Global Nanotechnology Regulatory Framework

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Global Nanotechnology Regulatory

Framework - An overview

By

Dr. H. Purushotham

Head-CKMNT

Centre for Knowledge Management of Nanoscience & Technology

(A Project of ARCI, Department of Science & Technology, Govt. of India)

Secunderabad-500 017, Telangana, India, Telephone: +91-40-27007032, 27000251

Fax: +91-40-27007031, Email: h.purushotham@gmail.com

National Summit "NANO-India" - Policy and Regulation & 3 rd

Excellence Awards on 10 th

Innovation

June, 2014, ASSOCHAM, New Delhi

Agenda

About ARCI/CKMNT

Global Nanotechnology

Regulatory Framework -

An overview

International Advanced Research Centre for

Powder Metallurgy and New Materials (ARCI)

(An autonomous R&D Centre of Department of Science & Technology ( DST) , Govt. of India)

ARCI, Hyderabad

Headquarters

1. Surface engg.

2. Nanomaterials

3. Ceramic processing.

4. Laser processing.

5. Non oxide ceramics

6. Carbon Materials

7. Sol-Gel Coating

8. Solar Energy Materials

9. Materials Charc. & Testing

10. Tech. Acquisition,Transfer,

Internatl. Coop.

ARCI, Secunderabad

1. Centre for Knowledge Management of Nanoscience & Technology

(CKMNT)

ARCI, New Delhi Cell

1. Liaison & Patent Filing

ARCI, Chennai

1. Centre for Fuel Cell Technology

2. Centre for Automotive Energy

Materials (CAEM)

ARCI is “Translating Research to Technology “

KM Services offered by CKMNT

Market Research Reports

Techno-Commercial Reports

Patents Search & Analysis

Technology Assessment Reports

Techno Economic Feasibility Reports

Facilitating Technology Collaborations / Transfers

Literature Search & Analysis

Support to Nano Mission

Publication of “Nanotech Insights”

CKMNT Reports/ Publications

Silver-Silica-

Silicon Oil

Composite

Nano-ZnO

Nano-

Copper

Nano-

Sensors

Guidelines and

Best Practices

Regulatory

Frame Work

Directory

Newsletter

Nanofibers

Multi-Client Reports

Customised Reports

The Cloud

WHY NANOREGULATIONS?

Most Engineered nanoparticles do not appear in nature, so living organisms may not have appropriate means to deal with nanoparticles

Some of the engineered nanomaterials are dangerous because of their size and reactivity as they have high specific surface area

As they are tiny, they can float in the air and might easily penetrate into human, animal and plant cells causing adverse environmental and health impacts

Environmental

Issues

Human Health and

Safety Issues

Economic and

Equity Issues

Regulatory activity is political activity and combines science, public expectations and opportunity…

Toxic & Health Effects of Nanomaterials

Nanomaterial Toxic Effect Source

Carbon nanotubes

(CNTs) & fullerenes

Titanium Oxide

Zinc Oxide

Cerium Oxide

Nanosilver, copper, alluminium

Gold

May be retained within the narrow space surrounding the lungs the ‘pleural cavity’ - for long periods of time which may lead to diseases such as granulomas, fibrosis and lung cancer

Distribute into several tissues (notably spleen, liver and lungs) and there were suggestions of substantial acute systemic toxicity

Toxicity was shown to be associated with oxidative stress

Both cytotoxic and genotoxic in human dermal fibroblasts.

http://www.hse.gov

.uk/ http://www.nicnas.

gov.au/ http://www.nicnas.

gov.au/ http://www.nicnas.

gov.au/ copper and silver NPs were more neurotoxic than aluminium NPs http://www.nicnas.

gov.au/

Gold nanoparticles decreased cell proliferation rate, adhesion, and motility of Human dermal fibroblast http://www.ncbi.nl

m.nih.gov/pmc/arti cles/PMC2988217/

More Toxicological Studies are needed to evaluate toxic effects of engineered nanoparticles

