FSMA and Food Safety Systems E-Book

Jeffrey T. Barach

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 350

Veröffentlichungsjahr: 2016

Beschreibung

The FDA's (Food and Drug Administration) FSMA (Food Safety Modernization Act) is the most sweeping reform of United States food safety laws in more than 70 years. The key to successful implementation of FSMA rules depends on building a comprehensive Food Safety System with effective prerequisite programs in place and a well-designed Food Safety Plan that incorporates risk-based preventive controls to mitigate hazards. This book provides essential guidance for small to mid-sized businesses on how to design, implement, and maintain a world-class Food Safety Plan that conforms to FSMA regulations. With practical and up-to-date advice, the author offers a straight forward approach for readers to successfully migrate into FSMA. The inclusion of fully developed Food Safety Plans as well as examples of hazards and preventative controls make this a must-read not only for those that are new to the regulations, but also those with a plan already in place. FSMA and Food Safety Systems: A Guide to Understanding and Implementing the Rules is an indispensable resource for all those managing the manufacture of FDA regulated products, food safety regulators and educators, as well as scientists and students of food science and technology.

Leseprobe

Table of Contents

Cover

Title Page

Preface

About the Author

1 What is Modern Food Safety, and How is that Different from HACCP?

1.1 Introduction

1.2 FSMA Sanitation and cGMPs

1.3 FSMA Preventive Controls

1.4 Process Controls

1.5 Sanitation Controls

1.6 Supplier Controls

References

2 Why Is a Food Safety System the Best Path to Food Safety?

2.1 What are Biological Hazards and Their Controls?

2.2 What are Chemical Hazards, Including Allergens and Radioactivity, and Their Controls?

2.3 What are Physical Hazards and Their Controls?

References

3 What are the Essential Elements of a Food Safety System?

3.1 What are Prerequisite Programs, and What Do They Do?

3.2 What is a Hazard Analysis, and Why is it Performed?

3.3 What are Risk‐Based Preventive Controls, and How are they Assigned?

3.4 What is a Food Safety Plan, and Who Develops It?

4 How is a Food Safety System Managed?

4.1 What is the Role of Management and Plant Operations in a Food Safety System?

4.2 How are SOPs Developed and Managed?

4.3 How are Preventive Controls Managed?

4.4 How are Records Established and Maintained?

4.5 Why and How is a Recall Plan Developed and Managed?

References

Supplemental References for Recalls

5 How is a Food Safety System Developed and Implemented?

5.1 Developing a Food Safety Plan

5.2 Assemble the Food Safety Team

5.3 Describe the Food and its Distribution

5.4 Describe the Intended Use and Consumers of the Food

5.5 Develop a Flow Diagram that Describes the Process

5.6 Verify the Flow Diagram

5.7 Conduct a Hazard Analysis

5.8 Essential Elements of the Food Safety Plan

6 What Triggers a Reanalysis of the Food Safety Plan?

7 Resources for Preparing Food Safety Preventive Controls Plans

7.1 Examples of Prerequisite Programs

7.2 Examples of Allergen Preventive Controls

7.3 Examples of Sanitation Preventive Controls

7.4 Examples of Process Preventive Controls

7.5 Examples of Supplier Controls

7.6 Useful Forms

7.7 FSMA Training and the Food Safety Preventive Controls Alliance

8 Example Food Safety Plans

Barbeque Sauce – Example Food Safety Plan

Chocolate Chip Walnut Cookies – Example Food Safety Plan

Deli Potato Salad – Example Food Safety Plan

Macaroni & Cheese Frozen Meal – Example Food Safety Plan

9 FSMA Regulations

FDA Regulations on cGMP's, Hazard Analysis and Risk‐based Preventive Controls for Human Foods

Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk–Based Preventive Controls for Human Food

Appendix A: Food Safety Plan Checklist

Food Safety Plan Checklist

References

Appendix B: HACCP Principles and Application Guidelines

National Advisory Committee on Microbiological Criteria for Foods

References

Glossary

End User License Agreement

List of Tables

Chapter 02

Table 1 Excerpt From a Hazard Analysis Summary Table.

Table 2 Excerpt from a HACCP Plan.

