U.S. Customs and Standards Regulations

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Peter Quinter, U.S. Attorney
Director, Customs & International Trade Law Group
Presentation on US Customs and Standard Regulations for Exporters to US Markets

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U.S. Customs and Standards Regulations

  1. 1. U.S. CUSTOMS ANDSTANDARDS REGULATIONS Peter Quinter, U.S. Attorney Director, Customs & International Trade Law Group GrayRobinson, P.A. (954) 270-1864 Peter.Quinter@Gray-Robinson.com August 2012 www.gray-robinson.com
  2. 2. Questions?www.gray-robinson.com 2
  3. 3. Do you have questions about importing/exporting? http://www.grcustomslaw.comwww.gray-robinson.com 3
  4. 4. Today’s Agenda1) About U.S. Customs and Border Protection (CBP)2) CBP’s Reasonable Care Checklist3) Special Requirements for Certain Goods 1) Cosmetics 2) Drugs 3) Medical Devices 4) Foodwww.gray-robinson.com 4
  5. 5. U.S. Department of Homeland Security (DHS) • Created in response to 9/11 terrorist attacks • DHS goal: prepare for, prevent, and respond to domestic emergencies, particularly terrorism. • DHS is responsible for: – Managing the nation’s borders and ports-of-entry. – Preventing the passage of individuals or goods from entering the United States unlawfully – Working overseas to strengthen U.S. defenses against illegal smuggling and immigration www.gray-robinson.com 5
  6. 6. U.S. Customs and Border Protection (CBP)• CBP is the federal law enforcement agency of the United States Department of Homeland Security (DHS).• Charged with regulating and facilitating international trade, collecting import duties, and enforcing U.S. regulations, including trade, customs and immigration.• CBP’s Goals - Preventing terrorism; unifying as one border agency; balancing trade and travel with security; protecting America; modernizing and managing for results.www.gray-robinson.com 6
  7. 7. ON A TYPICAL DAY, CBP:• Processes 932,456 passengers and pedestrians.• Processes 64,483 truck, rail, and sea containers.• Executes 932 apprehensions at and in between the ports of entry for illegal entry; 470 refusals of entry at our ports of entry and 61 arrests of criminals at ports of entry.• Seizes 13,717 pounds of drugs.• Seizes 470 pest interceptions submitted to USDA at ports of entry.www.gray-robinson.com 7
  8. 8. Customs Trade Partnership Against Terrorism (C-TPAT)• The purpose of C-TPAT is to partner with the trade community for the purpose of securing the U.S. and international supply chains from possible intrusion by terrorist organizations.• C-TPAT requires the trade company participant to document and validate their supply chain security procedures in relation to existing CBP C-TPAT criteria or guidelines.• Voluntary Program – started 2002.• CBP “certifies” membership of applicant as a C-TPAT member.www.gray-robinson.com 8
  9. 9. CBP Reasonable Care – A Checklist• Merchandise Description & Tariff Classification• Customs Valuation• Country of Origin Marking• Intellectual Property Rights• Free Trade Agreements We will now go through each one.www.gray-robinson.com 9
  10. 10. Merchandise Description and Tariff ClassificationBasic Question: Do you know what you ordered, where it was made,and what it is made of?• Have you provided a complete, accurate description of your merchandise to CBP?• Have you provided CBP with the correct tariff classification of your merchandise?• Have you consulted with an expert (e.g., lawyer, customs broker, accountant, customs consultant) to assist in the description and/or classification of the merchandise?• Have you obtained a CBP ruling regarding the description of your merchandise or its tariff classification? (see next slide!) www.gray-robinson.com 10
  11. 11. CBP Binding Ruling Process• Enables importers and other interested parties to get binding pre- entry classification decisions regarding: – the Harmonized Tariff Schedule (HTS) – certain marking requirements – Country of origin – Applicability of Trade Program rulings• Written Procedure done prior to importing a product and filing entries with Customs and Border Protection (CBP).• Ruling is Official Position of CBP• Quick response timewww.gray-robinson.com 11
  12. 12. www.gray-robinson.com 12
  13. 13. Customs Valuation - GSPIf you are claiming a conditionally free or special tariffclassification or provision for your merchandise like GSP,have you reported the required value information andobtained the documentation necessary to support theclaim? See Bill Jackson’s presentation regarding GSP eligibilitywww.gray-robinson.com 13
  14. 14. Country of Origin Marking Do you know how your goods are made, from raw materials to finished goods, by whom and where?• Have you assured that the merchandise is properly marked upon entry with the correct country of origin (if required) ?• Have you obtained a CBP ruling regarding the proper marking and country of origin of the merchandise?• Have you consulted with a customs expert regarding the correct country-of-origin/ proper marking of your merchandise?www.gray-robinson.com 14
  15. 15. Intellectual Property Rights Basic Question: Have you determined whether your merchandise or its packaging use any trademarks or copyrighted material or are patented? If so, can you establish that you have a legal right to import those items into and/or use them in the United States?www.gray-robinson.com 15
