Kyunghee CHOI (nierchoi@me.go.kr)Kyunghee CHOI (nierchoi@me.go.kr)

Intergovernmental Forum on Chemical Safety (IFCS) VI

 September. 15-19, Dakar, Senegal

Intergovernmental Forum on Chemical Safety (IFCS) VI

 September. 15-19, Dakar, Senegal

NIERNIER

Importance of study on manufactured nanomaterials

Characteristic physico-chemical properties of nanomaterials

Characteristic physico-chemical properties of nanomaterials

Undefined risk of manufactured nanomaterials

Undefined risk of manufactured nanomaterials

Difficult application of commercial analysis

Difficult application of commercial analysis

Increased exposure-frequency of nanomaterials

Increased exposure-frequency of nanomaterials

International issueInternational issue Complex risk-prediction due to manufacturing (e.g. surface modifications)

Complex risk-prediction due to manufacturing (e.g. surface modifications)

NIERNIER

Point : Manufacturing,Landfills,Wastewater effluent

Non-Point : Wear/Attrition of tires,Sunscreen, Brake pads, etc;Storm water run-off;Wet deposition

Ingestion Food, Drinking water, Incidental

Dermal Sunscreen, Cosmetics

Air filtration

Coagulation andSedimentation

Sand filtration

Uptake Accumulation

Release

Aggregation

Biotransformation

PhotolysisUV

Surface Water

Ground Water Air

Inhalation Ambient air, Workplace exposure

Transport and Transformation Removal

SourcesExposure

Nanomaterials : Emission & Exposure to Environment

NIERNIER

The Research for Nanotechnology in Ministries and Institutes

Korea government is promoting the research of nanotechnology based on ‘Korea National Nanotechnology Development Plan’. At present, it is in ‘the 2nd Korea National Nanotechnology Development Plan (2006~2010)’.

In the 2nd Korea National Nanotechnology Development Plan, 4.8 mil. USD was invested from government and private corporations for the vision of ‘developing competitive power of nanotechnology for the technical big country.

The many ministries have been participated in the research of nanotechnology. The Ministry of Education, Science and Technology (MEST) generalizes the research of nanotechnology at the governmental levels.

By describing clearly as “After the head of the related ministries build the policy about nanotechnology in order to enhance the effectiveness of the policy promotion, it should be notified to the minister of the MEST (Nanotechnology Promotion Law, Clause 4, Art. 2)”, the national nanotechnology development policies have been promoted through the MEST to enhance effectiveness

NIERNIER

The 2nd National Nanotechnology Development Plan

Authorization of the risk assessment center for nanotechnology

- Analysis of social and economic effects of nanotechnology- Research about health, safety, environment, and ecosystem of nanotechnology- Establishment of DB and information service

Preparation of toxicity/environmental test guideline

- Mutual cooperation and connection to Ministry of Environment (NIER), Korea Food & Drug Administration (KFDA), Korean Agency for Technology and Standards(KATS), and Korea Research Institute of Standards and Science (KRISS).

Improvement of the related law and system

- Survey on the existing laws relating to the effects such as health, safety, environment, and ecosystem of nanotechnology. The review about need for future legal and regulatory- Supporting the monitoring research for the environment surveillance system of nanomaterials release.- Research and preparing procedures for detecting the pollution source of nano-products and nanomaterials

MEST et. al. (2005), 2006-2015 The 2nd Korea National Nanotechnology Development Plan

NIERNIER

The Research Areas for Safety of Nanotechnology

• In the National Institute of Toxicological Research (NITR) under the KFDA, total 5.5 mil. USD will be invested to ‘the fundamental project about the toxicity of nanomaterials’ from 2007 to 2011 (1 mil. USD in 2007).

• In the Korea Institute of Environmental Science and Technology (KIEST) under the Ministry of Environment (MOE), total 1.5 mil. USD will be invested to ‘Eco-technopia 21 Project’ from 2007 to 2010.

• In the Korea Science and Engineering Foundation (KOSEF) under the MEST, the research expenses of total 5 mil. USD, 1.5 mil. USD per year, will be invested to ‘three detail projects of creative research initiatives in the nanotechnology development project’ from 2008 to 2010.

