Hazard Analysis and Risk Based Preventive Controls: Building a (Better) Food Safety Plan

Hazard Analysis and Risk Based Preventive Controls

Building a (Better) Food Safety Plan

Patricia A. Wester

Founder and Board Chair, AFSAP, The Association for Food Safety Auditing Professionals, a 501(c)3 non-profit trade association representing food safety auditors, President, PA Wester Consulting, Alachua, FL, United States

Table of Contents

Cover image

Title page

Copyright

Prologue

The Origins of Food Safety Modernization Act

Creating the Regulations to Implement The Food Safety Modernization Act 2011–15

Standard Setting and Guidance

Introduction

Chapter 1. Develop an Implementation Strategy

Abstract

Get Trained!

2016 Implementation Theme: Get a PCQI Certificate—Compliance Will Follow

Time, Resources, and Budgets: How Much Is Enough?

Lessons Learned in Year 1

Management’s Understanding of FSMA’s Requirements

Resources and Budgeting

Step 1: Verify Your Compliance Requirements

Step 2: Identify All Roles and Training Needs in the Regulation

Impact on Food Safety

Food Safety Training Options

Chapter 2. Preparing for the Hazard Analysis

Abstract

Develop a Product Profile

Five Preliminary Tasks of HACCP/Preventive Controls

The PCQI

A Practical Approach to Document Management

The Purpose of Document Control

Document Control Procedures

A Process Tailored to the Environment

Implementing a Document Control Process

Understanding Hazards: Information Resources

Chapter 3. Hazards, The Hazard Analysis, and The Food Safety Plan

Abstract

FSMA Hazard Updates

Chapter 4. Preventive Controls and Process Controls

Abstract

What Are Preventive Controls

Preventive Controls Management Components

§ 117.150 Corrective Action Procedures

§ 117.155 Verification

§ 117.160 Validation

Process Controls

Process Control Management Components

Chapter 5. Sanitation Preventive Controls and Sanitation Basics

Abstract

Sanitary Design Principles

Nonproduct Contact Surfaces

Niches and Harborages

Wet Processes

Dry Processes

Use of Sanitation Controls for the Cleanliness of FCS

The Basic Sanitation Steps and FCS Management

Sanitation Controls

Chapter 6. Allergen Preventive Controls

Abstract

In the Zone and Beyond

Personnel Practices

Labeling as a Preventive Control

Chapter 7. Supply Chain Program

Abstract

Subpart G—Supply Chain Program

Upstream Hazards—Outside the Comfort Zone

Supply Chain Controls for Chemical Hazards

Supply Chain Controls for Pesticides

Supply Chain Controls for Drug Residues

Heavy Metals

Supply Chain Controls for Mycotoxins

Risk Assessment Example

Verification Activities—Looking at Audits in a New Light

Auditor Training and an Audit Checklist—Enough to Audit?

FDA Accredited Third Party Certification

Supply Chain Controls Management Components—Nonconformances and Corrective Actions

Verification Records

Chapter 8. Verification Activities

Abstract

§ 117.165 Verification of Implementation and Effectiveness

Environmental Monitoring Program

The EMP Sampling Plan

Product and/or FCS Testing: Contamination Events

Factors Contributing to Pathogens in the Environment

Defining Growth Niches

Managing and Controlling Growth Niches

Investigation of a Positive Result—Niche or Transient?

DNA Mapping

Chapter 9. Recalls, Records, and Reanalysis

Abstract

Recalls

Records

Forms and Format

Retention and Review

Reanalysis

Appendix 1. Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Final Rule Comments and Responses

Redesignation of § 110.3

Additional Definitions to Clarify Terms Not Defined in the Proposed Rule

X. Subpart A: Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food

Index

Copyright

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Prologue

The Origins of Food Safety Modernization Act

As the calendar rolled on toward the new millennium, the US food safety community felt as if the entire industry was stuck in a horrible loop of massive foodborne illness outbreaks and recalls. As microbial pathogens emerged as one of the deadliest threats to consumer safety in recent history. The meat industry battled valiantly to develop environmental testing plans that would contain Listeria monocytogenes, while E. coli:0157:H7 continued to slip past most attempts to establish controls capable of containing it. Sadly, the industry’s learning curve was just too steep to prevent enough of them, and the late 1990 to early 2000s were littered with devastating headlines.

