# Presentation: 107986

## The Importance of Defining Chemical and Physical Parameters forToxicological Testing

- Richard C. Pleus, Ph.D.
- Intertox, Inc.
- Seattle, WA

## The following project is currently under development by ISO/TC 229 WG 3 ISO/TC 229 WG 3 – Health, Safety, and EnvironmentProject Group 5Technical ReportProject Leader: Richard C. Pleus, Ph.D.Countries Represented on Committee

| Canada |
| --- |
| Czech Republic |
| France |
| Germany |
| Islamic Republic of Iran |
| Japan |
| United Kingdom |
| United States |
| JWG 2 Liaison |
| OECD Liaison |

## Why?

- A list of chemical and physical parameters could be used for:
- Material identification
- Predictive toxicology
- Standardization/requirements for peer-reviewed publications

## Current Process

## Current Status:Proposed List of Physico-Chemical Characteristics of Engineered Nano-Objects for Toxicological Assessment May 27, 2008 version

- Agglomeration state / Aggregation
- Composition (e.g., chemical composition and structure)
- Particle size / size distribution
- Purity
- Shape
- Solubility
- Stability
- Surface area
- Surface chemistry
- Surface charge

## Material Identification
Composition
Particle size / size distribution
Shape
Stability 
Surface area
Surface chemistry

- Composition
- Particle size / size distribution
- Shape
- Stability
- Surface area
- Surface chemistry

**Predictive Toxicology**
- Agglomeration state / Aggregation
- Oxidizing properties
- Particle size / size distribution
- Shape
- Surface area
- Surface chemistry
- Surface Charge

**Peer-reviewed Literature**
- Purity
- Composition
- Particle size / size distribution
- Shape
- Surface area
- Surface Charge

- Examples:

## OECD Draft

- DRAFT
- Focus List of Physico-Chemical Characteristics of Engineered Nano-Objects for Toxicological Assessment May 27, 2008 version

- Agglomeration state / Aggregation
- Composition (e.g., chemical composition and structure)
- Particle size / size distribution
- Purity
- Shape
- Solubility
- Stability
- Surface area
- Surface chemistry
- Surface charge

- DRAFT
- Project 4
- Physical Chemical Properties
- 2007

- Agglomeration / aggregation
- Composition
- Hydrodynamic size / particle size measurement / distribution
- Purity
- Shape
- Specific surface area
- Surface chemistry
- Surface charge
- Catalytic properties
- Concentration (needs to be defined)
- Crystalline phase
- Dustiness
- Fat Solubility / oleophilicity
- Grain Size
- Length
- Water solubility / hydrophilicity
- Zeta potential

- ISO Draft

## Why Nanotechnology Standards Are Important

- Encourage the development and commercialization of new technologies
- Improve communication among stakeholders
- Foster innovation – encourage diffusion of new technologies
- Lower barriers to market entry
- Promote market efficiency
- Protect public health and environment
- Serve as one of the bases for regulations

## Summary:  Organizational Relationships

- Summary:  Organizational Relationships

**ISO Technical Committee 229**
**Nanotechnologies**

**Notes:**
Along with the United States, nearly thirty other member nations participate actively in the TC; nine additional nations are now registered as observer members.  The United Kingdom provides the ISO/TC 229 chairman, Dr. Peter Hatto, and supports administration of the committee

The ANSI-Accredited U.S. TAG to ISO/TC 229 was also formed in June 2005 (about the same time that the ISO TC was established)
Dr. Clayton Teague, Director, National Nanotechnology Coordination Office (NNCO) serves as Chair of the U.S. TAG and Head of the U.S. Delegation to TC 229
ANSI acts as TAG Administrator
Currently there are more than 55 TAG members representing Industry, Government, Academia, Standards Developing Organizations and Legal Entities

## ISO/TC 229, Nanotechnologies

- Established in June 2005
- Led by the United Kingdom
- Currently 30 Participating member bodies and10 Observer member bodies
- Works in cooperation (i.e., liaison) with organizations such as OECD, VAMAS, Asia Nano Forum and others

**Specific tasks include** developing standards for: terminology and nomenclature; metrology and instrumentation, including specifications for reference materials; test methodologies; modeling and simulations; and science-based health, safety, and environmental practices.

**Notes:**
The statement of scope for ISO TC 229:

Standardization in the field of nanotechnologies that includes either or both of the following: 

Understanding and control of matter and processes at the nanoscale, typically, but not exclusively, below 100 nonametres in one or more dimensions where the onset of size-dependent phenomena usually enables novel applications, 

2. Utilizing the properties of nanoscale materials that differ from the properties of individual atoms, molecules, and bulk matter, to create improved materials, devices, and systems that exploit these new properties. 

Specific tasks include developing standards for: terminology and nomenclature; metrology and instrumentation, including specifications for reference materials; test methodologies; modelling and simulations; and science-based health, safety, and environmental practices.

