USDA-APHIS submits emergency exemption request for Tanidil for NWS; EPA grants request
On April 27, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service announced it had recently submitted an Emergency Exemption request to the U.S. Environmental Protection Agency to allow the importation and use of Elanco’s product, Tanidil.
Tanidil is a topical powder used to treat or prevent New World screwworm. On April 27, EPA granted USDA’s request and issued the Emergency Exemption under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act.
This authorization will support APHIS and state animal health officials in preparing for possible cases of NWS in livestock and other animals in the United States.
Product availability and import timeline
Tanidil is manufactured in Brazil and is not currently available in the United States, so it must be imported. With the EPA authorization finalized, APHIS will now begin the process of ordering and importing the product. Importation and relabeling are expected to take approximately 90 to 100 days from the time the official order is placed.
Some states also require state-level Tanidil registration, so APHIS will notify individual states of the emergency exemption and request registration in those states. As a result, Tanidil may not be available in certain states.
Distribution and use
Tanidil will be available only through APHIS via the National Veterinary Stockpile and will be distributed in coordination with state animal health officials and federally recognized tribal agencies. If there is an NWS incursion in the United States, the product may be used only by federal, state, local agencies, and federally recognized tribal agencies, and persons working under their supervision, including:
• Personnel at quarantine stations and areas;
• Veterinarians;
• Certified applicators at livestock and game facilities, zoos, wildlife facilities, animal rehabilitation centers; and
• Wildlife professionals.
This differs from typical processes, as the National Veterinary Stockpile does not usually distribute countermeasures directly to private entities.
Tanidil is authorized for use across multiple species, including livestock, captive and temporarily captured wildlife, and some species of zoo animals. It is not for use in domestic pets or birds. State officials or others using it should refer to and follow specific labelled instructions and product factsheet prior to use.
Once the product is imported, APHIS will share additional information about the requirements for use, including tracking and reporting requirements and required safety and personal protective equipment for use.
Tanidil is similar to the product Negasunt—which contains an added antibiotic and is regulated by the U.S. Food and Drug Administration rather than EPA. The two products have different distribution requirements and regulatory pathways, but both will only be available in the United States through the National Veterinary Stockpile. FDA granted an emergency use authorization for Negasunt recently.
Additional information will be shared at screwworm.gov as it is available.
