G L O B A L F O O D S A F E T Y R E S O U R C E® P R E S E N T S :

THE FSMA
FA C T B O O K
KEY DETAILS YOU NEED FOR STAYING COMPLIANT
WITH THE FOOD SAFETY MODERNIZATION ACT
EXECUTIVE SUMMARY
The global food supply chain is becoming
increasingly complex and food businesses
are being called to invest ever more resources
in staying abreast of regulatory changes that
affect food safety. The most notable change
to date has been the legislation implementing
more rigorous food safety standards that has
been passed in the United States in response
to wide-scale food recalls, some involving
deaths. The goal of this legislation—the
2010 FDA Food Safety Modernization Act
(FSMA)—is to improve overall health outcomes
for Americans by switching to a regulatory
framework that is proactive, and based on
preventive, rather than reactive, measures.
The FSMA legislation is considered the first
major piece of federal legislation addressing
food safety since the 1938 Federal Food, Drug
and Cosmetic Act. The US Senate passed the
legislation in late 2010, and former President
Barack Obama signed it into law in early
2011; the Food and Drug Administration (FDA)
subsequently published a number of Rules
in 2015 and 2016 outlining requirements for
different aspects of it. The FDA gave food
businesses a specified amount of time—
generally either one or two years—to bring their
operation into compliance with the legislation.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
This new piece of legislation addresses the
way in which food safety is regulated, and
it allows the FDA to:
• Obtain full access to safety records and
testing results
• Order recalls, rather than rely on voluntary
compliance by businesses
• Require all food manufacturers with annual
sales over $500,000 to have a Hazard
Analysis Critical Control Point (HACCP)
food safety plan, or an acceptable
equivalent, in place.
Companies that do not comply with the
FSMA legislation risk fines, substantial brand
damage, loss of business to competitors and,
if they are found guilty of knowingly distributing
contaminated food, criminal convictions. By
contrast, compliance means a company will
remain competitive in a global marketplace,
ensuring free flow of trade for imports into
the United States and reducing the number
of recalls associated with their products. This
legislation is intended to enhance consumer
protection by mitigating risks to consumers
through greater transparency intended to build
brand trust. Ensuring preventive controls are in
place will provide great brand protection and
reduce liabilities associated with costly recalls.
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I M P L E M E N TAT I O N C H A L L E N G E S
Regulatory Affairs Professor and Food Safety
expert Dr. Darin Detwiler is Founder and
President of Detwiler Consulting Group, LLC.
He acknowledges the need for the FDA’s new,
proactive approach, but notes that the FDA’s
initial implementation phase of FSMA was
highly dependent on the assistance of state
and county agencies in building an Integrated
Food Safety System. While the investigation
and reporting of foodborne illnesses by state
and county health departments are critical in
the prevention of foodborne disease in the US,
the question of individual states’ capacity to
monitor FSMA’s provisions has also been in
the spotlight.
THE NEW POLITICAL
FOOD LANDSCAPE
WILL INCLUDE MANY
CHALLENGES
“States often vary in the amount of time
between a trigger event, the detection of
an outbreak, the identification of the source,
and the official end of the outbreak,” he says.
“A true integrated system is only as strong as its
weakest member and, unfortunately, the states’
capacity, in this concern, is nearly impossible to
measure. The states that are considered to be
leaders in food safety are those that have strong
surveillance programs, can quickly get on top of
food illnesses when they occur, and can usually
find the source of an outbreak quickly.”
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
While state capacity to deal with an outbreak
is a crucial consideration, we live in a world
where a global food supply chain means
greater imports into the United States.
The FSMA response is to bring a strong focus
on imports and their management, both before
they enter the country and while they are in
transit through it.
“The food industry is left to pick up the pace
of FSMA implementation and, especially for
firms with facilities in multiple states, the new
political food landscape will include many
challenges,” Dr. Detwiler adds.
The US Food and Drug Administration’s (FDA)
sweeping changes to American food safety
regulations require food businesses to be
more vigilant than ever in the way they develop
and monitor their food safety systems. New
rules were developed that have been rolled
out, some over 800 pages, and our goal with
this Global Food Safety Resource® eBook is
to provide an overview of the various rules
under FSMA in one simplified document.
We outline here their impact on both foreign
importers and domestic businesses so
you can access the pertinent regulatory
information as a jumping-off point to assess
your business risk. Additional FSMA-related
information can be found on our website at
globalfoodsafetyresource.com, and you can
search for courses related to FSMA training
at safefoodtraininghub.comTM .
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TABLE OF CONTENTS

