The probabilistic aggregate consumer exposure model (PACEM): Validation and comparison to a lower-tier assessment for the cyclic siloxane D5

a b s t r a c t a r t i c l e i n f o Current practice of chemical risk assessment for consumer product ingredients still rarely exercises the aggregation of multi-source exposure. However, focusing on a single dominant source/pathway combination may lead to a significant underestimation of the risk for substances present in numerous consumer products, which often are used simultaneously. Moreover, in most cases complex multi-route exposure scenarios also need to be accounted for. This paper introduces and evaluates the performance of the Probabilistic Aggregate Consumer Exposure Model (PACEM) applied in the context of a tiered approach to exposure assessment for ingredients in cosmetics and personal care products (C&PCPs) using decamethylcyclopentasiloxane (D5) as a worked example. It is demonstrated that PACEM predicts a more realistic, but still conservative aggregate exposure within the Dutch adult population when compared to a deterministic point estimate obtained in a lower tier screening assessment. An overall validation of PACEM is performed by quantitatively relating and comparing its estimates to currently available human biomonitoring and environmental sampling data. Moderate (by maximum one order of magnitude) overestimation of exposure is observed due to a justified conservatism built into the model structure, resulting in the tool being suitable for risk assessment

Assessing Human Exposure to SVOCs in Materials, Products, and Articles : A Modular Mechanistic Framework

A critical review of the current state of knowledge of chemical emissions from indoor sources, partitioning among indoor compartments, and the ensuing indoor exposure leads to a proposal for a modular mechanistic framework for predicting human exposure to semivolatile organic compounds (SVOCs). Mechanistically consistent source emission categories include solid, soft, frequent contact, applied, sprayed, and high temperature sources. Environmental compartments are the gas phase, airborne particles, settled dust, indoor surfaces, and clothing. Identified research needs are the development of dynamic emission models for several of the source emission categories and of estimation strategies for critical model parameters. The modular structure of the framework facilitates subsequent inclusion of new knowledge, other chemical classes of indoor pollutants, and additional mechanistic processes relevant to human exposure indoors. The framework may serve as the foundation for developing an open-source community model to better support collaborative research and improve access for application by stakeholders. Combining exposure estimates derived using this framework with toxicity data for different end points and toxicokinetic mechanisms will accelerate chemical risk prioritization, advance effective chemical management decisions, and protect public health.Peer reviewe

How various ventilation rates affect the aerogenic transmission of SARS-CoV-2.A risk assessment using the AirCoV2 model

