Development of Generic Exposure Scenario Descriptions

Transcription

1 Development of Exposure cenarios for Manufactured Nanomaterials Work Package 2 Development of Generic Exposure cenario Descriptions (Including Deliverables D2.1 and D2.2) Martie van Tongeren 1, Rob Aitken 1, Derk Brouwer 4, Frans Christensen 3, Katherine Clark 5, teffi Friedrichs 6, heona Peters 1, hazid Rashid 1, Michael Riediker 5, Peter Ritchie 1, Celina Vaquero 2 December Institute for Occupational Medicine (IOM), Edinburgh, United Kingdom 2 Fundaciòn CDT (LEIA), Miñano (Álava), pain 3 European Commission - DG Joint Research Centre (JRC), Institute for Health and Consumer Protection (IHCP), Ispra, Italy 4 Netherlands Organisation for Applied cientific Research (TNO), Utrecht Area, Netherlands 5 Institute for Work and Health (IT), Lausanne, witzerland 6 Nanotechnology Industries Association (NIA), Brussels, Belgium

2 ii

3 Project website: Funded under the seventh framework programme: NMP : Exposure scenarios to nanoparticles Grant agreement no.: Funding scheme: Coordination and upport Actions (supporting action) iii

4 iv

5 Executive summary Work package 2 (WP2) principally served two functions; first, to provide the format for describing occupational and consumer exposure scenarios (with associated environmental release); and second, to develop the library of exposure scenarios (together with WP7). In addition, WP2 facilitated other work packages of the project by providing reference lists of relevant peer-reviewed literature and published reports, as well as information from other EC FP 6/7 projects. WP2 also provided WP7 with a list of possible exposure scenario titles for the three candidate manufactured nanomaterials (MNMs) and their downstream use: i) Manufacture of carbon nanotubes (CNTs) and their use in composite materials; ii) Manufacture of titanium dioxide nanoparticles (nano-tio 2 ) and their use in cosmetics; and iii) Manufacture of silver nanoparticles (nano-ag) and their use in textiles. Different options were considered in relation to the exposure scenario format to be developed and used for the NANEX project, but in the end the format for describing exposure scenarios provided by the REACH guidance document was adopted. 1 format was used to develop a Microsoft Access database, which was subsequently used to facilitate the description and recording of exposure scenario information for occupational and consumer exposure scenarios by WP3 and WP4. Information to be reviewed in WP3, 4 and 5 the NANEX project was identified by undertaking a comprehensive literature search, which was complemented by further web-based searching to identify relevant outputs from current and recent FP 6/7 projects funded by the European Commission as well as reports from other organisations and standardised bodies. A list of generic exposure scenario titles was developed for the three candidate MNMs based on expert knowledge and opinion. These lists of generic exposure scenario titles were used by WP7 as part of the gap analysis of current knowledge on exposure within these scenarios. The initial intention of NANEX was to develop an extensive web-based library of occupational and consumer exposure scenarios that would be publicly available. However, it was clear that the many of the scenarios were not of sufficient quality to be included in a web-based library. It was therefore decided to only provide a number of examples of occupational and consumer exposure scenarios, for which contextual information was made available. One note of caution is that the exposure scenarios developed within the 1 It should be noted that the REACH format guidance was undergoing revision during the period when NANEX had to decide on format for the project, and thus the draft format available mid March (provided by ECHA) was used. This v

6 NANEX project do not describe safe use of the MNMs (as defined under REACH), but rather describe the exposure situation (i.e., no risk assessment was carried out). We believe with more measurement data and contextual information becoming available over time (e.g., from EU and other projects), that the expansion of the exposure scenario library would provide a useful source of information for risk assessment and other purposes. However, rigorous quality assurance procedures will need to be developed and applied to ensure that the exposure scenarios are of sufficiently high quality. vi

7 Table of contents Executive summary... v Table of contents... vii 1. Introduction Objectives Format for description of exposure scenarios (Deliverable 2.1) Exposure scenario library for occupational and consumer exposures (Deliverable 2.2) Introduction Identification of relevant sources of information Development of list of generic exposure scenario Titles Development of a web-based library of exposure scenarios Overall conclusions/discussion Annex I: Format for description of exposure scenarios Annex II: Workshop 8-9 March 2010, Lausanne Annex III: A brief introduction and guide to the NANEX Exposure cenario Database Annex IV: A brief introduction and guide to the NANEX Exposure References Database. 35 Annex V: Description of literature search carried out for the NANEX project Annex VI: List of exposure scenario titles Annex VII: Example exposure scenario vii

8 viii

9 1. Introduction Nanotechnology is a fast growing industry producing a wide variety of manufactured nanomaterials (MNMs) and numerous potential applications. Estimation of exposure to MNMs is complicated and requires the use of equipment which is usually very expensive and not widely available. In addition, operation of these instruments and interpretation of the results require specific and detailed expertise in aerosol science. Therefore, in order to facilitate assessment of the potential for exposure and, hence, risk to human health, it is important that any available data are shared and used as widely as possible and appropriate. The NANEX project aimed to develop a catalogue of exposure scenarios for MNMs relevant for human exposure. In addition, the NANEX project aimed to identify the key knowledge gaps and set research priorities. The work was set out in a number of work packages (WPs). This report describes the work carried out in work package 2, which facilitated the completion of the following tasks and aims in the other WPs. - WP3 (Occupational exposure) aimed to collect and review measurement and contextual information to describe and characterize occupational exposure and review available tools and models to predict occupation exposure to MNMs. - WP4 (Consumer exposure) aimed to collect and review similar information but focussed on consumer exposure and characterizing possible specific consumer groups being exposed. - WP5 (Environmental release/exposure) aimed to identify exposure scenarios that result in a release of MNMs to the environment and may subsequently result in human exposure. - WP6 (Case illustrations) collected information on specific exposure scenarios for a limited number of MNMs. - WP7 (cientific integration and gap) subsequently integrated all the information and knowledge obtained during work packages WP2 to WP6. WP2 of the NANEX project was led by the Institute of Occupational Medicine, with input from several other partners (IT, LEIA, TNO, and JRC) and principally served a facilitating function for the other NANEX work packages. 1

10 1.1. Objectives The main objective of WP2 was to describe requirements for the development of exposure scenarios for MNMs and to develop a catalogue of exposure scenarios describing representative life cycle stages for three types of nanomaterials: i) high aspect ratio nanomaterials (HARNs); ii) mass-produced nanomaterials; and iii) specialised nanomaterials produced on small scale. In addition, WP2 facilitated other work packages by providing reference lists of relevant peer-reviewed literature and published reports, as well as information from other EU FP 6/7 projects, and providing WP7 with a list of realistic exposure scenario titles for the three candidate MNMs and their downstream usage. During the early stages of the project, it was agreed that, within these broad categories, the NANEX project would focus on the specific case examples of: 1. Carbon nanotubes (CNTs) and their use in composite materials, 2. Titanium dioxide nanoparticles (nano-tio 2 ) and their use in cosmetics, 3. ilver nanoparticles (nano-ag) and their use in textiles. The deliverables of WP2 were defined as: D2.1: D2.2: Format for description of exposure scenarios; and Exposure scenario library for occupational and consumer exposures and environmental release. 2

11 2. Format for description of exposure scenarios (Deliverable 2.1) Prior to development of the occupational and consumer exposure scenarios and addition of the environmental release from these scenarios, it was necessary to establish a standard format for describing and recording exposure scenario information for MNMs. Different current approaches were considered including whether the NapiraHub structure would be suitable. However, the current version of NapiraHub does not contain very detailed/structured fields for exposure information. It was on the other hand identified that the European Chemical Agency (ECHA) was developing an IT tool (CHEAR), inter alia, aiming at providing an IT tool for building exposure scenarios and it was decided to align with those activities to the extent possible. Once ready, the CHEAR tool would become a plug-in to IUCLID and in the longer term could be integrated in NapiraHub. In order to fit into the CHEAR tool, the part of the REACH guidance on the development of exposure scenarios 2 related to the exposure scenario format was updated. When NANEX had to "freeze" its format mid March, ECHA provided the latest draft exposure scenario format available. NANEX has built on that, although the final exposure scenario format was finalised later and is slightly different. Four different versions are provided in the REACH exposure scenario format guidance, which deal with the following: 1. Uses of substances by workers; 2. Uses of substances by consumers; 3. Handling of articles by workers during service life; and 4. Handling of articles by consumers during service life. The first two formats (i.e., uses of substances by workers and consumers) are reproduced in Annex I of this report; the formats for handling of articles are very similar. The exposure scenarios under REACH are required to provide a description of conditions suitable to ensure control of risks related to the uses of a substance or article covered by the exposure scenario. The descriptions incorporate both operational conditions (OCs) (e.g. duration of tasks) and risk management measures (RMMs) (e.g. local exhaust ventilation). The exposure scenario format consists of several sections: 2 Guidance on information requirements and chemical safety assessment. Exposure cenario Format. Version 2, May

12 1. Title of the exposure scenarios, including a list of descriptors and a list of contributing scenarios; 2. Exposure scenario descriptions: a. Contributing scenario (1) controlling environmental exposure, b. Contributing scenarios (2-n) controlling worker/consumer exposure; 3. Exposure estimation and reference to source; and 4. Guidance to downstream user (DU) to evaluate whether he works inside the boundaries set by the exposure scenario. The format was reviewed by the NANEX team and presented during a workshop in Lausanne on 8-9 March 2010, a programme and outputs of which are provided in Annex II. There is one clear distinction between the exposure scenario defined under REACH and the exposure scenarios that are developed for the NANEX project. An exposure scenario under REACH should describe the OCs and RMMs, ensuring that the exposure is controlled sufficiently to control risk to health or to the environment during the use of the substance or article covered by the exposure scenario. This is done through an iterative process, whereby the initial exposure estimate for the exposure scenario is compared with a DNEL 3 for potential health effects or a PNEC 4 for environmental effects. If exposure is too high (i.e. the estimated exposure is higher than the DNEL or PNEC), then either the exposure assessment has to be refined or changes made to the operational conditions and/or risk management measures to lower the estimated exposure until control of risk can be demonstrated. If this cannot be done, it may be necessary to conclude that some uses may not be safe and should be advised against. There are currently no or few DNELs or PNECs developed for MNMs and it was outside the scope of NANEX to develop such values. Therefore, the exposure scenarios developed within the NANEX project are a description of the existing exposure situation, rather than a description of the exposure scenarios that would ensure that there is no or minimal risk to health and environment. Despite this distinction, it was agreed that the REACH Exposure cenario format was an appropriate tool for collecting and describing exposure scenarios for MNMs. The REACH scenario format was used to develop the NANEX Exposure cenario Database that was distributed to WP3 and WP4 for collation of occupational and consumer exposure scenarios. WP6 used a slightly different format for collection of exposure scenario information. To complement the higher level exposure scenario database, WP7 developed a lower tier database for facilitating review of the literature 3 DNEL: Derived No Effect Level 4 PNEC: Predicted No Effect Concentration 4

