FSMA Requirements For Exporting Food to the United States

FSMA Requirements For
Exporting Food to the United States
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Dr Dima Faour-Klingbeil
Webinar 18.01.2023

DFK for Safe Food Environment
Consultancy. Auditing. Training
BRC food standards | HACCP | FSMA & EU regulatory compliance

"Just ship it."
WHAT PROMPTED THE
LEGISLATION ?

Enacted by the Congress and signed into law in 2011
President Obama signs FSMA into law.

Preventive controls
• For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the
food supply to prevent or significantly minimize the likelihood of problems occurring
Inspection and compliance
• FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection
approaches
Imported food safety
• FDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example,
for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to
ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are
complying with U.S. food safety standards
Response
• For the first time, FDA has mandatory recall authority for all food products, expanded administrative detention of
products that are potentially in violation of the law, and suspension of a food facility’s registration.
Enhanced partnerships
• Strengthening existing collaboration among all food safety agencies to achieve public health goals
Key Areas of FSMA

Dima Faour-Klingbeil, Ph.D.
Expert Food Safety and regulatory systems

Standards for
the Growing,
Harvesting,
Packing, and
Holding of
Produce for
Human
Consumption
cGMP, Hazard
Analysis, and
Risk-Based
Preventive
Controls for
Animal Food
Accreditation
of Third-Party
Certification
Bodies to
Conduct Food
Safety Audits
and to Issue
Certifications
Foreign
Supplier
Verification
Programs for
Importers of
Food for
Humans and
Animals
cGMP, Hazard
Analysis, and
Risk-Based
Preventive
Controls for
Human Food
Sanitary
Transportation
of Human and
Animal Food
Mitigation
Strategies to
Protect Food
Against
Intentional
Adulteration
FSMA RULES: WHAT APPLIES TO YOUR FOOD FACILITY ?

FOREIGN SUPPLIER VERIFICATION PROGRAM
Ø Private residences of individuals
Ø Non-bottled water drinking water collection and distribution
establishments and structures, such as municipal water
systems.
Ø Transport vehicles that hold food only in the usual course of
their business as carriers.
Ø Primary production farm
Ø Secondary activities farm–Restaurants Retail food
establishments, Non-profit food facilities
Ø Fishing vessels that do not process fish
Ø Facilities regulated exclusively and throughout the entire
facility by the U.S. Department of Agriculture under one of its
inspection acts
FSVP defines the obligations of the importers to control and verify the ability of
their non-US based suppliers:
Determine known or reasonably foreseeable hazards with each food, exported by
the foreign facility
Evaluate the risk posed by a food, based on the hazard analysis and the
performance of a foreign supplier”
Food imported into the United States must meet the same laws and regulations as
food produced in the United States.

Food
importers
Food
manufacturers
and suppliers
(Preventive Controls
rule, other applicable
reg.)
(FSVP)
FOOD SAFETY MOERNISATION ACT:
AN AMENDMENT OF THE FOOD, DRUG AND COSMETIC ACT

WHAT DOES THE FDA EXPECT FROM FOOD
FACILITIES EXPORTING TO THE US MARKET?

Ø Registration information and assurance for the FDA inspection
Ø Renewal of registrations biennially (every two years) beginning
October 1 – Dec 31
Owner, agent or operator in charge of either a domestic or foreign facility
engaged in manufacturing/processing/, packing, or holding food for human
and animal consumption in the US must register with the FDA, unless
exempted.
Registration via FURLS Food Facility Registration Module (FFRM) at
https://www.access.fda.gov
Food facilities must register with the FDA
1|

FORM FDA
3537
ØFacility name, address, phone number, and emergency contact phone number;
ØPreferred mailing address, if different from that of the facility;
ØParent company name, address, and phone
ØAll trade names the facility uses;
ØName, address, and phone number of the owner, operator, or agent in charge;
Email address of the owner, operator, or agent in charge, unless FDA has
granted a waiver under 21 CFR 1.245;
ØApplicable food product categories and the type(s) of activity at the facility for
each food product category ( 21 CFR 1.232(a)(8));
ØAn assurance that FDA will be permitted to inspect the facility at the times and
in the manner permitted by the FD&C Act;
ØAttestation that the information submitted is true and accurate.
ØIf the individual submitting the form is not the owner, operator, or agent in
charge of the facility, the registration must also include a statement in which
the individual certifies that the information submitted is true and accurate,
certifies that he/she is authorized to submit the registration, and identifies by
name, address, and telephone number, the individual who authorized
submission of the registration. In addition, the registration must identify the
individual who authorized submission of the registration by email address,
unless FDA has granted a waiver under 21 CFR 1.245.

U.S. AGENT
Communication link
(Emergency, routine)
Importer verifies the
Food Safety Programs
WHAT IS REQUIRED FROM FOOD FACILITIES TO EXPORT FOODS TO THE US
MARKET?
FSVP
2| Registered Facilities must have a US AGENT

PREVENTION STANDARDS MADATES:
Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventive Controls for Human Food rule
(CFR 21 Part 117)
3|
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 as well as the
modernized Current Good Manufacturing Practices (CGMPs) of this
rule (unless an exemption applies).