List of Illustrations

Chapter 02

Figure 1 Preliminary Tasks in the Development of the HACCP Plan.

Figure 2 Example of a Company Established HACCP Verification Schedule.

Chapter 05

Figure 1 Preliminary tasks in the development of the food safety plan.

Guide

Cover

Table of Contents

Begin Reading

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FSMA and Food Safety Systems

Understanding and Implementing the Rules

Jeffrey T. Barach

Barach Enterprises, LLC

This edition first published 2017 © 2017 by John Wiley & Sons, Ltd.

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Cover image: Background: AdShooter/Getter Images; Smarties: Foodio/Shutterstock; Ice cream: ASA studio/Shutterstock; Cookies: Goran Bogicevic/Shutterstock; Vegetables: margouillat photo/Shutterstock

Preface

The concept of Food Safety Systems to control food hazards has been advancing over the past twenty‐five years with the global adoption of Hazard Analysis Critical Control Point (HACCP) principles. This has been both on a voluntary industry basis and as a mandatory regulation in the United States for seafood, juice, and meat & poultry products. Prior approaches of in‐plant inspections and end‐product testing have proven of limited value and generally result in reacting to problems, rather than being proactive to prevent problems from occurring. Recently, we see that FDA has been building upon the basic principles and practices of HACCP with a further refined and more comprehensive Food Safety System outlined in the final rules for “Current Good Manufacturing Practice, Hazard Analysis, and Risk‐Based Preventive Controls for Human Food (Federal Register (80) September 17, 2015). The final rule for human foods is the subject of this book; however, the Food Safety Modernization Act of 2011 (FSMA) is quite extensive. Since January 2013, FDA has proposed seven foundational rules to implement FSMA. Those rules became final in 2015 and 2016: Preventive Controls for Human Food, Preventive Controls for Animal Food, Produce Safety, Foreign Supplier Verification Program, Third Party Certification, Sanitary Transportation, and Intentional Adulteration. The goal of industry and regulators is to have a Food Safety System that is built upon a corporate food safety culture, a sound foundation of Good Manufacturing Practices (GMPs) prerequisite programs, and incorporates risk‐based preventive controls directed at controlling hazards.

If your business already has HACCP in place, the transition to the human foods rules of the Food Safety Modernization Act of 2011will be relatively straightforward. If you currently have only GMPs in place, the upgrade will require more time and resources to make the change. This guide will help you in either case by guiding you through what is required and developing a Food Safety Plan. The guide also addresses managing the plan and confirming its effectiveness. Within the guide, you will find both information you need to explain how a Food Safety System works and what you must do to develop and properly administer it. You will also find forms you may use to help structure your own Food Safety Plan and many examples of things to consider in addressing food safety hazards. Several example Food Safety Plans are included, since a main purpose of this guide is designed to teach by example.

Developing and implementing your Food Safety System according to the rules of FSMA is not as difficult as you might imagine. Hopefully, as you read the material presented here and follow along with the examples, you will gain the knowledge you need.

Although the recommendations in this publication are based upon scientific literature, regulatory guidance, and wide industry experience, examples of Food Safety Plans and Food Safety System components are not to be construed as a guarantee that they are sufficient to prevent damage, spoilage, loss, accidents, or injuries resulting from the use of this information. Furthermore, the study and use of this publication by any person or company is not an assurance that a person or company is then proficient in the operations and procedures discussed in this publication. The use of the examples, statements, recommendations, or suggestions contained, herein are not to be considered as creating any responsibility for damage, spoilage, loss, accident, or injury resulting from such use.

About the Author

Jeffrey T. Barach, PhD; Principal, Barach Enterprises, LLC

Jeffrey Barach is a food scientist who has been active in research and development, regulatory liaison activities, teaching, problem solving, and trouble shooting for the food industry for over thirty years. He routinely participates as a consultant in planning, development, and management of special projects and programs for the food industry on health and safety issues, production of foods, regulatory compliance issues, and training. He is a subject matter expert (SME) on issues related to food safety modernization, biotechnology, food irradiation, nanotechnology, and other new processing and testing technologies. Dr. Barach was formerly with Grocery Manufacturers Association as head of their Science Policy Group and previously directed the GMA Laboratory in Washington, D.C. His education includes receiving his MS and PhD in food science from North Carolina State University and his undergraduate degree in Chemistry from the University of North Carolina. Dr. Barach is also a lecturer, lead instructor training professional and educator in food safety and food sanitation, with a focus on HACCP and FSMA food safety systems.

