Www.gray-robinson.com October 14-16, 2014 by Peter Quinter, Esq. Mobile (954) 270-1864.

www.gray-robinson.com

October 14-16, 2014

by Peter Quinter, Esq.

Mobile (954) 270-1864

TOCContainer Supply Chain

AmericasCartagena, Colombia


Peter Quinter, AttorneyCustoms & International Trade Law Group

GrayRobinson, P.A.

Mobile (954) 270-1864

Office (305) 416-6960

[email protected]

Skype: Peter.Quinter1

www.gray-robinson.com 3

Recognized as one of the “Best Lawyers in America” in the area of FDA law for years:

2010 2011 2012 2013 2014


Do you have questions about importing/exporting?

http://www.grcustomslaw.com


Questions??


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


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


Colombia’s Waterborne Exports to Florida Ports

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

Jacksonville, FL 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

Colombian Exports to Florida Ports1/1/2014-5/14/2014

Source: U.S. Customs and Border Protection (CBP)


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


Top Food Product Refusals – February 2014Industry 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

http://www.accessdata.fda.gov/scripts/importrefusals/ir_byProduct.cfm?DYear=2013&DMonth=2




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.


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.


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 large-scale 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.


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.


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


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.


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.


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.


Refusal

• The product then has to be exported or destroyed (in accordance with CBP Bulletin) within 90 days otherwise subject to Liquidated Damages.


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.


Removal from Import Alert List

• FDA’s Regulatory Procedures Manual– Chapter 9 – Import Operations and Actions– 9-6 – Detention without Physical

Examination (DWPE)


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


Data Elements for the U.S.- Colombia Trade Promotion Agreement Certification


Continuation: Data Elements for the U.S.- Colombia Trade Promotion

Agreement Certification


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/

cgov/newsroom/publications/trade/iius.ctt/iius.pdf


Harmonized Tariff Schedule of the United States (2014)

General Note34. United States-Colombia Trade Promotion Agreement:


Peter Quinter, AttorneyCustoms & International Trade Law Group

GrayRobinson, P.A.

Mobile (954) 270-1864

Office (305) 416-6960

[email protected]

Skype: Peter.Quinter1


October 14-16, 2014

by Peter Quinter, Esq.

Mobile (954) 270-1864

TOCContainer Supply Chain

AmericasCartagena, Colombia

Www.gray-robinson.com October 14-16, 2014 by Peter Quinter, Esq. Mobile (954) 270-1864.

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Transcript of Www.gray-robinson.com October 14-16, 2014 by Peter Quinter, Esq. Mobile (954) 270-1864.