Shipping labels with the universal biohazard symbol, the importer name and address, permit number, and expiration date are issued with the permit. Many U.S.-based research institutions have a preferred Licensed Customs Broker. Due to Customs import and documentation requirements, most importers choose to have their imports handled by Licensed Customs Brokers. When you are shipping blood samples, they require the proper CDC shipping category label, which mandates what kind of shipping requirements are needed to ship your package safely. A formal entry may be required at the port of arrival if, any of the following conditions apply: Note: There is no legal requirement to hire a licensed Customs Broker. The import document paperwork includes: AFC International: Custom Brokerage Support, Shipping Blood Samples: The Import Regulations You Need to Know, USDA permit applications can be found online, U.S. West Coast Ports of Entry: What You Need to Know, The Importer’s Guide to Shipping Imports from Europe and China, Animal or human body fluids, tissues or body parts, Environmental samples (air, water, soil surfaces, etc. If the biological materials are imported through baggage, applicable regulations include, but are not limited to: Certain federal agencies, such as the Department of Transportation (DOT), Centers for Disease Control & Prevention (CDC), Department of Agriculture (USDA), and Fish and Wildlife Services (FWS), as well as certain individual states, may require import permits for entry. Cell/tissue culture product (includes monoclonal antibodies, ascitic fluid, tissue culture supernatants, used/conditioned culture media, enzymes, other proteins, extracts, nucleic acids [DNA/RNA]). Transporting such samples is controlled by federal and state regulations. Please check with your local Director of Research Compliance or equivalent to see if your institution has retained a Licensed Customs Broker for university business. Cell or tissue culture (includes primary cell/tissue cultures, recombinant cell lines, non-recombinant cell lines, hybridomas). Blood storage and transportation J. Hardwick Introduction In terms of blood processing, quality may be defined as a series ... product may be stored, provided that the requirements of temperature, preservative solutions and physical environ-ment are met. The following substances are not required to follow the IATA or DOT regulations, but are still subject to U-M restrictions on moving materials around campus:. Wipe any bottles with CSF or blood on the outside thoroughly with a disinfectant, such as a 70% alcohol swab. Risk assessments and mitigation measures are dependent on: 1. Dedicated last minute delivery, temperature reporting and packaging return. Wipe any bottles with CSF or blood on the outside thoroughly with a disinfectant, such as a 70% alcohol swab. • For transport to a microbiology laboratory, place the specimen in a container that can be securely sealed. For the most part, labs are on the receiving end of samples, and packaging is often at the discretion of the client. The laboratory equipment and facility 5. A list of licensed customs brokers may also be found here: Licensed Customs Brokers. Transporting blood samples is never simple, but our specimen courier service can help prevent delays, financial losses and ensure that results are never compromised. The top exporters of human or animal blood are: The top importing countries of human or animal blood are: Biological materials of a public health nature such as blood, vaccines and toxins are highly regulated. The latest general information on the Coronavirus Disease 2019 (COVID-19) is available on Coronavirus.gov.For USDOT specific COVID-19 resources, please visit our page. Human or animal blood can also be classified as toxins or vaccines. These biological materials require import permits from either the Center for Disease Control (CDC) and/or the U.S. Department of Agriculture (USDA). Division 6.2 includes biological products, cultures, specimens, genetically modified microorganisms (GMMs), genetically modified organisms (GMOs) and medical/clinical waste. Importers should adhere to entry requirements under CBP regulations for commercial or noncommercial importation; depending on the mode of importation, different regulations apply. These are: 1. Hand carrying biological material without, or in violation of, a permit may result in delays, seizure, and civil or criminal penalties. By using our service for transporting blood samples, you can reduce your transport costs by up to 40%. • For transport to a microbiology laboratory, place the specimen in a container that can be securely sealed. The competency level of the personnel who perform the procedures 4. Blood, plasma, blood cells, clotting factors, Fetal Bovine Serum (FBS), other sera, Bovine Serum Albumin (BSA), enzymes, hormones, Materials collected from endangered species, It is deemed necessary by the port for the purposes of enforcing entry or admissibility requirements. All of these are extremely important to the medical industry and the health of patients world-wide. Histopathological slides (fixed in formalin). Products of micro-organisms (includes plasmids, nucleic acids (DNA/RNA), toxins, enzymes, recombinant human insulin, other proteins and extracts). Means of Transport. Factors to consider include the source of the biological material; method of production or synthesis; packaging (bulk or final dosage form); terminal use in humans, animals, or research; state of infectiousness; potential as a vector of human, animal, or plant disease; and status as an endangered species (if applicable). ); or, Commercial shipments of biological materials that exceed $2,500 in value; or. However, lab officials and technicians tend to guide clients in how to package their samples to protect both the sample and those who might be handling the parcels. Importers of biological materials are encouraged to participate in the new Entry Type 86 pilot. Materials that do not contain pathogens or only contains inactivated or neutralized pathogens; Environmental samples that do not pose a significant threat of infection (i.e, food, water soil, or dust samples) The importer must send the labels and one or more copies of the permit to the shipper. Labs typically purchase packaging materials such as sealable plastic bags and boxes for transporting blood specimens. Annex 18 applies to fiThe Safe transport of Dangerous Goods by Airfl ... Other exceptions, e.g. The regulations also specify specimens where the risk is so low the specimens can be transported without following Department of Transportation packaging requirements. Import permits must be secured prior to the importation of any material. ... International Air Transport Regulations! With the transportation of blood, efficiency can help save lives, find cures and prolong life. The permit and labels inform the carrier and CBP of the package contents. Transport Blood and Blood Products (contact ARCBS1, for more information) transport of medical waste — refer to relevant jurisdictional legislation requirements for the packaging of genetically modified organisms (GMOs) — see the Guidelines for the Transport of GMOs issued by the Office of the Gene Technology Regulator.2 All laboratories should perform a site-specific and activity-specific risk assessment to identify and mitigate risks. The aliquot is to be placed in a blue biohazard labeled specimen bag. However, clients and labs rarely deal directly with these regulations and rely instead on carriers, such as UPS or FedEx, to comply with the necessary transport laws. Federal, international, and state laws strictly regulate shipping, transport, and import of biological materials. Specimen requirements include information such as specimen volume, collection and transport containers as well as transport temperature. Samples: Air Transport View. Micro-organisms (includes recombinant or non-recombinant, bacteria, fungi, yeast, protozoa, viruses, prions), live or killed. AFC International has the tips you need for shipping blood samples safely and effectively. Blood Importing and Exporting is a Big Industry. Transporting. Thanks to our experience with the transportation of blood, you can rest assured that our blood courier service will mean that all of your shipments will arrive on time and intact. Partner Government Agency permitting websites: For additional information or clarification on importing biological materials into the United States, please contact your intended port of arrival or CBP at [email protected], United States Department of Agriculture (USDA) Permits, Centers for Disease Control & Prevention (CDC) Permits, Joint CDC and USDA Federal Select Agent Program (FSAP), United States Fish & Wildlife Service (USFWS) Permits, Food & Drug Administration (FDA) Prior Notice & Review, Federal Aviation Administration (FAA) Specific Packaging & Shipping Requirements, Pipeline and Hazardous Materials Safety Administration, EPA Requirements for Importers and Exporters. Originate with International Civil Aviation Organization (ICAO)! Federal, international, and state laws strictly regulate shipping, transport, and import of biological materials. Highly visible packing, identifying samples in transit, Pre printed with all marketing requirements, Gel wrap included for temperature control samples, Highly visible packaging identifying samples in transit, Different configurations that allows the box to be used in summer and winter, Can be used between 2-8 degrees and 15-25 degrees, Highly visible packaging, identifying samples in transit, Prepared in fulfilment centre and delivered to site ready to ship. The U.S. Customs and Border Protection (CBP) closely monitors and enforces laws and regulations for all of your imports and import paperwork. While this topic makes us think about Halloween and horror movies, shipping blood samples is actually a highly regulated business and it’s critical to follow the proper importing procedures. The DOT Hazardous Material Regulations (49 CFR Parts 171-180) regulates the movement of Division 6.2 Infectious Substances and are regulated when carriage is considered to be "in commerce". We have a unique range of services and delivery options for people requiring temperature controlled delivery options. Frozen: If your test requires the specimen to be frozen after processing, the specimen must be centrifuged and serum/plasma must be transferred to an aliquot tube by pipette without disturbing gel or packed cells. Note: Biological materials requiring a permit under federal or state law must have a permit that specifically authorizes hand-carry on the permit.