§1105. Pre-requisite Programs (PPs)

A. HACCP is not a stand-alone program but is part of a larger control system. PPs 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 CCPs in that they are background programs that reduce the potential for the occurrence of a food safety hazard. Frequently, both HACCP plan CCPs and PPs control measures are necessary to control a food safety hazard.

B. HACCP may be implemented only in a facility that is constructed and operated in a manner that provides a sanitary environment. Dairy plant premises, building construction, maintenance and housekeeping shall be maintained in a manner sufficient to provide such an environment.

C. Dairy plants that are required to develop and implement HACCP systems by this Part shall develop and implement the following pre-requisite programs that conform with the following requirements prior to the implementation of the HACCP Plan:

1. safety of the water, steam or ice that comes into contact with food or food contact surfaces;

2. condition and cleanliness of the food contact surfaces of equipment;

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.

D. Each dairy plant shall monitor the conditions and practices of all required PPs 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.

E. Each dairy plant shall maintain records that document the ongoing application of the PPs including a brief written description, monitoring and correction records.

F. 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.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2687 (September 2011).

§1107. Hazard Analysis

A. Each dairy plant 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 dairy product processed by that dairy plant, receiving station or transfer station and to identify the control measures that the dairy plant, receiving station or transfer station can apply to control those hazards.

B. The plant shall develop or have developed for it a hazard analysis each time a product, product ingredient or process is added or changed.

C. 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.

D. The hazard analysis shall be submitted in writing to the state health officer for approval prior to processing of a product or change of process for which the hazard analysis was made.

E. A hazard that is reasonably likely to occur is one for which a prudent dairy plant 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 requirement 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:

a. microbiological contamination;

b. parasites;

c. chemical contamination;

d. unlawful drug and pesticide residues;

e. natural toxins;

f. unapproved use of food or color additives;

g. presence of undeclared ingredients that may be allergens or sensitivity producing ingredients; and

h. physical hazards.

2. Dairy plant operators shall 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.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2688 (September 2011).

§1109. HACCP Plan

A. Dairy plants that are required by the state health officer to implement a HACCP system or have authorization from the state health officer to be regulated under the provisions of this Chapter 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 meets the requirements contained in the PMO and shall be subject to record keeping requirements as described in this Code. 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 for each are essentially identical and 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.

B. Written HACCP plans shall be submitted to the state health officer for review and approval prior to processing a product addressed by the plan and prior to processing a new product or making changes in a product or the manner in which a product is processed. Such review and approval shall be performed by a registered sanitarian that meets the PMO requirements for auditing HACCP plants.

C. The HACCP plan shall, at a minimum:

1. include complete up-to-date process flow diagrams for all products manufactured. Flow diagrams may be combined when process, products and hazards are similar;

2. 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;

3. list the critical control points for each of the identified hazards, including the appropriate:

a. critical control points designed to control hazards that could occur or could be introduced in the plant environment;

b. critical control points designed to control hazards introduced outside the plant environment, including hazards that occur before arriving at the dairy plant, receiving station or transfer station; and,

c. critical control points for pasteurization as described in Appendix H, Section VIII of the PMO (Milk and milk products HACCP CCP models for pasteurization equipment);

4. list the critical limits that shall be met at each of the critical control points;

5. 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;

6. 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;

7. list the verification procedures and the frequency with which they are to be performed, that the dairy plant will use in accordance with verification and validation requirements as described in this Part;

8. 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 Part. The records shall contain the actual values and observations obtained during monitoring.

D. Sanitation. Sanitation controls may be included in the HACCP plan. However, to the extent that they are monitored in accordance with the pre-requisite programs, they need not be included in the HACCP plan.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2688 (September 2011).

§1111. Corrective Actions

A. Whenever a deviation from a critical limit occurs, a dairy plant shall take corrective action as follows.

1. Dairy plants may develop written corrective action plans, which become part of their Hazard Analysis and Critical Control Point (HACCP) plans, in accordance with this Part, by which dairy plants 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:

a. no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation.

b. if such product has entered commerce, it is expeditiously removed; and,

c. the cause of the deviation is corrected.