The visual-based regulatory inspection system at U.S. Department of Agriculture (USDA) was no match for these pathogens either. Although both the industry and regulatory communities continued to fight these invisible threats, it seemed as if each recall sets new records in size and scope. In response to the increasing number and size of these events, the USDA Food Safety and Inspection Service (FSIS) published The Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule in 1996, with compliance deadlines pushing through the end of the 1999. The close of the century would usher in a new era of science-based regulatory systems at USDA. The person at the helm for USDA’s FSIS was none other than Michael R. Taylor.

Microbial Challenges not Limited to the Meat Industry

During this period, the FDA faced similar food safety challenges when a number of food products under the agency’s oversight were found to contain pathogens that required regulatory actions. Recognizing this problem was not confined to meat and poultry products, FDA implemented Juice and Seafood HACCP as they scrambled to manage these expanding microbial concerns while facing shrinking budgets and resource limitations. As global sourcing picked up momentum, FDA’s inspection resources were further strained by the increasing amount of imported foods entering the United States. Some products, such as imported shrimp, were continually found to be contaminated with Salmonella. FDA began detaining imported shrimp for Salmonella testing under an Automatic Detention Without Physical Examination system to ensure product safety before releasing it into commerce. With a broader scope than individual import alerts, it is likely that fewer consumers may have been directly impacted by illness, although it may have affected price and availability as millions of dollars of frozen seafood inventory began stacking up in cold storages all over the United States waiting on test results to determine if they were safe for consumption.

Like USDA’s FSIS, FDA’s inspection system was outmoded, outmanned, and underfunded against the emerging microbial contaminants, so FDA began allocating resources using a risk-based approach. FDA's risk-based approach meant that the agency used its limited inspection resources to look at products that posed the greatest risk to public health. Although FDA was not required to inspect foreign firms that exported food or feed products to the United States at that time, there were targeted inspections when necessary at foreign firms. The addition of the HACCP regulations for Juice and Seafood provided some opportunities for reductions in food safety events, but these would turn out to be limited since the vast majority of products produced by FDA-regulated facilities were still only required to implement current good manufacturing practices (CGMPs).

Unfortunately, adding the HACCP regulations and using a risk-based approach to identify inspection targets proved to be inadequate, there simply were not enough FDA Inspection resources or Industry knowledge, to overcome these emerging threats.

The Final Straw: Melamine Tainted Pet Food

On March 15, 2007, a pet food manufacturer alerted FDA to this startling news: 14 animal deaths had occurred in the United States: four cats and one dog were reported by consumers, and nine cats that died during routine taste trials conducted by the company. The animals were reported to have developed kidney failure after eating certain cuts and gravy style dog and cat food produced at Menu Foods' facilities between December 3, 2006, and March 6, 2007.

In the following months, consumers and veterinarians reported many more illnesses and deaths potentially associated with a wide variety of contaminated, imported pet foods made by several manufacturers. Once the melamine outbreak began expanding, it was clear that criminal charges would be filed against the parties responsible. On February 6, 2008, FDA announced that two Chinese nationals and the businesses they operated, along with a US company and its president and chief executive officer, were indicted by a federal grand jury for their roles in a scheme to import products purported to be wheat gluten into the United States that were contaminated with melamine.

An Interagency Working Group was appointed by President Bush, and Congress went to work to address these issues through the lengthy process of getting a bill passed through both the House & Senate. The first version entitled The Food Safety Enhancement Act (HR 2749) passed the House on June 9, 2009, nearly 2 years after the initial reporting of the melamine contamination.

A small group of food safety professionals from the auditing industry took great interest in these activities, eventually forming the Food Safety Services Providers or FSSP. The FSSP enjoyed the extraordinary representation of Phillip Olsson, founding partner at Olsson, Frank, Weeda, Terman, Matz, PC (OFW), to guide the group and ensure that the goals and objectives established were within reach and yet limitless if the members were willing to work hard. As a trade association with a focus on the use of audits, the challenges ahead were substantial. Consumer groups were extremely vocal during this period, raising objections to any use of third-party audits in the legislation after it was revealed that several of the facilities involved in high-profile outbreaks had been the subject of recent audits that appeared to have failed to identify glaring deficiencies.

FSSP’s senior representatives spent a good deal of time in Washington describing the intricacies of accredited third-party certification audits, often called on to explain why and how these audits differed from the audits attributed to those involved in the outbreak cases.