The author has met and worked with many outstanding food scientists from industry, academia, and the regulatory agencies in his career. He is grateful to those that shared their expertise, wisdom, and knowledge with him. He also is pleased to share his knowledge, as a teacher, with his many students and fellow colleagues. Hopefully, this guide book will extend that desired ambition of knowledge sharing. Special thanks goes to his wife Kathy and to those that helped him with the review of this publication. Their encouragement and suggestions are kindly taken and greatly appreciated.

1What is Modern Food Safety, and How is that Different from HACCP?

1.1 Introduction

President Obama signed the Food Safety Modernization Act of 2011 (FSMA) in response to Congress' efforts to address the food safety issue demands of a broad coalition of stakeholders – including produce growers, food processors, retailers, and consumers who were disturbed by a series of illness outbreaks and contamination incidents. These significant foodborne illness events, which involved both domestic and imported foods, undermined consumer confidence and imposed harmful and costly disruptions on consumers and food producers. Many believed that these events would be largely preventable if new laws were developed and implemented that utilized best practices for preventing food safety problems.

The bills and subsequent law was focused on making these practices the norm for all domestic FDA‐regulated products in the United States (U.S.) market. Congress and the FDA realized that a significant portion of the food consumed in the U.S. is produced in foreign countries. They recognized the need to address food safety at a global scale to address the wide range of food, ingredients, and commodities the U.S. imports from over 200 countries and territories.

For both domestic and foreign food, FSMA regulatory mandates keyed in on two proven basic principles of food safety that could address the concerning incidents of food safety problems and the growing diversity of the global food supply. The new rules were, in principle, to be a scientific assessment of risk and were to implement controls that would prevent significant food safety problems, rather than just to react to them after the fact.

FSMA regulations (Fed. Reg., 2015) explicitly recognize the food safety role of the food industry while giving regulatory authority to the FDA. With that, it rests on a third core principle that empowers those who produce food for the commercial market to have the responsibility and capability to make it safe in accordance with recognized best practices for preventing harmful contamination and preventing food safety hazards.

FSMA uses a risk‐based strategy and preventive controls to achieve its broad goals by fundamentally changing FDA’s food safety role and redefining its relationship with other participants in the food system. These broad steps toward modernizing food safety are fundamentally sound and inherently necessary in the global environment and under existing resource limitations if food safety goals are to be achieved.

The language of FSMA is consistent with the Hazard Analysis Critical Control Points (HACCP) approach. In the U.S., HACCP is required for many foods, including meat and poultry, seafood and juice (NACMCF, 1997; see Appendix B). Regulations within the European Economic Community require HACCP plans. Likewise, the Codex Alimentarius Commission notes that HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end‐product testing. The keystone of FSMA, like HACCP, is the development of risk‐based preventive controls for food facilities. Food facilities are required to develop and implement a written plan for preventive controls and a written recall plan.

This involves:

Evaluating the hazards that could affect food safety;

Specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards;

Specifying how the facility will monitor these controls to ensure they are working;

Maintaining routine records of the monitoring, and

Specifying what actions the facility will take to correct problems that arise.

The final rule implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes sound sanitation programs, a hazard analysis, and risk‐based preventive controls. Specifically, the rule establishes requirements for:

A written food safety plan;

Hazard analysis;

Preventive controls;

Monitoring;

Corrective actions and corrections;

Verification;

Supply‐chain program;

Recall plan; and

Associated records.

However, in order for the food safety plan to be effective, it must be built on a strong foundation of current good manufacturing practices (cGMPs). FSMA addresses cGMPs in the new rules under the Subpart B provisions. The importance of having effective and well implemented cGMPs can't be overstated. Many of the problems associated with low‐moisture foods, such as peanut butter, that lead to foodborne illnesses were because of poor basic sanitation practices.

1.2 FSMA Sanitation and cGMPs

Several steps to modernize cGMPs have been incorporated in FSMA rules. For a better understanding of these developments, it may be helpful to recap where these initiatives originated. As background, the FDA issued a white paper in 2005, titled “Food cGMP Modernization – A Focus on Food Safety,” to address significant changes that had occurred both in industry and in the science and technology of food safety. The last time cGMPs were revised was in the mid 1980s. As FSMA regulations were being formulated by FDA, it became apparent that new food safety regulations should combine this earlier cGMP effort with the new initiative that was focused on preventive controls. This strategy led to the rewrite of 21 CFR Part 110 into 21 CFR Part 117 (Subpart B). Rather than having FDA pursue further modernization of cGMPs as a separate task, almost all stakeholders agreed with incorporating those improvement activities within the FSMA framework. As a result, the new FSMA rules for human foods are titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk‐Based Preventive Controls for Human Food” to included both cGMP and preventive control updates.

Under the FSMA framework, cGMPs are revised and industry responsibilities are clarified. The rule states what must be done in a facility to control sanitation, and the language in the regulation was updated, such as using the term “must” instead of “shall.” As with HACCP programs, requirements under cGMPs are included for personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing, and distribution. The cGMPs were modified to clarify that certain provisions requiring protection against contamination of food also require protection against allergen cross‐contact. Regulations also now require cleaning of non‐food‐contact surfaces as frequently as necessary to protect against contamination of food and food‐contact surfaces. Additionally, food‐contact surfaces used for manufacturing/processing or holding low‐moisture food must be in a clean, dry, and sanitary condition at the time of use. The rules place emphasis on education and training to ensure employees have the knowledge and/or experience necessary to make and produce safe food.

The following is a summary of the major components of FSMA regulations regarding cGMPs:

21 CFR Part 117 (Subpart B) – Current Good Manufacturing Practices

Part 117.10 Personnel

Part 117.20 Plant and grounds

Part 117.35 Sanitary operations

Part 117.37 Sanitary facilities and controls

Part 117.40 Equipment and utilities

Part 117.80 Processes and controls

Part 117.93 Warehousing and distribution

Part 117.95 Holding and distribution of human food by‐products for use as animal food

Part 117.110 Defect action levels

Note: Additional regulations may be applicable, see final rules.

1.3 FSMA Preventive Controls

HACCP is the predecessor of FSMA. Both approaches have the goal of establishing a food safety system that will provide the environment for safe food production. That includes cGMPs and controls to prevent the food product from becoming adulterated by any known or foreseeable hazards coming from the foods or hazards resulting from faulty manufacturing operations. Contamination of food products typically comes from one of three different sources: 1) ingredients, 2) the processing environment, including equipment, or 3) people. A major difference between FSMA and HACCP is that HACCP is focused mainly on processing controls (called critical control points) while FSMA expands the aspects of controls to include allergen preventive controls, sanitation preventive controls, and supplier controls, as well as maintaining the importance process controls.

FSMA focuses on identifying hazards that are then mitigated by specific types of preventive controls. It requires a written analysis of potential hazards to determine if they are known or reasonably foreseeable and if they are severe enough to require a preventive control to be implemented. The first part of hazard analysis is the identification of potential biological, chemical (including radiological), and physical hazards that may be associated with the facility or the food. These hazards may occur naturally, may be unintentionally introduced, or may be intentionally introduced for economic gain. Controls are needed to manage the hazards introduced from these sources. With the significant hazards identified, preventive controls (of the types described above) are assigned and managed by plant personnel through well developed and documented actions and procedures. FSMA also requires a written Food Safety Plan, and if hazards are identified that need preventive controls, they are included in the plan. The Food Safety Plan is the primary document that guides the preventive controls of the food safety system.

FSMA details the requirements and contents of the Food Safety Plan:

Part 117.126 Food Safety Plan requirements.

Prepare, or have prepared, and implement a Food Safety Plan. It must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals.

The written Food Safety Plan must include the written:

Hazard analysis

Preventive controls

Supply‐chain program

Recall plan

Procedures for monitoring the implementation of the preventive controls

Corrective action procedures

Verification procedures, and

Records

Note: Additional regulations may be applicable, see final rules.

