Federal Food Safety and Veterinary Office (FSVO), Risk Assessment Division, Schwarzenburgstrasse 155, 3003, Bern, Switzerland.
Arch Toxicol. 2018 Jan;92(1):157-167. doi: 10.1007/s00204-017-2052-4. Epub 2017 Sep 19.
Dietary risk assessment (DRA) of pesticides includes the estimation of chronic and acute exposures from crop residues, but assesses acute exposures only for pesticides with an acute reference dose (ARfD). Acute estimation uses high percentiles of food consumption surveys which are considerably higher than per capita lifetime averaged food consumption values which are used for chronic estimations. Assessing acute risks only for pesticides with an ARfD tacitly assumes that chronic risk assessment covers also intermittent occurring exposures which could significantly exceed chronic estimates. The present investigation conducted on 2200 rat studies from 436 pesticides provides evidence demonstrating that pesticides with and without ARfD have no-observed-adverse-effect levels (NOAELs) which remain statistically unchanged in developmental, subacute, subchronic, reproductive and chronic toxicity studies covering exposure durations between 2 and 104 weeks. DRA of pesticides without ARfD needs reconsideration in light of equally high toxic dose levels after short- and long-term exposures, suggesting that intermittent exposures could be toxic, if they repeatedly exceed the acceptable chronic daily intake (ADI; conceptually the human counterpart of chronic animal NOAEL). As such risks are currently not assessed for pesticides without ARfD, the current DRA concept, which automatically presumes the use of low chronic exposure estimates entirely covers the risks of not acutely toxic pesticides, needs reconsideration. Furthermore, risks to intermittent occurring high exposures are probably also insufficiently assessed for pesticides where the ARfD is significantly higher than the ADI. As an example, the maximum residue limit for bifenazate in peaches is discussed.
膳食农药风险评估(DRA)包括对作物残留的慢性和急性暴露的估计,但仅对具有急性参考剂量(ARfD)的农药进行急性评估。急性评估使用食物消费调查的高百分位数,这些值远高于用于慢性评估的人均终生平均食物消费值。仅对具有 ARfD 的农药进行急性风险评估,默认假定慢性风险评估也涵盖了可能显著超过慢性估计的间歇性发生的暴露。本研究对 436 种农药的 2200 项大鼠研究进行了调查,提供了证据表明,具有和不具有 ARfD 的农药在发育、亚急性、亚慢性、生殖和慢性毒性研究中具有无观察不良效应水平(NOAEL),这些水平在涵盖 2 至 104 周暴露持续时间的研究中保持统计学不变。鉴于短期和长期暴露后同样高的毒性剂量水平,需要重新考虑对无 ARfD 的农药进行 DRA,这表明如果间歇性暴露反复超过可接受的慢性每日摄入量(ADI;概念上是慢性动物 NOAEL 的人类对应物),则可能具有毒性。由于目前对没有 ARfD 的农药没有评估这些风险,因此需要重新考虑当前的 DRA 概念,该概念自动假定使用低慢性暴露估计完全涵盖了非急性毒性农药的风险。此外,对于 ARfD 明显高于 ADI 的农药,对间歇性高暴露的风险也可能评估不足。以双苯噁唑酸在桃中的最大残留限量为例进行了讨论。