Hazards & Controls Guide For Dairy Foods HACCP


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CFSAN/Office of Compliance June 16, 2006; Revised October 2007
Hazards & Controls Guide For Dairy Foods HACCP
Guidance for Processors Version 1.1 June 16, 2006

I. Introduction

Table of Contents

A. Status B. Purpose C. Comparison with the FDA Juice HACCP Regulations D. Scope and Limitations
II. Terms and Definitions

III. Overview of the NCIMS HACCP Program A. Voluntary Nature of the Program B. Key Requirements of the NCIMS HACCP Program
IV. Prerequisite Programs

A. Required Prerequisite Programs B. Acceptable Level of Protection by Prerequisite Programs
V. Hazard Analysis

A. Preparing for a Hazard Analysis - Five Preliminary Steps B. Overview of the Hazard Analysis
VI. The HACCP Hazard Decision Process

VII. HACCP Decision Trees

A. NACMCF CCP Decision Tree #1 B. NACMCF CCP Decision Tree #2 C. IDFA Modified Decision Tree for HACCP
VIII. Control Measures

A. HACCP Control Measures B. Activities Not Considered to be HACCP Control Measures
IX. Preparing for HACCP

A. Getting People Ready B. HACCP Training and HACCP Resource Materials
X. Hazards and Control Guide

A. Table 1 - Milk Plant Raw Materials B. Table 2 - Milk Plant Processing Operations
XI. References

A. Published Text B. Articles Published in Peer Reviewed Scientific Journals

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I. Introduction
A. Status
This Hazards and Controls Guide represents the National Conference on Interstate Milk Shipments (NCIMS) perspective on identifying and evaluating potential hazards in milk and milk products and their control. It is designed to assist processors in the development of Hazard Analysis Critical Control Point (HACCP) systems to satisfy the requirements of the NCIMS HACCP alternative to the traditional regulatory system for Grade A dairy products that are regulated by the states under the NCIMS milk safety system. The guide should also be useful to State Regulators who are responsible for the evaluating the completeness of a plants hazard analysis.
This Hazards and Controls Guide provides a framework for answering some of the questions to be considered when conducting a hazard analysis for the processing of milk and milk products.
This guide has been separated into two parts. The first part provides background information that can be useful in understanding the basic food safety concerns and goals to be addressed by the hazard analysis. The second part of the hazard guide is an evaluation of specific potential hazards associated with the processing of milk and milk products. It is also divided into two major sections. The first section identifies many potential food safety hazards associated with ingredients and packaging materials. In the second section, a "unit operations" approach has been used to identify food safety potential hazards which may be associated with processing.
HACCP, as it relates to the NCIMS HACCP alternative, is a food safety system whose design is based on practical experience and the scientific understanding of the potential hazards associated with various types of milk and milk products. References to the available scientific literature can be found throughout this document. A list of references can be found at the end of this guide.
B. Purpose
The purpose of this guidance is to assist you in the development of a written HACCP program, as defined by the NCIMS Voluntary HACCP System. You will find information in this guidance that will help you identify hazards that may potentially occur in your products and help you identify and use methods of controlling and preventing hazards. This guidance is also intended to serve as a tool for Federal and State regulatory officials in the evaluation of HACCP systems for dairy products.
To help understand some key aspects of the NCIMS Voluntary HACCP System and plan how you will initiate your HACCP activities, we have included information on some other important aspects of the Dairy HACCP System.
C. Comparison with the FDA Juice HACCP Regulations
The following table is provided to dairy processors as a visual comparison of the FDA Juice HACCP regulations and the NCIMS Voluntary Dairy System.
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Requirements

FDA Juice HACCP

Regulation Implementation Dates:

1/22/02 Large Business(>500 employees)1/21/03 for Small Business(<500 employees)1/20/04 for Very Small Businesses(<100
employees)

Prerequisite Program Concept

Yes(GMP & SSOP)

Written Sanitation Standard

No

Operating Procedure (SSOP) or

Required PP

Sanitation Monitoring & Documentation(SSOP) or
Required PP

Yes(8 elements)

Perform Hazard Analysis

Yes

Written Hazard Analysis

Yes

Written HACCP Plan

Yes

Written Corrective Action Plan

Yes

Required:

HACCP Plan shall be signed and dated

Yes,updated annually

Plan RevalidationUpon plan development

Yes, at least once within 12 months of implementation

Upon any change that affect

Yes

ingredients, process, hazard

analysis or HACCP Plan

At least annually

Yes

Regulator Consumer Complaint

No

Record Access

Maintain Customer Complaint

Yes

Summary

Monitoring & Corrective Action Records Review

Within 7 days

Required Info on Records

Name & LocationDate & Time Yes (if more than 1 location)Yes

Monitor's Initials or Signature

Yes, where appropriate

ID of product & Code

Yes, where appropriate

NCIMS HACCP January 1, 2004
Yes (PP) Yes
Yes (8 elements)
Yes Yes Yes Yes Yes Yes Yes
Yes No Yes No minimum specified, appropriate to records being kept Yes Yes Yes Yes

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Requirements

FDA Juice HACCP

NCIMS HACCP

Record Retention

1 year after the production of the product

At least 1 year after the date that such products were prepared.