Het RIVM heeft berekend wat het effect is van verschillende hoeveelheden ventilatie van binnenruimten op 'aerogene transmissie' van het coronavirus SARS-CoV-2. Aerogene transmissie betekent besmettingen met het virus via kleine druppels (aerosolen) die over een grotere afstand dan anderhalve meter en over langere tijd kunnen blijven zweven in de lucht. Ventileren helpt om aerogene transmissie te beperken. Bij ventileren wordt continu verse buitenlucht aan een ruimte toegevoerd waardoor de lucht in een binnenruimte wordt ververst. Vanwege een goed binnenklimaat moeten alle gebouwen in Nederland, waaronder woningen, aan de minimale ventilatie-eisen van het Bouwbesluit voldoen. Het blijkt dat ventilatie volgens de minimale eisen van het Bouwbesluit 2012 voor bestaande gebouwen de kans op aerogene transmissie flink verkleint in vergelijking met niet-ventileren. Nog meer ventileren maakt de kans nog kleiner, maar het effect daarvan is minder groot. Ventilatie neemt het risico op aerogene transmissie nooit helemaal weg. Ook bij heel veel ventilatie, waarbij de binnenlucht bijvoorbeeld elke 2 minuten helemaal wordt ververst, blijft een kans bestaan dat het virus op deze manier wordt overgedragen. Het RIVM heeft voor bepaalde publieke binnenruimtes berekend welk effect ventilatie naar verwachting heeft op het aantal mensen dat ziek wordt. Voorbeelden zijn een nachtclub, een kleine en een grote concertzaal, een klaslokaal, een kantoorruimte en een supermarkt. Ventilatie verkleint het verwachte aantal zieken het meest in de nachtclub en beide concertzalen. Het onderzoek geeft handvatten om beleidskeuzes te maken. Het is niet mogelijk om op basis van de resultaten aan te geven welk risico acceptabel is en wat een optimale hoeveelheid ventilatie is. Hiervoor zijn andere afwegingen nodig tussen aanvaardbare risico’s en eisen aan comfort, de kosten van aanschaf en onderhoud, en energiegebruik. Het is een beleidskeuze om te bepalen welk risico na deze afwegingen acceptabel wordt gevonden. Het gaat in dit onderzoek alleen om het risico op besmetting via aerogene transmissie. Het gaat niet om andere manieren waarop mensen besmet kunnen raken, zoals besmetting binnen anderhalve meter afstand (directe transmissie).The National Institute for Public Health and the Environment (RIVM) has calculated how various ventilation rates in indoor spaces affect the 'aerogenic transmission' of the coronavirus SARS-CoV-2. Aerogenic transmission means people getting infected with the virus through very small droplets (aerosols). These droplets can stay floating in the air for a long time and can travel distances greater than one-and-a-half metres. Ventilation helps to reduce aerogenic transmission. Ventilation means that fresh air from outdoors flows continually into a space, renewing the air in an indoor space. In order to create a good indoor climate all buildings in the Netherlands, including homes, must meet the minimum ventilation requirements of the Building Decree (Bouwbesluit). It turns out that if ventilation is carried out in line with the minimum requirements of the Building Decree 2012 for existing buildings, this strongly reduces the chance of aerogenic transmission when compared to no ventilation. An even higher ventilation rate reduces this chance even more, but in this case the extra benefit is not much greater. However, ventilation never completely removes the risk of aerogenic transmission. Even with very high ventilation, with all the indoor air being completely renewed every two minutes, there is still a chance of the virus being transmitted in this way. The RIVM has looked at ventilation for selected types of public indoor spaces, calculating the effect that ventilation can be expected to have on the number of people who will become infected. Examples of the spaces they looked at: a nightclub, a small concert hall, a large concert hall, a classroom, an office space and a supermarket. Ventilation reduced the number of expected sick people most strongly in the nightclub and the two concert halls. This study provides a basis for making policy choices. However, the results cannot be used to say which risks are acceptable and what an optimum ventilation rate is. For this, other factors need to be weighed up: acceptable risks on the one hand and comfort requirements, costs of buying and maintaining equipment, and energy consumption on the other hand. The policy choice means deciding what risk is seen as acceptable after these factors have been weighed up. This study only considers the risk of infection through aerogenic transmission. It does not consider other ways in which people can become infected, such as infection at a distance of less than one and a half metres (direct transmission)

Health impact assessment of a skin sensitizer: Analysis of potential policy measures aimed at reducing geraniol concentrations in personal care products and household cleaning products.

A methodology to assess the health impact of skin sensitizers is introduced, which consists of the comparison of the probabilistic aggregated exposure with a probabilistic (individual) human sensitization or elicitation induction dose. The health impact of potential policy measures aimed at reducing the concentration of a fragrance allergen, geraniol, in consumer products is analysed in a simulated population derived from multiple product use surveys. Our analysis shows that current dermal exposure to geraniol from personal care and household cleaning products lead to new cases of contact allergy and induce clinical symptoms for those already sensitized. We estimate that this exposure results yearly in 34 new cases of geraniol contact allergy per million consumers in Western and Northern Europe, mainly due to exposure to household cleaning products. About twice as many consumers (60 per million) are projected to suffer from clinical symptoms due to re-exposure to geraniol. Policy measures restricting geraniol concentrations to <0.01% will noticeably reduce new cases of sensitization and decrease the number of people with clinical symptoms as well as the frequency of occurrence of these clinical symptoms. The estimated numbers should be interpreted with caution and provide only a rough indication of the health impact

Skin sensitisation quantitative risk assessment (QRA) based on aggregate dermal exposure to methylisothiazolinone in personal care and household cleaning products.

