1 Nanotechnology Regulatory Framework - A Global Perspective
2 The Cloud
3 Human Health and Safety Issues Economic and Equity IssuesWHY 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…
4 Toxic & Health Effects of NanomaterialsToxic 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 Titanium Oxide Distribute into several tissues (notably spleen, liver and lungs) and there were suggestions of substantial acute systemic toxicity Zinc Oxide Toxicity was shown to be associated with oxidative stress Cerium Oxide Both cytotoxic and genotoxic in human dermal fibroblasts. Nanosilver, copper, alluminium copper and silver NPs were more neurotoxic than aluminium NPs Gold Gold nanoparticles decreased cell proliferation rate, adhesion, and motility of Human dermal fibroblast More Toxicological Studies are needed to evaluate toxic effects of engineered nanoparticles
5 Balance Safety Health Environment R&D Activity Economic GrowthSocietal Benefits Economic Growth Environment Health Nanotech Regulations
6 Fundamental PrinciplesRegulation based on a precautionary approach Mandatory nano-specific regulations Health and safety of the public and workers Environmental protection Transparency Public participation Inclusion of broader impacts Manufacturer liability
7 TIMELINE OF NANOTECHNOLOGY REGULATORY FRAMEWORKEU, NT Action Plan Many countries are taking initiatives for NS & T regulations like Australia, Switzerland, China, Japan, India (Nano-Mission), etc. US, EPA Holds its first public meeting for nanosacale materials stewardship program Recommendation on a code of conduct, EU regulatory aspects of nanomaterials USFDA Guidance for Industry 2nd regulatory review of REACH (2012) 2007 2009 2011 2013 2005 2012 2014 2008 2010 NS & T First implementation report of EU EU planned second implementation report EU Safety at workplace Directives US would consider any nanomaterial 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
8 WHO IS DOING WHAT? European Union 2012 2011 2009European Commission (EC) is reviewing all relevant legislation with a view to propose regulatory changes wherever necessary and to develop more nano specific instruments for the implementation of regulation. 2012 Acts: Regulation (EC) No 1223/2009 (Article 13) Regulatory Activities: Established the Cosmetics Product Notification Portal (CPNP) 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). REACH, CLP and Biocides Regulation ECHA, together with the Member States included some substances with nanoforms in the Community rolling action plan (CoRAP) list of substances to be evaluated in 2011 Acts: Food information to consumers regulation (EU Regulation 1169/2011), approved by the EC (July 2011) which will come into force in December 2014 Regulatory Activities: This regulation includes the requirement for labeling of ingredients in the form of nanomaterials (material plus word “nano” in brackets). 2009 Acts: Cosmetic Regulation (EC No 1223/2009, which will come into force in 2013) Regulatory Activities: Included Specific provisions for nanomaterials (definition, requirement for notification labeling and reporting of nanomaterials).
9 European Union Up until now, the Commission has permitted one mineral UV-filter usually used in its nanoscale in sunscreen products (titanium dioxide). Another substance at nanoscale, zinc oxide, has been assessed by the SCCS in 2003 as a UV-filter. The SCCS Scientific Committee on Consumer Safety, in its opinion SCCNFP/0649/03 , concluded that the safety of zinc oxide as a UV-filter had not been sufficiently demonstrated. As a result, zinc oxide has not been permitted as a UV-filter by the Commission. The substance multi-walled carbon nanotubes has been registered under REACH. There is another registration of multi-walled carbon nanotubes under graphite. classified as hazardous with the following Hazard Statements (GHS): H319: Causes serious eye irritation; and H335: May cause respiratory irritation.
10 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 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. 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: 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
11 USA 2014 Commission & Agency: Food and Drug AdministrationDraft Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology Guidance for Industry Safety of Nanomaterials in Cosmetic Products Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives Guidance for Industry Use of Nanomaterials in Food for Animals Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
12 USA EPA researchers are studying the unique chemical and physical features of nanomaterials (such as size, shape, chemical composition, stability, etc) to help develop predictive models to determine which nanomaterials may pose a higher probability of risk and those expected to have little impact. Carbon Nanotubes : Under section 5 of TSCA, a manufacturer (defined to include an importer) must notify EPA through a PMN at least 90 days in advance of a new chemical’s commercialization, to provide EPA an opportunity for review. Case Studies conducted by EPA on various nanomaterials Nano Silver in disinfactant spray and muncipal solid waste Cerium dioxide Impact on Fuel Emissions and Air Pollution Titanium dioxide Water Treatment and in Topical Sunscreen Micronized Copper Particles from Pressure-treated Wood Products
13 CANADA Nanomaterials are being regulated in Canada under existing legislation including the Canadian Environmental Protection Act, 1999, the Pest Control Products Act, the Fertilizers Act, the Feeds Act and the Food and Drugs Act. Some examples of nanomaterial that fall within the Health Canada's regulatory mandate are described in the table below. Name of Nanomaterial Example of a Regulated Product/Substance Quantum dots Medical diagnostic agent Nanoscale colloid/emulsion/liposome Drugs- formulation and delivery Nano silver Antibacterial coatings (for example (e.g.) bandages, clothing, & surgical instruments) Nano gold Facial cream Nano titanium dioxide Sunscreen Nanocrystalline cellulose Industrial coatings and paints (mechanical reinforcement and optical properties) Single and multi-wall carbon nanotubes Polymer products (electrical conductivity and mechanical reinforcement) Surface coated nano-silicas Polymer products and coatings (increased resistance to wear)
14 AUSTRALIA Industrial nanomaterials are regulated within the framework for conventional ('bulk') chemicals through the Industrial Chemicals Notification and Assessment Act 1989 Any new food manufactured using nanotechnologies that may present safety concerns will have to undergo a comprehensive scientific safety assessment before it can be legally supplied in Australia or New Zealand. This requirement is set out in FSANZ.’s Application Handbook . FSANZ has engaged a leading toxicologist to undertake a review of nanotechnology and its applications with a subsequent report expected to be published in late 2015/early 2016.
