The Framework focuses on engineered nanoscale materials that exhibit novel properties and that consist of particles or physically discrete entities smaller than 100 nanometers (nm) in one or more dimensions. The term “nanomaterial,” as used in the Framework document, applies to such components, either in their original form or as ingredients in products from which they could be released during downstream activities, including disposal.
Nanotechnology has great potential to deliver environmental and other benefits, but it may also pose significant risks to human health and the environment. As materials reach the nanoscale, novel properties emerge, such as changes in surface chemistry, reactivity, and electrical conductivity, which could alter toxicological properties or exposure potential.
Specific health and environmental risks depend on numerous factors, including the physical and chemical properties of the material; inherent toxicity; biological and environmental behavior; dose, route, and frequency of exposure; and the characteristics of the exposed individual. The available, limited data indicate that some nanomaterials appear to have the potential to damage skin, brain, and lung tissue; to be mobile or persistent in the environment; or to kill microorganisms.
In a June 2005 op-ed that ran in The Wall Street Journal, DuPont CEO Chad Holliday and Environmental Defense President Fred Krupp jointly called for broad collaboration by interested stakeholders to identify and address potential environmental, health, and safety risks of nanotechnology. Soon after, Environmental Defense and DuPont entered into a partnership to develop this Framework. DuPont wanted to develop a robust program for examining risks during development of products that incorporate nanomaterials, and Environmental Defense wanted to promote a credible approach to identifying and mitigating risks for use within the nanotech industry.
The Framework was created by a multidisciplinary team from both organizations, including experts in biochemistry, toxicology, environmental sciences and engineering, medicine, occupational safety and health, environmental law and regulations, product development, and business development.
We received a wide range of comments. Many people congratulated us for taking such a big step forward in developing this Framework. A broad range of people applauded both its principles and its content. We also received a number of suggestions that helped us to further strengthen the Framework by adding discussion of available and needed resources to implement the Framework, specific commentary on test methods, and additional guidance on accountability, transparency, and stakeholder involvement.
The purpose of the base sets and their associated additional information elements is to enable the development of data profiles of a nanomaterial’s properties, inherent hazards, and exposure potential. Information gained from the data profiles provides a basis for making reasonable and responsible decisions about the material across its full lifecycle of development, production, use, and end-of-life disposal or recycling.
When a nanomaterial has few specific hazard data, one way to inform decisions about it is to extrapolate or “bridge” it to a material that has robust hazard data for a specific type of endpoint of interest (e.g., pulmonary toxicity). While the results of bridging are not as reliable as actually performing thorough toxicity studies on the material of interest, they can provide useful insights into its relative toxicity.
There are provisions throughout the Framework designed to protect workers considering the full lifecycle of the material and application, including:
The Nano Risk Framework calls for a set of tests to understand and prevent potential harm to humans, animals and the environment. Some of these tests require the use of laboratory animals where there are not yet alternatives accepted by the scientific community. As described further in the Framework, we support the development of validated in vitro methods for application to nanomaterials, and the Framework already incorporates such tests where they exist.
The Framework is a practical guide for use both on its own and as a supplement to existing product stewardship processes for the responsible development of nanomaterials. The Framework establishes a systematic and disciplined process for product developers to identify and reduce potential risks. DuPont will use the Framework on all products incorporating nanomaterials as a way of meeting its continued product stewardship commitment with regard to nanomaterials.
We encourage users to follow the six-step process laid out in the Framework and to utilize the output worksheet [PDF] located in the appendix, which provides a template for organizing and evaluating relevant information and transparently communicating it to stakeholders.
The Framework is not a regulation – it is a guidance document for DuPont and any other company or organization that chooses to adopt it. DuPont and Environmental Defense believe that a comprehensive, consistent, and appropriate regulatory policy for nanomaterial development is needed. To the extent that the Framework helps in the development of such a policy – as one piece of input in an open process – we support that goal.
The Framework is intended to be implemented concurrently with product development and therefore would not delay development. Implementation of the Framework is consistent with DuPont’s existing product stewardship commitment and is expected to be consistent with other companies’ existing product stewardship practices. Like any procedure, the cost and time will be determined by the specific product, the intended application, identified risks, and known information/data about the material.
Our hope is that the Framework is complementary to other risk management processes and that companies with well-established processes may find it relatively easy to supplement or modify their established processes to incorporate the Framework.
The Framework speaks directly to this point: "There are many different ways to insure transparency, such as having key stakeholders (e.g., NGOs) on the review team and making risk information and decisions public. Throughout the process of risk evaluation it is particularly important to clearly identify what assumptions are made and where professional judgment is used in the absence of data, and the basis of the expert assessment should be clearly documented and justified."
We will continue to engage with other companies to help them understand the need for a thorough assessment of nanomaterial risk and adopt the Framework and its guiding principles into their own product stewardship processes. We will also provide input to inform appropriate government policies to ensure the responsible development of nanotechnology.
We would define success as: