Source: https://el.b-ok.org/book/3406309/b51085
Timestamp: 2019-10-15 12:08:51
Document Index: 78269877

Matched Legal Cases: ['art193', '§ 110', '§ 110', '§ 117', 'art 110', 'art 117', '§ 117', '§ 117', '§ 110', 'art 117', '§ 1', '§ 117', '§ 117', 'art 1', 'art 117', '§ 1', 'art 117', '§\n117']

Hazard Analysis and Risk Based Preventive Controls | Patricia A. Wester | download
Κύρια Hazard Analysis and Risk Based Preventive Controls
Hazard Analysis and Risk Based Preventive Controls: Building a (Better) Food Safety Plan is directed to those food safety professionals charged with ensuring or assisting with FSMA’s preventative controls (PC) implementation and compliance in their routine job duties. The target audience includes those currently involved in the development, management, and execution of HACCP and/or other advanced food safety management systems, as well as those interested in advancing their knowledge base to gain a more thorough comprehension of HARPC requirements.
FSMA topics covered include: identifying the food safety team and PCQI; creating the HARPC implementation strategy; starting the food safety plan; conducting a thorough hazard analysis; identifying adequate preventive control measures; determining appropriate PC management components; recognizing applicable verification and validation activities; supply chain management program; recall plans. Other operational topics include: document control systems; internal audit programs; third party audit management; regulatory visit preparation; and maintaining compliance.
Provides a step-by-step guide to achieving FSMA compliance for food safety professionals who develop and manage food safety management systems
Written by industry experts with direct experience in the formulation of the HARPC regulations
Presents insights into the underlying approach of FSMA’s preventative controls
Transitions readers from HACCP to HARPC using GAP assessment to adapt existing food safety programs to the FSMA preventative controls requirements
Σελίδες: 264 / 701
ISBN 10: 0128111887
ISBN 13: 9780128111888
Series: Building a (Better) Food Safety Plan
Κατεβάστε (pdf, 16.28 MB) Διαβάστε βιβλίο online
hazard1898
controls1487
preventive1440
facility1224
hazards1072
preventive controls925
fda710
hazard analysis708
sanitation535
qualified531
verification530
supplier520
preventive control509
processing492
document470
procedures421
allergen393
haccp353
monitoring352
ingredients328
pathogens316
packaging292
contamination290
regulations263
foods254
requiring253
audit252
regulatory249
corrective247
good manufacturing244
applicable236
current good manufacturing234
manufacturing practice234
compliance232
practice and hazard228
good manufacturing practice228
reasonably226
pathogen208
subpart193
threshold192
comments assert189
ingredient189
verification activities188
fsma186
fsp186
receiving facility185
qualified individual176
guidance175
food allergen172
adequate171
Исследование влияния вида обработки на шероховатость и микротвердость обработанной поверхности методические указания к лабораторной работе № 9 для студ., обуч. по направ. подготовки 27.03.05 - Инноватика Университет машиностроения (МАМИ), каф. «Технологи
Методические указания к выполнению курсовой работы по дисциплине «Режущий инструмент» для студ., обуч. по направ. подгот. 151900.62 «Конструкторско-технологическое обеспечение машиностроительных производств» ... Университет машиностроения (МАМИ), каф. «А
Hazard Analysis and Risk Based
Based Preventive Controls
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
ISBN: 978-0-12-811188-8
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
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
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
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
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
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
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
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
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).
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
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,
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
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
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.
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
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
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
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.
I 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;
I preventive controls to significantly minimize or prevent identified
I procedures for monitoring and verifying the preventive controls;
I corrective action procedures if a preventive control fails; and
I 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
2. is based on science, and
3. takes into consideration conservation and environmental practice
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
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
Guidance. To supplement formal regulations will be an essential
part of an effective FSMA implementation, as they will give industryspecific 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 commodityspecific 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
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
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;
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 and firms;
collecting data to inform understanding and analysis of sector-wide
hazards, practices, and preventive control deficiencies; and
collecting data on compliance rates to evaluate program performance
and plan future efforts.
FDA believes that a more flexible, multifaceted approach to inspection will
not only be more effective but can also be more efficient. For example, as
one alternative approach to be used when appropriate, FDA is piloting a
focused, shorter “component” inspection model, one in which the investigator reviews in depth one or more of the most critical control systems at the
food manufacturing facility during an inspection, as determined through the
use of a risk model, as opposed to performing a comprehensive inspection
of al systems. FDA believes that such an approach can provide a clear indication of whether the facility has the ability, commitment, and systems to successfully implement modern controls. If such an inspection reveals problems,
they would pursue further inspection and action as needed. Under such a
system, however, the current 18-hour average time for domestic food facility
inspections could be reduced without compromising food safety.
To carry out this broader approach to inspection and compliance, FDA will
expand the skills and capacities of its scientific, technical, and operational
staff and change its internal operational practices. This includes enhancing
capacity and improving internal procedures to enable the agency to make
quick decisions and take immediate action when needed to protect public
health, using an array of tools, and working more closely with local and state
agencies to coordinate compliance and enforcement efforts.
D. FSMA-Directed Programs and Practices
Prevention-Based Inspections
FDA’s historical model for conducting food facility inspections has been centered around industry’s implementation of CGMP regulations. CGMPs are
focused predominately on sanitation, training of industry personnel, and
general requirements that protect food products from contamination with
various adulterants. As outlined above, FSMA will require a shift from this
inspection model and regulatory paradigm to one that focuses on the adequate implementation of science-based preventive controls for identified
Under FSMA, food facilities will develop food safety plans (FSPs) for each
product they produce. These plans will identify the hazards reasonably likely
to occur during the production of the firm’s food products. In addition, the
plan must specify the preventive controls or practices that will be put in place
to mitigate identified hazards. Implementing these FSPs will require that
industry, in part, to develop procedures, provide and document employee
training, and establish monitoring records that demonstrate the firm is following its plan.
Under FSMA, FDA and state inspectors will still make observations regarding
the conditions in the facility on the day of the inspection, but they will also
review records to determine if the firm has identified accurately all hazards
associated with its processes and has implemented on a continuing basis
appropriate controls to prevent the manufacture of unsafe food.
Building an Integrated, Risk-Based Food Safety System
FSMA directs FDA to build a food safety system for the future that makes
modern, science, and risk-based preventive controls the norm across all sectors of the food systems. There are prevention-oriented systems already in
place for some product segments, such as Juice HACCP and Seafood HACCP,
and high-risk foods such as Infant Formula and Low Acid Canned Foods, so
these and a limited number of other product segments are exempt from
FSMA regulations. It reaches past the traditional post “farm gate” emphasis
on manufacturing, and dives into the arena of primary production.
The new system must meet the food safety challenges of the global food supply chain by holding foreign producers to the same standards as domestic
manufacturers. FDA accomplishes this by holding importers accountable for
their supply chain, while proactively working to improve foreign food production at the manufacturing source, rather than relying on point of entry
To avoid creating further silos within the complex network of government
agencies involved in regulating food in the United States, it directs FDA to
establish stronger partnerships for food safety across all levels of government:
there are as many as 15 federal agencies involved in the federal oversight of
food production, which work with tribal, state, and other local authorities to
form the complete set of regulatory requirements for a food producer.
government does not produce food, industry does.
