The FDA’s Center for Veterinary Medicine (CVM) last week proposed to update its rules regarding tolerances for residues of new animal drugs in food. The new proposal would, according to CVM, standardize, simplify, and clarify the standards of determination and codification style for tolerances. The document also revises or removes some of the previously
The proposal revises definitions for ``marker residue'', ``tolerance'', ``not required'', and ``zero.” FDA proposes removing the definition for “acceptable single-dose intake (ASDI)'' and adding a definition for ``acute reference dose''.
FDA proposes to add the definition of acute reference dose (ARfD) to mean ``an estimate of the amount of residues expressed on a body weight basis that can be ingested in a period of 24 hours or less without adverse effects or harm to the health of the human consumer.'' ARfD would be used in place of ASDI.
Previously, FDA proposed to define the ASDI as ``the amount of total residue that may safely be consumed in a single meal. The ASDI may be used to derive the tolerance for residue of a drug at the injection site where the drug is administered according to the label.''
The FDA is accepting public comments beginning on October 28, 2016. To electronically submit comments to the docket, visit the government regulations website and type FDA-2012-N-1067 in the search box.
Read the full proposal from FDA/CVM.