1.4 Process Controls

Process controls for biological hazards depend on the organism(s) of public health significance, the characteristics of the food, and the process used to product the food. In many foods that have a high‐moisture environment, pathogenic vegetative cells like E. coli O157:H7 and Salmonella are fairly easily killed during processing by heating or cooking. In low‐moisture foods, however, Salmonella has unique thermal‐resistance and durability characteristics that need to be carefully considered in the context of developing the food safety controls where Salmonella can survive. For pathogens that produce bacterial spores that can survive heat and outgrow, producing toxic food, a different control approach is necessary. If the spore‐forming organism of public health concern is Clostridium botulinium, FSMA recognizes that well established regulations already exist in 21 CFR Part 113 and an exemption allows low‐acid canners to control this biological hazard using those regulations (see Part 177.5). Other toxin‐producing spore formers, such a Clostridium perfringens and Bacillus cereus require a different control approach, usually a cooling temperature control. When the hazard analysis indicates a pathogen hazard, there are many factors in deciding the appropriate process control. The type of organism (vegetative cell or spore), the nature and characteristics of the pathogen, the condition of the food product (e.g., moisture, pH, aw) and other factors need to be considered. This may not be a simple task, given all the factors and variables involved. Often designing the proper process control may require the input from subject‐matter experts such as a microbiologist, a process authority, a consultant and/or other food scientists.

In HACCP terminology, using a processing step to kill vegetative pathogens would typically be considered a critical control point (CCP). In FSMA, the concept is the same, and the action is called a process control. The potential hazard from bacterial pathogens and the appropriate mitigating steps would be identified in the hazard analysis with the oversight of the Preventive Control Qualified Individual (PCQI). Preventive controls would then become part of the Food Safety Plan as a process control, if a processing step is used to inactivate the pathogen. For example, a cooking process may be part of a high‐moisture food manufacturing operation. With proper validation, it could be scientifically shown that this heating step will control Salmonella and remove the hazard. The cooking step becomes the point of control to be managed to ensure a Salmonella hazard does not exist for the food product.

When incorporating process controls into the Food Safety Plan, the preventive controls required include only those appropriate to the facility and the food, as determined by hazard analysis. Process controls would typically be at CCPs, similar to HACCP.

Part 117.135 (c)(1) Process controls.

Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as heat processing, acidifying, irradiating, and refrigerating foods. Process controls must be included, as appropriate to the nature of the applicable control and its role in the facility’s food safety system:

Parameters associated with the control of the hazard; and

The maximum or minimum value, or combination of values, to which any biological, chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process control.

Note: Additional regulations may be applicable, see final rules.

1.5 Sanitation Controls

Like process controls, sanitation preventive controls are those determined through a hazard analysis as necessary to significantly minimize or prevent: 1) environmental pathogens in a ready‐to‐eat (RTE) food exposed to the environment prior to packaging where the packaged food does not receive a treatment that would significantly minimize the pathogen; 2) biological hazards in a RTE food due to employee handling; and 3) food allergen hazards. Other aspects of routine (cGMP) sanitation such as pest control and safety of water and employee health do not need to be in a Food Safety Plan unless these programs/procedures are determined to be of a nature where hazards will result unless a preventive control is applied.

Part 117.135 (c)(3) Sanitation controls.

Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards. Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:

Cleanliness of food‐contact surfaces, including food‐contact surfaces of utensils and equipment;

Prevention of allergen cross‐contact and cross‐contamination from insanitary objects and from personnel to food, food packaging material, and other food‐contact surfaces and from raw product to processed product.

Note: Additional regulations may be applicable, see final rules.

In all cases, effective sanitation procedures are a front‐door to back‐door necessity to ensure safe food production. A hazard may be re‐introduced in an open plant environment postprocess. Routine plant sanitation standard operating procedures and specific sanitation preventive controls work together to ensure food safety.