13 information used to develop the exposure scenarios. This reference database (NANEX Exposure References Database) was also included in the overall NANEX database. Instructions for the use of the database are presented in Annex III and IV. 5

14 6

15 3. Exposure scenario library for occupational and consumer exposures (Deliverable 2.2) 3.1. Introduction This task was comprised of the following three main activities, which are described in further detail below: 1) Identification of sources of information from literature and other projects; 2) Development of lists of generic exposure scenario titles; and 3) Development of a web-based library for occupational and consumer exposure scenarios Identification of relevant sources of information A strategy for the identification of relevant information was implemented at an early stage in the NANEX project. As an initial step, key organisations, FP6/7 projects and other national projects of relevance to the scope of the project were identified. Publically-available reports and outputs from these sources, of relevance to the project, were then identified and obtained directly from associated websites and/or through web-based searching. Next, a comprehensive literature search was carried out (see Annex V) and relevant sources of information were provided to WP3, 4 and 5 for review. Overall, 65 distinct references were entered into the NANEX Exposure References Database. These references contained information used to build the exposure scenarios. Thirty-three of the references were relevant to occupational exposure, 17 to consumer exposure, and 12 to environmental release. Additionally, 3 general references on regulatory guidance and modeling were included. About 40% of the references in the database were published in 2009 or Very few references were found on occupational downstream uses of MNMs (e.g., secondary manufacturing or use of products containing MNM). A detailed analyses of the metadata associated with the NANEX Exposure References Databaseis provided in the deliverables for WP Development of list of generic exposure scenario Titles As the NANEX project was keen to determine to what extent exposure information was available for existing exposure situations, three lists of generic exposure scenario titles were developed for: 1) Manufacture of CNTs and their use in composite materials; 2) Manufacture of nano-tio 2 and its use in cosmetic products; and 3) Manufacture of nano-ag and its use in textiles. The lists were developed by a team of experts at the IOM based on the literature sources. An important source of information for CNTs was the study by Chaudry et al 7

16 (2009) 5, who carried out a life cycle assessment study for commercially available products and applications containing CNTs. The lists were circulated for review to the whole NANEX project team; the final versions of these lists are provided in Annex VI. They are not intended to provide a complete overview of all existing exposure situations for these MNMs in Europe, but rather to cover what are most likely to be the main exposure scenarios associated with the three MNMs of interest. The lists were used by WP7 to identify gaps in current knowledge on exposure to MNMs in these scenarios Development of a web-based library of exposure scenarios The exposure scenarios were developed by WP3 and 4 and entered in the NANEX Exposure cenario Database. The exposure scenarios were subsequently forwarded to WP5 for review and inclusion of information into the sections of the environmental contributing scenarios of the occupational and consumer exposure scenarios in the database. 6 In total, 57 occupational exposure scenarios were provided by WP3 and 5 consumer exposure scenarios by WP4. The occupational exposure scenarios were based on information obtained from the literature (n=22) and from data collected during surveys carried out as part of the NANOH project and as part of a nation-wide survey carried out in France by CEA (n=35). The consumer exposure scenarios were all based on information obtained from the literature. In contrast with the occupational exposure scenarios, for which all the (inhalation) exposure estimates were obtained from measurements, the exposure estimates for the consumer exposure scenarios were obtained by applying models estimating dermal and inhalation exposure. Following a critical review of all the scenarios, it was clear that there was insufficient information provided in the scenarios, due to the limited information available from the original sources. It was therefore decided to present a limited number of example exposure scenarios in the web-based library (i.e. those that provide a more complete description of the exposure), rather than present all the scenarios that were described 5 Chaudhry Q, Aitken R, Hankin, Donaldson K, Olsen, Boxall A, Kinloch I, Friedrichs (2009) A lifecycle assessment study of the route and extent of human exposure via inhalation for commercially available products and applications containing carbon nanotubes. The Food and Environment Research Agency. 6 Unfortunately, for the occupational exposure scenarios there was generally no information available from the literature and measurement that could be included in the environmental contributing scenario, and therefore these sections could not be completed nor could the environmental release from the occupational scenarios be estimated. For the consumer exposure scenarios, the environmental contributing scenario for nano-tio 2 used in sunscreen could be completed based on a number of assumptions and results from experimental studies. 8

17 in the NANEX project. The following example scenarios are presented on the NANEX website: Occupational, based on measurement surveys: CNT: Production of MWCNT using a tube furnace CNT production using vapour phase deposition Handling small quantities of CNTs Nano-TiO 2 : Production of nano-tio 2 by laser ablation Production of printing inks with nano-tio 2 Nano-Ag: Maintenance of physical vapour deposition reactor used to produce nano-ag. Occupational, based on literature: CNT: ynthesis of CNT by chemical vapour deposition and handling of CNTs Machining of hybrid advanced composites using CNTs Nano-Ag: Production of nano-ag using wet chemistry process Consumer, based on literature (and assumptions): Nano-TiO 2 : Use of sunscreens containing nano-tio 2. These exposure scenarios were exported as PDF files (see example in ANNEX VII) and included on the NANEX website ( The case studies scenarios included confidential business information (CBI), and therefore could not be made publicly available. 9

18 10

19 4. Overall conclusions/discussion The main function of WP2 was to facilitate activities in the other work packages by providing a format for WP3, 4 and 5 for describing and recording exposure scenario information in the reviewed literature and for building exposure scenarios for the three candidate MNMs included in the project. WP6 initially used a slightly different format. WP2 collated and distributed reference lists on occupational, consumer and environmental exposure studies for MNMs, as well as a list of relevant research projects. WP2 also developed a list of generic exposure scenario titles for the three candidate MNMs (i.e., CNTs and their use in composite materials; nano-tio 2 and their use in cosmetics; and nano-ag and their use in textiles). The main aim was to develop a web-based library for all the exposure scenarios developed during the project. Following review of the exposure scenarios based on information from the literature and information obtained during two relatively large measurement surveys, it was decided to provide only a small number of example scenarios, which provide a more complete description. One note of caution is that the exposure scenarios developed within the NANEX project do not describe how risks are controlled for MNMs (as they should under REACH), but rather describe the exposure situations as could be deducted from available information sources. In other words, no risk assessment was carried out by comparing exposure estimates with hazard data, as this was outside the scope of NANEX. Despite the fact that it wasn t possible to develop an extensive library of exposure scenarios, we believe that it would be useful to continue to expand the NANEX Exposure cenario Database with exposure scenario descriptions and exposure estimates, thereby facilitating the sharing of information between all stakeholders. 11

20 12

21 Annex I: Format for description of exposure scenarios tandard exposure scenario format for uses of substances by workers Exposure cenario Format (1) addressing uses carried out by workers Title of Exposure cenario List of all use descriptors related to the life cycle stage and all the uses under it; include market sector (by PC) if relevant Name of contributing environmental scenario (1) and corresponding ERC List of names of contributing worker scenarios (2-n) and corresponding PROCs Further explanations (if needed) 1. Exposure cenario 2.1 Contributing exposure scenario (1) controlling environmental exposure for... Name of contributing exposure scenario Further specification Product characteristics Product related conditions, e.g. the concentration of the substance in a mixture; viscosity of product; package design affecting exposure Amounts used Daily and annual amount per site (for uses in industrial setting) or daily and annual amount for wide disperse uses Frequency and duration of use Intermittent ( used < 12 times per year for not more than 24 h) or continuous use/release Environment factors not influenced by risk management Flow rate of receiving surface water (m³/d) (usually 18,000 m³/d by default for the standard town); please note: the default flow rate will be rarely changeable for downstream uses; Other given operational conditions affecting environmental exposure Other given operational conditions: e.g. technology or process techniques determining the initial release of substance from process (via air and waste water); dry or water based processes; conditions related to temperature and pressure; indoor or outdoor use of products; work in confined area or open air Technical conditions and measures at process level (source) to prevent release Process design aiming to prevent releases and hence exposure to the environment; this includes in particular conditions ensuring rigorous containment; performance of the containment to be specified (e.g. by quantification of a release factor ) Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil Technical measures, e.g. on-site waste water and waste treatment techniques, scrubbers, filters and other technical measures aiming at reducing releases to air, sewage system, surface water or soil; this includes strictly controlled conditions(procedural and control technology) to minimise emissions; specify effectiveness of measures; specify the size of industrial sewage treatment plant (m³/d), degradation effectiveness and sludge treatment (if applicable); Organisational measures to prevent/limit release from site pecific organisational measures or measures needed to support the functioning of particular technical measures. Those measures need to be reported in particular for demonstrating strictly controlled conditions Conditions and measures related to municipal sewage treatment plant ize of municipal sewage system/treatment plant (m³/d); specify degradation effectiveness; sludge treatment technique (disposal or recovery); measures to limit air emissions from sewage treatment (if applicable); please note: the default size of the municipal TP (2000 m³/d) will be rarely changeable for downstream uses. Conditions and measures related to external treatment of waste for disposal Fraction of used amount transferred to external waste treatment for disposal; Type of suitable treatment for waste generated by workers uses, e.g. hazardous waste incineration, chemical-physical treatment for emulsions, chemical oxidation of aqueous waste,: specify effectiveness of treatment; Conditions and measures related to external recovery of waste 13

