CDC CDC INTERNATIONAL IMPORT REGULATIONS Liz Harton, Officer in Charge | Public Health Advisor CDC Detroit Quarantine Station October 10, 2017 Centers for Disease Control and Prevention Office of Public Health Preparedness and Response
CDC Quarantine Station Jurisdictions AK ME Minneapolis Seattle Chicago VT Anchorage Detroit WA ND MT MA NY MN ID IA OH NE IN Philadelphia NV VA CO NC TN So.CA SC OK AR Atlanta NM AZ Los Angeles Washington DC KY MO KS E WV IL UT New York Newark D MD No.CA Boston RI NJ PA SD WY San Francisco CT MI WI OR NH AL North TX MS GA San Diego El Paso West TX East TX LA FL Houston Dallas Honolulu HI GU Miami PR CDC Quarantine Station (n=20) San Juan
Federally Quarantinable Communicable Diseases in the U.S. Presidential Executive Order 13295, April 2005 • Cholera • Diphtheria • Infectious Tuberculosis • Plague • Smallpox • Yellow Fever • • • Viral Hemorrhagic Fevers Severe acute respiratory syndrome (SARS) Novel or reemerging influenza causing or with potential to cause a pandemic 5
Other Communicable Diseases of Public Health Concern* Malaria Typhoid Varicella Rabies Measles Meningococcal disease • Legionellosis • • • • • • • • • • • • • Polio Dengue Zoonotic poxvirus Pertussis Mumps Rubella Infectious diarrhea * Based on their ability to spread and cause significant illness or death 6
Sect ion 361 of the Public Healt h Service Act Authorizes the HHS Secret ary to make and enforce regulat ions necessary to prevent : Introduction Transmission or Spread of communicable diseases from foreign countries into the United States
The Basics The import permit program: Prevents the introduction, transmission, or spread of communicable diseases from foreign countries into the United States. Accomplished in part by: • Reviewing applications ( over 3,000 reviewed & under 2000 approved annually) • Conducting inspections (30-40 annually)
42 CFR 71.54 Infectious biological agent Infectious substance A microorganism (including, but not limited to, bacteria (including rickettsiae), viruses, fungi, or protozoa) or prion, or a component of such, that is capable of causing communicable disease in a human. Any material that is known or reasonably expected to contain an infectious biological agent. Vector Any animals including arthropods, or any noninfectious self-replicating system, or animal products, that are known to transfer, or are capable of transferring an infectious biological agent to a human.
Importations Imported animal and human products that may pose a threat to human health • • • • • • • • • Cats, dogs, & other domestic pets (rabbits, ferrets, etc.) Animals (bats, rodents, etc.) Animal products (trophies, skins, skulls, goatskin drums) Turtles, turtle eggs, tortoises, terrapins Nonhuman primates (monkeys, baboons, tamarins, etc.) Human remains Human products (stem cells, bone marrow, blood, serum, etc.) Cultures of living bacteria, virus or similar material Living insects (mosquitoes, ticks, fleas, lice, mites, maggots, etc.)
Certification Statement The certification statement must include: • A detailed description of material • A statement on official letter head signed by the sender or the recipient clearly stating that • (1) the material is not known or suspected to contain an infectious biological agent • (2) how the person making the certification knows that the specimen does not contain an infectious biological agent; or a detailed description of how the material was rendered noninfectious.
Infectious Importation Criteria A researcher may not import into the United States any infectious biological agent, infectious substance or vector unless: It is accompanied by a permit issued by the CDC AND a copy of the permit is affixed to the outer most packaging of the shipment. The “Notice to Carrier” label with the Permit # must be affixed to the outer container The importer is in compliance with all permit requirements and conditions Importer help ensure the shipper complies with all legal requirements. (e.g., packaging/labeling) Importer has implemented adequate biosafety measures (IATA, for example)
CDC Restricted Materials Product Documents Needed African Rodent, NHP, Family Viverrridae CDC/IPP CDC DGMQ Permission Letter OR Certification Statement of Non-infectiousness Bats and other Vectors of Human Disease CDC/IPP OR Certification Statement of Non-infectiousness Bacteria, viruses, fungi, prions, infectious nucleic acids CDC/IPP OR Certification Statement of Non-infectiousness
Importation of Public Health Importance Review & Initial Determination • Paperwork reviewed • Item is declared? • Determination is made • May be released • May be released conditionally or • May be denied Possible Outcomes • If paperwork is not in order, importer may need to provide additional information • If paperwork looks of, it could take some time • If all documents are available and known to the passenger, materials will be released • Formal Entry may be required
Hand-Carrying Infect ious Mat erial In order to ensure the safety of the public, CDC’s Import Permit Program will not approve the importation of infectious material if it is being hand-carried in the cabin of a passenger aircraft. 49 CFR 175.75 (b) No person may carry a hazardous material in the cabin of a passenger-carrying aircraft or on the flight deck of any aircraft, and the hazardous material must be located in a place that is inaccessible to persons other than crew members. Hazardous materials may be carried in a main deck cargo compartment of a passenger aircraft provided that the compartment is inaccessible to passengers and that it meets all certification requirements for a Class B aircraft cargo compartment in 14 CFR 25.857(b) or for a Class C aircraft cargo compartment in 14 CFR 25.857(c).
APPLICATION FOR PERMIT TO IMPORT • SECTION E - Description of Biological Agent • SECTION F - Description of Material(s) Containing the Agent(s) • SECTION G - Receiving Laboratory Capabilities • SECTION H - Signatures
Inspections By the CDC Import Program and/or NIOSH Conducted to verify: Accuracy of the IP application (e.g. , lab rooms, Safety levels, agents) Importer has implemented adequate biosafety measures. Website has inspection checklists: http:// www.cdc.gov/phpr/ipp/inspection/index.htm
Criteria used to determine if an inspection may be required Biological safety level where work will be conducted Report of possible documentation tampering Report of packaging issues Risk of the agent and work conducted May not be inspected if the laboratory has been inspected by the Federal Select Agent Program
Import Permit Inspection Program Common descriptions of work associated with Import Permit Inspections: Human diagnostic testing Susceptibility testing Animal studies Exempt human specimens Molecular biology research
African Rodents Embargo includes all African rodents • All rodents imported directly from Africa • All rodents born in Africa, even if imported from a third country • All rodents with a native range that includes Africa, even if born outside of Africa Applies to live animals and animal products • Products may be imported without a permit if rendered noninfectious • Shipment must be accompanied by a statement of how the products were rendered noninfectious using one of the methods listed at http://www.cdc.gov/importation/animal-pro ducts.html Permission leter applicaton process • Entry allowed only for science, education or exhibition • Submit request to [email protected]
Human Tissues & Products Medical, research, or educational • Permit to import • Rendered non-infectious • No human pathogens and/or preserved tissue • Leak-proof container Commercial, collectible, or ceremonial • Not contaminated • Clean, dried • Leak-proof and puncture proof
Thank You • For more information, please contact: • Detroit Quarantine Station • Michigan | Ohio | Kentucky • Telephone: 734-955-6197 • http:// www.cdc.gov/quarantine/stati ons/detroit.html • Email: [email protected] Centers for Disease Control and Prevention Office of Public Health Preparedness and Response
Questions? For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Mailstop C-01, Atlanta, GA 30333 Telephone: 1-800-CDC-INFO (232-4636)/TTY: 1-888-2326348 E-mail: [email protected] Web: http://ww w.cdc.gov/importation/ National Center for Emerging and Zoonotic Infectious Diseases Division of Global Migration and Quarantine