October 14-16, 2014
by Peter Quinter, Esq.
Mobile (954) 270-1864
www.gray-robinson.com
Peter Quinter, Attorney
Customs & International Trade Law Group
GrayRobinson, P.A.
Mobile (954) 270-1864
Office (305) 416-6960
Peter.Quinter@gray-robinson.com
Skype: Peter.Quinter1
www.gray-robinson.com
Recognized as one of
the “Best Lawyers in
America” in the area
of FDA law for years:
 2010
 2011
 2012
 2013
 2014
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Do you have questions about importing/exporting?
http://www.grcustomslaw.com
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Questions??
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Agenda
 Colombia’s Exports to the U.S.
 U.S.-Colombia Free Trade Agreement
 Food Security
 FDA Import Process
 FDA Detention and Refusal Process
 Import Alerts
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Colombia’s Exports to the US
Colombia’s Top 10 Exports to the US- Rolling Year (March 2013 through February 2014)
Based on FOB US $ value
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Colombia’s Waterborne Exports
to Florida Ports
Colombian Exports to Florida Ports
1/1/2014-5/14/2014
Arrival Port
Bills of
Lading
Container
Quantity
Metric Tons
TEUS Quantity
Port Everglades,
FL
1899
1886
64679.47
3306.3
Miami, FL
1089
1284
26544.83
2204.62
342
621
449608.16
1106
Port Manatee, FL
5
7
124.16
14
West Palm Beach,
FL
2
1
47.47
1.5
Totals
3337
3800
541004.09
6632.42
Jacksonville, FL
Source: U.S. Customs and Border Protection (CBP)
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Federal Food, Drug and Cosmetic Act
 Imported products must fully comply with the
Federal Food, Drug and Cosmetic Act before
merchandise is released by U.S. Customs and
FDA.
 21 U.S.C. 301
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Top Food Product Refusals – February 2014
Industry
Number of Refusals
16 – Fishery/Seafood Prod
161
03 – Bakery Prod/Dough/Mix/Icing
113
02 – Whole Grain/Milled Grain Prod/Starch
103
24 – Vegetables/Vegetable Products
100
28 – Spices, Flavors and Salts
98
12 – Cheese/Cheese Prod
77
21 – Fruit/Fruit Product
74
1
Available at: http://www.accessdata.fda.gov/scripts/importrefusals/ir_byProduct.cfm?DYear=2013&DMonth=2
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Food Safety
• Modernization Act
– (FSMA)
• A. Relates to the intentional adulteration of food for:
– Manufacturers
– Processors
– Packers
• B. Applies to both domestic and foreign food facilities
that are required to register with the FDA.
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Food Security
Preventive measures operators of food establishments may
take to minimize the risk that food under their control will be
subject to tampering or other malicious, criminal, or terrorist
actions. It is relevant to all sectors of the food system,
including farms, aquaculture facilities, fishing vessels,
producers, transportation operations, processing facilities,
packing facilities, and warehouses.
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Food Defense Plan
•
Each facility covered by this rule would be required to prepare and implement a written food
defense plan, which would include the following:
–
Actionable process steps: Identify any actionable process steps, using one of two
procedures. The FDA analyzed data from vulnerability assessments conducted using the
CARVER+Shock methodology and identified four key activity types, as described above. The
FDA has determined that the presence of one or more of these key activity types at a
process step indicates a significant vulnerability to intentional adulteration aimed at largescale public harm. Facilities may identify actionable process steps using the FDA-identified
key activity types or conduct their own facility-specific vulnerability assessments.
–
Focused mitigation strategies: Identify and implement focused mitigation strategies at
each actionable process step to provide assurances that the significant vulnerability at each
step will be significantly minimized or prevented and that food manufactured, processed,
packed, or held by the facility will not be adulterated.
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Food Defense Plan Continued
•
Monitoring: Establish and implement procedures, including the frequency with which they are to
be performed, for monitoring the focused mitigation strategies.
•
Corrective actions: Using corrective actions if focused mitigation strategies are not properly
implemented.
•
Verification: Verification activities would ensure that monitoring is being conducted and
appropriate decisions about corrective actions are being made. It would also help ensure that the
focused mitigation strategies are consistently implemented and are effectively and significantly
minimizing or preventing any significant vulnerabilities. In addition, the rule includes requirements
for periodic reanalysis of the food defense plan every three years or under certain conditions.