  16. 16. Fair Use of a Trademark Test for Trademark Infringement Is the use likely to cause confusion, mistake or deceive the public?www.gray-robinson.com 16
  17. 17. www.gray-robinson.com 17
  18. 18. Special Requirements – Other AgenciesIn addition to complying with CBP’s requirements, importers must be sure thattheir merchandise complies with other agencies’ requirements, such as:Goods Agency GoverningFood, Drugs, Cosmetics, Medical Devices FDA – Food and Drug AdministrationAlcohol, Tobacco TTB - Alcohol and Tobacco Tax and Trade BureauMeat, Poultry, Eggs, Dairy, Cheese USDA – US Department of AgricultureArms, Ammunition, Explosives, and Bureau of Alcohol, Tobacco, Firearms andImplements of War. Explosives of the Department of JusticeConsumer Products Energy Issues – Department of Energy Safety Issues – CPSC – Consumer Product Safety Commissionwww.gray-robinson.com 18
  19. 19. Federal Food, Drug, and Cosmetic Act• The Act prohibits the importation of any food, drug, device, or cosmetic that is adulterated or misbranded – Under the FD&C Act, the term "misbranding" applies to-- • False or misleading information,* • Lack of required information, • Conspicuousness and readability of required information, • Misleading packaging, • Improper packaging and labeling of color additives, and • Deficiencies where the Poison Prevention Packaging Act requires special packaging.• The Act also prohibits products that are defective, unsafe, filthy, or produced under unsanitary conditions.www.gray-robinson.com 19
  20. 20. Cosmetics• Cosmetics = Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance• Examples - skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.• Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations. As its name indicates, this program is voluntary. The FD&C Act does not require cosmetic firms to register their establishments or list their product formulations with FDA. But…..• A cosmetic product must be labeled according to cosmetic labeling regulations.www.gray-robinson.com 20
  21. 21. Drugs• "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals"• it is mandatory for drug firms to register their establishments and list their drug products with FDAwww.gray-robinson.com 21
  22. 22. What is a Medical Device?• A device is: An instrument, apparatus, implement machine, contrivance, implant, in vitro reagent, or other similar or related including any component, part, or accessory which is: – (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, – (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or – (3) intended to affect the structure or any function of the body of man or other animals, which does not achieve its primary intended purposed through chemical action within or on the body of man or other animal and which is not dependent upon being metabolized for the achievement of its primary intended purposes.• If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. www.gray-robinson.com 22
  23. 23. Which of the following products is NOT a medical device?1. Tongue Depressor2. Lipstick3. Eyeglasses4. Pacemakerwww.gray-robinson.com 23
  24. 24. Examples of Medical Devices:• Pacemakers• Contact Lenses• Hearing Aids• Dental Floss• Thermometerwww.gray-robinson.com 24
  25. 25. Checklist to Import Medical Devices• Premarket Notification (510(k)), unless exempt, or Premarket Approval (PMA)• FDA Establishment Registration on Form FDA--2891• FDA Device Listing on Form FDA--2892• Quality System Regulation (QSR) (sometimes referred to as good manufacturing practices or GMPs)• Labeling Requirements• Medical Device Reporting• U.S. Designated Agent (for imported devices) (http://usagent www.fda.gov/cdrh/usagent) )www.gray-robinson.com 25
  26. 26. Medical Device ClassesUse the classification database to determine what Class your device is:(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm)www.gray-robinson.com 26
  27. 27. Foodwww.gray-robinson.com 27
  28. 28. Food• “Food” is defined as: – Articles used for food or drink for man or other animals, – Chewing gum, – Articles used for components or any such article.• Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions.• Under FDAs laws and regulations, FDA does not pre- approve labels for food products.www.gray-robinson.com 28
  29. 29. Bioterrorism Act of 2003 (BTA)• Public Health Security and Bio-Terrorism Preparedness and Response Act of 2002, or BTA, was implemented on December 12, 2003The BTA’s purpose is to ensure the security of food for human and consumption.• BTA requires that: – manufacturers, processers, packers, and shippers register the facilities from which they export food and food products to the U.S. with the Food and Drug Administration. – FDA be given advance notice on shipments of imported food.www.gray-robinson.com 29
  30. 30. Useful Links• CBP Import Information – www.cbp.gov/xp/cgov/trade/basic_trade• U.S. Consumer Product Safety Commission – www.cpsc.gov• FDA – www.fda.gov/ora/import• Reasonable Care Checklist – http://www.cbp.gov/linkhandler/cgov/newsroom/publications/trad e/iius.ctt/iius.pdf• My Blog – GR Customs Law – www.grcustomslaw.comwww.gray-robinson.com 30
  31. 31. QUESTIONS??www.gray-robinson.com 31
  32. 32. U.S. Customs andStandards Regulations Peter Quinter, U.S. Attorney Director, Customs & International Trade Law Group GrayRobinson, P.A. (954) 270-1864 Peter.Quinter@Gray-Robinson.com August 2012 www.gray-robinson.com

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