Record Retention

2 years for frozen, preserved or shelf stable, or the shelf life of the
product, whichever is greater.

In the case of frozen, preserved or shelf stable products 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.

Industry Training (HACCP plan developers, validators and record
reviewers) or equivalent experience

Yes(Juice HACCP Core Curriculum)

YES(NCIMS Dairy HACCP Core Curriculum)

Confidentiality

Yes, within the limits of FOIA

Not Addressed

Copying Records

Yes

Not Addressed

Electronic Records

Yes

Yes

5-Log Pathogen Reduction Performance Standard

Yes

Mandatory CCP for pasteurization

LACF or One Step Thermally Processed Shelf-Stable Juice or
Juice Concentrates

Exempt from the 5-log performance standard. Other hazards must be controlled. Shelfstable and concentrate processors must include a copy of their thermal process in their written hazard analysis. Must be packaged in final form under single roof or
5-log needs to be done.

Hazards addressed as critical factors by process authority are not required to be addressed in the HACCP Plan Summary Table

D. Scope and Limitations
This guide addresses development of a product flow diagram, description of the product, hazard identification and hazard evaluation. It is not intended to provide examples for development of prerequisite programs, formation of the HACCP team, product distribution, risk analysis, etc.
Prior to conducting the hazard analysis, the HACCP team must complete the following preliminary steps:
1. Develop a product description; 2. Develop and verify a process flow diagram 3. Describe the intended use and distribution parameters.

