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The regulatory requirements discussed below are in addition to dangerous goods transport regulations (DOT, IATA, ICAO) that apply to biological materials, dry ice and other dangerous goods. In most instances, additional documentation is required by carriers, and by regulatory authorities in the importing country. In some instances, additional certificates or licenses are needed from various U.S. government agencies. Import/Export regulations can vary widely from country to country and are dependent on the specific item(s) being shipped. Regulatory requirements both in the US and the importing country must be reviewed prior to shipment to ensure adherence to all government regulations, and also to prevent delays and/or package rejection at customs. Non-compliance with regulatory requirements can carry heavy civil and criminal fines and penalties. The table below summarizes the most common documents required for international shipments and describes critical import/export steps and processes that must be completed prior to shipping internationally. Where applicable, the table indicates the party responsible for documents and verification. Internal and external resources available to RISC users and Certified Shippers shipping independently of RISC are also included in the table. More detailed information on each of the topics is available below the table. Please contact RISC directly for questions regarding your shipment.INTERNATIONAL SHIPMENTS THROUGH RISC REQUIRE AT LEAST ONE BUSINESS DAY NOTIFICATION (SHIPPING ORDER FORM SUBMISSION) AND MAY REQUIRE ADDITIONAL TIME PRIOR TO SHIPMENT IF ADDITIONAL IMPORT/EXPORT DOCUMENATION IS REQUIREDDocumentation/Item verificationDescriptionRequired?Responsible Party –RISC Full Service ShipmentsResponsible Party -Certified Shipper Prepared ShipmentsResourcesAir Waybill (Carrier label)Carrier label and transport document, contains tracking number, shipper/recipient information and package/commodity informationYESFedEx requires Expanded Service International Waybill for international shipments containing Dangerous Goods, including UN3373 and Dry IceRISC (via FedEx)CERTIFIED SHIPPER (carrier of choice)FedExUPS or UPS via CampusShipVisit Supply Chain website for information on CampusShipCommercial Invoice or Proforma InvoicePrimary document used for importation control, valuation and duty determinationYES - for most international shipments. Indicate value of items being shipped. Specify if your items are for research purposes and not for re-sale.RISC (via FedEx)CERTIFIED SHIPPER (carrier of choice or use of template)FedExUPSCommercial Invoice Basic Template Import Permits Issued by regulatory authorities in destination country. May list criteria/conditions that must be met by shipper and recipient in order for package to clear customs (e.g. special documentation or labeling). A copy of the permit must usually accompany the shipping documents. VARIES - Dependent on destination country and commodity. *Items of animal origin, or containing them, typically have stricter import requirements than non-animal origin materials. If a permit is required and not provided to customs officials, the package will be delayed or rejected. RECIPIENT - CHOP shipper (PI or lab contact) to have recipient verify if an import permit is needed. RISC can assist verifying with recipient upon CHOP contact request.RECIPIENTCertified Shipper to request confirmation from the recipient. RECIPIENTPrimary point of contact.USDA website for guidance on animal product and by-products based on product and destination.General country profiles available on FedEx and UPS. Not to be used in place of confirmation from regulatory authorities in destination country.RISC for guidance based on historical shipments and USDA guidanceInternational Declaration LetterDeclaration of material being shipped, by whom, to whom and for what purpose. Prepared by someone knowledgeable about the material from shipper site.*Countries which require a declaration will likely have specific statements that need to be included in declaration letter to clear customs with, or in lieu, of an import permit.REQUIRED by some countries dependent on commodity and?import regulations of destination countryRECOMMENDED for international shipments, even if not required by destination country?(use basic template)CHOP LAB CONTACT OR PI to complete declaration letter as directed by recipient and/or import permit (if required). *Optional (but recommended) -Modify basic template if no destination country requirements specifiedCHOP LAB CONTACT OR PI to complete declaration letter (basic template or as directed by recipient and/or import permit, if required*Optional (but recommended) -Modify basic template if no destination country requirements specifiedBasic template Recommended for all international shipments. *Countries which require a declaration will likely have specific statements that need to be included in declaration letter to clear customs with, or in lieu, of an import permit. USDA Export Health Certificate (for animal products, human products exposed to, or containing animal products)USDA certificate endorsed by USDA State Veterinarian's office. Required by some countries for the import of animal products or human products exposed to animal origin products into their country.VARIES – For animal origin products or specimens, or human products expose to or containing them. Dependent on commodity and import regulations of destination country. RECIPIENT to verify if certificate is required for commodity based on destination country import regulations. CHOP shipper and RISC to obtain certificate from USDA (permit fee applies). RECIPIENT to verify if certificate is required for commodity. CHOP shipper and RISC to obtain certificate from USDA (permit fee applies). RECIPIENT - Primary point of contact for confirmation?from regulatory authorizes in destination country.?USDA website provides preliminary country guidance.Contact RISC for assistance in obtaining a USDA certificate?or for?help in interpreting USDA guidance.US Export Control License Licenses issued by US federal government (Depts. Of State, Commerce or Treasury) allowing the transmission or shipment of certain information, technology and commodities which may have intended or potential dual-use military applications. VARIES - Need for a license is dependent