Centre for Knowledge Management of Nanoscience & Technology

1. 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 & 3rd Innovation Excellence Awards on 10th June, 2014, ASSOCHAM, New Delhi

2. Agenda • About ARCI/CKMNT • Global Nanotechnology Regulatory Framework - An overview

3. 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 ARCI, New Delhi Cell 1. Liaison & Patent Filing Surface engg. Nanomaterials Ceramic processing. Laser processing. Non oxide ceramics Carbon Materials Sol-Gel Coating Solar Energy Materials Materials Charc. & Testing Tech. Acquisition,Transfer, Internatl. Coop. ARCI, Chennai Centre for Fuel Cell Technology Centre for Automotive Energy Materials (CAEM) • ARCI, Secunderabad • Centre for Knowledge Management of Nanoscience & Technology (CKMNT) ARCI is “Translating Research to Technology “

4. 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” Directory Regulatory Frame Work Guidelines and Best Practices Nano-Sensors Nano-Copper Nano-ZnO CKMNT Reports/Publications Nanofibers Newsletter Silver-Silica-Silicon Oil Composite • Multi-Client Reports • Customised Reports

5. The Cloud

6. 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… Environmental Issues Human Health and Safety Issues Economic and Equity Issues

7. Toxic & Health Effects of Nanomaterials More Toxicological Studies are needed to evaluate toxic effects of engineered nanoparticles

8. 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

9. 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

10. Timeline of Nanotechnology Global Regulatory Framework (Major) Many countries are taking initiatives for NS & T regulations like Australia, Switzerland, China, Japan, India (Nano-Mission), etc. 2nd regulatory review of REACH (2012) (Registration, Evaluation, Authorisation and Restriction of Chemicals) 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 2011 2013 2009 2007 2005 2012 2008 2010 USA Published a proposed significant new rules (SNUR) for 14 nanomaterials that were the subject of pre-manufacture notice )PMN NS & T First implementation report of EU 2005-2007 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)

11. 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 (ECNo 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 toconsumers regulation (EU Regulation 1169/2011), approved by the EC (July 2011) which will apply from December 2014 Regulatory Activities:Thisregulation 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).

12. 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 nanoformsof 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

13. 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. 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 activityand required to notify the risks 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). Yearly Commission & Agency: NationalInstitute for Occupational Safety and Health (NIOSH) Regulatory Activities: Regularly updates its series of authoritative guidance on Occupational Health and Safety (OHS) issues of nanomaterials

14. 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

15. WHO IS DOING WHAT? ASIA-China • State Food and Drug Administration ('SFDA') issued a new regulation in 2006to 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)

16. 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

17. 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

18. Proposed Regulatory Framework in India Source: CKMNT Report on Regulatory FrameWork for Nanotechnology: A global perspective, 2013

19. 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 The recently agreed size-based definition (i.e. 1-100nm) for nanoparticles (ISO 27687), which is scheduled to be adopted by many governments, StAnDaRdS Things Get weird without STANDARDS At what I am aiming?

20. Standards CHALLENGES COMMITEES 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 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.

21. GB/T19627-2005 Particle size analysis -Photon correlation spectroscopy(ISO 13321:1996) GB/T19619-2004 Terminology for nanomaterials Sizing GB/T19588-2004 Nano-nickel power China –National standards published Dec 2004, implemented Apr 2005 GB/T19587-2004 Determination of the specific surface area of solids by gas absorption using the BET method(ISO 9277:1999) GB/T19591-2004 Nano-titanium dioxide GB/T19589-2004 Nano-zinc oxide GB/T19590-2004 Nano-calcium carbonate Examples of Evolving Standards Terminology and definitions for nanoparticles –to be published as a TS GB/T13221-2004 Nanometer powder -Determination of particle size distribution -Small angle X-ray scattering method (ISO/TS13762) NWIP: generation of data on silver nanoparticles for inhalation toxicity testing Current TC 229 work items NWIP: the Use of Transmission Electron Microscopy in the Characterization of Single-walled Carbon Nanotubes

22. Global Nanotechnology Regulatory Framework-An over view • 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 India Planning for regulatory framework North America Europe China Japan • 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 • 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

23. 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

24. 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

25. Conclusion A lot to think and to be done Later it should not be Nanotechnology: The next asbestos?