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II. Terms and Definitions
A. AUDIT: An evaluation of the entire milk plant, receiving station or transfer station facility and NCIMS HACCP System to ensure compliance with the NCIMS HACCP System and other NCIMS regulatory requirements.
B. Centralized Deviation Log: A centralized log or file identifying data detailing any deviation of critical limits and the corrective actions taken as required in Appendix K of the Pasteurized Milk Ordinance (PMO).
C. Control: To manage the conditions of an operation to maintain compliance with established criteria. The state where correct procedures are being followed and criteria are being met.
D. Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a significant hazard that is managed at a Critical Control Point.
E. Corrective Action: Procedures followed when a deviation occurs. F. Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or
eliminate a milk or milk product safety hazard or reduce it to an acceptable level. G. Critical Limit (CL): 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 milk or milk product safety hazard. H. CRITICAL LISTING ELEMENT (CLE): An item on the MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT identified with a double star (**). The marking of a CLE by a State Rating Officer or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk or milk product safety, or that violate NCIMS requirements regarding drug residue testing and trace back or raw milk sources, whereby a listing may be denied or withdrawn. I. DAIRY HACCP CORE CURRICULUM: The core curriculum consists of:
1. Basic HACCP training; plus 2. An orientation to the requirements of the NCIMS HACCP Program J. DEFICIENCY: An element inadequate or missing from the requirements of the HACCP System or Appendix K of the PMO. K. DEVIATION: A failure to meet a Critical Limit. L. FOOD ALLERGENS: Are proteins in foods that are capable of inducing an allergic reaction or response in some individuals. There is specific consensus that the following foods account for more than 90% of all food allergies: peanuts, soybeans, milk, eggs, fish, crustaceans, tree nuts, and wheat. M. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP): A Systematic approach to the identification, evaluation, and control of significant milk or milk product safety hazards. N. HACCP PLAN: The written document, which is based upon the principles of HACCP and delineates the procedures to be followed. O. HACCP SYSTEM: The implemented HACCP Plant and Prerequisite Program, including other applicable NCIMS requirements. P. HACCP TEAM: The group of people who are responsible for developing, implementing, and maintaining the HACCP system. Q. HAZARD: A biological, chemical, or physical agent that is reasonable likely to cause illness or injury in the absence of its control.
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R. HAZARD ANALYSIS: The process of collecting and evaluating information on hazards associated with the milk under consideration, to decide which are reasonable likely to occur and must be addressed in the HACCP Plan.
S. MONITOR: To conduct a planned sequence of observations or measurements to assess that a CCP is under control or to assess the conditions and practices of all required Prerequisite Programs.
T. NON-CONFORMITY: A failure to meet specified requirements of the HACCP System as described in Appendix K of the PMO.
U. POTENTIAL HAZARD: Any hazard to be evaluated by the hazard analysis. V. PREREQUISITE PROGRAMS (PP's): Procedures, including Good Manufacturing Practices
(GMP's), which address operational conditions that provide the foundation for the HACCP System. The required PP's specified in Appendix K of the PMO, are something called Sanitary Standard Operating Procedures (SSOP's) in other HACCP Systems. W. 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. X. VERIFICATION: Those activities, other than monitoring, that determine the validity of the HACCP Plan and that the HACCP System is operating according to the plan.
III. Overview of the NCIMS HACCP Program
The following section is a brief synopsis of Appendix K of the PMO detailing the requirements of the NCIMS alternative HACCP program. For a complete understanding of the NCIMS HACCP Alternative, please refer to the most recent version of the PMO.
A. Voluntary Nature of the Program
The NCIMS HACCP Program alternative to the traditional inspection system is a voluntary system as described in the applicable sections and Appendices of the Pasteurized Milk Ordinance (PMO). No plant, receiving station or transfer station may participate in the voluntary NCIMS HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the NCIMS HACCP Program. Both parties must provide written commitment to each other that the necessary resources to support participation in the NCIMS HACCP Program will be made available. Management responsible for both the State and plant, receiving station or transfer station must be willing to provide the resources needed to develop and implement a successful HACCP System.
B. Key Requirements of the NCIMS HACCP Program 1. Specialized Training in NCIMS HACCP Principles Required
HACCP training for industry and regulatory personnel will be based on the current "Hazard Analysis and Critical Control Point Principles and Application Guidelines" of NACMCF, the current FDA HACCP recommendations, and the regulatory requirements of Appendix K and related Sections of the PMO.
Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities using the NCIMS HACCP Program will have equivalent training to the training required to perform traditional NCIMS functions. They shall also have specialized training in conducting HACCP System audits.
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Industry, State and Federal regulatory and listing personnel should be trained together.
a. HACCP Training  Core Curriculum. The Dairy HACCP Core curriculum consists of:
1. Basic HACCP training; plus 2. An orientation to the requirements of the NCIMS HACCP Program.
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 component ideally is coupled with the basic HACCP training, but can be taught separately. The content of the orientation will be conducted under the guidance of the NCIMS. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the NCIMS HACCP Program. It is to be taught by instructors experienced in the application of HACCP under the NCIMS HACCP Program.
The industry individual(s) performing the functions listed in Part 2 of this Section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum.
 Industry Personnel: Only industry individuals who have met the requirements of Part 1 of Appendix K Section III of the Pasteurized Milk Ordinance (PMO) - Training and Standardization, shall be responsible for the following functions. a. Developing the hazard analysis, including delineating control measures as required. b. Developing a HACCP Plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements. c. Validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities as specified; and d. Performing required HACCP Plan records reviews.
 Regulatory Personnel: Regulatory personnel performing HACCP audits shall have successfully completed the appropriate training in the application of HACCP principles for milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum.
2. Recordkeeping and Electronic Records . Required Records: It is essential that plants, receiving stations and transfer stations use consistent terminology to identify each piece of equipment, record, document, or other program throughout their written HACCP System. A milk plant, receiving station or transfer station shall maintain the following records documenting the milk plant, receiving station or transfer station's HACCP System:  A brief description of the monitoring and correction records shall be written documenting the ongoing application of the prerequisite program.  A hazard analysis shall be written