Overview of The Food Safety Modernization Act (FSMA) Page 5

Accredited Third-Party Certification Rule Page 7

Voluntary Qualified Importer Program (VQIP) Page 9

Foreign Supplier Verification Programs (FSVP) for Importers Page 11

Sanitary Transportation of Human and Animal Food Rule Page 15

Mitigation Strategies to Protect Food Against Intentional Adulteration Page 17

TACCP AND VACCP: What’s the Difference? Page 19

Preventive Controls for Animal Food Final Rule Page 21

Preventive Controls for Human Food Final Rule Page 23

Standards for Produce for Human Consumption Final Rule Page 26

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 4

O V E R V I E W O F T H E F O O D S A F E T Y M O D E R N I Z AT I O N A C T ( F S M A )
The primary purpose of the
FSMA
American Food Safety Modernization
Act (FSMA) is to improve food
safety standards by changing
both industry’s and government’s
approach to food safety from
reactive to preventive. This
ground-breaking piece of food
safety legislation is broken down
into four main sections:
• Improving capacity to prevent food
safety problems through: registration
of food facilities; risk-based
preventive controls; performance
standards; produce safety standards;
anaphylaxis and allergy management,
and many other criteria
• Improving capacity to detect and
respond to food safety problems
through such measures as:
allocating inspection resources
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
between domestic and foreign facilities and
ports of entry; laboratory accreditation; tracking
and tracing foods; mandatory recall authority
• Improving the safety of imported foods
through: a foreign supplier verification
program; authority to require import
certifications; inspection of foreign
facilities; third party auditors; etc.
• Miscellaneous provisions such as: funding
for food safety; employee protections;
jurisdiction and authorities; compliance
with international agreements.
I M P O R TA N T A S P E C T S O F
FOOD SAFETY
As part of this comprehensive change,
the Food and Drug Administration (FDA) has
been releasing rules to specifically address
important aspects of food safety. These
include the Foreign Supplier Verification
Programs (FSVP) for Importers of Food for
Humans and Animals, the Standards for the
Growing, Harvesting, Packing, and Holding
of Produce for Human Consumption, and the
FSMA Final Rule for Preventive Controls for
Human Food. Other rules include:
• Preventive Controls for Animal Food Final Rule
• Accredited Third-Party Certification Final Rule
• Sanitary Transportation of Human and Animal
Food Final Rule
• Mitigation Strategies to Protect Food Against
Intentional Adulteration Final Rule
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The changes are dramatic. For example, the
regulations address Preventive Controls. The
details of this are outlined in the Preventive
Controls Rule but, briefly, companies are
now required to:
• carry out a hazard/risk assessment
• create a written plan to deal with the
identified hazards
• document the implementation of and ongoing
testing procedures outlined in this plan
• plan for any corrective measures that may
be necessary.
On their side, staff members at the FDA are
working to establish science-based standards
for testing. One area they are specifically
focusing on is safe production and harvesting
of produce. The Produce Rule is one part of
this ongoing process.
PREVENTIVE CONTROLS AND
A C C O U N TA B I L I T Y
The FDA’s Food Safety Modernization Act also
gives the FDA the power to hold companies
accountable for these preventive controls,
primarily through inspection. This represents
a huge change in food safety legislation and
so the FDA is changing the way its inspection
resources are allocated, utilizing a proactive,
risk-based assessment process. The focus
is on innovation with the goal of providing
effective and efficient services.
Special attention is given to ensuring that
imported foods meet the same food safety
standards as domestic foods. The Foreign
Supplier Verification Rule details the
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
requirements, but beyond stating that importers
are required to carry out supplier verification
procedures to ensure the imported food is
safe, the legislation also:
• offers an incentive for suppliers to improve
their food safety procedures by granting
expedited clearance if they provide
assurances that allow them to qualify
for a voluntary program
• allows the FDA to require certification that
the food is safe
• gives the FDA the right to refuse admission
if the foreign facility or the other country does
not allow the FDA to carry out an inspection
Should anything go wrong, FSMA gives the FDA
the right to issue a mandatory recall. Although
historically most companies have been very
cooperative when asked to implement a
voluntary recall, this change is an important
step in protecting the public health.
In most cases, the Act gives dates of
compliance based on the size of the operation
and defines very small and small businesses.
Very small businesses are given the longest
time to reach compliance, small businesses
slightly less time and the rest have the shortest
time to comply.
Finally, the legislation also recognizes the need
for the FDA to partner with state, local, territorial
and tribal authorities to enhance the food safety
network. The FDA is mandated to work with
all of these authorities to provide food safety
training, and it offers grants to help increase the
number of labs and certified testing facilities.
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A C C R E D I T E D T H I R D-PA RT Y C E RT I F I C AT I O N R U L E
As part of the US Food Safety
FSMA
Modernization Act (FSMA), the
US Food and Drug Administration
(FDA) has issued several rules to
further clarify the requirements
of the regulations. This is one of
these rules, and it was developed
after extensive consultation with
numerous stakeholders.
This rule creates a voluntary
program for third-party accreditation
bodies and third-party certification
bodies; the latter are accredited
by the former. These bodies can
carry out food safety audits and
issue certifications to companies
producing human and animal food
outside of the US. The purpose
of this rule is to ensure that such
enterprises are competent, and that
they are truly independent.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
FSMA notes two specific uses for these
certifications:
• To verify an importer’s eligibility for the
Voluntary Qualified Importer Program (VQIP),
which expedites the entry and review of food
into the USA.
• In certain instances, the FDA can require that
a certification from an accredited third-party
certification body be provided before allowing
the import of a specific food.
SCOPE
The rule sets out the framework, procedures
and requirements for bodies seeking
accreditation and recognition from the FDA.
The FDA can offer accreditation directly, should
there be no successful applicants within two
years of the creation of the program.
The accreditation bodies can use their existing
International Organization for Standardization
(ISO) and International Electrotechnical
Commission (IEC) documentation to meet
this program’s requirements; this is a familiar
system that is internationally consistent.
There are oversight and monitoring procedures
which allow the FDA to revoke or withdraw
accreditation as necessary.
REQUIREMENTS FOR RECOGNIZED
A C C R E D I TAT I O N B O D I E S
The rule requires these enterprises to:
• Assess third-party certification bodies
for accreditation, including reviewing a
representative sample of their work
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• Monitor those it accredits and notify the FDA
of any changes to, or withdrawals of, these
accreditations
• Assess and correct their own performance
• Create and submit monitoring and self-
assessment reports to the FDA
• Maintain required records and allow the
FDA access to them.
REQUIREMENTS FOR RECOGNIZED
A C C R E D I TAT I O N B O D I E S
The program requires these enterprises to
perform unannounced facility audits and notify
the FDA if they discover anything that could
pose a risk to public health. The rule also
requires these bodies to:
• Ensure their audit agents are competent
and objective
• Verify that any corrective actions
recommended to address deficiencies are
undertaken by the audited entities, and
that they are effective
• Assess and correct their own performance
• Maintain required records and allow the
FDA access to them
There are two kinds of audits: consultative
and regulatory. In both types, compliance with
applicable federal food safety requirements
will be examined. A consultative audit is for
internal use and is conducted in preparation
for a regulatory audit. Auditors will assess
the facility’s performance in terms of industry
standards and practices. Certification is only
given following a regulatory audit.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
R E L AT E D F D A A C T I O N S
The FDA’s final recommendations on
standards for third-party certification bodies
are contained in the Model Accreditation
Standards guidance. They include required
educational and experience qualifications.
The FDA also published a final guidance
on VQIP. Importers must import food from
certified facilities. Importers with a robust
supply-chain management system may qualify
for expedited review and entry, which allows
the FDA to focus on imports that are more
likely to present a risk to public health.
There is a user-fee for the Accredited
Third-Party Certification Program. This pays
for the work of the FDA in establishing and
administering the program.
EXEMPTIONS
Mandatory import certification authority
does not apply to:
• Alcoholic beverages under certain circumstances
• Certain meat, poultry and egg products
that are subject to US Department of
Agriculture oversight.
I M P L E M E N TAT I O N
In June 2017, the FDA launched a website where
organizations can apply to be recognized as
an accreditation body. Once a body has been
accredited, it can begin accepting applications
from third-party certification bodies.
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VOLUNTARY QUALIFIED IMPORTER PROGRAM (VQIP)

As part of the US Food Safety

FSMA

Modernization Act (FSMA), the US

Food and Drug Administration (FDA)
has issued several rules, published
guidelines and created tools to help
companies understand and comply
with the updated regulations. The
Voluntary Qualified Importer Program
(VQIP) is a fee-based program designed
to help streamline the importation
process for those who qualify.

