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.
To obtain additional information on how to request establishment of an import tolerance, please contact: Ms. Joanne M. Kla, Program and Operations Support Team (HFV-235), Division of Compliance, Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2733; phone: 240-402-5605; email: CVMImportTolerance@fda.hhs.gov.
The following tolerances have been established for residues of these unapproved new animal drugs in imported food:
|Drug||Species||Import Tolerances for Drug Residues in Edible Tissues||Year Established||Public Documents|
|lufenuron||salmonids||1.35 ppm lufenuron in muscle/adhering skin||2016||FOI Summary 1|
|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|
|azamethiphos||salmonids||0.02 ppm azamethiphos in muscle/adhering skin||2016||FOI Summary 1|
|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|
|teflubenzuron||Atlantic salmon||0.5 ppm telflubenzuron in muscle/adhering skin||2014||FOI Summary 1|
|fluazuron||cattle||7 ppm fluazuron in fat|
0.5 ppm fluazuron in liver
0.5 ppm fluazuron in kidney
7 ppm fluazuron in muscle
Persons using assistive technology may not be able to fully access information in these documents. For assistance, please call 240-402-7002.
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.