Published on February 15, 2014
Nanotechnology: Regulatory Perspectives, Challenges & Issues AJAZ S. HUSSAIN, PH.D. | INSIGHT, ADVICE & SOLUTIONS, LLC Keynote address: NanoSciTech 2014, Punjab University, Chandigarh, India 2/15/2014 AJAZ@AJAZHUSSAIN.COM 1
Nanotechnology Dimensions in 1 and 100 nm range Unique phenomena Understanding Control Benefit >> Risk National Nanotechnology Initiative Website, http://www.nano.gov/htmVfacts/whatIsNano.html 2/15/2014 AJAZ@AJAZHUSSAIN.COM 2
“Proactive Risk Management in a Dynamic Society”*: Many nested levels of decision-making Research disciplines Economics; Decision Theory; Organizational Sociology Political Science; Law; Economics; Sociology Public opinion Incident or accident Report Analysis Government Regulators Judgment Laws (e.g., FDASIA) Political climate & public opinion Operations review Company Judgment Regulations Industrial Engineering; Management & Organization Logs, Reports Management Changing market conditions and financial pressure Chemistry; Pharmacy; Biotechnology; Engineering,… Observations, Data Staff Judgment Judgment Plans Company Policy Environmental pressure 2/15/2014 Psychology; Human factors; Human-Machine Interaction Changing Competency & levels of education Work Judgment Action Changing product mix, technologies, and regulatory requirements *Jens Rasmussen & Inge Svedung (2000) AJAZ@AJAZHUSSAIN.COM 3
A ‘process of migration’ to explain how accidents can occur Boundary to functionally acceptable performance Gradient towards least effort Boundary to economic failure Safety Zone Gradient towards cost effectiveness Boundary to unacceptable workload Rasmussen (1997) 2/15/2014 AJAZ@AJAZHUSSAIN.COM 4
Perceived risk in the present controversyfree period Nanotechnology risk perceptions appear to contradict traditional findings: • unfamiliarity (contrary to expectations) not strongly associated with risk aversion • reduced ‘knowledge deficits’ are correlated with positive perceptions NATURE NANOTECHNOLOGY | VOL 4 | NOVEMBER 2009 2/15/2014 AJAZ@AJAZHUSSAIN.COM 5
Risk-Benefit Perceptions: Effect of Information, Familiarity and Cultural Worldviews Cultural Cognition of the Risks and Benefits of Nanotechnology. Nature Nanotechnology, 4(2), 87-91. (2009) 2/15/2014 AJAZ@AJAZHUSSAIN.COM 6
Emerging dynamics of nanotechnology commercialization From 1990 – 2008, ~ • published about 52,100 scientific articles and 17,600 companies • applied for about 45,050 patents worldwide (and • 18,000 patents granted to corporate assignees 5,440 US companies) A relative shift in emphasis from discovery to application: 1999 • Considering the ratio of corporate nanotechnology patent applications to corporate nanotechnology publications by year The Journal of Technology Transfer December 2011, Volume 36, Issue 6, pp 587-60 2/15/2014 AJAZ@AJAZHUSSAIN.COM 7
Social science perspective High priority in various national agenda for science and technology development • Expected to impact an entire range of industries • Significant implications on human health, the environment, sustainability, …. Not a single homogenous science or technology field • Researchers from different disciplines are involved • Most firms specialize in a particular technology Importance of access to tacit knowledge • Scientists engaged in both scientific research and technology development tend to have an advantage • Large firms expand their knowledge by building up new capabilities; small firms rely on their existing capabilities J Technol Transf (2011) 36:145–172 2/15/2014 AJAZ@AJAZHUSSAIN.COM 8
Key points In the current phase (controversy-free period) traditional risk-aversion to new technology is muted The ‘pendulum shifted’ towards commercialization about a decade ago The need for, and adequacy of, risk-assessment and risk-management in commercial setting is highly variable Nanoscience and nanotechnology publications often tout ‘transdisciplinary’; evidence from social science perspective suggests much of the research is ‘uni-disciplinary’ Tactic knowledge plays a significant role in science to technology transfer; ability to do both within a group or organization is advantageous A transdisciplinary approach to regulatory policy development would be important for efficient standardizations of frameworks, concepts, tools and vocabulary 2/15/2014 AJAZ@AJAZHUSSAIN.COM 9