on the commodity and/or information to be exported as well as the destination country.Contact ORC to determine if US EXPORT CONTROLS applyContact ORC to determine if US EXPORT CONTROLS applyORC – Office of Research Compliance Department of CommerceUS Export Controls – Restricted Party Screening (RPS) and the Consolidated Screening List (CSL)The Depts. of State, Commerce and Office of Foreign Assets Control, and other US agencies maintain lists of restricted individuals or entities with whom export transactions are strictly prohibited or which require an export license. The CSL is a consolidated list of parties for which the US government maintains restrictions that can be used to screen recipients and receiving institutions. YES - screen recipient/institution against United States government restricted parties listsRISC CERTIFIED SHIPPERConsolidated Screening List In the event that a company, entity or person on the list appears to match a party potentially involved in your export transaction, additional due diligence must be conducted before proceeding.Contact ORC for review and clearance prior to shipment.Carrier service available to destination address/zip codeDoes the carrier (FedEx, UPS etc.) deliver to the international location and how long will it take YES ALL PARTIES(Recipient, CHOP contact, RISC, Carrier)ALL PARTIESFedExUPSOther - Contact carrier of choiceCommodity accepted for delivery to destination address/zip code Is the item or refrigerant accepted or prohibited in the country? Does the carrier support the transit of the item and/or refrigerant to that country, e.g., FedEx and UPS will not ship on dry ice to China, China prohibits Category A Infectious substances and Category B biological substancesYESALL PARTIES(Recipient, CHOP contact, RISC, Carrier)ALL PARTIES(Recipient, CHOP contact, Certified Shipper, Carrier)FedEx Country ProfilesFedEx Dangerous Goods GuideUPSEXPORTING FROM THE UNITED STATESShipments sent from the US to international destinations may require regulatory documents from the country of import and the United States. In almost all cases, the documents required need to be obtained prior to shipment of the material in question. Some documents must be included with the shipping documents when the package is sent. Some countries require documentation from the United States in addition to, or in lieu of an import permit from their regulatory authorities. It is the responsibility of the recipient to verify what additional documentation is required from the shipper in the United States. If an import permit is issued, it may list specific instructions for the recipient and shipper to comply with. Examples of the most common import requirements include enclosing a declaration letter or a USDA export certificate (for animal products or materials exposed to them, e.g. cells grown with fetal bovine serum) with the shipping documents, and/or to label the package with certain statements.Import PermitsImport regulations are specific to the country receiving the shipment and the item being imported. These country requirements can change depending on circumstances in the country or region of import. For these reasons, it is the responsibility of the recipient to verify and obtain import permits from the appropriate regulatory authorities in their country. If an import permit is needed, the recipient is responsible for obtaining the permit from their regulatory authorities and providing a copy and/or instructions to the shipper, as applicable. Most countries require that the import permit is obtained prior to the package arriving in customs and that a copy of the permit is included with the shipping documents. The permit may list specific criteria that need to be met in order for the package to clear customs. Examples of some common requirements include: a declaration letter with specific statements from the shipper, special labeling on the outside of the package, inclusion of the permit with the shipping documents or a USDA Health Certificate. Some countries require the recipient to submit paperwork for an import permit or other type of authorization once the package arrives in customs. These permits or authorizations can take several days to obtain, so it is critical to verify the requirements for the specific country and the material prior to shipping and to ensure a sufficient amount of temperature controls are added (as applicable). Based on historical shipments, RISC can provide some preliminary guidance to core users and certified shippers on whether or not additional documentation may be needed. Since regulations in other countries can also change frequently, it is ultimately the responsibility of the recipient to confirm import requirements for the specific item(s) that they will be receiving. Declaration LetterA declaration letter may be required by the destination country as a condition of the import permit or to allow the material to be imported in lieu of an import permit. In either case, the declaration letter should include the statements necessary to fulfill the requirements of the permit and/or the instructions of the regulatory authorities in order for the package to clear customs. If the destination country does not require a declaration letter, it is still recommended to include a basic declaration letter to help prevent delays in customs. The declaration letter should include a brief description of the material being shipped, by whom, to whom and for what purpose. It should be prepared by someone knowledgeable about the material from the shipper site (e.g., the CHOP lab contact or PI). The letter should be a signed original on company letterhead and included with the shipping documents. A basic template is available on the RISC website for modification for your shipment. Please note that RISC does not prepare the declaration letter for shipments sent using our full service option. The declaration letter must be completed by someone in the originating lab/office.USDA Export Health Certificate: Live Animals, Animal Products or Products Containing Animal Products This is an official USDA document endorsed by the State Veterinarian (shipper’s state) that helps facilitate customs clearance in the importing country. The need for a USDA Export Certificate is determined by the destination country, it is not a US requirement. If a certificate is required by the importing country, it is