scholarly journals GM organisms and the EU regulatory environment: allergenicity as a risk component

2005 ◽  
Vol 64 (4) ◽  
pp. 481-486 ◽  
Author(s):  
Howard V. Davies
Keyword(s):  
Risk Assessment ◽  
Recombinant Dna ◽  
Human Subjects ◽  
Protein S ◽  
Hazard Identification ◽  
Assessment Process ◽  
Guidance Document ◽  
Gm Crop ◽  
Gm Plants ◽  
Food And Feed

The European Food Safety Authority, following a request from the European Commission, has published a guidance document for the risk assessment of GM plants and derived food and feed to assist in the implementation of provisions of Regulation (EC) 1829/2003 of the European Parliament and Council on GM food and feed. This regulation has applied since 18 April 2004. In principle, hazard identification and characterisation of GM crops is conducted in four steps: characterisation of the parent crop and any hazards associated with it; characterisation of the transformation process and of the inserted recombinant DNA, including an assessment of the possible production of new fusion proteins or allergens; assessment of the introduced proteins (toxicity, allergenicity) and metabolites; identification of any other targetted and unexpected alterations in the GM crop, including changes in the plant metabolism resulting in compositional changes and assessment of their toxicological, allergenic or nutritional impact. In relation to allergenicity specifically, it is clear that this property of a given protein is not intrinsic and fully predictable but is a biological activity requiring an interaction with individuals with a predisposed genetic background. Allergenicity, therefore, depends on the genetic diversity and variability in atopic human subjects. Given this lack of complete predictability it is necessary to obtain, from several steps in the risk-assessment process, a cumulative body of evidence that minimises any uncertainty about the protein(s) in question.

scholarly journals Risk assessment for chemical substances: the link between toxicology and public health

1993 ◽  
Vol 9 (4) ◽  
pp. 439-447 ◽  
Author(s):  
Francisco J. R. Paumgartten
Keyword(s):  
Public Health ◽  
Risk Assessment ◽  
Health Effects ◽  
Scientific Data ◽  
Hazard Identification ◽  
Assessment Process ◽  
Chemical Substances ◽  
Risk Assessment Process ◽  
Adverse Health Effects ◽  
Adverse Health

Virtually all chemical substances may cause adverse health effects, depending on the dose and conditions under which individuals are exposed to them. Toxicology - the study of harmful effects of chemicals on living organisms - provides the scientific data base on which risk assessment of adverse health effects stands. Risk assessment (RA) is the process of estimating the probability that a chemical compound will produce adverse effects on a given population, under particular conditions of exposure. Risk assessment process consists of four stages: Hazard Identification (HI), Exposure Assessment (EA), Dose-Response Assessment (DRA), and Risk Characterization (RC). The risk assessment process as a whole makes it possible to carry out cost(risk)/benefit analysis, and thus risk management, on a rational basis. A capacity to undertake risk assessment is thus sine qua non for making decisions that are concerned with achieving a balance between economic development and adequate protection of public health and the environment.

scholarly journals Assessing and monitoring impacts of genetically modified plants on agro-ecosystems: the approach of AMIGA project

Entomologia ◽  
2014 ◽  
Author(s):  
S. Arpaia ◽  
A. Messéan ◽  
N.A. Birch ◽  
H. Hokannen ◽  
S. Härtel ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Genetically Modified ◽  
Genetically Modified Crops ◽  
Genetically Modified Plants ◽  
Guidance Document ◽  
Systematic Analysis ◽  
Gm Plants ◽  
Protection Goals ◽  
Functional Components ◽  
The Eu

The environmental impacts of genetically modified crops is still a controversial issue in Europe. The overall risk assessment framework has recently been reinforced by the European Food Safety Authority(EFSA) and its implementation requires harmonized and efficient methodologies. The EU-funded research project AMIGA − Assessing and monitoring Impacts of Genetically modified plants on Agro-ecosystems − aims to address this issue, by providing a framework that establishes protection goals and baselines for European agro-ecosystems, improves knowledge on the potential long term environmental effects of genetically modified (GM) plants, tests the efficacy of the EFSA Guidance Document for the Environmental Risk Assessment, explores new strategies for post market monitoring, and provides a systematic analysis of economic aspects of Genetically Modified crops cultivation in the EU. Research focuses on ecological studies in different EU regions, the sustainability of GM crops is estimated by analysing the functional components of the agro-ecosystems and specific experimental protocols are being developed for this scope.

