U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Division of HACCP Programs
January 2000

At the October 1997 National Conference on Interstate Milk Shipments (NCIMS), the delegates voted for passage of proposals #126 and #203.

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 is grateful for the contributions it received from many interested individuals.

Claudia G. Coles, Chair, Washington State Department Of Agriculture
Judy Baron, Arizona Department Of Agriculture
John A. Beers, Virginia Department Of Agriculture and Consumer Services
J. Russell Bishop, Ph.D., University of Wisconsin Center for Dairy Research
Michele Bradley, Kraft Foods, Inc.
Rob Byrne, Ph.D., National Milk Producers Federation
John A. Ciccarelli, Anderson Instrument Company, Inc. - Technical Advisor
Susan Crawford, Michigan Department Of Agriculture
Paul Dersam, Upstate Milk Cooperative, Inc.
Don Goldsmith, Minnesota Department Of Agriculture
Richard F. Graham, Louisiana Department Of Health and Human Resources
John Rushing, Ph.D., North Carolina State University
Allen Sayler, International Dairy Foods Association
Steven T. Sims, Food and Drug Administration - Technical Advisor

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 prior to the 1999 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 new regulations have been proposed for juices. 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 can be 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.

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.

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 1997 R-5 Revision

NOTE: The public health intent of various portions of Sections 12, 13, 18, 19 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.

Section l. Definitions.	Replace I-1 through I-10 with HACCP definitions in this proposal.
Section 2. Adulterated or Misbranded Milk or Milk Products.	No change.
Section 3. Permits.	Milk plants, transfer stations and receiving stations permitted under the HACCP alternative will follow the HACCP permit procedures specified in this proposal.
Section 4. Labeling.	No change.
Section 5. Inspection of Dairy Farms and Milk Plants.	Milk plants, transfer stations and receiving stations issued permits under the HACCP alternative will receive those permits based on regulatory audits of each plant's HACCP system. These audits will be made at the frequencies specified in this proposal. The audits will be performed in place of quarterly inspections. The audits will include a physical evaluation of the milk plant construction and sanitation conditions as well as a review of the milk plant HACCP system records as described in this proposal. Permit suspensions will be based on unsatisfactory audit results as described in this proposal.
Section 6. The Examination of Milk and Milk Products.	Section 6 and CCP3r (Appendix N) Milk requirements apply as written, except that under the HACCP alternative, the action to prevent repeated violations of current PMO bacterial, temperature or coliform standards will be specified in the individual milk plant HACCP systems. These systems must be approved by the regulatory agency as specified in this proposal.
Section 7. Animal Health.	No change.
Section 8. Milk and Milk Products Which May be Sold.	No change.
Section 9. Transferring, Delivery, Containers; and Cooling.	No change.
Section 10. Milk and Milk Products From Beyond the Limits of Routine Inspection.	Milk and milk products which are listed under the HACCP alternative will also be acceptable. Receiving states may still test and reject milk not meeting PMO Section 18 temperature, chemical or bacteriological requirements.
Section 11. Plans for Construction and Reconstruction.	No change.
Section 12. Personnel Health.	Under the HACCP plan, the regulatory agency is permitted some flexibility in satisfying safety requirements.
Section 13. Procedure When Infection Or High Risk of Infection is Discovered.	Same as Section 12.
Section 14. Enforcement.	No change.
Section 15. Penalty.	No change.
Section 16. Repeal and Date of Effect.	No change.
Section 17. Separability Clause.	No change.
Section 18. Prerequisites for Grade "A" Milk and Milk Products.	Under the HACCP alternative, flexibility will be allowed with regard to how each stated public health reason will be satisfied.
Section 19. Critical Control Points.	Same as Section 18. The pasteurization requirements in CCP2p will be used as written. Under the HACCP alternative, as under the traditional system, conceptual modifications of PMO-required pasteurization systems must be evaluated and accepted by the state and must be acceptable to FDA.
Appendix A-P will apply as written except that: Under Appendix I the regulatory agency may accept testing and sealing of pasteurizer equipment by other than regulatory personnel as described in this proposal. If a public health requirement described in Sections 12,13, 18 or 19 is satisfied in a manner not described in the current text, appendixes referenced in that text may or may not apply.

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 1997 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.

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in Title 21 Code of Federal Regulations (CFR), part 110, the current Good Manufacturing Practices (GMP), part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, part 131, Milk and Cream, and the Pasteurized Milk Ordinance (PMO) are applicable to such terms when used in this document, except where they are herein redefined. The following definitions shall also apply:

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.

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:

A deficiency or nonconformity which is likely to result in an adverse health consequence.

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.

Dairy Foods HACCP Core Curriculum:

For the purposes of the pilot program, appropriate HACCP training can be used for state regulatory, dairy industry and FDA personnel involved with the pilot. This training will be developed and presented jointly by the dairy industry, states and FDA. It is anticipated that an appropriate long-term Dairy Foods HACCP Core Curriculum will be developed, standardized and certified by an appropriate certification/standardization body similar to that of other functioning HACCP alliances.

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 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.

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 prerequisite program and that the system is operating according to the plan.

Prerequisite Programs

HACCP is not a stand-alone program but is part of a larger control system. Prerequisite programs 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 design, produce and distribute safe products in a clean, sanitary environment.

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 shall address public health concerns identified in 21 CFR part 110, 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.

The existence and effectiveness of prerequisite programs should be assessed during the design and implementation of each HACCP plan. All prerequisite programs should be documented and regularly audited. Prerequisite programs are established and managed separately from the HACCP plan. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan. For example, many establishments have preventive maintenance procedures for processing equipment to avoid unexpected equipment failure and loss of production.

The exact set of prerequisite programs will vary since their application is product and process specific, just like a HACCP plan. A milk plant, receiving station or transfer station will have some flexibility in determining whether a hazard can best be controlled under a prerequisite program or the HACCP plan. Many prerequisite programs can reduce the likelihood that hazards will occur in the product. When this is possible, firms tend to expand and strengthen their prerequisite programs to minimize the likelihood of hazards occurring and the number of hazards to be controlled under the HACCP plan. The HACCP hazard analysis process can help with this determination. Therefore, the following list is meant to be informational. That is, it may include programs that are not needed in some situations and may not include programs that are needed in other situations. Prerequisite programs may address:

1. Premises
   1. Outside Property
   2. Building
   3. Sanitary Facilities
   4. Water/Steam/Ice Quality Program

2. Receiving
   1. Incoming Material
   2. Specifications
   3. Supplier Controls

3. Transportation and Storage
   1. Food (Milk) Carriers
   2. Temperature Control
   3. Storage of incoming materials, non-food chemicals and finished product

4. Equipment
   1. General Equipment Design
   2. Equipment Installation
   3. Equipment Maintenance and Calibration

5. Personnel
   1. Training
   2. Hygiene and Health Requirements

6. Recalls
   1. Recall Procedures
   2. Distribution Records

Sanitation Standard Operating Procedure (SSOP)

Each milk plant, receiving station or transfer station shall have and implement, a written sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing and relates to the following:

1. Safety of the water that comes into contact with food or food contact surfaces;
2. Condition and cleanliness of food contact surfaces;
3. Prevention of cross-contamination;
4. Protection of food, food packaging material, and food contact surfaces from adulteration;
5. Control of employee health conditions and hygiene that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and
6. Exclusion of pests from the plant.

The milk plant, receiving station or transfer station shall monitor the conditions and practices during processing with sufficient frequency to ensure conformance with those conditions and practices specified in 21 CFR part 110 and the PMO that are appropriate both to the plant and to the food being processed. Each milk plant, receiving station or transfer station shall correct those conditions and practices that are not in conformance.

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

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; and

   2. 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. A review of any consumer complaints that have been received by the milk plant, receiving station or transfer station to determine whether such complaints relate to the performance of the HACCP plan or reveal previously unidentified critical control points;

      2. The calibration of process-monitoring instruments;

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

      4. 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

         3. The calibrating of any process monitoring instruments used at critical control points 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.

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

   2. The calibration of process-monitoring instruments, and the performance of any periodic end-product and in-process testing, in accordance with paragraphs (a)(1)(iv)(B) and (a)(1)(iv)(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 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. The written prerequisite program.

   2. Records documenting the ongoing application of the prerequisite program, including required sanitation monitoring and corrective action records;

   3. The written hazard analysis;

   4. The written HACCP plan;

   5. 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

   6. Records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis.

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), (a)(3) and (a)(4) 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), (a)(3) and (a)(4) 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.

HACCP training for industry and regulatory personnel will be based on the current Hazard Analysis and Critical Control Point Principles and Application Guidelines of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), the current FDA HACCP recommendations, and the regulatory requirements of this document.

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, 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.

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 will be trained together in the Dairy Foods HACCP Core Curriculum.

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 or shall be otherwise qualified through job experience to perform these functions. Job experience may qualify an individual to perform these functions if such experience has provided knowledge at least equivalent to that provided through the standardized curriculum.

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.

State Enforcement Audits, Actions and Follow-Up

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.

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
      

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	initial audit; next audit in 30 to 45 days; 4 month follow-ups
Subsequent Audits	every 6 months & compliance follow ups
Listing Evaluations	every 2 years

Listing Procedure

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.

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
   

Criteria for Denial of Listing:

The plant has failed to recognize or correct a deficiency(s) or nonconformity(s) indicating 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.

In addition, a listing may be denied if:

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

2. Drug Residue Traceback requirements are not met.

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.

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
   

Actions To Be Taken:

1. 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.

2. When Product Safety Is In Doubt

   1. 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.

   2. 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.

   3. Should a plant's HACCP system be found to be either invalid or improperly verified, FDA shall request that the state initiate regulatory action. If deficiencies 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 shall be corrected and the correction confirmed by an appropriate listing official.

   4. If after notice, the HACCP system deficiency has not been corrected, the plant listing shall be withdrawn by the state.

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 reporting format 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. 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.

2. When Product Safety Is In Doubt

   1. 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.

   2. 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.

   3. Should a plant's HACCP system be found to be either invalid or improperly verified, FDA shall request that the state initiate regulatory action. If deficiencies 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 shall be corrected and the correction confirmed by an appropriate listing official.

   4. If after notice, the HACCP system deficiency has not been corrected, the plant listing shall be withdrawn by the state.

3. 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.

Raw commingled, heat treated and finished product testing shall be conducted in accordance with the PMO except that the HACCP system of each milk plant, receiving station, or transfer station shall address what appropriate action(s) will be taken if regulatory sample test results exceed the maximum levels specified in the 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.

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.

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 the required quarterly (three (3) month) checks. The semi-annual (six (6) month) tests shall be physically supervised or conducted by a qualified regulatory official.
   

   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.

NCIMS HACCP Pilot Program, Phase II Expansion May 2001