My role as the FSSP Chair provided FSSP an opportunity to participate in one of the most significant regulatory changes to food safety of this era. Working with one of the most respected legal minds in food safety, a select group of people that were normally professional competitors, united with common purpose and good intent, collaborated to contribute their expertise on this landmark event. These contributions stand in the final rule as evidence of the impact a few can have to achieve a positive outcome that benefits public health

The Senate version (S510) followed, mirroring the House version in some areas, diverging in others and the trips to Washington began again. While some of the consumer concerns had been addressed, it is important to understand the context of the time as yet another group of politicians, many with years of interest in upgrading food safety oversight worked through various questions. Several months passed while the final negotiations between all parties were completed, leading to the agreed version entitled the Food Safety Modernization Act. Apparently the victim of politics, surprisingly it passed by a vote of 73–25 in the Senate in November, 2010.

However, because of a fee provision added in the Senate, the passing vote did not count. Revenue-based legislation must originate in the House, so it appeared we may be back to square one. There was concern that with the short time left in the lame-duck session, the bill simply did not have the time needed to successfully complete another chance to be voted on and passed. Attempts to add the bill to the continuing resolution for government funding were scraped over the objection of Senator Tom Coburn.

As 2010 drew to a close, it appeared as if the battle to achieve this food safety milestone may have been lost, and to say there was disappointment in the group would be vastly understating the mood. However, the Senate quietly moved to pass the fixed bill on December 19, 2010, and it passed with unanimous consent by a voice vote. The House went on to approve the bill by a vote of 215 to 144 on December 21, 2010.

Creating the Regulations to Implement The Food Safety Modernization Act 2011–15

Public Law 111–353: The Food Safety Modernization Act

On January 4, 2011, President Obama signed the Food Safety Modernization Act and Public Law 111–353 was officially on the record. The Food Safety Modernization Act (FSMA) is considered to be the most comprehensive piece of legislation on food safety since The Meat Products Act and The Poultry Products Act were passed in 1938 during the height of the Great Depression. On July 7, 2009, Mike Taylor had returned to government as the new Senior Advisor to the FDA Commissioner. On January 13, 2010, he was appointed to a newly created post at the FDA, Deputy Commissioner for Foods, and in early 2011, he was once again was leading the charge to execute a massive update in food safety regulations. The mission to develop and implement the regulations necessary under FSMA would turn out to be far more complicated (and lengthy) than the previous experience at USDA.

As 2011 began, the food safety community was cautiously optimistic while waiting to see the proposed regulations FDA would develop to implement FSMA. To be sure, FSMA included extremely tight deadlines and a massive amount of work for FDA to meet all of the requirements outlines in the law. None foresaw the extended time it would take to achieve the lofty goals set out in FSMA.

Congress had incorporated an aggressive timeline for FDA to develop the implementing regulations for FSMA; the need to address the growing public concern over food safety was urgent. FDA was only allowed 18 months to issue the landmark product safety regulations (eventually entitled as Human Food, Animal Food and Produce) that would form the backbone of FSMA. At the same time, the sheer quantity of regulations, documents, reports, and agency actions required by the law was unprecedented. Even though most recognized implementation would require additional resources and funding, FDA eventually fell behind as the budgeting cycle and funding lagged.

Industry interest peaked as the initial 18-month deadlines approached, news outlets for the food industry seemed to have almost daily headlines but the delays continued, and interest perhaps waned a bit while the proposed rules seemed stuck in Office of Management and Budget (OMB) limbo. Once again, the FSSP was called into action as OMB requested meetings to address key questions on the pending proposed regulations.

The original 2012 deadlines came and went, and industry began to lose interest as the daily demands of business took precedence. Some even began to doubt if the rules would ever be published, and eventually consumer groups took legal steps in California to refocus attention and get the rules published.

FDA’s Perspective on FSMA

FDA’s perspective on the scope and scale of the challenges that FSMA posed can be best understood by a review of select portions of a 2013 FDA Report to Congress.

Ensuring a Safe Food Supply

Report to Congress on Building Domestic Capacity to Implement the FDA Food Safety Modernization Act (FSMA) Submitted pursuant to FSMA Section 110(a)(1). U.S. Department of Health and Human Services Food and Drug Administration 2013 (April).