•
Training: Personnel and supervisors assigned to the actionable process steps would be trained in
food defense awareness and in their responsibilities for implementing focused mitigation
strategies.
•
Recordkeeping: Establish and maintain certain records, including the written food defense plan;
records documenting monitoring, verification activities and corrective actions, and documentation
related to training of personnel.
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Adulterated
•
A food shall be deemed to be adulterated:
(1) if it bears or contains any poisonous or deleterious substance which
may render it
• Injurious to health; but in case the substance is not an added
substance such food shall not be considered adulterated under this
clause if it the quantity of such substance in such food does not
ordinarily render it injurious to health; or
(2) If it bears or contains any added poisonous or added deleterious
substance
(3) if it consists in whole or in part of any filthy, putrid, or decomposed
substance
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Misbranded
• A food shall be deemed misbranded if:
– (1) its labeling is false or misleading in any particular
way; or
– (2) its advertising is false or misleading in a material
respect
• If it is offered for sale under the name of another food
• If it is an imitation of another food, unless its label bears, in
type of uniform size and prominence, the word “imitation”
and, immediately thereafter, the name of the food imitated
• If its container is so made, formed or filled as to be
misleading.
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Detention without Physical
Examination (DWPE)
 DWPE is appropriate when there exists a
– history of the importation of violative products,
– or products that may appear violative,
– or when other information indicates that future
entries may appear violative
 Detention without physical examination properly places
the responsibility for ensuring compliance with the law
on the importer.
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Notice of FDA Action
• Products that appear (from examination or
otherwise) to be violative may be detained
and ultimately refused entry into the U.S.
• The standard for detention and refusal is
extremely low – detention is permissible
without actual observation of a product or
its labeling.
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Refusal
• The product then has to be exported or
destroyed (in accordance with CBP Bulletin)
within 90 days otherwise subject to Liquidated
Damages.
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Import Alert




Import Alert: #16-81
Published Date: May 13, 2010
Type: DWPE (detention without physical examination)
Import Alert Name:
– “Detention Without Physical Examination of Seafood Products Due
to Presence of Salmonella”
– Reason for Alert:
• Division of Import Operations and Policy has received
recommendations from districts for detention without physical
examination of seafood products due to Salmonella contamination
from specific manufacturers/shippers. This import alert has been
developed for seafood products from firms/countries which do not
readily fit into previously existing import alerts.
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Removal from Import Alert List
• FDA’s Regulatory Procedures Manual
– Chapter 9 – Import Operations and Actions
– 9-6 – Detention without Physical
Examination (DWPE)
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Removal from Import Alert List
• FDA’s Regulatory Procedures Manual provides guidance to
those who wish to get off the Import Alert list:
• Generally, one would need:
– A minimum of five consecutive non-violative
commercial shipments must enter the U.S.,
– At least one of the five non-violative entries should be
audited by the FDA to ensure compliance,
– The five shipments must be over a reasonable time
period, not one day
– A Petition must be filed with the FDA requesting that the
importer be removed from the automatic detention list
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Data Elements for the U.S.- Colombia Trade
Promotion Agreement Certification
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Continuation: Data Elements for the
U.S.- Colombia Trade Promotion
Agreement Certification
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Reasonable Care and Informed Compliance
•
•
CBP Checklist:
– Tariff classification
– Customs valuation
– Country of origin marking
– Intellectual property rights
– Free Trade Agreements
Reasonable Care Checklist:
– http://www.cbp.gov/linkhandler/c
gov/newsroom/publications/trade
/iius.ctt/iius.pdf
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Harmonized Tariff Schedule of the
United States (2014)
General Note
34. United States-Colombia Trade Promotion Agreement:
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Harmonized Tariff Schedule of the
United States (2014)
General Note
34. United States-Colombia Trade Promotion Agreement:
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Peter Quinter, Attorney
Customs & International Trade Law Group
GrayRobinson, P.A.
Mobile (954) 270-1864
Office (305) 416-6960
Peter.Quinter@gray-robinson.com
Skype: Peter.Quinter1
www.gray-robinson.com
October 14-16, 2014
by Peter Quinter, Esq.
Mobile (954) 270-1864
www.gray-robinson.com