The realization of the package of measures directed at the consecutive decrease of the negative effect of hazardous chemical and biological factors on the population and environment to the acceptable risk level stipulates the development of standard legal regulation in the field of ensuring the chemical and biological safety. For this purpose article presents substantiation and conceptual approaches to the creation of legislation in the field of the chemical and biological security of the Russian Federation within the pursued state policy. In determination of conceptual approaches, in the article there are reported: the main idea, the purpose, a subject of legal regulation, the circle of people who will be subjected to the laws, the place offuture laws in the system of current legislation, the provisions of the Constitution of the Russian Federation, the Federal backbone laws of the Russian Federation to realization of which laws are directed, there is given the general characteristic and an assessment of a condition of legal regulation in this field, results of the analysis of the information on the need for correspondence of Russian laws to provision of international treaties, concerning prohibitions of the biological and chemical weapon, safe handling with biological agents and chemicals, and also the development of uniform procedures of ensuring chemical and biological safety. The major aspect in the shaping of the legislation is the global character ofproblems of chemical and biological safety in this connection in article there is indicated the need of rapprochement of rules of law for this area with partners in economic cooperation and integration. Taking into account an orientation of future laws on the decrease in the level of the negative impact of dangerous chemical and biological factors on the population and environment, there are designated medical, social, economic and political consequences of their implementation. There are presented the proposed structure for bills: “About biological safety”, “On Chemical Safety” and “On the National collection of pathogens.
While regulations for workplace lead exposure become more strict, their effectiveness in decreasing blood lead concentrations and the method by which this is attained have not been evaluated.
An analysis was conducted of 10,190 blood lead samples from employees of 10 high-risk workplaces collected in Manitoba, 1979-87, as part of regulated occupational surveillance.
A significant decrease in blood lead concentrations was observed overall as well as for each individual company. A 1979 government regulation to reduce blood lead to below 3.38 mumol/L (70 micrograms/dl) was followed by a drop in blood lead concentrations; a 1983 order to reduce blood leads to below 2.90 mumol/L (60 micrograms/dl) was not followed by such a drop. Longitudinal analysis by individual workers suggested that companies were complying by use of administrative control, i.e., removing workers to lower lead areas until blood lead levels had fallen, then returning them to high lead areas.
Focusing upon blood lead as the sole criterion for compliance is not effective; regulations must specifically require environmental monitoring and controls. Biological surveillance serves as "back-up" to environmental surveillance and this database illustrates the usefulness of a comprehensive centralized surveillance system.
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As part of achieving national environmental goals, the Swedish Government commissioned an official report from the Swedish Medical Products Agency on environmental effects of pharmaceuticals. Considering half-lives/biodegradability, environmental occurrence, and Swedish sales statistics, 27 active pharmaceutical ingredients were selected for environmental hazard and risk assessments. Although there were large data gaps for many of the compounds, nine ingredients were identified as dangerous for the aquatic environment. Only the sex hormones oestradiol and ethinyloestradiol were considered to be associated with possible aquatic environmental risks. We conclude that risk for acute toxic effects in the environment with the current use of active pharmaceutical ingredients is unlikely. Chronic environmental toxic effects, however, cannot be excluded due to lack of chronic ecotoxicity data. Measures to reduce potential environmental impact posed by pharmaceutical products must be based on knowledge on chronic ecotoxic effects of both active pharmaceutical ingredients as well as excipients. We believe that the impact pharmaceuticals have on the environment should be further studied and be given greater attention such that informed assessments of hazards as well as risks can be done.
As part of achieving national environmental goals, the Swedish Government commissioned a report from the Swedish Medical Products Agency on environmental effects of pharmaceuticals and cosmetics and hygiene products. Five excipients used in pharmaceutical products were selected for environmental risk assessments, applying the computer-based model EUSES. Docusate sodium was identified as a possible risk for sediment-dwelling organisms when taking the total amount used into account. Although, experimental toxicity data on sediment-dwelling organism and data on concentrations in sediments are still required before firm conclusions regarding the environmental risk can be made. The environmental risks posed by excipients used in pharmaceutical products are likely to be negligible. This study identifies that knowledge gaps regarding environmental risks posed by pharmaceutical excipients are evident.
An important step in the implementation of the Water Framework Directive is to define and characterize the natural status, designated as the reference condition (RC). Here we present the results of a type-specific screening for reference stream sites in Denmark using two different approaches. First, we performed a screening applying physicochemical, hydro-morphological and pressure criteria at the catchment, reach and site level of a total of 128 sites a priori selected by the regional water authorities as representing the best sites in Denmark. Second, we performed a GIS screening of all mapped streams in Denmark (26,000 km representing app. 90% of all Danish streams) using solely land use characteristics in the catchment area to target the search for larger stream sites to comply with the WFD requirements of type-specificity. Among the 128 sites we did not find any that fulfilled all criteria applied at the catchment, reach and site level using recommended RC threshold values and only three sites using threshold values that were less strict. Similarly very few km (