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Functional feed for farm animals from oil mill waste waters
S10
Abstracts / Toxicology Letters 238S (2015) S2–S11
CEC 6: Modern Risk Assessment in Food Safety CEC6-1 What is GRAS? W. Hayes 1,∗ , C. Kruger 2 1 2
Harvard University, Andover, United States Spherix, Rockville, United States
“GRAS” is an acronym for the phrase Generally Recognized As Safe and is a regulatory process peculiarly unique to the United States. Under sections 201(s) and 409 of the US Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. Science and regulation are never static, nor should they be. Therefore, the risk assessment process for food additives, including the GRAS process, must constantly question old paradigms, test new methodologies, and incorporate better strategies and must do so in a thoughtful, deliberate and unbiased fashion to keep the processes that work well while incorporating innovations that add value. The GRAS paradigm is a rigorous scientific peer-review process based on publicly available studies and consensus of opinion among a community of qualified experts designed to safeguard the public health. Because the GRAS process relies on publicly available data, GRAS is one of the most transparent and robust processes in the world and one of the reasons that both innovation and assurance of safety can be incorporated into the US food supply. Thus, eliminating processes that have served well for 55 years with no evidence that there is a compromise in the assurance that we are protecting public health is unconscionable. http://dx.doi.org/10.1016/j.toxlet.2015.08.067
CEC6-2 Functional feed for farm animals from oil mill waste waters D. Kouretas University of Thessaly, Biochemistry-Biotechnology, Larisa, Greece Olive oil obtained from olive tree fruit is a main part of the Mediterranean diet. Many of the beneficial effects of olive oil on human health are attributed to its polyphenolic compounds (e.g. tyrosol, hydroxytyrosol, oleuropein and pinoresinol) having potent antioxidant property. Apart from olive oil itself, some of the byproducts of olive oil production such as olive oil mill waste water (OMWW) present important bioactivities. Apart from toxic effects, disposal of OMWW causes serious environmental problems such as soil contamination, water body pollution, underground seepage and odour. Our research group has developed a patented methodology for obtaining polyphenols from OMWW based on the use of ceramic membrane microfiltration. A major problem of this methodology was that a large quantity of byproducts was produced. These byproducts contain a part of the OMWW polyphenols and have to be discharged in an ecofriendly and sustainable way. For this purpose, in the present study, these byproducts were used for making broilers’ feed containing antioxidant compounds as a disposable method. In farm animals, oxidative stress may be involved in several pathological conditions (e.g. pneumonia, sepsis)
affecting animal production and general welfare. Thus, the administration of antioxidants to the farm animals has been suggested for protecting them from such pathologies or mitigating their symptoms. The antioxidant effects of the feed containing the byproducts from OMWW processing were assessed by measuring oxidative stress biomarkers (GSH, total antioxidant activity, catalase, lipid peroxidation, protein carbonyls) in broilers’ blood and different tissues (i.e. muscle, cardiac and liver). The findings suggested for the first time that feed containing products from OMWW processing could be used for enhancing broilers’ redox status. http://dx.doi.org/10.1016/j.toxlet.2015.08.068
CEC6-3 The Margin-of-Exposure approach in food safety risk assessment: Acrylamide as an example D. Schrenk University of Kaiserslautern, Food Chemistry and Toxicology, Kaiserslautern, Germany Chemical/toxicological risk assessment in food safety relies on a variety of general principles. However, methods and approaches may differ in fields such as the risk assessment of contaminants, residues, food contact materials, natural constituents etc. Contaminants in food are defined chemicals which are neither present naturally nor have been added or used on purpose during manufacturing including the agricultural production (plants, animals). The risk assessment of contaminants usually starts with a description of the chemical and physico-chemical properties, followed by a description of the origin, the methods of production, use, occurrence and levels in food, and in environmental samples. Subsequently, the exposure is usually analyzed based on probabilistic considerations taking into account consumption data and their distribution in the cohort of interest. 50th and 95th percentile of exposure can thus be calculated for groups in the population. The description of the hazards (toxicological properties) of the compound, both in animals and humans (if available) and a characterization of the risk (exposure combined with hazard) follow. Mechanistic and in vitro considerations aim at an understanding of the mode(s) of action of the chemical. The latter becomes more and more relevant for interspecies extrapolations since some hazards are known to occur mainly in rodents etc. but not to comparable extend in humans. Distinction between genotoxic and non-genotoxic (MoA), in particular if positive carcinogenicity findings are available, is of particular importance. In case of genotoxic carcinogens, a Margin of Exposure (MOE) approach is widely used describing the margin between relevant human exposure and a carcinogenic benchmark dose in animals. For benchmark dose calculation a dose–response modeling with sufficient data is required. In case of non-genotoxic chemicals a NOAEL or BD is used as point of departure (POD). This is divided by an appropriate safety factor in order to derive a tolerable daily intake as a health-based guidance value. In many cases, the database for one or more of the required elements in risk assessment is insufficient. In these cases, the use of surrogate parameters such as read-across from ‘related’ chemicals or TTC (threshold of toxicological concern) are under discussion. http://dx.doi.org/10.1016/j.toxlet.2015.08.069
