U.S. Customs and Standards Regulations

www.gray-robinson.com

Peter Quinter, U.S. AttorneyDirector, Customs & International Trade Law Group

GrayRobinson, P.A.

(954) 270-1864

[email protected]

August 2012

U.S. CUSTOMS AND STANDARDS REGULATIONS

mailto:[email protected]

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Questions?


Do you have questions about importing/exporting?

http://www.grcustomslaw.com


Today’s Agenda

1) About U.S. Customs and Border Protection (CBP)

2) CBP’s Reasonable Care Checklist

3) Special Requirements for Certain Goods

1) Cosmetics

2) Drugs

3) Medical Devices

4) Food


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


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.


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.


Customs Trade PartnershipAgainst 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.


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.


Merchandise Description and Tariff Classification

Basic 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!)


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 time


Customs Valuation - GSP

If you are claiming a conditionally free or special tariff classification or provision for your merchandise like GSP, have you reported the required value information and obtained the documentation necessary to support the claim?

See Bill Jackson’s presentation regarding

GSP eligibility


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?


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?


Fair Use of a Trademark

Test for Trademark Infringement

Is the use likely to cause confusion, mistake or

deceive the public?


Special Requirements – Other Agencies

In addition to complying with CBP’s requirements, importers must be sure that their merchandise complies with other agencies’ requirements, such as:

Goods Agency Governing

Food, Drugs, Cosmetics, Medical Devices FDA – Food and Drug Administration

Alcohol, Tobacco TTB - Alcohol and Tobacco Tax and Trade Bureau

Meat, Poultry, Eggs, Dairy, Cheese USDA – US Department of Agriculture

Arms, Ammunition, Explosives, and Implements of War.

Bureau of Alcohol, Tobacco, Firearms and Explosives of the Department of Justice

Consumer Products Energy Issues – Department of EnergySafety Issues – CPSC – Consumer Product Safety Commission


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.


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.

http://wcms.fda.gov/FDAgov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm

http://wcms.fda.gov/FDAgov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm


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 FDA


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.


Which of the following products isNOT a medical device?

1. Tongue Depressor

2. Lipstick

3. Eyeglasses

4. Pacemaker


Examples of Medical Devices:

• Pacemakers• Contact Lenses• Hearing Aids• Dental Floss• Thermometer


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) )


Medical Device ClassesUse the classification database to determine what Class your device is: (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm)


Food


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 FDA's laws and regulations, FDA does not pre-approve labels for food products.


Bioterrorism Act of 2003(BTA)

• Public Health Security and Bio-Terrorism Preparedness and Response Act of 2002, or BTA, was implemented on December 12, 2003

The 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.


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/trade/iius.ctt/iius.pdf

• My Blog – GR Customs Law– www.grcustomslaw.com

http://www.cbp.gov/xp/cgov/trade/basic_trade

http://www.cpsc.gov/

http://www.fda.gov/ora/import

http://www.cbp.gov/linkhandler/cgov/newsroom/publications/trade/iius.ctt/iius.pdf



http://www.grcustomslaw.com/


QUESTIONS??

www.gray-robinson.com

U.S. Customs and Standards Regulations

Peter Quinter, U.S. AttorneyDirector, Customs & International Trade Law Group

GrayRobinson, P.A.

(954) 270-1864

[email protected]

August 2012

mailto:[email protected]

U.S. Customs and Standards Regulations

Business

Transcript of U.S. Customs and Standards Regulations