• The chemical management division under the MOE is drawing up the 5-year roadmap for safe management of nanomaterials. The environmental health policy division is promoting the detail industrialization process of the large research field, ‘development of safe management for new environmental risky factors’ in the fusion environmental technology development project.

NIERNIER

The Research Investment for Potential risk of Nanotechnology in Ministries and Institutes

Projects about Environmental, Health and Safety (EHS) of Nanomaterials

Current EHS projects (completed/on-going) about nanomaterials

Researcher Subject title Sector Subsector Year

Korea Research Foundation

Environmental toxicity analysis and risk assessment of

SiO2 and Ce2O3 nanopowderRisk

Safety assessment

2006

Korea Occupational Safety & Health Agency

Nanomaterial hazardous assessment and prevention strategy of occupational health effect

EHS

system/education/

public relations

2007

Korea Institute of Environmental Science

and Technology

Assessment of environmental exposure and effects and management technology of nanomaterials assessment and management

RiskSafety

assessment2007

National Institute of Environmental Research

Database inventory for risk assessment of nanomaterials and methodological research of risk assessment

RiskSafety

assessment2007

Ministry of Environment Investigation of nanomaterials distribution (transfer and mitigation) and introduction strategy of survey system.

RiskManagemen

t2008

Korea Research Foundation

Personal protection equipment for safety assessment of nanomaterials and penetration research on artificial skin

RiskSafety

assessment2008

Korea Science and Engineering Foundation

Creative research of basic science program about nanomaterials) – project no. 5, 6, & 7 (7/25)

RiskSafety

assessment2008NIERNIER

Ministry of Labor

Ministry of Knowledge& Economy

(Korean Agency for Technology and

Standard)

Food & Drug Administration

(National Institute of Toxicological Research)

Ministry of Environment

(National Institute of Environmental Research)

Ministry of Education,

Science ad Technology(Korea Research Institute

of Standard & Science)

Cooperation of Ministries and Institutes

3-year Program (MoE)The present state of production, manufacturing

study, toxicity experimental data of nanomaterials

Screening of nano-monitoring

methods

Source examination

Characterization of physico-chemical

properties

Selection of exposure pathway

Suggestion of method for nanoLCA

Selection / Development

Applicability test

Standardization

Applicability test of LCA methods

Exposure assessment by

nanoLCA

Selection of group of prior

managing nanomaterials

Env. monitorin

g

Source monitorin

gExposure

assessment

environmental/human risk assessment

Selection of prior managing

nanomaterials

Test guide line for evaluation of Test guide line for evaluation of nanotoxicitynanotoxicity

Toxicity evaluati

on

1st year(2007)

2nd year

(2008)

3rd year(2009)

Adjustment

Survey on the perception of

the nanotechnology

hazard

Drawing up road-map

Supporting international cooperation

Report of state in Korea

Determination of

‘metric’ for

nanotoxicity test

+Quantitative

analysis for

nanotoxicity

NIERNIER

Priority scoring of nanomaterials

Supporting decision making

Development/achievement of nanomaterials' LCA

A close examination of sources of nanomaterials

Development of monitoring methods in environment and

sources

Characterization of physico-chemical properties

Establishment of nanotoxicity D/B

Survey on the perception of the nanotechnology hazard

Supporting international cooperation of ministry of environment

Road-map

Development of environmental/human risk assessment and OECD test guide

lines

Systemization of molecular biological analytic methods based on omics for investigation of nanomaterials' toxic

mechanism

NIERNIER

Exposure assessment for nanomaterials

NIERNIER

Status of use of nano materials in Korea

NIERNIER

Example of Nano-consumer Products in Korea

Frying pan   (ZrO2 coating)

Nano lab

Refrigerator(AgNP)

Samsung, LG

Filter of water purifier (AgNP)

Hankook bionano-tech

1. Consumer products large companies2. Raw materials Venture, small companies

Toothpaste(AgNP)

NPC

Lexon: conductivity coating solNanochemical: Photocatalyst

Carbon nonotec: CNT, NanofilterABC nanotec: Antibiotic AgNPNanomirea: Carbon nanofiber