2. When a deviation from critical limit occurs, and the dairy plant does not have a corrective action plan that is appropriate for that deviation, the dairy plant shall:

a. segregate and hold the affected product.

b. 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.

c. 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.

d. take corrective action, when necessary, to correct the cause of the deviation; and,

e. 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 action taken in accordance with this Section shall be fully documented in records that are subject to verification.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2689 (September 2011).

§1113. Verification and Validation

A. Every dairy plant shall verify that the hazard analysis and critical control point (HACCP) system is being implemented according to design:

1. verification activities shall include:

a. the calibration of CCP process-monitoring instruments, (pasteurization tests, thermometers, etc.) and instruments/equipment used to monitor PPs;

b. a review, including signing and dating, by an individual who has been trained in accordance with the training requirements contained in this Part, of the records that document:

i. the monitoring of CCPs. The purpose of the monitoring of CCPs review shall be, at a minimum, to ensure that the records are complete and to verify that the records document values that 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;

ii. the taking of corrective actions. The purpose of corrective actions 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 of §1111 of this Part. This review shall occur at a frequency that is appropriate to the importance of the record. A centralized deviation log is required; and

iii. the calibrating of any process monitoring instruments used at CCPs and the performance of any periodic end-product or in-process testing that is part of the dairy plant, receiving station or transfer station’s verification activities. The purpose of the calibrating of any process monitoring instruments used at CCPs and the performance of any periodic end-product or in-process testing that is part of the dairy plant reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the dairy plant written procedures. These reviews shall occur within a reasonable time after the records are made;

c. 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 shall be documented in records that are subject to the record keeping requirements in this Part.

B. Validation of the HACCP Plan. Every dairy plant shall validate that the HACCP plan is adequate to control hazards that are reasonably likely to occur. This validation shall occur at least once within 12 months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan and prerequisite program.

1. Such changes may include 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. Consumer complaints may also reveal a need for validation.

2. The validation shall be performed by a qualified individual(s) and shall be subject to the record keeping requirements of §1115 of this Part. 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 Part.

C. Validation of the hazard analysis. Whenever a dairy plant has no HACCP plan because a hazard analysis has revealed no hazards that are reasonably likely to occur, the dairy plant shall reassess the adequacy of the hazard analysis whenever there are any changes in the process that could reasonably affect whether a hazard exists.

1. Such changes may include 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.

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

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2689 (September 2011).

§1115. Records

A. Dairy plants shall use consistent terminology to identify each piece of equipment, record, document or program throughout their written HACCP system. Dairy plants shall maintain the following records documenting the dairy plant, receiving station or transfer station’s hazard analysis and critical control point (HACCP) system:

1. records documenting the ongoing application of the pre-requisite programs, 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:

a. 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

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

5. records documenting verification of the HACCP system and validation of the HACCP system including, HACCP plan, hazard analysis and pre-requisite programs; and

6. Records and documents shall be dated and each page of documents and forms marked with a new date or version number whenever updated.

B. General Requirements. All records required by this Part shall include:

1. the identity and location of the dairy 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.

C. Documentation. The records in §1115.A.1-3 shall be signed and dated by the most responsible individual onsite at the dairy plant, receiving station or transfer station. These signatures shall signify that these records have been accepted by the firm.

1. The records in §1115.A.1-3 shall be signed and dated:

a. upon initial acceptance;

b. upon any modification; and

c. upon verification and validation in accordance with the requirements of §1113 of this Part.

D. Record Retention. In the case of perishable or refrigerated products, all records required by this Part shall be retained at the dairy plant facility for at least one year after the date that such products were prepared and, in the case of frozen, preserved, or shelf - stable products, two 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.

1. 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 dairy plant facility for at least two years after the date that the dairy plant, receiving station or transfer station last used such equipment or process.

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

3. 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 by the state health officer.

E. Official review. All records required by this Section shall be available for official review by the state health officer.

F. Records maintained on a computer. The maintenance of records on computer, in accordance with the above, is acceptable.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2690 (September 2011).