Future (FDA) Needs for a Modernized Inspection
Implementing the modernized inspection and compliance program needed
to implement FSMA and achieve its public health goals requires a range of
investments in training, capacity, and infrastructure. This will take a significant amount of time and financial support that includes:
a more data-driven, risk-based prioritization system for inspection and
compliance activities that enables FDA to better focus its inspection
and compliance resources on facilities and foods that are most likely to
pose a threat to health;
enhanced, interoperable internal/external data systems that capture data
on, among other things, the risks of specific pathogens in specific
foods; data for inspections conducted by other regulatory partners and
by private, third-party organizations; and the compliance history of
food facilities subject to inspection;
training for FDA and state inspectors in preventive controls and the
new systems and prevention-oriented approach to inspections and
compliance. FSMA calls for a transformation in FDA’s food safety
oversight role, which will succeed only if FDA is able to adequately
train its frontline workforce;
stronger and more timely technical support for inspectors from FDA’s
food safety experts to enhance the scientific quality of inspection and
compliance decisions, which requires expanding expert capacity at FDA
headquarters and in the field;
new information technology tools for inspectors, such as handheld
inspection recording devices and “intelligent questionnaires,” to
shorten and promote consistency in the conduct of food facility
inspections and inspection report writing. Less time expended on report
writing, in particular, may permit more timely reporting of adverse
findings to compliance officers, resulting in speedier administrative and
regulatory actions, when warranted. In addition, implementing
described strategies to make more efficient use of resources.
Federal—State Integration
While FDA has the broadest food safety jurisdiction within the federal government, covering about 80% of the food supply and most food imports, a
successful nationwide food safety program will not be possible without harnessing and leveraging the efforts of state, local, territorial, and tribal regulatory and public health partners, who already play key roles in food safety
and are willing to work with federal agencies to plan and implement a public
health focused, Integrated National Food Safety System (IFSS).
The result will be a more unified and efficient system for protecting the
domestic food supply via leveraging of inspectional and laboratory resources
to reduce duplication, better information sharing and coordination, increased
capacity and capability at the state, local, tribal, and territorial level, greater
inspectional coverage with a primary focus on preventing illnesses, and
improved rapid response when foodborne disease outbreaks or food contamination events occur.
Path to an Integrated National Food Safety System
FDA has been working with its state and local partners for over a decade to
develop an IFSS. FSMA included several provisions aimed at carrying forward
this partnership and effort:
Section 201 authorizes FDA to rely on certain inspections conducted by
state and local agencies in meeting FSMA’s inspection frequency
mandate, which is a central part of FDA’s strategy for making optimal
use of public resources to improve food safety.
Section 203 directs FDA to include state laboratories in FSMA’s new lab
accreditation program and to continue building, in partnership with
the states. It also directs FDA (in coordination with other agencies) to
report on progress in implementing a national Food Emergency
Response Network that coordinates the capacity of state and local
laboratories to be integrated with federal laboratories to respond to
food-related emergencies.
Section 205(c) directs FDA to leverage and enhance the food safety and
defense capacities of the states to improve outbreak response and
investigation, build state inspection capacity and coordination with
FDA, and better share information among federal and state agencies.
Section 209 directs FDA to administer programs to improve the
training of state and local food safety officials. It also authorizes and
encourages FDA to partner with state and local officials on inspections
and other efforts to ensure compliance with the food safety
requirements under the Federal Food, Drug, and Cosmetic Act.
Section 210 authorizes FDA to make grants to the states and local
governments to support their capacity to improve food safety and
partner with FDA.
Toward this end, FDA and its state and local partners are working to develop
national standards for state food and feed regulatory programs, which establish a uniform foundation and requirements for Federal, state, local, tribal,
and territorial food and feed programs. Historically, an obstacle to creating
an IFSS has been the widely varying approaches of food safety programs
among federal and state agencies. The solution will be implementation of
national food and feed regulatory program standards that provide clear, consistent minimum foundational requirements for a high-quality regulatory
The critical elements of regulatory program standards, which have been or
are being developed collaboratively by FDA and its state and local partners,
include the regulatory foundation, training, inspection, quality assurance,
response to food-related illness and outbreaks, compliance and enforcement,
and laboratory resources among others. Program standards are important to
establish a uniform foundation for the design and management of federal,
state, territorial, tribal, and local food programs that encompass best practices of a high-quality regulatory program. Implementation of these regulatory program standards will ensure uniformity of inspectional coverage and
allow partner regulatory agencies to rely on each other’s data to protect public health.
FSMA provides FDA with the authority to rely on inspections completed by
partner agencies to meet the inspection mandate established by FSMA. In
turn, there will be more and better information about the state of the food
supply chain and improved reactions when problems occur.
Current regulatory program standards include the Manufactured Food
Regulatory Program standards for regulatory agencies that inspect food processors, Voluntary National Retail Food Regulatory Program standards for
regulatory agencies that inspect supermarkets and other retailers, and under
development are the Animal Feed Regulatory Program Standards for animal
IFSS—Integrated Food Safety System;
Primary Objective: Uniform, national training and certification programs.
A common concern echoed by food manufacturers and members of
Congress has been the observation that regulatory activities, especially
inspections and data collection, appear at times to differ among the many
agencies at the state and federal level. Thus, the need for consistent training
and personnel certification is evident, and FDA intends to make that a focus
of its national integrated food safety system strategy.
Already, FDA’s Office of Regulatory Affairs has developed classroom and
web-based training for state and local retail food inspectors, and in 2009
over 2000 state and local participants attended classroom training and over
11,000 enrolled in online training. That work is being expanded and
enhanced by a joint effort with the IFPTI (International Food Protection
Training Institute, created by the Kellogg Foundation, with additional specific
funding from Congress provided for 1 year, supplemented by its designation
as the National Center of Excellence). A goal will be a nationwide set of baseline training and certification requirements for regulatory and public health
partners at varying stages of their career and specialization, followed by the
creation of a network of food safety training programs, provided through
(four Regional) Centers of Excellence among academic institutions, states
Training will be broad and cover all aspects of an integrated food safety oversight system—scientific expertise, best practices in conducting inspections,
administrative processes and procedures, appropriate sampling and laboratory analysis methodology, and effective development of enforcement actions
that will withstand legal challenges.
As training expands, certification and proficiency testing programs will also
need to expand to ensure that state and local regulators can adequately demonstrate that they can perform the necessary core competencies. An accreditation approach will also be devised to ensure the quality of the training and
that it is comparable and competent among all training providers.
An integrated, coordinated national emergency preparedness and response
network should be followed. While the primary goal of an integrated system
is to prevent foodborne disease in the first place, no prevention program can
be 100% effective. A recognized need of the current food safety infrastructure
is to have all federal, state, and local agencies working closely together to
stop the exposures to contaminated foods, identify the root cause of the
contamination, and develop appropriate preventive controls to minimize the
risk of recurrence of an outbreak, thus minimizing deaths, illnesses, and their
associated costs to the public and the food.
This report review should serve as a general overview of the full scope of
related activities surrounding the development of the primary regulations.
FDA continues this work today, and areas such as the national curriculum
standard and IFSS will serve to further advance food safety by establishing
the educational foundations extending beyond the scope of the alliances.
Round 1 The Initial Proposed Regulations—A First look
2013 also provided industry’s first look at the product safety related proposed rules. Major interest resulted in published “reviews” and expert opinion presentations at nearly every industry meeting, along with articles in
every major publication designed to help industry interpret content and
assess the potential impact for various product sectors. Everywhere you
looked, something related to FSMA could be found. The question was, and
still is, how accurate is the information given by the “experts”?
Interest in the proposed rules resulted in a record setting level of public comments. The huge number of responses and public comments from the initial
proposed rules can be attributed in part to the relatively large number of
requests for comments FDA included in the initial proposed rules.