Contact allergy to preservatives is an important public health problem. Ideally, new substances should be evaluated for the risk on skin sensitization before market entry, for example by using a quantitative risk assessment (QRA) as developed for fragrances. As a proof-of-concept, this QRA was applied to the preservative methylisothiazolinone (MI), a common cause of contact allergy. MI is used in different consumer products, including personal care products (PCPs) and household cleaning products (HCPs). Aggregate exposure to MI in PCPs and HCPs was therefore assessed with the Probabilistic Aggregated Consumer Exposure Model (PACEM). Two exposure scenarios were evaluated: scenario 1 calculated aggregate exposure on actual MI product concentrations before the restricted use in PCPs and scenario 2 calculated aggregate exposure using the restrictions for MI in PCPs. The QRA for MI showed that in scenarios 1 and 2, the proportion of the population at risk for skin sensitisation is 0.7% and 0.5%, respectively. The restricted use of MI in PCPs does not seem very effective in lowering the risk on skin sensitization. To conclude, it is important to consider aggregate exposure from the most important consumer products into consideration in the risk assessment

Human and environmental risks of containers containing dangerous volatile substances

Dit rapport is vervangen door 609021091 (20090526)Mensen in de directe nabijheid van een net geopende (gegaste) zeecontainer staan mogelijk bloot aan hoge concentraties vluchtige organische stoffen. Blootstelling hieraan kan leiden tot een acuut gezondheidsrisico. Consumenten kunnen met deze stoffen in aanraking komen als deze uitdampen uit goederen die in die containers zijn vervoerd. Het RIVM onderzocht drie van zulke producten: twee matrassen en een paar schoenen. Deze producten zijn geselecteerd omdat de consument bij het gebruik ervan langdurig aan de stoffen wordt blootgesteld. Ondanks deze lange duur treden geen onacceptabele gezondheidsrisico's op. Het RIVM kan niet voor alle situaties gezondheidsrisico's uitsluiten. Het is echter niet mogelijk deze risico's te kwantificeren. Gegevens ontbreken en er bestaan veel blootstellingsroutes. De gevaarlijke stoffen komen op twee manieren in containers en producten terecht. Stoffen als methylbromide en 1,2-dichloorethaan worden gebruikt om goederen en verpakkingshout te ontsmetten. Ze worden voor het transport in de containers ingebracht. Tijdens langdurig transport kunnen ze in de vervoerde producten gaan zitten. Andere stoffen, zoals benzeen en tolueen, worden tijdens het productieproces als bestanddeel of oplosmiddel gebruikt. Als de stoffen in de producten zitten kunnen ze daaruit binnenshuis uitdampen. Voor het verminderen van de blootstelling van burgers ziet het RIVM verschillende opties. Het verminderen van het gebruik van deze middelen is er een. Dit kunnen producenten en importeurs bereiken door meer eisen te stellen aan het gebruik van dergelijke stoffen tijdens productie of voor transport.People in the immediate surroundings of a maritime container that has been opened recently may be exposed to high concentrations of volatile organic substances. Exposure to such substances may result in an acute health risk. These substances may come into contact with consumers if they evaporate from products that were transported in those containers. RIVM has examined three such products: two mattresses and a pair of shoes. These products were selected because the consumer, when using these products, is exposed to these substances for a long time. Despite this prolonged duration, no unacceptable health risks were found. RIVM cannot rule out health risks in all situations. However, it is not possible to quantify these risks: the relevant data are lacking and there are many exposure pathways. The hazardous substances get into containers and products in two ways. Substances such as methyl bromide and 1,2-dichloroethane are used to disinfect products and packaging timber, and are put into the container before transport. During prolonged transport they may enter the relevant goods. Other substances, e.g. benzene en toluene, are used as components or solvents in the production process. If such substances are contained in the products, they may evaporate from the products in enclosed areas. RIVM sees various options for reducing exposure to these substances. One option is to reduce their use. Producers and importers may achieve this by placing additional requirements on the use of such substances in the production process or during transport.VROM-Inspecti

The risks of environmentally hazardous substances in import containers. State of affairs 2007