22 Exposure cenario Format (1) addressing uses carried out by workers Fraction of used amount transferred to external waste treatment for recovery: specify type of suitable recovery operations for waste generated by workers uses, e.g. re-distillation of solvents, refinery process for lubricant waste, recovery of slag: heat recovery outside waste incinerators; specify effectiveness of measure; Additional good practice advice (for environment) beyond the REACH CA Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH, Thus, the downstream user is not obliged to i) carry out an own CA and ii) to notify the use to the Agency, if he does not implement these measures. Use specific measures expected to reduce the predicted exposure beyond the level estimated based on the exposure scenario Contributing exposure scenario (2-n) controlling worker exposure for... Name of contributing exposure scenario 2 Further specification: Product characteristics Product related conditions, e.g. the concentration of the substance in a mixture, the physical state of that mixture (solid, liquid; if solid: level of dustiness), package design affecting exposure) Amounts used Amounts used at a workplace (per task or per shift); note: sometimes this information is not needed for assessment of worker s exposure Frequency and duration of use/exposure Duration per task/activity (e.g. hours per shift) and frequency (e.g. single events or repeated) of exposure Human factors not influenced by risk management Particular conditions of use, e.g. body parts potentially exposed as a result of the nature of the activity Other given operational conditions affecting workers exposure Other given operational conditions: e.g. technology or process techniques determining the initial release of substance from process into workers environment; room volume, whether the work is carried out outdoors/indoors, process conditions related to temperature and pressure Technical conditions and measures at process level (source) to prevent release Process design aiming to prevent releases and hence exposure of workers; this in particular includes conditions ensuring rigorous containment; effectiveness of containment to be specified (e.g. by quantification of residual losses or exposure) Technical conditions and measures to control dispersion from source towards the worker Engineering controls, e.g. exhaust ventilation, general ventilation; specify effectiveness of measure Organisational measures to prevent /limit releases, dispersion and exposure pecific organisational measures or measures needed to support the functioning of particular technical measures. Those measures need to be reported in particular for demonstrating strictly controlled conditions (to justify exposure based waiving) Conditions and measures related to personal protection, hygiene and health evaluation Personal protection, e.g. wearing of gloves, face protection, full body dermal protection, goggles, respirator; specify effectiveness of measure; specify the suitable material for the PPE (where relevant) and advise how long the protective equipment can be used before replacement (if relevant) Additional good practice advice beyond the REACH CA Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH, Thus, the downstream user is not obliged to i) carry out an own CA and ii) to notify the use to the Agency, if he does not implement these measures. Use specific measures expected to reduce the predicted exposure beyond the level estimated based on the exposure scenario. 3. Exposure estimation and reference to its source Estimation of exposure and risk characterisation ratios (for all route of exposure for consumer and all compartment for the environment) resulting from the conditions described above (entries 2.1 and 2.2) and the substance properties; make reference to the exposure assessment method applied (specify for the routes if relevant); Alternatively: Include a link to a website from where the information described above can be retrieved: 4 Guidance to DU to evaluate whether he works inside the boundaries set by the E 14

23 Exposure cenario Format (1) addressing uses carried out by workers Guidance how the DUs can evaluate whether they operate within the conditions set in the exposure scenario. This may be based on a set of determinants (and a suitable algorithm) which together ensure control of risk, but which have some flexibility in the respective values for each determinant. This section may also include a link to a suitable calculation tool. Where relevant: Other methods for DU to check whether they work within the boundaries set by the E may be included here 15

24 tandard exposure scenario format for uses of substances by consumers Exposure cenario Format (2) addressing uses carried out by consumers Title of Exposure cenario List of all use descriptors related to the life cycle stage and all the uses under it; include market sector (by PC) if relevant Name of contributing environmental scenario (1) and corresponding ERC List of names of contributing consumer scenarios (2-n) and corresponding PC and sub-product-categories, as applicable Further explanations (if needed) 1. Exposure cenario 2.1 Contributing exposure scenario (1) controlling environmental exposure for... Name of contributing exposure scenario Further specification Product characteristics Product related conditions, e.g. the concentration of the substance in a mixture; package design affecting exposure Amounts used Annual amount supplied into the consumer use(s) covered in this exposure scenario Frequency and duration of use Usually continuous use/release (365 days) to be assumed, unless there are significant seasonal variations. Environment factors not influenced by risk management Flow rate of receiving surface water (m³/d) (usually 18,000 m³/d by default for the standard town); please note: the default flow rate will be rarely changeable for downstream uses; Other given operational conditions affecting environmental exposure Other operational conditions, e.g. indoor or outdoor use of products Technical conditions and measures at process level (source) to prevent release Process design aiming to prevent releases and hence exposure to the environment; this includes in particular conditions ensuring rigorous containment; performance of the containment to be specified (e.g. by quantification of a release factor ) Conditions and measures related to municipal sewage treatment plant ize of municipal sewage system/treatment plant (m³/d) (usually 2000 m³/d by default for the standard town); specify degradation effectiveness; sludge treatment technique (disposal or recovery); measures to limit air emissions from sewage treatment (if applicable; ) please note: the default size of the municipal TP will be rarely changeable for downstream uses. Conditions and measures related to external treatment of waste for disposal Fraction of used amount transferred to external waste treatment for disposal: type of suitable treatment for waste generated by consumer uses, e.g. municipal waste incineration, hazardous waste incineration: specify efficacy of treatment; provide corresponding instructions regarding separation of waste to be communicated to consumers; Conditions and measures related to external recovery of waste Fraction of used amount transferred to external waste treatment for recovery: pecify type of suitable recovery operations for waste generated by consumer uses, e.g. refinery process for lubricant waste; specify efficacy of measure; provide corresponding instructions regarding separation of waste to be communicated to consumers Additional good practice advice (for environment) beyond the REACH CA Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH, Thus, the downstream user is not obliged to i) carry out an own CA and ii) to notify the use to the Agency, if he does not implement these measures. Use specific measures expected to reduce the predicted exposure beyond the level estimated based on the exposure scenario Contributing exposure scenario (2-n) controlling consumer exposure for... Name of contributing scenario Further specification: 16

25 Exposure cenario Format (2) addressing uses carried out by consumers Product characteristics Product related conditions, e.g. the concentration of the substance in a mixture, the physical state of that mixture (solid, liquid; if solid: level of dustiness), package design affecting exposure Amounts used Amounts used per event Frequency and duration of use/exposure Duration of exposure per event and frequency of events; please note: Tier 1 exposure assessment usually refers to external event exposure, without taking into account the duration and frequency of the event (see Guidance Chapter R.15); Human factors not influenced by risk management Particular conditions of use, e.g. body parts potentially exposed; population potentially exposed (adults, children) Other given operational conditions affecting consumer exposure Other operational conditions e.g. room volume, air exchange rate, outdoor or indoor use Technical conditions and measures at process level (source) to prevent release Process design aiming to prevent releases and hence exposure of workers; this in particular includes conditions ensuring rigorous containment; effectiveness of containment to be specified (e.g. by quantification of residual losses or exposure) Conditions and measures related to information and behavioural advice to consumers afety advice to be communicated to consumers in order to control exposure, e.g. technical instruction, behavioural advice; please note: usually such measures are not expected to be effective, unless the registrant has available particular evidence that consumers follow the advice. These measures may however be included under the Good Practice Advice, and thus the effectiveness of the instructions/advice would not be taken into account when deriving exposure estimates and risk characterisation in the CR. Conditions and measures related to personal protection, hygiene and health evaluation Usually personal protection measures are not expected for consumer products; however if e.g. gloves are recommend this can be specified here; specify the suitable material for the PPE (where relevant,) and advise how long the protective equipment can be used before replacement (if relevant);please note: usually such measures are not expected to be effective if applied by consumers. Thus, is recommended to include these measures under the Good Practice Advice, rather than taking the use of PPE into account when deriving exposure estimates and risk characterisation in the CR. Additional good practice advice beyond the REACH CA Note: The measures reported in this section have not been taken into account in the exposure estimates related to the exposure scenario above. They are not subject to obligation laid down in Article 37 (4) of REACH, Thus, the downstream user is not obliged to i) carry out an own CA and ii) to notify the use to the Agency, if he does not implement these measures. Use specific measures expected to reduce the predicted exposure beyond the level estimated based on the exposure scenario. 3. Exposure estimation and reference to its source Estimation of exposure and risk characterisation ratios (for all route of exposure for consumer and all compartment for the environment) resulting from the conditions described above (entries 2.1 and 2.2) and the substance properties; make reference to the exposure assessment method applied (specify for the routes if relevant); Alternatively: Include a link to a website from where the information described above can be retrieved: 4 Guidance to DU to evaluate whether he works inside the boundaries set by the E Guidance how the DUs can evaluate whether they operate within the conditions set in the exposure scenario. This may be based on a set of determinants (and a suitable algorithm) which together ensure control of risk, but which have some flexibility in the respective values for each determinant. This section may also include a link to a suitable calculation tool. Where relevant: Other methods for DU to check whether they work within the boundaries set by the E may be included here 17

26 18

27 Annex II: Workshop 8-9 March 2010, Lausanne Aims of the Workshop: 1) Engagement of Key takeholders in NANEX 2) Discuss data requirements for exposure scenarios for nanomaterials 3) Present, discuss and agree work plan for data collection for occupational and consumer exposure scenarios and environmental release. 4) Identify sources information from the key experts/stakeholders and elsewhere 5) Define data requirements for identifying gaps and research needs Programme: Monday 8 March 1900: Welcome dinner/drinks (only those who signed up with Katherine.Clark@hospvd.ch) Tuesday 9 March: : Registration and coffee : Welcome and Programme of the Workshop Morning Programme : REACH, exposure scenarios and NANO (Frans Christensen) Aims and Objectives of NANEX (Martie van Tongeren) Introduction to the breakout groups Breakout groups to discuss NANEX approach and data requirements, sources of information, use of models, etc. for exposure scenario development I) Occupational Exposure cenarios (Chair Derk Brouwer, Rapporteur: TBC) II) Environmental Release and Consumer Exposure cenarios (Chair: Bernd Nowack, Rapporteur: Frans Christensen) Reporting back to plenary session Lunch iesta /opportunity to visit Museé Olympique/hang out at the lake. Afternoon Programme Introduction to ession on Gap Analyses and Research Needs (Michael Riediker) Breakout groups to discuss data requirements for gap analyses I) Chair: Michael Riediker, Rapporteur: Willie Peijnenburg II) Chair: Katherine Clarke, Rapporteur: Vladimir Murashov Reporting back to plenary session Buffet Dinner ummary of the workshop and presentation of NANEX timeline 19

