U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
May 2001

NCIMS HACCP Proposals

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The NCIMS HACCP Committee has recognized that if the HACCP pilot program expands within the NCIMS system, there will be a need to evaluate and understand the changes that might be necessary in the NCIMS documents (PMO, [Note: Appendix K of the PMO "THE HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) SYSTEM" is listed as a separate document] DMO, MMSR and Procedures). In an attempt to begin the process, the NCIMS HACCP Committee is posting on the FDA website, the first attempt to incorporate the HACCP pilot concepts into the four documents. These suggested changes are not part of the existing HACCP pilot proposal and will not have any official effect."

"This effort is just a beginning and posted for the purpose of requesting feedback from all parties interested or affected by the development of a voluntary alternative HACCP dairy product safety program within the current NCIMS system. Please feel free to advance any comments, suggestions or questions to any of the NCIMS HACCP Committee members listed below.

NCIMS HACCP Committee Members
Updated December 11, 2000

Claudia G. Coles - Chair Program Manager, Food Safety Program Washington State Department of Agriculture P.O. Box 42560 Olympia, WA 98504-2560 Tel: (360) 902-1905 - Olympia OR: (425) 643-7306 - Field Fax: (360) 902-2087 Email: ccoles@agr.wa.gov	Don Goldsmith Minnesota Department of Agriculture 14342 Skrove Road NW Brandon, MN 56315 - 8108 Tel: (320) 524-2009 Fax: (320) 524-2009 Email: donrgold@gctel.com	Randal Arbaugh FDA Federal State Relations 5600 Fishers Lane, Rm. 12-07 Rockville, MD 20857 Tel: (301) 827-2904 FAX: (301) 443-2143 Email: rarbaugh@ora.fda.gov *Technical Advisor
John A. Beers Program Supervisor, Dairy Service Virginia Department of Agriculture & Consumer Services PO Box 1163 Richmond, VA 23218 Tel: (804) 786-1453 Fax: (804) 371-7792 Email: jbeers@vdacs.state.va.us	Richard F. Graham Louisiana Department of Health and Human Resources 6867 Bluebonnet Road Baton Rouge, LA 70810 Tel: (225) 765-5022 Fax: (225) 763-5552 Email: rgraham@dhhmail.dhh.state.la.us.	Leslie Bluhm, Ph.D. FDA Division of HACCP 200 "C" Street SW Washington, D.C. 20204 Tel: (202) 205-8884 Fax: (202) 260-0136 Email: lbluhm@cfsan.fda.gov *Technical Advisor
Rob Byrne Vice President, Regulatory Affairs National Milk Producers Federation 2101 Wilson Boulevard, Suite 400 Arlington, VA 22201 Tel: (703) 243-6111 - 345 Fax: (703) 841-9328 Email: rbyrne@nmpf.org	Paul M. Hoge Pennsylvania Department of Agriculture 5349 William Flynn Hwy Gibsonia, PA 15044 Tel: (724) 443-1585 Fax: (724) 443-8150 Email: phoge@state.pa.us	Gary German FDA, HFC - 60 Div. of Human Resource Development 5600 Fishers Lane Rockville, MD 20855 Tel: (301) 594 -1710 Fax: (301) 594 - 1966 Email: ggerman@ora.fda.gov *Technical Advisor
Michele Bradley Senior Quality Manager Kraft Foods, Inc. Three Lakes Drive NF- 405 Northfield, IL 60093 Tel: (847) 646-0600 Fax: (847) 646-7130 Email: mbradley@kraft.com	Dave J. Robbins Corporate Q.A. Manager -- Private Label Dairy Dean Foods Company P.O. Box 7005 Rockford, IL 61125-7005 Tel: (815) 395-6455 Fax: (815) 395-8799 Email: dave_robbins@deanfoods.com	Kathy Gombas FDA Division of HACCP 200 "C" Street SW Washington, D.C. 20204 Tel: (202) 205-4231 Fax: (202) 260-0136 Email: kgombas@cfsan.fda.gov *Technical Advisor
SusanEsser Program Manager, Dairy Section Michigan Department of Agriculture PO Box 30017 Lansing, MI 48909 Tel: (517) 373-1086 Fax: (517) 373-9742 Email: essers2@state.mi.us	John Rushing ,Ph.D. Professor, Department Extension Leader Box 7624 North Carolina State University Raleigh, NC 27695-7624 Tel: (919) 515-9512 Fax: (919) 515-7124 Email: john_rushing@ncsu.edu	John C. Mowbray FDA Division of Dairy & Egg Safety 200 C Street SW, Room 4411 Washington, DC 20204 Tel: (202) 205-1731 Fax: (202) 205-4422 Email: jmowbray@cfsan.fda.gov *Technical Advisor
Paul Dersam Upstate Milk Coop., Inc. 7115 West Main Street LeRoy, NY 14482 Tel: (716) 937-3432 1-800-724-6455 Fax: (716) 768-2089 Email: pdersam@handtech.com	Allen Sayler International Dairy Foods Association Director Regulatory Affairs & International Affairs 1250 H Street NW, Suite 900 Washington, DC 20005 Tel: (202) 220-3544 Fax: (202) 331-7820 Email: asayler@idfa.org	Chris Newcomer New-Tech Consulting Inc. 9 Burnham Street Cincinnati, Ohio 45218 Tel: (513) 851-6256 Fax: (603) 388-7096) Email: cnewcomer@prodigy.net *Technical Advisor
		Steven T. Sims FDA Milk Safety Branch 200 "C" Street SW Washington, DC 20204 Tel: (202) 205-9180 Fax: (202) 205-5560 Email: ssims@cfsan.fda.gov *Technical Advisor
*Technical Advisor ( non voting member)