E L I G I B I L I T Y O F C O M PA N I E S
Importers must maintain a high level
of control over the safety and security
of their supply chain by implementing
a Quality Assurance Program (QAP)
(see below). They must also:
• Ensure that supplier verification
and other applicable importer
responsibilities, as outlined in the
Foreign Supplier Verification
Program (FSVP), Juice HACCP
(Hazard Analysis and Critical
Control Points), or Seafood HACCP
regulations, are met
• Hold a current third-party
certification, issued by an FDA-
accredited certification body, for
each foreign food supplier, or for
raw produce, for each farm
• Have a minimum three-year history
of importing to the US
• Be subject to no ongoing judicial or
administrative actions by the FDA, and have
no history history of non-compliance within
the supply chain
• Possess a Dun & Bradstreet (D&B)
Data Universal Numbering System
(DUNS) number
ELIGIBILITY OF FOODS
• The food must come from a facility (or farm)
that is certified under the FDA’s Accredited
Third-Party Certification regulations.
• No food that an applicant imports may be
subject to an import alert or Class 1 recall.

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 9

B E N E F I T S O F PA R T I C I PAT I N G
The FDA will expedite the entry into the US of
any food covered by VQIP. This means that
their import screening system will recognize,
and release shipments covered by VQIP as
soon as the entry information is received. In
addition, examination and sampling will only
occur for necessary statistical analysis or
to audit VQIP, where the food is, or may be
associated with, a public health risk.
VQIP QUALITY ASSURANCE
PROGRAM (QAP)
The QAP must be submitted with the VQIP
application and should include:
• A Corporate Quality Policy Statement that
applies to the whole supply chain, as well as
an explanation of how this is communicated
internally
• A description of the organization’s structure
and responsibilities
• Policies and procedures that ensure food
safety from source to entry, including a range
of compliance and procedural information
• Knowledge and qualifications requirements
for all relevant employees
• Written procedures for establishing and
maintaining records.
A P P LY I N G F O R V Q I P
Applications must be renewed each year
and online accounts can be created by visiting
the FDA Industry Systems website. If the
application is approved, the VQIP benefits
will apply from October 1st to September 30th.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
There is a fee which must be paid by October 1st.
The amount of the fee will be published each year
in the Federal Register on or before August 1st.
E V A L U AT I O N
The FDA will first review your application to
determine if you meet the criteria. If you are
accepted, the FDA will conduct an inspection
to verify you have implemented your QAP
procedures. If your facility is covered under
other regulations, the inspection will cover
these, and your labels may be reviewed to
ensure there are no labelling violations. Should
there be an outbreak, recall or newly identified
hazard linked to a food included in your VQIP,
or violations associated with one or more
entities associated with your company, the
FDA may conduct more frequent inspections.
PERMITTED AMENDMENTS
During the VQIP year, you can amend your
application to:
• Add a food from a foreign supplier already
included in your VQIP
• Remove a food, supplier or importer
• Replace a foreign supplier or importer for
a food that is in your VQIP, as long as they
have a current facility certification
• Add or remove a filer/broker.
R E V O C AT I O N
The FDA may revoke your participation if
they receive evidence that you no longer meet
one or more of the eligibility requirements, or
that you participated in smuggling or other
fraudulent activities. This revocation will apply
to all foods you import under VQIP.
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F O R E I G N S U P P L I E R V E R I F I C AT I O N P R O G R A M S
(FSVP) FOR IMPORTERS
As part of the US Food Safety
FSMA
Modernization Act (FSMA), the
US Food and Drug Administration
(FDA) has issued several rules to
further clarify the requirements
of the regulations. This is one of
these rules, which was developed
after extensive consultation with
numerous stakeholders.
SCOPE
The rule governing Foreign Supplier Verification
Programs (FSVP) for Importers of Food for
Humans and Animals applies to importers,
defined for this purpose as the US owner or
consignee of a food offered for import into
the United States. If there is no such entity,
the importer is considered to be the US agency
or representative of the foreign owner or
consignee at the time of entry, as confirmed
in a signed statement of consent.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
The FSMA compliance goal is to ensure that
foods from foreign suppliers are as safe as
those covered domestically under the Produce
and the Preventive Controls rules. Therefore,
for each food and each supplier of a food
product, should they use several suppliers,
the FSVP requires importers to:
• Determine known or reasonably foreseeable
hazards for each food
• Evaluate the risk posed by the food, based
on both the hazard analysis and the foreign
supplier’s performance
• Use the above to approve suppliers and
determine appropriate verification activities
• Conduct supplier verification activities
• Re-evaluate risk assessment and supplier
verification every three years
• Conduct corrective actions as necessary
All of these must be based on proper
documentation and written plans.
Importers that are also manufacturers/
processors may be deemed to be in
compliance with most FSVP requirements if:
• they are in compliance with the supply-chain
program requirements or they implement
preventive controls in compliance with the
Preventive Controls Rule
• for the food in question, preventive controls
are not required due to certain
circumstances: for example coffee beans,
11
 which could not be consumed without
application of a preventive control
• they receive written assurance that a
subsequent entity in the distribution chain
will process the food in some way that will
mitigate the hazard. However, importers
must disclose in documents accompanying
the food that it has not already been
processed to control the identified hazard.
H A Z A R D A N A LY S I S
A hazard is defined as something that is
reasonably likely to cause illness or injury. Each
food must be assessed for likely and foreseeable
hazards including biological (e.g. microbes),
chemical (e.g. pesticide residues) and physical
dangers (e.g. foreign objects like glass).
Hazards may occur naturally, be unintentionally
introduced, or be intentionally introduced
for many reasons including economic gain
(e.g. substituting a less costly ingredient).
The analysis must assess the probability of
these hazards occurring in the absence of any
controls and the likely severity of any resulting
illness or injury.
Importers can rely on qualified agents to conduct
the hazard analysis, but they must review and
retain the relevant documentation. The evaluation
must consider many factors, including:
• The formulation of the food
• The condition, function and design of the
establishment, and the equipment therein,
of a typical entity that produces the food
• Raw materials and other ingredients
• Transportation practices
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
• Harvesting, raising, manufacturing,
processing and packing procedures
• Packaging and labelling activities
• Storage and distribution
• Intended or reasonably foreseeable use
• Sanitation, including employee hygiene
E V A L U AT I O N
As already noted above, under FSMA’s Foreign
Supplier Verification Program, the importer
must evaluate both the food risk and the
supplier’s performance. If an entity in the supply
chain will be using a process that will reduce
a specific risk, the importer must assess that
entity’s procedures and practices. The importer
is also required to review the supplier’s past
performance in terms of both food safety and
responsiveness in correcting any problems.
And, finally, the imported food must meet the
applicable FDA food safety requirements.
S U P P L I E R V E R I F I C AT I O N
Based on the above evaluations, the importer
must create and implement written procedures
to ensure that it only imports from approved
foreign suppliers, and it must conduct
appropriate supplier verification activities on
an on-going basis.
THE IMPORTER MUS T
C O N D U C T A P P R O P R I AT E
S U P P L I E R V E R I F I C AT I O N
ACTIVITIES ON AN
ON-OGOING BASIS
12
Importers have several options to tailor
supplier verification activities to unique food
risks and supplier characteristics, including:
• Annual on-site audits of the supplier’s
facility. This is generally required where
possible “Serious Adverse Health
Consequences or Death to Humans or
Animals,” or SAHCODHA hazard, are identified.
However, the importer can choose another
means of verification provided that they
document that the alternate choice is
appropriate and provides adequate
assurances that the supplier is producing
the food in accordance with applicable US
safety standards.
• Sampling and testing
• Reviewing the supplier’s relevant food
safety records
CORRECTIVE ACTIONS
It is up to the importer to ensure that
immediate and appropriate corrective actions
are taken should something go wrong. As
well as the risks noted for evaluation above,
this also includes mislabelling with regard to
allergens and adulteration.
The corrective actions will be dictated by the
circumstances but the most common one is
to stop importing from that supplier until the
necessary corrective actions are taken and
documented as effective.
EXEMPTIONS AND MODIFIED
S TA N D A R D S
Modified standards apply to certain foods
imported from a country whose food safety
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
standards have been deemed equivalent
to the US. The exemptions for dietary
supplements vary depending on whether
the imported food is a finished product
or an ingredient/component for further
processing. Many dietary supplements are
already covered under their own Current Good
Manufacturing Practices (CGMP) regulations
and so importers who can verify that they are
meeting these would not be required to meet
FSVP requirements as well. If the imported
supplement is not already covered by these
regulations, the FSVP requirements would
apply but the verification process would focus
on meeting the CGMP regulations.
Very small importers (less than $1 million in
sales of human food or $2.5 million of animal
food) and importers of food from certain small
suppliers (see below) must meet modified
FSVP requirements. For example, certain
importers could verify their foreign suppliers
by obtaining written assurances from their
supplier instead of conducting their own
hazard analysis.
Some of the small foreign suppliers noted
above include:
• Facilities that qualify for modified
requirements under the preventive
controls rules
• Farms not under the Produce Safety Rule
because they average $25,000 or less in
annual produce sales or because they meet
requirements for a qualified exemption
• Shell egg producers with fewer than 3,000
laying hens
• And, finally, certain categories of imported
food are not covered by FSVP. These include:
13
 Juice, fish, and fishery products (and certain
ingredients for use in these products) that
comply with the applicable HACCP regulations
Food for research or evaluation
Food for personal consumption
Alcoholic beverages and certain
ingredients for use in alcoholic beverages
Food that is imported for processing and
future export
Low-acid canned foods (LACF), such
as canned vegetables, as well as certain
ingredients for use therein, but only with
respect to microbiological hazards covered
by other regulations.
Certain meat, poultry and egg products
regulated by the US Department of
Agriculture at the time of importation

