Department of Homeland Security  Customs and Border Protection October 10, 2017

Customs and Border Protection (CBP) Mission Statement: To safeguard America's borders, thereby protecting the public from dangerous people and materials while enhancing the Nation's global economic competitiveness by enabling legitimate trade and travel. CBP is responsible to administer and enforce all Federal laws including all Partner Government Agency (PGA) laws at the border. We are the frontline at the border to ensure that nothing detrimental or harmful to our country or it’s citizens crosses our borders.

How does CBP protect our borders? By working in partnership with government agencies such as the EPA, FDA, CDC and several other esteemed agencies present today. By enforcing Federal laws such as: United States Code Code of Federal Regulations Customs Modernization Act Toxic Substance Control Act Bioterrorism Act

Customs Modernization Act Title VI of the North American Free Trade Agreement Implementation Act December 8, 1993 It’s aim was to increase the voluntary compliance with customs laws and to improve customs enforcement. It introduced the concept of "informed compliance" and "shared responsibility." These concepts are based on the idea that to maximize voluntary compliance with Customs laws and regulations, the trade community needs to be clearly and completely informed of its legal obligations. The Mod Act imposes a greater obligation on Customs to provide the public with improved information concerning the trade community's responsibilities and rights under Customs and related laws. Both the trade and Customs share responsibility in carrying out import requirements: CBP: Providing an atmosphere of informed compliance. Importer: The trade community shall exercise reasonable care. Classification and valuation of goods are the responsibility of the importer.

Customs Importer Resources Informed Compliance Pubs: CBP has published 95 importation guides that are available online for free download. Most are commodity specific but some will give you a better understanding of how a broker can help you and provide basic importation terminology. Available at: https://www.cbp.gov/trade/rulings/informed-compliance-publications Examples: Reasonable Care Record Keeping Rules of Origin Customs Brokers Tariff Classification Customs Value Terminology & Methods for Marking of Country of Origin on U.S. Imports While these resources will help you understand the importation process, they are not enough to prevent you from experiencing importation pitfalls.

Role of the Broker Broker Responsibilities: to facilitate Customs business on behalf of the Importer. Records Management – retention, confidentiality, available to CBP, audit/inspection. Responsible supervision and control of business: Making sure that all employees conduct Customs procedures as if they were doing it for themselves. Diligence in correspondence and paying monies. They take care of the details leaving you free to tend to other business matters.

Role of the Broker, cont. Why does a Broker Require a Power of Attorney? A Customs Broker is a person who is licensed and regulated by U.S. Customs and Border Protection to conduct Customs business on behalf of others. Customs business means those activities involving transactions with CBP concerning the entry and admissibility of merchandise, its classification and valuation, the payment of duties, taxes, or other charges assessed or owed to CBP on merchandise by reason of its importation, and the refund, rebate, or drawback of those duties, taxes, or other charges. Except when importing for one’s own account, or acting as an employee of a broker, a person must obtain a customs license in order to transact customs business as a broker. The Power of Attorney is the legal document that provides the Broker with the authority to act on behalf of the importer (as your agent).

Role of the Broker, cont. Duties of a Broker to Ensure a Proper Entry: Ensure importers Right to Make Entry: Goods may only be entered by their owner, purchaser, or a licensed customs broker. Examination of goods and entry documents preparation: Filing the documents necessary to determine whether the biologicals may be released by CBP. Filing the documents that contain information for duty assessment and statistical purposes. The shipment may be examined or examination may be waived. The shipment is then released if no legal or regulatory violations have occurred. Once the goods are released from CBP custody, an entry summary must be filed and all estimated duties and fees must be paid within 10 working days of the goods’ entry.

Role of the Broker, cont. Duties of a Broker to Ensure a Proper Entry: Determine any applicable duties and fees are paid: Harbor Maintenance Fee (HMF) Merchandise Processing Fee (MPF) (min. $25, max $485, Formal/Informal) Special Commodity Fees: Cotton, Honey, Beef, Pork, and Alcohol Antidumping and Countervailing fees Use all resources available to insure accuracy in entry filing Arrange the delivery of client’s goods Educate on changes in Customs law and Trade issues

Benefits of Using a Broker Understands the Rule of Origin and Marking requirements Knowledgeable in Free Trade Agreements which could save you money Assist with classification and value concerns Knowledge of Special Requirements: CAS Requirements - Chapters 27-29 and Subheading 3204 EPA - TSCA Requirements Other Prohibitions, Restrictions and other agency requirements Can save you from costly mistakes and legal penalties caused by non-compliance

Do I hire a broker or try to import on my own? You choose… Do I hire a broker or try to import on my own? How to obtain a Customs Broker: Visit our web site at https://www.cbp.gov/contact/ports. Then click on the State in which you will be importing into, click on the city, below the city information there is a link for Broker listing.

What questions should you ask when hiring a broker? How long have you been practicing as a licensed customs broker? Are you employed as part of a customs brokerage (who are they?) or are you practicing as an individual licensed broker as a sole proprietor? From which countries have you managed the export of biologicals from? What do I need to be concerned with for my specific biological import? What PGA’s and considerations need to be taken into account when importing biologicals? Will this slow the movement of my products through Customs? How can I as an importer obtain knowledge of PGA unique requirements?

Conclusion The role of the broker is to facilitate customs business on behalf of the importer, and to encourage compliant trade processes and practices. Brokers must be knowledgeable concerning importing and exporting transactions. By utilizing a broker you are facilitating the movement of your shipment and allowing the broker to manage your business to meet all federal requirements and safety guidelines. Importing biological materials is not as simple as buying a handbag for personal use from a website. Biological importations require much consideration, the concerns of PGA’s – FDA, EPA, etc. are in place to protect both the importer and the general public and must be taken into account. Laws are in place to protect the safety and security of our citizens and the environment. The importer and/or his agent (broker) are responsible for ensuring PGA laws are respected during the import process.

U. S. Customs and Border Protection established the Center of Excellence and Expertise for Pharmaceuticals, Health & Chemicals as a central point of contact for inquiries and resolution of issues regarding Pharmaceutical, Health & Chemical imports. Contact Information U.S. Customs and Border Protection Pharmaceuticals, Health & Chemicals Center of Excellence and Expertise 1100 Raymond Boulevard Newark, NJ 07102 CEE-Pharmaceuticals@cbp.dhs.gov Prepared by: Sr. Import Specialist Kathy Brenske Pharmaceutical, Health and Chemical CEE Email: Kathy.Brenske@cbp.dhs.gov