FDA rule addresses residue tolerance levels
By Steven Hedlund, SeafoodSource editor
19 April, 2012
The 90-day public comment period on a U.S. Food and Drug Administration (FDA) proposed rule involving the presence of banned animal drugs on imported food ends on Tuesday.
The rule would establish a framework for setting a tolerance level for residues of animal drugs that have not been approved for use in the United States. The FDA commissioner would be allowed to set a tolerance level if the manufacturer sufficiently proves that the drug is safe at a particular level. Essentially, the rule establishes methods for submitting, amending or revoking an import tolerance application.
Currently, the FDA has a zero tolerance policy for residues of unapproved animal drugs on imported food. Many U.S. seafood importers support the rule, the final step in the process of fully implementing the Animal Drug Availability Act of 1996. Imported seafood can be detained at the port of entry and barred from entering the marketplace for containing trace amounts — often measures in parts per billion — of an unapproved animal drug.
However, the Catfish Farmers of America (CFA) is among those opposing the rule because it says the rule could compromise the safety of the U.S. food supply.
“U.S. consumers deserve to know that their fish is safe,” said CFA President Butch Wilson. “This proposed rule would create a loophole where potentially dangerous and banned drugs, reach American dinner tables. If a drug hasn’t been approved for use here in the United States, it should not be allowed in imports. We strongly urge the Obama administration to reconsider this ill-advised rule.
“It is concerning that the administration is moving toward allowing unapproved drugs to be used in imported food while those same drugs are banned for use here in the United States — it is a double standard,” added Wilson.
19 April, 2012