usually listed as a requirement on the import permit issued by the destination country. Clearance in the destination country may be denied if the certificate is not included with the shipping documents. The USDA website provides helpful guidance based on the material being shipped and the country of import. To find information based on your specific shipment:Select the country of destination and region (if applicable) from the drop-down menu For countries in the European Union (EU), be sure to review both the EU and country specific pages as there may be additional requirements/criteria for the specific country Review the list of commodities to see if any closely match the commodity you are shipping Select commodities closely matching the commodity that you are sending and review the information provided to determine if the requirements apply to your shipment Note: In some instances, contact information for the appropriate regulatory authorities in the importing country is provided, forward this information to your recipient for confirmationHave your recipient verify import requirements Import regulations may change without notice, so the importer is ultimately responsible with confirming requirements with their regulatory authorities. RISC will help core users and certified shippers obtain any necessary USDA certificates. USDA Export Certificates take several days to obtain, and may require notarized affidavits from the lab depending on the material and its specific import requirements. The USDA charges a fees for the certificates, which will be billed to the PIs activity number, along with any shipping charges associated with obtaining the certificate. There are no RISC handling fees associated with procuring USDA certificates. Please contact RISC for additional information regarding USDA export certificates or visit the USDA website. Export Controls and Export Control Licenses Federal laws govern how certain information, technology and commodities can be transmitted overseas, including to US citizens overseas, or to foreign nationals in the US (“deemed exports”). Some items that are regulated under export control laws include pathogens (typically select agents) or their genetic elements, specialty metals, high technology or experimental equipment including sensors and lasers, cryptography and certain software code. When applicable, these regulations may require an export control license. Visit the ORC website for more information on export controls. Contacts for Export ControlsKaren Burke?at 267-425-2447 or burke6@email.chop.eduMatthew Hodgson at 267-426-8723 or?Hodgsonm@email.chop.eduExport Controls Restricted Party Screening (RPS)Some individuals and organizations are prohibited from receiving US exports. Some may only receive goods or information if the transaction has been licensed by US government. Several US government agencies maintain their own lists of individuals and organizations that are covered under these restrictions. The Consolidated Screening List (CSL) is a compilation of parties for which the US government maintains restrictions on for certain exports, re-exports or transfers of items. It is the shipper’s responsibility to screen the recipient and receiving organization against these lists. In the event that a company, entity or person on the list appears to match a party potentially involved in your export transaction, additional due diligence must be conducted before proceeding. Contact ORC for assistance!To use the CSL:Scroll down to the “Tools” section. Select your preferred method of screening the CSL (CSL Search Engine, CSV Download, or TSV Download).Screen both the recipient’s name and the receiving institution name against the CSL for matches.In the event of a match, additional due diligence is required before proceeding with the shipment. Contact ORC for review and clearance to ship. If no matches are found, you may proceed with the shipment, provided the item/information is not subject to other export control regulations and is not being sent to an embargoed or sanctioned country or region. Contact ORC for material review prior to export.Live Animal shipments within the US and InternationallyFor assistance with shipments of live animals within the United States or to an international destination, please contact the Department of Veterinary Resources (DVR). Imports to the United StatesThe importation of materials into the United States may require a permit from one or more regulatory agencies, depending on the material being imported. Materials that do not require a permit to clear customs usually require documentation indicating why an import permit is not required. USDA Permits Imports of live animals, animal products or materials containing animal products, including human cell lines grown in media containing animal products into the US, are subject to USDA regulations. Information regarding the process to import these products can be found at the following links: Animal Products that Do Not Require an Import Permit (Guidelines)Live Animals (includes semen, embyros…)Animal Products Organisms and VectorsCDC PermitsImports of infectious biological agents, infectious substances and vectors of human disease to the US are subject to regulations of the CDC’s Import Permit Program. Information regarding the CDC’s permit program can be found here: diagnostic specimens which are known not to contain, or are not suspected of containing infectious agents can be imported without a CDC import permit if they are accompanied by a certification statement. Information required on the certification statement can be found at the following link under General Questions: facilitate clearance of materials that do not require a CDC import permit, each shipment must be accompanied by a certification statement, on an official letterhead, from the sender or the recipient of this material.The certification statement must include:A detailed description of the material.Statements affirming: The material is not known or suspected to contain an infectious biological agent, andOne of the following: How the person knows that the material does not contain an infectious biological agent, orWhy there is no reason to suspect that the material contains an infectious biological agent, orA detailed description of how the material was rendered noninfectious. ................
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