FDA also initiated a huge number of public outreach events—hearings, webinars, and meetings with vested groups as they sought feedback on the
proposed rules and prepared the revisions for final publication. Agency
activity at these levels ensured QA management interest across all sectors was
at a peak, and industry groups welcomed the opportunity to provide input
into the proposed rules.
The proposed rules looked a lot like HACCP in general approach, with
changes in terms, definitions, and common phrases that reinforced that perception. The use of common HACCP language such as “reasonably likely to
occur” came under fire as “too much like HACCP.”
Other changes included the introduction of new hazards that must be
addressed, such as radiological and a modified approach to the hazard analysis; the CCP decision tree was replaced with a two-step risk analysis approach
of “identify and evaluate” hazards. The introduction of the term parameter to
supplement the use of critical limits required lengthy explanation, as did
many of the new terms and definitions used.
It is extremely important to recognize the impact of the multiple revisions of
the preventive controls regulations, doing so provides the necessary insight
into why FDA made many of the choices found in the final rules as they
sought to move the HACCP system further along the prevention spectrum.
HARPC Is Born
Regardless of similarity or difference to HACCP, industry immediately coined
the acronym HARPC, for the regulatory phrase Hazard Analysis and Risk-based
Preventive Controls, to describe and differentiate these new preventive
controls based regulations from HACCP. Despite a concerted effort to
encourage the use of the preferred phrase “preventive controls,” HARPC was
already well established in the industry vocabulary and remains so today.
FDA was bombarded with comments on the proposed rule; some discussed
areas where FDA requested industry input, while many others covered various sections across the entire proposed rule. All comments submitted must
be reviewed by FDA, considered, and the final decision to use or discard suggested changes must be explained. Regardless of final disposition (accepted
or declined) most comments must be responded to officially. In many cases,
FDA accepted the suggested changes, and they were incorporated into the
rule. Appendix 1 contains selected Comments and Responses from the rules
that will provide additional insight into many of the recommendations
found in the book.
Round 2: Supplemental Proposed Regulations
Because of the vast number of comments and the scope and scale of the
resulting changes to the published proposed rules, FDA took an unusual
route by publishing a round of supplemental proposed rules to gather additional industry feedback. FDA once again requested public comments on
multiple key areas in the supplemental rules, generating another round of
meetings and webinars as this latest available news was absorbed, discussed,
and explained to the affected public at meetings. The term “FSMA Groupies”
was even coined to describe those that frequented these meetings, hanging
on every word in the hopes of gaining additional insight into final rule
Round 3: Finally, a Final Rule!
For the regulatory affairs community, the November 2015 final rule publication for the foundational FSMA rules represented the beginning of the end of
an era of unprecedented regulatory activity that went as far back as 2007.
After taking nearly 5 years just to get through the House and Senate to
become law . . . and another 5 years to publish the first final rules, the first
compliance deadlines were finally known and calendars were marked with
Clearly, FSMA represents some of the most significant regulatory actions
taken since the advent of the global supply chain. Domestic producers and
foreign suppliers exporting to the US struggle to understand the complete set
of requirements that collectively make up “FSMA Regulations.”
Many of those drafting FSMA understood the need for training and included
establishment of alliances to ensure this was addressed. The FSPCA was created and charged to develop and deliver preventive controls training for
industry in the early post-final rule period.
The FSPCA curriculums for preventive controls are focused solely on that
topic: the course scope is Preventive Controls, and the knowledge necessary
to fulfill the role of the PCQI. The scope of that training is meant to address
this area only—of course this is a key, no critical component in the development of an FSP, and much of that material will be referenced throughout
this book as the framework for a sound, defendable FSP. As an FSPCA Lead
Instructor that has taught the PCQI course for human food many times,
I have a deep respect for those food safety professionals that crafted the
FSPCA content and did so under the challenging conditions created by an
extended rulemaking period, multiple proposed rule versions, and an
extremely tight timeline from final rule to course publication. In short, job
However, as a producer of food for the US market, obtaining a PCQI
Certificate is not equivalent to FSMA Compliance, in fact, is barely the beginning. COMPLIANCE is the primary goal/objective for any covered facility, so
we will also cover other portions of the PCHF regulation, focusing on understanding its evolution, new terms, new definitions for common terms, and
most important, the FDA’s reasoning behind the direction taken on many
different topics. Appendix 1 contains FDA’s responses to comments found in
the final rule that should answer many of the most common questions that
consistently come up during a PCQI training.
Yes, regulatory language can be challenging, but it is a situation where words
truly matter, so in many instances, the actual language is used, because that
is what is legally binding. In cases where needed, it will be followed by an
explanation for clarity.
FSMA Compliance Versus Implementing Preventive Controls
This book was written to provide food safety professionals with a comprehensive resource to understand what your compliance requirements are, and
where required, design and implement an effective, compliant FSP. It is not
intended to replace the FSPCA PCQI curriculum but is meant to support and
extend that knowledge for the PCQI role by addressing the need for additional information in areas where the knowledge, skills, and abilities necessary for compliance may exceed the scope of materials available.
Simply put, FSMA is much more than the preventive controls regulations,
but covering all the related regulations would far exceed the scope of
any single book. There are instances, such as Facility Registrations or the
Reportable Food Registry changes, where compliance is directly related to
what portions of the PCHF rule apply, and in those cases, this book fulfills
that need by including other regulations.
In summary, using the expanded regulatory scope coupled with a framework
that enhances the PCQI curriculum and integrating that knowledge with
recommendations for a practical implementation plan provides you the optimal success in building or improving your FSP.
þ HANDY HINTS
Food facilities that manufacture/process, pack or hold food for consumption in the United
States are required to register with the FDA, and this final rule adds new provisions to the
current regulations to codify certain provisions of FSMA that were self-implementing and
effective upon enactment of FSMA.
These provisions include the requirement for:
an email address for registration,
required renewal of registration every two years, and
that all food facility registrations must contain an assurance that the FDA will be
permitted to inspect the facility at the times and in the manner permitted by the Federal
Must include the type of activity conducted at the facility.
The final rule also amends the definition of a retail food establishment in a way that
expands the number of establishments that are considered retail food establishments, and
that are therefore not required to register with the FDA as food facilities. However, all food
establishments, including retail food establishments, continue to have a responsibility to
ensure their food is safe.
In addition, the final rule adds certain new requirements that will improve the food facility
registration system. All food facility registrations are required to be submitted to the FDA
electronically, although this requirement does not take effect until January 4, 2020.
Note: Page numbers followed by “f,” “t,” and “b” refer to figures, tables, and boxes, respectively.