Need for Regulation in Nano S&T

Global R & D funding in Nano S & T is increasing and reached US

$20 billion/yr

Nanotechnology found to have potential applications in allmost all spheres of human activity including household, medical, industrial and military

Nanotechnology based consumer products are growing year after year (54 in 2005 to 1317 in 2010)

The market for nanotechnology products & services are expected to reach 1.5 trillions by 2015

Diversity of materials and applications, surrounded with uncertainty and lack of adequate information about its impacts on safety, health and environment

Lack of standardization in nomenclature, metrics, and test materials for assessment of nanomaterials

Challenges

Scientific Knowledge gaps (Enough Data for Framing

Regulations) e.g. Toxicology of nonmaterial's is poorly understood, as there are no suitable methods to test nanoparticles for safety, health and environmental impacts

Regulatory gaps (non-mature mandatory rules may be counter-productive)

Maintaining the Balance (encourage innovation with appropriate precaution)

Evaluating what works (Strengths and weaknesses)

Transparency for trust (Credibility and Legitimacy)

Education & Engagement

Economics

Timeline of Nanotechnology Global Regulatory

Framework (Major)

EU, NT Action Plan

US, EPA Holds its first public meeting for nanosacale materials stewardship program

Recommendation on a code of conduct, EU regulatory aspects of nanomaterials

Many countries are taking initiatives for

NS & T regulations like Australia,

Switzerland, China,

Japan, India (Nano-

Mission), etc.

2 nd regulatory review of REACH (2012)

(Registration,

Evaluation,

Authorisation and

Restriction of

Chemicals)

2005

2007

2009

2011 2013

NS & T First implementation report of EU

2005-2007

2008

2010

2012

EU planned second implementation report 2009-2015

EU Safety at workplace

Directives

US would consider any nanomaterial under

Federal Insecticide,

Fungicide and

Rodenticide Act

(FIFRA)

USA Published a proposed significant new rules (SNUR) for 14 nanomaterials that were the subject of pre-manufacture notice )PMN

WHO IS DOING WHAT?

European Union

European Commission (EC) is reviewing all relevant legislations with a view to propose regulatory changes wherever necessary and to develop more nano specific instruments for the implementation of regulation.

2009 Acts: Cosmetic Regulation (

EC No 1223/2009, which came into force in Jul 2013)

Regulatory Activities:

Included Specific provisions for nanomaterials (definition, requirement for notification, labeling and reporting of nanomaterials).

2011 Acts:

Food information to consumers regulation (EU Regulation 1169/2011), approved by the EC (July 2011) which will apply from December 2014

Regulatory Activities:

This regulation includes the requirement for labeling of ingredients in the form of nanomaterials

(material plus word “nano” in brackets).

2012 Acts: Regulation

(EC) No 1223/2009 (Article 13)

Regulatory Activities:

Established the Cosmetics, Product Notification Portal (CPNP)

2013 Acts: EU Biocides Regulation

Regulatory Activities:

Labeling (material plus word “nano” in brackets) and a separate evaluation of the risks deriving from nanomaterials used in various kinds of products

(antifouling agents, biocides in building materials, and antimicrobial surfaces).

WHO IS DOING WHAT?

European Union

European legislation covers nanomaterials in the new chemical legislation termed Registration, Evaluation and Authorization and restriction of Chemicals

(REACH), food laws, the safety at workplace directives, and finally waste management directives.

REACH set guidelines to establish Occupational Exposure

Limits (OELs) for workers.

Emphasises about the labeling of nanoforms of substances having altered properties compared to their macroform.

The introduction of Material Safety Data Sheets (MSDS) is mentioned

Emphasis is placed on strict containment procedures for CNTs

WHO IS DOING WHAT?

USA

A number of different US Agencies are involved in nanotechnology regulation, including the Food and

Drug Administration (FDA), EPA, Occupational Safety and Health Administration (OSHA), the Consumer

Product Safety Commission (CPSC) and NIOSH. Like

EU, the United States is following the similar approach.

