OECD Questionnaire on the Safety of Manufactured Nanomaterials
OECD’s Working Party on Manufactured Nanomaterials
Questionnaire for national authorities (and other delegations to the WPMN) responsible for the safety of manufactured nanomaterials
Responses Requested by 19th October 2007
Background
The Working Party on Manufactured Nanomaterials (WPMN) was established in 2006 as subsidiary body of OECD’s Chemicals Committee[1]. Its programme of work (which addresses human health and environmental safety issues associated with nanomaterials) is currently undertaken through six projects listed as follows:
· An OECD Database on Human Health and Environmental Safety Research;
· Human Health and Environmental Safety Research Strategies on Manufactured Nanomaterials;
· Safety Testing of a Representative Set of Nanomaterials;
· Manufactured Nanomaterials and Test Guidelines;
· Co-operation on Voluntary Schemes and Regulatory Programmes; and
· Co-operation on Risk assessment.
In developing the operational plans for these projects, the WPMN further identified a number of information needs, which if addressed, would greatly facilitate the implementation of these projects. This questionnaire identifies those information needs. It is known that this will include issues which may still be in the early stages of consideration in many member countries. It is recognised, therefore, that responses to this survey are likely to be partial. Nevertheless, it will be appreciated if delegations are able to complete the questionnaire as fully as possible.
This document is organised in several main sections addressing the following information related to Manufactured Nanomaterials (MN):
· Section I: Human health and environmental safety research of MN;
· Section II: Voluntary schemes and regulatory programmes; and
· Section III: Risk assessment.
The document also includes an annex (page 7) List of Research Themes of manufactured nanomaterials, which were identified by the WPMN and should be used when completing Section I of this request.
Target Audience
The questionnaire is targeted at delegations to the WPMN who have an interest in the safety of manufactured nanomaterials. It is expected that delegations will also forward it to other stakeholders in their countries who might be in a position to address some of the issues.
Returning responses
Please send your completed responses to Diana Morales e-mail to . Any additional documentation or reference materials, to support responses, will be welcome. The deadline for responses is 19th October 2007. If you have any enquiries concerning this questionnaire, please also contact Diana Morales.
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OECD Questionnaire on the Safety of Manufactured Nanomaterials
OECD Questionnaire on the Safety of Manufactured Nanomaterials
General Information
COUNTRY
This questionnaire was completed by:
Ministry/ Agency information;
Contact details;
Name;
Email Address.
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OECD Questionnaire on the Safety of Manufactured Nanomaterials
I. Information on Human Health and Environmental Safety Research on Manufactured (engineered) Nanomaterials
The WPMN has developed a detailed list of Research Themes (see Annex). It is divided into 9 sections and an additional number of sub-sections (keywords). In answering this part of the questionnaire, you are invited to cross-reference by number, the relevant research section identified in the annex; and if possible, the sub-section (keyword).
1. Please provide information on current/ completed as well as any planned research projects in your country.
“Current/ Completed research” refers to those completed or continuing research projects;
“Planned research” refers to those research projects already included and/ or approved in national (or similar) programmes of work and budget.
Please go to the Annex and update the Matrix as requested. You will need to fill-in the column on the right with: “C” for Current/ Completed research and “P” for Planned research.
2. Please Identify Urgent Research Priorities.
“Urgent research" is that which is considered to be necessary to address immediately or in the immediate short term. This is that should be part of the next national (or similar) programmes of work and budget. Not more than 5 Research Themes should be provided.
Please accommodate the urgent priorities in descending order
i) Research Theme: please indicate the main section (name and number) from the Matrix on Research Themes (see Annex).
ii) Keywords: please indicate the sub-sections (name and number) from the Matrix on Research Themes (see Annex).
iii) Funding source: If known, please provide the name of a funding source.
iv) Rationale: If possible, please provide a short rationale for the priority of each project.
Research Theme / Keywords(sub-section) / Funding source / Rationale
1
2
3
4
5
3. Please Identify Medium/long-term research needs.
"Medium/long-term research needs" are those "research needs" that should be addressed in the medium or longer term. This is that should start to be considered by national delegations for their inclusion in future national (or similar) programmes of work and budget.
i) Research Theme: please indicate the main section (name and number) from the Matrix on Research Themes (see Annex).
ii) Keywords: please indicate the sub-sections (name and number) from the Matrix on Research Themes (see Annex).
iii) Rationale: If possible, please provide a short rationale for the priority of each project
iv) Time: If possible, please provide the foreseen timing for doing the research (for example: within next 2 years, 5 years, 10 years). 1-5: please accommodate the most immediate first.
