safety hazard.

Critical Listing Elements: An item on the NCIMS HACCP System Pilot Audit Report identified with a double star (**). The marking of a critical listing element by an auditor (state listing or FDA) indicates a condition which constitutes a major dysfunction likely to result in a potential compromise to food safety whereby a listing may be denied or withdrawn.

Dairy Foods HACCP Core Curriculum: The core curriculum consists of 1) Basic HACCP training, plus 2) an orientation to the requirements of the NCIMS HACCP alternative.

Deficiency: An element inadequate or missing from the requirements of the HACCP System or of this document.

Deviation: A failure to meet a critical limit.

FDA Audit: An evaluation conducted by FDA of the milk plant, receiving station, transfer station facility, and HACCP system to ensure compliance with the HACCP system and other associated NCIMS regulatory requirements.

HACCP (Hazard Analysis Critical Control Point): A systematic approach to the identification, evaluation, and control of significant food safety hazards.

HACCP Listing: An inclusion in the Interstate Milk Shippers(IMS) list of interstate milk shippers based on a State Listing Officer's evaluation of a milk plant HACCP system and applicable NCIMS requirements. Unless specified otherwise, references in the document to ratings will also apply to HACCP listings.

HACCP Listed Shipper: An interstate shipper (receiving station, transfer station, or milk plant) which has been audited by a State Listing Officer. The listing is based on compliance with the NCIMS HACCP Pilot Program.

HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

HACCP System: The result of the implementation of the HACCP plan and prerequisite program.

HACCP Team: The group of people who are responsible for developing, implementing, and maintaining the HACCP system.

Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.

Listing Audit: An evaluation conducted by a State Listing Officer of the milk plant, receiving station, transfer station facility, and HACCP system to ensure compliance with the HACCP system and other associated NCIMS regulatory requirements.

Monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.

Non-Conformity: A failure to meet specified requirements of the HACCP System or of this document.

Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

Shall: Requirements that are mandatory.

Should: Recommended or advisory procedures.

State Listing Officer: A qualified State employee who performs HACCP listing audits of milk plants under the voluntary HACCP listing procedure. The State Listing Officer may have direct responsibility for the routine audits and enforcement of the shipper to be listed.

Validation: The element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the hazards.

Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

HACCP is not a stand-alone program but is part of a larger control system. Prerequisite programs (PP's) are the universal procedures used to control the conditions of the plant environment that contribute to the overall safety of the product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe products in a clean, sanitary environment. They differ from Critical Control Points (CCP's) in that they are background programs that reduce the potential occurrence of a food safety hazard. Frequently, both HACCP Plan CCP's and prerequisite program (PP's) control measures are necessary to control a food safety hazard.

The exact set of prerequisite programs will vary since their application is product and process specific. The existence and effectiveness of prerequisite programs should be assessed during the design and implementation of each HACCP plan. Prerequisite programs should be documented and regularly audited. An audit review consists of verifying that the company has a program implemented that indicates how the company monitors and controls each of the PP's. PP's are established and managed separately from the HACCP plan.

1. Required Prerequisite Programs.

   The following required prerequisite programs (PP's) shall have a brief written description or checklist that the PP's can be audited against to ensure compliance.

   Each milk plant, receiving station or transfer station shall have and implement prerequisite programs (PP) that address conditions and practices before, during, and after processing. The PP's shall address:
   

   1. Safety of the water that comes into contact with food or food contact surfaces (including steam and ice);
      
   2. Condition and cleanliness of equipment food contact surface;
      
   3. Prevention of cross contamination from insanitary objects and or practices to food products, packaging material and other food contact surfaces, including utensils, gloves, outer garments, etc, and from raw product to processed product (e.g. pasteurizer pressure differential);
      
   4. Maintenance of hand washing, hand sanitizing, and toilet facilities*;
      
   5. Protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants;
      
   6. Proper labeling, storage, and use of toxic compounds*;
      
   7. Control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
      
   8. Pest exclusion from the food plant;

      *These two Prerequisite Programs are required under the FDA Juice HACCP Regulation, 21 CFR Part 120. They have been included in Phase 2 of the pilot and will be studied by the NCIMS HACCP Committee for potential inclusion in the final document.

2. Monitoring and Correction.
   

   The milk plant, receiving station or transfer station shall monitor the conditions and practices of all required PP's with sufficient frequency to ensure conformance with those conditions and that are appropriate both to the plant and to the safety of the food being processed. Each milk plant, receiving station or transfer station shall correct those conditions and practices that are not in conformance.

3. Required Records.

   Each milk plant, receiving station or transfer station shall maintain records that document the monitoring and corrections required by this section. These records are subject to the record keeping requirements of this document.

4. In addition to the required prerequisite programs, any other prerequisite programs that are being relied upon in the Hazard Analysis to reduce the likelihood of hazards such that they are not reasonably likely to occur shall also be monitored and documented.

Hazard Analysis:

Each milk plant, receiving station or transfer station shall develop, or have developed for it, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of milk product processed by that milk plant, receiving station or transfer station and to identify the control measures that the milk plant, receiving station or transfer station can apply to control those hazards.

The hazard analysis shall include hazards that can be introduced both within and outside the processing plant environment, including hazards that can occur during production, transportation, processing and distribution.

A 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 possibility that, in the absence of these controls, the hazard will occur in the particular type of product being processed. The hazard analysis shall be developed by an individual(s) trained in accordance with this program and shall be subject to the record keeping requirements as described in this document.