Yearly

Commission & Agency:

National Institute for

Occupational Safety and Health (NIOSH)

Regulatory Activities:

Regularly updates its series of authoritative guidance on Occupational

Health and Safety (OHS) issues of nanomaterials

2011

Commission & Agency:

Environmental Protection

Agency (EPA)

Acts:

Federal Insecticide,

Fungicide and Rodenticide

Act (FIFRA)

Regulatory Activities: EPA

proposed a new approach that would consider any nanomaterial as a new active ingredient for the pesticide regulation (thus differentiating them from their macro-form).

2013

Commission & Agency:

Environmental Protection Agency

(EPA)

Acts:

Toxic Substances Control

Act (TSCA - the US regulatory provision for chemical substances

Regulatory Activities:

Published a proposed Significant New Use

Rules (SNUR) for 14 nanomaterials that were the subject of pre-manufacture notices

(PMN). If issued in final the

SNURs would require persons who intend to manufacture, import, or process new nanoscale materials based on the chemical substances designated for a Significant new use to notify EPA at least 90 days before commencing that activity and required to notify the risks

WHO IS DOING WHAT?

Canada

Canada has developed a proposal for a regulatory framework for nanomaterials under the Canadian Environmental Protection

Act (CEPA), 1999. Under the provisions of this legislation

Engineered nano-materials have to get a risk assessment under

CEPA’s New Substances Notification Regulations (NSNR) before they can be manufactured or used in Canada.

Nanomaterials should be banned in foods and some packaging

There should be mandatory labeling for these novel compounds in cosmetics, personal-care products and cleaning agents.

Develop initiatives to gather information from industry on the uses, properties, and effects of nanomaterials

Introduced a mandatory safety reporting scheme for companies producing nanomaterials

WHO IS DOING WHAT?

ASIA-China

State Food and Drug Administration ('SFDA')

issued a new regulation in

2006

to replace the previous regulation. Under the new regulations,

'medical devices made with nanometer biological materials

(for example medical instruments made with

nanometer metal silver Material

) will be classified as Class III medical devices, and be subject to the administration of the relevant regulations of Class III medical devices

National centre for nanoscience & technology (NCNST) is the governing body for developing standards

Japan

Ministry of Economy, Trade and Industry (METI)

created the Committee on

Safety

Management for Nanomaterials

to increase knowledge on risk management of nanotechnologies.

Republic of South Korea

Established the inter-ministerial

“National Nano-safety Strategic Plan (2012-2016)”

Taiwan

Nanomark

Certification system by the Industrial Technology Research Institute (ITRI) since

2004

.Voluntary reporting and certification scheme for nanotechnology products was introduced

Thailand

Industrial standards certification system

(NanoQ)

managed by National

Nanotechnology Center (Nanotec)

WHO IS DOING WHAT?

India

Debate is on whether nanotechnology regulation requires a new legislation?

Can the present regulatory regime address the challenges of this new technology or applications from this technology?

What are the components of the current regulatory regime that will be able to address these new challenges?

To what extent modifications need to be made?

DST

constituted a working group for the regulation of NT

 CSIR initiated a major project “

Nano-SHE

” in 12th Five Year plan to evaluate and create a database on various toxicological aspects of nanostructured materials

Guidelines and best practices for safe handling of nanomaterials was

compiled by CKMNT as directed by NanoMission for circulation among the nanotechnology stakeholders

 CKMNT prepared a report on “Regulatory Framework for Nanotechnology-A Global

Perspective” for the working group on nanotechnology regulation of Nano mission

BIS is adapting new standards for nanomaterials

Regulatory Matrix in India

In India regulatory matrix has been developed and categorized under the following broad heads www.teriin.org/div/ST_BriefingPap.pdf

Proposed Regulatory Framework in India

Source: CKMNT Report on Regulatory FrameWork for Nanotechnology: A global perspective, 2013

StAnDaRdS

There is a need for standardization in various fields of nanotechnology to provide a basis for procurement, and support appropriate legislation/regulation.