Changes needed in the "Grade A Pasteurized Milk Ordinance 1999 Revision" (To Implement a Voluntary HACCP Alternative as Described in a New Appendix K.)

These are the wording changes through out the PMO (excluding Appendix K) that are needed in order to accept and implement such a HACCP Appendix.

Section 1. Definitions -- Add a new definition K to include the HACCP Definitions from the pilot

(And renumber subsequent definitions) as follows:

"HACCP Terms (For use in conjunction with Appendix K):

K.1  Adulterated: See the Federal Food, Drug, and Cosmetic Act, section 402.

K.2  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.

K.3  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.

K.4  Control Measure: Any action or activity that can be used to prevent, eliminate, or reduce a significant hazard.

K.5  Control Point: Any step at which biological, chemical, or physical factors can be controlled.

K.6  Corrective Action: Procedures followed when a deviation occurs..

K.7  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.

K.8  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.

K.9  Critical Listing Element: An item on the NCIMS HACCP System Plot Audit Report identified with a double star (* *). The marking of a critical listing element by an auditor (state listing or FDA) indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to food safety whereby a listing may be denied or withdrawn.

K.10  Dairy HACCP Core Curriculum: The core curriculum consists of 1) Basic HACCP training, plus 2) an orientation to the requirements of the NCIMS HACCP alternative.

K.11  Deficiency: A failure or incompleteness in the design of a HACCP system to the extent that it will not fully meet the requirements of this document.

K.12  Deviation: A failure to meet a critical limit.

K.13  HACCP (Hazard Analysis Critical Control Point): A systematic approach to the identification, evaluation, and control of significant food safety hazards.

K.14  HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

K.15  HACCP System: The result of the implementation of the HACCP plan and prerequisite program.

K.16  HACCP Team: The group of people who are responsible for developing, implementing, and maintaining the HACCP system.

K.17  Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

K.18  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.

K.19  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.

K.20  Non-Conformity: A failure to meet specified requirements of the HACCP System or of this document.

K.21  Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

K.22  Shall: Requirements that are mandatory.

K.23  Should: Recommended or advisory procedures.

K.24  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.

K.25  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."

(Re-letter the remaining definitions as appropriate. Change PMO references to these re-lettered definitions as needed in the text.)

Section 2. Adulterated or Misbranded Milk or Milk Products

(No changes needed in this section.)