1. In evaluating what food hazards are reasonably likely to occur, at a minimum, consideration should be given to the following:
   1. Microbiological contamination;
      
   2. Parasites;
      
   3. Chemical contamination;
      
   4. Unlawful drug and pesticide residues;
      
   5. Natural toxins;
      
   6. Unapproved use of food or color additives;
      
   7. Presence of undeclared ingredients that may be allergens; and
      
   8. Physical hazards.

2. Milk plant, receiving station or transfer station operators should evaluate product ingredients, processing procedures, packaging, storage, and intended use; facility and equipment function and design; and plant sanitation including employee hygiene to determine the potential effect of each on the safety of the finished product for the intended consumer.

Hazard Analysis Critical Control Point (HACCP) Plan:

1. HACCP plan. Every milk plant, receiving station or transfer station shall have and implement a written HACCP plan whenever a hazard analysis reveals one or more hazards that are reasonably likely to occur. The HACCP plan shall be developed by an individual(s) who has been trained and shall be subject to record keeping requirements as described in this document. A HACCP plan shall be specific to each location and product. The plan may group types of products together, or group types of production methods together, if the hazards, critical control points, critical limits, and procedures required to be identified and performed by paragraph (b) of this section are essentially identical, provided that any required features of the plan that are unique to a specific product or method are clearly delineated in the plan and are observed in practice.

2. The contents of the HACCP plan. The HACCP plan shall, at a minimum:
   1. List all hazards that are reasonably likely to occur as identified in the hazard analysis specified above, and that must be controlled for each type of product.

   2. List the critical control points for each of the identified hazards, including the appropriate:
      1. Critical control points designed to control hazards that could occur or could be introduced in the plant environment; and

      2. Critical control points designed to control hazards introduced outside the plant environment, including hazards that occur before arriving at the milk plant, receiving station and/or transfer station.

   3. List the critical limits that shall be met at each of the critical control points;

   4. List the procedures, and the frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

   5. Include any corrective action plans that have been developed in accordance with the corrective action requirements as described in this document, and that are to be followed in response to deviations from critical limits at critical control points;

   6. List the verification and validation procedures, and the frequency with which they are to be performed, that the milk plant, receiving station or transfer station will use in accordance with verification and validation requirements as described in this document; and

   7. Provide for a record keeping system that documents the monitoring of the critical control points in accordance with the record requirements as described in this document. The records shall contain the actual values and observations obtained during monitoring.
      

3. Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with the prerequisite program, they need not be included in the HACCP plan.

Corrective Actions:

Whenever a deviation from a critical limit occurs, a milk plant, receiving station or transfer station shall take corrective action by following the procedures set forth in paragraph (a) or paragraph (b) of this section.

1. Milk plants, receiving stations or transfer stations may develop written corrective action plans, which become part of their Hazard Analysis and Critical Control Point (HACCP) plans, in accordance with this document, by which milk plants, receiving stations or transfer stations predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:
   1. No product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation in commerce; or

   2. If such product has entered commerce, it is expeditiously removed; and

   3. The cause of the deviation is corrected.

2. When a deviation from a critical limit occurs, and the milk plant, receiving station or transfer station does not have a corrective action plan that is appropriate for that deviation, the milk plant, receiving station or transfer station shall:
   1. Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met;

   2. Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals qualified by training or experience to perform such a review.

   3. Take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

   4. Take corrective action, when necessary, to correct the cause of the deviation; and;

   5. Perform or obtain timely validation as required in this document, by a qualified individual(s), to determine whether modification of the HACCP plan is required to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

3. All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification.
   

Verification and Validation:

1. Verification. Every milk plant, receiving station or transfer station shall verify that the Hazard Analysis and Critical Control Point (HACCP) system is being implemented according to design.
   1. Verification activities shall include:
      1. The calibration of CCP process-monitoring instruments, (e.g. pasteurization tests);
         

      2. At the option of the milk plant, receiving station or transfer station, the performance of periodic end-product or in-process testing;

      3. A review, including signing and dating, by an individual who has been trained in accordance with the training requirements with this document, of the records that document:
         1. The monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that the records document values are within the critical limits. This review shall occur at a frequency that is appropriate to the importance of the record and as specified in the HACCP plan.

         2. The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with the corrective action requirements above. This review shall occur at a frequency that is appropriate to the importance of the record; and a centralized deviation log is required.

         3. The calibrating of any process monitoring instruments used at critical control points (CCP'S) and the performance of any periodic end-product or in-process testing that is part of the milk plant, receiving station or transfer station's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the milk plant, receiving station or transfer station's written procedures. These reviews shall occur within a reasonable time after the records are made.

      4. The taking of corrective action procedures whenever any verification procedure establishes the need to take a corrective action.
         

   2. The calibration of CCP process-monitoring instruments, and the performance of any periodic end-product and in-process testing, in accordance with paragraphs (a)(1)(iii)(B) and (a)(1)(iii)(C) of this section, shall be documented in records that are subject to the record keeping requirements in this document.

2. Validation of the HACCP plan. Every milk plant, receiving station or transfer station shall validate that the HACCP plan is adequate to control hazards that are reasonably likely to occur. This validation shall occur at least once within twelve (12) months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan and prerequisite program. Such changes may include changes in the following:
   • Raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and consumer complaints.

     The validation shall be performed by a qualified individual(s) trained in accordance with the requirements described in this document and shall be subject to the record keeping requirements below. The HACCP plan shall be modified immediately whenever a validation reveals that the plan is no longer adequate to fully meet the requirements of this document.