Abuse of products, 29
Final Rule, 130 132
Acrylamide exposure, 36
Adequate, 155 156
Adulteration, 34, 67
economically motivated, 34
intentional, 34
Affiliate, 156 159
Survey (ARMS), 198 201
Allergen cross-contact, 109, 159 160
Allergen preventive controls, 109,
112t, 113t
personal practices, 111 112
(AMIF), 144
Listeria Control Workshop, 138,
sanitary design principles, 147t
AMI Sanitary Design Checklist and
Fact Sheet, 92
Ammonia exposure, 36
Approval of suppliers, 116 117
Association of Food Safety Auditing
Professionals (AFSAP), 129
Audit, 221
checklist, 130
Auditor training, 130
Census of Agriculture (Ag Census),
Certification Body (CB), 131
Certified in Comprehensive Food
Safety (CCFS), 13
Chemical hazards, 36 39, 46
facility-related, 37 39
ingredient-related, 37
process-related, 37
supply chain controls for,
Cochineal extract, 39
general provisions, 9 10
verification of, 9 10
Contamination events, 142 143
Controlled wet cleaning, 99 100
Cooking, 76 77
Cooling after cooking, 78 79
Corrections, 72 73, 82 85,
sanitation, 89 90, 90b
Corrective actions, 82 85
procedures, 71 73
Critical control point, 160 161
Cross contact, 89
Cross contamination, 89
Defect action level, 218
Disease control, 16
DNA mapping, 147 149, 147t
implementation of, 33 34
procedures, 31 32
purpose of, 31
Biological contamination, sources of,
Biological hazards, 46
Budget(s/ing), for food safety plan,
3 4, 8 9, 8f
Bureau of Labor Statistics (BLS), 13
Document management, practical
approach to, 30 31
Drug residues, supply chain controls
for, 124
Dry cleaning, 99 101, 103
Drying, 105
hazards, 43, 45 46, 45t
adulteration, 34
Effectiveness of training, evaluation
of, 19, 19t
(EMP), 137
postpackaging high pressure,
sampling plan, 137 142, 139b
sampling sites, defining, 139 142,
Environmental pathogens, 90,
factors contributing to, 143
Evaluation of hazards, 53 54,
factors associated with, 54t,
Exception records, 71
Exclusion process controls, for
physical hazards, 80
Facility, 164
Facility-related chemical hazards,
FALCPA, 39
Farm, 164
Act (FD&C), 34 37
section 201(qq), 166 167
section 201(r), 166 167
section 418, 115, 119
section 402, 68, 82 83, 120 122,
section 403(w), 68, 82 83, 109,
section 403(w)(1), 166 167
section 409, 220 221
section 418(b)(1)(A), 169 171
section 418(l), 198 201,
section 418(l)(1), 181 182
section 418(l)(1)(A), 205 216
section 418(l)(1)(B), 205 216
section 418(l)(1)(C), 198 201,
section 418(l)(2)(B)(ii), 181 182
section 418(l)(4), 180 181
section 418(l)(4)(B), 203 205
section 418(l)(4)(B)(ii)(I),
section 418(l)(5), 198 201,
section 418(n)(1)(B), 205 216
section 418(o)(3), 223
section 419, 219 220
section 808, 179 180
section 808(b)(2), 130 131
Fields, Randy, 7
(FRIA), 198 201
1st year experience of food safety
plan, 4 5
Food, defined, 164 166
Food additives, unapproved, 40
Food allergen controls, 64, 69
Food allergens, 39, 166 167,
(FDA), 3 5, 9, 30
Draft Guidance Document, 108
document, 46 47
Health Hazard Evaluation Board,
section 402(a)(2)(c), 40
section 402(c), 38 39
section 403(m), 38 39
section 721(c), 38 39
section 1005, 35
responsibility for, 15t
Food colors, unapproved, 40
Food contact surfaces (FCS), 138
management, 102 103
basic steps and, 103 105
sanitation controls for cleanliness
of, 101 103
sanitation of, 87, 91
Food equipment installation and
relocation, 96, 97f
Food-packaging material,
(FSMA), 9, 128 129, 131,
biological contamination, sources
of, 52 53
compliance, 1
requirements, verification of, 9
evaluation of hazards, 53 54, 54t,
hazard analysis, 46 48, 46b
conducting, 48 52
template, 49
hazard updates, 43 65
likely occurrence estimation,
other regulations and resources
into FSP, integrating, 45 46
radiological hazards, 44 45
recalls, 151
requirements, management’s
understanding of, 6 8, 6b
risk assessment, 55 58, 55b
risk measurement, 54
section 103(i), 205 216
severity evaluation, 58 59
additional requirements for,
food safety team, creating and
training, 11 12
food safety team, potential
members of, 12
training beyond preventing
controls, 13 14
training, 12 13
components of, 21
format of, 21, 152 153
forms of, 152 153
organized by OOAIC, 21
into, integrating, 45 46
overview of, 21
Q&A preventive controls for
human food, 21
Alliance (FSPCA), 25, 30, 43,
46 47, 152
PCQI course, 1, 12 13, 123
PCQI training, 27
Food safety team, 26 27
creating and training, 11 12
potential members of, 12
Food safety training options, 17 20
benefits of training, 20
effectiveness of training,
evaluation of, 19, 19t
objectives of training,
identification of, 17 18, 18t
training delivery, 18 19
Formulation as control, 80
FSMA: Lessons Learned in Year 1, 5
FSVP rule, 128, 169 171, 221
Full-time equivalent employee,
GAP analysis, 7
Glass hazards, 41
Global Food Safety Initiative (GFSI),
(GMP), 142, 145 146
GRAS substance, 29, 40
Growth niches, 142
defining, 144
managing and controlling,
Harborages, 97 99, 98f
Hard plastic hazards, 42
Hazard analysis, 43, 46 48, 46b
Hazard analysis, preparation for, 21
food colors and additives,
unapproved, 40
forms of, 27 30
information resources, 35 42
chemical hazards, 36 39
Reportable Food Registry, 35
physical hazards, 40 42, 41t
data, 28, 28b
development of, 22
practical approach to document
management, 30 31
qualified individual, PCQI
requirements for, 25
training the team, 27
Point (HACCP), 1 3, 8,
11 12, 19, 21, 127, 129 131
plan development, 22
preliminary tasks, 23 25, 23b
Hazard Analysis Worksheets, 46 47
Hazard, defined, 43, 47, 167 169
Heavy metals, supply chain controls
High pressure processing (HPP), 137
Human food final rule
CGMP and hazard analysis and
Hygiene zone, 105, 139b
establishing, 105 108
in facility with lethality step,
in facility with no lethality step,
food safety training options,
impact on food safety, 14 17
job training, 15 17, 15t, 16t,
management’s understanding of
FSMA’s requirements, 6 8, 6b
PCQI certificate, 2, 2f
PCQI requirements, 11
resources, 3 4, 8 9
roles and training needs in
regulation, identifying, 10 14
timing, 3 4, 4f
training, 1 2
Ingredient-related chemical hazards,
In-process controls, 64 65
Intended customers, 29
Intentional adulteration, 34
Intrinsic factors as controls, 79
ISO 17021, 130 131
ISO 17065, 130 131
ISO 19011, 130
Implementation records, 72,
budgets, 3 4, 8 9, 8f
1st year experience, 4 5
Food Safety Plan, additional
requirements for, 11 14
Job training, 15 17, 15t, 16t, 17t
Known or reasonably foreseeable
hazards, 43, 46 48, 167 171
Labeling, as preventive control,
LACF, 128 129
Lactose, 38
Lead exposure, 36
Likely occurrence estimation, 59 61
Lot, 171 172
responsibility, 6
understanding of FSMA’s
requirements, 6 8, 6b
Manager perspective on training, 19t
Metal detection validations, 74
Metal hazards, 40 41
Microorganisms, 172 173
temperature ranges for, 77
“Mind of the Food Worker”, 13
Monitor, 174
Must, 218 219
Mycotoxins, 36
supply chain controls for, 124 125
NACMCF HACCP guidelines,
23 25, 23b
Microbiological Criteria for
Control Point Principles and
Application Guidelines, 50
Association (NEHA), 129
“Certified in Comprehensive Food
Safety” program, 13
(NPDW) regulations,
Niche(s), 97 99, 98f
contamination, 143
Non-food-contact surfaces, sanitation
Nonproduct contact surfaces, 93 96,
95f, 96f
Objectives of training, identification