Section 3. Permits (Add the following paragraph at the end of this section[page 7 of the 1999 PMO].)

Section 4. Labeling     (No changes needed in this section.)

Section 5. Inspection of Dairy Farms and Milk Plants

"Enforcement Procedures --Milk Plants With HACCP Systems Regulated under Appendix K. For those milk plants, transfer stations and receiving stations which have HACCP systems which are regulated under Appendix K., regulatory audits shall replace the regulatory inspections described in this section. The requirements for these regulatory audits as found in Appendix K must be met in order for these milk plants, transfer stations and receiving stations to be considered in compliance with this section. In these milk plants, transfer stations and receiving stations, permit suspensions will be based on unsatisfactory regulatory audit findings, upon failure to take corrective actions required in "Corrective Action Reports" and upon violations of other applicable provisions of this ordinance. Required HACCP records shall be maintained for regulatory audit as required in PMO Appendix K."

Section 6. The Examination of Milk and Milk Products

Section 7. Standards for Grade "A" Milk and Milk Products

Standards for Grade "A" Pasteurized, Ultra-pasteurized and Aseptically Processed Milk and Milk Products, page 40.

On page 79 at the end of item 16p(E). 2. add:

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

Section 8. Animal Health

(No changes needed in this section.)

Section 9. Milk and Milk Products Which May Be Sold

(No changes needed in this section.)

Section 10. Transferring; Delivery Containers; Cooling

(No changes needed in this section.)

Section 11. Milk and Milk products From Beyond the Limits of Routine Inspection

Section 12. Plans for Construction and Reconstruction

(No changes needed in this section.)

Section 13. Personnel Health

Section 14. Procedure When Infection or High Risk of Personnel Health

Section 15. Enforcement (No changes needed in this section.)

Section 16. Penalty (No changes needed in this section.)

Section 17. Repeal and Effective Date

(No changes needed in this section.)

Section 18. Separability clause

(No changes needed in this section.)

Appendix A-D (No changes needed in Appendix A-D.)

Appendix E. Examples of 3-out-of-5 Compliance Enforcement Procedures

(No changes needed in Appendix E.)

Appendix F-L (No changes needed in Appendix F-L.)

Appendix M. Reports and Records

Appendix N-P (No changes needed in Appendix N-P.)

Changes needed in the "Grade A Condensed and Dry Pasteurized Milk Products and Condensed and Dry Whey--Supplement I to the Grade A Pasteurized Milk Ordinance" (DMO) 1995 Revision (to Implement a Voluntary HACCP Alternative as Described in a New PMO Appendix K.)

These are the wording changes through out the DMO that are needed in order to accept and implement such a HACCP Appendix.

Section 1. Definitions -- Add a new definition K in both Part I and Part II to include the HACCP Definitions from the pilot (to replace the words "for future use") as follows:

HACCP Terms (For use in conjunction with Appendix K):

K.1  Adulterated: See the Federal Food, Drug, and Cosmetic Act, section 402.

K.2  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.

K.3  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.

K.4  Control Measure: Any action or activity that can be used to prevent, eliminate, or reduce a significant hazard.

K.5  Control Point: Any step at which biological, chemical, or physical factors can be controlled.

K.6  Corrective Action: Procedures followed when a deviation occurs..

K.7  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.

K.8  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.

K.9  Critical Listing Element: An item on the NCIMS HACCP System Plot Audit Report identified with a double star (* *). The marking of a critical listing element by an auditor (state listing or FDA) indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to food safety whereby a listing may be denied or withdrawn.

K.10  Dairy HACCP Core Curriculum: The core curriculum consists of 1) Basic HACCP training, plus 2) an orientation to the requirements of the NCIMS HACCP alternative.

K.11  Deficiency: A failure or incompleteness in the design of a HACCP system to the extent that it will not fully meet the requirements of this document.

K.12  Deviation: A failure to meet a critical limit.

K.13  HACCP (Hazard Analysis Critical Control Point): A systematic approach to the identification, evaluation, and control of significant food safety hazards.