3. Validation of the hazard analysis. Whenever a milk plant, receiving station or transfer station has no HACCP plan because a hazard analysis has revealed no hazards that are reasonably likely to occur, the milk plant, receiving station or transfer station shall reassess the adequacy of the hazard analysis whenever there are any changes in the process that could reasonably affect whether a hazard exists. Such changes may include changes in the following:
   • Raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and consumer complaints.

   The validation shall be performed by a qualified individual(s) trained in accordance with the training requirements of this document.

Records:

1. Required records. Milk plant, receiving station or transfer station shall maintain the following records documenting the milk plant, receiving station or transfer station's Hazard Analysis and Critical Control Point (HACCP) system:
   1. Records documenting the ongoing application of the prerequisite program, including a brief written description, monitoring and correction records;
      

   2. The written hazard analysis;

   3. The written HACCP plan;

   4. Records documenting the ongoing application of the HACCP plan that include:
      1. Monitoring of critical control points and their critical limits, including the recording of actual times, temperatures, or other measurements, as prescribed in the establishment's HACCP plan; and

      2. Corrective actions, including all actions taken in response to a deviation; and a centralized deviation log is required.

   5. Records documenting verification of the HACCP system and validation of the HACCP system including, HACCP plan, hazard analysis & Prerequisite Programs.

2. General requirements. All records required by this section shall include:
   1. The identity and location of the milk plant, receiving station or transfer station;

   2. The date and time of the activity that the record reflects;

   3. The signature or initials of the person(s) performing the operation or creating the record; and

   4. Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring.

3. Documentation.
   
   1. The records in paragraphs (a)(1) -- (3) of this section shall be signed and dated by the most responsible individual onsite at the milk plant, receiving station or transfer station. These signatures shall signify that these records have been accepted by the firm.

   2. The records in paragraphs (a)(1) - (3) of this section shall be signed and dated:
      1. Upon initial acceptance;

      2. Upon any modification; and

      3. Upon verification and validation in accordance with the requirements above.

4. Record retention.
   1. All records required by this part shall be retained at the milk plant, receiving station or transfer station facility for, in the case of perishable or refrigerated products, at least one (1) year after the date that such products were prepared, and for, in the case of frozen, preserved, or shelf- stable products, two (2) years or the shelf life of the product, whichever is greater, after the date that the products were prepared unless longer retention time is required by other regulations. Retention time will be evaluated during the pilot program.

   2. Records that relate to the adequacy of equipment or processes used, such as commissioning or process validation records, including the results of scientific studies and evaluations, shall be retained at the milk plant, receiving station or transfer station facility for at least two (2) years after the date that the milk plant, receiving station or transfer station last used such equipment or process. Retention time will be evaluated during the pilot program

   3. Off-site storage of processing records is permitted after six (6) months following the date that the monitoring occurred, if such records can be retrieved and provided on-site within twenty-four (24) hours of request for official review. Electronic records are considered to be on-site if they are accessible from an on-site location.

   4. If the processing facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location but shall be immediately returned to the processing facility for official review upon request.

5. Official review. All records required by this section shall be available for official review at reasonable times unless such records would be available for public disclosure.

6. Records maintained on computers. The maintenance of records on computers, in accordance with the above, is acceptable.

REGULATORY SAMPLE TESTING:

Raw commingled, heat treated, finished product testing and water testing shall be conducted in accordance with the Pasteurized Milk Ordinance (PMO).

Each milk plant, receiving station, or transfer station shall adequately document its response to each regulatory sample test result that exceeds the maximum level specified in the PMO. The state regulatory agency will monitor and verify that appropriate action(s) were taken by the milk plant, receiving station, or transfer station.

In addition to the actions taken under the plant's HACCP System, enforcement actions resulting from regulatory sample testing shall be administered utilizing the requirements of Section 3; Permits and Section 6; The Examination of Milk and Milk Products of the Pasteurized Milk Ordinance (PMO).

1. Test results for Pasteurization & Aseptic Processing Equipment Testing shall be recorded on a similar document for all milk plants.

2. Industry personnel conducting the Pasteurization & Aseptic Processing Equipment Testing must be adequately trained and must be able to demonstrate acceptable ability to the regulatory agency.
   1. Industry must demonstrate to the state regulatory that they understand and can perform the required equipment tests according to the PMO standards.

   2. State regulatory could accept a regulatory field practical, a written exam, formal classroom training, or on the job training or any combination of these.

   3. If industry personnel do not demonstrate the appropriate capability to perform the tests adequately to the satisfaction of the regulator, they are not acceptable for conducting such tests.

   4. Continued training such as, but not limited to, on the job training with supervision or an acceptable pasteurizer training course should be completed before they reapply for pasteurizer equipment testing approval.

3. Pasteurization & Aseptic Processing Equipment Tests shall be done at a frequency not less than the PMO standards. Industry shall have responsibility for the performance of all required tests. The semi annual (six (6) month) tests should be performed at a time that is mutually convenient to all parties.

   Upon initial installation or extensive modification of Pasteurization & Aseptic Processing Equipment, Tests shall be physically supervised or conducted by a qualified regulatory official.

4. Sealing guidance for pasteurization equipment by industry is as follows:
   1. The sealing points required to be sealed under the traditional system shall also be done under the HACCP alternative system. The sealing shall be done by a qualified individual who is acceptable to the milk plant and the regulatory agency.

   2. The regulatory agency may verify any equipment sealing and evaluate (accept or reject) the skills and knowledge of the individual performing the sealing.

5. During an audit, the auditor may conduct any or all Pasteurization & Aseptic Processing Equipment Tests through a combination of physical examination of the equipment and/or record review to satisfy the auditor that the equipment is properly installed and operated. The state regulatory agency shall physical supervise the semi annual (six (6) month) test. In any event, the industry is responsible to conduct the tests even in the absence of the state official.

