Health risk assessment review committees

Chapter 5 of the document reviews the UFs used by UK Government departments, agencies, and their advisory committees in human health risk assessment. Default values for UFs are provided in Table 3 in the UK document with the factors separated into four classes (1) animal-to-human factor, (2) human variability factor, (3) quality or quantity of data factor, and (4) severity of effect factor. The following chemical sectors are addressed food additives and contaminants, pesticides and biocides, air pollutants, drinking water contaminants, soil contaminants, consumer products and cosmetics, veterinary products, human medicines, medical devices, and industrial chemicals. 

National Research Council (NRC), Committee on Toxicology, Subcommittee on Chronic Reference Dose for Chemical Warfare Agents (1999). Review of the US Army s Health Risk Assessment for Oral Exposure to Six Chemical Warfare Agents. National Academy Press, Washington, DC. 

Article 56). Articles containing an Annex XIV substance may be imported to the EU without authorisation.16 Authorisation is to be granted by the Commission on a case-by-case basis for a specified period and under conditions subject to review, if the risks to health and the environment arising from the listed intrinsic properties of a substance are adequately controlled (Article 60, as defined in Annex I). However, the adequate control route is closed for a SVHC that has the properties PBT or vPvB or that is a CMR for which a threshold cannot be determined (Article 60). For such substances, or when control is not adequate, authorisation requires that socioeconomic benefits outweigh risks and that there are no substitutes available (Article 64). These aspects must be considered by a Committee for Risk Assessment and a Committee for Socioeconomic Analysis before the Commission can take a decision on an application, which must include a socio-economic analysis according to Annex XVI. 

The primary task of SCHER is to review Risk Assessment Reports established according to the regulation on evaluation and control of risks of existing substances (EEC 1993). These reports evaluate the risks of prioritised substances, and they are drafted by member state rapporteurs and decided on through comitology procedures. The job of SCHER is to review the scientific quality of these reports, particularly with regard to how they specify risks to public health, consumers and the environment. The committee put together its review in an opinion , which basically clarifies what it considers to be the health and environmental risks of the substance under study. Opinions also discuss the level and conditions of scientific uncertainty as well as whether and, if so, what further research is called for. The Commission may also ask SCHER for advice on other specific issues, even if there is no RAR to review. 

Risk assessment is the scientific evaluation of known or potential advCTse health effects resulting from human exposure to food-borne hazards. The remit of any scientific committees should be regularly reviewed to ensure that the risk assessors are able to address the relevant issues raised by the risk managers, and that no issues are being missed. 

Aspartame has also been considered by other bodies including the UK Committee on Toxicity and the European Commission s Health and Consumer Protection Directorate-General s Scientific Committee on Food (SCF). In December, 2002, the SCF concluded that, on the basis of its review of all the data in animals and humans available to date, there is no evidence to suggest that there is a need to revise the outcome of the earlier risk assessment or the... 

Public Health and associate professor of medicine at Harvard Medical School. Her research interests are in neurotoxicity, metals, pediatric environmental health, and iimovative education in environmental and occupational medicine. Dr. Goldman was a member of two Institute of Medicine Committees on Gulf War and Health, which evaluated potential health effects of exposure to pesticides and Sarin, the National Research Council Committee on Handling and Disposal of Biohazards from the Laboratory, and the National Research Council Committee to Review the 0MB Risk Assessment Bulletin. She received her MD from the Yale University School of Medicine and her MS and MPH from the Harvard School of Public Health. Dr. Goldman is certified by the American Board of Internal Medicine and by the American Board of Preventive Medicine in occupational medicine. 

A Task Based Risk Assessment wiU he performed after the detailed designs are completed.. .. A review of anticipated equipment and/or processes with the shop committee and the Local Joint Health and Safety Committee will he held. 

The meta-analysis involved four products that contain LABA and were approved in the United States for the treatment of asthma. The analysis included 60,954 patients in 110 trials. To assess risk, a composite end point of asthma-related death, intubation, or hospitalization was used. The meta-analysis found 2.80 (95% Cl 1.11, 4.49) more events per 1000 patients in the group that received LABAs compared to the group that did not (Levenson, 2008 Kramer, 2009). The 4-11 age group had an estimated risk difference of 14.83 (95% Cl 3.24, 26.43) per 1000 subjects (Levenson, 2008). In addition to reviewing meta-analysis results, the advisory committees also discussed issues of the meta-analysis itself such as whether the data are adequate to address the important clinical and public health questions. For example, most patients in the FDA meta-analysis participated in studies years ago, when LABA monotherapy was common (Kramer, 2009). 

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