FSMA identifies certain ready‐to‐eat (RTE) foods where environmental monitoring would be appropriate as a verification tool to confirm the effectiveness of the sanitation control. Foods such as peanut butter, dried dairy products for use in RTE foods, and roasted nuts are among the products for which manufacturing operations would need to have an environmental monitoring program when such foods are exposed to the environment. However, FSMA qualifies the need for implementing environmental monitoring as a possible verification activity as being appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring generally would be required if contamination of a RTE food with an environmental pathogen is a hazard requiring a preventive control. If environmental monitoring is used as a verification tool for sanitation controls, the following procedures are recommended by FDA:

Environmental Monitoring Procedures

Identify test microorganism

Identify locations (may be guided by zoning*) and number of sites to be tested

Identify timing and frequency for collecting and testing samples

Identify test, including the analytical method

Identify the laboratory conducting testing

Include corrective action procedures

*(For information about zones and environmental monitoring, see 78 Federal Register 3646 at 3816).

Part 117.165 (a)(3) Verification – Environmental Monitoring

Environmental monitoring, for an environmental pathogen or for an appropriate indicator organism, if contamination of a RTE food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples.

Note: Additional regulations may be applicable, see final rules.

1.6 Supplier Controls

Globalization of the food supply has brought new challenges to the food industry. Fortunately, many of the same practices and procedures used for managing foods and ingredients from domestic suppliers also apply to foreign suppliers. When an identified bacterial hazard is mitigated and controlled within the facility, the burden of controlling the pathogen is taken in‐house. However, when a facility relies on their supplier to control the hazard: for example, if the food operation does not include a thermal processing step, the Food Safety Plan may need to include a supplier control to prevent pathogen‐contaminated source material from entering the plant's operations. Also, when a potential pathogen is passed on to a customer, that customer needs to be alerted to that fact and take proper actions to control the hazard.

Supply‐chain controls, implemented through a supply‐chain program, are required for ingredients or raw materials for which the receiving facility’s hazard analysis identified a hazard requiring a supply‐chain‐applied control. Other preventive controls may be identified as appropriate based on the hazard analysis. FSMA has introduce a regulation for supply chain programs that are designed to be flexible, recognizing that many food operations have many different suppliers both domestically and foreign. The rule mandates that a manufacturing/processing facility have a risk‐based supply chain program for those raw materials and other ingredients for which it has identified a hazard requiring a supply‐chain applied control. Manufacturing/processing facilities that control a hazard using preventive controls, or who follow applicable requirements when relying on a customer to controls hazards, do not need to have a supply‐chain program for that hazard. Covered food facilities are responsible for ensuring that these foods are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. If a facility identifies a hazard that they will not control because the hazard will be controlled by a subsequent entity, such as a customer or other processor, the facility will have to disclose that the food is “not processed to control (identified hazard)” and obtain written assurance from its customer regarding certain actions the customer agrees to take.

Part 117.410 General requirements applicable to a supply‐chain program:

The supply‐chain program must include:

Using approved suppliers;

Determining appropriate supplier verification activities (including determining the frequency of conducting the activity);

Conducting supplier verification activities;

Documenting supplier verification activities; and

When applicable, verifying a supply‐chain‐applied control applied by an entity other than the receiving facility’s supplier and documenting that verification, or obtaining documentation of an appropriate verification activity from another entity, reviewing and assessing that documentation, and documenting the review and assessment.

The following are appropriate supplier verification activities for raw materials and other ingredients:

Onsite audits;

Sampling and testing of the raw material or other ingredient;

Review of the supplier’s relevant food safety records; and

Other appropriate supplier verification activities based on supplier performance and the risk associated with the raw material or other ingredient.

Note: Additional regulations may be applicable, see final rules.

The following table summarizes the major differences between a Food Safety Plan vs. a HACCP Plan for human foods:

Food Safety Plan

HACCP Plan

Hazard Analysis

Hazard Analysis

Preventive Controls

CCPs

Parameters, Values and Critical Limits

Critical Limits

Monitoring

Monitoring

Corrective Actions

Corrective Actions

Verification

Verification

Records

Records

Recall Plan

See also (Fed. Reg., 2015): Table 29, p. 56024.

References

1 Federal Register. 2015. Current Good Manufacturing Practice, Hazard Analysis, and Risk‐Based Preventive Controls for Human Food. Vol. 80, Sept 17, 55908.