Research Theme / Keywords(sub-section) / Rationale / Time
1
2
3
4
5
II. Information on Voluntary Schemes and Regulatory Programmes
4. Identify existing or proposed guidance documents on:
a)Practices to reduce occupational or environmental exposure to manufactured nanomaterials;and/ or
b)Exposure measurement.
These documents may apply to manufacture or use of products in industrial, academic, institutional and commercial settings or to use of products by consumers.
III. Information on Risk Assessment of Manufactured Nanomaterials
5. Do you have risk assessmentmethods in place that are currently being used to assess the safety of nanomaterials or that will be used to such an end in the future? Please identify
6. Alternatively, are you developing such methods and, if so, what is their development status?
7. Is there documentation of the relevant risk assessment guidance and methods available? Please provide the context, references and contacts, below
8. When available, please providecitations or documentsshowing the application of risk assessment methods to the evaluation of nanomaterials.TheWPMN would considerwhat isprovided under this requestin development ofcase studies for risk assessment approaches that may be useful for manufactured nanomaterials
9. Which supporting tools (e.g. Life Cycle Assessment, QSARs, Emission Scenario Documents or Control Banding approaches, etc) do you think have strong potential to enhance and strengthen risk assessment in the context of nanomaterials?
10. In which aspect of risk assessment should they be used?
11. Are any of these techniques currently being used in your country?
ANNEX
OECD Working Party on Manufactured Nanomaterials (WPMN)
List of Research Themes relevant to Human Health and Environmental Safety aspects of manufactured nanomaterials
Background
This List of Research Themes was developed by the WPMN in order to identify research topics that are considered to be relevant to human health and environmental safety aspects of manufactured nanomaterials. It has been prepared by the WPMN so that relevant needs can be first identified and then compared with completed, existing and planned research. It is expected that this can identify gaps in research and this will be important in developing a research strategy concerning safety aspects of nanomaterials.
“Research” is defined in a broader sense. Thus, not only experimental studies, but also e.g. evaluation of available literature, database generation, comprehensive risk assessment of specific substances, international standard setting, public dialogue, etc. is included. All those activities which need funding can be addressed. This is a living list to be adapted with increasing experience.
The list of Research Themes is structured in 9 sections as follow:
i) Characterisation and measurement of nanomaterials
ii) Exposure assessment for humans and the environment
iii) Interaction of nanomaterials with biological systems (human and environment)
iv) Human Health
v) Ecotoxicology
vi) Control measures at workplace
vii) Preliminary handling guidelines
viii) Information transfer
ix) National and international collaboration
At this time, detailed comments are not requested on this annex. It is provided so that a cross-reference can be made to information presented under Section I of this request.
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OECD Questionnaire on the Safety of Manufactured Nanomaterials
WPMN List of Research Themes
Research themes / “Current/ Completed” (C) or“Planned” (P) /
1 Characterisation and measurement of nanomaterials
1.1 Physico-chemical properties
1.1.1 Research for the development of characterisation methods as necessary
1.1.2 Physico-chemical characterisation (incl. flammable, combustible, explosive, oxidising pyrophoric properties etc.)
1.1.2.1 size, shape, surface area, surface chemistry, aggregation, solubility, wetability, dispersability etc.
1.1.2.2 flammable, combustible, explosive, oxidising pyrophoric properties etc
1.1.2.3 friability, porosity, resistance to fire etc. of nanomaterials embedded in a solid matrix (see also 3.2.4)
1.1.3 Physico-chemical classification
1.1.4 Definition, standardisation
1.1.5 Preparation of reference standards (neat, in commercial forms, in matrices)
2. Exposure assessment for humans and the environment
2.1 Research for the development and validation of exposure measurement and exposure modelling[2] methods for nanomaterials
2.1.1 Research for the development and testing of measurement methods including instruments (based on measurement parameters relevant for human health hazards; see 4.1.1)
2.1.2 Validation[3] and standardisation of measurement methods (incl. measurement strategy, standardized sampling methods)
2.1.3 Research for the development and testing of modelling methods
2.1.4 Validation2 of modelling methods (incl. sensitivity analysis)
2.1.5 Primary fields of application:
2.1.5.1 At workplaces
2.1.5.2 In foods (as well as feed)
2.1.5.3 In consumer products (food contact material, cosmetics, clothing, health care products and other consumer products)