15 SWITZERLAND Current legislation for chemicals, foodstuffs, the environment, and medicines also applies to nanomaterials. Work is underway to determine any legal changes that are needed to take account of nanomaterials. In Switzerland the Chemicals Ordinance, the Ordinance on Biocidal Products and the Plant Protection Products Ordinance include specific requirements for nanomaterials. Existing requirements for "Action plan for synthetic nanomaterials“ are listed below: Authorisation and registration procedures, self-monitoring Reporting obligation Labelling Emission and immission thresholds, quantity thresholds Employee protection (thresholds and recommended levels)
16 Republic of South KoreaASIA 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 Notice on Standard Draft Planning on 17 National Standards including "the Standard on the Health and Safety Practices in Occupational Settings Relevant to Nanotechnologies (22 August 2011, Standardization Administration of China) Republic of South Korea Established the inter-ministerial “National Nano-safety Strategic Plan ( )” National Chemicals Control Basic Plan (2011) Under the Plan, nanosubstances are among priority chemicals that will be subject to indepth hazard assessment, exposure analysis, and safety studies. Guidance on Safety Management of Nano-based Products (2011) Contd……….
17 Japan Ministry of Economy, Trade and Industry (METI) created the Committee on Safety Management for Nanomaterials to increase knowledge on risk management of nanotechnologies. (5 year project on toxicity test protocols and risk assessment methodologies for manufactured nanomaterials) Discussion Committee on Chemical Substances (first meeting in fiscal year 2011) Committee on Safety Management for Nanomaterials established Taiwan Nanomark Certification system ITRI, the Industrial Technology Research Institute) since 2004.Voluntary reporting and certification scheme for nanotechnology products Thailand Industrial standards certification system (NanoQ) managed by National Nanotechnology Center (Nanotec)
18 India Department of Science and Technology constituted a task force for the regulatory framework for nanotechnology Council of of Scientific and Industrial Research (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 for Developing Safe Work Practices in Laboratories Dealing with Nanomaterials Compiled and Circulated as a Guidelines by Centre for Knowledge Management of Nanoscience and Technology (CKMNT) A status report on work done in different countries towards establishing a regulatory framework for nanotechnology was prepared by CKMNT for Nano Mission BIS is adapting new standards for nanomaterials
19 For Consideration Current Acts which can be considered for initial stages for the regulation of nanoproducts, should be amended in such a way that progress should also not be affected. The Water (Prevention and Control of Pollution) Act The Air (Prevention and Control of Pollution) Act Environment (Protection) Act 1986, Environment (Protection) Third Amendment Rules, 2002 Public Liability Insurance Act 1991 The Factories Act Insecticide Act Prevention of Food Adulteration Act 1954
20 Regulatory Matrix in IndiaIn India regulatory matrix has been developed and categorized under the following broad heads
21 Proposed Regulatory Framework in IndiaSource: CKMNT Report on Regulatory FrameWork for Nanotechnology: A global perspective, 2013
22 CKMNT’s Role Status update of nanotechnology regulations worldwide periodically Maintaining the toxicological database from the various sources Monitor the developments in nanotechnology at national and international level Creating public awareness Engaging with various regulatory agencies/ R&D institutes for regulation related activities
23 Challenges Scientific Knowledge gaps (Enough Data for FramingRegulations) 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 of scale
24 Nanoregulations RoadmapMore focus on Toxicological Studies of Nanomaterials Reviewing Existing Laws Risk Assessment Collection and Maintenance of Different Types Data Development of Standards & Metrological Studies Education & Engagement Guidance for Safe Handling of Nanomaterials at Workplace Voluntary reporting and certification system
25 STANDARDS The need for standardization exists 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 nm) for nanoparticles (ISO 27687), which is scheduled to be adopted by many governments
26 STANDARDS COMMITEES ANSI-Nanotechnology Standards Panel in the U.S.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 references 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
27 ISO/TC 229 NanotechnologiesGB/T 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/T Terminology for nanomaterials Sizing GB/T Determination of the specific surface area of solids by gas absorption using the BET method(ISO 9277:1999) GB/T Particle size analysis -Photon correlation spectroscopy(ISO 13321:1996) GB/T Nano-nickel power GB/T Nano-zinc oxide GB/T Nano-calcium carbonate GB/T Nano-titanium dioxide EXAMPLES Terminology and definitions for nanoparticles –to be published as a TS Current TC 229 work items NWIP: generation of silver nanoparticles for inhalation toxicity testing ISO/TC 229 Nanotechnologies Participating countries: 35 Observing countries: 13 NWIP: the Use of Transmission Electron Microscopy in the Characterization of Single-walled Carbon Nanotubes
28 Global Nanotechnology Regulatory Framework-An over viewREACH 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 , 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
29 Summary Regulation is important since nanotechnology involves certain risks EU, US, and Asian countries are already reviewing their existing regulations 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 been started
30 A lot to think and to be done Nanotechnology: The next asbestos?Conclusion A lot to think and to be done Later it should not be Nanotechnology: The next asbestos?