Alleen digitaal verschenenDuitse vertaling van rapport 609021091 ; in het Engels verschenen met nummer 609021094 ; 200907023: vervanging van rapport 609021070In den niederlaendischen Haefen werden jaehrlich etwa 2,5 Mio. Container mit Waren aus aller Welt eingefuehrt. Messungen haben ergeben, dass in diesen Containern hohe Konzentrationen fluechtiger organischer Stoffe gefunden werden koennen, und zwar als Folge der Begasung der Containern oder weil diese fluechtigen organischen Stoffe im Herstellungsverfahren der Waren als Loesemittel benutzt worden sind. Das niederlaendische Ministerium fuer Wohnungsbau, Raumordnung und Umwelt (VROM) hat das Staatlich-niederlaendisches Institut fuer Gesundheit und Umwelt (RIVM) beauftragt, ihm die Risiken dieser Gase in Containern fuer Mensch und Umwelt einsichtig zu machen. Auftrag war, diese Risikoanalyse auf bereits vorhandenen Informationen ueber Begasung und Konzentrationen fluechtiger organischer Stoffe zu basieren. Die Analyse der Risiken fuer die Arbeitnehmer war nicht Teil dieses Auftrags. Aus der Beurteilung der Daten geht hervor, dass die Konzentrationen flchtiger organischer Stoffe in Containern so hoch sein koennen, dass Umstehende beim Oeffnen der Container sowie generell bei einer Exposition an diese Konzentrationen Gesundheitsschaeden erleiden koennen. Auch Verbraucher koennen diesen Substanzen ausgesetzt werden, wenn sie die Waren aus den begasten Containern benutzen. Dies kann dadurch geschehen, dass die Waren innerhalb des Hauses ausduensten, aber auch durch Einnahme begaster Nahrungsmittel und Arzneimittel. Es stellte sich heraus, dass die vorhandenen Informationen ueber Konzentrationen in und das Ausduensten aus Waren sehr beschraenkt ist; die Informationen stammten berwiegend aus frueheren von VROM an das RIVM in Auftrag gegebenen Studien an Forschungsobjekten. So lagen Daten ueber das Ausduensten aus etwa zwanzig Produkttypen und das Nachgasen aus zwei Matratzen und einem Paar Schuhe vor. In diesen spezifischen Fdllen erwartete das RIVM keine Risiken oberhalb der Grenzen, von denen normalerweise bei staatlichen Regelungen ausgegangen wird. Auf dieser Grundlage lassen sich jedoch Risiken in anderen Faellen weder quantifizieren noch ausschliessen. Dafuer ist die Zahl der moeglichen Situationen und sind die Unsicherheiten einfach zu gross. Aus der Sicht der Umweltvertrdglichkeit ist besonders Methylbromid von Bedeutung, weil es die Ozonschicht schaedigen kann und bei Containerbegasungen relativ haeufig eingesetzt wird.Approximately 2.5 million containers carrying goods from all over the world arrive each year in Dutch harbours. Measurements revealed that containers may contain high concentrations of volatile organic compounds (VOCs). The presence of these substances can be explained by their use in gassing containers and/or their use in the production process of the goods being carried as either a constituent or a solvent. The Ministry of Housing, Spatial Planning and the Environment of the Netherlands (VROM) commissioned the RIVM to analyse the risks of the concentrations of VOCs in containers to human health and the environment. The risk assessment was based on existing data due to the need for an answer within a very short period of time. The risks to employees in their work places were not included in the assessment. One of the conclusions of the assessment is that the concentrations of VOCs may be high enough to lead to an increased risk of acute health effects in those people in the immediate surroundings of a container when it is opened, or shortly thereafter, and who are subsequently exposed to the substances. Consumers may also be exposed to VOCs when they use goods from gassed containers. This may occur when these substances vaporize from the goods during use in the home or when gassed food or medicines are ingested. The information available on the concentrations of VOCs in goods and the extent of their vaporization from goods was limited and mainly derived from an earlier assessment carried out by the RIVM on a number of products made available for testing by the VROM. As such, vaporization data were available on only twenty different products, and exposure data were available for only two mattresses and one pair of shoes. Based on the measurements in these specific cases, the RIVM expects that the risks will not surpass those considered to be acceptable according to currently applied public health standards. Due to the limited data available, however, it was not possible to quantify the risks or to exclude them in other cases. In terms of the environment, serious consideration must be given to the use of methyl bromide for gassing containers worldwide as it is a potent ozone layer-depleting substance, and it is used in great amounts.VROM-Inspecti

