21 C.F.R. § 556.3

Current through October 31, 2024

Section 556.3 - Definitions

As used in this part:

Acceptable daily intake (ADI) means the daily intake which, during up to an entire life of a human, appears to be without adverse effects or harm to the health of the consumer. The ADI most often will be set on the basis of the drug's toxicological, microbiological, or pharmacological properties. It is usually expressed in micrograms or milligrams of the chemical per kilogram of body weight per day.

Acute reference dose (ARfD) means 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.

Edible tissues means muscle, liver, kidney, fat, skin with fat in natural proportions, whole eggs, whole milk, and honey.

Marker residue means the residue whose concentration is in a known relationship to the concentration of total residue in an edible tissue.

mg/kg means milligrams per kilogram.

Not required, in reference to tolerances in this part, means that at the time of approval:

(1) No withdrawal period was necessary for residues of the drug to deplete to or below the concentrations considered to be safe, or an adequate withdrawal period was inherent in the proposed drug use, and there was a rapid depletion of residues, so there was no concern about residues resulting from misuse or overdosing; or

(2) No withdrawal period was necessary because the drug was poorly absorbed or metabolized rapidly so as to make selection of an analyte impractical or impossible.

ppb means parts per billion (equivalent to nanograms per gram (ng/g) or [MICRO]g/kg).

ppm means parts per million (equivalent to micrograms per gram ([MICRO]g/g) or mg/kg).

ppt means parts per trillion (equivalent to picograms per gram (pg/g) or nanograms per kilogram (ng/kg)).

Residue means any compound present in edible tissues that results from the use of a drug, and includes the drug, its metabolites, and any other substance formed in or on food because of the drug's use.

Target tissue means the edible tissue selected to monitor for residues in the target animals.

Tolerance means the maximum concentration of a marker residue, or other residue indicated for monitoring, that can legally remain in a specific edible tissue of a treated animal.

Total residue means the aggregate of all compounds that results from the use of an animal drug, including the drug, its metabolites, and any other substances formed in or on food because of such drug use.

[MICRO]g/kg means microgram per kilogram.

Zero, in reference to tolerances in this part, means any residues detected in the edible tissue renders it unsafe.

21 C.F.R. §556.3

84 FR 32993 , 9/9/2019