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

2. 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

3. 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

4. www.gray-robinson.com 4 Do you have questions about importing/exporting? http://www.grcustomslaw.com

5. www.gray-robinson.com 5 Questions??

6. www.gray-robinson.com 6 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

7. www.gray-robinson.com 7 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

8. www.gray-robinson.com 8 Colombia’s Waterborne Exports to Florida Ports Arrival PortBills of Lading Container Quantity Metric TonsTEUS Quantity Port Everglades, FL 1899188664679.473306.3 Miami, FL1089128426544.832204.62 Jacksonville, FL342621449608.161106 Port Manatee, FL57124.1614 West Palm Beach, FL 2147.471.5 Totals33373800541004.096632.42 Colombian Exports to Florida Ports 1/1/2014-5/14/2014 Source: U.S. Customs and Border Protection (CBP )

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11. www.gray-robinson.com 11 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

12. www.gray-robinson.com 12 Top Food Product Refusals – February 2014 IndustryNumber of Refusals 16 – Fishery/Seafood Prod161 03 – Bakery Prod/Dough/Mix/Icing113 02 – Whole Grain/Milled Grain Prod/Starch103 24 – Vegetables/Vegetable Products100 28 – Spices, Flavors and Salts98 12 – Cheese/Cheese Prod77 21 – Fruit/Fruit Product74 1 Available at: http://www.accessdata.fda.gov/scripts/importrefusals/ir_byProduct.cfm?DYear=2013&DMonth=2http://www.accessdata.fda.gov/scripts/importrefusals/ir_byProduct.cfm?DYear=2013&DMonth=2

13. www.gray-robinson.com 13 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.

14. www.gray-robinson.com 14 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.

15. www.gray-robinson.com 15 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.

16. www.gray-robinson.com 16 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.

17. www.gray-robinson.com 17 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

18. www.gray-robinson.com 18 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.

19. www.gray-robinson.com 19 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.

20. www.gray-robinson.com 20 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.

21. www.gray-robinson.com 21 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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23. www.gray-robinson.com 23 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.

24. www.gray-robinson.com 24 Removal from Import Alert List FDA’s Regulatory Procedures Manual –Chapter 9 – Import Operations and Actions –9-6 – Detention without Physical Examination (DWPE)

25. www.gray-robinson.com 25 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

26. www.gray-robinson.com 26 Data Elements for the U.S.- Colombia Trade Promotion Agreement Certification

27. www.gray-robinson.com 27 Continuation: Data Elements for the U.S.- Colombia Trade Promotion Agreement Certification

28. www.gray-robinson.com 28 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

29. www.gray-robinson.com 29 Harmonized Tariff Schedule of the United States (2014) General Note 34. United States-Colombia Trade Promotion Agreement:

30. www.gray-robinson.com 30 Harmonized Tariff Schedule of the United States (2014) General Note 34. United States-Colombia Trade Promotion Agreement:

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32. 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

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