C O M P L I A N C E D AT E S
For full FSMA compliance, importers were
required to comply within 18 months of
publication of the rule, which took place on
November 27, 2015. However, if their supplier
is subject to the Preventive Controls or Produce
Safety Rules, they are required to comply six
months after the foreign supplier is required to
meet the relevant regulations.
If an importer is itself a manufacturer
or processor subject to the supply-chain
program provisions in the preventive controls
regulations, the date established in the
Preventive Controls Rules apply.

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 14

S A N ITA RY T R A N S P O RTAT I O N O F H U M A N
AND ANIMAL FOOD RULE

practices. It covers both local and interstate

commerce. Transportation by ship or air is not
covered due to legal limitations. It applies to
companies shipping food to the USA by motor
or rail. As well, it covers containers that arrive by
ship or air that are then transported by motor or
rail within the USA, if the food will be consumed
or distributed within the United States.
It does not apply to food being shipped
through the USA where the food does not enter
American distribution (for example foods
moving from Canada to Mexico).
Export shipments are covered until they leave
the United States.

As part of the Food Safety

FSMA

Modernization Act (FSMA), the US THE RULE IS INTENDED

Food and Drug Administration has TO PROTECT FOODS FROM
issued several rules to further clarify C O N TA M I N AT I O N D U R I N G
the requirements of the regulations. T R A N S P O R T, F R O M FA R M
The Sanitary Transportation of TO TABLE
Human and Animal Food Rule is
intended to protect foods from
contamination during transport,
KEY REQUIREMENTS
from farm to table. It enhances the
• Vehicles and transportation equipment are
safeguards contained in the Sanitary
to be designed and maintained to ensure
Food Transportation Act (SFTA).
the appropriate food safety. For example,
they must be easily cleaned to the standard
SCOPE required for the food they are intended
The rule requires shippers, loaders, to handle, and they must be capable of
carriers and receivers transporting maintaining the correct temperature.
food by motor or rail to use sanitary