EXEMPTIONS TO PREVENTIVE CONTROLS RULE
• FDA regulated sea food products HACCP (CFR 21 Part 123)
• FDA regulated fresh juice products HACCP (CFR 21 Part 120)
• FDA regulated low acid canned food regulations (CFR 21 Part 113,microbial hazards)
• USDA regulated food
• Dietary supplement
• Alcoholic beverages
• Facilities engaged in storage of packaged food not exposed to the environment
• Modified rule for storage of enclosed products that require refrigeration
• Farms or activities that fall within the definition of farms
• Low risk foods by small and very small farm-mixed types facilities

Registered Facilities must have a FOOD SAFETY PLAN*
A major requirement of the Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food rule
(CFR 21 Part 117)
4|
*for facilities covered by FDA Preventive Controls Regulation (Part 117)

Registered Facilities must have Preventive Control
Qualified Individual (117.180) (CFR 21 PART 117)
5|
PCQI is “a qualified individual who has
successfully completed training in the development
and application of risk-based preventive controls at
least equivalent to that received under a
standardized curriculum recognized as adequate
by FDA or is otherwise qualified through job
experience to develop and apply a food safety
system.”

Registered Facilities must have Preventive Control
Qualified Individual (117.180) (CFR 21 PART 117)
1. Preparation of the Food Safety Plan
2. Validation of the process preventive controls
3. Determine if validation is not required
4. Verification – review of records
5. Reanalysis of the Food Safety Plan
A PCQI must do or oversee the following
activities:
5|

Registered Facilities must have a FOOD SAFETY PLAN*
Source: FSPCA PCQI course

COMMON MISTAKE COMPANIES MAKE:
ASSUMING GFSI CERTIFICATION EQUATES PCHF
FSMA FOOD
SAFETY PLAN

ü Successful completion of the PCQI
training course is one way to meet
the FDA requirements
ü To comply with FSMA you need to
have established a risk-based food
safety management system.
ü This system should be verified by
your US based partner

Other regulations
• Food Additive regulation
• Compliance of Components of a Food Contact Article
1. General Indirect Food Additives (21 CFR 174)
2. Adhesives and Components of Coatings (21 CFR 175)
3. Paper and Paperboard Components (21 CFR 176)
4. Polymers (21 CFR 177)
5. Adjuvants, Production Aids, and Sanitizers (21 CFR 178)
6. Irradiation in the Production, Processing and Handling of Food (21 CFR 179)
• Food labeling
• Standards of identity, and others as applicable.
1/22/23

PRIOR NOTICE
Submission of prior notice through the U.S. Customs and Border
Protection (CBP) Automated Broker Interface of the Automated
Commercial System (ABI/ACS) or FDA Prior Notice System
Interface (PNSI)
Several tools, such as tutorials, instructions, and question-and-
answer documents, to help importers and other affected
persons submit prior notice either through ABI/ACS or PNSI.

PRIOR NOTICE
8 hours for food arriving by water
4 hours for food arriving by air or land/rail
2 hours for food arriving by land/road

FOOD TRACEABILTY RULE
The FDA final rule on Requirements for Additional Traceability
Records for Certain Foods (Food Traceability Final Rule) included
on the Food Traceability List (FTL).
ØCovers the entire food supply chain
Ø Includes both foreign and domestic
entities
ØFull and partial exemptions may apply
ØThe additional recordkeeping requirements apply to the foods
specifically listed on the FTL, and to foods that contain listed
foods as ingredients, provided that the listed food that is used
as an ingredient remains in the same form (e.g., fresh) in
which it appears on the list.

Key Data Elements (KDEs) associated with specific Critical
Tracking Events (CTEs)
Key Data Elements Required
records would need to contain
specific Key Data Elements
(KDEs). The KDEs would depend
on the CTE being performed.
Harvesting, Cooling, Initial
Packing, First Land-based
Receiving, Shipping, Receiving,
and Transforming are Critical
Tracking Events (CTEs) for which
records would be
required
ü The KDEs required would vary depending on the CTE that is being performed.
ü The records required at each CTE would need to contain and link the KDEs to
the traceability lot

• The Food Traceability Rule requires persons who manufacture, process, pack, or hold foods on the
Food Traceability List (FTL) to maintain and provide to their supply chain partners with key data
elements (KDEs) for certain critical tracking events (CTEs) in the food’s supply chain.
• The information that firms must keep and send forward under the rule varies depending on the type
of supply chain activities they perform with respect to an FTL food, from harvesting or production of
the food through processing, distribution, and receipt at retail or other point of service.
• Central to the proposed requirements is the assignment, recording, and sharing of traceability lot
codes (TLCs) for FTL foods, as well as linking these TLCs to other information identifying the foods as
they move through the supply chain.
• Once a food has been assigned a TLC, the records required at each Critical Tracking Event (CTE) must
include that TLC. All of the Key Data Elements (KDEs), including the TLC, must be linked to the
relevant traceability lot.

Exemptions to the Food Traceability Rule

Traceability Plan (§ 1.1315)
If you are subject to the requirements of the final rule, you must establish and
maintain a traceability plan containing the following information:
ØA description of the procedures you use to maintain the records you are required to
keep under this rule, including the format and location of these records.
ØA description of the procedures you use to identify foods on the Food Traceability
List that you manufacture, process, pack, or hold;
ØA description of how you assign traceability lot codes to foods on the Food
Traceability List, if applicable;
ØA statement identifying a point of contact for questions regarding your traceability
plan and records;

https://www.fda.gov/food/workshops-meetings-webinars-
food-and-dietary-supplements/webinar-food-traceability-final-
rule-12072022

1
Food Safety Plan and
HACCP development
and reviews
HOW CAN DFK
FOR SAFE FOOD
ENVIRONMENT
HELP? 2 Product labels
compliance - EU and
FSMA
3 Gap Analysis and
System verification
5 Official and
Customized Training in
Various Areas of Food
Safety
4 Suppliers Audits

FSMA Requirements For Exporting Food to the United States

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FSMA Requirements For Exporting Food to the United States