Human and environmental risks of containers containing dangerous volatile substances

Dit rapport is vervangen door 609021091 (20090526)Mensen in de directe nabijheid van een net geopende (gegaste) zeecontainer staan mogelijk bloot aan hoge concentraties vluchtige organische stoffen. Blootstelling hieraan kan leiden tot een acuut gezondheidsrisico. Consumenten kunnen met deze stoffen in aanraking komen als deze uitdampen uit goederen die in die containers zijn vervoerd. Het RIVM onderzocht drie van zulke producten: twee matrassen en een paar schoenen. Deze producten zijn geselecteerd omdat de consument bij het gebruik ervan langdurig aan de stoffen wordt blootgesteld. Ondanks deze lange duur treden geen onacceptabele gezondheidsrisico's op. Het RIVM kan niet voor alle situaties gezondheidsrisico's uitsluiten. Het is echter niet mogelijk deze risico's te kwantificeren. Gegevens ontbreken en er bestaan veel blootstellingsroutes. De gevaarlijke stoffen komen op twee manieren in containers en producten terecht. Stoffen als methylbromide en 1,2-dichloorethaan worden gebruikt om goederen en verpakkingshout te ontsmetten. Ze worden voor het transport in de containers ingebracht. Tijdens langdurig transport kunnen ze in de vervoerde producten gaan zitten. Andere stoffen, zoals benzeen en tolueen, worden tijdens het productieproces als bestanddeel of oplosmiddel gebruikt. Als de stoffen in de producten zitten kunnen ze daaruit binnenshuis uitdampen. Voor het verminderen van de blootstelling van burgers ziet het RIVM verschillende opties. Het verminderen van het gebruik van deze middelen is er een. Dit kunnen producenten en importeurs bereiken door meer eisen te stellen aan het gebruik van dergelijke stoffen tijdens productie of voor transport.People in the immediate surroundings of a maritime container that has been opened recently may be exposed to high concentrations of volatile organic substances. Exposure to such substances may result in an acute health risk. These substances may come into contact with consumers if they evaporate from products that were transported in those containers. RIVM has examined three such products: two mattresses and a pair of shoes. These products were selected because the consumer, when using these products, is exposed to these substances for a long time. Despite this prolonged duration, no unacceptable health risks were found. RIVM cannot rule out health risks in all situations. However, it is not possible to quantify these risks: the relevant data are lacking and there are many exposure pathways. The hazardous substances get into containers and products in two ways. Substances such as methyl bromide and 1,2-dichloroethane are used to disinfect products and packaging timber, and are put into the container before transport. During prolonged transport they may enter the relevant goods. Other substances, e.g. benzene en toluene, are used as components or solvents in the production process. If such substances are contained in the products, they may evaporate from the products in enclosed areas. RIVM sees various options for reducing exposure to these substances. One option is to reduce their use. Producers and importers may achieve this by placing additional requirements on the use of such substances in the production process or during transport.VROM-Inspecti