K.14  HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

K.15  HACCP System: The result of the implementation of the HACCP plan and prerequisite program.

K.16  HACCP Team: The group of people who are responsible for developing, implementing, and maintaining the HACCP system.

K.17  Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

K.18  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.

K.19  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.

K.20  Non-Conformity: A failure to meet specified requirements of the HACCP System or of this document.

K.21  Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

K.22  Shall: Requirements that are mandatory.

K.23  Should: Recommended or advisory procedures.

K.24  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.

K.25  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."

(Re-letter the remaining definitions as appropriate. Change PMO references to these re-lettered definitions as needed in the text.)

Section 2. Adulterated or Misbranded Milk or Milk Products

(No changes needed in this section.)

Section 3. Permits (Add the following paragraph at the end of this section[page 7 of the 1999 PMO].)

" When a permit suspension has been due to HACCP system violations specified in Appendix K., the permit shall be reinstated when findings justify that the conditions specified in Appendix K. are again being met."

Section 4. Labeling     (No changes needed in this section.)

Section 5. Inspection of Condensing and/or Drying Plants

(Insert the following at the end of the Section 5 Administrative Procedures, just prior to Section 6, [page 37 of the DMO].)

"Enforcement Procedures --Condensing and Drying Plants With HACCP Systems Regulated under Appendix K. For those condensing and drying plants which have HACCP systems which are regulated under Appendix K., regulatory audits shall replace the regulatory inspections described in this section. The requirements for these regulatory audits as found in Appendix K must be met in order for these condensing and drying plants to be considered in compliance with this section. In these plants, permit suspensions will be based on unsatisfactory regulatory audit findings, upon failure to take corrective actions required in "Corrective Action Reports" and upon violations of other applicable provisions of this ordinance. Required HACCP records shall be maintained for regulatory audit as required in PMO Appendix K."

Section 6. The Examination of Milk and Milk Products

Section 7. Standards for Grade "A" Milk and Milk Products and Condensed and Dry Milk Products

On page 70 at the end of item 16p(C). 2. add:

6. Test results for Pasteurization & Aseptic Processing Equipment Testing shall be recorded on a similar document for all milk plants (see Appendix M for an example).
7. 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.

5. Industry must demonstrate to the state regulatory that they understand and can perform the required equipment tests according to the PMO standards.
6. State regulatory could accept a regulatory field practical, a written exam, formal classroom training, or on the job training or any combination of these.
7. 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.
8. 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.
8. 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.

9. Sealing guidance for pasteurization equipment by industry is as follows:

3. 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.
4. The regulatory agency may verify any equipment sealing and evaluate (accept or reject) the skills and knowledge of the individual performing the sealing.
10. 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.

Section 8. Condensed and dry Products and Dry Whey From Beyond the Limits of Routine Inspection

Section 9. Future Condensing and Dry Milk Plants

(No changes needed in this section.)

Section 10. Personnel Health

Section 11. Procedure When Infection or High Risk of Personnel Health

Section 12. Enforcement (No changes needed in this section.)

Section 13. Penalty (No changes needed in this section.)

Section 14. Repeal and Effective Date

(No changes needed in this section.)

Section 15. Separability clause (No changes needed in this section.)

Appendix A-I (No changes needed in Appendix A-I.)

Appendix J. Reports and Records

Appendix K-N (No changes needed in Appendix K-N.)

New Procedures" to be added to the "Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments" 1999 Revision.

The new procedures to be inserted as a new Section VIII (the existing Section VIII to become IX).

Any system to implement a HACCP based alternative listing procedure must speak to almost all of the issues addressed in the existing Procedures... document.

Therefore, for ease of use, the new Section VIII is formatted to follow the same flow as the existing Procedures... document.

Also, in order to facilitate a comparison of this new section with the existing Procedures... document, the analogous sections have been indicated in shaded type. It is not intended that the shaded references be carried into the final Section VIII.

Add a new Section VIII and re-number current Section VIII to become Section IX.