Things Get weird without STANDARDS

China took the early lead in being first to establish its United Working Group

for Nanomaterials

standardization in

December 2003

The recently agreed sizebased definition (i.e. 1-100nm) for nanoparticles (ISO 27687), which is scheduled to be adopted by many governments

,

Standards

CHALLENGES COMMITEES

No internationally agreed terminology/definitions

No internationally agreed protocols for toxicity testing

No standardized protocols for evaluating environmental impact

No standardized measurement techniques and instruments

No standardized calibration procedures and certified reference materials.

ANSI-Nanotechnology Standards Panel in the U.S.

ASTM Committee E56 British Standards

Committee for Nanotechnologies (NTI/1)

European Committee for Standardization

(CEN/TC 352)

IEC group nanotechnology standardization for electrical and electronic products and systems (TC 113)

The Technical Committee on

Standardization TC 441 “Nanotechnologies and

Nanomaterials” RUSSIA

Examples of Evolving Standards

GB/T19619-2004

Terminology for nanomaterials

Sizing

GB/T19591-

2004 Nanotitanium dioxide

GB/T19627-2005 Particle size analysis -Photon correlation spectroscopy(ISO 13321:1996)

China

–National standards published

Dec 2004, implemented Apr

2005

GB/T19588-2004 Nano-nickel power

GB/T19587-2004 Determination of the specific surface area of solids by gas absorption using the BET method(ISO 9277:1999)

GB/T19590-2004

Nano-calcium carbonate

GB/T13221-2004

Nanometer powder -

Determination of particle size distribution -Small angle X-ray scattering method (ISO/TS13762)

GB/T19589-

2004 Nano-zinc oxide

NWIP: generation of data on silver nanoparticles for inhalation toxicity testing

ISO/TC 229 Technical Committe

Participating countries:

Observing countries:

35

13

Terminology and definitions for nanoparticles

–to be published as a TS

Current TC 229 work items

NWIP: the Use of Transmission

Electron Microscopy in the

Characterization of Single-walled

Carbon Nanotubes

Global Nanotechnology Regulatory Framework-An over view

India

Planning for regulatory framework

REACH and Nanomaterials

manufacturers and importers have to submit a registration dossier (for substances manufactured or imported at or above

1 tonne per year) and a chemical safety report (for substances manufactured or imported at or above 10 tonnes per year).

The European Chemicals Agency can require any information on the substance if deemed necessary

North

America

Europe

China

Japan

U.S. National Nanotechnology

Initiaive (NNI)

1.EHS regulatory/research issues delegated to

Nanotechnology

Environmental and Health

Implications Working Group

(NEHI)

2.U.S. National Labs play growing role in NT research, infrastructure and commercialization

CHINA

2003-2006, 10% of the [Chinese government's] investment in nanotechnology [was] allocated [to environmental, health, and safety research].

In 2004, the National Bureau of the State Food and Drug

Administration ('SFDA') issued a regulation classifying 'nanometer silver antibiotic device for women’s use.

Japan

No direct regulation of nanomaterials has as yet been implemented

in Japan

The Ministry of Economy, Trade, and Industry (METI) and the

Ministry of the Environment (MOE) have established specific nanomaterial safety working groups and conducted a preliminary survey on the safety of nanomaterials in occupational settings

Things to Do

More focus on Toxicological Studies of Nanomaterials

(CSIR-SHE)

Reviewing Existing Laws

(DST- NanoMission Working Group)

Risk Assessment

Collection and Maintenance of Different Types Data

(MSDS)

Development of Standards & Metrological Studies

Education & Engagement

Guidance for Safe Handling of Nanomaterials at

Workplace (CKMNT)

Voluntary reporting and certification system

Summary

Regulation is important since nanotechnology involves certain risks

EU, US, and Asian countries are already reviewing their existing regulation

Various programs and certification system have been started

Various challenges are associated before making regulation it should not affect innovation

Standards are important

ISO TC 229 and various committees have been established to develop standard for nanotechnologies

In India no regulations for nanotechnology till date.

However certain initiatives have started

Conclusion

A lot to think and to be done

Later it should not be

Nanotechnology: The next asbestos?

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