Violative drug residues in animal-derived foods are a global food safety concern. The use of a fixed main metabolite to parent drug (M/D) ratio determined in healthy animals to establish drug tolerances and withdrawal times in diseased animals results in frequent residue violations in food-producing animals. We created a general physiologically based pharmacokinetic model for representative drugs (ceftiofur, enrofloxacin, flunixin, and sulfamethazine) in cattle and swine based on extensive published literature. Simulation results showed that the M/D ratio was not a fixed value, but a time-dependent range. Disease changed M/D ratios substantially and extended withdrawal times; these effects exhibited drug- and species-specificity. These results challenge the interpretation of violative residues based on the use of the M/D ratio to establish tolerances for metabolized drugs.

Results of the present study suggested that outcome for horses with DDFT injuries treated medically depended on injury severity, presence of concurrent injury to other structures in the foot, type of activity, and owner compliance with specific treatment recommendations. Although some horses successfully returned to prior activity, additional treatment options are needed to improve outcome in horses with severe injuries and to improve long-term prognosis.

Cattle injuries can occur during transportation due to vehicle design, transport conditions, and loading or unloading procedures and lead to carcass bruising and economic loss due to decreased carcass value. The objectives of this study were to determine whether a relationship exists between trauma incurred during unloading and prevalence of carcass bruising in finished beef cattle at commercial slaughter facilities and determine related risk factors which contribute to both trauma and carcass bruising. Breed (classified as either Holstein cattle or beef breeds), sex, distance traveled, and trailer type (“fat/feeder combination” vs. “fat” trailer) were considered risk factors which may contribute to traumatic event prevalence. When carcass bruise prevalence within each lot was used as the dependent variable, breed, sex, distance traveled, traumatic event prevalence, ribeye area, fat thickness, yield grade, and average carcass weight were considered potential risk factors. Carcass bruises were categorized by location and size, according to the Harvest Audit Program Carcass Bruise Scoring System. Traumatic events were observed while cattle exited trailers onto the unloading docks, and were categorized by location on the animal. Average traumatic event prevalence per lot was 20.4% (± 1.11%). Average carcass bruise prevalence by lot was 68.2% (± 1.15%). There was an interaction between breed and trailer type when multiple linear regression was used to explore variables contributing to traumatic events observed at unloading (P ≤ 0.05). Traumatic events were not associated with prevalence of carcass bruising, while average carcass weight and breed were associated with carcass bruising prevalence. Carcass bruising was more prevalent in Holstein cattle than in cattle which were predominantly beef breeds (P ≤ 0.01). Average carcass weight was negatively associated with carcass bruise prevalence (P ≤ 0.05). The association between traumatic events at unloading and carcass bruising is not significant when multiple variables are considered, indicating that bruising may occur at numerous other points prior to and during the transportation process, including loading and transport, and that other variables can contribute to carcass bruise prevalence. These areas should be explored to determine all potential causes of bruising in beef carcasses, and to help implement prevention practices.

Risk assessment is an important step in the process of deregulating a genetically modified (GM) crop and its derived products for food and feed. The European Food Safety Authority (EFSA) evaluates safety by testing for the average equivalence between the GM crop and a group of commercial non‐GM reference varieties representing a population of crops with a history of safe use. This paper defines the equivalence tests described by EFSA in terms of parameters in the mixed model. A basic strategy for the equivalence tests is proposed. Generalized inference is employed to overcome two challenges in testing equivalences: the unconventional parameter of interest and the limited number of reference varieties. Balanced or partially balanced incomplete designs are recommended in equivalence testing. Simulation indicates this new method maintains the desired type I error rate and holds good power under practical designs. An illustrative data example is used to demonstrate the execution of the proposed method in SAS. Finally, issues associated with the equivalence tests and suggested topics for future research are discussed.

SUMMARYSafety evaluation of a genetically modified (GM) crop is accomplished by establishing its substantial equivalence to non-GM reference crops with a history of safe use. Testing hypotheses of equivalence rather than difference is the appropriate statistical approach. A necessary first step in this regard is to specify a reasonable equivalence criterion that includes a measure for discrepancy between the GM and reference crops as well as a regulatory threshold. The present work explored several equivalence criteria and discussed their pros and cons. Each criterion addresses one of three ordered classes of equivalence: super, conditional and marginal equivalence. Their implications were investigated over an array of parameter values estimated from a real-world dataset. Marginal equivalence was identified as adhering most closely to the concept of substantial equivalence. Because conditional equivalence logically implies marginal equivalence and is practically quantifiable from current field designs, the present work recommends conditional equivalence criteria while encouraging producers to improve their design to enable testing marginal equivalence in the future. Contrary to concerns of the ag-biotech industry, empirical evidence from recent publications indicates that a linear mixed model currently implemented by the European Food Safety Authority is adequate for assessing equivalence despite its lack of genotype-by-environment interaction terms.