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 15

• Transportation operations must ensure
measures are taken to protect food safety.
Examples include preventing contamination
of ready-to-eat food by contact with raw
foods, or with non-food items in the same
load or previous loads, or by cross-contact
with food allergens.
• Training of carrier personnel in sanitary
transportation practices is required. The
FDA has published a Training Module on
this topic.
• Records of written procedures, agreements
and training (required of carriers) must be
maintained and retained.
WAIVERS
The Sanitary Food Transportation Act (SFTA)
allows the agency to waive the requirements of
this rule if it determines that the waiver will not
result in the transportation of food in a manner
that is unsafe, or contrary to the public interest.
Three waivers have been granted:
• Businesses that transport bulk and finished
Grade “A” milk and milk products, which
hold permits and are inspected under the
Milk Safety Program
• Businesses that are permitted to provide food
directly to consumers, including restaurants,
retail food establishments and non-profit food
establishments and only when:
They receive food, whether at their
establishment or at a location where they
receive and immediately transport the food
to their establishment
They transport food as part of normal
operations such as food delivery or food
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
moved to another location operated by the
same company
• Businesses transporting molluscan shellfish
in vehicles permitted by the State National
Shellfish Sanitation Program (NSSP), where
such businesses are appropriately certified
and inspected by the NSSP.
C O M P L I A N C E D AT E S
Small businesses, which are defined as those
other than motor carriers who are not also
shippers and/or receivers employing fewer
than 500 persons and motor carriers having
less than $27.5 million in annual revenue, have
two years to comply.
All other businesses have one year to comply.
EXEMPTIONS
• Shippers, receivers or carriers that have less
than $500,000 in average annual revenue
• Transportation activities performed by a farm
• Transportation of food that is shipped
through the USA to another country or is
imported for future export and is neither
consumed nor distributed in the US
• Transportation of compressed food gases
and food contact substances
• Transportation of human food by-products
to be used as animal food without further
processing
• Transportation of food that is completely
enclosed in a container, except for foods
that require temperature controls
• Transportation of live food animals,
except shellfish.
16
M IT I G AT I O N S T R AT E G I E S TO P R OT E CT F O O D
A G A I N S T I N T E N T I O N A L A D U LT E R A T I O N
As part of the US Food Safety
FSMA
Modernization Act (FSMA), the
US Food and Drug Administration
(FDA) has issued several rules to
further clarify the requirements of
the regulations. This rule’s intent is
to prevent deliberate adulteration of
foods intended to cause widespread
harm, including acts of terrorism.
Although it is not specifically called a
“Threat Assessment Critical Control
Point (TACCP) rule, this final rule has
essentially the same function.
In developing the provisions
of this rule, the FDA consulted
the intelligence community, as
well as the food industry, to
identify vulnerabilities.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
WHO IS COVERED?
The rule applies to both foreign and domestic
companies whose products reach many
people. At the time the FDA published the rule,
3,400 companies operating 9,800 foreign and
domestic food facilities were identified as
falling within the provisions. Exemptions are
noted below.
THIS RULE’S INTENT IS
T O P R E V E N T D E L I B E R AT E
A D U LT E R A T I O N O F F O O D S
INTENDED TO CAUSE
WIDESPREAD HARM
KEY PROVISIONS
Because this is the first-time companies
have been asked to create a food defense
plan, the FDA has used an approach very
similar to HACCP but instead it focuses
on identifying vulnerabilities.
• A vulnerability assessment must evaluate:
the severity and scale of the impact on
public health including such things as
volume of product, number of servings,
number of exposures, speed of flow
through the distribution system, possible
number of illnesses and deaths
the physical access to the product
including such barriers as gates, railings,
doors, lids, seals and shields.
17
 how easy it would be to successfully
contaminate the product
• Mitigation strategies must be identified and
implemented for each step in the production
process and should be tailored to the facility
and its procedures. These include both broad
strategies, such as a fence around the overall
facility, and focused ones, such as security
gates around key processing areas.
• Mitigation strategy management components:
Monitoring: establishing and implementing
the procedures and their frequency
Corrective actions: planned responses
if mitigation strategies are not properly
implemented
Verification: activities that ensure that the
above steps are taking place
• Training and record-keeping: personnel
assigned to vulnerable areas must receive
training and records must be kept of the
monitoring, corrective actions and verification
procedures.
C O M P L I A N C E D AT E S
As this rule is the first of its kind, and because
most of the food facilities covered by this rule
will also be working towards compliance
with the other FSMA rules, the FDA provided
a longer timeline. The rule came into effect
in July 2016.
• Very small businesses (averaging less than
$10 million per year for the last three years
in sales of human food plus the value of
inventory of food manufactured, processed,
packed or held for a fee but without sale):
five years after the publication of the final rule
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
• Small businesses (employing fewer than
500 people): four years
• All other businesses: three years
EXEMPTIONS
• A very small business, which would have
to provide documentation to the FDA to
demonstrate that the business is very small
• The holding of food except where the food
is held in liquid storage tanks
• The further processing of food where the
container that directly contacts the food
remains intact (e.g. repacking or re-labelling)
• Activities that fall within the definition of “farm”
• Food for animals
• Alcoholic beverages under certain conditions
• On-farm manufacturing by small or very small
businesses of certain foods with low-risk
production practices including certain types
of eggs and game meats
A S S I S TA N C E T O I N D U S T R Y
• The FDA has established an Intentional
Adulteration Subcommittee to develop food
defense training resources for manufacturers
and regulators
• They will publish guidance documents to
provide additional information
• Additional tools and resources are available
• There is also a searchable Mitigation
Strategies Database
• The FDA FSMA Food Safety Technical
Assistance Network provides information
on implementation of all FSMA rules and
includes online support from experts.
18
TA C C P A N D VA C C P: W H AT’S T H E D I F F E R E N C E?

TACCP and VACCP are relatively new M I T I G AT I O N S T R AT E G I E S

FSMA

programs based on the more familiar Similar to HACCP, both programs require a
Hazard Analysis Critical Control control plan that covers mitigation strategies
Points (HACCP) program, but they and correction procedures. They may require
address threats and vulnerabilities audits of the entire supply chain, assessments
instead of hazards. of various suppliers and extensive quality
TACCP stands for Threat Assessment control checks of ingredients.
and Critical Control Points. This protocol
focuses on tampering, intentional
adulteration of food, and food defense.
TACCP generally requires a wider
range of employee involvement
than HACCP, as it covers issues
such as manufacturing plant and
transportation security, IT security,
and employee background checks.
Some points will overlap with HACCP,
such as tamper-proof seals and
various quality control checks.
VACCP stands for Vulnerability
Assessment and Critical Control
Points. It focuses on food fraud FOOD FRAUD IS BIG
as well, and widens the scope to BUSINESS
include systematic prevention of any
potential adulteration of food, whether Food fraud is big business, and, like any other
intentional or not, by identifying business, perpetrators generally have no wish
the vulnerable points in a supply to make their customers sick and thus call
chain. It is especially concerned with attention to their activities. Therefore, it is
economically motivated adulteration unlikely they would intentionally put the public
(EMA). Examples include product health at risk. However, such risks can occur due
substitutions, unapproved product to inexperienced or untrained food handlers, bad
enhancements, counterfeiting, stolen packaging causing food spoilage, unlabelled or
goods and others. mislabelled ingredients, etc.