Executive Summary

The FDA Food Safety Modernization Act (FSMA) was enacted in response to a series of illness outbreaks and contamination incidents involving both domestic and imported food, which revealed the need to modernize the nation’s system of food protection. It passed Congress with broad consumer and industry support and reflects their shared vision that all will benefit from a modernized food safety system that reduces foodborne illness, strengthens public confidence in the safety of our food, and minimizes costly disruptions of the food supply.

To fulfill its vision, FSMA mandates an overhaul and expansion of the FDA’s current food safety program and authorities, and directs an historic shift from reacting to and solving problems after they occur to preventing contamination of food in the first place, thus preventing human illness. The elements of that overhaul, and of this report, can be summarized as follows:

1. Standard Setting and Guidance—Developing and implementing the new prevention standards mandated by Congress is FDA’s most critical activity in the initial phase of its implementation of FSMA; these standards will be the foundation upon which a new food safety system will be built. FSMA requires a sea change in the standards FDA promulgates for assuring safe food production, with three major new areas of focus:

a. preventive control standards requiring food processors to identify potential hazards associated with their processes and prevent those hazards from occurring,

b. specific risk-based standards for safe production and harvesting of produce that take account of the diversity of sizes and operations, and

c. verification of the safety of foods from foreign suppliers by importers of food.

Progress in the first two years: In January 2013, FDA proposed the first two landmark regulations that set science-based standards for preventing foodborne illness.

Standard Setting and Guidance

A. Background

The production of safe food is the responsibility of the food industry, but it is FDA’s responsibility to set food safety standards and to ensure that these standards are met. FDA standards and guidance address four major categories of contaminants that have the potential to adulterate foods: chemical, biological, physical, and radiological. Section 110 of FSMA directs FDA to provide Congress with an analysis of the need for new standards and guidance for the food industry.

B. Background on Standards and Guidance Documents

The authority for food safety standards is rooted in the Federal Food, Drug, and Cosmetic Act (FD&C Act). Standards, which are set through rulemaking, are binding. In addition to regulatory standards, FDA issues guidance documents, which express FDA’s current thinking on topics such as the point at which FDA may consider taking regulatory action or the steps industry can take that FDA would consider acceptable. However, guidance documents are not binding requirements.

Safety Standards

There are two principal types of safety standards that apply to human and animal food safety:

1. conditions of manufacture describe the production or processing system, environment, and controls that must (or should) be in place (e.g., CGMPs, HACCP controls, and other preventive controls) and

2. product standards are usually numerical and describe the maximum level of a substance (e.g., contaminant, additive, and drug residue) that can safely be present in the finished food or specific processing parameters, such as time and temperature controls for microbial hazards

Safety standards relating to the conditions of manufacture of a food are designed to prevent introduction of potential hazards and to ensure that the product standards that apply to that food are consistently met.

Before the passage of FSMA, performance standards have been an important means by which FDA has sought the end result of safe food. Emphasis has been placed on verifying/monitoring the end result—the safety and sanitary production of the food that people consume—rather than on the crucial need for industry to evaluate, institute, and verify control measures to ensure that the introduction of hazards is prevented, conditions of manufacture are appropriate, and their products meet established food safety standards. An exception to this is where FDA has required HACCP (juice and seafood). Commodity-specific regulations have provided additional standards for conditions of manufacture; an example is the recent regulations governing the production, transportation, and storage of eggs, prompted by the frequency of egg-associated Salmonella illnesses. GMP regulations, describing the methods, equipment, facilities, and controls for producing processed food also provide an important regulatory control over the safety of the nation’s food supply.

C. Changes Under FSMA

Under FSMA, the product standards described above still are in place but FSMA focuses on having systems in place to prevent problems rather than relying on their detection after the fact. Under FSMA, FDA is required to issue rules establishing a basic framework of prevention-oriented standards, including rules requiring:

a. facilities producing food to have preventive controls in place,

b. farms to comply with science-based minimum standards for the safe production and harvesting of fruits and vegetables, and

c. importers to perform risk-based verification of their foreign suppliers to verify that the food is produced in accordance with the same modern prevention standards FSMA establishes for domestically produced food.

a. Preventive Controls. Hazards in food, whether pathogenic microorganisms, chemical, or other hazards, can be eliminated, reduced, or controlled with preventive controls. With FSMA section 103, Congress amended the FD&C Act by adding Section 418 on Hazard Analysis and Risk-Based Preventive Controls. This section requires owners, operators, or agents in charge of human and animal food facilities to develop and implement a written plan that describes and documents how their facilities will implement the hazard analysis and preventive controls required by this section.