28 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 1 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 10 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 13 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 2 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 5 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 8 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 14 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 17 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 6 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 9 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 12 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 15 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra : REACH, exposure scenarios and NANO (Frans Christensen) REACH Exposure cenarios and nanomaterials European Commission, Joint Research Centre (JRC) Institute for Health and Consumer Protection (IHCP) Nanobiosciences unit Frans M. Christensen Nanex Workshop, Lausanne, 9 March, 2010 Key messages REACH Exposure cenario = conditions of use = risk management measures + operational conditions Double role of Exposure cenarios! Basis for exposure estimation Output of the assessment process communicated to the (downstream) users Exposure scenarios trigger new and integrated thinking.. Nanoforms are addressed within REACH HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 3 REACH Registration AIM: manufacturers and importers obtain information on their substances and use this knowledge to enable well-informed management of the risks these substances may present throughout their life cycle Registration Dossier = Documentation Technical Dossier: starting at 1 tonnes per year Chemical afety Report: starting at 10 tonnes per year No formal acceptance - industry retain responsibility Registration dossier - content ubstance to be registered > 10 tonne/year ubstance dangerous or PBT/vPvB Also Also Technical Dossier Identify of the manufacturer/importer Identity of substance Info- manufacture and use of the substance Classification and labelling Guidance on safe use of the substance tudy summaries substance properties Test proposals (if relevant) Exposure information Chemical afety Report Hazard and PBT Assessment Chemical afety Report Hazard and PBT Assessment Exposure Assessment Exposure cenarios Exposure Estimation Risk Characterisation Content of exposure scenarios Description of conditions suitable to ensure control of risks related to the uses of a substance during its entire life cycle. Environment, workers and consumers to be covered. One E can cover one or more uses. Operational conditions (OC) determining the exposure (e.g. duration of task) Practical risk management measures (RMM) suitable/needed to prevent or limit exposure (e.g. exhaust ventilation) Explanation how the exposure estimates related to these conditions and RMM have been derived. Title of exposure scenario indicting for which uses it can be applied Boundaries within which the exposure scenario is applicable. Iterative development of exposure scenarios in the chemical safety assessment process Information: available required/needed substance intrinsic properties manufacture, use, tonnage, exposure, risk management Hazard Assessment (HA) Exposure Assessment (EA)* Hazard Classification Build Exposure cenarios and PBT conclusion (RMM and OC) Dose/Concentration-Response Estimate Exposure Level Characterisation n y Dangerous top or PBT? Risk Characterization (RC)* Document y Risk n Iteration in CR controlled? Communicate E via ed Required if substance is dangerous or PBT/vPvB, or Required for * exposure based waiving according to annex XI all CAs Dual role of Exposure cenarios! 1. Basis for exposure estimation (in the itertive process of preparing the CA) Exposure cenarios enable a quantitative release and exposure estimation by describing the determinants of exposure; i.e. the parameters that affect the exposure level 2. Communication (CA output, annex to Ds) E is the communication tool to the user on how to use the chemical in a way that risks are controlled, including specifying the necessary Risk Management Measures How will the user know? Exposure cenarios will be attached to the afety Data heet (D) -> Extended afety Data heets (e-d) afety Data heet Annex: Es Es Es For which uses/processes are Es required? Chemical life cycle Manufacturer/Importer Professional / industrial use Own Use Value chain Manufacture On Market P 1 P 2 P 1 P 2 A 1 A 2 A 1 A 2 P Disposal A Exposure cenarios from the Downstream User (DU) point of view P A ubstance Preparation Article Consumer use P 1 P 2 A 1 A 2 A P The Downstream User (DU) Must: Implement Operational Conditions and Risk Management Measures communicated to him via the exposure scenarios in the D Annex If he uses the substance outside the conditions described in the exposure scenario(s) Inform his supplier of this use to make it an identified use Alternatively: Conduct a safety assessment for his own use (and for his downstream uses if he is a supplier) and implement E from own safety assessment and report to the Agency witch to another supplier Communicate further down the supply chain if he is supplier What is new - 2? HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 16 The manufacturer or importer needs to cover the whole life cycle of the substance in his exposure scenarios Use-specific information for controlling risks (Exposure scenarios) in extended D Increased (pro-active) supply chain communication The downstream users of substances as such or in preparations are obliged to work within the conditions described by the suppliers Es or to carry out an own CA for own processing for chemicals supplied further down the chain forward corresponding information to customers Manufacturer Importer Communication needs What does M/I need to know about the conditions of use in his market? What does M/I need to tell his customers about the conditions and measures to control risks? Minimum Requirements E Downstream Users Contains practical and relevant OC and RMM pecifies the boundaries of applicability Covers health and environmental aspects of the uses/activities covered by the E OC and RMM can be linked to predicted or measured exposure (health and environment) The CA documents that risks are controlled at these exposure levels (i.e. that risks are controlled when E implemented) Information on the exposure estimation is available to downstream user (values and methods) What is new - 1? New ways of thinking for the exposure experts REACH Exposure cenarios contain the conditions of use; i.e. risk management measures and operational conditions controlling exposure An exposure scenario for an occupational setting shall control exposure to workers and the environment Likewise an exposure scenario for a consumer use shall control exposure to consumers and the environment => Need for integrated thinking!!! => Note this in the break-out group discussions! ome of the challenges Mind set: Risk management to become integral part of the iterative assessment process Organising the communication up and down the supply chain well before the first registration deadline Linking the risk management focus under REACH to traditional exposure assessment Identification of exposure estimation methodology allowing high throughput without being overly conservative Translating exposure scenarios for substances into guidance for controlling risk for use of preparations 20

29 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 19 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 25 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 28 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 20 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 23 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 26 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 29 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 21 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 24 HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 27 REACH and nano There are no provisions in REACH referring specially to nanomaterials, but REACH addresses chemical substances, in whatever size, shape or physical state. ubstances at the nanoscale are therefore covered by REACH and its provisions apply. Registration and Chemical afety Assessment for nanomaterials A registration of a nanomaterial has to include all relevant information on the nanomaterial covering the properties, uses, effects and exposure related information as well as the classification and labelling and the safety assessment. Nanomaterials having specific properties may require a different classification and labelling compared to the bulk material. Reg. (EC) 1272/2008 on Classification, Labelling & Packaging (CLP) implementing the global Harmonised ystem HEALTH AND ENVIRONMENTAL AFETY OF MANUFACTURED NANOMATERIAL 20 February 2009, Ispra 22 Exposure cenarios and supply chain communication for nanomaterials Exposure scenarios should cover nanomaterials, incl. relevant Operational Conditions and Risk Management Measures These Exposure cenarios should be communicated down the supply chain NB! When Es are not required, a D with risk management measures addressing the specific properties of the nanoform should be communicated as part of the main body of the D No specific REACH guidance for substances in nanoscale, but the document Nanomaterials in REACH (CA/59/2008rev.1) outlines: Current guidance can be used by companies as a starting point to prepare their registration dossiers for substances at the nanoscale Further work is ongoing and planned on substance identification and information requirements and chemical safety assessment (see next slide) CA/59/2008rev.1 available via: _en.htm REACH implementation projects on nano (RIP-oNs) RIP-oN1: ubstance identification An expert group (Member tates, Industry, NGOs, ECHA and Commission) has been established The group works on four cases (Carbon nanotubes, nano-silver, nano-tio2 and nano-caco3) and analyses how the guidance on ubstance Naming and Identification can be updated Results expected during 2010 RIP-oN2 (Information Requirements) and RIP-oN3: (Chemical afety Assessment) Work will start Q1, 2010 and last 12 months Are mainly addressing how the guidance on Information Requirements and Chemical afety Assessment (including exposure scenarios) could be updated Conclusions REACH registration and nano REACH registration includes nanomaterials pecific properties for nanomaterials must be addressed Operational conditions and risk management measures to control the risks from nanomaterials must be identified and communicated to the supply chain Follow the guidance available Guidance to be further developed and exemplified to better address nanomaterials Thank you for your attention Back-up slides What is the Chemical afety Report (CR)? The CR (>10 tonne/year) is the documentation of the Chemical afety Assessment (REACH Annex I) covering: Hazard Assessment of the inherent properties Physicochemical, Human Health, Environmental PBT and vpvb assessment* and when substance is dangerous or PBT/vPvB Development of Exposure cenarios for controlling risks Exposure estimation quantifying human and environmental exposure levels Risk Characterisation * PBT: Persistent, Bio-accumulative and Toxic * vpvb: very Persistent and very Bio-accumulative Aims of the Chemical afety Assessment process Collect/generate/assess information on uses, exposures and intrinsic properties. Based on this: Identify the conditions under which the risks arising from manufacture and use(s) of a substance are controlled. Prepare a set of corresponding information on operational conditions and risk management measures (= Exposure cenarios) to be communicated to the users of the substance (for dangerous/pbt/vpvb substances). Document the assessment in a Chemical afety Report (CR) for the companies own documentation. ubmit the CR to the authorities as part of the registration. 21

30 Aims and Objectives of NANEX (Martie van Tongeren) AIM NANEX Workplan WORKING FOR A HEALTHY FUTURE NanEx: Aims and Proposed Tools Tuesday 9 March 2010 Museé Olympique 1. Describe generic requirements for describing exposure scenarios for MNMs. 2. Collect and review exposure data, exposure metrics, risk management measures and existing models for the development of occupational exposure and consumer exposure, including environmental release 3. Carry out a number of case illustrations 4. Develop a catalogue database with Es 5. Identify gaps and research needs 6. Disseminate information to stakeholders. WP 2: Generic E (IOM) WP1: Project Management (ER) WP 3: Occupational E (TNO) WP 4: Consumer E (JRC) WP 5: Environmental E (EMPA) WP 6: Case Illustrations (NIA) WP 7: Integration and gap analyses (IT) WP 8: Dissemination (CEA) Quai d Ouchy Lausanne, witzerland WP9: cientific Coordination (IOM) INTITUTE OF OCCUPATIONAL MEDICINE. Edinburgh. UK NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar Nanomaterials included in NanEx CNTs Carbon nanotubes (CNTs) TiO2 and other mass produced MNM Nano-Ag Manufacture Chemical vapour deposition Arc-vapour discharge laser ablation/pulsed laser evaporation Application: Composites (ceramic and polymer composites, conducting composites, adhesives) Electronic components (Heat transfer units, capacitors, flexible displays, hydrogen storage, etc) Textiles (military textiles, wearable electronics, clothing and furnishing) Biomedical (drug delivery systems) Cosmetics (hair colouring) (From Gottschalk et al, 2010) NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar (From Gottschalk et al, 2010) Content E - REACH Description of conditions suitable to ensure control of risks related to the uses of a substance during its entire life cycle. Environment, workers and consumers to be covered. One E can cover one or more uses. Operational conditions determining the exposure (e.g. duration of task) Practical risk management measures (RMM) suitable/needed to prevent, reduce or limit risks (e.g. exhaust ventilation) Explanation how the exposure estimates related to these conditions and RMM have been derived. Title of exposure scenario indicting for which uses it can be applied Boundaries within which the exposure scenario is applicable Iterative development E Descriptions - NanEx No risk assessment, no iterative development Manufacture and use of MNMs Occupational, Consumer and Environmental Release pecific information required for describing exposure to MNMs Physico-chemical properties Exposure assessment Metric (mass, number, surface area) Particle size distribution Classification of nanoparticles NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar Classification of nanoparticles (From Maynard & Aitken, 2007) REACH Guidance Four standard formats for E Workers use of substance Consumer s use of substance ervice life of substance in articles (workers) ervice life of substance in articles (consumers) Operational conditions controlling Environmental Release is included in each of these E formats! E Template Table: 2.2.2: The generic E format for the extended safety data sheet 1 Exposure cenario (1) Title of exposure scenario 2.1 Contributing exposure scenario (1) controlling environmental exposure for Contributing exposure scenario (2) controlling worker exposure for Contributing exposure scenario (3) controlling worker exposure for... 2.n Contributing scenario (n) controlling worker exposure for Exposure estimation and reference to its source Information for contributing exposure scenario (1) Information on contributing exposure scenario (2) Information on contributing exposure scenario (3) Information on contributing exposure scenario (n) 4. Guidance to DU to evaluate whether he works inside the boundaries set by the E NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar Access/Word tools E Gap analyses and research needs Microsoft Access format Word format Upon completion, both templates will be available from the NanEx website for use in the project Information will be collated and transferred to a web-based library Topic of this afternoon (introduced by Michael Riediker and Katie Clark Critical review of information sources Assessment of quality of E entries NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar Breakout discussion sessions Breakout groups Identify special requirements for E for MNMs Review tools for describing E To identify and exchange information on sources of data and exposure information Availability and applicability of exposure models I) Occupational Exposure cenarios Chair Rapporteur : Derk Brouwer, : tbc II) Environmental Release and Consumer Exposure cenarios Chair Rapporteur : Bernd Nowack : Frans Christensen Feedback in Plenary session NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar

31 I) Occupational Exposure cenarios (Chair Derk Brouwer, Rapporteur: TBC) NANEX Workshop Occupational Exposure Objectives WP 3 Occupational Exposure cenarios tructured description of identified situations with potential for worker exposure to manufactured nanomaterials along their life cycle (i.e. during synthesis/manufacturing, down-streamuse/formulation, professional use of nanoproducts, service life, and end-of-live) How is the product used (conditions and type of activities) What is the duration and frequency of activities Which measures are taken to reduce exposure What is the level of exposure How many workers will potentially be exposed.. In case of lacking info/data can info other substances/products/ processes etc be used ( read across ) or (exposure)models? What are knowledge gaps and research priorities Exposure cenario and Life Cycle from the perspective of REACH Production Intermediate preparation Product Professional use Waste handling Industrial use Consumer use Derk Brouwer 2 3 Life cycle of Manufactured Material containing End-product Potential for exposure to MNO in different exposure situations `MNO embedded coating products as an example Industrial CNTs, Intermediates, CNT end-products, and CNT embedded end-products Nanocyl A MNP END MNP Products YNTHEI PRODUCTION AEMBLY UE END of LIFE Collection/ separation NP prod NP d-su Assembly Finishing Use Maintenancedisassembly sorting/ re-use Preparation recycling MNO MNO Down-stream user ynthesis product MNO product package Modification Up-stream Bag/ bin dumping Application Dispersion/ user end-product compounding e.g. coating of a surface by variety of application MNO containing end-product techniques Coated surface Catalytic Carbon Vapor Deposition Catalyst: Me-oxides/salts (Al,Co,Fe) Multiwalled CarbonNanotube Primary endproducts Average Diameter nanometers 9.5 T Average Length microns 1.5 Carbon Purity % 90 Metal Oxide % 10 urface Area m2/g > BET Intermediates Ready-to-use endproducts 4 Incineration Landfill 5 Aging/wear/ abrasion Treatment/ machining e.g. sanding 6 Exposure scenarios and life cycle Format(s) of description of initial exposure scenarios Operational Conditions and Risk Management Measures (1) ubstance #1 #2 #n Production Downstream Processing/ End ervice End of Use product Life Life G1 G11 G1 G2 G n G n REACH E format offers a harmonized format to describe the activities (Process Categories (PROC)), Operational Conditions (OC) and Risk Management Measures (RMM). In case exposure data are lacking the format enables the use of a first tier exposure assessment tool (ECETOC-TRA) to generate estimates of exposure The REACH format (PROCs /OC and RMM) is useful as a minimum requirement Other tools to predict exposure, e.g..toffenmanager, also offer a harmonized format to describe the exposure situation with a higher level of detail, e.g. tasks/ activities, factors modifying transport of contaminants, control measures etc. Exposure cenario = Description of Operational Conditions (OC) and Risk Management Measures (RMM) for control of risk Operational Conditions = aspects related to activity or process, surrounding, exposed population or situation that influence exposure and risk (excluding Risk Management Measures) Duration of activity Amount used or use rate Room size Working indoors or outdoors Operational Conditions and Risk Management Measures (2) Exposure cenario = Description of Operational Conditions (OC) and Risk Management Measures (RMM) for control of risk Risk Management Measures = aspects related to the activity or process, the source, the surrounding, the situation or the exposed person that are intended to limit emission, dispersion, exposure, risk Closing an open batch process Local exhaust ventilation (LEV) Using closed coupling system instead of open transfer Personal Protective Equipment (PPE) (G)E format for communication Title and covered activities 1 hort title for Exposure cenario 2 Processes and activities covered Operational conditions 3 Duration and frequency of use 4.1 Physical form of substance or preparation 4.2 Concentration of substance in preparation or article 4.3 Amount used per time or activity 5 Other relevant operational conditions of use Risk Management Measures 6.1 Risk management related to human health (worker, consumer) 6.2 Risk management related to the environment 7 Waste management measures References to exposure estimation 8 Exposure prediction and reference to its source 9 Guidance to the DU to check whether he is working within the E toffenmanager as (supplemental) template? Conceptual Model (Tielemans et al., 2008) Category TRA (process) TM (task) Physical state Liquid/ solid Emission Fugacity/ intrinsic Vapour pressure/ dustiness emission Handling (sub)proc (33) 7+6 types Transmission Local control 1 (LEV) 4 Ventilation 2 (Out-/ indoors) 4 Background 2 (Inspection/ emission cleaning) Immission eparation 2 (eparation/ cabin) Respiratory RPE (4) RPE (2) protection Duration 4 4 Different output models TRA output :point estimate daily average mass concentration toffenmanager: distribution of mass concentration per activity Frequency 6 15 Data collection: type of information & sources Type Overview manufacturing processes and applications CNT, TiO2, nanoag through life cycle Handling/ activities with potential for exposure Operational conditions etc and exposure data ources Open access/ published literature pecific papers (life cycle and/or exposure) Reviews/ ummaries ( read across ) e.g. eaton et al., 2009, Brouwer, 2009 Methner et al., 2010 (NIOH surveys). Restricted access/ grey literature Data generated by EU/ National projects NANOH/NANOAFE/NAOCARE?/NANOKEM?/ In house data (project participants) Quality requirements information & exposure data Identification of exposure situations `completeness? Checking UE descriptors `completeness? Description of actual exposure situations[ PROCs/ OC and RMM(REACH template) alternatively toffenmanager format] completeness?/ reliability? Estimates of exposure Relevant exposure metric(s) (N.B. Output models= mass conc.) Emission/ Workplace air vs breathing zone Identification/ characterization of particles (element/ size/shape/aggl Decision logic (likelihood of presence of manufactured nano particles Accuracy Model estimates Topics to be discussed Identification of scenarios CNT, nano-tio2, nano-ag (products, articles) Template/ Format(s) Data/ information (nano specific) Data required Data sources including models Data quality Knowledge gaps (REACH) initial E Worker exposure assessment/ exposure management

32 Ma terials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y 16 Ma terials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Ma terials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y Materials ci ence & Technolog y II) Environmental Release and Consumer Exposure cenarios (Chair: Bernd Nowack, Rapporteur: Frans Christensen) Consumer Exposure cenarios and Environmental Release Bernd Nowack, Empa, witzerland Frans Christensen, JRC, Italy Consumer exposure scenarios Chemical life cycle Manufacturer/Importer Manufacture Own Use On Market Professional / industrial use Value chain P 1 P P 1 P 2 2 A 1 A 2 A 1 A 2 P Disposal A P A ubstance Preparation Article Consumer use P 1 P 2 A 1 A 2 A P Basic considerations What does the consumer apply? ubstance, preparation or article? For nano, it is often articles, but also sometimes preparations. Agree? How is the consumer exposed? What is released to the environment? Operational conditions How often is the product applied (frequency) For how long (duration) How much is used per use/application (amount) Where is it applied (outdoor, closed room, ventilated room ). Risk management measures Are risk management measures recommended? If so, are they followed? For consumer products, risk management is often built into the product to limit release, e.g.: Pellets rather than powder Design of the packaging (dosing devices, child secure taps/lids,.) Design of the product, e.g. use in solid matrix Consumer exposure estimation - nano First question: What metric(s) to use (mass, number, surface area,.?) Measurements Where, when, what (metric), technical feasibility, representativeness, etc. Modelling Are current models applicable for nano? (Release to the environment and environmental exposure addressed later) Question for discussion What do we know about use of nanomaterials in consumer products? Is the Woodrow Wilson database a good starting point? Other sources welcome! hould we scope Nanex (WP4) to look at specific nanomaterials and/or applications? What do we know about these products in terms of: 1.Operational conditions (frequency, duration, amount of use, etc.), 2. How they are designed to limit release (release rates ) and 3. Do we know how exposure estimates link to 1. and 2? Exposure: What to estimate (metric) and how (measurements, models.) Different strategies for different types of products (e.g. is NM in preparation or solid matrix)? Environmental release Information needed for release estimation Tonnage (based on production or calculated by product use) Life Cycle tage (manufacture, formulation, industrial use, professional and private use, service life, waste treatment Type of use in the life cycle stage (processing aid, inclusion into/onto matrix, reacting in use) Distribution of production volume in the market Emission Pattern Distribution in time and space (local vs. Regional) Emission Pathways (Air, oil, Water): industrial point sources, wide dispersive use, intended release, unintended release Multiple emissions Emission factors (processes, products, service life, waste disposal) Risks management measures to reduce emissions (e.g. water treatment, containment) Environmental Release Classes in REACH ERC used for Tier 1 estimates ERC are based on Life cycle stage Emission pattern Level of containment Type of use and technical fate Dispersion of emission sources Indoor or outdoor use Release potential during service life and waste stage Normally much more information on use conditions is needed than contained in ERC Modeling Environmental Release Mueller, N. C.; Nowack, B. (2008) Exposure modeling of engineered nanoparticles in the environment. Environ. ci. Technol. 42: Gottschalk, F. onderer, T.; cholz, R. W.; Nowack, B. (2009) Modeled environmental concentrations of engineered nanomaterials (TiO 2, ZnO, Ag, CNT, fullerenes) for different regions. Environ. ci. Technol. 43: Gottschalk, F.; onderer, T.; cholz, R. W.; Nowack, B. (2010) Possibilities and Limitations of Modeling Environmental Exposure to Engineered Nanomaterials by Probabilistic Material Flow Analysis. Environ. Toxicol. Chem. In press. Distribution to product categories, example nano-ag (in % of total nano-ag) Product category Mode Min-Max urface treatment Textiles Paint Dietary uppl electronics filters plastics cosmetics Glas & Ceramics Metals Material-flow model for nano-ag for the U (mode values in tons/year) Questions for discussion Emission factors used in ERC often for volatile or soluble compounds: application to nanoparticles? Particles may be reactive: disappear during use What is the released form? ingle NP or larger pieces? till nano? Almost completely missing experimental data Example nano-ag: Two studies on release available: Benn and Westerhoff (2008) and Geranio et al., (2009) How to make the appropriate link between how the substance was used (i.e. the information that should be in an exposure scenario) and the exposure estimation ize fractionation of Ag released from nanotextiles X-TATIC PLAMA-NP Geranio et al., E&T (2009) <4 <4 <50 <15 AgCl AgCl binder NP-PE surface NP-PE NP-PE/PA na X-YTEM Ag KillBact Ag + <450 nm >450 nm Question for discussion What do we know about use of nanomaterials in consumer products? Is the Woodrow Wilson database a good starting point? Other sources welcome! hould we scope Nanex (WP4) to look at specific nanomaterials and/or applications? What do we know about these products in terms of: 1.Operational conditions (frequency, duration, amount of use, etc.), 2. How they are designed to limit release (release rates ) and 3. Do we know how exposure estimates link to 1. and 2? Exposure: What to estimate (metric) and how (measurements, models.) Different strategies for different types of products (e.g. is NM in preparation or solid matrix)? Question for discussion What do we know about use of nanomaterials in consumer products? Is the Woodrow Wilson database a good starting point? Other sources welcome! hould we scope Nanex (WP4) to look at specific nanomaterials and/or applications? What do we know about these products in terms of: 1.Operational conditions (frequency, duration, amount of use, etc.), 2. How they are designed to limit release (release rates ) and 3. Do we know how exposure estimates link to 1. and 2? Exposure: What to estimate (metric) and how (measurements, models.) Different strategies for different types of products (e.g. is NM in preparation or solid matrix)? 24