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 19

In one incident, a company was paying a
premium for a special chili powder that was
distinguished by its rich red colour. They were
offered a cheaper supply, but testing revealed
the presence of a carcinogenic food colouring
that has been banned in most countries.
Food tampering, on the other hand, is often
malicious, motivated by an urge to cause
harm. Food terrorism is one scenario that has
been raised as a possibility. Therefore, TACCP
focuses on a defensive strategy and analysis
of the socio-economic factors that might
influence someone to commit such a crime.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
ADOPTED BY THE GFSI IN EUROPE
While both programs have been adopted by the
Global Food Safety Initiative (GFSI) in Europe,
neither have been formally accepted by the US
Food and Drug Administration (FDA). The Food
Safety Modernization Act (FSMA) includes the
Mitigation Strategies to Protect Food Against
Intentional Adulteration Rule, but this focuses
only on public health concerns. Adulteration
that does not present a risk to food safety is
outside of the scope of the FSMA Rules.
Industry experts agree that if a processor
meets their GFSI certification requirements,
they will also meet the current requirements
of the FSMA.
20
PREVENTIVE CONTROLS FOR ANIMAL FOOD FINAL RULE
As part of the US Food Safety
FSMA
Modernization Act (FSMA), the
US Food and Drug Administration
(FDA) has issued several rules to
further clarify the requirements
of the regulations. This is one of
these rules, which was developed
after extensive consultation with
numerous stakeholders.
KEY REQUIREMENTS
Current Good Manufacturing
Practices (CGMPs) have been
established for animal food
production. These have been
finalized by the FDA. Of note:
• Processors of human food selling
a by-product of their production do
not need to implement additional
preventive controls except to
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
prevent physical or chemical contamination
during holding or distribution.
• Further processing of a by-product requires
the facility to comply with CGMPs, but
they can choose whether to implement those
required for human food or animal food
Facilities must implement a food safety system
that is based on an analysis of hazards and
risk-based preventive controls. A written food
safety plan is required and must include:
• hazard analysis
• preventive controls
• oversight and management to include
monitoring of the preventive controls
verification that the above activities are
scientifically valid, effective and are being
carried out regularly
• a recall plan
S U P P LY- C H A I N P R O G R A M
The supply-chain program for animal food
safety is more flexible than it is for human food
safety, with offset compliance dates so that
processors are not required to implement the
rule before their suppliers are.
Should the facility identify a hazard within the
supply chain, they must implement a supply-
chain control. This does not apply if the facility
uses verification procedures themselves, or
if they rely on their customers to implement
hazard controls.
21
 PROCESSORS MUST
E N S U R E T H AT T H E Y
RECEIVE THEIR
INGREDIENTS FROM
APPROVED SUPPLIERS
Where supply chain controls are implemented,
processors must ensure that they receive their
ingredients from approved suppliers only.
Unapproved suppliers can be used temporarily
but these ingredients must be subjected to
verification activities.
A facility is not required to implement hazard
controls if another entity in the supply chain
will be doing so, such as a customer or another
processor. In this case, the facility provides a
written notice that the food is “not processed
to control (identified hazard)” and has their
customer sign a letter stating that they will
undertake the necessary actions.
D E F I N I T I O N O F A FA R M
For the definition of a farm, please see the
Preventive Controls for Human Food Rule.
Facilities meeting the definition of a farm
are NOT subject to this rule.
If a farm includes a feed mill, the mill would
not need to implement preventive controls if:
• the mill is owned or managed by the same
farm or company
• the feed is supplied only to the animals on that
farm or other farms owned by the same company
• the mill is located on or near the farm.
If any of these are not true however, the
rule applies.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
F E E D M I L L S A S S O C I AT E D W I T H
FA R M S N O T C O V E R E D
The FDA is concerned because feed mills
produce a significant percentage of animal
food. Therefore, the FDA intends to create a rule
that requires feed mills to implement CGMPs.
C O M P L I A N C E D AT E S
The Rule was passed in September 2015 with
compliance required from that date as follows:
• Very small businesses (averaging less than
$2.5 million per year for the last three
years in sales plus the market value of food
processed, packaged or held): three years
for CGMPs, four years for Preventive
Controls (PCs). Records to establish it as
a very small business were required by
January 1, 2017.
• Small businesses (fewer than 500 full-time
equivalent employees): two years for CGMPs,
three for PCs
• All other businesses: one year for CGMPs,
two years for Preventive Controls.
For the supply chain, compliance is required
six months after the receiving facility’s
supplier is required to comply with the CGMP
requirements of this rule, where the supplier is
required to implement CGMPs, but not PCs.
If the supplier is subject to preventive controls,
small and very small business have two years,
and the rest have three years, to comply, or six
months after the supplier must be compliant,
whichever is later.
22
PREVENTIVE CONTROLS FOR HUMAN FOOD FINAL RULE
As part of the Food Safety
FSMA
Modernization Act (FSMA), the US
Food and Drug Administration has
issued several rules to further clarify
the requirements of the regulations,
one of which relates to Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human Food. The rule was
developed after extensive consultation
with numerous stakeholders.
EXEMPTIONS
The limitations and definitions of which
facilities are covered by this rule are many
and varied and take pages to define. A few
examples of the exemptions include:
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
• Farms (to be discussed below) that engage
in low-risk on-farm activities and are small
or very small businesses
• Operations already subject to the seafood
or juice HACCP requirements
• Operations that process low-acid
canned foods
• Producers of dietary supplements,
alcoholic beverages or cosmetics,
all of which have their own separate
regulations
• Facilities that store raw agricultural
commodities (RACs) other than fruits
or vegetables or that store already
packaged foods.
REQUIREMENTS FOR NON-EXEMPT
FA C I L I T I E S
All other facilities are covered by the rule and
therefore must establish and implement a food
safety system. This requires a written food
safety plan that covers:
• hazard analysis
• preventive controls
• oversight and management:
• monitoring of the preventive controls
• corrective actions and corrections
• verification that the above activities are
scientifically valid, effective and are being
carried out regularly
23
D E F I N I T I O N O F A FA R M
Farms are not subject to this rule; instead they
are subject to the Produce Safety Rule, which
has expanded and clarified the definition of
what constitutes a farm. There are two main
types identified:
• a Primary Production Farm:
Is under one management in one general
area but not necessarily on the same or
adjoining piece of property
Is dedicated to growing and harvesting
crops, raising animals (including seafood)
or any combination thereof
May conduct some manufacturing or
processing activities, such as dehydrating
grapes to make raisins, as well as
packaging and labelling
• A Secondary Activities Farm:
Is not located on the Primary Production
Farm but is harvesting, packing and/or
holding RACs
May or may not have the same owners as
the Primary Production Farm
This means that facilities that do off-farm
packing are now included within the definition
of a farm, as are companies that do nothing
but harvest crops, and companies that merely
hold or store RACs.
S U P P LY- C H A I N P R O G R A M S
Another important area that is addressed by this
rule is the supply chain. The aim is to make this
process more flexible. As well, it establishes
separate compliance dates so that a food facility
does not have to comply before its suppliers do.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
A facility must have a risk-based preventive
assessment supply-chain program for any
ingredient or material that has been identified as
needing one, unless it either institutes preventive
measures to deal with the hazard itself or
passes the ingredient on to a customer who will
implement their own preventive measures.
A F O O D FA C I L I T Y
D O E S N OT H AV E TO
C O M P LY B E F O R E I T S
SUPPLIERS DO
Foods should be received from approved
suppliers, which are defined as those approved
by the facility after an assessment of the
hazard associated with that particular food
and the track record of the entity that will be
controlling that hazard. Of course, foods may
be brought in temporarily from unapproved
suppliers, but such ingredients are then subject
to verification before they can be used.
Preventive controls are not required within
the facility if the hazard will be controlled by a
subsequent entity such as the final customer or
another processor. However, the facility must
disclose that this food has not been processed
to control its associated risk (e.g. Salmonella
or Listeria) and must obtain written assurance
that the subsequent entity will do so.
Another entity, such as a broker or a distributor,
can conduct supplier verifications but the
receiving facility must review and assess that
entity’s documentation of the verification.
24
C U R R E N T G O O D M A N U FA C T U R I N G
PROCESSES (CGMPS)
The rule attempts to update and clarify
CGMPs. As well, the rule no longer includes
any non-binding provisions or guidelines.
All provisions are now binding. These include:
• Education and training:
All employees must be qualified to perform
their assigned duties
All employees managing risk as well as
those implementing preventive controls
must be qualified to do so either by training
or experience
• Allergen cross-contact: this has long been
included in the FDA’s CGMPs but now they
are included within the regulatory text.
• 2 years or 6 months after the supplier is
required to comply, whichever is later, if
the receiving facility is a small business
and its supplier will be subject to the human
preventive controls rule or the produce
safety rule
• 18 months if the receiving facility is not a
small or very small business, and its supplier
will not be subject to the human preventive
controls rule or the produce safety rule
• 6 months after the supplier is required
to comply with the applicable rule if the
receiving facility is not a small or very small
business and its supplier will be subject
to the human preventive controls rule or
the produce safety rule.