Regulation and oversight that ensure the fulfillment of legitimate objectives Principles Scientific Integrity Protection of safety, health and the environment while avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barrier Public Participation Communication Benefits and costs • Executive Order 13563, to guide the development and implementation of policies for oversight of emerging technologies at the agency level • The White House Emerging Technologies Interagency Policy Coordination Committee: Principles for Regulation and Oversight of Emerging Technologies (March 11,2011) 2/15/2014 AJAZ@AJAZHUSSAIN.COM Flexibility Risk Assessment and Risk Management Coordination International Cooperation 10
Nanoscale materials Size Degradation mechanism Adsorptive capacity Surface charge 2/15/2014 Shape Composition Route, Exposure & Duration Surface modificaiton AJAZ@AJAZHUSSAIN.COM 11
Risk mitigation To protect workers Hazard identification Exposure assessment Risk characterization Risk management What we know today Health effects of industrial ultrafine, fibers and air pollution Nanoparticle can be measured Animal models for human exposureresponse Good practices to control exposure What we don’t know Applicability to engineered nanoparticles What are the most relevant measures Exposureresponse relationships Appropriate OELs for engineered nanoparticles http://www.cdc.gov/niosh/topics/nanotech/ 2/15/2014 AJAZ@AJAZHUSSAIN.COM 12
Weight of evidence Given the emerging nature of the field and complexity of nanomaterials • multiple studies on even basic material properties often result in varying data • pointing in different directions when data interpretation is attempted. • Need WOE approach that explicitly integrate expert evaluation of data quality of available information. Nanotoxicology Feb 2014. http://informahealthcare.com/doi/abs/10.3109/17435390.2012.750695 2/15/2014 AJAZ@AJAZHUSSAIN.COM 13
Regulating drug products based on nanotechnology FDA will ask: Evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit ◦ Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or ◦ Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer. ◦ These considerations apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm#conclusion 2/15/2014 AJAZ@AJAZHUSSAIN.COM 14
Dimension-dependent properties used for functional effects For example • Increased bioavailability, Decreased dosage, • Increased potency of a drug product, Decreased toxicity of a drug product • Better detection of pathogens Due to altered chemical, biological, or magnetic properties, altered electrical or optical activity, increased structural integrity, etc. (not normally observed in their larger counterparts). • These changes may raise questions about the safety, effectiveness, performance, quality or public health impact of the products. • In addition, considerations such as routes of exposure, dosage, and behavior in various biological systems (including specific tissues and organs) are critical for evaluating the wide array of products under FDA’s jurisdiction. http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm#conclusion 2/15/2014 AJAZ@AJAZHUSSAIN.COM 15
FDA’s Initiative on Pharmaceutical st Century Quality for the 21 Initiated more that a decade ago with clear recognition on the need to be prepared to address increasing complexity • Process Analytical Technology • Increased emphasis on design and risk-based approaches • ICH Q8 - 11 • New update to process validation emphasizing statistical confidence http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm128080.htm 2/15/2014 AJAZ@AJAZHUSSAIN.COM 16
An important lesson on measurement 2/15/2014 AJAZ@AJAZHUSSAIN.COM 17
Has the measurement system capability been verified? 2/15/2014 AJAZ@AJAZHUSSAIN.COM 18
Calibration & Gauge R&R 2/15/2014 AJAZ@AJAZHUSSAIN.COM 19
My conclusion in 2004 at the USP’s Annual Scientific Meeting - "The Science of Quality" Is still relevant today. Fundamental approach that utilizes QbD is the way forward. Given that today I am speaking at the Punjab University that has a unique, award winning program on QbD, I very much look forward to learning what you are doing in the area of QbD of nanotechnology based products. Thank you for the kind invitation. September 26–30, 2004 Sheraton at Woodbridge Place, Iselin, NJ 2/15/2014 AJAZ@AJAZHUSSAIN.COM 20
Nanotechnology: Regulatory Challenges. Presented By: Phillip M. Buckler Vice President of Regulatory Affairs and Quality Kereos, Inc. St. Louis, MO.
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