Fitzpatrick S C, Vilim A, Lambert G, Yong M S, Brynes S D
Veterinary Drug Consultant, Rockville, Maryland 20853, USA.
Regul Toxicol Pharmacol. 1996 Oct;24(2 Pt 1):177-83. doi: 10.1006/rtph.1996.0123.
The Free Trade Agreement between the United States and Canada (FTA) went into effect January 1, 1989. To implement certain provisions of the agreement on technical regulations and standards, the United States Food and Drug Administration's Center for Veterinary Medicine, Health and Welfare Canada's Bureau of Veterinary Drugs, and Agriculture Canada established the Working Group on Veterinary Drug Tolerances. The progress of the working group and its continuing efforts to harmonize tolerances for approximately 15 veterinary drugs are discussed. This paper proposes use of the toxicologically determined acceptable daily intake (ADI) for the drug as the safety standard for reaching conclusions on the acceptability of residues in meat for human consumption. Specifically, the "equivalence" of different MRLs for the same veterinary drug would be determined by considering whether they are likely to result in dietary residues that exceed the other country's ADI for the drug. Estimates are made for the veterinary drugs lasalocid, fenbendazole, morantel tartrate, halofuginone, and tilmicosin. Based on these estimates, the U.S. and Canadian MRLs for each drug would be considered equivalent for trade purposes.
美国和加拿大之间的自由贸易协定(FTA)于1989年1月1日生效。为实施该协定中有关技术法规和标准的某些条款,美国食品药品监督管理局兽药中心、加拿大卫生部兽药局以及加拿大农业和农业食品部共同成立了兽药残留限量工作组。本文讨论了该工作组的进展情况及其为协调约15种兽药残留限量所做的持续努力。本文建议将通过毒理学确定的药物每日允许摄入量(ADI)用作判断供人类食用肉类中残留可接受性的安全标准。具体而言,同一兽药不同最大残留限量(MRL)的“等效性”将通过考虑它们是否可能导致膳食残留量超过另一国家该药物的ADI来确定。文中对拉沙洛西钠、芬苯达唑、酒石酸噻嘧啶、常山酮和替米考星等兽药进行了评估。基于这些评估结果,出于贸易目的,美加两国每种药物的MRL将被视为等效。