C O M P L I A N C E D AT E S
The rule was passed on September 17, 2015 and
compliance was required from that date as follows:
• 3 years for very small businesses (averaging
less than $1 million in sales and/or held
inventory per year). Records to establish
it as a very small business were due by
January 1, 2016.
• 3 years for businesses subject to the
Pasteurized Milk Ordinance
• 2 years for small businesses (fewer than
500 full-time equivalent employees)
• 1 year for all other businesses
Compliance dates for the requirements of the
supply-chain program:
• 2 years if the receiving facility is a small
business and its supplier will not be subject
to the human preventive controls rule or the
produce safety rule

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 25

STANDARDS FOR PRODUCE FOR HUMAN
CONSUMPTION FINAL RULE

As part of the Food Safety

FSMA

Modernization Act (FSMA), the

US Food and Drug Administration
(FDA) has issued several rules to
clarify regulatory requirements.
The rule regarding Standards for
the Growing, Harvesting, Packing,
and Holding of Produce for Human
Consumption was developed after
extensive consultation with numerous
stakeholders and it follows the same
definition for farms that are laid out in
the Preventive Controls for Human Food
Rule. Following are some of the most
important aspects of this rule.

A G R I C U LT U R A L W AT E R
No E. coli is allowed in water that
may transfer the contamination
directly or indirectly to produce.
Examples include water that is used:
• for sprout irrigation
the water source. The FDA intends to have an
• to make ice for storage or
online tool that allows farmers to input their
• for washing hands during harvesting water sample data and calculate these values.
Water that is applied directly to The GM must be 126 or less and the STV must
growing produce (not including be 410 Colony Forming Units (CFU) or less of
sprouts) can have some E. Coli in generic E. Coli per 100 mL of water.
it, using two measurements: The
Geometric Mean (GM), which is an These measurements are meant to be flexible
average level for the water source enough to allow for slightly elevated readings
and the Statistical Threshold (STV) due to exceptionally high rains, for example,
which represents the variability of while maintaining consumer safety.

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 26


I F W AT E R S A M P L E S
EXCEED ALLOWABLE
VALUES, CORRECTIVE
ACT I O N M U S T B E TA K E N
WITHIN A YEAR
If water samples exceed allowable values,
corrective action must be taken within a
year. This might include treating the water,
allowing the microbes to die off between the
last irrigation and the harvest, or storing and
treating the produce after harvest to remove
harmful microbes.
Water from public water systems or that is
treated in compliance with the regulations
need not be tested.
BIOLOGICAL SOIL AMENDMENTS
RAW MANURE
While the FDA is conducting extensive risk
assessments of raw manure usage, the rule
suggests that farmers follow the USDA’s
National Organic Program, which calls for a
120-day interval between the application of raw
manure for crops in contact with the soil, and
90 days for crops not in contact with the soil.
S TA B I L I Z E D C O M P O S T
The rule includes two examples of scientifically
valid composting methods that meet the
standards for minimizing the presence of
several harmful agents including Salmonella
and Listeria as well as E. coli. Even then, as
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
with manure, the compost must be applied
in a manner that minimizes the potential for
contact with produce during and after application.
SPROUTS
Sprouts have been associated with a high number
of very serious cases of foodborne illnesses and
the new food safety regulations include special
requirements for them. These include:
• Treating beans or seeds used for sprouting
• Measures to prevent introduction of
dangerous microbes to the soil
• Testing spent irrigation water from each
batch of sprouts
• Testing each production batch of the
sprouts themselves
• Testing the growing, harvesting and
packaging areas
• Taking corrective actions if any of these
tests reveal the presence any pathogens.
DOMESTIC AND WILD ANIMALS
Animal incursions into a produce-growing area
represent a contamination risk via fecal matter.
If this occurs, farmers must not harvest those
plants for human consumption. Farmers are
asked to do everything reasonably possible
to avoid animal incursions into their fields,
but the rule makes it clear that they are not
required to destroy animal habitat or clear
surrounding areas. They are to visually inspect
their crops and clearly mark areas where
incursions have occurred.
27
The rule doesn’t specify times to allow
between grazing and harvesting if farmers
allow domestic animals to graze in crop
fields, but the FDA will provide guidelines
later, if needed.
W O R K E R T R A I N I N G , H E A LT H
AND HYGIENE
Basic common-sense requirements are
included here, such as:
• Preventing ill or infected employees from
having contact with the produce
• Requiring basic hygiene such as hand
washing after bathroom use
• Making sure visitors are not allowed to
contaminate the produce
• Giving employees basic hygiene training
E Q U I P M E N T, T O O L S A N D
BUILDINGS
This part of the rule outlines procedures
for ensuring the equipment, tools and work
surfaces used for holding, cleaning and
packaging produce are clean.
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
EXEMPTIONS
The rule does not apply to:
• Produce that is not consumed as a
raw agricultural commodity. The FDA has
recognized that most Americans are unlikely
to eat the following foods raw:
asparagus; black beans, great Northern
beans, kidney beans, lima beans, navy
beans, and pinto beans; garden beets
(roots and tops) and sugar beets; cashews;
sour cherries; chickpeas; cocoa beans;
coffee beans; collards; sweet corn;
cranberries; dates; dill (seeds and weed);
eggplants; figs; horseradish; hazelnuts;
lentils; okra; peanuts; pecans; peppermint;
potatoes; pumpkins; winter squash; sweet
potatoes; and water chestnuts
Food grains including barley, dent- or
flint-corn, sorghum, oats, rice, rye, wheat,
amaranth, quinoa, buckwheat, and oilseeds
(e.g. cotton seed, flax seed, rapeseed, etc.)
Produce grown for personal consumption
Farms that have sold less than $25,000
worth of produce over the last three years
Modified and/or qualified exemptions are
granted to produce that will be further processed
in a way that reduces any microorganisms to
below acceptable levels, as well as very small
or small farms (as defined below), although
they must still maintain careful records. The
exemption can be withdrawn if an outbreak
is traced directly to the farm or if the FDA
determines that it is necessary to prevent or
mitigate an outbreak. Reinstatement can occur if
further investigation shows the farm was not the
source of the outbreak or if the FDA is satisfied
that the cause has been adequately dealt with.
28
VA R I A N C E S
Importers into the United States can request
variances, if, for example, local growing
conditions make adherence too difficult,
as long as they can prove that the subject
produce will not be adulterated and that there
is no more risk to public safety than there
would be if they complied with the rule.
The variance must be submitted by a
competent authority and must be backed
up with scientific data.
C O M P L I A N C E D AT E S
Compliance dates vary depending on the size
of the business and are defined as follows:
• Very small businesses are those which have
averaged between $25,000 and $250,000
annual produce sales during the previous
three years
• Small businesses are those which have
averaged between $250,000 and $500,000
Compliance dates for all but those producing
sprouts are:
• Four years for very small businesses
• Three years for small businesses
• Two years for all others
• Also, two years’ additional time to comply
with the water quality requirements.
Compliance dates for sprout producers are:
• Three years for very small businesses
• Two years for small businesses
• One year for all others
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
• No additional time allowed to comply
with the water quality requirements.
For farms eligible for a qualified exemption,
the compliance dates are:
• Immediately for records supporting eligibility
for a qualified exemption
• January 1, 2020 for the labelling requirement
(if applicable)
For all other modified requirements:
• Four years for very small businesses
• Three years for small businesses
E N V I R O N M E N TA L I M PA C T
S TAT E M E N T
The FDA has published an Environment Impact
Statement which places this rule in the context
of its likely effect on the environment.
A S S I S TA N C E T O I N D U S T R Y
The FDA will make various guidance
documents around compliance and modified
exemptions available, including those relating
to small and very small businesses. Training
and technical assistance will be a priority.
They have already established the FDA FSMA
Food Safety Technical Assistance Network,
to provide a central source of information
to support industry’s understanding and
implementation of the FSMA.
29
CONCLUDING THOUGHTS
The world is changing and the new FSMA
regulations require that all food producers,
manufacturers, packagers and handlers become
fully apprised of what they need to do in order
to protect their customers, meet compliance,
manage supply chains, stay competitive and
protect their brand. This trend has built a case
for improving food safety practices around the
world with other governments following suit
to improve legislation and harmonize with
the United States.
Technological advances are making it easier
for food companies to ensure they are in
compliance through providing efficiencies
in their processes while providing greater
Published by: Global Food Safety Resource in collaboration with Crossman Communications
© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.
transparency and recall alerts. We’ve compiled
additional resources through links in the next
section of this report that will allow you to
research more fully what the regulations, and
others, are saying about food safety in the
United States and elsewhere.
According to Dr. Dettwiler the impact of
these changes is going to be enormous but
the ultimate goal of enhancing food safety
is within our reach. And, as collaborators
educating food professionals through
resources, solutions, and training, we
believe that:
T O G E T H E R , W E C A N M A K E F O O D S A F E ®.
30
ADDITIONAL RESOURCES AND LINKS:

Accredited Third-Party Certification Final Rule

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm

Current Good Manufacturing Processes

http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm079496.htm
https://www.fda.gov/food/guidanceregulation/cgmp/

E.Coli
https://globalfoodsafetyresource.com/ecoli-o157-h7/

Environmental Impact
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm396564.htm

FDA and FSMA:

http://www.fda.gov/
http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm
http://www.fda.gov/Food/GuidanceRegulation/FSMA/
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-
modernization-act-fsma
https://www.fda.gov/food/newsevents/constituentupdates/ucm563215.htm
https://www.access.fda.gov/

Foodborne Illness
https://globalfoodsafetyresource.com/foodborne-illness/

Food Fraud
https://globalfoodsafetyresource.com/food-fraud/

Food Safety Training

https://safefoodtraininghub.com

Food Safety Standards

https://globalfoodsafetyresource.com/food-safety-standards/

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 31

Foreign Body Contaminants
https://globalfoodsafetyresource.com/preventing-foreign-body-contaminants-from-entering-the-food-
supply-chain/

Foreign Supplier Verification Program

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm
https://globalfoodsafetyresource.com/foreign-supplier-verification-programs-fsvp-for-importers/

FSMA Food Safety Technical Assistance Network

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm

Hazards
https://globalfoodsafetyresource.com/prevent-physical-hazards/

HACCP
https://globalfoodsafetyresource.com/haccp/

Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm
https://www.accessdata.fda.gov/scripts/fooddefensemitigationstrategies/

National Organic Program

https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program

Packaging
https://globalfoodsafetyresource.com/packaging-risk-based-systems/

Preventive Controls for Food for Animals Final Rule

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

Produce Rule
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm

Recalls
https://globalfoodsafetyresource.com/six-tips-avoiding-food-recalls/

Regulations
https://globalfoodsafetyresource.com/food-safety-regulations/

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 32

Salmonella
https://www.cdc.gov/salmonella/

Sanitary Transportation of Human and Animals Food Final Rule

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-
transportation-human-and-animal-food

Supply Chain
https://globalfoodsafetyresource.com/minimize-supply-chain-risk/
https://globalfoodsafetyresource.com/three-key-suggestions-for-building-a-safer-more-integrated-
supply-chain/
https://globalfoodsafetyresource.com/supply-chain-traceability/

Threat Assessment and Critical Control Points

https://www.food.gov.uk/sites/default/files/media/document/pas962017.pdf

Training
https://globalfoodsafetyresource.com/global-food-safety-training/
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm576097.htm

Voluntary Qualified Importer Program

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
ucm448728.htm

Voluntary Recall
https://globalfoodsafetyresource.com/voluntary-recall-food-business-ready/

Vulnerability Assessment and Critical Control Points

https://www.foodsafety.com.au/blog/haccp-vaccp-taccp-and-harpc-food-safety-plans-explained

© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC. 33

 As Managing Editor of Global Food Safety Resource® (GFSR),
Susan Crossman is responsible for directing the creation
of all editorial content on the Global Food Safety Resource®
and Safe-Food Training Hub™ platforms, and their
associated content channels.

If you would like to put Susan and her team

to work on behalf of your content creation project,
please visit her website at www.foodsafetycontent.com
or connect with her directly at scrossman@gfsr.ca

This document is a collaborative venture between Crossman Communications

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© 2019 GLOBAL FOOD SAFETY RESOURCE CENTRE INC.

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