33 Breakout groups to discuss data requirements for gap analyses I) Chair: Michael Riediker, Rapporteur: Willie Peijnenburg Quality analysis, integration and gap analysis Breakout group 1 1 -Most important issue with regard to discuss the quality of a study used for E Method issues Operational conditions of use clearly described and adequate for the NM/matrix Proper instrumentation covering various exposure matrices ufficient time resolution of the measurement 1 -Most important issue with regard to discuss the quality of a study used for E ubstance issues Characterisation of substance agglomeration state Test for stability of agglomerates Good characterization of materials and instrumentation Presence of contextual data Exposure metric should be related to hazard metric Need to convert exposure metric to dose metric (or vice versa), at least mass or concentration of fibres should be included (current RA metrics) Quantify reliably the relevant metric of target substance Likelihood of the study being on the intended NM (is what you measured what you think you measured?) background verification of the concentration of NM Information on application Include total external surface area as nano indicator (e.g. BET) in list of particle characteristics Include size distribution as well 1 -Most important issue with regard to discuss the quality of a study used for E Mixed issues Authors trustworthy? Method to measure protection Make sure not to give a number or use a method that is associated with knowledge gaps Questionable whether detailed QA system is needed given the apparent lack of studies Toxicity of substance 1 -Most important issue with regard to discuss the quality of a study used for E Relevance - reliability (adequacy) issues tudy indicated to be on personal exposure, workplace or emissions Measurement strategy Completeness of info on accuracy, reproducibility, target of exposure, and matrix Repeatability represenativeness Quality of contextual data Generalization of results possible importance of this issue is questioned in 2 nd round of discussion Applicability of data for E Detailed reportingof methods and results (exposure determinants) Additional issues: Key difficulty is how to measure exposure important to measure exposure at the point of exposure Key question: are the metrics relevant for dose, hazard, risk Key approach: have all the data there (i.e. without a pre-selection of endpoints/metrics) Key issue: reliability/quality versus relevance. A starting point would be quality of data versus quality of study evaluate supporting information Completeness issues versus adequacy of the methodology Learn from extensive experience of evaluations of E on non-nano s Issue of concern is that different evaluators will come up with different evaluations of studies Recommendation: have more persons evaluate the same study as an exercise to identify the critical issues calibrate the rating system OVERALL RECOMMENDATION WITH REGARD TO METHOD EVALUATION: Analytical QC in most cases difficult to assess current lack of standards Interpretation levels of detail of evaluation Breakout group 2 ize Issues for description of particle characteristics AED v. EMD v. TEM Use ultrafinesas a guide for characterizing/describing particles Issues of consistency of measurements hape How to describe it 3:1 ratio for fibers? Aggregation index needed Dustiness Need to characterize Quality assessment tudy type Being an accredited laboratory assures high quality Peer-reviewed publications are not necessarily high quality Laboratory v. field studies may have differences in which parameters are controlled Exposure characterization - Exposure metrics still under debate, mass has important historical significance. - ome correlations can be done with size and particle number - Common problems: - quality of instrumentation and experience of personnel using these instruments - Quality of data must be ensured at preparation/generation/analysis steps - Need for internationally harmonized methods, ie, IO Integration of other information sources Exposure data has been generated by other FP7 projects. We should contact and collect experience of those involved in these projects: Nanosafe Nanocare Nanosh Industry also has data Need consistency in rating of data and experiences Description of exposure tart with existing mathematical models of exposure and use most detailed models as starting point for descriptors of exposure For control measures, either use free text or most commonly used exposure mitigation techniques Environmental exposures Very few experimental exposure data, therefore must use modeling Modeling The goal of this project is to identify generic experimental data, which can be later used to develop or validate models If there is a gap, use modeled data Take note of whether studies are model-based or experimental Existing models can be used to provide estimates of extreme conditions Dermal Distinguish whether we want to focus on exposure v. uptake -> focus on exposure Differentiate soluble v. insoluble? Mass of NP/unit area of skin could be starting point for discussing exposure to skin Integration Gaps should be ranked according to magnitude of use Match industrial activity and market data with systematically ranked data on exposure Industrial data can be obtained within EU for ZnO and TiO 2 Validity of EU analysis better for occupational, less for consumer and environmental Gap analysis will feed decisions on what should be funded by EC Read across for exposure ome can be done for broad classes and specific tasks, or for specific physical chemical endpoints Exp. scenarios are for very specific materials, so read across can be inappropriate For environmental scenarios, may have to use read across because there is no data available Final remarks WP7 will review the answers to the questionnaire and report back on some of the key issues 25

34 Breakout groups to discuss data requirements for gap analyses II) Chair: Katherine Clarke, Rapporteur: Vladimir Murashov Nanex Workshop 8-9 March 2010 Breakout groups on elements of a gap analysis Most important issue with regard to discuss the quality of a study used for E: ubstance issues o Characterisation of substance agglomeration state o Test for stability of agglomerates Good characterization of materials and instrumentation Presence of contextual data Exposure metric should be related to hazard metric Need to convert exposure metric to dose metric (or vice versa), at least mass or concentration of fibres should be included (current RA metrics) Quantify reliably the relevant metric of target substance Likelihood of the study being on the intended NM (is what you measured what you think you measured?) background verification of the concentration of NM Information on application Include total external surface area as nano indicator (e.g. BET) in list of particle characteristics Include size distribution as well Most important issue with regard to discuss the quality of a study used for E Relevance - reliability (adequacy) issues tudy indicated to be on personal exposure, workplace or emissions Measurement strategy Completeness of info on accuracy, reproducibility, target of exposure, and matrix Repeatability represenativeness Quality of contextual data Generalization of results possible importance of this issue is questioned in 2 nd round of discussion Applicability of data for E Detailed reporting of methods and results (exposure determinants) Most important issue with regard to discuss the quality of a study used for E Method issues Operational conditions of use clearly described and adequate for the NM/matrix Proper instrumentation covering various exposure matrices ufficient time resolution of the measurement Most important issue with regard to discuss the quality of a study used for E Authors trustworthy? Method to measure protection Make sure not to give a number or use a method that is associated with knowledge gaps Questionable whether detailed QA system is needed given the apparent lack of studies Toxicity of substance Breakout group 2: Description of particle characteristics ize AED v. EMD v. TEM Use ultrafines as a guide for characterizing/describing particles Issues of consistency of measurements hape How to describe it 3:1 ratio for fibers? Aggregation index needed Dustiness Need to characterize Quality assessment tudy type Being an accredited laboratory assures high quality Peer-reviewed publications are not necessarily high quality Laboratory v. field studies may have differences in which parameters are controlled Exposure characterization Exposure metrics still under debate, mass has important historical significance. ome correlations can be done with size and particle number Common problems: quality of instrumentation and experience of personnel using these instruments Quality of data must be ensured at preparation/generation/analysis steps Need for internationally harmonized methods, ie, IO Integration of other information sources Exposure data has been generated by other FP7 projects. We should contact and collect experience of those involved in these projects: Nanosafe Nanocare Nanosh Industry also has data Need consistency in rating of data and experiences Description of exposure tart with existing mathematical models of exposure and use most detailed models as starting point for descriptors of exposure For control measures, either use free text or most commonly used exposure mitigation techniques Environmental exposures Very few experimental exposure data, therefore must use modeling Modeling The goal of this project is to identify generic experimental data, which can be later used to develop or validate models If there is a gap, use modeled data Take note of whether studies are model-based or experimental Existing models can be used to provide estimates of extreme conditions Integration Gaps should be ranked according to magnitude of use Match industrial activity and market data with systematically ranked data on exposure Industrial data can be obtained within EU for ZnO and TiO 2 Validity of EU analysis better for occupational, less for consumer and environmental Gap analysis will feed decisions on what should be funded by EC Read across for exposure ome can be done for broad classes and specific tasks, or for specific physical chemical endpoints Exp. scenarios are for very specific materials, so read across can be inappropriate For environmental scenarios, may have to use read across because there is no data available 26

35 Reporting back to plenary session Workshop ummary Tuesday 9 March 2010 Museé Olympique Quai d Ouchy Lausanne, witzerland WORKING FOR A HEALTHY FUTURE NanEx E Development to request information Terminology Tentative E, not final E (ie no risk characterisation) Use IO terminology for nanomaterials E template from latest REACH guidance, but also a report on the method for the assessment Importance of the links between the environmental release and Occupational and Consumer E E Template Access or word document to describe the E Need guidance for the users How to describe the exposure to MNMs What should be described as part of the process in the development of the E Aim to have this available for the NANEX project next week From NANEX website INTITUTE OF OCCUPATIONAL MEDICINE. Edinburgh. UK NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar Gap Analyses 2 levels tructural and critical review of information Overall gap analyses (workshop in October) Knowledge gaps rather than data gaps General quality issues and specific nano measurements related issues Analytical/QC/Interpretation Good characterisation of materials Good contextual information Relevance/reliability/adequacy Gap analyses Particle characteristics ize hape Dustiness Quality assessment tudy type Exposure characterisation NanEx Workshop 8 rd Mar NanEx Workshop 8 rd Mar