Section VIII. Procedures Governing the Certification of Milk Plant HACCP Systems for IMS Listing

(Section I. Purpose) Because the purpose of Section VIII is the same as the purpose of the entire document, no new text is needed.

1. Scope (Corresponds to Section II. Scope)
1. Products Covered Under HACCP Listings

Listings made under the voluntary alternative HACCP listing system described in this section may be made for milk plants, transfer stations and receiving stations. Such a HACCP listing shall include all Grade "A" raw heat-treated products, pasteurized, ultra-pasteurized, and aseptically processed milk and milk products, condensed and dry milk products, and whey and whey products processed at these milk plants, transfer stations and receiving stations. In those milk plants, transfer stations and receiving stations that choose this voluntary alternative, the HACCP listing shall also apply to raw, heat-treated and pasteurized milk and milk products that are received in bulk and resold without further processing.

2. Supervision Requirements

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

2. HACCP Definitions (In addition to the definitions in Section II the following Shall apply to Milk Plants, Transfer Stations and Receiving Stations with HACCP systems regulated under Appendix K. of the Grade A Pasteurized Milk Ordinance.
   (Corresponds to Section III. Definitions)

   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.

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

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

   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.

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

   State Listing Officer (SLO): 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.

3. PHS/FDA HACCP Responsibilities (Numbers 1-3 of this part correspond with Section IV. A. PHS/FDA Responsibilities numbers 1-3. Number 4 "Follow-up Actions" is new. Numbers 5-9 correspond with old numbers 4-8)

1. The PHS/FDA shall standardize at least every three (3) years the Audit procedures of:

   1. PHS/FDA regional personnel who:

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

      2. Comply with the directives of the PHS/FDA Milk Safety Program as administered by the Milk Safety Team (MST).
      3. Must not fail, without cause, to attend the FDA Regional Milk Seminar when offered, and the PHS/FDA Regional Milk Specialists Conference, and attended at least one (1) training course on Special Problems in Milk Protection or other training courses judged by the PHS/FDA to be equivalent.
      4. Meet the HACCP training requirements in VIII. E.

   2. State Milk Sanitation Listing Officers (SLOs) who:

      1. Comply with Section V., D., or who are able to demonstrate an equivalent level of technical expertise.

      2. Meet the HACCP training requirements in VIII. E. Training

3. 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 required under Section IV. A. 3.

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.

Flexibility may be used in the format of the HACCP evaluation, particularly with regard to how it is integrated into an overall state program evaluation. Regardless of the format chosen, the HACCP state program evaluation shall contain at least the following information:

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.

4. Follow-up actions (New)

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 that 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 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 substantial state program weaknesses are not corrected as agreed to by the FDA and State, FDA shall send a notice requiring corrections to the state's program within thirty (30) days. If after this 30-day notice, FDA determines that the corrections were not made, FDA shall notify the affected industry and receiving states of this action.
   7. 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.
5. Laboratory Evaluations (See IV. A. 4. ).
6. Publication of HACCP Listings (Section IV. A. 5. applies as written except that for purposes of this section, an acceptable HACCP listing (or HACCP listing) shall be substituted for an acceptable sanitation and enforcement rating (or enforcement rating) in IV. A. 5. a.).
7. Publication of HACCP Qualified PHS/FDA Milk Specialists and State Personnel (Section IV. A. 6. applies as written except that for purposes of a. of this section, a State Listing Officer (SLO) will be substituted for a State Rating Officer (SRO) when referring to those individuals certified to make HACCP listings).

8. Interpretations and Editorial Updates (See IV.A. 7.).
9. FDA Audits of HACCP Listings

1. The PHS/FDA shall conduct onsite plant audits of the HACCP compliance status of listed interstate milk shippers in each state to ensure compliance with the HACCP system and other associated NCIMS regulatory requirements. Within a State, FDA audits will be made of a representative number of HACCP IMS Listed shippers. The selection of shippers for audit 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.

