Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

The resolution sets out a series of demands in different areas related to nanotechnology development:

• Marketing:

The seven principles are:

1. Meaning:  N&N research activities should be comprehensible to the public.  They should respect fundamental rights and be conducted in the interest of the well-being of individuals and society in their design, implementation, dissemination, and use.
2. Sustainability:  N&N research activities should be safe, ethical, and contribute to sustainable development.  They should not harm or threaten people, animals, plants, or the environment, at present or in the future.
3. Precaution:  N&N research activities should be conducted in accordance with the precautionary principle, anticipating potential environmental, health, and safety impacts of N&N outcomes and taking due precautions, proportional to the level of protection, while encouraging progress for the benefit of society and the environment.
4. Inclusiveness:  Governance of N&N research activities should be guided by the principles of openness to all stakeholders, transparency, and respect for the legitimate right of access to information.  It should allow the participation in decision-making processes of all stakeholders involved in or concerned by N&N research activities.
5. Excellence:  N&N research activities should meet the best scientific standards, including integrity of research and good laboratory practices.
6. Innovation:  Governance of N&N research activities should encourage maximum creativity, flexibility, and planning ability for innovation and growth.
7. Accountability:  Researchers and research organizations should remain accountable for the social, environmental, and human health impacts of their work.

EFSA requests data on the following issues:

• Data on the safety of nanomaterials used in food and feed;
• Food and feed applications and products containing or consisting of nanomaterials or produced by nanotechnology;
• Methods, procedures, and performance criteria used to analyze nanomaterials in food and feed;
• Use patterns and exposure to humans and environment;
• Risk assessments performed on nanomaterials used in food and feed;
• Toxicological data on nanomaterials used in food and feed;
• Environmental studies performed on nanotechnologies and nanomaterials used in food and feed; and
• Other data of relevance for risk assessment of nanotechnology and nanomaterials in food and feed.

The summary includes the following conclusion:

Conclusion -- Are existing methodologies to assess the potential human health and environmental risks associated with products of nanotechnology appropriate?

To the question: “Are existing methodologies appropriate to assess potential and plausible risks associated with different kinds of nanotechnologies and processes associated with nanosized materials as well as the engineered and adventitious products of nanotechnologies?,” the SCENIHR is of the opinion that:

• Although the existing methods are appropriate to assess many of the hazards associated with the products and processes involving nanoparticles, they may not be sufficient to address all the hazards.
• More specifically, the mode of delivery of the nanoparticle to the test system should adequately reflect the exposure scenarios. Additional tests may be needed.
• Expressing the dose of exposure in terms of mass alone is not sufficient; it also needs to be expressed in terms of total surface area, number of particles, or a combination of the two.
• Also, the existing methods used for environmental exposure assessment are not necessarily appropriate.
• Therefore, the current risk assessment procedures require modification for nanoparticles.

To the question: “If existing methodologies are not appropriate to assess the hypothetical and potential risks associated with certain kinds of nanotechnologies and their engineered and adventitious products, how should existing methodologies be adapted and/or completed?,” the SCENIHR is of the opinion that:

Existing methodologies need to be modified or new ones developed so that they are able:

• To determine the physical and chemical properties of nanoparticles routinely.
• To measure the representative exposure to free nanoparticles in air, soil, water.
• To better assess the potential hazard of nanoparticles, including whether or not they can exacerbate pre-existing medical conditions.
• To better detect the movement of nanoparticles inside living systems.

More specifically, these methodologies need to provide information on how nanoparticles distribute in human tissues and in the environment.

To the question: “In general terms, what are the major gaps in knowledge necessary to underpin risk assessment in the areas of concern?,” the SCENIHR is of the opinion that:

The major gaps in knowledge that need to be filled to allow for satisfactory risk assessments for humans and ecosystems to be performed include:

• The mechanisms and the rate at which nanoparticles are released from products and processes.
• The actual levels of exposure to nanoparticles, both for humans and the environment.
• The extent to which it is possible to calculate the toxicology of nanoparticles from the knowledge on the same chemicals in larger physical forms.
• The movement of nanoparticles inside the body, the effects that nanoparticles cause at cellular level, and how target organs respond to different doses of nanoparticles.
• The exposure and related health effects of workers involved in the production and processing of nanoparticles.
• The behaviour of nanoparticles in the environment, how they are distributed, if they persist in it, and whether they accumulate in different species, including micro-organisms.
• The effects of nanoparticles on various environmental species.