scholarly journals New Approaches in Setting Drinking Water Standards

1992 ◽  
Vol 11 (3) ◽  
pp. 321-324 ◽  
Author(s):  
Edward V. Ohanian
Keyword(s):  
Risk Assessment ◽  
Drinking Water ◽  
Regulatory Process ◽  
Hazard Identification ◽  
Assessment Process ◽  
Weight Of Evidence ◽  
Maximum Contaminant Level ◽  
Drinking Water Standards ◽  
Contaminant Level ◽  
Human Exposure Assessment

The Safe Drinking Water Act Amendments of 1986 required that the U.S. Environmental Protection Agency (EPA) establish standards for 83 contaminants by June 1989, and at least 25 added standards by January 1991, then 25 more every three years hence. Conceptually, the regulatory process employed by EPA consists of two steps. First, a detailed health risk assessment of a contaminant is performed in order to determine the Maximum Contaminant Level Goal (nonenforceable health goal) in water that should result in no known or anticipated health effects and allows adequate margin of safety. Second, the results of risk assessment and management (taking best available technology, treatment techniques, cost, and other means into consideration) are combined to derive the Maximum Contaminant Level (enforceable standard) which is set as close to the MCLG as feasible. With this overall regulatory process in mind, a detailed risk assessment process (hazard identification, dose-response assessment, human exposure assessment, and risk characterization) used in setting drinking water standards is discussed. In addition, this article discusses our efforts in exploring new and improved risk assessment methodologies addressing the mechanism of action of toxicants, relative source contribution, weight of evidence, carcinogenic potency, and toxicokinetics.

scholarly journals Immunotoxicology—Regulatory and Risk Assessment Concepts

2000 ◽  
Vol 19 (2) ◽  
pp. 95-106 ◽  
Author(s):  
James A. Blank ◽  
Michael I. Luster ◽  
John J. Langone ◽  
Susan D. Wilson
Keyword(s):  
Risk Assessment ◽  
Drug Administration ◽  
Clinical Chemistry ◽  
Food And Drug Administration ◽  
Environmental Chemicals ◽  
Hazard Identification ◽  
Contact Hypersensitivity ◽  
Alternative Methods ◽  
Guidance Document ◽  
Central Research

Disclaimer: This article was written by Susan D. Wilson in her private capacity. No official support or endorsement by the Food and Drug Administration is intended or should be inferred. Address correspondence to James Blank, Pfizer Central Research (Mailbox #8014), Eastern Point Road, Groton, CT 06340, USA. E-mail: [email protected] This article provides a review of presentations given at the symposium on Immunotoxicology: Regulatory and Risk Assessment Concepts held at the American College of Toxicology meeting in Orlando, Florida, in November, 1998. Immune system alterations have typically been assessed by histopathology of select lymphoid tissue, clinical pathology, clinical chemistry, plaque forming cell assay for humoral immunity, and allergic contact hypersensitivity. Advances in immunology and molecular biology have led to various activities to optimize hazard identification and risk assessment processes and strategies for immunotoxicants. With such advances, regulatory agencies have been either implementing immunotoxicology guidance as part of the safety of medical devices, evaluating environmental chemicals, or considering immunotoxicologic criteria for nonclinical assessments. Reviews of the guidance document provided by the Food and Drug Administration (FDA)/Center for Device and Radiological Health and concepts being considered by the FDA/Center for Drug Evaluation and Research are presented. In addition, a review of the process for evaluation of the murine local lymph node assay by the Interagency Coordinating Committee on the Validation of Alternative Methods and the state of risk assessment for chemical-induced autoimmunity are presented.

Hazard identification, qualitative risk assessment and monitoring on the Western Corridor Recycled Water Project

2010 ◽  
Vol 5 (1) ◽  
Author(s):  
Annalie Roux ◽  
Cedric Robillot ◽  
Heather Chapman ◽  
Frederic Leusch ◽  
Mary Hodge ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Relative Risk ◽  
Hazard Identification ◽  
Assessment Process ◽  
Recycled Water ◽  
Ionic Charge ◽  
Water Project ◽  
Monitoring Programs ◽  
Qualitative Risk Assessment ◽  
Assessment And Monitoring

This paper explains how the results of the source water characterisation for the Western Corridor Recycled Water Project in South East Queensland was used to augment the qualitative water quality risk assessment process and design of the monitoring programs. Results were evaluated against health standards published in 2008 by Queensland Health and also against level of reporting. This determined the relative risk of exceeding the health standard for parameters detected in the source. The relative risk was used to inform the qualitative risk assessment as well as the frequency of monitoring in both the source and purified water. Categorising hazards using their ionic charge and hydrophobicity enabled the selection of indicators for both source and purified water compliance monitoring programs.