36 28

37 Annex III: A brief introduction and guide to the NANEX Exposure cenario Database 1. Introduction The NANEX Exposure cenario Database has been created for the entry of exposure scenario data and to allow the collation and merging of this information for the creation of the catalogue of generic exposure scenarios in NANEX WP2. This document contains basic instructions and guidance for the use of the Access version of the E (exposure scenario) data collection template. An alternative, but less structured format that can be used is provided via a Microsoft Word file with text entry into data entry fields. This Access database has been designed to enter the exposure assessment details of four generic scenario types. The format is very closely based on the ECHA Exposure cenario definition document: To use the NANEX Exposure cenario Database 1. Use the Navigation buttons at the bottom of form to browse records 2. Use the ADD button at bottom to enter a new record 3. Use EDIT button at bottom to view/change an existing record 4. Use filtering options on top of form to filter existing records by Exposure Type and ubstance Type The NANEX Exposure cenario Database preserves the order, acronyms, section headings and prompts for each of the E items in the tables in the ECHA document: Guidance On Information Requirements And Chemical afety Assessment; Part D: Exposure cenario Building; Part F: CR Format. - Draft Update of Exposure cenario Format. ECHA, 2010, (version 0.1),Guidance for the implementation of REACH ( and The four generic formats cover the following activities with a substance: 1. Format related to workers use (including production), and conditions controlling workers exposure and conditions controlling the environment exposure. 2. Format related to consumer s use, including conditions controlling consumers exposure and conditions controlling the environment exposure. Note: the content of this exposure scenario is to be communicated to the downstream users producing consumer products (mixtures). 3. Format related to the service life (and subsequent waste life stage) following from downstream uses, including conditions controlling workers and environment exposure. 4. Format related to the service life (and subsequent waste life stage) following from downstream uses, including conditions controlling consumers and environmental exposure. 29

38 2. Getting started with the NANEX Exposure cenario Database To enter new exposure details in the NANEX Exposure cenario Database click the Add New button To view previously entered exposure records, click Overview button. Instead of the Access database, if you would like to use the alternative Word format to enter exposure details then click Open Alternative Word Document button. The Word version, also provided separately, is a more basic format, and has its own set of instructions for use. The Word document should open at this point and the database will close. 30

39 3. Add New If you click Add New button, this will open a screen to select exposure scenario type. The following four scenario types are available: Use of substance by workers (including production) Use of substance by consumers Handling of articles by workers Handling of articles by consumers elect the exposure type from the drop down and press select. Enter the most general details for this cenario record i.e. ubstance type and initials of the partner institution making the entry. Below this there are two tabs: Exposure cenario General Details Controlling environmental exposure 3.1 Exposure cenario Details Enter general exposure scenario details. Note that the number of the E is optional and is only for your reference. pecify as many contributing worker/consumer exposure scenarios as needed in this tab. By pressing Add Details, you can add more specific information on these contributing exposure scenarios. 31

40 3.2 Controlling worker/consumer exposure If further workers exposure data is available for this scenario, multiple records can be entered for controlling workers exposure by using the browsing buttons at the bottom of the page; Using the new record button marked. Note that the fields are general in nature and not necessarily specific to the four types of exposure scenarios available; fill them in as appropriate for the scenario you are addressing. At the bottom of each contributing exposure scenario sheet, there is an opportunity to provide exposure estimates for this situation, and to link the estimate to a study mentioned in the NANEX Exposure References Database. To link with studies in the reference database, press to select the reference you would like to link, and then press the ADD Ref button at the top right of the page. 3.3 Controlling environmental exposure Enter environmental exposure details. If further environmental exposure data is available for this scenario, multiple records can be entered for controlling environmental exposure by using browsing buttons at bottom of the page; Using the new record button marked. 32

41 4. Overview This screen presents a summary of the exposure records that are currently available in the NANEX Exposure cenario Database. Where there are many records, they can be filtered by Exposure type of substance by using the filter buttons at top to produce a subset of records. Records can be browsed using the navigation toolbar at the bottom of the page. To open a previously entered record, press the Edit button markedopen details screen; where changes can be made and saved.. This will To create a new record, press the Add New button marked -. 33

42 34

43 Annex IV: A brief introduction and guide to the NANEX Exposure References Database 1. Introduction The NANEX Exposure References Database has been created for the entry of exposure study reference data. Reference records entered in this database can be referred to the exposure scenarios database. The goal of this database, as it relates to NANEX, is twofold: a) Catalogue references relevant to nanomaterial exposure b) Create a system for identifying gaps and weaknesses in this data Critically review the studies, identify the strengths and weaknesses of the approaches used, and note them here. You will create one entry per reference reviewed; several individual tasks evaluated in a single reference can be entered within a single database entry. (Note: if one reference is applicable to both consumer and occupational exposure scenarios, it will need to be entered twice, once in each section). Not all fields are required and in many cases may not be relevant. everal opportunities are provided for you to add more details or to explain aspects of the study that may not be captured by the fields provided. To use the NANEX Exposure References Database: 1. Use the Navigation buttons at the bottom of form to browse records 2. Use the ADD button at bottom to enter a new record 3. Use EDIT button at bottom to view/change an existing record 4. Use filtering options on top of form to filter existing records by Exposure Type and ubstance Type This document contains basic instructions and guidance for the use of the Exposure References data collection template. This Access database has been designed to enter the reference exposure details of the following two types. 1. Occupational exposure tudy 2. Consumer exposure tudy 35

44 2. Getting started with the NANEX Exposure References Database To enter new reference details in the database click the Add New button To view previously entered reference records, click Overview button. 3. Add New If you click Add New button, this will open a screen to select reference type. The following two types are available: Occupational exposure study Consumer exposure study elect the reference type from the drop down and press select. 36

45 Enter the most general details for this reference record on top i.e. Title, Author(s), year, partner institution initials, etc. Below this, there are following four tabs to enter further details about the scenario: Basic Exposure cenario Information tudy/report quality assessment Particle characteristics Description of worker exposures If the box on environmental exposures in the first tab is selected, a fifth tab with a Description of environmental exposures will appear. 3.1 Basic Exposure cenario Information Enter basic exposure scenario details. Describe general situation under study: This is where you describe the general situation under study in the most general terms (e.g., manufacturing MWCNTs using the CVD process in a university laboratory setting). If separate tasks are assessed in the study (e.g., opening the reactor, handling powders, cleaning), you can enter these individually later. Relevance to scenario: state whether this situation is highly relevant or marginally relevant to the preliminary exposure scenario you selected above. 3.2 tudy/report quality assessment This section addresses whether the methods are well-described, and whether they are appropriate for the situation under study. Please spend time to critically review the methods of this study, as your review will form the basis for the gap analysis at the end of the project. Enter study/report quality assessment details. 37

46 Overall assessment: please provide your general impression of the study. ub-assessments (quality control, analytical, and interpretation): these are not required, but can be used to indicate which aspects of the study were done well. Description drop-down menus: the options are none, limited, detailed. Please select that which best describes how well the authors characterized the situation they were studying. Quality assessment drop down menus: options are insufficient, some limitations, complete. This is independent of the description above: please select whether the methods used to characterize exposure in the study were thorough and state-ofthe-art (i.e., complete), or were of lesser quality (e.g., some limitations or insufficient ). 3.3 Particle characteristics Enter particle characteristics. Overall evaluations of method description and quality: please use these drop down menus to describe how well the authors described what they did (method description), and then whether their methods were sound (quality assessment). For example, assess whether the authors used well-accepted methods to describe particles (e.g., MP or EM), or whether their study was limited (e.g., relied on manufacturer information about particles). If one aspect of the study was particularly lacking or outstanding, please note separately. Fiber length/primary particle size: Fill in only one of these fields. Particle phase: please identify which particle phases are included in this study. Describe measurement principle and size distribution: Provide how the size of the particles was characterized (e.g., MP, EM, etc.). Further, give the size range provided in the study. Description of aggregation/agglomeration: If addressed, please describe here, including how it was characterized. Propensity to become airborne: This is not a standardized measure, but please provide any information offered in the study. 3.4 Description of worker exposures This section describes exposure measurements in the study, by task. 38

47 Enter the Process/Task/Activity details on this tab. If more than one process/tasks data is available then multiple records can be entered by using the browsing buttons at the bottom of the page; Using the new record button marked. To Delete a process/task, browse to a specific process/task using navigation buttons and press Delete this task/process button. For each individual task assessed, briefly describe the task in the top field of a column, and then enter descriptors for that same task below. Estimate exposure: provide the estimates given in the study, including point estimates and/or ranges (e.g., GM, GD, 95% CI, etc.) Don t forget to include metrics. Amount used/unit time: provide any information on usage (amt per year, month, day, etc.) Technical control measures and use of PPE: please check as many boxes as needed Notes: add anything not covered above that is pertinent to the exposure assessment 3.5 Description of environmental exposures Enter description of environmental exposures. 39

48 4. Overview This screen presents a summary of the reference records that are currently available in the NANEX Exposure References Database. Where there are many records, they can be filtered by Author and Title using the filter buttons at top to produce a subset of records. Records can be browsed using the navigation toolbar at the bottom of the page. To open a previously entered record, press the Edit button marked - open details screen; where changes can be made and saved.. This will To create a new record, press the Add New button marked -. To delete an existing record, press the Delete button marked -. 40

49 Annex V: Description of literature search carried out for the NANEX project. A strategy for the identification of relevant information was implemented at an early stage in the NANEX project. As an initial step, key organisations, FP6/7 projects and other national projects of relevance to the scope of the project were identified and publicallyavailable reports and outputs from these sources of relevance to the project were then identified and obtained directly from their associated websites and/or through web-based searching. In addition, a considerable resource of peer-reviewed literature references has been constructed. Literature from the recently completed FP7 Coordination & upport Action entitled Engineered Nanoparticles Review of Health & Environmental afety (ENRHE) (tone et al., 2009) 7, in which IOM acted as the cientific Co-ordinator, was already available within a RefWorks database, a proportion of which was relevant to exposure and thus the NANEX project. These provided an initial comprehensive listing of literature published up to 31st December The ENRHE literature search was updated for the period 1 st January rd March 2010 using PubMed and Web of Knowledge, according to a two-stage Boolean search strategy (herein termed the ENRHE Update earch ). The first-stage of the ENRHE Update earch combined search terms based on nano-object or material descriptive terms using logic operators e.g. AND, OR, NOT. Initially, the wildcard term nano* was used, but this resulted in an excessive number of irrelevant references (e.g. nanolitre). To address this, a set of specific search terms were subsequently used (ultrafine, nanoparticle, nanoparticulate, nanomaterial, nanotube, nanofiber, nanofibre, fullerene). The secondstage of the search strategy combined the first-stage search terms sequentially with specific topic terms of relevance to exposure, as listed in Table 1. Table 1: pecific exposure-related search terms used in the ENRHE Update earch pecific search terms workplace worker occupational exposure consumer exposure environmental exposure occupational consumer environment incidental industrial exposure expose survey inventory use application product In cases where excessively large numbers of references were obtained for a particular second-stage term, a refinement of the first-stage search terms was undertaken by incorporating one or more additional specific topic terms. For example, the search addressing the specific search term of consumer exposure comprised of the following initial search strategy: (ultrafine OR nanoparticle OR nanoparticulate OR First-stage search terms 7 tone, V., Hankin,., Aitken, R., Aschberger, K., Baun, A., Christensen, F., Fernandes, T., Hansen,.F., Hartmann, N.B., Hutchison, G., Johnston, H., Micheletti, C., Peters,., Ross, B., okull-kluettgen, B., tark, D., Tran, L. 2009, ENRHE Engineered nanoparticles: review of health and environmental safety, EC contract number

