Safety of residues

GL22 Safety reproduction Studies to evaluate the safety of residues of veterinary drug in human food reproduction studies... 

Indicate the most relevant NOEL for the evaluation of the safety of residues (mg/kg bw/day) ... 

A summary of the results of the various pharmacological studies, with particular emphasis on results which may be relevant to the evaluation of the safety of residues of the substance. A.2.1 Pharmacodynamics A.2.2 Pharmacokinetics... 

Complete, detailed proposed use patterns for the product, including dose rate, regimen, and proposed withholding period data showing the nature, level and safety of residues and metabolites in livestock and poultry... 

The EC Committee for Veterinary Medicinal Products (CVMP) -working group on the safety of residues of veterinary medicines... 

Ecotoxicity assessment and studies where necessary Safety of Residues... 

The CPMP working parties are concerned with biotechnology, efficacy, safety, and pharmacovigilance. The CVMP working parties are concerned with safety of residues, immunological veterinary products, veterinary pharmacovigilance, and efficacy. 

Similarly to the CPMP Working Parties, the Efficacy, Safety of Residues, Immunologicals, and Pharma-covigilance Working Parties develop guidelines for the testing and reporting requirements of studies for products for veterinary use. 

In 1985, the Codex Alimentarius Commission recognized that the occurrence and safety of residues of veterinary drugs in foods of animal origin was of significance to public health and consumer concern. Therefore, they established a Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF). The primary tasks of the CCRVDF include ... 

Recently, the VICH has completed the development of a Safety Working Group, which is responsible for evaluating the safety of residues of veterinary drugs in human food. 

FDA/CVM Guidance for Industry ( 159), Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food General Approach to Establish a Microbiological ADI-VICH GL-36. Finalized 02-10-05, http // www.fda.gov/cvm/guidance/guidel59.doc (accessed 02-18-05). 

Where does this lead us relative to the safety of residue levels of pesticides in food Most of the focus on MCS has been related to inhalational exposure of pesticides and volatile organic chemicals. This is central to the olfactory nerve pathway for chemicals to reach the brain. This is not relevant to our... 

Requirements to establish the safety of residues of veterinary drugs in food vary internationally. Table 3.7, later in the chapter, provides some of the national, regional, and internahonal guidelines and online sources for these requirements. 

Toxicological studies have been performed on nicarbazin and on mixtures of DNC and HDP and of nicarbazin and narasin. Some assessments" of the consumer safety of the use of nicarbazin in food-producing animals have set limits based on the toxicity of nicarbazin, but a more recent assessment has focused on the safety of residues of DNC.As DNC is absorbed less readily than nicarbazin and is of lower oral toxicity, it has been possible to recommend lower MRLs that more realistically reflect the risk to consumers from food residues of DNC. In the past, there have been a number of instances in which residues of DNC (the marker residue) have exceeded the low values for MRLs that were at the time based on the safety of nicarbazin. Higher and more realistic MRL values based on the safety of DNC make MRL violations less likely without compromising consumer safety. 

VICH (International Cooperation on Harmonisation of Technical Requirements of Veterinary Medicinal Products), Studies to evaluate the safety of residues of human drugs in human food General approach to establish a microbiological ADI, VICH Topic GL36 (Safety), 2005. http // www.ema.europa.eu/docs/en GB/document library/Scientific guideline/2009/ 10/WC500004537.pdf... 

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