State regulators responsible for the evaluation, licensing and regulatory concerns of facilities using the HACCP alternative will have equivalent training to the training required to perform traditional NCIMS functions. They shall have specialized training in conducting HACCP system evaluation audits.

State listing officers shall be accepted by the state listing agency and the FDA based on specialized training, qualification, and standardization. State listing personnel shall hold a current certificate of qualification from FDA, have participated in at least one Regional Milk Sanitation Rating Officer's Seminar, and in addition, have attended at least one training course in the auditing of dairy plant HACCP systems and NCIMS listing for the period of qualification.

The State shall appoint a State NCIMS HACCP Listing Officer who has attended NCIMS HACCP training in conducting HACCP system audits. If this person is not a State Rating Officer who has been certified for plants by FDA, the state NCIMS HACCP listing shall be jointly conducted with a certified plant rating officer who has also attended the NCIMS HACCP training. This is intended to provide the requirement for standardization in the interim for the pilot program. HACCP listing standardization criteria will be developed by the NCIMS HACCP Committee.

The state regulator assigned to audit a plant under the NCIMS HACCP pilot program may also conduct the NCIMS HACCP listing audit if that regulator is also a certified plant rating officer.

FDA personnel responsible for HACCP audits and state program evaluations shall, at a minimum, be required to meet the same level of training and standardization required for state listing officers.

Industry, State and Federal regulatory and listing personnel should be trained together.

HACCP Training:

1. The individual(s) performing the functions listed in paragraph (b) of this section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk products processing at least equivalent to that received under the Dairy Foods HACCP Core Curriculum.

   The Dairy Foods HACCP Core Curriculum consists of (1) Basic HACCP training plus (2) an orientation to the requirements of the NCIMS HACCP alternative.

   Basic HACCP training consists of instruction in the application of the NACMCF Principles of HACCP to Food Safety. This training includes practical exercises in conducting a hazard analysis and evaluating potential hazards, in writing a HACCP plan, and in the validation of the plan. It should be taught by experienced instructors.

   The orientation ideally is coupled with the basic training, but can be taught separately. The content of the orientation will be supervised by the NCIMS HACCP committee or its designees for the time being. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the NCIMS alternative. It is to be taught by instructors experienced in the application of HACCP under the NCIMS alternative.

2. Only individuals who have met the requirements of paragraph (a) of this section shall be responsible for the following functions:
   1. Developing the hazard analysis, including delineating control measures, as required;

   2. Developing a HACCP plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements;

   3. Validating and modifying the HACCP plan in accordance with the corrective action procedures and the validation activities as specified; and

   4. Performing required records reviews.

3. Regulatory personnel performing HACCP audits shall have successfully completed appropriate training in the application of HACCP principles to milk and milk products processing at least equivalent to that received under the Dairy Foods HACCP Core Curriculum.

Specialized Training for HACCP Auditing and Listing Procedures:

FDA shall assist in providing training to regulatory officials and/or state listing officers in each of its regions in the evaluation, licensing and regulatory concerns of facilities to bring the processing facility into the HACCP alternative, listing the facility with NCIMS, conducting the HACCP audit, and providing feedback and guidance to the firm. Others charged by law with the enforcement of milk HACCP regulations, along with representatives of the regulated industry should attend such training.

These personnel should already be familiar with the principles of HACCP and the requirements for developing, implementing, and maintaining a HACCP plan. In addition, they should be familiar with the elements of public health protection and the requirements of the PMO from previous training.

FDA personnel responsible for HACCP audits and state program evaluations shall, at a minimum, be required to meet the same level of training and standardization required for state listing officers.

Audit: An evaluation conducted of the milk plant, receiving station, transfer station facility, and HACCP system to ensure compliance with the HACCP system and other associated NCIMS regulatory requirements.

The audit may be announced at the discretion of the auditor under certain circumstances, e.g. initial audit, follow-up audit, new construction, pasteurizer checks. When unannounced audits are conducted, the audits shall not be completed until appropriate plant personnel have had an opportunity to make all pertinent records available for review by the auditor.

Auditing Procedures:

1. Pre-Audit Management Interview.
   Review and discuss the plant HACCP system including:
   
   1. Changes in the management structure
      
   2. The Hazard Analysis - ensure that all food hazards are addressed
      
   3. Changes in the HACCP plan
      
   4. Changes in the prerequisite program
      
   5. Changes in the flow diagram
      
   6. Changes in products or processes
2. Review past Audit Reports (AR) and corrections of deficiencies and non-conformities, if any.
   
3. In-plant review of implementation and verification of HACCP System.
   
4. Review records of the HACCP System.
   
5. Review compliance with *other applicable NCIMS regulatory requirements.
   
6. Discuss findings and observations.
   
7. Prepare and issue an AR based on findings of deficiencies and non-conformities. The AR shall include timelines for correction of all identified deficiencies and non-conformities, if any.
   
8. Conduct the exit interview.
   

*Examples of other applicable NCIMS Requirements

1. Raw Milk Supply Source
   
2. Labeling compliance
   
3. Adulteration
   
4. Licensing Requirements
   
5. Drug Residue Traceback Requirements
   
6. Regulatory samples in compliance
   
7. Pasteurization Equipment design and construction
   

State Enforcement Action/Follow-Up:

1. The state agency shall prepare and issue Audit Reports (AR) based on findings of deficiencies and non-conformities.

2. The state agency shall review the AR with the plant and establish time lines for correction of all identified deficiencies and non-conformities.