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 The written HACCP Plan  Required HACCP documents and forms specified in a.1) through 3) of this Section shall be
dated or identified with a version number. Each page shall be marked with a new date or version number whenever that page is updated.
 A Table of Contents and centralized list of the HACCP program records, by title, documenting the ongoing application of the HACCP System shall be maintained and provided for review.
 A document change log shall be kept.  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 plant's receiving station's or transfer station's HACCP Plan;
a. Corrective actions, including all actions taken in response to a deviation. b. A centralized deviation log is required; and
c. Plan validation dates. d. Records documenting verification and validation of the HACCP System, including
the HACCP Plan, hazard analysis and PP's.
2. General Requirements: Records required include: a. The identity and location of the milk plant, receiving station or transfer station;
b. The date and time of the activity that the record reflects; c. The signature or initials of the person(s) performing the operation or creating the
record; and
d. 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:
a. The records in paragraphs a.1) through 3) of this Section shall be signed and dated by the most responsible individual onsite at the milk plant, receiving station or transfer station. This signature shall signify that these records have been accepted by the firm.
b. The records in paragraphs a.1) through 3) of this Section shall be signed and dated:
1. Upon initial acceptance; 2. Upon any modification; and
3. Upon verification & validation in accordance with requirements cited above 4. Record Retention: c. All records, required by this section, shall be retained at the milk plant, receiving station or transfer station for perishable or refrigerated products, for at least one (1) year after the date that such products were prepared, and in the case of frozen, preserved, or shelf-stable products, for two (2) years after the date that the products were prepared or the shelf-life of the product, whichever is greater, unless longer retention time is required by other regulations.
d. 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
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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. e. 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 onsite within twenty-four (24) hours of a requires for official review. Electronic records are considered to be on-site if they are accessible from an on-site location.
IV. Prerequisite Programs
The following required Prerequisite Programs shall have a brief written description or checklist that the prerequisite programs can be audited against to ensure compliance. Prerequisite Programs shall include procedures that can be monitored, records that specify what is monitored, and how often it will be monitored.
A. Required Prerequisite Programs 1. Safety of the water that comes into contact with milk or milk products or product contact surfaces, including steam and ice 2. Condition and cleanliness of equipment product contact surface. 3. Prevention of cross-contamination from unsanitary objects and or practices to milk or milk products or product contact surfaces, packaging material and other food contact surfaces, including utensils, gloves, outer garments, etc., and from raw product to processed product; 4. Maintenance of hand washing, hand sanitizing and toilet facilities. 5. Protection of milk or milk product, packaging material, and product 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, including employee exposure to high risk situations, that could result in the microbiological contamination of milk or milk products, package materials, and product contact surfaces; and 8. Exclusion of pests. 9. Required Programs (PP's) used as justification in the Hazard Analysis
In addition to the required PP's specified above, any other prerequisite programs that are being relied upon in the Hazard Analysis to reduce the likelihood of occurrence of hazards such that they are not reasonably likely to occur must also be monitored, audited, and documented as required PP's.
B. Acceptable level of protection by prerequisite programs
Prior to the implementation of a HACCP Plan, there is a requirement for dairy plants, receiving stations and transfer stations to develop, document and implement written PP's. PP's 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 and State regulations and guidelines.
HACCP is not a stand-alone program, but is part of a larger control system. 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 CCP's in that they are basic sanitation programs that reduce the potential occurrence of a milk or milk product safety hazard.
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Frequently, both HACCP Plan CCP's and PP's control measures are necessary to control a food safety hazard.
HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant, receiving station or transfer station premises, building construction, maintenance, and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective plant, receiving station or transfer station programs or by PP's, as the plant, receiving station or transfer station chooses.
PPs are the universal procedures used to control the condition 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 CCP's in that they are basic sanitation programs that reduce the potential occurrence of a food safety hazard. Frequently, both HACCP Plan CCP's and PP's control measures are necessary to control a food safety hazard. The exact set of PP's will vary since their application is product and process specific. The existence and effectiveness of PP's should be assessed during the design and implementation of each HACCP Plan. PP's 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.
V. Hazard Analysis
A. Preparing for a Hazard Analysis - Five Preliminary Steps
Although not required by the NCIMS HACCP alternative, the 5 preliminary steps of HACCP as outlined by the National Advisory Committee of Microbiological Criteria for Foods (NACMCF) will help you in conducting your hazard analysis and developing your HACCP plan, and will prove valuable for other HACCP functions. The steps you should follow are:
1. Step 1 Assemble a HACCP Team. 2. Step 2 Describe the food and its distribution. 3. Step 3 Identify the intended use and consumers of the food. 4. Step 4 Develop a flow diagram that describes the process. 5. Step 5 Verify the accuracy of the flow diagram. For more information, see the NACMCF publication "Hazard Analysis and Critical Control Point Principles and Application Guidelines," Journal of Food Protection, Vol. 61, No. 9, pp. 1246-1259 (1998), (the "HACCP Principles and Guidelines" publication).
B. Overview of the Hazard Analysis 1. Description
The dairy hazard analysis is a process of collecting and evaluating information on hazards associated with dairy products, to determine which hazards are reasonably likely to occur and must be addressed in a HACCP Plan. Under the dairy HACCP alternative, you are required to produce, for each type of Grade A dairy product you process, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur and to identify measures that you can apply to control those hazards. The dairy alternative requires a written hazard analysis for each type
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Hazards & Controls Guide For Dairy Foods HACCP