1. 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

2. CDC Quarantine Station Jurisdictions
San Diego VT ME MA NY PA NH WV VA MD NJ RI AZ IN WI KY MI OH IA MN MO IL NE KS SD ND AL TN GA SC NC AR LA MS OK
Atlanta
Chicago
Seattle WY ID WA AK OR MT NV UT NM CO
East TX
Miami FL
No.CA
So.CA
Los Angeles
San Francisco HI
Honolulu
Washington DC
El Paso
Houston
Newark
New York
Boston GU
San Juan
Minneapolis
Detroit
Anchorage
West TX PR
Philadelphia
Dallas
North TX CT DE
CDC Quarantine Station (n=20)

3. Usually it’s all sick people and TB

4. Our branch is part of the Division of Global Migration and Quarantine which works together to protect the health of globally mobile populations and US communities. The 5 main components of the division are shown on the slide:
Immigrant, Refugee and Migrant Health Branch:
Provides guidance for evaluation of high-risk migrants after they enter the United States, particularly refugees and adoptees
Provides technical instructions for medical screening of individuals applying for US residency
Works to improve the health of migrant populations relocating to the United States, including immigrants, refugees and adoptees
2. Travelers’ Health
In collaboration with the International Society for Travel Medicine, conducts surveillance for illness associated with travel through the Geosentinal Surveillance Network (a worldwide network of travel medicine clinics)
Provides health information to US residents traveling abroad and their physicians through the CDC Travelers’ Health website and the CDC Yellow Book (Health Information for International Travel), both of which they publish
3. US-Mexico Unit
Works with public health authorities in Mexico to coordinate binational preparedness and response for public health issues affecting the shared community around the US-Mexico land border.
4. Community Interventions for Infection Control Unit
Provides guidance and conducts research related to the use of nonpharmaceutical interventions to control large outbreaks such as an influenza pandemic.
Such interventions range from simple hygiene measures (cover your cough, wash your hands) to social distancing measures (e.g. school closures) to prevent spread of disease.
5. This presentation focuses on the Quarantine and Border Health Services Branch, which is responsible for protecting the public’s health through detection and response to communicable diseases related to travel and imported pathogens. 4

5. 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
Only in the case of these nine illnesses listed in the Executive Order signed by the President of the United States does CDC have the authority to isolate and quarantine persons.
SARS was added in 2003 during the outbreak in Asia and Toronto.
Novel/re-emergent influenza viruses (for example avian influenza) was added in 2005 as a preemptive legal maneuver to prepare for a possible pandemic situation.
Individuals arriving at U.S. ports of entry can be legally detained by the CDC if they are reasonably believed to be infected with an illness from this list. These persons would be isolated to prevent exposing others and offered medical care.
In addition, persons who may have been exposed to the sick individual can be legally detained in quarantine. This public health measure would be used to ensure that they do not expose others and remain quarantined for a duration to ensure they are no longer a health risk for the community. While in quarantine their health will be monitored. Anyone who becomes sick will be isolated and provided medical care and treatment.
Note: Executive Order was last updated by President George W. Bush on April 1, 2005 5

6. Other Communicable Diseases of Public Health Concern*
Malaria
Typhoid
Varicella
Rabies
Measles
Meningococcal disease
Legionellosis
Polio
Dengue
Zoonotic poxvirus
Pertussis
Mumps
Rubella
Infectious diarrhea
In addition, Under the PHS act, we have the authority to take measures to prevent the entry and spread of communicable diseases into the US from foreign countries. We use this authority to conduct surveillance and PH interventions for disease of public health significance. These diseases were selected based on their ability to spread and cause significant morbidity and/or mortality.
Much of our surveillance efforts illness response and control efforts are focused on TB among the Q diseases, and some diseases of PH concern more than others such as measles, varicella, rubella, mumps.
* Based on their ability to spread and cause significant illness or death 6

7. 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

8. The import permit program:
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 approved annually)
Conducting inspections (30-40 annually)

9. CDC DGMQ Regulatory Authority Importation of Animals & Animal Products
42 Code of Federal Regulations (CFR) 71 – Foreign Quarantine
Subpart F – Importations
71.51 – Dogs and cats
71.52 – Turtles, tortoises, and terrapins
71.53 – Nonhuman Primates
71.54 – Import Regulations
71.56 – African rodents
Subpart D – Health Measures at U.S. Ports
71.32(b) – Persons, carriers, things

10. 42 CFR 71.54 Infectious biological agent Infectious substance Vector
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.
Infectious substance
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.

11. 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.)

12. 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.

13. 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)

14. 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
Bacteria, viruses, fungi, prions, infectious nucleic acids

15. Importation of Public Health Importance
Review & Initial Determination
Possible Outcomes
Paperwork reviewed
Item is declared?
Determination is made
May be released
May be released conditionally or
May be denied
If paperwork is not in order, importer may need to provide additional information
If paperwork looks off, it could take some time
If all documents are available and known to the passenger, materials will be released
Formal Entry may be required

16. Permit Sticker

17. Carry-on or Checked Luggage
“Checked luggage” is NOT THE SAME as “Cargo”
Some items may NOT be imported in checked or carried on bags, such as NHP products

18. 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 (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 (b) or for a Class C aircraft cargo compartment in 14 CFR (c).

19. Emerging Agents/Outbreaks
Applications expedited – 24 hour release
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Avian influenza A virus (H7N9) or any novel or potentially pandemic influenza virus
Ebola surge outbreak
Material suspected to contain the Ebola virus
Cholera
Zika virus

20. APPLICATION FOR PERMIT TO IMPORT
SECTION A - Person Requesting Permit
• SECTION B - Sender
SECTION C - Shipment Information
SECTION D - Final Destination

21. 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

22. 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:

23. 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

24. 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

25. If you don’t know what it is…….
QARS

26. Let’s think about this……
If you didn’t package it?
If you didn’t collect it?
If you don’t know exactly what it is?
If you want to do some one a “favor”?

27. Guinea 10/30/2014 at UPS AWB Package
Package addressed to private home in NJ with contents labeled as “cotton”

28. 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 products.html
Permission letter application process
Entry allowed only for science, education or exhibition
Submit request to

29. 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

30. Example: Denied Entry Human Remains
Improper documentation
Contaminated specimens
Not properly sealed
These are NOT Exempt Human Specimens

31. These are NOT exempt human specimens they are larynges

32. Thank You For more information, please contact:
Detroit Quarantine Station
Michigan | Ohio | Kentucky
Telephone:
stations/detroit.html
Centers for Disease Control and Prevention
Office of Public Health Preparedness and Response

33. Contact information for the CDC Import Program
Import permit website is
FAQ
Import Permit Regulations
Inspection Checklist
Import Permit Applications
Guide for Shipping Infectious Substances

34. Questions?
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Mailstop C-01, Atlanta, GA Telephone: CDC-INFO ( )/TTY:
Web:
National Center for Emerging and Zoonotic Infectious Diseases Division of Global Migration and Quarantine