of, 17 18, 18t
One-time event, 143
Onsite audits, 127 128
OOAIC (Owner, Operator, Agent in
Charge), 5, 10, 27
Food Safety Plan organized by, 21,
roles and training needs,
identifying, 10
Packaging, 175 176
Parameter, 219
Pasteurized Milk Ordinance (PMO),
Pathogens, 176 177
environmental. See Environmental
compliance, 3 4, 7 8
final rule, 1, 3 5, 11 12, 128,
137 138, 151
Pest, 177
Pesticides, supply chain controls for,
Physical hazards, 40 42, 41t, 46 47
exclusion process controls for, 80
Plant, 177
Postpackaging high pressure, 137
Prerinse, 103 104
Preventive control of hazards, 43, 47
Preventive controls, 68 70,
allergen, 109
labeling as, 112 113
management components, 70
monitoring, 70 71
Preventive Controls Qualified
Individual (PCQI), 25 30,
certificate, 2, 2f
qualified individual, requirements
for, 25
identifying, 10 11
training, 1
Process controls, 64, 69, 75 81
management components, 81 85
corrections, 82 85
monitoring, 81 82
metal detection validations,
microorganisms, temperature
ranges for, 77
physical hazards, exclusion process
controls for, 80
refrigeration, 77
storage to prevent mold growth,
Process flow diagram, 29 30
Process-related chemical hazards, 37
Product description, 29 30
Product profile data, 60 61
Qualifications of individuals engaged
in manufacturing, processing,
packing, or holding food,
223 231, 224t
Qualified auditor, 179 180
Qualified end-user, 180 181
Qualified facility, 181 182,
Qualified facility exemption,
Qualified individual, 222
Radiological hazards, 44 45,
Random positive event, 143
Raw agricultural commodity,
Raw materials, 219
Ready-to-eat food (RTE food), 111,
Reanalysis, 153 154, 153b
Receiving facility, 183 184
Records, 152
Reportable Food Registry (RFR), 35,
Resources of food safety plan, 3 4,
Retention, 153
Review, 153
Risk assessment, 55 58, 125 126
graphs and nomenclature, 55b
Risk communication, 58
Risk management, 58
RTE food handling areas, cleaning
drains in, 105
SAHCODHA (Serious Adverse
Health Consequences or
Death to Humans and
Animals) criteria, 125, 130,
Sanitary design principles, 91 92
Sanitary operations, 87
Sanitary practices, 49
Sanitation controls, 64, 69, 87,
CGMPs, 87
for cleanliness of food-contact
surfaces, 101 103
corrections, 89 90, 90b
equipment and utensils, 87
FDA draft guidance, 87
Sanitize, 184 185
Scrub, 104
Significant hazard, 185 197, 188t
Significantly minimize, 198
Small business, 198 201
Soap, 104
Storage and distribution, 29
Storage to prevent mold growth, 80
Subsidiary, 156 159
Sulfiting agents, 38
Supermarket distribution centers,
Supervisor perspective on training,
Supervisory personnel, additional
requirements for, 230 231
Supplier, 201 203
Supplier verification, 120 122
activities, determining, 121
activities, conducting, 121
Supply chain applied control,
69 70, 115, 222
Supply-chain controls, 64
for chemical hazards, 123
for drug residues, 124
for heavy metals, 124
for mycotoxins, 124 125
for pesticides, 124
Supply chain program, 115
audit checklist, 130
controls. See Supply-chain controls
documentation for, 121
exclusions and exemptions of,
FDA Accredited Third Party
Certification Final Rule,
general requirements for,
116 122, 116b
requirement to establish and
implement, 115 116
risk assessment, 125 126
supply chain controlled hazards,
verification activities, 126 130
verification records, 133 134,
TAG/Safety Chain FSMA Readiness
Survey, 6 7
Target organism, identification
of, 99
Temperature ranges, for
microorganisms, 77
Third Party Auditor/Certification
Body Accreditation for Food
Safety Audits: Model
Timing of food safety plan, 3 4, 4f
Training, 1 2, 12 13
benefits of, 20
beyond preventing controls,
delivery, 18 19
effectiveness of, evaluation of, 19,
job, 15 17, 15t, 16t, 17t
manager perspective on, 19t
objectives of, identification of,
17 18, 18t
programs versus required training,
supervisor perspective on, 19t
team, 27
Transfer point, 142
Undesirable microorganisms,
Unexposed packaged food, 220 221
Upstream hazards, 122 123
User Fee Proposed Rule, 130 131
Validation, 74 75, 74b, 203 205
as verification activity, 74
Value, 219
Verification, 73 74, 203 205
activities. See Verification activities
records, 133 134, 133b
supplier, 120 122
Verification activities, 126 130, 135
effectiveness, 135 136
Program, 137
sampling sites, defining,
139 142, 140f
environmental pathogens, factors
contributing to, 143
growth niches, defining, 144
implementation, 135 136
positive result, investigation of,
test results, 146 147
validation as, 74. See also
Very small business, 205 216
Voluntary Qualified Importer
Program, 131
Wet cleaning, 99 101
Written procedures for receiving raw
ingredients, 222
Yellow No. 5 (tartrazine), 38 39
You, 216
Appendix 1: Current Good Manufacturing
Practice and Hazard Analysis and RiskBased Preventive Controls for Human Food
Final Rule Comments and Responses
REDESIGNATION OF § 110.3
FDA proposed to redesignate all definitions in § 110.3(a) through (r) as proposed § 117.3, eliminate paragraph designations (such as (a), (b), and (c)),
and add new definitions in alphabetical order. FDA received no comments
that disagreed and finalized the proposed redesignations.
Definitions in Current Part 110 That We (FDA) Proposed
to Delete in Final Rule
FDA proposed to delete the definition of “shall” and use “must” instead.
FDA received no comments that disagreed and are deleting the definition of
“shall” as proposed.
Definitions FDA Proposed and/or Established in Part 117
We (FDA) proposed to define the term “adequate” to mean that which is
needed to accomplish the intended purpose in keeping with good public health
(Comment 76) Some comments assert that the definition is vague
and ask us to clarify what constitutes “adequate” for systems such as
operating systems for waste treatment and disposal. Other comments
ask us to develop guidance on thresholds and processes that qualify as
“adequate.” Other comments assert that the word “adequate” must be
used in combination with the word “reasonable” to properly describe
the intended measures and precautions. As an example, these
comments assert that the definition of “adequate” could lead to
excessive requirements when applied to the provisions for disease
control and hygiene (§ 117.10).
Appendix 1: Current Good Manufacturing Practice and Hazard Analysis
(Response 76) We (FDA) disagree that this long-standing definition
of the term “adequate” is vague. The comments do not provide any
examples of how we have interpreted this definition in the past in a
way that creates practical problems when applying current good
manufacturing practice (CGMP) requirements, including requirements
directed to the management of waste or the provisions for disease
control and hygiene. Our intent in using the term “adequate” is to
provide flexibility for a food establishment to comply with the
requirement in a way that is most suitable for its establishment. We
decline the request to develop guidance to explicitly address
“thresholds” or to describe processes that qualify as adequate. The
CGMPs established in this are broadly applicable procedures and
practices rather than very specific procedures and practices where
additional interpretation from FDA might be appropriate (Table 1).