2. The number of shippers selected for FDA audits of HACCP listings will be based on consideration of the number of HACCP listed shippers in the State as well as the demonstrated validity of the state HACCP program. Validity of a state HACCP program will be based on the results of previous HACCP audits in the state and upon the strength of the State program as measured in previous state program evaluations.

3. When dairy farms are rated with a HACCP listed milk plant, transfer station or receiving station, the farms will be check rated in conjunction with the FDA HACCP audit. Selection of farms to be check rated will be made from records provided at the time of the check rating.

4. In no case can a FDA audit be made with greater frequency than the official HACCP listing.

5. For the purpose of these Procedures and all related forms, the terms "listing" or "HACCP listing", "official listing" and "published listing" shall mean the most recent listing. Each listing must be accompanied by written permission by the shipper to publish, and submitted to the PHS/FDA Regional Office by the state HACCP listing agency.

6. Except as provided in Section VIII. C. 3. b. 3.) the PHS/FDA shall release the detailed results of its audit of listed individual interstate shippers only to the state listing agency which originally certified the shipper for listing and the state regulatory agency.
7. FDA Auditing 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.

1. Pre-Audit Management Interview

Review and discuss the plant HACCP system including:

1. The management structure

3. The Hazard Analysis - ensure that all food hazards are addressed
4. The HACCP plan
5. The prerequisite program
6. The flow diagram
7. 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.
9. 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.

   *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
4. State HACCP Responsibilities (Section IV. B. State Responsibilities. Numbers 1-6 in this Section correspond to numbers 1-6 in Section IV.B.

   1. State Listings

      State HACCP Listings for Milk Plants (Section IV. B. 1. shall apply as written except that in the case of milk plants transfer stations and receiving stations, HACCP listings shall be used in lieu of ratings).

   2. Enforcement Responsibilities

      Regulatory program elements that effect the ability to verify that the HACCP system is assuring safety are monitored by the State listing officer and FDA under this program. Enforcement responsibilities that immediately and directly effect public health must be incorporated in an acceptable HACCP listing and must assure that those concerns are being continuously addressed.

   3. Lab Evaluations (Under HACCP Section IV. B. 3. shall apply as written).
   4. The State shall cooperate with PHS/FDA in order to correct any deficiencies in state programs.
   5. States regulatory or rating agencies shall submit drug residue summary data to a third party database.

   6. Challenges and Remedies

   1. Complaints from Receiving States and Municipalities (Section IV. B. 6. a. shall apply as written except that in the case on milk plants transfer stations or receiving stations that have a HACCP listing ratings in substitution for ratings, the words rating or ratings shall mean listing or listings).

   2. Complaints from Shipping States and Municipalities (Section IV. B. 6. b. shall apply as written except that in the case on milk plants transfer stations or receiving stations that have a HACCP listing ratings in substitution for ratings, the words "milk sanitation rating agency" shall mean "HACCP listing agency").
   3. Action to be Taken if the PHA/FDA Audit of a Milk Plant HACCP Listing Indicates that the Listing is Not Justified

   1. Producer dairies (raw milk) (Section IV. B. 6.c.1.) shall apply as written).
   2. Milk Plants Transfer Stations and/or Receiving Stations (Replaces Section IV. B. 6.c.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. When product safety is In doubt based on regulatory agency practices or concerns FDA shall immediately investigate and may audit other plants affected.

   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. 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.
   3. 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.

5. Qualifications and Certifications (Numbers 1-3 in this part of the text correspond to A-C in Section V. Qualifications and Certifications. Number 4 is new. Number 5 corresponds to D. Number 6 is new. Numbers 7-9 correspond to E-G. Number 10 corresponds to H, I, and J. Number 11 correlates to K.)

1. Supervision requirements, (Section V. A. applies as written except that for purposes of this section, an acceptable HACCP listing shall replace an acceptable sanitation and enforcement rating).

2. Procedures for requesting a HACCP listing

   A shipper desiring a HACCP listing of their supply (milk plant, transfer station or receiving station) for the purpose of interstate certification shall submit a request the State milk listing agency(s) in their own State.

