Questions and Answers

Questions and Answers on the Direct Final Rule and Notice of Proposed Rulemaking to Establish a User Fee for Filovirus Testing of Nonhuman Primates

On February 10, 2012, the Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC) published two notices in the Federal Register: a Direct Final Rule (DFR) and Notice of Proposed Rulemaking (NPRM) proposing that CDC establish a testing program to perform the required filovirus antigen-capture testing on imported African green, cynomolgus, and rhesus monkeys that die during the required 31-day quarantine period. CDC proposes to charge importers a user fee of $540 to cover the costs of the testing program.

What does the term "nonhuman primate" mean?

The term "nonhuman primate" (NHP) means all nonhuman members of the order Primates, including, but not limited to, animals commonly known as monkeys, chimpanzees, orangutans, gorillas, gibbons, apes, baboons, marmosets, tamarins, lemurs, and lorises.

What is the risk to human health from NHPs?

NHPs may carry infectious diseases that are dangerous and sometimes fatal to humans. Examples of these diseases include tuberculosis, yellow fever, monkeypox, and hemorrhagic fever caused by filoviruses such as Ebola and Marburg. People working in temporary and long-term holding facilities or involved in transporting NHPs (e.g., cargo handlers and inspectors) are especially at risk for infection. Quarantine requirements for imported NHPs are designed to prevent these diseases from spreading to the public. Current CDC requirements on importation of nonhuman primates can be found at 42 CFR 71.53.

Why is filovirus antigen-capture testing required?

In 1990, CDC implemented a Special Permit notice requiring the filovirus antigen-capture testing for any imported African green, cynomolgus or rhesus monkey that dies during the required 31-day quarantine period because:

filoviruses have been associated with NHPs;
filoviruses cause a deadly bleeding disease in humans and NHPs;
filoviruses are not found in the United States; and
early detection of filoviruses may prevent spread of disease to humans and animals.

Why must CDC do the testing?

Since 1990, there has only been one commercial laboratory that had the capability of performing the required antigen-capture laboratory test. Recently, the laboratory informed CDC that it no longer has access to a biosafety level four (BSL-4) facility and that it would not be able to continue performing these tests. Under the Special Permit notice, CDC requires importers to have this special antigen-capture test performed. CDC has one of the few laboratories in the United States with the expertise, the required reagents, and the BSL-4 laboratory needed to do the testing.

Who is affected by the DFR and NPRM for filovirus testing?

The DFR and NPRM both apply to importers of African green, cynomolgus, and rhesus monkeys into the United States, including existing importers and individuals who apply to become an importer.

Are there any additional requirements for importers based on the DFR or NPRM for filovirus testing?

No, there are no additional requirements for importers based on the DFR or NPRM. The only changes are in the laboratory that is performing the testing and the cost of each filovirus antigen-capture test.

How often are filovirus antigen-capture tests conducted?

The number of tests performed can vary from year to year. Based on past experience, about 100 to 150 requests are made each year for filovirus antigen-capture testing.

Why is a user fee being charged by CDC?

A user fee has been charged to NHP importers by the commercial laboratory since 1990, when the Special Permit requirement was put into place. Because there is currently no commercial laboratory that can perform the test, these proposed rules will establish a mechanism for CDC to collect a user fee to cover the costs of testing. The proposed CDC user fee, adjusted for inflation, is $540 per test. The fee covers CDC’s costs to perform the tests, including the materials used to conduct the test. It also covers personnel and administrative costs and the cost of operating the BSL-4 laboratory facility during testing.

Will the cost of the user fee ever change?

At this time CDC is not planning to change the user fee. However, after the regulation is final, if the costs do change, CDC will contact registered importers directly and publish another public notice in the Federal Register.

Will the location for testing ever change?

In the future, if a commercial laboratory within the United States becomes available to perform the filovirus testing as required by CDC, NHP importers may choose which facility to submit the samples to for testing.

Why is HHS/CDC publishing two rules for the same change at the same time?

HHS/CDC is publishing a Direct Final Rule (DFR) and Notice of Proposed Rulemaking (NPRM) at the same time because NHP importers are required to test for filoviruses and commercial laboratories are unable to offer this test at this time. Both rulemaking processes are being used to ensure that no time is lost in providing an alternative testing site and method for recovering the cost for the testing.

How do this DFR and NPRM for filovirus testing relate to the NPRM on Regulations for the Importation of Nonhuman Primates that was published on January 5, 2011?

All of these proposed rules are intended to amend the Foreign Quarantine Regulations for the Importation of Nonhuman Primates (42 CFR Part 71.53). Among other proposed changes, the NPRM on Regulations for the Importation of Nonhuman Primates published in January 2011, proposes to include a requirement for filovirus antigen-capture testing which is currently required under the Special Permit notice. However, the January 2011 NPRM on Regulations for the Importation of Nonhuman Primates does not provide details about location and cost for this testing. The DFR and NPRM to Establish a User Fee for Filovirus Testing of Nonhuman Primates published on February 10, 2012, provide these details by proposing that CDC perform the testing and establish a user fee.

The public comment period for the NPRM on Regulations for the Importation of Nonhuman Primates ended on April 25, 2011, and CDC is now working toward finalizing the proposed rule. The public comment period for the DFR and NPRM to Establish a User Fee for Filovirus Testing of Nonhuman Primates will end on April 10, 2012.