3. The state agency shall follow-up to ensure corrections are made as a result of the issuance of the AR.

4. The state agency shall take immediate action when an imminent health hazard is observed to prevent further movement of milk and milk products until such hazards have been eliminated.
   

5. When the plant has failed to recognize or correct a deficiency(s) or nonconformity(s), the state shall initiate regulatory action such as permit/license suspension, revocation, hearings, court actions, and/or other equivalent measures.

Audit Timeframes:

Audits	Frequency Minimums
First Year:	1. Initial audit; 2.Next audit in 30 to 45 days; and 3. Four (4) month follow-ups
Subsequent Audits	1. Every six (6) months; or 2. Compliance follow ups
Listing Evaluations	1. Every two (2) years

Listing Procedures:

Listing Audit: An evaluation conducted by a state listing officer of the milk plant, receiving station, transfer station facility, and HACCP system to ensure compliance with the HACCP system and other associated NCIMS regulatory requirements.

The audit may be announced at the discretion of the auditor under certain circumstances, e.g. initial audit, follow-up audit, new construction, pasteurizer checks. When unannounced audits are conducted, the audits shall not be completed until appropriate plant personnel have had an opportunity to make all pertinent records available for review by the auditor.

Prior to a HACCP Listing, the plant shall have a HACCP System implemented and functioning.

Listing Audit Procedures:

1. Pre-Audit Management Interview
   Review and discuss the plant HACCP system including:
   
   1. The management structure
      
   2. The Hazard Analysis - ensure that all food hazards are addressed
      
   3. The HACCP plan
      
   4. The Prerequisite program
      
   5. The flow diagrams
      
   6. The products/processes
2. Review past Audit Reports (AR) and corrections of deficiencies and non-conformities if any.
   
3. In-plant review of implementation and verification of HACCP System.
   
4. Review records of the HACCP System.
   
5. Review compliance with *other applicable NCIMS regulatory requirements.
   
6. Discuss findings and observations.
   
7. Prepare and issue an AR based on findings of deficiencies and non-conformities.
   
8. Conduct the exit interview.

*Examples of other applicable NCIMS Requirements

1. Raw Milk Supply Source
   
2. Labeling compliance
   
3. Adulteration
   
4. Licensing Requirements
   
5. Drug Residue Traceback Requirements
   
6. Regulatory samples in compliance
   
7. Pasteurization Equipment design and construction

Criteria and Procedures for Denial or Withdrawal of Listing:

1. A HACCP Listing may be denied or withdrawn when Critical Listing Elements have been noted indicating:
   1. The plant has failed to recognize or correct a deficiency(s) or nonconformity(s) indicating:
      1. A major HACCP system dysfunction that is reasonably likely to result in a food safety hazard* or an adverse health consequence(s).
         *A food 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 food hazard will occur in the particular type of product being processed.

      2. A series of observations that leads to a finding of a potential HACCP System failure that is likely to result in a compromise to food safety.

      3. Drug Residue Traceback requirements are not met.

      4. Milk is received from a supply other than a NCIMS listed source.
         

2. Critical Listing Elements (CLE's) have been identified to assist the auditor in determining condition(s) which constitute a major dysfunction in the NCIMS HACCP system. When one or more critical listing elements are determined to be out of compliance, it is likely that product safety has been compromised to some degree. Significant deficiencies involving one or more critical listing elements constitute grounds for denial or withdrawal of a plant's NCIMS HACCP listing. The auditor must carefully evaluate, however, to determine whether the observation is merely an anomaly in a plant which is making a rigorous effort to properly operate their HACCP system. In this case, professional judgment should be exercised to allow the plant to retain its listing and benefit from the observation by making the necessary corrections to their system.

   Critical Listing Elements (CLE's) are noted on the NCIMS HACCP System Pilot Audit Report with a double Star (**) and cover these areas of the NCIMS Pilot Program:

   1. HAZARD ANALYSIS
      
      • Hazard analyses conducted & written for each kind or group of milk or milk product processed.

   2. HACCP PLAN
      
      • HACCP plan prepared for each kind or group of milk or milk product processed.

   3. HACCP PLAN CRITICAL LIMITS (CL)
      • Critical Limits(s) are adequate to control the hazard identified.

   4. HACCP PLAN CORRECTIVE ACTION
      
      • Corrective action taken for products produced during a deviation from critical limits defined in the HACCP plan

   5. HACCP PLAN VERIFICATION & VALIDATION
      
      • Calibration of 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
      
      • Drug residue control program implemented.
        
      • Raw milk supply from NCIMS listed source(s).

   8. HACCP SYSTEM AUDIT FINDINGS
      
      • A series of observations that lead to a finding of a potential HACCP System failure that is likely to result in a compromise to food safety.

FDA Audit Procedures:

FDA Audit: An evaluation conducted of the milk plant, receiving station, transfer station facility, and HACCP system to ensure compliance with the HACCP system and other associated NCIMS regulatory requirements.

FDA shall conduct on-site plant audits of the HACCP compliance status of listed interstate milk shippers. If there is reason to doubt the safety of any state's milk and milk products, FDA shall immediately investigate and may audit the plants affected.

The audit may be announced at the discretion of the auditor under certain circumstances, e.g. initial audit, follow-up audit, new construction, pasteurizer checks. When unannounced audits are conducted, the audits shall not be completed until appropriate plant personnel have had an opportunity to make all pertinent records available for review by the auditor.

The state regulatory and listing authority shall have the option to accompany FDA at the time of the on-site plant audit. This audit may be used in the overall state program evaluation.