The risks of environmentally hazardous substances in import containers

Alleen digitaal verschenenDuitse vertaling van rapport 609021091 ; in het Engels verschenen met nummer 609021094 ; 20090723: nieuwe versie van dit rapport verschenen met nummer 609021093Personen in der unmittelbaren Umgebung eines gerade geoeffneten (begasten) Seecontainers koennen hohen Konzentrationen fluechtiger organischer Stoffe ausgesetzt sein. Die Beruehrung mit solchen Stoffen kann akute Gesundheitsrisiken mit sich bringen. Verbraucher koennen diesen Stoffen ausgesetzt sein, wenn diese Stoffe aus mit diesen Containern verfrachteten Produkten ausduensten. Das RIVM hat drei solcher Produkte untersucht: zwei Matratzen und ein Paar Schuhe. Es wurden diese Produkte ausgewaehlt, weil der Verbraucher bei der Benutzung den Stoffen ueber lange Zeit ausgesetzt ist. Trotz der langen Dauer dieser Exposition ergaben sich keine inakzeptablen Gesundheitsrisiken. Das RIVM kann Gesundheitsrisiken nicht in allen Situationen ausschliessen. Diese Risiken lassen sich jedoch nicht quantifizieren. Es fehlen Daten und es gibt viele Expositionspfade. Die gefaehrlichen Stoffe gelangen auf zweierlei Weise in Container und Produkte. Stoffe wie Methylbromid und 1,2-Dichlorethan werden fuer die Desinfektion von Guetern und Holzverpackungsmaterial eingesetzt. Sie werden vor dem Transport in die Container eingefurhrt. Bei einem laengeren Transport koennen sie in die befoerderte Ware eindringen. Andere Stoffe, wie Benzol und Toluol, werden im Fertigungsprozess als Bestandteil oder als Loesemittel eingesetzt. Wenn die Stoffe sich in den Produkten befinden, koennen sie daraus innerhalb des Hauses ausduensten. Das RIVM sieht mehrere Moeglichkeiten, um die Exposition von Buergern zu verringern. Die Beschraenkung des Einsatzes dieser Mittel ist eine Moeglichkeit. Hersteller und Importeure koennen dies erreichen, indem sie striktere Anforderungen an den Einsatz solcher Stoffe waehrend der Fertigung oder fuer den Transport stellen.People in the immediate surroundings of a maritime container that has been opened recently may be exposed to high concentrations of volatile organic substances. Exposure to such substances may result in an acute health risk. These substances may come into contact with consumers if they evaporate from products that were transported in those containers. RIVM has examined three such products: two mattresses and a pair of shoes. These products were selected because the consumer, when using these products, is exposed to these substances for a long time. Despite this prolonged duration, no unacceptable health risks were found. RIVM cannot rule out health risks in all situations. However, it is not possible to quantify these risks: the relevant data are lacking and there are many exposure pathways. The hazardous substances get into containers and products in two ways. Substances such as methyl bromide and 1,2-dichloroethane are used to disinfect products and packaging timber, and are put into the container before transport. During prolonged transport they may enter the relevant goods. Other substances, e.g. benzene en toluene, are used as components or solvents in the production process. If such substances are contained in the products, they may evaporate from the products in enclosed areas. RIVM sees various options for reducing exposure to these substances. One option is to reduce their use. Producers and importers may achieve this by placing additional requirements on the use of such substances in the production process or during transport.VROM-Inspecti

PACEMweb: a tool for aggregate consumer exposure assessment

Background: To ascertain the safe use of chemicals that are used in multiple consumer products, the aggregate human exposure, arising from combined use of multiple consumer products needs to be assessed. Objective: In this work the Probabilistic Aggregate Consumer Exposure Model (PACEM) is presented and discussed. PACEM is implemented in the publicly available web tool, PACEMweb, for aggregate consumer exposure assessment. Methods: PACEM uses a person-oriented simulation method that is based on realistic product usage information obtained in surveys from several European countries. PACEM evaluates aggregate exposure in a population considering individual use and co-use patterns as well as variation in product composition. Product usage data is included on personal care products (PCPs) and household cleaning products (HCPs). Results: PACEM has been implemented in a web tool that supports broad use in research as well as regulatory risk assessment. PACEM has been evaluated in a number of applications, testing and illustrating the advantage of the person-oriented modeling method. Also, PACEM assessments have been evaluated by comparing its results with biomonitoring information. Significance: PACEM enables the assessment of realistic aggregate exposure to chemicals in consumer products. It provides detailed insight into the distribution of exposure in a population as well as products that contribute the most to exposure. This allows for better informed decision making in the risk management of chemicals. Impact: Realistic assessment of the total, aggregate exposure of consumers to chemicals in consumer products is necessary to guarantee the safe use of chemicals in these products. PACEMweb provides, for the first time, a publicly available tool to assist in realistic aggregate exposure assessment of consumers to chemicals in consumer products