Compliance Strategies for Mexican Manufacturers and Distributors
By: Benjamin L. England, Esq.
Founder & CEO, FDAImports.com
© 2012 FDAImports.com, LLC
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Basics of the FSMA
Food Industry Generally
Importers and Imported Food
Other FSMA Information
FSMA Hidden Challenges
Fees and Costs
Conclusions
Questions & Workshop Time
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Enacted: January 4, 2011
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Applicability
 Specifically affects “food”
 Beverages, dietary supplements, fresh produce, alcoholic
beverages, seafood, dry goods, finished and ingredients
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Did not include funding – U.S. has not passed a federal
budget for three years
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U.S. Congress is more likely to fund eventually
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Hazard Analysis & Risk Preventive Controls
Standards for Produce Safety
Facility Inspections
Mandatory Recall Authority
Facility Registrations
Record Inspection & Maintenance
Import/Foreign Industry Provisions
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Similar to FDA’s Seafood HACCP regulations
Requirements:
• Conduct hazard analysis, develop and implement
preventive controls, and monitor the control’s
effectiveness
• Develop a written plan for controlling hazards
• Reanalyze for potential hazards at least every three years
• Verify the effectiveness of the controls
• Maintain records of the verification process
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Facilities Exempt from HARPC Requirement:
• Facilities subject to Standards of Produce Safety
• Facilities subject to the HACCP requirement and lowacid canned food standards
• Facilities subject to dietary supplement cGMPs
Most facilities will not be exempt from HARPC
FSMA required FDA to propose regulations by July 4, 2012
(unless small or very small business) Missed Deadline!
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FDA to work with USDA to establish standards for
safely producing and harvesting raw agricultural
products
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Prioritize for agricultural commodities that have been
associated with food borne illnesses in the past
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Exemptions:
• Facilities subject to HARPC requirements
• Directly from farm to –
 Consumers, or
 Restaurant or retail food establishments (in the same state or
within 275 miles)
Extra time to comply allotted to:
• Small businesses (given 1 extra year)
• Very small businesses (given 2 extra years)
FSMA required FDA to propose regulations by January 4, 2012
Missed Deadline!
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Domestic Food Facilities
• High Risk Facilities: Once by January 2016
(then every three years)
• Non-High Risk Facilities: Once by January 2018
(then every five years)
Foreign Food Facilities
• 600 inspections by January 4, 2012
• 19,200 inspections by January 4, 2017
• FDA can consider requiring records be submitted for
review instead of an inspection
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FDA Burden
• Reasonable probability the food is adulterated or
misbranded by failing to disclose major food allergens
• Reasonable probability the food will cause serious
adverse health consequences or death
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Process
1. FDA provides responsible party opportunity to cease
distribution and recall food
2. FDA requires immediate stop on food’s distribution
3. Following an informal hearing, FDA may recall the food
or vacate and cease distribution
Responsible party pays for all FDA recall activity
expenses
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Biennial registration requirements: Now every 2 years
instead of “once for all time” (Must re-register by Dec. 31)
Additional information required with registration: New
Mandatory Food Categories
FDA Authority
• To revoke registration
• Require declaration of more information in registration
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FSMA requires new food categories in facility registration
(38 + new categories)
Previous mandatory/optional category declarations no
longer apply
Getting this wrong could lead to invalid registration,
suspension of facility
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Two ways for FDA to require Records production:
• Adulterated food
• Use of or exposure to food
Both routes allow FDA greater access to records
• Access to the food “and any other…[food] affected in a
similar manner”
• Very broad authority to demand/obtain records
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FDA has authority to require additional record keeping
for “High-Risk Foods” (more than just records relating to
receipt or delivery of food)
• FSMA required FDA to designate “high-risk foods” by
January 4, 2012 Missed Deadline!