2 NACMCF. 1997. HACCP Principles and Application Guidelines, August 14, 1997 (see Appendix B).

2Why Is a Food Safety System the Best Path to Food Safety?

FDA's final FSMA regulations are focused on a preventive approach to food safety. Preventive controls, when properly established and implemented, provide a superior approach over a reactive program, which just fixes and repairs problems after they occur. Preventive controls are also superior to the practice of substantial amounts of end‐product testing. It is statistically very difficult to find low levels of contamination in food. To do enough end‐product testing to be useful, it would be very expensive and would likely destroy large amounts of product looking for the needle in the haystack. To be truly effective, the preventive control approach must have all elements of the system implemented and operational to be working properly. The system uses a foundation of good manufacturing practices and risk‐based preventive controls to mitigate food safety risk. Constructing a working Food Safety System brings together management, line‐workers, food safety specialists to design, develop, implement and manage a viable and dynamic system to produce safe and wholesome food.

2.1 What are Biological Hazards and Their Controls?

Each year in the U.S., the Centers for Disease Control and Prevention (CDC) estimates there are approximately 48 million illnesses with 128,000 hospitalizations and 3,000 deaths associated with foodborne illness (CDC, 2011a). Hoffmann et al. (2012) estimated the cost of illness for five of the most common bacterial foodborne pathogens (Escherichia coli O157:H7, other Shiga‐toxin producing E. coli, Campylobacter, Listeria monocytogenes, and Salmonella) as $7.9 billion per year. Although there are limitations to using data estimates, there is no doubt that foodborne illness is a serious problem that warrants attention.

Foodborne illness can result when biological hazards in foods are not properly controlled (CDC, 2011b). An understanding of the types of biological hazards in a specific food is important for an adequate hazard analysis and assignment of effective preventive controls. The characteristics of the microorganism(s) of public health significance must be examined in the context of the food and the environment to determine the appropriate controls.

Surveys have shown that foods most frequently involved in outbreaks are foods of animal origin, although outbreaks from contaminated fruits and vegetables have become more common in recent years, increasing from 0.7% in the 1970s to 6% in the 1990s (Sivapalasingam et al., 2004). Yet when examining the total number of illness, poultry, beef, pork, seafood, and eggs are still most commonly involved (Painter et al., 2013; CDC, 2013).

Ready‐to‐eat and ready‐to‐cook foods have also become a new vehicle for outbreaks. Spinach and peanut products were involved in large outbreaks of foodborne illness in 2006 and 2009, respectively. The 2006 outbreak was linked to fresh spinach contaminated with the E. coli O157:H7. At least 199 people had been infected, including 3 people who died and 31 who suffered a type of kidney failure called hemolytic uremic syndrome (HUS) (CDC, 2010). Following the 2006 outbreak, various state and federal legislative proposals have emerged that require stricter food production, processing and handling of the food. Industry participants have also adopted improved programs to address food safety. The California Leafy Greens Handler Marketing Agreement (LGMA) developed best practices for farmers that produce lettuce, spinach, and other leafy greens. In May 2011, FDA, USDA, and Cornell University announced the formation of a Produce Safety Alliance to provide produce growers and packers with access to food safety educational materials, science‐based best food safety practices, and information about future regulatory requirements.

In late 2008 and early 2009, at least 691 people contracted Salmonellosis from eating products containing peanuts, nine of whom died and 23% were hospitalized (CDC, 2009). FDA confirmed that the outbreak of illnesses was caused by Salmonella typhimurium and the source of illness was low‐moisture foods including peanut butter, peanut paste, and peanut meal products. Even though Salmonella does not grow in low‐moisture foods, it can survive and remain viable for extended periods of time. In response to Salmonella outbreaks in low‐moisture foods, the Grocery Manufacturers Association (GMA) developed several industry guidance documents for controlling Salmonella in low‐moisture foods (Chen et al., 2009a; 2009b; Scott et al., 2009).

In the past, the development of classic Hazard Analysis Critical Control Points (HACCP) programs focused mainly on the control of microbial hazards. Pathogens in foods remain a top problem for the food industry and a significant public health issue, considering that one in six people are estimated to be stricken with a foodborne illness. The new rules focus on prevention and implementing effective preventive controls to reverse advancing trends in foodborne illnesses.

