Suppl. information on additional options as defined by various participants

a) Agencies should use their current authorities (under for instance OSHA) to regulate nanomaterials. Current general problems with agencies like EPA and OSHA being under-funding, under-employment, and lack of political will to take regulatory action need to be addressed. Existing laws should be adapted proactively now in the view of nanomaterials and in the view of the precautionary principle and the process should be used as a motivation for creating a whole new “better than REACH-like approach” that covers both nanomaterials as well as chemicals. We need social discussion about commercialization of nanomaterials in a broader social spheres sector by sector. A ban or a moratorium might be appropriate in some cases (for instance with over-the-counter products such as cosmetics, foods, and food packages) where commercialized products are untested or unsafe, because there is a high level of exposure. Industry should not be relied upon to do EH&S testing, but instead you could have a structure partly government and partly industry funded like the EMF RAPID program. Companies should be able to hand in a sample and the Government should do and have done the EH&S testing so that you would have data you could trust and that would be publicly available. SME should not be charged the same as larger companies

b) Setting up an info generation management system that is evaluated by a outside board. Information generation on safety, management, ect. An Environmental Management System like the ones in the EU

c) Reactive incremental approach defined as a moratorium on some materials based on level of exposure and avoid broad releases learning as we go and allowing specific products that would allows us to understand safety, monitoring protocols

d) Combination of a moratorium of commercialization plus forming and implementing a new regulatory framework which should be based on human cell assay from the target organs and bacteria, plants, daphnia and worms and not on higher-level organisms such as rats and mice and should not be based on multiple species testing

e) Launching an incremental process using existing legislative structures—e.g., dangerous substances legislation, classification and labeling, cosmetic legislation, etc.—to the maximum, revisiting them, and, when appropriate only, amending them. This includes issuing mandatory requirements, commissioning studies on the impact of the legislation and how they are implemented, mandatory risk assessment throughout the life cycle of a nanotechnology; mandatory actions of existing institutions for worker protection; supporting the setting up an observatory of nanotechnologies. Setting up a framework for dialogue within which stakeholders incl. the public can participate in shaping the course of nanotechnologies versus the government just telling the stakeholders that it is doing

f) Preventive incremental approach combining an incremental approach with enhanced regulatory access to information on the developing product in the pipelines and placing the burden of proof on manufacturers to proof safety prior to marketing

g) Proportional incremental approach defined as implementing voluntary measures in combination of an incremental approach while ensuring appropriate and proportional regulation

h) Incremental approach combined with a program that requires environmental, health and safety research on the properties of nanomaterials and health and safety issues to be performed by developers and manufacturer and that this information has to be publicly available

i) Evidentiary approach plus coordinated framework approach similar to a incremental approach, but not just step-wise since it is based on evidence leading to an informed decision about whether additional regulation is needed. It should be a proportional approach taking the knowledge; benefits; oversight entities into consideration including a voluntary reporting component for all stakeholders; and appropriate current/best practices

j) Combination of voluntary measures and increased agency discretionary authority while the current regulatory system is being revised. Includes calls for data and voluntary registration from government agencies, information incentives, such as lists of nanomaterials of high concern that should be avoided, and use of other regulatory authorities to issue restrictions on materials of high concern. A rapid revamping of chemicals and materials policy would occur so that these would be in line with safer nanotech and chemicals. One option, while broad reform is being discussed, is a placeholder bill that would limit commercialization of nanomaterials of high concern while research is being conducted to understand their risks.