The Note includes the following questions and answers:

What are the requirements under the Regulations for nanomaterials which are manufactured or imported?

Nanomaterials which are manufactured in or imported into Canada are subject to the same regulatory requirements as chemicals and polymers, and notifiers must submit a New Substances Notification package prior to the manufacture in or import into Canada of the new substance.

Although not required, Environment Canada and Health Canada recommend notifiers request a Pre-notification Consultation (PNC) during the planning or preparation of a notification. For example, a notifier can request a PNC to assist with determining whether the substance is notifiable, as well as to clarify notification procedures or information requirements, and to determine the acceptability of waiver requests and/or test protocols.

What nanomaterials are subject to the Regulations?

Nanomaterials which are manufactured in or imported into Canada that are not listed on the Domestic Substances List (DSL) are considered new. The nanoscale form of a substance on the DSL is considered a “new” substance if it has unique structures or molecular arrangements. New nanomaterials are subject to notification under the Regulations. For example, the nanomaterial fullerene (CAS No. 99685-96-8) is not listed on the DSL and is considered a “new” substance under the Regulations.

What nanomaterials are not subject to the Regulations?

Substances listed on the DSL whose nanoscale forms do not have unique structures or molecular arrangements are considered existing. Existing nanomaterials are not subject to the Regulations and do not require notification. For example, titanium dioxide (CAS No. 13463-67-7) is listed on the DSL and since its nanoscale form does not have unique structures or molecular arrangements, it is not subject to the Regulations.

In addition, incidentally produced or naturally occurring nanomaterials are not subject to notification.

The authors analyzed in a life cycle perspective three commercially available products containing fullerenes to map current applicable regulations, determine their applicability to nanomaterials, identify their gaps, and suggest proper solutions. After mapping the life cycle of the three products, the authors reviewed applicable regulations in the order in which they became relevant in their life cycle, i.e.:

• The Safety at Workplace Directives;
• Directive 61/1996 on the Integrated Pollution Prevention and Control;
• The European Union’s Directive on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH); and
• The Waste Management Directives.

The report offers the following main conclusions identified by the workshop participants:

• There is no generic LCA of nanomaterials, just as there is no generic LCA of chemicals.
• The International Organization for Standardization (ISO) framework for LCA (ISO 14040:2006) is fully suitable to nanomaterials and nanoproducts, even if data regarding the elementary flows and impacts might be uncertain and scarce. Since environmental impacts of nanoproducts can occur in any life cycle stage, all stages of the life cycle of nanoproducts should be assessed in an LCA study.
• While the ISO 14040 framework is appropriate, a number of operational issues need to be addressed in more detail in the case of nanomaterials and nanoproducts. The main problem with LCA of nanomaterials and nanoproducts is the lack of data and understanding in certain areas.
• While LCA brings major benefits and useful information, there are certain limits to its application and use, in particular with respect to the assessment of toxicity impacts and of large-scale impacts.
• Within future research, major efforts are needed to assess fully potential risks and environmental impacts of nanoproducts and materials (not just those related to LCA).
• There is a need for protocols and practical methodologies for toxicology studies, fate and transport studies, and scaling approaches.
• International cooperation between Europe and the U.S., together with other partners, is needed to address these concerns.
• Further research is needed to gather missing relevant data and to develop user-friendly eco-design screening tools, especially ones suitable for use by small and medium sized enterprises.

The report also offers specific recommendations in the following areas:

• Case-studies/prioritizing efforts: With limited resources, a case-study research approach could be adopted to enhance significantly knowledge on environmental impacts of nanomaterials and nanoproducts.
• LCA studies and presentations of results: Any LCA study on nanoproducts and nanomaterials most likely suffers from high uncertainty issues.
• Approaches.
• Actions from stakeholders: Different stakeholders/authorities can potentially support the application and use of LCA for nanoproducts and nanomaterials through a large set of actions.