This guide book will not provide a full review of all possible biological hazards. Other resources are readily available for details about the growth and toxin characteristics, disease properties, and potential food sources of biological hazards in foods. The table below lists many of the common organisms to consider; however, take note that this list is not comprehensive and is for illustrative purposes only. The hazard analysis for identifying potential biological hazards must include a person(s) knowledgeable in bacterial pathogens (vegetative cells and spore formers), toxins from microorganisms, viruses and parasites.

Biological Organism

Example

Potential HazardousCondition

Bacterial Pathogens

Vegetative cells

Eschericia coli (STEC).............

Listeria monocytogenes...........

Fecal contamination of raw foods and ingredientsRaw foods, ingredients, and soil, can grow at refrigeration temperatures

Salmonella spp........................

Shigella spp.............................

Raw foods and ingredients, very durable, dry and heat resistant in low‐moisture foodsFecal contamination, water or workers

Staphyloccus aureus...............

Streptococcus group A............

Contamination from workers, temperature abuse (toxin)Contamination from workers handling food

Spore formers

Vibrio spp.................................

Yersinia enterocolitica..............

Marine seafoods‐ contamination and temperature abuseContamination from raw meats, especially RTE foods.

Bacillus cereus........................

Temperature‐abused rice, starchy foods (toxin)

Clostridium botulinum.............

Clostridium perfringens............

Outgrowth in low‐acid foods under anaerobic conditions (toxin)Temperature abused meats, stews (toxin)

Viruses

Norovirus..................................

Contamination from infected workers handling food

Hepatitus A..............................

Contamination from infected workers handling food

Parasites

Campylobacter jejuni...............

Contamination from raw food and undercooking

Cryptosporidium parvum..........

Contamination from water and unpasteurized food

Toxoplasma gondii...................

Contamination from raw meat and undercooking

Trichinella.................................

Contamination from raw meat and undercooking

STEC (Shiga‐toxin producing E. coli).

In addition to the information provided here, it may be helpful to review more information about specific microorganisms in foods by consulting references, especially the International Commission on Microbiological Specifications for Foods (ICMSF) texts (ICMSF, 2005; 2011) and FDA's Bad Bug Book (FDA, 2013). FDA is developing a Hazards and Control Guide and when this becomes available, it will help industry in hazard assessments of biological hazards (see guidance at: http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM517610.pdf).

Classically, there are three major ways of preventing foodborne disease: prevent contamination of the foods, destroy foodborne disease agents that may be present in food, and prevent foodborne disease agents from growing in foods.

Common preventive controls for biological hazards include the following:

Specifications for microbiological levels in raw materials or ingredients

Time/temperature controls (thawing/tempering, cooking, freezing, holding, cooling rates, refrigerating, storing, etc.)

Preservative factors for the food (pH, a

w

, etc.)

Prevention of cross‐contamination (e.g., zoning)

Equipment/environmental sanitation

Food‐handling practices

Employee hygiene

Packaging integrity

Storage, distribution display practices

Consumer directions for use (to prevent abuse)

2.2 What are Chemical Hazards, Including Allergens and Radioactivity, and Their Controls?

Biological hazards are generally of greatest concern because they are capable of causing widespread foodborne illnesses; however, chemical hazards also have been associated with foodborne illness or injury, albeit generally affecting fewer individuals. Chemical hazards, specifically due to unintended allergens in foods, are a major cause of recalls today. Radiological hazards in foods would be extremely rare but must be considered when developing the Food Safety Plan or during a reanalysis of the hazards and the plan (e.g., purchasing products from an area having a major radiological event like at Fukushima, Japan may warrant a radiological preventive control).

The hazard analysis must consider potential chemical hazards and if present, develop a Food Safety Plan with appropriate control measures. The discussions during the hazard analysis will help decide whether potential chemical hazards warrant inclusion within a Food Safety Plan or whether these potential hazards should be managed within a prerequisite program. This review of chemical hazards, as with other sections on hazards, presents information needed for the identification of potential hazards during the first stage of the hazard analysis.