§1117. Training and Standardization

A. HACCP training for industry and state regulatory personnel shall be based on the August 14, 1997 “Hazard Analysis and Critical Control Points Principles and Application Guidelines” of the U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF), current FDA and NCIMS HACCP requirements and the requirements of this Part. State regulatory personnel responsible for auditing dairy plants being regulated under this Part shall have the training required to inspect dairy plants and specialized training in conducting HACCP System Audits that is approved by the FDA.

B. Only industry personnel who have received the training requirements contained in §1117.A 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 each individual dairy plant;

3. validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities contained in this Part; and,

4. performing required HACCP plan record reviews.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 37:2690 (September 2011).

§1119. Audit of Dairy Plants that Operate under the HACCP Systems Defined in this Part

A. Procedures that shall be used by the state health officer in the audit of dairy plants which are required to implement HACCP Systems:

1. conduct a pre-audit management interview during which he shall review and discuss the plant HACCP system including:

a. changes in management structure;

b. the hazard analysisensure that all food hazards are addressed;

c. changes in the HACCP plan;

d. changes in the prerequisite programs (PPs);

e. changes in the flow diagrams; and

f. changes in products or process;

2. review past audit reports and correction of deficiencies;

3. perform a comprehensive in-plant review of the facilities, equipment, operations and implementation of the HACCP system;

4. review records of the implementation of the plant’s HACCP system;

5. review the plant’s compliance with other applicable requirements of this Part including:

a. raw milk supply source;

b. labeling compliance;

c. adulteration;

d. permit requirements;

e. drug residue testing;

f. regulatory sample compliance; and

g. pasteurization equipment design, construction and operation;

6. conduct an exit interview with plant management and the plant HACCP team, which includes:

a. discussing the findings and observations;

b. establishing time lines for the correction of all identified deficiencies and non conformities; and

c. preparing and issuing the audit report;

7. take appropriate action to verify that all deficiencies have been corrected within the established time frame as soon as practical after the established time or date;

8. take immediate action when an imminent health hazard is observed to prevent further movement of products until such hazards have been eliminated;

9. initiate regulatory enforcement such as permit suspension, revocation or other equivalent measures when the dairy plant has failed to recognize or correct a deficiency or non conformity;

10. critical listing elements. It is essential that each regulatory audit includes a thorough review of each of the critical listing elements of the plant’s HACCP System;

a. Deficiencies or non conformities related to Critical Listing Elements require immediate attention and constitute grounds for suspension of the permit;

b. The following are critical listing elements:

i. hazard analysisflow diagram and a hazard analysis has been conducted and written for each kind or group of dairy products, including frozen desserts, which are processed;

ii. HACCP plana written HACCP plan prepared for each kind or group of dairy products, including frozen desserts, which are processed;

iii. HACCP plancritical limits (CL) are adequate to control the hazard identified.

iv. HACCP plancorrective action taken for products produced during a deviation from the critical limits defined in the plan;

v. HACCP planverification and validationcalibration of CCP process monitoring instruments and equipment was performed as required and at the frequency defined in the plan;

vi. HACCP system recordsinformation on HACCP records were not falsified;

vii. Other NCIMS requirementsin coming milk supply from NCIMS listed source(s) with sanitation scores of 90 or better or acceptable HACCP Listing;

viii. other NCIMS requirementsdrug residue control program implemented; and,

ix. HACCP system audit findingsfollow up actionno major HACCP system dysfunction exists, but if a series of observations made during an audit indicate that a plant does not have sufficient control of its HACCP system or operations to prevent a compromise to food safety, this shall constitute grounds for immediate suspension of permit.

AUTHORITY NOTE: Promulgated in accordance with the provisions of R.S. 40:4(A)(1)(a). Also see R.S. 40:5(2)(3)(5)(7)(15)(17) and R.S. 40:922.

HISTORICAL NOTE: Promulgated by the Department of Health and HospLR 28:1277 (June 2002), amended LR 37:2691 (September 2011).

Chapter 13. Receiving Stations