These requirements include:

 the identification of hazards (i.e., a hazard analysis) that may be associated with a food facility, those occurring naturally and those that might be intentionally introduced;

 preventive controls to significantly minimize or prevent identified hazards;

 procedures for monitoring and verifying the preventive controls;

 corrective action procedures if a preventive control fails; and

 recordkeeping.

b. Standards for Produce Safety. FSMA section 105 amended the FD&C Act by adding section 419, Standards for Produce Safety. This section requires FDA to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables for which it is determined that such standards minimize the risk of serious adverse health consequences or death. FSMA directs FDA to develop a produce safety regulation that requires measures FDA determines are reasonably necessary to prevent the introduction of reasonably foreseeable hazards, and that, among other things,

1. provides sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables,

2. is based on science, and

3. takes into consideration conservation and environmental practice standards.

Section 110 of FSMA also directs FDA to describe the effects of new FSMA-related food safety standards on certified organic farms and facilities. FDA has consulted with technical experts and representatives from the National Organic Program to ensure that its produce safety rulemaking does not conflict with or duplicate requirements of the National Organic Program.

c. Foreign Supplier Verification Program. FSMA also addresses the safety of imported food by requiring importers to perform risk-based verification of their foreign suppliers to verify that the food is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, which provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the FD&C Act, is not adulterated, and is not misbranded with respect to food allergen labeling.

d. Performance Standards. Section 104 of FSMA directs FDA to determine the most significant contaminants on a biannual basis and to set appropriate performance standards for those contaminants as needed.

Guidance. To supplement formal regulations will be an essential part of an effective FSMA implementation, as they will give industry-specific information intended to help processors and others to understand how to do their part in ensuring the safety of food. As such, guidance will be developed in two ways:

1. Specific guidance to accompany the regulations that carry out the intent of Congress in enacting FSMA, such as the produce standards and the new preventive controls regime (as well as commodity-specific guidance, as needed, to clarify how the new FSMA rules apply in specific areas)

2. A significant ongoing guidance effort, over the next decade or more, to clarify and explain requirements as new evidence and techniques of protecting food emerge as a result of the close collaboration between government, academia, and industry.

In addition to recognizing the need for adequate inspection frequency, FSMA calls for and empowers FDA to transform its approach to inspection and compliance—shifting from a primary focus on detecting legal violations and building judicial enforcement cases to a focus on ensuring that firms are consistently implementing the modern prevention measures mandated by FSMA.

This shift is based on the widely shared understanding that the foundation for reducing the risk of preventable foodborne illness in today’s global food system is the action by the food industry. Specifically, food safety depends primarily on the food industry working in a continuous improvement mode to:

1. implement science- and risk-based preventive measures at all appropriate points across the farm-to-table spectrum, and

2. manage their operations and supply chains in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day.

FDA’s role under FSMA is to foster implementation of such modern preventive measures using a wide range of tools, including education and technical assistance, inspection and other compliance measures to assess and incentivize compliance, and swift action when firms fall short. Inspection with a strong public health prevention focus is a central element of FDA’s FSMA compliance strategy and will be most effective when carried out in the context of a comprehensive effort to foster compliance with modern food safety standards, including:

 commodity- and sector-specific guidance on implementation of prevention-oriented standards;

 education and outreach to industry to ensure expectations and requirements are understood;

 technical assistance to facilitate compliance, especially by small and mid-size operators;

 regulatory incentives for compliance, such as less frequent or intense inspection for good performers;

 reliable third-party audits to verify compliance;

 public education, transparency, and publicity to promote compliance and prevention; and

 modernized approaches to inspection and enforcement based on the prevention framework and the enhanced inspection and enforcement tools provided by FSMA.

A Paradigm Shift for Inspections

The report also includes a snapshot of the impact FSMA has on inspections:

Under this new FSMA framework, inspection will take a wider array of forms and have a wider range of purposes than in the past, and thereby make a greater contribution to food safety and protection of public health. Examples of the different roles inspection can play in a modernized food safety system include:

 efficiently screening firms for food safety performance as a guide to inspection priority, frequency, depth, and approach;

 providing firms incentives for compliance through enhanced presence and targeted scrutiny of high-risk firms and products and reduced scrutiny of firms with records of demonstrated good performance;

 assessing the compliance of individual firms through a range of inspection and sampling techniques used in a strategic, risk-based way to maximize coverage of priority sectors