FDA Auditing Procedures:

1. Pre-Audit Management Interview
   Review and discuss the plant HACCP system including:
   
   1. The management structure
      
   2. The Hazard Analysis - ensure that all food hazards are addressed
      
   3. The HACCP plan
      
   4. The prerequisite program
      
   5. The flow diagram
      
   6. The product/process
      
2. Review past Audit Reports (AR) and corrections of deficiencies and non-conformities if any.
   
3. In-plant review of implementation and verification of HACCP System.
   
4. Review records of the HACCP System.
   
5. Review compliance with *other applicable NCIMS regulatory requirements.
   
6. Discuss findings and observations.
   
7. Prepare and issue an AR based on findings of deficiencies and non-conformities.
   
8. Conduct the exit interview.
   

*Examples of other applicable NCIMS Requirements

1. Raw Milk Supply Source
   
2. Labeling compliance
   
3. Adulteration
   
4. Licensing Requirements
   
5. Drug Residue Traceback Requirements
   
6. Regulatory samples in compliance
   
7. Pasteurization Equipment design and construction
   

Actions To Be Taken by States and FDA:

1. If a plant's HACCP system is found to be valid and properly verified, the plant's listing shall be valid until the next listing audit.

2. Should a plant'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.
   1. RE-AUDIT
      1. If 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 adulteration, the deficiency 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 deficiency or non-conformity shall be specified by the FDA auditor in writing to the State.

      2. If after notice the HACCP system deficiencies or non-conformities have not been corrected, the plant listing shall be withdrawn by the state.

         If the HACCP System deficiency or non-conformities have been corrected, the state listing agency shall notify the regional office of FDA and no further action will be necessary.

   2. WITHDRAWAL OF CERTIFICATION
      
      1. A HACCP Listing may be requested to be withdrawn when Critical Listing Elements (CLE's) have been noted indicating:
         1. The plant has failed to recognize or correct a deficiency(s) or non-conformity(s) indicating:
            1. A major HACCP system dysfunction and is reasonably likely to result in a food safety hazard* or an adverse health consequence(s).

               * A food 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 food hazard will occur in the particular type of product being processed.

            2. A series of observations that leads to a finding of a potential HACCP System failure that is likely to result in a compromise to food safety.

            3. Drug Residue Traceback requirements are not met.

            4. Milk is received from a supply other than a NCIMS listed source.

      2. Critical Listing Elements (CLE's) have been identified to assist the auditor in determining condition(s), which constitute a major dysfunction in the NCIMS HACCP system. When one or more critical listing elements are determined to be out of compliance, it is likely that product safety has been compromised to some degree. Significant deficiencies involving one or more critical listing elements constitute grounds for denial or withdrawal of a plant's NCIMS HACCP listing. The auditor must carefully evaluate; however, to determine whether the observation is merely an anomaly in a plant, which is making a rigorous effort to properly operate their HACCP system. In this case, professional judgment should be exercised to allow the plant to retain its listing and benefit from the observation by making the necessary corrections to their system.

         Critical Listing Elements (CLE's) are noted on the NCIMS HACCP System Pilot Audit Report with a double Star (**) and cover these areas of the NCIMS Pilot Program:

         1. HAZARD ANALYSIS
            
            • Hazard analyses conducted & written for each kind or group of milk or milk product processed.
         2. HACCP PLAN
            
            • HACCP plan prepared for each kind or group of milk or milk product processed.
         3. HACCP PLAN CRITICAL LIMITS (CL)
            • Critical Limits(s) are adequate to control the hazard identified.
         4. HACCP PLAN CORRECTIVE ACTION
            • Corrective action taken for products produced during a deviation from critical limits defined in the HACCP plan
         5. HACCP PLAN VERIFICATION & VALIDATION
            • Calibration of 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
            
            • Drug residue control program implemented
              
            • Raw milk supply from NCIMS listed source(s).
         8. HACCP SYSTEM AUDIT FINDINGS
            
            • A series of observations that lead to a finding of a potential HACCP System failure that is likely to result in a compromise to food safety.

      3. When FDA audit data indicates that the milk plant, receiving station and/or transfer station requires a withdrawal of certification, the state listing agency, upon written recommendation of the FDA, shall immediately withdraw the current certification of the shipper and notify such shipper, the FDA, and all known receiving States thereof. In case of withdrawal, a new listing shall be made when the State listing agency has reason to believe an audit would result in an acceptable listing. The effective date for action shall be determined from the date of the letter of notification by the state listing agency. Such letter shall be dated within five (5) working days following the date of the official notification.

      4. If a state listing agency fails to immediately notify all known receiving States when current certification of a listed shipper is to be withdrawn as recommended by FDA, the FDA, after a reasonable lapse of time (not to exceed five (5) days), shall provide all participating States with the FDA Audit conclusion. The states, 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.

      5. If the state milk listing agency informs FDA that it is unable to make arrangements for FDA to audit HACCP listed shippers, 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 state listing 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, FDA shall, after five (5) days, provide this information to all receiving states.

      7. Imminent health hazard
         1. When an imminent health hazard is observed, FDA shall request the state regulatory agency to take immediate action to prevent further movement of such milk or milk products until such hazards have been eliminated. If such violation results in a product that presents a public health risk, the state regulatory agency shall take action against product produced and/or processed that has already entered the distribution system.

         2. The state agency shall report in writing to FDA concerning actions taken within five (5) working days.

         3. If the regulatory agency fails to take immediate appropriate corrective action, FDA may take any action necessary to protect the public health.

         4. If the state fails to take immediate action to correct identified hazards, or fails to notify FDA concerning actions taken within five (5) working days, FDA shall provide this information to the receiving states.