AFFILIATE AND SUBSIDIARY
We (FDA) proposed to define the term “affiliate” to mean any facility
that controls, is controlled by, or is under common control with another
facility. We proposed to define the term “subsidiary” to mean any company
which is owned or controlled directly or indirectly by another company. These
proposed definitions would incorporate the definition in sections 418
(l)(4)(A) and (D) of the FD&C Act and would make the meanings of
these terms clear when used in the proposed definition of “qualified
(Comment 77) Some comments ask us to clarify that a facility that
has no material connection with another food processing operation
would not be considered as an “affiliate” of that operation.
(Response 77) It is not clear what the comments mean by “no
material connection with another food processing operation.” To the
extent that a facility does not control, is not controlled by, or is not
under common control with another facility, we agree that the facility
would not be considered an affiliate of that food processing operation.
(Comment 78) Some comments assert that the definitions of
“affiliate” and “subsidiary” fail to account for the legal differences
between a piece of property (i.e., a facility) and a business entity or
person. These comments ask us to consider amending the proposed
definition of “qualified facility” to clarify what sales to include in
determining whether a facility so qualifies.
(Response 78) See Response 118.
(Response 118—added for clarity) We have not revised the proposed
definition of “qualified facility” as requested by these comments. The
sales to be included when a facility determines whether it meets the
definition of a qualified facility are the sales of human food by a
business entity, which includes the parent company and all its
Table 1 Summary Final Rule Definitions in § 117.3
(§ 110.3)
If Current,
Did FDA
Did FDA Receive Any
Definition Proposed for
Part 117?
Did FDA Make Any Changes
to the Proposed Definition,
Other Than the Editorial and
Conforming Changes?
See discussion of § 1.227 in
foreseeable hazard
section IV.D
Acid foods or
Allergen crosscontact
Table 1 Summary Final Rule Definitions in § 117.3 Continued
Mixed-type facility
Packaging (when
used as a verb)
Qualified end-user
Raw agricultural
Replace the term “establishment”
with “structure”
No, except to change the name
of the term from “qualified
individual” to “preventive controls
qualified individual”
Deleted the definition
Yes, including changing the term
to “hazard requiring a preventive
section IV.F
The final rule does not include a
definition of packaging (when
Supply-chainapplied control
for receiving raw
subsidiaries and affiliates. The total sales are applicable to each entity,
whether it is the parent, the subsidiary, or the affiliate. We intend to
address issues such as these in guidance as directed by section 418(l)
(2)(B)(ii) of the FD&C Act. (See also Comment 77 regarding the
definitions of “affiliate” and “subsidiary” and our associated responses.
See also Response 154 regarding the applicability of the monetary
threshold of sales of human food plus the market value of human
food manufactured, processed, packed, or held without sale (e.g., held
for a fee)).
ALLERGEN CROSS-CONTACT
We (FDA) proposed to define the term “allergen cross-contact” to mean
the unintentional incorporation of a food allergen into a food.
(Comment 79) Some comments assert that the term “incorporation”
used in the definition is a vague term that has entirely different
meanings when used by different segments of the food industry (e.g.,
the term would mean something different to a produce wholesaler than
to a cereal manufacturer). These comments ask us to provide either a
clarification or a definition for the term “incorporation.”
(Response 79) By “unintentional incorporation of a food allergen
into food” we (FDA) mean that the food allergen would be in a food
when the producer of the food did not intend it to be in the food—
e.g., if a milk-based beverage contains soybeans in addition to milk.
Several provisions of the rule require that a facility take steps to prevent
such unintentional incorporation of a food allergen into food.
We (FDA) proposed to revise the definition for “critical control point”
to mean a point, step, or procedure in a food process at which control can be
applied and is essential to prevent or eliminate a food safety hazard or reduce
such hazard to an acceptable level.
(Comment 80) Some comments ask us to specify that a critical
control point is essential to reduce the presence of hazards such as
microorganisms to “minimize the risk of foodborne illness” rather than
to “reduce such hazard to an acceptable level.” These comments assert
that this revision would be consistent with the approach in the
proposed produce safety rule. Other comments disagree with the
proposed definition because it does not define a term (i.e.,
acceptable level) used in the definition.
(Response 80) We decline to modify the definition as requested by
these comments. The proposed definition matches the statutory
definition in section 418(0)(1) of the FD&C Act and is consistent with
definitions in the NACMCF HACCP guidelines, the Codex HACCP
Annex, and Federal HACCP regulations for seafood, juice, and meat
and poultry (78 FR 3646 at 3695). The proposed produce safety rule,
which did not propose to define “critical control point,” focused on
biological hazards. However, critical control points may be established
to control chemical or physical hazards in addition to biological
hazards. The standard suggested by the comments is not inconsistent
with the definition we proposed for “critical control point” in the
human preventive controls rule, because preventing or eliminating a
food safety hazard or reducing such hazard to an acceptable level
would minimize the risk of foodborne illness. However, the standard
suggested by the comments was narrowly directed to biological
hazards, because chemical and physical hazards generally cause injury
rather than illness.
We do not need to define every term used in the definition. By
specifying that a point, step, or procedure in a food safety process
would reduce a hazard to an “acceptable level,” the definition provides
flexibility for a facility to determine an appropriate level in a particular
circumstance. Consistent with the approach recommended in the
proposed produce safety rule (78 FR 3504 at 3545), a facility could use
current FDA guidance on microbiological hazards (e.g., Refs. 29 and
30) to inform its decision on what constitutes an acceptable level. In
those documents, we use the phrase “adequately reduce” to mean
capable of reducing the presence of Salmonella to an extent sufficient to
prevent illness. The extent of reduction sufficient to prevent illness
usually is determined by the estimated extent to which Salmonella spp.
may be present in the food combined with a safety factor to account
for uncertainty in that estimate. For example, if it is estimated that
there would be no more than 1000 (i.e., three logs) Salmonella
organisms in the food, and a safety factor of 100 (i.e., two logs) is
employed, a process adequate to reduce Salmonella spp. would be a
process capable of reducing Salmonella spp. by five logs.
We (FDA) proposed to define the term “environmental pathogen” to
mean a pathogen capable of surviving and persisting within the
manufacturing, processing, packing, or holding environment such that food
may be contaminated and may result in foodborne illness if that food is
consumed without treatment to significantly minimize or prevent the
environmental pathogen. We also proposed to specify that environmental
pathogen does not include the spores of pathogenic sporeformers.
(Comment 81) Some comments ask us to include Salmonella spp.
and Listeria monocytogenes in the regulatory text as examples of
environmental pathogens because of the likelihood that these
environmental pathogens could contaminate ready-to-eat (RTE) food.
Other comments ask us to provide a broader list (including Escherichia
coli, Campylobacter, pathogenic Vibrio, Staphylococcus aureus, Clostridium
botulinum, Shigella, Yersinia enterocolitica, and viruses such as rotoviruses
and noroviruses) in the preamble to the final rule or in guidance, and
to make clear that the list is not all-inclusive. Some comments
emphasize the need for flexible language because any list of
microorganisms might change over time, particularly as new
environmental pathogens emerge.
Some comments ask us to include the indicator organism Listeria
spp. in the regulatory text, because analysis of Listeria spp. is faster than
analysis of L. monocytogenes. Other comments ask us to include
pathogens that have been associated with raw agricultural commodities
(RACs), as reported by CDC.
(Response 81) We agree that Salmonella spp. and L. monocytogenes are
useful examples of environmental pathogens and have added these two
examples to the proposed definition, which had not included
examples. As the comments point out, adding these two examples to
the definition does not mean that these two pathogens are the only
environmental pathogens that a facility must consider in its hazard
analysis. New environmental pathogens can emerge at any time, and
other pathogens (e.g., Cronobacter spp.) can also be environmental
pathogens (78 FR 3646 at 3816).