• FSMA requires FDA to propose regulations by January
4, 2013
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Foreign Supplier Verification Program
Qualified Importer Program
Inspection/Examination Fees
Other Information
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Every importer must establish a plan that verifies:
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That the foreign supplier complies with HARPC or Standards for
Produce Safety
That the food is not adulterated or misbranded by failing to disclose
major food allergens
Importer must maintain records for no less than 2 years
Noncompliance is grounds for refusal of an imported article
(Beginning Jan 4, 2013 – or when regulations issued)
Grounds for criminal enforcement
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Exemptions:
Facilities required to comply, and are in compliance, with
 Seafood HACCP requirements
 Juice HACCP requirements or
 Low-acid food package standards
FSMA requires FDA to propose regulations by January
4, 2013
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FDA must establish voluntary program in order to
expedite importation of safe and secure food.
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Eligibility is determined by overall safety of food
offered for import by the specific importer.
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Importers must obtain certification by third-party
auditors (designated by FDA)
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FDA to review importers eligibility no less than once
every three years.
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FSMA required FDA to propose regulations by
January 4, 2012 Missed Deadline!
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Importation Certificates
• Grants FDA authority to require certification for certain
foods based on risks associated with either
 The food or
 The country of origin of the food
Prior Notice
• Prior to importation, importers must notify FDA if any
country has refused admission of the food
• Effective Date: July 3, 2011
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Be ready for HARPC requirements
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Watch how FDA talks about “High-Risk” foods
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Be ready for inspections… Even if they never come
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Re-register your facility NOW (Once the FDA website
lets you)
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Convert your records to something FDA can
read/understand
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FSMA provisions that appear as if they are not
important (and most people are not talking about
them)
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The FSMA language is vague and imprecise
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FSMA provisions that are ignored in the overall
context of FDCA, the law that is being amended
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FSMA
Federal Food, Drug,
and Cosmetic Act
(FD&C Act)
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When viewed in
context, just 1
set of rules
Refusal Authority
If it “appears” from the examination of samples “or otherwise”
that:
(1) Article manufactured, processed, packed under insanitary
conditions
(2) Article forbidden or restricted in sale in the country in
which it was produced or from which it was exported
(3) Article adulterated, misbranded or unapproved
(4) Article is a High Risk food subject to record keeping (and
doesn’t comply)
(5) Article is a food subject to certification (doesn’t comply)
(6) Article is a supplement subject to adverse event reports
(and doesn’t comply)
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FDA Refusal Authorities (Cont.)
Refusal Authority
If it “appears” from the examination of samples “or otherwise”
that:
• Any of the previously enumerated conditions exist…
Then such article shall be refused admission
Refused goods shall be destroyed unless exported
Plus:
- No Prior Notice – Refusal (can be cured)
- No Registration – Refusal (can be cured)
- Importer is debarred person (can be cured)
- Foreign facility unreasonably denies/delays inspection
- Importer in violation of FSVP (eff. 01/04/2013)
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What FSMA Says:
“In the interest of national security…The Secretary shall—
(A) conduct a vulnerability assessment of the food system, including by
consideration of the Department of Homeland Security biological, chemical,
radiological, or other terrorism risk assessments;
(B) consider the best available understanding of uncertainties, risks, costs,
and benefits associated with guarding against intentional adulteration of food
at vulnerable points; and
(C) determine the types of science-based mitigation strategies or measures
that are necessary to protect against the intentional adulteration of food.”
– FDCA 420(a)(2) (21 USC 350i(a)(2)), others
What It Means:
This will have significant impact on much of the food trade
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FDA to work with DHS (and consult with USDA) to issue
regulations to “protect against intentional adulteration of food”
• Specify mitigation strategies you must implement
• How to assess required mitigation strategies
• Only applies to food with a high risk that intentional
adulteration would result in serious adverse health
consequences or death
Time Frames
FSMA required FDA to propose Guidance by Jan 4, 2012 and
Regulations by July 4, 2012 Missed Deadlines!
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What it says:
”…each importer shall perform risk-based “foreign supplier” verification
activities for the purpose of verifying that the food imported by the
importer or agent of an importer is—
(A) produced in compliance with the requirements [HARPC] of
section 418 or section 419 [Standards for Produce Safety], as
appropriate; and
(B) is not adulterated under section 402 or misbranded under
section 403(w)[allergen labeling].” - FDCA 805(a)(1) (21 USC 384a(a)(1))
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FSMA does not define a “foreign supplier”
• Exporter?