FDA STATE PROGRAM EVALUATIONS AND
FOLLOW UP ACTIONS TO BE TAKEN BY STATES AND FDA

FDA State Program Evaluations:
In the event a state has a participating HACCP plant, FDA shall conduct an evaluation of the NCIMS HACCP program, as a part of the state program evaluation.

FDA shall conduct on-site plant audits of the HACCP compliance status of listed interstate milk shippers. Within a state, audits will be made of a representative number of IMS Listed Shippers. The selection of shippers for audits in a given state will be made randomly. The state regulatory and listing authority shall have the option to accompany FDA at the time of the on-site plant audit. This audit shall be used in the overall state program evaluation.

FDA will use the following elements to determine substantial compliance and to develop a written state program evaluation.

1. Background

1. Discuss governing regulations, state statutes and administrative procedures. Include which department(s) and division(s) implement the NCIMS HACCP program.
2. Note any significant changes from previous years.
3. Provide a state program charter, vision and/or mission statement and an organization chart if available.

2. Substantial Compliance

1. Are the state laws and regulations substantially equivalent to the NCIMS requirements?

1. Has the state adopted the current PMO/DMO or does it have equivalent regulations in place that ensure the provisions of the NCIMS HACCP program can be effectively implemented and enforced?
2. Does the state agency follow the provisions of the state statutes and administrative rules?

   (FDA should comment on areas, which are not followed and explain why).

3. Has the state adopted or enforced any rules or regulations, which deny the movement of milk, and milk products that originate from points beyond the limits of routine inspection that are produced and pasteurized under the NCIMS HACCP program, PMO/DMO or equivalent regulations?

   (FDA shall review current state statutes, comparing them to the current edition of the PMO/DMO and attendant documents and describe any changes in state statutes or regulations since the last program evaluation.)

2. Is the state following the procedures of the NCIMS conference as applied to NCIMS HACCP program participation?

1. Qualifications/Training/Acceptance

1. State Program Resources:

   Does the state program have adequate staffing and resources to support participation in the NCIMS HACCP program?

2. State Listing Agency/Officers:

   Have state listing officers received training in HACCP principles and HACCP program evaluations including validation, on-site auditing, and verification?

   Have state listing officers been accepted by the state listing agency and FDA based on training, qualifications, and standardization with FDA?

   Have state listing officers attended continuing education courses required in the HACCP Training & Standardization Section?

   Have state listing officers conducted HACCP audits based on the current HACCP Audit & Listing Procedures Section?

2. State Listing Agency

1. Does the state listing agency follow HACCP Audit & Listing Procedures for accepting a plant into the NCIMS HACCP Program?
2. Does the state listing agency conduct regular HACCP audits of the plant in accordance with HACCP Audit & Listing Procedures?
3. Does the state listing agency submit HACCP listing reports to FDA on a timely basis to maintain a current listing in the IMS List?
4. Does the state listing agency notify shipping or receiving states and FDA of any change in status of a listed shipper following HACCP Audit & Listing Procedures?

3. State Enforcement Action/Follow-up

1. Does the state agency prepare and issue Audit Reports (AR) based on findings of deficiencies and non-conformities?
2. Does the state agency review the AR with the plant and establish time lines for correction of all identified deficiencies and non-conformities?
3. Does the state agency follow up in a timely manner to ensure corrections are made as a result of the issuance of the AR?
4. Does the state agency take immediate action when an imminent health hazard is observed to prevent further movement of milk and milk products until such hazards have been eliminated?
5. Does the state agency conduct permit issuance, suspension, revocation, reinstatement, hearings, court actions, and/or equivalent measures as required?

4. Lab Evaluation Officers (LEO's) Listing Evaluations /Sampling Surveillance Officers

1. Does the state maintain or employ the use of certified LEO's and participate in the Laboratory Quality Assurance Branch (LQAB) laboratory evaluation process?
2. Does the state conduct split sample analysis with laboratories used by certified interstate milk shippers and notify FDA per the specified time lines?
3. Does the state maintain standardized sampling surveillance officers?

5. State Reciprocity

   Does the state follow the steps outlined in HACCP Audit & Listing Procedures to address complaints (in accordance with Section 7 of the Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers), inquiries and shipper actions following an adverse decision from a FDA state evaluation?

3. Do FDA conducted on-site audits indicate that the State Regulatory HACCP Program is effective in providing public health protection to consumers?

1. Do all milk plants, receiving stations and transfer stations under HACCP have a valid NCIMS HACCP program?
2. Is there evidence either through FDA/State consumer complaints, recalls, FDA on-site audits, sampling surveillance programs or other means to show the state program may fail to provide appropriate regulatory oversight, or that the industry may fail to provide a safe and wholesome product to the consumer? (FDA shall document and comment on areas of concern.)

3. Conclusion

   FDA will analyze administrative and field data to make a determination of substantial compliance with the NCIMS HACCP program and any substantial public health weaknesses in the state's milk safety program. In addition, a discussion of the state's program strengths and areas for improvement will be included, as well as a comparison of current and past program evaluation elements.

4. Recommendations

   FDA will provide guidance to the state program managers on how to better strengthen and improve the state program within the framework of the NCIMS.

5. Summary and Publication

   FDA shall prepare a summary report noting significant findings of the FDA State Program Evaluation. This summary shall be published in the IMS List.

