FSMA and Food Safety Systems

Understanding and Implementing the Rules

Jeffrey T. Barach

• Publisher: Wiley
• Year: 2016
• Print ISBN: 9781119258070
• eBook ISBN: 9781119258124
• Edition: 1
• Topic: Technology & Engineering
• Subtopic: Food Science
• Index: Technology & Engineering

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.

1
What 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:

1. Evaluating the hazards that could affect food safety;
2. Specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards;
3. Specifying how the facility will monitor these controls to ensure they are working;
4. Maintaining routine records of the monitoring, and
5. 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 p...

Table of contents

• Cover
• Title Page
• Table of Contents
• Preface
• About the Author
• 1 What is Modern Food Safety, and How is that Different from HACCP?
• 2 Why Is a Food Safety System the Best Path to Food Safety?
• 3 What are the Essential Elements of a Food Safety System?
• 4 How is a Food Safety System Managed?
• 5 How is a Food Safety System Developed and Implemented?
• 6 What Triggers a Reanalysis of the Food Safety Plan?
• 7 Resources for Preparing Food Safety Preventive Controls Plans
• 8 Example Food Safety Plans
• 9 FSMA Regulations
• Appendix A: Food Safety Plan Checklist
• Appendix B: HACCP Principles and Application Guidelines
• Glossary
• End User License Agreement