We have not included the indicator organism Listeria spp. as an
example of an environmental pathogen, whether in the regulatory text,
in the preamble of this document, or in guidance. Although we agree
that Listeria spp. is an appropriate indicator organism when conducting
verification testing for sanitation controls, the definition in question is
for a pathogen, not for indicators of a pathogen. Other provisions of
the rule are more appropriate to provide the context that a facility has
flexibility for how to conduct verification testing for an environmental
pathogen, including an option to test for an indicator organism.
Listeria monocytogenes, Salmonella spp., and some of the other
pathogens mentioned in the comments have been associated with
RACs. To the extent that the comments are asking us to identify some
environmental pathogens that have been associated with RACs, by
identifying these pathogens in the regulatory text or in this preamble
we have done so. However, it is important to note that the term
“environmental pathogen” as defined in this rule is directed to
pathogens in the food processing environment (such as the insanitary
conditions in a facility that packed cantaloupes linked to an outbreak
of listeriosis (78 FR 3646 at 3814)), not to pathogens present in the
growing environment for an RAC.
(Comment 82) Some comments ask us to define “environmental
pathogen” as a microorganism that is of public health significance and
is capable of surviving and persisting within the manufacturing,
processing, packing, and holding environment of the food being
(Response 82) We decline this request. The definition of
“environmental pathogen” should not change depending on the food
being prepared in a particular facility. As a practical matter, the facility
will consider the manufacturing, processing, packing, and holding
environment of the food being prepared when it conducts its hazard
analysis (§ 117.130).
(Comment 83) Some comments ask us to focus attention on the
areas where environmental monitoring is particularly important by
modifying the definition to address the risk of contamination to RTE
food and to foods exposed to the environment after a lethality step.
Other comments ask us to consider the number and types of different
products produced, the complexity of processing procedures, the
amount of product produced, and whether an environmental sampling
(Response 83) We decline these requests, which are asking us to
specify in a definition factors associated with developing an
environmental monitoring program. The purpose of a definition is to
simply explain what a term means, not to establish requirements, or
provide guidance about requirements that use the term.
(Comment 84) Some comments ask us to clarify the meaning of the
term “persisting” as used in the definition, such as whether it means
that a sanitation process will not remove the microorganism.
(Response 84) We use the term “persisting” to mean that a pathogen can
become established if cleaning is not adequate. Once a pathogen becomes
established, appropriate sanitation measures can remove the pathogen.
However, sanitation procedures necessary to eliminate an
environmental pathogen that has become established generally are
more aggressive than routine sanitation procedures.
(Comment 85) Some comments ask us to revise the definition to
specify that the microorganisms are “potentially” of public health
(Response 85) We decline this request. The definition is only directed
at those microorganisms that are of public health significance.
(Comment 86) One comment asserts that the proposed definition of
“environmental pathogen” excludes the waterborne pathogens
Cyclospora and Cryptosporidium and asks us to revise the definition so
that these pathogens will be considered “environmental pathogens” for
the purposes of the human preventive controls rule. The comment
asserts that excluding these waterborne pathogens does not take into
account the considerable food safety hazard of “spores” of “pathogenic
sporeformers” that can be present in and delivered to a food processing
facility by processing and ingredient water, both well water and surface
water from either private or municipal supply, in both domestic and
foreign facilities. The comment asks us to delete the statement that an
environmental pathogen does not include the spores of pathogenic
sporeformers so that, according to the comment, Cyclospora and
Cryptosporidium would fall within the definition of “environmental
pathogen.”
(Response 86) We disagree that the pathogens Cyclospora and
Cryptosporidium should be considered “environmental pathogens” as we
use that term in this rule. Our definition of “environmental pathogen”
is directed to those pathogens that are capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment of a food establishment, not the water that is used in a
food processing establishment. The available data and information
associate insanitary conditions in food facilities with contamination of
a number of foods with Salmonella spp. and L. monocytogenes. Such
contamination has led to recalls and to outbreaks of foodborne illness.
As a result, the rule includes several provisions directed to those
pathogens, such as Salmonella spp. and L. monocytogenes, which are
capable of surviving and persisting within a food establishment
(thereby serving as a source of contamination of the food
establishment environment) and uses the defined term “environmental
pathogens” to describe those pathogens. These specific provisions do
not apply to waterborne pathogens that do not survive and persist
within a food establishment.
By “pathogenic sporeformers,” we mean “pathogenic sporeforming
bacteria,” and we are substituting the term “pathogenic sporeforming
bacteria” for “pathogenic sporeformers” in the definition of
“environmental pathogen” to make that clearer. Both of the waterborne
pathogens discussed by this comment are protozoan parasites, not
The fact that waterborne organisms such as Cyclospora and
Cryptosporidium are not “environmental pathogens” as that term is used
in this rule does not mean that a facility has no responsibility to
evaluate whether Cyclospora or Cryptosporidium are known or reasonably
foreseeable hazards that require a preventive control. For example,
when a fresh-cut produce processing facility receives produce from a
geographic region where Cyclospora or Cryptosporidium have been
associated with food safety problems, the facility likely would address
the potential for contamination of incoming produce with Cyclospora or
Cryptosporidium in its supply chain program (see subpart G for the
requirements of the supply chain program).
We (FDA) proposed to define the term “facility” to mean a domestic
facility or a foreign facility that is required to register under section 415 of the
FD&C Act in accordance with the requirements of 21 CFR part 1, subpart H.
Comments directed to the meaning of the term “facility” address its
meaning as established in the section 415 registration regulations,
rather than this definition established in part 117. See Comment 4 and
We (FDA) proposed to define the term “farm” by reference to the
definition of that term in proposed § 1.227 (The Produce Safety
Standard) rather than by repeating the full text of the “farm” definition
in part 117.
We (FDA) proposed to define the term “food” to mean food as defined
in section 201(f) of the FD&C Act and to include raw materials and
ingredients. Under section 201(f), the term “food” means: (1) Articles
used for food or drink for man or other animals, (2) chewing gum, and
(Comment 87) Some comments ask us to include examples in the
definition, particularly dietary supplements and dietary ingredients.
These comments also ask us to clarify whether the definition applies to
food for human consumption, animal consumption, or both.
(Response 87) We decline the request to include examples in the
definition. Dietary supplements and dietary ingredients are articles used
for food or drink for man, as are many other articles. There are many
examples of food and adding a limited list of examples could be
confusing rather than helpful. Although the definition of food includes
food for both human consumption and animal consumption, the
provisions of the rule are clearly directed to food for human
consumption (see Responses 6 and 72).
(Comment 88) Some comments ask us to consider fundamental and
important differences between food additives and GRAS substances and
finished food. These comments explain that food additives and GRAS
substances may be synthesized using various chemical and biochemical
processes, or may be extracted, hydrolyzed or otherwise modified from
their natural sources, and result in food safety hazards that are quite
different from finished food preparations. These comments also explain
that food additives and GRAS substances are often produced using
processes that minimize microbial contamination hazards and are
almost always used in food products that undergo further downstream
processing. These comments assert that food additives and GRAS
substances generally present a significantly lower public health hazard
compared to finished food and should be regulated accordingly.
(Response 88) Substances such as food additives and GRAS
substances are food and are subject to the requirements of this rule.
