The EC directives (1981, 1992) stipulate that in requesting registration of a veterinary medicinal product, information will have to be provided for carrying out an environmental risk assessment. The risk assessment methodology presented here is, on the whole, structured around the risk-quotient approach. Calculated environmental concentrations are compared with effect data established in toxicity studies. Directive 81/852/EEC describes the assessment process in two phases. Phase I is to assess if the product, the ingredients or the relevant metabolites will, in fact, result in environmental exposure. For this reason the first phase is limited to product identification and to exposure assessment. Several exemptions for further testing are given, e.g. the limit values for calculated environmental concentrations. If these exemptions do not apply , and limit values are exceeded, one enters Phase II. Once again, Phase II is split into Tiers A and B. Tier A begins with an elaborate evaluation of the possible fate and effects. If the applicant is unable to demonstrate that exposure is minimised to a level of no concern to the environment, the effects in the relevant compartments must be adequately investigated in Tier B. The non-uniform Tier B evaluation is dependent on expert judgement, therefore beyond the scope of this document.

In order to evaluate the safety of a tetravalent pneumococcal conjugate vaccine, the final product was tested in 24 female rats, 6 weeks of age, by duplicate intramuscular injections. Parameters for general toxicity were body weight gain, food consumption, general clinical parameters and hematology. Local tolerance was evaluated by histopathology of injection sites and regional (iliac and popliteal) lymph nodes. The latter were also weighed. Results indicated no effect of the test vaccine on clinical parameters, body weight gain, food consumption and hematology. The weight of the regional lymph nodes was slightly increased (though without statistical significance), but not as dramatically as in the reference control vaccine (DPT-polio). Local reactions after adjuvant or complete vaccine were mild compared to the reference control vaccine (DPT-polio). Provided a protective immune response is conferred, the responses after pneumococcal conjugate vaccines in rats as observed in this study, are acceptable because: 1- The widely accepted local reaction after DPT-polio injection is more severe. 2- The administered doses in this local tolerance and general toxicity study are 1/4 of the DPT-polio human dose and 1/2 of the pneumococcal vaccine human dose, which are great overdoses on body weight basis for the animals used in this study.

On the basis of this literature review on "accessibility", a proposal has been made for a new measure of accessibility, which can be used to estimate if jobs are accessible to the employment market. Generally speaking, accessibility relates to the amount of money, time and trouble required to travel from the place of origin to the desired destination (either for persons or goods). The literature review also showed the notion of "accessibility" to be multi-interpretable. "Accessibility" is only meaningful when it is clear, for instance, from what perspective and for what goal, activity, travel motivation and travel mode accessibility is applied. Even then, the usefulness of the different accessibility measures found in the literature strongly depends on the precise research issue.

A method is presented for a comparative analysis of species put at risk by chemical contaminants. This comparative risk-analysis was carried out setting off the sensitivity of fifteen taxonomic groups of aquatic organisms against concentrations of two anilines, seven pesticides and the metal mercury in Dutch surface waters. Arthropods such as malacostracans and phyllopodans are most at risk because of concentration levels of the pesticides malathion and parathion in local waters. A comparative risk-analysis for other relevant species and compounds can be obtained in combining further literature searches with modelling techniques.

This report, representing the fourth in a series on a biological monitoring programme, describes the nematodes found in the mineral soil of 18 dairy-cattle farms located on grasslands with peat soils. These nematodes are also compared with the nematodes found on earlier sampled dairy-cattle farms on sandy soils. The farms had different numbers of cattle (mainly cows) per ha, leading to differences in the amounts of manure per ha which were supposed to be indicated by the concentrations of phosphate. The average number of nematodes found (9400 per 100 g soil ) comes very close to the number found on the extensive cattle farms on the sandy soils (10,000 per 100 g soil). The numbers of nematodes found in the intensive farms on sandy soils are higher (12,400 per 100 g soil), while those of the most intensive farms (6600 per 100 g soil) are lower. Increases in cattle intensity lead, on average, to the different farm types showing higher numbers of bacterivores and lower numbers of plantfeeders. The different indices, trophic diversity index T, maturity indices MI and Sigma MI, Shannon-Weaver index H', index of richness SR and the index of 'evenness' J', as well as the number of taxa N, are highest in the peat and sandy soils of the extensive farms, while lowest in the intensive farms. The number of nematodes from c-p group 1 (colonizers) increases with higher manure production.

This report is the english version of the two reports on the Dutch pharmaceutical industries and deals with both the sources and releases as the measures which can be taken to reduce the environmental releases. It focusses on the chlorinated and aromatic hydrocarbons in particular. For the comparison of factories with total different products and processes the emissions were related to characteristic parameters such as multi-purpose factor, throughput and number of plants. From calculations with the computer model POLCOL for a number of model plants, which reflect the present Dutch situation as good as possible, an estimation has been made of the reductions which are possible in practice. Cost levels depend on the measures taken already, e.g. biological waste water treatment. In general a combination of process-internal and additional add-on treatment seems to be more attractive.<br>

Using the multimedia model SimpleBox, Steady-State soil/air Concentration Ratios (SSCR) have been computed for 21 chemicals. With the SSCRs, critical concentrations of the chemicals in air were computed, starting from the Maximum Permissible Concentrations of the chemicals in soil. The uncertainties in computed SSCRs were assessed by means of Monte Carlo simulations, starting from uncertainties and variabilities in input parameters. For the chemicals studied, the uncertainty in the SSCRs was approximately a factor of 5. The time necessary for establishing 95% of the steady-state (t 95%) was also computed. For the chemicals studied, the response times varied from 0.2 to 40 years.<br>

Emission measurements at 4 Dutch hospital waste incinerators show dioxin concentrations in the flue-gas from 70 to 460 ng I-TEQ/m3 (101,3 kPa, 273 degrees K, dry 11 % O2). The emission of dioxins from hospital waste incinerators is high compared with the emission of dioxins from Dutch municipal waste incinerators. Hospital waste was incinerated in the Netherlands by about 25 hospitals in august 1991. The quantity of hospital waste incinerated in the Netherlands by hospitals, for the situation till august 1991, was about 4275 tons/year. The emission of dioxins caused by the incineration of this waste was about 5 g I-TEQ/year. With reference to the results of the measurements 3 of the 4 measured hospital waste incinerators are closed now, the 4th installation was already closed before the results of the measurements became known. The quantity of hospital waste incinerated by hospitals is decreased to about 675 tons/year in june 1992. By closing these installation the emission of dioxins by hospital waste incinerators is decreased to 2 g I-TEQ/year in june 1992.

By using this report decisions about the realization of a soil expertise network can be made by those who are involved. For policy- making and -implementation complementary technical information is necessary ; the knowledge for that is mostly not available or accessable. For the solution of the issue a combination of directives guidelines and technical manuals on soil protection techniques, quality control and company-internal environmental control are considered indispensable, together with an expertise network for knowledge transfer. The network wil be focussed on State, provincial and municipal authorities. RIVM will be the centre of the network with TNO, KIWA and Staring Centre.

This "Informative document sewage sludge" forms part of a series of "Informative documents waste materials". These documents are conducted by RIVM on the instructions of the Directorate General for the Environment, Directorate Waste Materials, in behalf of the program of action on "prevention and recycling of waste materials". In the documents a survey is given of the main facts and figures on specific waste materials, for example data on sources, amount(s), composition and properties, way of treatment, etc. Besides prognoses of the amount(s) in the year 2000 are made and finally the main options for prevention, recycling and treatment are summarized.