Questions and Answers on the Final Rule to Establish a User Fee for Filovirus Testing of Nonhuman Primates
On February 12, 2013, the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) published a final rule establishing a user fee for filovirus testing of nonhuman primates (NHPs). According to the final rule, CDC will charge a $540 user fee to cover the costs for performing the required filovirus antigen-capture testing on imported Old World NHPs that die for any reason other than trauma during the mandatory 31-day quarantine period or that have illness consistent with filovirus infection. This rule became effective on March 14, 2013.
What does the term "nonhuman primate" mean?
Primates are members of the group of animals that includes human beings, apes, and monkeys. The term "nonhuman primate" (NHP) means all nonhuman members of the order Primates. Other Primates include, but are not limited to, baboons, chimpanzees, gibbons, gorillas, lemurs, lorises, marmosets, orangutans, and tamarins. Old World NHP refers to all nonhuman primates from Asia or Africa.
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.
What measures are put in place to protect human health from the risk of NHP-associated diseases?
Quarantine requirements for imported NHPs are designed to prevent these diseases from spreading to the public. Current CDC requirements on importation of (NHPs) can be found at 42 CFR 71.53. On February 12, 2013, CDC published a separate final rule updating its requirements for the importation of NHPs.
Why is filovirus antigen-capture testing required?
On February 12, 2013, CDC published a separate final rule updating its requirements relating to the importation of NHPs. Filovirus antigen-capture testing is required for all Old World NHPs that die for any reason other than trauma during the mandatory 31-day quarantine period or that have illness consistent with filovirus infection. This is because:
- filoviruses have been found in these NHPs;
- filoviruses cause a deadly bleeding disease in both 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?
Under the separately published final rule, filovirus antigen-capture testing is required for all Old World NHPs that die for any reason other than trauma during the mandatory 31-day quarantine period or that have illness consistent with filovirus infection. Since 1990, only one commercial laboratory has had the capability to perform the filovirus antigen-capture laboratory test which has been a long-standing CDC requirement. In 2011, the laboratory informed CDC that it could not continue performing these tests. CDC has one of the few laboratories in the United States with the expertise, the required testing materials, and the biosafety level 4 (BSL-4) laboratory needed to do the testing.
Who is affected by the Direct Final Rule for filovirus testing?
The final rule advises nonhuman primate importers that they may send NHP liver samples to CDC for filovirus testing and allows CDC to charge a user fee for performing this service. Filovirus antigen-capture testing is required for all Old World NHPs that die for any reason other than trauma during the mandatory 31-day quarantine period or that have illness consistent with filovirus infection.
Are there any additional requirements for importers based on the final rule for filovirus testing?
On February 12, 2013, CDC published a separate final rule updating its requirements for the importation of NHPs. Importers should make themselves aware of the requirements of the new final rule. However, there are no additional requirements based on this final rule, which only advises importers that CDC is offering filovirus antigen-capture testing on NHP liver samples and allows CDC to charge a user fee for this service.
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 CDC charging a user fee?
A user fee has been charged to NHP importers by the commercial laboratory since 1990, when the testing requirement was put into place. Because currently no commercial laboratory can perform the test, this final rule establishes a mechanism for CDC to collect a user fee to cover the costs of testing. The fee covers CDC’s costs to perform the tests, including the materials used. It also covers personnel and administrative costs and the cost of operating the laboratory facility during testing. The CDC user fee is $540 per test.
Will the cost of the user fee ever change?
Changes in the cost to perform the tests, personnel and administrative costs, or the cost of operating the laboratory facility could change and could result in a need to change the user fee. Any changes in the user fee schedule will be published in the Federal Register.
How do importers pay the user fee?
Guidance for submitting samples and payment to CDC for filovirus testing will be provided to each registered NHP importer.
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 testing facility to use.
Can I submit comments on the final rule for filovirus testing?
Public comments on the final rule for filovirus testing closed on April 10, 2012. This final rule became effective March 14, 2013 and contains CDC’s response to all public comments it received.
Where can I find more information?
For more information, read the final rule on filovirus testing.