## ISO/TC 229 Working Groups

**Terminology & Nomenclature**
- Define and develop unambiguous and uniform terminology and nomenclature in the field of nanotechnologies to facilitate communication and to promote common understanding.

**Working Group 1**

**Working Group 2**

**Working Group 3**

**Measurement & Characterization**
- The development of standards for measure-ment, characterization and test methods for nanotechnologies, taking into consideration needs for metrology and reference materials.

**Health, Safety &**
**Environment**
- The development of science-based standards in the areas of health, safety, and environmental aspects of nanotechnologies.

**Working Group 4**

**Materials Specifications**
- Scope under development.

##                                 ISO/TC 229 Programme of Work			

- The ISO/TC 229 Programme of Work can be found on the web
- http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983&development=on

## U.S. TAG formulates U.S. positions to put forward to ISO as well as nominates delegates to represent the United States at ISO/TC 229 Meetings
Dr. E. Clayton Teague, Director of the National Nanotechnology Coordination Office, Chairs the U.S. TAG and is Head of Delegation to the ISO/TC 229 Plenary meetings
TAG members include:  Dow Chemical, E.I. DuPont, GE, Motorola, RTI International, Agilent Technologies, American Chemistry Council, Evonik Degussa, American Chemical Society, AIHA, AAMI

- Dr. E. Clayton Teague, Director of the National Nanotechnology Coordination Office, Chairs the U.S. TAG and is Head of Delegation to the ISO/TC 229 Plenary meetings
- TAG members include:  Dow Chemical, E.I. DuPont, GE, Motorola, RTI International, Agilent Technologies, American Chemistry Council, Evonik Degussa, American Chemical Society, AIHA, AAMI

## A Mirror Image:The ISO/TC – U.S. TAG Relationship

- ANSI-Accredited U.S. Technical Advisory Group

- A Mirror Image:The ISO/TC – U.S. TAG Relationship

**U.S. TAG**
**ISO/TC 229**
**Nanotechnologies**

**ISO/TC 229**
**Nanotechnologies**

- U.S. interested parties can engage in this activity and provide influence by participation:
**Working Group experts**
**U.S. delegates **
**Project leaders**
**Committee officers**

**Notes:**
There must be a U.S. TAG for each ISO Technical Committee or Subcommittee on which the U.S. is a “Participating” (“P”) Member. 

The role of the TAG is to:
determine the U.S. positions on matters arising before the ISO Technical Committee
submit U.S. proposals in the areas covered under the TC Scope
select delegations to represent U.S. interests to the ISO TC or SC

The TAG must have an Administrator that provides administrative support to the group.   

## TAG WG 3

**TAG WG 3**
**Health, Safety and the Environment**

**TAG WG 2 **
**Measurement and Characterization**

**TAG WG 1 **
**Terminology and Nomenclature**

- experts

- experts

- experts

- experts

**TAG WG 4**
**Materials Specifications**

**Notes:**
Consistent with the structure selected at the ISO level, the U.S. TAG to ISO TC/229 mirrors the ISO/TC 229 TC/WG structure
TAG WGs are advisory to the full U.S. TAG
The “parent” U.S. TAG retains final decision making authority on all U.S. positions and ballots

For the U.S. TAG to ISO/TC 229 TAG membership provides the following:

Ability to attend and participate in U.S. TAG and other U.S. TAG Working Group Meetings (including teleconferences) 
TAG membership allows for additional participants from your organization in each of the individual TAG WGs
 Ability to participate in the final consensus vote on issues and documents related to the formulation of U.S. positions in connection with nanotechnology standardization 
Ability to participate as a delegate to international Technical Committee and Working Group meetings 
Ability to participate as an expert on ISO/TC 229 Working Group Projects 
Ability to act as a Project Leader on ISO/TC 229 work items (e.g., proposed new standards) 
Access to U.S. TAG to ISO/TC 229 document repository in a password protected section of ANSI Online.  This contains all documentation relative to the work of ISO/TC 229 and its subsidiary Working Groups 

## Questions We Are Asking

- Should the parameter have the ability to **reliably identify a nano-object **/ Which parameters are **unique to nano**?
- Should each parameter that is to be listed have the goal of having a _number_ generated?
**Not all of the parameters have methods **for measuring. Is that a reason not to list?
- Should we **prioritize **the list?

## Next steps

- Definitions being developed
- Measures identified
- Methods identified
- ISO/TAG needs experts to support this work and the work of the three other working groups of the TAG

## Questions?

|  |  |  |
| --- | --- | --- |
| Intertox, Inc.
600 Stewart St. 
Suite 1101
Seattle, WA  98101 | Richard C. Pleus, Ph.D.
rcpleus@intertox.com              
T: 206.443.2115
www.intertox.com |  |
|  |  |  |

## For More Information

**Heather Benko**
- New York City
- Operations Office
- +1.212.642.4912
- hbenko@ansi.org

- American National Standards Institute
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