The Use of Basal Cytotoxicity and Target Organ Toxicity Tests in Hazard Identification and Risk Assessment

1992 ◽  
Vol 20 (3) ◽  
pp. 368-388 ◽  
Author(s):  
Michael Balls ◽  
Julia H. Fentem
Keyword(s):  
Risk Assessment ◽  
Hazard Identification ◽  
Assessment Process ◽  
Toxicity Tests ◽  
In Vitro Test ◽  
Human Risk Assessment ◽  
Human Risk ◽  
Test Systems ◽  
Vitro Test

Non-animal procedures, including in vitro test systems and test strategies, can already make a significant contribution to the background to risk assessment — in predicting both the toxic potential and toxic potency of chemicals, as well as, in some circumstances, the toxic hazard they may represent under specified conditions of exposure. They can be particularly useful for investigating molecular and cellular mechanisms of chemical-induced toxicity, and for identifying species-specific effects, which greatly limit the value of data from laboratory animal studies in the human risk assessment process. Attention is focused on the need for greater effort to be invested in the development of non-animal procedures for evaluating the biokinetic factors which will determine the ultimate form and concentration of a particular chemical at possible sites of toxic action. The relative merits of correlative and mechanistic approaches to test development and test validation are discussed. The need for realism is emphasised, not only in relation to our expectations of the validation process, but also in terms of the current and future status of regulatory toxicology, in vitro or in vivo, as a scientific discipline. Finally, it is concluded that the intelligent and strategic use of in vitro test systems, in conjunction with predictive computer modelling, could markedly improve the scientific basis of human risk assessment.

scholarly journals The Risk Assessment at the Workplace of Assembly Operation

2014 ◽  
Vol 62 (5) ◽  
pp. 869-874
Author(s):  
Marek Burda ◽  
Martin Kotus ◽  
Mária Burdová ◽  
Tomáš Holota ◽  
Tomáš Pauliček ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Assessment Tool ◽  
Risk Control ◽  
Health And Safety ◽  
Hazard Identification ◽  
Assessment Process ◽  
Assessment Procedure ◽  
General Process ◽  
Assembly Operation ◽  
Fmea Method

Risk Assessment Process by FMEA method involve hazard identification, risk assessment and risk control processes and their input is fundamental to a successful EH&S system. This Risk assessment tool follows the general process and requirements of the Health and Safety Risk Assessment Procedure.

Food and Feed Safety Assessment: The Importance of Proper Sampling

2015 ◽  
Vol 98 (2) ◽  
pp. 252-258 ◽  
Author(s):  
Harry A Kuiper ◽  
Claudia Paoletti
Keyword(s):  
Risk Assessment ◽  
Safety Assessment ◽  
Hazard Identification ◽  
World Health ◽  
The European Union ◽  
Potential Health ◽  
Food And Agriculture ◽  
Food And Feed ◽  
Health Organization ◽  
Feed Safety

Abstract The general principles for safety and nutritional evaluation of foods and feed and the potential health risks associated with hazardous compounds are described as developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) and further elaborated in the European Union-funded project Safe Foods. We underline the crucial roleof sampling in foods/feed safety assessment. High quality sampling should always be applied to ensure the use of adequate and representative samples as testmaterials for hazard identification, toxicologicaland nutritional characterization of identified hazards, as well as for estimating quantitative and reliable exposure levels of foods/feed or related compoundsof concern for humans and animals. The importance ofrepresentative sampling is emphasized through examples of risk analyses in different areas of foods/feedproduction. The Theory of Sampling (TOS) is recognized as the only framework within which to ensure accuracy and precision of all sampling steps involved inthe field-to-fork continuum, which is crucial to monitor foods and feed safety. Therefore, TOS mustbe integrated in the well-established FAO/WHO risk assessment approach in order to guarantee a transparent and correct frame for the risk assessment and decisionmaking process.

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