NIERNIER

Environmental health hazard assessment for Environmental health hazard assessment for nanomaterialsnanomaterials

NIERNIER

Test organisms

DNA microarray

Toxicogenomics- Bioinformatics tools- Public Web Database (NCBI, TIGR, EcoCyc, SGD )- Literature survey

mRNA extraction

Test toxicants[1] Silver Nanoparticles / [2] Silver Nitrate

[3] Gold Nanoparticles / [4] Silver

Microparticle

Control & exposure concentrations

Control & stock solutions

TEM ELSS ICP-OES FTIRNPs Analysis

Japanese Medaka

Saccharomyces cerevisiae

Stress-specific recombinant bioluminescent bacteria- Protein damage strain- Oxidative damage strain- DNA damage strain

- Real-Time RT-PCR- Superoxide dismutase and catalase

Toxicity ClassificationsModes of Toxic Actions

NIERNIER

Evaluation for toxicity mechanism based on the ‘Omics’

OECD Activities OECD Activities

International Cooperation on NanosafetyInternational Cooperation on Nanosafety

NIERNIER

OECD WPMN : 8 Steering group

EHS Research EHS Research Strategies on Strategies on

MNMN

EHS Research EHS Research Strategies on Strategies on

MNMN

Safety Testing of a Safety Testing of a Representative of MNRepresentative of MN

Safety Testing of a Safety Testing of a Representative of MNRepresentative of MN

Cooperation on Cooperation on Risk AssessmentRisk Assessment

Cooperation on Cooperation on Risk AssessmentRisk Assessment

Cooperation on Cooperation on Voluntary Schemes & Voluntary Schemes & regulatory Programsregulatory Programs

Cooperation on Cooperation on Voluntary Schemes & Voluntary Schemes & regulatory Programsregulatory Programs

OECD Database on EHS OECD Database on EHS Research Research

OECD Database on EHS OECD Database on EHS Research Research

MN & Test GuidelinesMN & Test GuidelinesMN & Test GuidelinesMN & Test Guidelines

OECDOECD

Alternative methods Alternative methods in Nano Toxicologyin Nano Toxicology

Alternative methods Alternative methods in Nano Toxicologyin Nano Toxicology

Exposure Measurements & Exposure Measurements & Exposure MitigationExposure Mitigation

NIERNIER

International Activities

Participation to OECD activities

SG 2:EHS Research Strategies

on Manufactured Nanomaterials

(Germany)

SG 2:EHS Research Strategies

on Manufactured Nanomaterials

(Germany)

SG 1:OECD Database on EHS

Research(Australia)

SG 1:OECD Database on EHS

Research(Australia) SG 5:

Co-operation on Voluntary

Schemes and Regulatory Programs (Canada)

SG 5:Co-operation on

Voluntary Schemes and Regulatory Programs (Canada)

SG 6:Co-operation on Risk Assessment

(UK)

SG 6:Co-operation on Risk Assessment

(UK)

SG 3:Safety Testing of

Representative Set of Manufactured Nanomaterials

(USA), (EC)

SG 3:Safety Testing of

Representative Set of Manufactured Nanomaterials

(USA), (EC)

SG 4:Manufactured Nanomaterials

and Test Guidelines(USA), (EC)

SG 4:Manufactured Nanomaterials

and Test Guidelines(USA), (EC)

Section 1:Physical Chemistry

PropertiesJeff Morris (US),

Peter Hatto (ISO/TC229)

Section 1:Physical Chemistry

PropertiesJeff Morris (US),

Peter Hatto (ISO/TC229)

Section 2:Effects on Biotic

SystemsSteve Diamond (US)

Section 2:Effects on Biotic

SystemsSteve Diamond (US)

Section 3:Degradation &

Accumulation

Vacant

Section 3:Degradation &

Accumulation

Vacant

Section 4:

Health EffectsRobin Fielder (UK)

Section 4:

Health EffectsRobin Fielder (UK)

SG 8:Exposure

Measurements and Exposure

Mitigation(USA)

SG 8:Exposure

Measurements and Exposure

Mitigation(USA)

SG 7:Alternative

Methods in Nano Toxicology

(UK)

SG 7:Alternative

Methods in Nano Toxicology

(UK)

WPMN (Working Party on Manufactured Nanomaterial) (3rd Meeting, Nov. 2007) decided to organize SG7 and SG8.

