U.S. Customs and Standards Regulations

U.S. CUSTOMS AND
STANDARDS 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

Questions?

www.gray-robinson.com 2

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 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.


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 Bureau of Alcohol, Tobacco, Firearms and
Implements of War. Explosives of the Department of Justice
Consumer Products Energy Issues – Department of Energy
Safety 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.


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 is
NOT 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 Classes
Use 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/trad
e/iius.ctt/iius.pdf
• My Blog – GR Customs Law
– www.grcustomslaw.com


QUESTIONS??


U.S. Customs and
Standards 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

U.S. Customs and Standards Regulations

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