50 nanomaterial OR nanotube OR nanofibre OR nanofiber OR fullerene) AND (consumer exposure) econd-stage search term However, this resulted in an excessively large number of references, and so the search strategy was further refined as follows: (ultrafine OR nanoparticle OR nanoparticulate OR nanomaterial OR nanotube OR nanofibre OR nanofiber OR fullerene) AND (expose OR exposure) NOT (assay) (consumer) AND First-stage search terms econd-stage search term Completing this search strategy for the terms listed in Table 1 provided a comprehensive bibliography of references across the topic area of exposure. To supplement the ENRHE review s bibliography and identify additional literature of specific relevance, a non-date limited Boolean search strategy similar to that of ENRHE was employed using PubMed and Web of Knowledge (herein termed the Project pecific earch ). The additional Project pecific earch was undertaken using the following search terms in the first-stage: ultrafine, nanoparticle, nanoparticulate, nanomaterial, nanotube, nanofiber, nanowire, reflecting a broad class-based approach and compatibility with the choice of case example materials (silver, titanium dioxide, zinc oxide, carbon nanotube). The second-stage of the search strategy combined the first-stage search terms sequentially with new exposure-related specific topic terms identified to be of relevance to the projects, as outlined in Table 2. In cases where excessively large numbers of references were obtained, the first-stage terms were further refined by incorporating material specific terms (silver, titanium dioxide, zinc oxide, carbon nanotube). Table 2: pecific exposure-related search terms used in the Project pecific earch pecific search terms Exposure assessment Exposure descriptors Exposure estimation Exposure measurement Exposure metrics Exposure mitigation Exposure model Exposure modelling Exposure sampling Exposure scenario Identified use Number concentration Completing this search strategy for the terms listed in Table 2 provided a comprehensive bibliography of additional references across the topic area of exposure. Both the ENRHE Update earch and the additional Project pecific earch have an effective cut-off date of 3 rd March 2010 for published papers. All search strategies and search results (in terms of numbers of references obtained) were recorded using Microsoft Excel spreadsheets. The obtained references were imported into RefWorks. The reference list were then screened by members of the project team based on an assessment of the title and/or abstracts of the publications, and a final set of relevant references of relevance to the NANEX project selected and extracted from RefWorks along with the original exposure-related ENRHE references. References from all of the identified sources were collated in a Microsoft Excel 42

51 spreadsheet, organised into separate worksheets for occupational, consumer and environmental exposure. These references were then further reviewed by the NANEX Work Package (WP) leaders for their relevance and used to inform the review activity. Any additional references known to the WP leaders were added to the spreadsheet. 43

52 44

53 Annex VI: List of exposure scenario titles Table 3: List of exposure scenario titles Exposure scenarios for carbon nanotubes (composite materials) E1 E2 E3 E4 E5 E6 E7 CNT Laboratory Production CE1.1 Environmental release CE1.2 mall scale production CE1.3 Testing CNT Manufacture using Chemical Vapour Deposition (CVD) CE2.1 Environmental release CE2.2 Furnace process CE2.3 Recovery CE2.4 Packing CE2.5 Internal transport CE2.6 Cleaning/maintenance CE2.7 torage and Distribution CNT Manufacture using Arc Vapour Discharge CE3.1 Environmental release CE3.2 Reactor process CE3.3 Recovery CE3.4 Packing CE3.5 Internal transport CE3.6 Cleaning/maintenance CE3.7 torage and Distribution Production of intermediate composite materials containing CNT CE4.1 Environmental release CE4.2 Weighing, mixing, loading CE4.3 Extrusion and granulation CE4.4 Packing CE4.5 Internal transport CE4.6 Cleaning and maintenance CE4.7 torage and Distribution Manufacturing of solid products with composite materials containing CNT CE5.1 Environmental release CE5.2 Weighing, mixing, loading CE5.3 Extrusion, moulding, forming CE5.4 haping and finishing CE5.5 Cleaning and maintenance CE5.6 torage and Distribution Professional use (service life) of solid composite materials containing CNT CE6.1 Environmental release CE6.2 Cutting, shaping, drilling, sanding CE6.3 Wear and tear Consumer use (service life) of solid composite materials containing CNT CE7.1 Environmental release CE7.2 Wear and tear 45

54 E8 E9 E10 E11 E12 E13 E14 E15 E16 Manufacturing of textile fibres containing CNT CE8.1 Environmental release CE8.2 Weighing, mixing, loading CE8.3 pinning CE8.4 Weaving CE8.5 Finishing and packing CE8.6 Cleaning and maintenance CE8.7 torage and Distribution Manufacturing of textile products containing CNT CE9.1 Environmental release CE9.2 Cutting, shaping, sewing CE9.3 Finishing and packing CE9.4 Cleaning and maintenance CE9.5 torage and Distribution Manufacturing of textile products coated with CNT CE10.1 Environmental release CE10.2 Preparation of coating CE10.3 Dipping, spraying CE10.4 Finishing and packing CE10.5 Cleaning and maintenance CE10.6 torage and Distribution Professional use (service life) of textile products containing CNT CE11.1 Environmental release CE11.2 Wear and tear Consumer use (service life) of textile products containing CNT CE12.1 Environmental release CE12.2 Wear and tear Professional use (service life) of textile products coated with CNT CE13.1 Environmental release CE13.2 Wear and tear Consumer use (service life) of textile products coated with CNT CE14.1 Environmental release CE14.2 Wear and tear Manufacturing of concrete masterbatch containing CNT E15.1 Environmental release E15.2 Weighing, mixing, loading E15.3 Packing E15.4 Cleaning and maintenance E15.5 torage and Distribution Manufacturing of concrete products containing CNT E16.1 Environmental release E16.2 Weighing, mixing, loading E16.3 Forming E16.4 Finishing and packing E16.5 torage and Distribution 46

55 E17 E18 E19 E20 E21 E22 E23 E24 Professional use of concrete masterbatch containing CNT CE17.1 Environmental release CE17.2 Loading and mixing CE17.3 Forming CE17.4 Finishing CE17.5 torage and Distribution Professional use of concrete products containing CNT CE18.1 Environmental release CE18.2 Installing CE18.3 Finishing Consumer use (service life) of concrete masterbatch containing CNT CE19.1 Environmental release CE19.2 Wear and tear Consumer use (service life) of concrete products containing CNT CE20.1 Environmental release CE20.2 Wear and tear Manufacturing of liquid products containing CNT (e.g. paint) CE21.1 Environmental release CE21.2 Weighing and mixing CE21.3 Packing CE21.4 Cleaning and maintenance Professional use of liquid products containing CNT CE22.1 Environmental release CE22.2 Application (brushing, spraying) CE22.3 Finishing CE22.4 Cleaning applicator Consumer use (service life) of liquid products containing CNT CE23.1 Environmental release CE23.2 Application (Brushing, spraying) CE23.3 Finishing CE23.4 Cleaning applicator CE23.5 Wear and tear Recycling and disposal of products containing CNT CE24.1 Environmental release CE24.2 Collection, sorting and processing CE24.3 Incineration CE24.4 Landfill 47

56 Exposure scenarios for nano-silver (textiles) E1 nano-ilver Laboratory Production CE1.1 Environmental release CE1.2 mall scale production CE1.3 Testing E2 E3 E4 E5 E6 E7 nano-ilver Manufacture as a dry product CE2.1 Environmental release CE2.2 ynthesis CE2.3 Packing CE2.4 Internal transport of powders CE2.5 Cleaning and maintenance CE2.6 torage and distribution nano-ilver Manufacture as a colloidal solution CE3.1 Environmental release CE3.2 ynthesis CE3.3 Packing CE3.4 Cleaning and maintenance Manufacturing of textile fibres and products coated with nano-silver CE4.1 Environmental release CE4.2 Preparation of coating CE4.3 Dipping, spraying CE4.4 Finishing and packing CE4.5 Cleaning and maintenance CE4.6 torage and distribution Professional use (service life) of textile fibres and products coated with nano-silver CE5.1 Environmental release CE5.2 Wear and tear Consumer use (service life) of textile fibres and products coated with nano-silver CE6.1 Environmental release CE6.2 Wear and tear Recycling and disposal of products textile fibres and products coated with nano-silver CE7.1 Collection, sorting and processing CE7.2 Incineration CE7.3 Landfill CE7.4 Environmental release 48

57 Exposure scenarios for titanium dioxide (cosmetics) E1 TiO 2 Laboratory Production CE1.1 Environmental release CE1.2 mall scale production CE1.3 Testing E2 TiO 2 Manufacture CE2.1 CE2.2 CE2.3 CE2.4 CE2.5 CE2.6 CE2.7 CE2.8 CE2.9 CE2.10 Environmental release Filtration Calcination Milling urface treatment Drying Packing Internal transport of powders Cleaning/maintenance torage and distribution E3 Production of cosmetics and personal care products containing TiO 2 CE3.1 Environmental release CE3.2 Weighing and mixing CE3.3 Packing CE3.4 Cleaning and maintenance CE3.5 torage and distribution E4 Professional use of cosmetics and personal care products containing TiO 2 (e.g. beauticians) CE4.1 Environmental release CE4.2 Application E5 Consumer use of cosmetics and personal care products containing TiO 2 CE5.1 Environmental release CE5.2 Application and use E6 Recycling and disposal of cosmetics and personal care products containing TiO 2 CE6.1 Environmental release CE6.2 Collection, sorting and processing CE6.3 Incineration CE6.4 Landfill 49

58 50

59 Annex VII: Example exposure scenario 51