Frequently Asked Questions on Filing Import Data Electronically

Electronic Filing of Certain Import Data into the Document Image System through the Automated Commercial Environment

On December 30, 2016, the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) published new guidance in the Federal Register, titled “Electronic Filing of Certain Import Data into the Document Image System through the Automated Commercial Environment.” The guidance was posted for importers, exporters, and brokers, and explains a new requirement for electronic filing of documents in the International Trade Data System (ITDS) when importing certain items regulated by the CDC, such as dogs, monkeys, or animal products capable of causing human disease. The guidance became effective on December 30, 2016.

What has not changed: As applicable, CDC-regulated imports must be accompanied by specific documents when imported into the United States.

What has changed: Import documents for certain CDC-regulated imports must be filed electronically through the U.S. Customs and Border Protection (CBP)’s Automated Commercial Environment (ACE), using the Document Image System (DIS).

  1. Animal and Plant Health Inspection Service (APHIS)/CDC Form 2 – Application to Transfer Select Agents and Toxins (42 CFR part 73)
  2. CDC Form 0.0728 – Permit to Import or Transfer Etiologic Agents or Vectors of Human Disease (42 CFR section 71.54)
  3. Rabies Vaccination Certificate (42 CFR section 71.51)
  4. CDC Approval of Confinement Agreement Issuance Letter (42 CFR section 71.51) (Note: We expect this form will be replaced by a “CDC Import Permit for a Dog Unimmunized against Rabies” in early 2017.)
  5. CDC Permission Letter – Permit to Import African Rodents, Civets, or Turtles (42 CFR sections 71.56, 71.32(b), and 71.52)
  6. CDC Nonhuman Primate Notification Message – Confirmation from the CDC to the importer that CDC has given permission to import the nonhuman primate shipment (42 CFR section 71.53)
  7. Certification statement of a material that is not known to contain or suspected of containing an infectious biological agent or that has been rendered noninfectious (42 CFR section 71.54)
  1. For select agents and toxinsExternal, an APHIS/CDC Form 2 may be required: www.selectagents.gov/forms.htmlExternal
  2. CDC Form 0.0728 – Permit to Import or Transfer Etiologic Agents or Vectors of Human Disease: www.cdc.gov/od/eaipp/index.htm
  3. A rabies vaccination certificate for a dog must be issued by a licensed veterinarian.
  4. and 5. For certain animals and animal products capable of causing human disease, you must have a permit or letter of permission. See www.cdc.gov/importation/bringing-an-animal-into-the-united-states/index.html.
  5. The CDC Nonhuman Primate Notification Message is automatically generated when a registered importer notifies CDC of an incoming shipment. Only registered importers may bring nonhuman primates into the United States. For information on how to become a registered importer, see: www.cdc.gov/importation/bringing-an-animal-into-the-united-states/monkeys.html.
  6. Importers must provide a certification statement or statement of noninfectiousness for material that is not known or suspected to contain an infectious biological agent. For biological materials that have been rendered noninfectious, importers must have documentation of how the material was rendered noninfectious.

The certification statement must include:

  • A detailed description of the material; and
  • A statement on official letterhead signed by the sender or the recipient clearly stating: (1) that the material is not known to contain or suspected of containing an infectious biological agent; and (2) how the person making the certification knows that the specimen does not contain an infectious biological agent; or why that person believes there is no reason to suspect that the specimen contains an infectious biological agent; or a detailed description of how the material was rendered noninfectious.

For acceptable means of rendering materials noninfectious, see “Rendering Animal Products Non-infectious” on Bringing Animal Products into the United States.

Filing electronically will expedite the release process of the imported item or animal because documentation can be verified and approved before the item or animal arrives. The 2006 Security and Accountability for Every Port Act (SAFE Port Act)External mandated all agencies that require documentation for clearing or licensing the importation and exportation of cargo participate in ITDS. Executive Order 13659, Streamlining the Export/Import Process for America’s BusinessesExternal, directed those agencies to use ITDS by December 2016. As part of the mandate, CDC is providing guidance on how to file importation documents within this new system.

Yes. It will expedite the approval and release process at the port of entry.

The documentation can be reviewed and pre-approved, but the animals cannot be released before their health is verified upon arrival at the US port of entry.

The pilots are completed but will officially conclude upon CBP’s publication of the Document Image System (DIS) pilot closeout Federal Register Notice.

No, processes to get permits will remain the same.

Yes, you can import CDC-regulated items. A broker is not required for importing formal, informal, or express courier shipments.

You can choose to self-file by providing paper documentation to CBP personnel at US ports of entry. They will file your documents in ACE. For CDC-regulated items not requiring electronic entry, you must send paper documentation with the item.

No, CDC is not collecting additional data. The agency is just changing how some data are submitted. Under the new policy, importers will continue to use the CDC application and filing processes. However, the processes will be electronic rather than paper for those CDC-regulated items filed within ACE.

CDC’s importation regulations are contained in the Code of Federal Regulations (CFR) title 42, part 71, subpart F (Public Health, Foreign Quarantine, Importations.)

For more information and to read the FRN, visit the Federal RegisterExternal.

Glossary of Terms

The Automated Commercial Environment (ACE) is this single system that allows companies and customs brokers to submit import information. The international trade community uses ACE to submit import data and communicate with CBP and other regulatory agencies. CBP and its partner government agencies uses ACE to determine if an import should be admitted into the United States.

The Security and Accountability for Every Port Act (SAFE Port Act) of 2006 mandated that all government agencies that regulate imports or exports participate in ITDS and use ACE by December 31, 2016.

Most importers choose to hire licensed representatives, known as customs brokers or entry filers. They can help the importer by submitting the necessary entry information and payments to CBP on behalf of the importer.

US Customs and Border Protection (CBP), an agency of the US Department of Homeland Security, provides security and facilitation operations at US ports of entry.

A customs entry is the declaration of information on imported or exported goods, prepared by a customs broker on an entry form or duty entry form, and submitted to customs. The entry summary refers to the documentation necessary to enable CBP to assess duties, collect statistics, and determine whether other requirements of law have been met.

The Document Image System (DIS) is a part of ACE that enables importers to send an importation document electronically. DIS also enables government personnel to expedite their review of documentation.

The International Trade Data System (ITDS) is a government-wide initiative that allows companies and customs brokers to submit import information into a single system.