Import Tolerances

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug Availability Act of 1996 (ADAA), provides a basis for legally marketing food of animal origin that is imported into the United States and contains residues of animal drugs that are not approved or conditionally approved in the United States (unapproved new animal drugs). The ADAA granted the Food and Drug Administration the authority to establish or revoke tolerances for residues of such unapproved new animal drugs present in imported, animal-derived food products. It is unlawful to import animal-derived food that bears or contains residues of an unapproved new animal drug unless an import tolerance has been established for residues of that drug and any residues do not exceed that tolerance. The procedures and information needed to establish, amend, or revoke import tolerances for animal drugs are published in the FEDERAL REGISTER (FR Vol. 86 No. 180 pg. 52401, September 21, 2021).

The Center for Veterinary Medicine (CVM) Office of New Animal Drug Evaluation (ONADE) can receive and process electronic submissions for import tolerance files. Submissions to CVM can be made after first registering with FDA’s Electronic Submissions Gateway (ESG) and CVM’s Electronic Submission System. Additional information and a user guide on eSubmitter can be obtained at the CVM eSubmitter Resource Center or the “Getting Started with eSubmitter” websites. Contact ESGHelpDEsk@fda.hhs.gov for help with the ESG or cvmesubmitter@fda.hhs.gov for help using CVM’s eSubmitter tool.

To obtain additional information on how to request establishment of an import tolerance, please contact: Dr. Charli M. Long, Division of Human Food Safety (HFV-150), Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855-2733; email: CVMImportTolerance@fda.hhs.gov.

The following tolerances have been established for residues of these unapproved new animal drugs in imported food:

Requester	Drug	Species	Import Tolerances for Drug Residues in Edible Tissues	Year Established	Public Documents
Alvis, Inc.	erythromycin	Perciformes fish	pending	pending
Alvis, Inc.	ampicillin	Perciformes fish	pending	pending
Benchmark Animal Health Ltd.	imidacloprid	salmonids	0.6 ppm for imidacloprid in muscle with adhering skin	2022	FOI Summary ¹ EA/FONSI ²
Elanco US Inc.	monepantel	cattle	7 ppm monepantel sulfone in fat 2 ppm monepantel sulfone in liver 1 ppm monepantel sulfone in kidney 0.3 ppm monepantel sulfone in muscle	2022	FOI Summary ¹ EA/FONSI ²
Zoetis Inc.	hexaflumuron	salmonids	0.5 ppm for hexaflumuron in muscle with adhering skin	2021	FOI Summary ¹ EA/FONSI ²
Intervet, Inc.	emamectin	salmonids	100 ppb for emamectin B_1a in muscle with adhering skin	2019	FOI Summary ¹ EA/FONSI ²
ACD Pharmaceuticals	benzocaine	Atlantic salmon and rainbow trout	50 ppb benzocaine in muscle with adhering skin	2018	FOI Summary ¹ EA/FONSI ²
Novartis Animal Health US, Inc.	lufenuron	salmonids	1.35 ppm lufenuron in muscle/adhering skin	2016	FOI Summary ¹ EA/FONSI ²
Elanco Animal Health	monensin	sheep	100 parts per billion (ppb) monensin in fat 20 ppb monensin in liver 10 ppb monensin in muscle 10 ppb monensin in kidney	2016	FOI Summary ¹ EA/FONSI ²
FVG Ltd.	azamethiphos	salmonids	0.02 ppm azamethiphos in muscle/adhering skin	2016	FOI Summary ¹ EA/FONSI ²
Elanco Animal Health	monepantel	sheep	7 ppm monepantel sulfone in fat 5 ppm monepantel sulfone in liver 2 ppm monepantel sulfone in kidney 0.7 ppm monepantel sulfone in muscle	2016	FOI Summary ¹ EA/FONSI ²
Skretting Agricultural Research Center	teflubenzuron	Atlantic salmon	0.5 ppm teflubenzuron in muscle/adhering skin	2014	FOI Summary ¹ EA/FONSI ²
Ciba-Geigy Corporation	fluazuron	cattle	7 ppm fluazuron in fat 0.5 ppm fluazuron in liver 0.5 ppm fluazuron in kidney 7 ppm fluazuron in muscle	1996

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¹Under the provisions of the Freedom of Information Act (FOIA) and 21 CFR part 20, a summary of the basis of approval (FOI Summary) has been prepared.

²Based on its review of an environmental assessment (EA) submitted by the sponsor, the Agency has concluded that this action will not have a significant impact on the human environment and that an environmental impact statement is not required. A finding of no significant impact (FONSI) has been prepared.