3. An acceptable HACCP listing shall be substituted for acceptable sanitation and enforcement ratings for milk plants, transfer stations and receiving stations participating in the voluntary HACCP alternative listing program.

4. Milk plants, transfer stations and receiving stations participating in the voluntary HACCP alternative listing program shall receive dairy ingredients, including raw milk, for use in listed products only from IMS listed sources that have been awarded an acceptable HACCP listing or acceptable sanitation and enforcement ratings. (New)

5. HACCP Listing Personnel

   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.

   HACCP listings shall be made by qualified State listing officers who:

   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.

   Are accepted by the state listing agency and the FDA based on specialized training, qualification, and a current FDA standardization.

   Have participated in at least one Regional Milk Sanitation Rating Officer's Seminar prior to certification,

   Have attended at least one training course in the auditing of dairy plant HACCP systems and NCIMS listing for the period of qualification

   Have, during the three (3) year period for which standardized, participated in at least one (1) Regional Milk Seminar and, in addition, attended at least one (1) training course on Special Problems in Milk Protection or other training courses judged by the PHS/FDA to be equivalent.

6. 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.

7. Drug Residue Compliance

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

8. Sampling Surveillance Personnel (See Section V. F.)

9. Milk Laboratory Evaluation Personnel (See Section V. G.)

10. Milk Plant HACCP Listings

    1. Milk plants, transfer stations or receiving stations participating in the voluntary HACCP listing process shall be audited for listing at a frequency of not less than once every twenty-four (24) months.

    2. If an audit for HACCP listing is unsatisfactory, another audit shall be conducted after written notification from an authorized representative of the IMS Listed shipper to the listing agency that the IMS Listed shipper is in substantial compliance. The audit shall be conducted in no more than fifteen (15) days from the date of receipt of the notification.

11. Denial of Listings

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

6. Standards to be used for the voluntary HACCP alternative shall be those specified in Section VI except that for purposes of this section, an acceptable HACCP listing shall be acceptable in substitution for an acceptable sanitation and enforcement rating.
7. Procedures governing a state's participation in the voluntary HACCP alternative cooperative program for certification of IMS Shippers, (Section VII. applies as written).

8. HACCP Training (New)

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 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.

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.

1. Core Curriculum 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.

2. 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.

9. Application of conference agreements under the voluntary HACCP alternative, (Section IX. [old section VIII.] applies as written).

Changes needed in the "Methods of Making Sanitation Ratings of Milk Shippers 1999 Revision" to Implement a Voluntary HACCP Alternative as Described in the PMO.

1. Definition of Terms

   Add the following definitions

    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.

   Critical Listing Element: An item on the NCIMS HACCP System Plot Audit Report identified with a double star (* *). The marking of a critical listing elment by an auditor (state listing or FDA) indicates a condition that constitutes a major

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

   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.

   State Listing Officer: A qualified State employee who performs HACCP listing audits of milk plants under the voluntary HACCP listing procedure.

2. Rating Methods for Raw Milk for Pasteurization

   No changes are needed in this section.

3. Rating Methods for Transfer Stations, Receiving Stations, and Milk Plants

   1. Drug Residue Compliance Procedure for Determining Transfer Station, Receiving Station, and Milk Plant Compliance with Appendix N. of the PMO.  

       No changes are needed in this section.

   2. Collection of Data

      No changes are needed in section (a) or (b).

      Add a new section as follows:

      3. Recording of Data For Milk Plants Being Listed Under the Voluntary HACCP Alternative Listing Procedure

      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

      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.
         3. Computation of Sanitation Compliance Ratings

            Add the following immediately beneath this heading:

            (The provisions of this section do not apply to milk plants listed under the voluntary HACCP listing procedure. Sanitation Ratings shall be made for dairy farms that are listed with milk plants listed under the voluntary HACCP listing procedure).

4. Computation of Enforcement Ratings

   Add the following immediately beneath this heading:

   (The provisions of this section do not apply to milk plants listed under the voluntary HACCP listing procedure. Enforcement Ratings shall be made for dairy farms that are listed with milk plants listed under the voluntary HACCP listing procedure. These enforcement ratings will be made using the procedures for raw milk for pasteurization only [#2 in this section]).

