Food Safety

Modernization Act
(FSMA)
By: ANGEL MAY S. CATALAN
Food Safety Act 2013 (Republic Act
No. 10611). An Act to strengthen the
Food Safety Regulatory System in the
Country to Protect Consumer Health
and Facilitate Market Access of local
foods and food products, and for other
purposes.
THE IMPLEMENTING RULES AND
REGULATIONS OF REPUBLIC ACT
NO. 10611, “AN ACT TO STRENGTHEN
THE FOOD SAFETY REGULATORY
SYSTEM IN THE COUNTRY TO
PROTECT CONSUMER HEALTH AND
FACILITATE MARKET ACCESS OF
LOCAL FOODS AND FOOD
PRODUCTS, AND FOR OTHER
PURPOSES” OTHERWISE KNOWN AS
THE “FOOD SAFETY ACT OF 2013.”
The Food Safety Modernization Act,
passed in the United States in 2011, was
a major reform of previous US food
safety laws. It involved a shift in focus
from responding to food contamination
events to prevention-based controls for
food manufacture, harvesting,
processing, packing, and storage.
The RA 10611 “An Act to Strengthen the
Food Safety Regulatory System in the
Country to Protect Consumer Health
and Facilitate Market Access of Local
Foods and Food Products and for Other
Purposes” otherwise known as the “Food
Safety Act of 2013”, specifies the detailed
mandates of FDC.
The FDA Food Safety Modernization Act (F
SMA)
is transforming the nation’s food safety system by
shifting the focus from responding to foodborne
illness to preventing it.
Congress enacted FSMA in response to dramatic
changes in the global food system and in our
understanding of foodborne illness and its
consequences, including the realization that
preventable foodborne illness is both a significant
public health problem and a threat to the economic
well-being of the food system.
 FDA has finalized several rules to
implement FSMA, recognizing that
ensuring the safety of the food supply is a
shared responsibility among many different
points in the global supply chain for both
human and animal food. The FSMA rules
are designed to make clear specific actions
that must be taken at each of these points to
prevent contamination.
PRODUCE SAFETY

The Produce Safety rule establishes, for the first

time, science-based minimum standards for the
safe growing, harvesting, packing, and holding
of fruits and vegetables grown for human
consumption. The rule is part of the agency’s
ongoing efforts to implement the FDA Food
Safety Modernization Act. The final rule went
into effect January 26, 2016.
Agricultural Water Assessment

The proposed rule, if finalized, would replace

the pre-harvest microbial quality criteria and
testing requirements in the Produce Safety
Rule for covered produce (other than sprouts)
with requirements for systems-based pre-
harvest agricultural water assessments to be
used for hazard identification and risk
management decision-making
 Under the proposed requirements, covered farms
would be required to conduct pre-harvest
agricultural water assessments once annually, and
whenever a change occurs that increases the
likelihood that a known or reasonably foreseeable
hazard will be introduced into or onto produce or
food contact surfaces. As part of their pre-harvest
agricultural water assessments, these farms would
be required to evaluate certain factors (listed
below) that could impact produce safety.
 FSMA Final Rule on Accredited Third-
Party Certification
The FDA Food Safety Modernization Act (FSMA)
rule on Accredited Third-Party Certification was
finalized in November 2015. The rule establishes a
voluntary program for the accreditation of third-
party certification bodies, also known as third-party
auditors, to conduct food safety audits and issue
certifications of foreign entities and the foods for
humans and animals they produce.
FSMA specifies two uses for certifications under
this program:
Certifications may be used by importers to
help establish eligibility for participation in the
Voluntary Qualified Importer Program (VQIP),
which offers expedited review entry of food.
To prevent potentially harmful food from
reaching U.S. consumers, the FDA can also require
in specific circumstances that a food offered for
import be accompanied by a certification from an
accredited third-party certification body.
 Key Features
Scope
This rule establishes the framework, procedures and requirements for
accreditation bodies seeking recognition by the FDA, as well as
requirements for third-party certification bodies seeking
accreditation.
These requirements cover legal authority, competency, capacity,
conflict-of-interest safeguards, quality assurance and record
procedures.
In limited circumstances, the FDA may directly accredit third-
party certification bodies. For example, FDA can directly accredit
third-party certification bodies if the agency does not identify and
recognize an accreditation body to meet the requirements of the
program within two years after establishing the program.
Requirements for Recognized Accreditation Bodies
An accreditation body recognized by FDA under this program could be a
foreign government/agency or a private third party. The final rule
requires recognized accreditation bodies to:
Assess third-party certification bodies for accreditation, including
observing a representative sample of the prospective certification
body’s work
Monitor performance of the third-party certification bodies it
accredits, including periodically conducting on-site observations,
and notifying the FDA of any change in, or withdrawal of,
accreditations it has granted
Assess and correct any problems in their own performance
Submit monitoring and self-assessment reports and other
notifications to the FDA
Maintain and provide the FDA access to records required to be kept
under the program
Requirements for Third-Party Certification Bodies
Third-party certification bodies accredited under this program
are required to perform unannounced facility audits and to
notify the FDA upon discovering a condition that could cause
or contribute to a serious risk to the public health. The final
rule requires these accredited third-party certification bodies
to:
Ensure their audit agents are competent and objective
Verify the effectiveness of corrective actions to address
identified deficiencies in audited entities
Assess and correct any problems in their own performance
Maintain and provide the FDA access to records required
to be kept under the program
Related FDA Actions
In November 2016, the FDA published a final guidance
for industry explaining how the Voluntary Qualified
Importer Program (VQIP) will work. In order to
participate in VQIP, importers must import food from
certified facilities. Importers with a robust system of
supply-chain management may qualify for expedited
review and entry for foods they seek to import.
Consumer protections are strengthened by enabling the
FDA to focus its resources on food imports that are more
likely to present a potential risk to public health.
FSMA Final Rule on Requirements for Additional
Traceability Records for Certain Foods