Abstracts / Toxicology Letters 238S (2015) S2–S11
CEC 6: Modern Risk Assessment in Food Safety CEC6-1 What is GRAS? W. Hayes 1,∗ , C. Kruger 2 1 2
Harvard University, Andover, United States Spherix, Rockville, United States
“GRAS” is an acronym for the phrase Generally Recognized As Safe and is a regulatory process peculiarly unique to the United States. Under sections 201(s) and 409 of the US Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. Science and regulation are never static, nor should they be. Therefore, the risk assessment process for food additives, including the GRAS process, must constantly question old paradigms, test new methodologies, and incorporate better strategies and must do so in a thoughtful, deliberate and unbiased fashion to keep the processes that work well while incorporating innovations that add value. The GRAS paradigm is a rigorous scientific peer-review process based on publicly available studies and consensus of opinion among a community of qualified experts designed to safeguard the public health. Because the GRAS process relies on publicly available data, GRAS is one of the most transparent and robust processes in the world and one of the reasons that both innovation and assurance of safety can be incorporated into the US food supply. Thus, eliminating processes that have served well for 55 years with no evidence that there is a compromise in the assurance that we are protecting public health is unconscionable. http://dx.doi.org/10.1016/j.toxlet.2015.08.067
CEC6-2 Functional feed for farm animals from oil mill waste waters D. Kouretas University of Thessaly, Biochemistry-Biotechnology, Larisa, Greece Olive oil obtained from olive tree fruit is a main part of the Mediterranean diet. Many of the beneficial effects of olive oil on human health are attributed to its polyphenolic compounds (e.g. tyrosol, hydroxytyrosol, oleuropein and pinoresinol) having potent antioxidant property. Apart from olive oil itself, some of the byproducts of olive oil production such as olive oil mill waste water (OMWW) present important bioactivities. Apart from toxic effects, disposal of OMWW causes serious environmental problems such as soil contamination, water body pollution, underground seepage and odour. Our research group has developed a patented methodology for obtaining polyphenols from OMWW based on the use of ceramic membrane microfiltration. A major problem of this methodology was that a large quantity of byproducts was produced. These byproducts contain a part of the OMWW polyphenols and have to be discharged in an ecofriendly and sustainable way. For this purpose, in the present study, these byproducts were used for making broilers’ feed containing antioxidant compounds as a disposable method. In farm animals, oxidative stress may be involved in several pathological conditions (e.g. pneumonia, sepsis)
affecting animal production and general welfare. Thus, the administration of antioxidants to the farm animals has been suggested for protecting them from such pathologies or mitigating their symptoms. The antioxidant effects of the feed containing the byproducts from OMWW processing were assessed by measuring oxidative stress biomarkers (GSH, total antioxidant activity, catalase, lipid peroxidation, protein carbonyls) in broilers’ blood and different tissues (i.e. muscle, cardiac and liver). The findings suggested for the first time that feed containing products from OMWW processing could be used for enhancing broilers’ redox status. http://dx.doi.org/10.1016/j.toxlet.2015.08.068
CEC6-3 The Margin-of-Exposure approach in food safety risk assessment: Acrylamide as an example D. Schrenk University of Kaiserslautern, Food Chemistry and Toxicology, Kaiserslautern, Germany Chemical/toxicological risk assessment in food safety relies on a variety of general principles. However, methods and approaches may differ in fields such as the risk assessment of contaminants, residues, food contact materials, natural constituents etc. Contaminants in food are defined chemicals which are neither present naturally nor have been added or used on purpose during manufacturing including the agricultural production (plants, animals). The risk assessment of contaminants usually starts with a description of the chemical and physico-chemical properties, followed by a description of the origin, the methods of production, use, occurrence and levels in food, and in environmental samples. Subsequently, the exposure is usually analyzed based on probabilistic considerations taking into account consumption data and their distribution in the cohort of interest. 50th and 95th percentile of exposure can thus be calculated for groups in the population. The description of the hazards (toxicological properties) of the compound, both in animals and humans (if available) and a characterization of the risk (exposure combined with hazard) follow. Mechanistic and in vitro considerations aim at an understanding of the mode(s) of action of the chemical. The latter becomes more and more relevant for interspecies extrapolations since some hazards are known to occur mainly in rodents etc. but not to comparable extend in humans. Distinction between genotoxic and non-genotoxic (MoA), in particular if positive carcinogenicity findings are available, is of particular importance. In case of genotoxic carcinogens, a Margin of Exposure (MOE) approach is widely used describing the margin between relevant human exposure and a carcinogenic benchmark dose in animals. For benchmark dose calculation a dose–response modeling with sufficient data is required. In case of non-genotoxic chemicals a NOAEL or BD is used as point of departure (POD). This is divided by an appropriate safety factor in order to derive a tolerable daily intake as a health-based guidance value. In many cases, the database for one or more of the required elements in risk assessment is insufficient. In these cases, the use of surrogate parameters such as read-across from ‘related’ chemicals or TTC (threshold of toxicological concern) are under discussion. http://dx.doi.org/10.1016/j.toxlet.2015.08.069