Both the CGMP requirements in subpart B and the requirements for
hazard analysis and risk-based preventive controls in subparts C and G
provide flexibility to address all types of food. (As discussed in section
XLII, the final rule establishes the requirements for a supply chain
program in subpart G, rather than within subpart C as proposed. As a
result, this document refers to subparts C and G when broadly referring
to the requirements for preventive controls.) Some comments point out
that one strength of the long-standing CGMPs is their applicability to
the broad spectrum of food manufacturing, from the manufacture of
processed products to production of food additives and GRAS
substances (see section VIII). A manufacturer of a food additive or
GRAS substance has flexibility to comply with the requirements of the
rule based on the nature of the production processes and the outcome
of the hazard analysis for that food substance (see also Response 221).
(Comment 89) Some comments ask us to limit the definition of
“food” as it would apply to the new requirements for hazard analysis
and risk-based preventive controls to only cover produce and processed
foods covered by the rules, rather than all food (human and animal,
produce and non-produce, low risk and high risk).
(Response 89) We decline this request. It is not necessary to modify
the definition of “food” to limit applicability of the rule to human
food (see Response 6). The umbrella CGMPs that we are establishing in
subpart B are long-standing provisions that establish basic requirements
for the manufacturing, processing, packing, and holding of food to
prevent adulteration and are not “one-size-fits-all” (see Response 221).
The new requirements for hazard analysis and risk-based preventive
controls likewise are not “one-size-fits-all,” and facilities that are subject
to the rule would consider the risk presented by the products as part of
their hazard evaluation; a facility that appropriately determines through
its hazard analysis that there are no hazards requiring preventive
controls would document that determination in its written hazard
analysis but would not need to establish preventive controls and
associated management components (see Response 222).
We (FDA) proposed to define the term “food allergen” to mean a major
food allergen as defined in section 201(qq) of the FD&C Act.
(Comment 90) Some comments ask us to narrow the definition of
food allergen by specifying that a substance is only a food allergen
when it is not disclosed on the product label.
(Response 90) We decline this request, which appears to confuse the
distinction between what a food allergen is and when a product would
be misbranded under section 403(w) of the FD&C Act. The substances
listed in section 201(qq) of the FD&C Act are food allergens; if any of
those substances are not disclosed on the product label, then the
product would be misbranded under section 403(w) of the FD&C Act.
(Comment 91) Some comments ask us to expand the existing
exemption for RACs from the definition of major food allergen in
section 403(w)(1) of the FD&C Act to include raw fish.
(Response 91) This comment is unclear and appears to be confusing
the definition of “major food allergen” in section 201(qq) of the FD&C
Act with criteria for when a food shall be deemed to be misbranded
under section 403(w) of the FD&C Act. Under section 403(w), a food
shall be deemed misbranded if it is not a raw agricultural commodity
and it is, or it contains an ingredient that bears or contains, a major
food allergen, unless certain labeling requirements are met. Under
section 201(r) of the FD&C Act, the term “raw agricultural commodity”
means any food in its raw or natural state, including all fruits that are
washed, colored, or otherwise treated in their unpeeled natural form
prior to marketing. Fish are food and, thus, raw, unprocessed fish are
RACs within the meaning of section 403(w). Thus, the misbranding
provisions of section 403(w) would not apply to raw, unprocessed fish,
because those misbranding provisions do not apply to RACs. However,
the exemption in section 403(w) from the conditions under which a
food shall be deemed to be misbranded do not establish an exemption
for RACs in the definition of “major food allergen” in section 201(qq).
To the extent that the comment is asking us to revise either the
statutory definition of “major food allergen” in section 201(qq) of the
FD&C Act, or to revise the criteria for when a food shall be deemed
misbranded under section 403(w) of the FD&C Act, we do not have
(Comment 92) Some comments ask us to include an example of an
ingredient derived from an allergen in the definition.
(Response 92) We decline this request. The definition of “major food
allergen” in section 201(qq) of the FD&C Act is sufficient to define the
term. Casein and whey protein, each of which are derived from milk,
are examples of ingredients that would satisfy the definition of “major
food allergen” in section 201(qq).
We (FDA) proposed to define the term “hazard” to mean any biological,
chemical (including radiological), or physical agent that is reasonably likely to
cause illness or injury in the absence of its control.
(Comment 93) Some comments express concern that the rule would
refer to four levels of “hazard”—i.e., “hazard,” “known or reasonably
foreseeable hazard,” “significant hazard,” and “serious adverse health
consequences or death to humans or animals hazard.” These comments
ask us to provide sufficient clarity to be able to distinguish between
these types of hazards and to provide examples in guidance as to how
these terms will be applied in determining compliance with the rule.
Other comments express concern that the definitions do not establish a
meaningful distinction between “hazard” and “significant hazards” and
do not sufficiently distinguish between the hazards identified in the
first and second steps of the hazard analysis (first narrowing hazards to
“known or reasonably foreseeable hazards” and then narrowing the
“known or reasonably foreseeable hazards” to “significant hazards”).
(Response 93) The rule uses three of these terms (i.e., “hazard,”
“known or reasonably foreseeable hazard,” and the proposed term
“significant hazard”) to establish a tiered approach to the requirements
for hazard analysis and risk-based preventive controls. The term
“hazard” is the broadest of these three terms—any biological, chemical
(including radiological), or physical agent that is reasonably likely to
cause illness or injury. To conduct its hazard analysis, a facility starts by
first narrowing down the universe of all potential hazards to those that
are “known or reasonably foreseeable” for each type of food
manufactured, processed, packed, or held at its facility. The outcome of
the facility's hazard analysis is a determination of “significant
hazards”—i.e., the subset of those known or reasonably foreseeable
hazards that require a preventive control.
To make this clearer, we have: (1) Revised the proposed definition of
“hazard”; (2) changed the term “significant hazard” to “hazard requiring a
preventive control”; and (3) revised the definition of “hazard requiring a
preventive control” (formerly “significant hazard”). See Responses 94, 126,
127, 128, and 129.
The rule does not define the term “serious adverse health consequences or
death to humans or animals” hazard. (SAHCODA) However, the
requirements for a supply chain program refer to a hazard for which
there is a reasonable probability that exposure to the hazard will result
in serious adverse health consequences or death to humans (see §
117.430(b)). For additional information on how we interpret “serious
adverse health consequences or death to humans or animals,” see our
guidance regarding the Reportable Food Registry, which addresses
statutory requirements regarding “reportable foods.” As explained in
that guidance, a “reportable food” is an article of food (other than dietary
supplements or infant formula) for which there is a reasonable probability that
the use of, or exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals. The guidance includes
examples of circumstances under which food might be reportable.
(Comment 94) Some comments assert that the distinction between
the definitions of “hazard” and “significant hazard” is not discernable
because the proposed definition of “hazard” currently takes into
account whether a “hazard” is or is not controlled. These comments ask
us to delete the phrase “in the absence of its control” from the
definition of “hazard” to clarify that hazards are simply the agents that
are reasonably likely to cause illness or injury. Likewise, other
comments assert that any hazard that is “reasonably likely to cause
illness or injury in the absence of its control” will, if known or
reasonably foreseeable, likely be controlled by any knowledgeable
(Response 94) We have deleted the phrase “in the absence of its
control” from the definition of “hazard.” As previously discussed, the
phrase “in the absence of its control” is not included in the definition
of “hazard” in the Codex HACCP Annex, our HACCP regulation for
seafood, or the HACCP regulation for meat and poultry, although it is
included in the NACMCF HACCP Guidelines and our HACCP
regulation for juice (78 FR 3646 at 3697). We agree that deleting this
phrase from the definition of “hazard” will more clearly distinguish
between the terms “hazard” and “hazard requiring a preventive
control” that we are establishing in this rule. We see no reason to
propose an analogous change to