The FDA final rule on Requirements for Additional Traceability

Records for Certain Foods (Food Traceability Final Rule)
establishes traceability recordkeeping requirements, beyond those in
existing regulations, for persons who manufacture, process, pack, or
hold foods included on the Food Traceability List (FTL). The final
rule is a key component of FDA’s New Era of Smarter Food Safety
Blueprint and implements Section 204(d) of the FDA Food Safety
Modernization Act (FSMA). The new requirements identified in the
final rule will allow for faster identification and rapid removal of
potentially contaminated food from the market, resulting in fewer
foodborne illnesses and/or deaths.
FSMA Final Rule on Foreign Supplier Verification
Programs (FSVP) for Importers of Food for
Humans and Animals
The food is produced in a manner that provides the same level of
public health protection as section 418 (concerning hazard analysis
and risk-based preventive controls) or 419 (concerning standards for
the safe production and harvesting of certain fruits and vegetables
that are raw agricultural commodities (RACs) of the FD&C Act (
21 U.S.C. 350g and 350h), if applicable;
The food is not adulterated under section 402 of the FD&C Act (
21 U.S.C. 342); and
The human food is not misbranded under section 403(w) of the
FD&C Act (21 U.S.C. 343(w)) (concerning food allergen labeling).
 FSMA Final Rule for Mitigation Strategies to
Protect Food Against Intentional Adulteration
The FDA Food Safety Modernization Act (FSMA) final
rule is aimed at preventing intentional adulteration from
acts intended to cause wide-scale harm to public health,
including acts of terrorism targeting the food supply. Such
acts, while not likely to occur, could cause illness, death,
economic disruption of the food supply absent mitigation
strategies.

Rather than targeting specific foods or hazards, this rule

requires mitigation (risk-reducing) strategies for processes in
certain registered food facilities.
 Laboratory Accreditation for Analyses of
Foods (LAAF) Program & Final Rule
The Laboratory Accreditation for Analyses of Foods (LAAF) Program
establishes a laboratory accreditation program for the testing of food
in certain circumstances. Under the LAAF program, FDA will
recognize “accreditation bodies” that will have the responsibility of
accrediting “LAAF-accredited laboratories” to the standards
established by the rule. In certain circumstances, owners and
consignees will be required to use a LAAF-accredited laboratory for
food testing.
The establishment of the LAAF program is intended to improve the
accuracy and reliability of certain food testing through the uniformity
of standards and enhanced FDA oversight of participating
laboratories.
 FSMA Final Rule for Preventive Controls for
Human Food
Generally, domestic and foreign food facilities that are
required to register with section 415 of the Food, Drug, &
Cosmetic Act must comply with the requirements for
risk-based preventive controls mandated by the FDA
Food Safety Modernization Act (FSMA) as well as the
modernized Current Good Manufacturing Practices
(CGMPs) of this rule (unless an exemption applies). It is
important to note that applicability of the CGMPs is not
dependent upon whether a facility is required to register.
 FSMA Final Rule for Preventive Controls
for Animal Food
The second major compliance dates for the FDA Food Safety
Modernization Act (FSMA) Preventive Controls for Animal
Food rule arrived in September 2017.
The final rule was published in September 2015 and larger
animal food facilities were required to comply with the
Current Good Manufacturing Practice (CGMP) requirements
by September 2016.
Now larger animal food facilities have been required to
comply with the preventive controls requirements since
September 18, 2017, and facilities that are small businesses
were required to implement the CGMPs by that date.
 FSMA Final Rule on Sanitary
Transportation of Human and Animal Food

The FDA Food Safety Modernization Act (FSMA)

rule on Sanitary Transportation of Human and Animal
Food is now final, advancing FDA’s efforts to protect
foods from farm to table by keeping them safe from
contamination during transportation. The earliest
compliance dates for some firms begin one year after
publication of the final rule in the Federal Register.
 This rule is one of seven foundational rules proposed since
January 2013 to create a modern, risk-based framework for
food safety. The goal of this rule is to prevent practices during
transportation that create food safety risks, such as failure to
properly refrigerate food, inadequate cleaning of vehicles
between loads, and failure to properly protect food.
The rule builds on safeguards envisioned in the 2005 Sanitary
Food Transportation Act (SFTA). Because of illness outbreaks
resulting from human and animal food contaminated during
transportation, and incidents and reports of unsanitary
transportation practices, there have long been concerns about
the need for regulations to ensure that foods are being
transported in a safe manner.
 Accredited Third-Party Certification
Program
Accredited Third-Party Certification is a voluntary
program in which FDA recognizes “accreditation
bodies” that will have the responsibility of accrediting
third-party “certification bodies.” The certification
bodies will conduct food safety audits and issue
certifications of foreign food facilities.
These certifications are used for two purposes.
Certifications can establish eligibility for participation
in the Voluntary Qualified Importer Program (VQIP), which
offers expedited review and entry of food.
In rare and specific circumstances FDA can require
that an imported product be certified to prevent a potentially
harmful food from entering the U.S.

