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, 27000251Fax: +91-40-27007031, Email: h.purushotham@gmail.com

Global Nanotechnology Regulatory Framework - An overview

National Summit "NANO-India" - Policy and Regulation & 3rd Innovation Excellence Awards on 10th June, 2014, ASSOCHAM, New Delhi

By

Dr. H. PurushothamHead-CKMNT

About ARCI/CKMNT

Global Nanotechnology Regulatory Framework - An overview

Agenda

ARCI, HyderabadHeadquarters

ARCI, Chennai1. Centre for Fuel Cell Technology2. Centre for Automotive Energy

Materials (CAEM)

1. Surface engg.2. Nanomaterials3. Ceramic processing.4. Laser processing.5. Non oxide ceramics6. Carbon Materials7. Sol-Gel Coating8. Solar Energy Materials9. Materials Charc. & Testing10.Tech. Acquisition,Transfer,

Internatl. Coop.

ARCI, New Delhi Cell 1. Liaison & Patent Filing

ARCI, Secunderabad1. Centre for Knowledge Management

of Nanoscience & Technology (CKMNT)

ARCI is “Translating Research to Technology “

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

International Advanced Research Centre for Powder Metallurgy and New Materials (ARCI)

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”

DirectoryRegulatory Frame WorkGuidelines and

Best PracticesNano-SensorsNano-

CopperNano-ZnO

Newsletter

Silver-Silica-Silicon Oil Composite

NanofibersCKMNT Reports/ Publications

Customised Reports

Multi-Client Reports

The Cloud

Human Health and Safety Issues

Environmental Issues

Economic and Equity Issues

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

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

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

http://www.hse.gov.uk/

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

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

Zinc Oxide Toxicity was shown to be associated with oxidative stress

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

Cerium Oxide Both cytotoxic and genotoxic in human dermal fibroblasts.

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

Nanosilver, copper, alluminium

copper and silver NPs were more neurotoxic than aluminium NPs

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

GoldGold nanoparticles decreased cell proliferation rate, adhesion, and motility of Human dermal fibroblast

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2988217/

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

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

Need for Regulation in Nano S&T

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)

2005

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

EU, NT Action Plan

2007

NS & T First implementation report of EU 2005-2007

2008

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

2009

EU planned second implementation report 2009-2015

2010

Many countries are taking initiatives for NS & T regulations like Australia, Switzerland, China, Japan, India (Nano-Mission), etc.

2012

EU Safety at workplaceDirectivesUS would consider any nanomaterial under Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

2011

2nd regulatory reviewof REACH (2012) (Registration, Evaluation, Authorisation and Restriction of Chemicals)

2013

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

European Union

WHO IS DOING WHAT?

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).

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

European Union

WHO IS DOING WHAT?

2013Commission & 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

2011Commission & 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).

YearlyCommission & 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

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.

USAWHO IS DOING WHAT?

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

Canada

WHO IS DOING WHAT?

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

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 KoreaEstablished the inter-ministerial “National Nano-safety Strategic Plan (2012-2016)”

TaiwanNanomark Certification system by the Industrial Technology Research Institute (ITRI) since 2004.Voluntary reporting and certification scheme for nanotechnology products was introduced

ASIA-ChinaWHO IS DOING WHAT?

Japan

ThailandIndustrial standards certification system (NanoQ) managed by National Nanotechnology Center (Nanotec)

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?

India

WHO IS DOING WHAT?

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 IndiaIn 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

At what I am

aiming?

The recently agreed size-based definition (i.e. 1-100nm) for nanoparticles (ISO 27687),

which is scheduled to be adopted by many

governments,

There is a need for standardization in various fields of nanotechnology to

provide a basis for procurement, and support appropriate

legislation/regulation.

China took the early lead in being first to establish

its United Working Group for Nanomaterials standardization in December 2003

Things Get weird without STANDARDS

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

Standards

CHALLENGES

GB/T13221-2004 Nanometer powder -

Determination of particle size

distribution -Small angle X-ray scattering method (ISO/TS13762)

China –National standards published

Dec 2004, implemented Apr

2005

GB/T19619-2004 Terminology for nanomaterials

Sizing

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

GB/T19627-2005 Particle size analysis -Photon correlation

spectroscopy(ISO 13321:1996)

GB/T19588-2004 Nano-nickel power

GB/T19589-2004 Nano-zinc

oxide

GB/T19590-2004 Nano-calcium

carbonate

GB/T19591-2004 Nano-

titanium dioxide

Current TC 229 work items

Terminology and definitions for nanoparticles –to be

published as a TS

NWIP: the Use of Transmission Electron Microscopy in the Characterization of Single-walled Carbon Nanotubes

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

Examples of Evolving Standards

ISO/TC 229 Technical Committe

Participating countries: 35

Observing countries: 13

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

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

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

North America

ChinaEurope

IndiaPlanning for regulatory

framework

Japan

Global Nanotechnology Regulatory Framework-An over view

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?