Follow-Up Actions To Be Taken By States And FDA:

1. Substantial State Program Weakness

1. If, after collecting and analyzing administrative and field data, FDA determines that there are substantial public health weaknesses in the state's milk safety program, FDA will provide comprehensive evaluations and documentation to the Regional Food and Drug Director (RFDD).
2. The RFDD will develop a follow-up plan or strategy.
3. Top FDA and state program officials will meet to discuss what actions can be undertaken to address the program weaknesses and what assistance FDA can provide.
4. The Division of Cooperative Programs should be advised of the follow-up steps, which will be undertaken by the region to encourage and assist the state in strengthening the state's milk safety program.
5. FDA is responsible for implementing and monitoring the follow-up action plan developed and mutually agreed upon at the joint FDA-State meeting concerning FDA's evaluation report. FDA's success in encouraging the state to correct substantial program weaknesses will depend in large part on the effectiveness of these follow-up efforts.
6. If FDA determines that there are no substantial public health weaknesses in the state milk safety program, the FDA region should request a meeting with the state to advise them of this finding and to plan how FDA can best continue to provide assistance to help the state preserve the public health.
7. FDA shall send a notice requiring corrections to the state's program within thirty (30) days and shall notify the affected industry and receiving states of this action.

HISTORY OF HACCP

The use of the Hazard Analysis and Critical Control Point (HACCP) system is not new to the dairy industry. HACCP is a logical, simple, effective, but highly structured system of food safety control.

The HACCP system was introduced to the food industry as a spin-off of the space program during the 1960's. The National Aeronautics and Space Administration (NASA) used HACCP to provide assurance of the highest quality available for components of space vehicles. This program, to develop assurance of product reliability, was carried over into the development of foods for astronauts.

The U.S. Army Natick Laboratories, in conjunction with NASA, began to develop the foods needed for manned space exploration. They contracted with the Pillsbury Company to design and produce the first foods used in space. While Pillsbury struggled with certain problems, such as how to keep food from crumbling in zero gravity, it also undertook the task to come as close as possible to 100% assurance that the foods they produced would be free of bacterial or viral pathogens.

Using traditional quality control methods for the food industry was soon proven to be unworkable for the task Pillsbury had undertaken. The degree of safety desired was not provided by the current programs, and the product sampling necessary to provide an adequate degree of safety would have been prohibitive to commercialization of space foods. Pillsbury discarded its standard quality control methods and began an extensive evaluation, in conjunction with NASA and Natick Labs, to evaluate food safety. They soon realized that to be successful they would have to have control over their process, raw materials, environment, and their people. In 1971, they introduced HACCP as a preventive system that enables manufacturers to produce foods with a high degree of assurance that the foods were produced safely.

HACCP is a management tool that provides a more structured and scientific approach to the control of identified hazards than that achievable by traditional inspection and quality control procedures. HACCP is a logical basis for better decision making with respect to product safety. HACCP has international recognition as the most effective means of controlling food borne disease and is endorsed as such by the joint FAO/WHO Codex Alimentarius Commission. It has also been endorsed by the U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF).

One of the key advantages of the HACCP concept is that it will enable those operating under and regulating under a HACCP plan to move to a preventive approach, whereby potential hazards are identified and controlled in the manufacturing environment (i.e., prevention of product failure). HACCP allows for a preventive, systematic approach to food safety, rather than a reactive method.

NCIMS DOCUMENTS COMPARISON

Preliminary NCIMS draft document for changes to the PMO, DMO, Procedures and MMSR are available on the FDA web site.

This comparison is presented to assist NCIMS voting delegates and others in understanding the recommended HACCP pilot program. It compares the HACCP pilot program recommended by the NCIMS HACCP Committee and the current NCIMS documents.

If the HACCP alternative is adopted, final wording changes to these documents based on both this proposal and lessons learned during the pilot study will be needed.

For purposes of this comparison, all portions of the NCIMS documents will apply as written during the pilot, unless noted.

Grade "A" Pasteurized Milk Ordinance 1999 Revision:

NOTE: The public health intent of various portions of Sections 7, 13 14 and the appendixes referred to in these sections may be met in ways not specified in this proposal or in the detail of current PMO requirements if regulatory and FDA audits of the milk plant HACCP system demonstrate that the applicable public health intent is fully met.

Grade "A" Condensed and Dry Milk Ordinance:

NOTE: The public health intent of various portions of Sections 7, 10 11 and the appendixes referred to in these sections may be met in ways not specified in this proposal or in the detail of current DMO requirements if regulatory and FDA audits of the milk plant HACCP system demonstrate that the applicable public health intent is fully met.

Evaluation of Milk Laboratories:

No change.

Methods of Making Sanitation Ratings:

Milk plants, transfer stations or receiving stations listed under the HACCP alternative will be listed using the criteria in this proposal.

Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for the Certification of Interstate Milk Shippers 1999 Revision:

The following are subject areas for which this document will need to be modified to implement the HACCP alternative after the pilot study.

For purposes of this recommended pilot study, participating industry, regulatory and FDA personnel will need to deal with these concepts as described in the proposal.

1. Listing audits will be used in place of ratings.
2. State Listing Officers (see proposal for details) will perform state listing audits.
3. FDA will conduct audits of state listings (see proposal for details) in place of check ratings.
4. Actions to be taken in response to unsatisfactory state regulatory audits, state listing audits and FDA audits are specified in this proposal.
5. HACCP training will be required for key industry individuals, State Regulators, State Listing Officers and FDA audit personnel. FDA will assist in this training effort as needed before, during and after the pilot.
6. Specialized training and standardization will be required for State Regulators, State Listing Officers and FDA audit personnel (see proposal for details).
7. FDA will evaluate state HACCP programs as a part of the FDA State Program Evaluation.
8. Nothing in this proposal will affect the rights of shipping or receiving states to use the current complaint procedure.

Background Information

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