The Agency’s imported food goal is twofold:

To address potential safety issues before the food reaches the
United States; and
To help ensure that imported foods are produced in
accordance with the same safety standards as those required of
U.S. foods.
Accreditation bodies under the Accredited Third-Party
Certification Program must:
Assess third-party certification bodies to determine if
they can be accredited. This includes observing a
representative sample of the applicant’s work;
Monitor the performance of the certification bodies it
accredits. Accreditation bodies must notify FDA of any
change in, or withdrawal of, accreditations it has granted;
Assess and correct any problem n the accreditation
body’s own performance; Submit monitoring and
self-assessment reports and other notifications to FDA;
Maintain and provide FDA with access to the records that the
program requires.
 Foreign Suppliers Verification Programs (FSVP) -
List of Participants
In accordance with section 805(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 384a(g)), we are publishing a list on our website of importers subject
to the Foreign Supplier Verification Programs for Food Importers (FSVP)
regulation (21 CFR part 1 subpart L, sections 1.500 – 1.514). The list includes
information provided to us at entry regarding the importers’ names and location
by state. The list will be updated on a quarterly basis. Please note that the
entities identified as FSVP importers may not be the same entities that serve as
the “importers of record” for purposes of U.S. Customs and Border Protection
requirements. Inclusion on this list does not in any way convey FDA’s approval
or endorsement of the listed importers. If you would like more information
regarding entries for which you were declared as the FSVP importer, you can
submit a Freedom of Information Act Request to request the publicly releasable
data points for those entries for a related timeframe.
 Foreign Suppliers Verification Programs (FSVP) -
Importer Portal for Records Submission

The FSMA Final Rule on FSVP requires importers to perform risk-based

foreign supplier verification activities to verify that:
The food is produced in a manner that provides the same level of public
health protection as section 418 (concerning hazard analysis and risk-based
preventive controls) or 419 (concerning standards for the safe production and
harvesting of certain fruits and vegetables that are raw agricultural
commodities (RACs) of the FD&C Act (21 U.S.C. 350g and 350h), if
applicable;
The food is not adulterated under section 402 of the FD&C Act (
21 U.S.C. 342); and
The human food is not misbranded under section 403(w) of the FD&C Act (
21 U.S.C. 343(w)) (concerning food allergen labeling).
 Background on the FDA Food Safety
Modernization Act (FSMA)

About 48 million people (1 in 6 Americans) get sick,

128,000 are hospitalized, and 3,000 die each year from
foodborne diseases, according to recent data from the
Centers for Disease Control and Prevention. This is a
significant public health burden that is largely
preventable.
The FDA Food Safety Modernization Act (FSMA),
signed into law by President Obama on Jan. 4, enables
FDA to better protect public health by strengthening the
food safety system.
Mandatory produce safety standards: FDA must
establish science-based, minimum standards for the
safe production and harvesting of fruits and
vegetables. Those standards must consider naturally
occurring hazards, as well as those that may be
introduced either unintentionally or intentionally,
and must address soil amendments (materials added
to the soil such as compost), hygiene, packaging,
temperature controls, animals in the growing area
and water
Authority to prevent intentional
contamination :FDA
must issue regulations to protect against the
intentional adulteration of food, including
the establishment of science-based
mitigation strategies to prepare and protect
the food supply chain at specific vulnerable
points. (Final rule due 18 months following
enactment)
Inspection and Compliance
The FSMA recognizes that preventive control
standards improve food safety only to the extent
that producers and processors comply with them.
Therefore, it will be necessary for FDA to provide
oversight, ensure compliance with requirements
and respond effectively when problems emerge.
FSMA provides FDA with important new tools
for inspection and compliance, including:
Mandated inspection frequency: The FSMA
establishes a mandated inspection frequency, based
on risk, for food facilities and requires the
frequency of inspection to increase immediately. All
high-risk domestic facilities must be inspected
within five years of enactment and no less than
every three years thereafter. Within one year of
enactment, the law directs FDA to inspect at least
600 foreign facilities and double those inspections
every year for the next five years.
•Records access: FDA will have access to
records, including industry food safety plans and
the records firms will be required to keep
documenting implementation of their plans.
•Testing by accredited laboratories: The
FSMA requires certain food testing to be carried
out by accredited laboratories and directs FDA to
establish a program for laboratory accreditation
to ensure that U.S. food testing laboratories
meet high- quality standards. (Establishment of
accreditation program due 2 years after
enactment)