2.1.5.4 In biological material
2.1.5.5 In the environment
2.1.5.6 In wastes and environmental releases
2.2 Human Exposure Assessment
Application of measurement and modelling methods on nanomaterials (incl. considerations on normal handling and use, reasonable worst case scenarios and possible accidents)
2.2.1 Identification of nanomaterials that are produced and marketed (incl. production volume, methods of production and processing, uses and application): surveys, reporting schemes
2.2.2 Measurement of exposure (workers, consumers)
2.2.3 Modelling of exposure (workers, consumers)
2.2.4 Categorisation of exposure
2.2.5 Consideration of the full life cycle and development of exposure scenarios of nanomaterials
2.3 Environmental Exposure Assessment (incl. considerations on normal handling and use, reasonable worst case scenarios and possible accidents)
2.3.1 Consideration of the full life cycle and development of exposure scenarios of nanomaterials, based on physico-chemical (PC) and biological properties
2.3.2 Examination of behaviour and fate (accumulation and persistence including modelling approaches) in the environment (air, water, soil, sediment, sewage / sewage sludge) and biological endpoints of concern along the food chain such as zooplankton, filter-feeding organisms, fish and wildlife)
2.3.3 Formation of possible degradation / transformation products in biota
2.3.4 Partitioning of nanomaterials and their degradation products in the environment (incl. agglomeration)
2.3.5 Examination of long-term fate of nanomaterials in use and post-use lifecycle stages (e.g. erosion, abrasion/ wear, leachability, in-place degradation)
2.3.6 Ability to act as carrier for other substances
2.3.7 Evaluation of characteristics (and industrial processes) affecting release, fate and transport
2.3.8 Establishment of environmental detection and monitoring protocols, incl. techniques to differentiate between manufactured and naturally occurring nanomaterials, and incl. development of techniques to detect long term fate of nanomaterials in individuals, populations, and ecosystems.
2.3.9 Development of structure-activity relationships to assist in predicting the behaviour and fate of nanomaterials in various media and biota
3. Interaction of nanomaterials with biological systems (human and environment)
Biological interactions should be explored for single particles, agglomerates and aggregates over the life cycle of the nanomaterials.
3.1 Interaction with normal physiological mechanisms
3.1.1 Interaction with biological molecules: DNA, proteins, lipids
3.1.2 Interaction with the cellular surface (cell membranes, plant cell wall, bacterial wall)
3.1.3 Molecular, cellular and organ system mechanisms
3.1.3.1 Mitosis
3.1.3.2 Apoptosis/necrosis
3.1.3.3 Inflammation
3.1.3.4 Oxidative stress
3.1.3.5 Immune response
3.1.3.6 Mutagenicity/DNA repair
3.1.3.7 Mitochondrial function
3.1.3.8 Cell binding, cell internalisation (endocytosis)
3.2 Toxicokinetics
3.2.1 Bioaccumulation/biotransformation
3.2.2 Adsorption, distribution (incl. translocation), metabolism, elimination
3.2.3 Effect of synthesis byproducts on absorbed dose
3.2.4 Relationship between the matrix in which nanomaterials are suspended or administered and absorbed dose
3.3 Inter- and intraspecies variability (see also 4.1.3.1)
3.3.1 Susceptible populations
3.3.1.1 Age and developmental status
3.3.1.2 Health status / pre-existing diseases
3.3.1.3 Genetic predisposition
3.3.2 Extrapolation between species and from in vitro studies and animal models to humans (see 4.1.1)
3.3.3 Extrapolation between species and from in vitro studies to ecosystem and population (see 4.1.1)
3.4 Predictive models (see also 4.1.3.1)
3.4.1 Physiology-Based Pharmicokinetic (PBPK) models
3.4.2.Structure Activity Relationships (SAR)
3.4.3 Computational approaches
3.4.4 Models which address a variety of ecosystem types and predict long term possible effects of manufactured nanomaterials on ecosystem structure
3.5 Long term monitoring and assessment of condition
3.5.1 Using established detection and monitoring protocols, assess the condition of individuals (human and ecological), populations (human and ecological), and ecological systems over the long term.
4 Human Health
4.1 Research for the development and validation of a testing and assessment strategy
4.1.1 Determination and validation of measurement parameters (dose metrics) relevant to assess human health hazards.
4.1.1.1 Studies on PC-properties
4.1.1.2 In vitro effects
4.1.1.3 In vivo effects
4.1.2 Test methods
4.1.2.1 Toxicological endpoints
4.1.2.1.1 Acute toxicity
4.1.2.1.2 Repeated dose toxicity (e g chronic toxicity)
4.1.2.1.3 Irritation/corrosion
4.1.2.1.4 Immunotoxicity/sensitisation
4.1.2.1.5 Mutagenicity
4.1.2.1.6 Carcinogenicity
4.1.2.1.7 Developmental toxicity
4.1.2.1.8 Fertility impairment
4.1.2.1.9 Endocrine disruption
4.1.2.2 Research for the development and validation of standardised testing methods:
including guidance on preparing materials for studies (e.g. aerosol generation, solubilisation), sampling methods, positive and negative reference materials