Suppl. information: List of the various criteria used (Weight assigned to Criteria in %)
Health and environmental concerns
  1. Protection of human health and environment (16, 19, 20, 42, 80, 80%)

  1. Limiting or controlling exposure to humans and environment (25%)

  1. Proactively protecting worker health and safety (25%)

  1. Effectiveness in protecting human health (43%)

  1. Case-by-case science-driven approach (30%)

  1. Preventing environmental releases (11%)

  1. Degree of uncertainty about risks (16%)

  1. Allows responsible development (22%)

  1. Availability of toxicological data (30%)

  1. Human health and worker safety (7%)

  1. Controllability of likely hazards (24%)

  1. Protection of the environment (10%)

  1. Should lead to sustainability (65%)

  1. Environmental sustainability (7%)

  1. Generating information (20%)

  1. Catastrophic potential (40%)

  1. Environmental impact (19%)

  1. Protecting the public (22%)

  1. Potential of exposure (5%)

  1. Limiting environmental, health and safety harm (34%)

  1. Science based risk (30%)

  1. Life cycle issues (25%)

  1. Minimizing risks (15%)

  1. Imminent threat (10%)

  1. State of science (33%)

  1. Possible risks (20%)

  1. Net risks (8%)

Efficacy
  1. Realistic within current Government and Industry (2%)

  1. Provide opportunity for flexibility (10%)

  1. Politically possible to implement (50%)

  1. Is it possible with current tools (34%)

  1. Realistic and viable (23, 50%)

  1. Political feasibility (10, 15%)

  1. Practical/efficient (10%)

  1. Practicality (8, 26, 35%)

  1. Practical/realistic (15%)

  1. Implementability (25%)

  1. Effectiveness (40%)

  1. Is it realistic? (50%)

  1. Quickness (27%)

  1. Flexibility (11%)

Benefits
  1. Does the process enable benefitial applications to be developed (12%)

  1. Gaining the benefits of nanotechnology on environment and health (10%)

  1. Promoting Environmental and health benefits (15%)

  1. Sparking innovation and seeking knowledge (15%)

  1. Degree of uncertainty about benefits (16%)

  1. Reaping the benefits of technology (20%)

  1. Reaping the benefits of nanotechnology (20%)

  1. Long-term benefits for society (23%)

  1. Societal and business benefits (45%)

  1. Maximizes benefits (10, 25%)

  1. Greatest benefits (10%)

  1. Unique benefits (25%)

  1. Net benefits (14%)

Social issues
  1. Increase industry engagement in getting public support (25%)

  1. Increase public understanding and support (26%)

  1. Getting benefits for society at large (34%)

  1. Societal and business benefits (45%)

  1. Protecting the pursuit of ideas (13%)

  1. Public perception of risk (22%)

  1. Ability of innovation (5%)

  1. Global collaboration (20%)

  1. Empowering people (10%)

  1. Public participation (10%)

  1. Collaborate opinion (8%)

  1. Public information (20%)

  1. Social benefits (19%)

Economic issues
  1. Development of economically profitable commercial products (16%)

  1. Allowing productivity and innovation (22%)

  1. Research and manufacturing process (12%)

  1. Not decreasing the pace of nanotech (10%)

  1. National economical competitiveness (5%)

  1. Maximizes business development (25%)

  1. Supporting green innovation (29%)

  1. Possibility of making money (33%)

  1. Leveling the playing field (20%)

  1. Impact on the economy (5, 14%)

  1. Economical benefits (20%)

Regulatory and legal issues
  1. Transparency in the decision-making process (7, 13, 15%)

  1. Ability to include social and ethical considerations (70%)

  1. Based on a evidencetory approach (10%)

  1. Prevention rather than reaction (50%)

  1. Allows a inclusive approach (15%)

  1. Importance of source of data (25%)

  1. Oversight and enforcement (25%)

  1. Level of enforcement (20%)

  1. Burden on industry (0%)

  1. Legally enforceable (9%)

Ethics
  1. Extend of relevant human cell based tests (42%)

  1. Fair distribution of risk and benefits (30%)

  1. Preventing unfair risk distribution (38%)

  1. Positive risk-benefit ratio (60%)

  1. Impact on ethical issues (15%)

  1. Ethical consideration (25%)

Proportionality
  1. Reasonable in the view of current environmental, health and safety evidence (47%)

  1. Benefits to risk ratio (70%)

  1. Proportional (15%)