5. Preparation of the Rating Officers Report

   Add the following immediately beneath this heading:

   (This report is not applicable to milk plants listed under the voluntary HACCP listing procedure. A narrative description similar to the narrative portion of this report is required as a part of all audits and is reported on the audit report form. See section H. for an example of a completed form.)

6. Publication of the Interstate Milk Shipper Report

   At the end of Section F. add the following:

   3. Preparation of Interstate Milk Shipper Report for HACCP Listings

      The provisions of this section apply to milk plants listed under the voluntary HACCP listing procedure except that:

      A statement regarding the acceptability (or unacceptability) of the HACCP system will be substituted on the 2359I for the information from the 2359L

         Parts II and III of the 2359j will not apply.

      The written permission to publish the HACCP listing will be documented using "Permission for Publication of Interstate Milk Shipper HACCP listing" forms.

   4. Examples of Rating Listing Forms (Note the change in title)

   Add the following to the cover page of this section:

   8. NCIMS HACCP System Audit Report
   9. Permission for Publication of Interstate Milk Shipper HACCP Listing

PERMISSION FOR PUBLICATION OF
INTERSTATE MILK SHIPPER HACCP LISTING

Shipper name: _____________________________________________________________

Address: _________________________________________________________________

________________________________________________________________________

You are hereby advised that on (date) ________ a State HACCP Listing Audit was completed with the following results:

Producer Supply (BTU): _________   Receiving Station:___________

Pasteurization Plant: ____________Enforcement Rating (farms only): ____________

Condensed or Dry Milk Plant:___________

The results will be transmitted to the U.S. Food and Drug Administration. They will publish the information in the semi-annual "IMS List Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers". The official HACCP Listing is valid for a period not to exceed two years, subject to the rules of the National Conference on Interstate Milk Shipments.

Publication Permission Section

Permission is hereby granted to release and publish the above-stated HACCP listing for use by state and territorial milk control authorities and prospective purchasers.

It is understood and agreed by the undersigned that the official HACCP listing agency may review this supply at any time during the two-year period referred to above. It is further understood that we will notify the HACCP listing agency if any significant change should occur which affects our raw milk supply, receiving station or pasteurization plant status including product list.

It is understood and agreed that the failure to maintain the milk plant HACCP System at a level, which is acceptable for listing, may result in immediate removal of this listing.

It is further agreed that plants receiving milk or milk products which are from a non-listed source or are from a source having a raw milk sanitation compliance rating of less than 90% shall be immediately withdrawn from the Interstate Milk Shippers List.

SIGN AND RETURN TO  NAME OF AGENCY    WITHIN FIVE (5) DAYS OF RECEIPT.

___________________________________________________

^{Name of Shipper}

___________________________________________________

^{Signature of Representative}

___________________________________________________

Title

___________________________________________________

^Date

7. Examples for Computing Ratings Completing Listing forms (Note the change in title)

(To be added later. Preferably a blend of "sanitized" examples from the pilot).

Appendix A

APPENDIX K.
THE HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) SYSTEM

Introduction

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 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.

Background

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

The HACCP concept 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.

HACCP Principles

The following are the seven (7) HACCP principles included in a HACCP plan.

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, and the HACCP System in total, 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.

Summary

The seven principles of HACCP are also called the HACCP Plan. When combined with the prerequisite programs, they constitute a HACCP system. The HACCP alternative described in this appendix includes the HACCP system and other prescribed PMO criteria such as drug screening, use of milk only from sources regulated under the provisions of this ordinance, and the labeling requirements of Section 3. When properly implemented, the HACCP alternative described in this annex will provide assurance of product safety that is equivalent to that provided under the traditional system.

IMPLEMENTATION OF THE
HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP) SYSTEM

Prerequisite Programs:

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.
6. 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.

TRAINING AND STANDARDIZATION

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 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.

HACCP AUDITS AND FOLLOW-UP ACTIONS

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.

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, i