• Manufacturer?
• Foreign warehouse/shipper?
• Everyone/Anyone in the supply chain?
Time Frames
FSMA required FDA to propose Guidance by Jan. 4, 2012
and Regulations by Jan 4, 2012 Missed Deadlines!
Takes effect Jan. 4, 2013 (regardless if FDA issues
regulations or not)
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What it says:
“…each importer shall perform risk-based foreign supplier
verification activities for the purpose of verifying that the food
imported by the importer or agent of an importer is—
‘‘(A) produced in compliance with the requirements of section 418
[HARPC] or section 419 [Standards for Produce Safety], as appropriate;
and
‘‘(B) is not adulterated under section 402 or misbranded under section
403(w).” - FDCA 805(a)(1) (21 USC 384a(a)(1))
What it means:
FSMA assumes (incorrectly) that international trade in food is
“bilateral” and that the U.S. Importer has a direct relationship with
foreign processors.
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Impact:
• Putting the burden on importer
• Exporting the U.S. Safety System
• FDA delays in implementation for so long that eventually
suppliers look for and find other markets
Time Frames
FSMA required FDA to propose Guidance by Jan. 4, 2012 and
Regulations by Jan 4, 2012 Missed Deadlines!
Takes effect Jan. 4, 2013 (regardless if FDA issues regulations
or not)
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What it says:
‘‘The owner, operator, or agent in charge of a facility shall (1) identify
and evaluate known or reasonably foreseeable hazards that may be
associated with the facility, including (A) [bio][chem][phys][radiol]
hazards, natural toxins, pesticides, drug residues, decomposition,
parasites, allergens, and unapproved or color additives; and (B)
hazards that occur naturally , or may be unintentionally introduced ;
and
(2) Identify and evaluate hazards that may be intentionally
introduced, including by acts of terrorism; and
(3) Develop a written analysis of the hazards
• Develop PREVENTIVE CONTROLS
- new FDCA 418(b)&(c) (21 USC 350g(b)&(c))
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This Language is REPLICATED in 419 (Standards for
Produce Safety)
What it means:
Among others, notice there is no limiting language on the
intentional adulteration language like there is in the
bioterrorism language FDA must coordinate with DHS
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Impact
• Like food GMPs and HACCP, FDA will write general regulations.
Problem will be deciding what are the hazards.
• HARPC includes unintentional and intentional adulteration
hazards – and FDA knows even less about intentional adulteration
risks
Time Frames
• FSMA required FDA to propose regulations by July 4, 2012
Missed Deadline!
How you should prepare:
• C-TPAT – get involved
• Review current FDA guidances regarding mitigating intentional
contamination risks
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Political Realities: Most likely nothing until after the election
• Will the regulations be overdone or underdone?
How to plan
• Investigate current guidances and programs you can get
involved with
• HARPC is probably drafted similarly to how the regulation
would be drafted
• Intentional Adulteration Language – C-TPAT and similar
programs can help with this requirement
• Be prepared for importer to start asking you for more
information to prove compliance with HARPC and Fresh
Produce Standards
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• FDA has new authority to charge fees to importers if the
agency must reinspect previously inspected, imported food
• FDA’s first attempt: Covered activities things that could not be
considered inspections or examinations
• Automatically detained shipments
• Commercial document and private laboratory reviews
• Submissions of Import Alert Petitions
• FY 2013 update – FDA “shelved” its proposal; recently met with
industry representatives about how to implement this
• The burden on small businesses, majority of importers and
foreign suppliers
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• FDA has new authority to charge fees to foreign or
domestic facilities if the agency must reinspect within 12
months
• Statute enables FDA to send bill for Reinspection Fees
due from foreign facilities or the U.S. Agent!!
• Fees that are due treated like a claim of the Government
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FDAImports.com, LLC ©2012
•
•
•
•
•
•
•
Basics of the FSMA
Food Industry Generally
Importers and Imported Food
Other FSMA Information
FSMA Hidden Challenges
Fees and Costs
Conclusions
FDAImports.com, LLC ©2012
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