Korea is working for SG1, SG3, SG4, and SG8 as a participant.

NIERNIER

The list of manufactured nanomaterials; This list of manufactured nanomaterial should be consider as a “snapshot in time” of those nanomaterials in commerce or likely to enter into commerce in the near term.

Fullerenes

Carbon nanotubes

Nanoparticles of elements

Nanoparticles of metal oxides

Polymers and other organics

Dendrimers

Nanoplates

2) Single-walled carbon nanotube (SWCNTs)3) Multi-walled carbon nanotubes (MWCNTs)

4) Silver nanoparticles, 5) Iron nanoparticles, 6) carbon black

7) Titanium dioxide 8) Aluminum oxide 9) Cerium oxide, 10) Zinc oxide 11) Silicon dioxide

12) polystyrene

14) Nanoclays

1) Fullerene (C60)

13) dendrimers

5 types of fullerene (C60), MWCNT, Silver nanoparticles, TiO2, SiO2 since 2007 (Eco-Technopia-21 project, Ministry of Environment).

Progress Status - (SG 3)

NIERNIER

Agglomeration/ aggregation Catalytic properties Composition Concentration Crystalline phase Dustiness Fat solubility/ oleophilicity Grain size Hydrodynamic size/particle size measurement/ distribution Length Purity Shape Specific surface area Surface charge Surface chemistry Water solubility/ hydrophilicity Zeta potential

Review of existing standards for physico-chemical test methods: SG4 is considering the following set of physico-chemical characteristics to be a necessary pre-requisite of such toxicological assessment.

Key metrics (bold letter) and researched nanotoxicity since 2007 (Eco-Technopia-21 project, Ministry of Environment)

Progress Status - (SG 4)

NIERNIER

Phase 1 (’08-’10)

- Data gathering - Research Project : “Exploratory” Interim Assessment : WPMN 8 (’11) Phase 2 - Based on the result of the phase 1 - Decide additional endpoints/material to

investigate

- develop data for decision support: “Regulatory”

NIERNIER

• How to share test materials

• How to account for testing already done on sponsored materials and endpoints

NIERNIER

http:://www.nature.com/nmat/journalhttp:://www.nature.com/nmat/journal

Materials Lead Sponsor(s) Co-Sponsor(s) Contributor

 Fullerenes (C60) Japan, USA China*

 SWCNTs Japan, USA Germany, Canada, EU, France, China*

MWCNTs Japan, USA  Korea, BIACGermany, Canada, EU,  France, China*

Silver USA, Korea Germany, Canada, Australia*

Australia, EUFrance, China*

Iron China* Canada, USA

 Carbon black Germany, USA

Titanium dioxide Germany Korea, Canada, Spain, BIAC, USA

France, China*

 Aluminum oxide Germany, USA

 Cerium oxide UK/BIAC(NIA), USA  Netherland Australia, Germany, EU

 Zinc oxide UK/BIAC(NIA)  Australia*, BIAC(CEFIC) Australia, Canada

Silicon dioxide EU*  Korea, BIAC(CEFIC) EU, France

Polystyrene Korea

Dendrimers Spain USA

 Nanoclays USA

NIERNIER

• Cooperation & coodination with relevant stakeholders : OECD, ISO & national activities

– Completed/On-going/Planned : Manufactured

nanomaterials/technology, Environment and health safety

⇒ Report research status to OECD secretariat for information sharing

- Testing for OECD test guideline application

(Target : Molecular, Cellular, Cultural level of biota)

• OECD Workshop on the Safety Testing of Manufactured

Nanomaterials (19-21 November 2008, Busan, Korea) DDP for Sponsorship Program : SG3, SG4, SG7

OECD Korea Workshop (Nov. 19-21, 2008, Busan) Development of DDP for Sponsorship Program : SG3, SG4, SG7

(alternatives) * Symposium on EHS of Nanomaterials (Nov. 18, 2008, Busan)

Information sharing

Nurimaru APEC House

NIERNIER

NIERNIER