On 01/13/2011, the Office of Science and Technology Policy published a notice in the Federal Register extending the time for filing comments for the Draft NNI Strategy for Nanotechnology Related Environmental, Health and Safety Research to 01/21/2011. The 2011 Draft Strategy is designed to replace and update the 2008 Strategy and is the product of a series of stakeholder workshops, responses to a request for information published in the Federal Register on 07/06/2010 and comments filed online in response to questions posted on the NNI Strategic Portal.
The Draft Strategy, dated 12/06/2010, notes NNI’s EHS "Research Strategy provides guidance to the federal agencies as they develop their agency specified nanotechnology EHS research priorities implementation plans, and timelines." Added to that guidance
. . . is the inclusion of ethical, legal and societal implications (ESLI) of EHS research. . . .How nanotechnology research and applications are introduced into society, how transparent decisions are; how sensitive and responsible policies are to the needs and perceptions of the full range of stakeholders; and how ethical, legal and social issues are address will determine public trust and the future of innovation driven by nanotechnology.
Chapter 1 of the draft is introductory. Chapter 2 discusses the need to develop "A Comprehensive Measurement Infrastructure Consisting of a Suite of Complementary Tools", defined here as protocols, standards (reference materials), instruments, models and Data (further defined as "benchmark data that have been measured using validated protocols and reference materials . . . or other well-characterized test materials . . .for accurate. precise and reproducible measurements . . . ." and identifies five "Research Needs" for the development of measurement tools:
1 – Determination of physico-chemical properties of engineered nanomaterials (ENMs) and nanotecnhology enable products (NEPs) in relevant media and during the lifecycles of ENMs and NEPs
2 – Detection and Monitoring of ENMs in realistic exposure media and conditions during the life cycles of the ENMs and NEPs
3 – Evaluation of transformations of ENMs in relevant media and during the life cycles of ENMs and NEPs
4 – Evaluation of biological responses to ENMs and NEPs in relevant media and during the life cycles of ENMs and NEPs
5 – Evaluation of response mechanisms in ENMS and NEPs in relevant media and during the life cycles of NEPs
Chapter 3. "Human Exposure Assessments" notes that
"The number of products in commerce and development that contain nanomaterials has grown rapidly . . . .Hence, research on potential exposure must evaluate whether, and to what degree, exposure will occur for each nanomaterial or NEP at each stage of its life cycle. . . .As the likelihood for exposure for key population segments is determined, care should be taken in determining what constitutes a "key segment" of the population, who is empowered to define groups of people, and what implications may arise from placing people in particular categories. In addition, subpopulations among the "general population" that are disproportionally exposed or more vulnerable to impacts from exposure should be identified."
"Because of the relative newness of nanotechnology" there is little reliable data regarding exposure to NEPs in the workplace (typically, in manufacturing facilities) or by consumers purchasing, handling, using, or wearing NEPs (for example, socks with nanosilver woven into them). Chapter 3 Identifies four research needs:
1- Understanding of the processes and factors that determine exposures to nanomaterials
2- Identify population groups exposed to ENMs and NEPs
3- Characterization of individual exposures to nanomaterials
4- Conduct health surveillance of exposed populations
While Chapter 3 focused on populations and subpopulations, Chapter 4, "Human Health", focuses on the individual. Chapter 4, as did previous chapters, notes the lack of "Critical data sets needed to understand fully the rise of exposure and develop science based" health and safety guidelines.
Six research needs are identified in this chapter:
1- Identify or develop appropriate, reliable, and reproducible in vitro and in vivo assays and models to predict in vivo human responses to ENMs
2 – Quantify and characterize ENMs in exposure matrices and biological matrices
3 – "Understand the relationship between the physio-chemical properties of engineered nanomaterials and their transport, distribution, metabolism, excretion and body burden in the human body"
4 – Understand the relationship between the physico-chemical properties of ENMs and their uptake through "port of entry" tissues in the human body
5 – Determine the "modes of action" beneath human biological response to ENMs at levels ranging from the molecular to that of the whole body
6 – Determine the extent to which life stages and/or susceptibility factors modulate health effects associated with ENMs/NEPs exposure
Chapter 5, "Environment", focuses on what, after the potential effects of nanomaterials on the human body, may be the most controversial aspect of nanotechnology and the growth of nanoindustry, the potential effect on ENMs and NEPs on the environment. As the draft notes:
Understanding . . . potential environmental implications is critical to implementing good product stewardship and to instilling public confidence in the safety of nanomaterials and nano-enabled products that could benefit society. . . .Fundamental studies of the potential hazards from nanomaterials . . .should be guided by a view of how nanomaterials behave in environmental systems. To Understand ecosystem-wide effects, the sources (production/use/disposal), the pathways, and the key environmental receptors need to be understood.
Chapter 5 identifies five Research Needs:
1- Understand environmental exposures through identification of principal sources of exposure and exposure routes
2 – Determine factors affecting the environmental transport of nanomaterials
3 – Understand the transformation of nanomaterials under different environmental conditions
4 – Understand the effects of engineered nanomaterials on individuals of a species and the applicability of testing schemes to measure effects
5 – Evaluate the effects of ENMs/NEPs at the population, community. and ecosystem levels
Chapter 6 is focused on "Risk Assessment and Risk Management Methods", defined here as (1) ". . . the application of analytical tools, data, and expert knowledge to the evaluation of potential exposures of humans and the environment to nanomaterials and the hazards . . . exposure might engender" and (2) the use of risk management methods to identify and implement strategies to address potential hazards. The draft report notes that while there are "A number of national and international activities relevant to RA and RMM. . . . most projects are in early stages" of information collection and evaluation.
Chapter 6 discusses five Research Needs:
1 – Incorporate relevant risk characterization information, hazard identification, exposure science, and risk modeling and methods into the safety evaluation of nanomaterials
2 – Understand, characterize, and control workplace exposures to nanomaterials
3 – Integrate life cycle considerations into risk assessment and risk management
4 – Integrate risk assessment into decision making frameworks for risk management
5 – Integrate and standardize risk communication within the risk management framework
Chapter 7, "Informatics and Modeling for NanoEHS Research" discusses the need to (1) improve the quality and availability of data, (2) expand theory, modeling, and simulation capabilities, and (3) build a collaborative informatics infrastructure.
Chapter 8, " The Path Forward", focuses on "near-term opportunities to target and accelerate progress in NanoEHS R&D, to maintain close accord with the overall goals and objectives of the National Nanotechnology Initiative, and effectively coordinate agency research activities and share their result."
Details on filing comments may be found in the FR notice. Comments need to be filed no later than 11:59PM on 01/21/2011.
