Risk Assessment of Human Consumption of Meat From Fenbendazole-Treated Pheasants

Marta Carreño Gútiez,Beatriz Martínez-López,Lisa A Tell

doi:10.3389/fvets.2021.665357

Marta Carreño Gútiez, Beatriz Martínez-López + Show 1 more

Open Access

https://doi.org/10.3389/fvets.2021.665357

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Abstract

Fenbendazole is a benzimidazole-class anthelmintic that is used for the control of immature and adult stages of internal parasites, such as nematodes and trematodes, in domestic food-animal species. It is not approved by the United States Food and Drug Administration for treating pheasants despite Syngamus trachea being one of the most prevalent nematodes that parasitize pheasants. Because it is a highly effective treatment, e.g., 90% effectiveness against S. trachea, and there are very few alternative therapeutic options, this anthelminthic is used in an extra-label manner in the pheasant industry, but few studies have been conducted assessing risks to humans. Therefore, we conducted a risk assessment to evaluate the potential repeat-dose and reproductive, teratogenic, and carcinogenic human risks that may be associated with the consumption of tissues from pheasants that were previously treated with fenbendazole. We conducted a quantitative risk assessment applying both deterministic and stochastic approaches using different fenbendazole sulfone residue limits (tolerance, maximum residue limits, and analytical limit of detection) established in different poultry species by the Food and Drug Administration, the European Medicines Agency, and other regulatory agencies in Japan, Turkey, and New Zealand. Our results show that fenbendazole poses minimal risk to humans when administered to pheasants in an extra-label manner, and a comparison of different fenbendazole sulfone residue limits can help assess how conservative the withdrawal interval should be after extra-label drug use.

Highlights

According to the United States (US) Food and Drug Administration (FDA), pheasants are considered to be “minor” food-animal species and categorized as game birds
To know if the consumption of pheasant tissue from animals that were previously treated with fenbendazole was safe for humans, these calculations were compared with the actual consumption data in the United States of America (USA) and Belgium (EU) and to food consumption values for edible tissues established by the FDA/European Medicines Agency (EMA) and using all the fenbendazole sulfone No-observedadverse-effect levels (NOAEL) (Table 1) and all the established limits (Table 2)
When evaluating all the results obtained after performing the deterministic analysis of the human safety of consuming pheasant tissues with fenbendazole sulfone residues by applying three different Standard Uncertainty Factor (Ufs), we found that in very few cases, those values were considered unsafe (Supplementary Tables 1, 2)

Summary

Introduction

According to the United States (US) Food and Drug Administration (FDA), pheasants are considered to be “minor” food-animal species and categorized as game birds. Raised game birds with parasitic infections are effectively treated with fenbendazole [2]. Fenbendazole is a benzimidazole-class anthelmintic that is used for the control of immature and adult stages of some internal parasites, such as nematodes and trematodes in domestic food-animal species [3]. Depending on the severity of the parasitic infection, morbidity and mortality can be quite high in pheasants, among other game birds [4]. The most prevalent nematode in pheasants is Syngamus trachea [5]. Two studies evaluating captive pheasants showed prevalences of 0.51 [6] and 0.37 [5] of S. trachea.

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