Responsibility - The benefits to humankind from the application of nanotechnologies are as varied as the different questions that need to be addressed to establish a reliable risk-based regulatory framework. Industry has critical continuing roles to ensure responsible, safe, and sustainable use of nanoscale materials and to work with regulators and the public to establish efficient and effective risk governance of manufactured nanoscale materials.

Nanotechnology: Promises And Challenges

The marketplace for manufactured nanomaterials (MNMs) will continue to see impressive growth well into the next decade. According to BCC Research, this market could be worth $25 billion to more than $2 trillion by 2015. Benefits resulting from application of nanotechnologies are vast and varied, with promises of cleaner soil and water, cheaper energy, improved and more effective consumer products, industrial equipment, and medical tools and devices. If regulatory complexities and public acceptance of these new applications of this emerging technology can be addressed, sustainable application of MNMs in products and devices stands to revolutionize life as we know it.
However, public acceptance of nanotechnology depends on many variables. Information is needed to establish an acceptable risk-based regulatory framework. Regulatory issues are also challenging, varied, and require a life-cycle approach, beginning with minimizing exposure during manufacturing, ensuring safe consumer use, and managing disposal of MNMs to protect the environment.

Based on this uncertainty, the largest challenge now is how to apply traditional regulatory approaches or develop novel risk-based decision frameworks. Other key challenges include understanding how critical physicochemical characteristics of individual MNMs, such as surface charge, composition, size, etc., influence biological reactivity and under what conditions. Previously published approaches to understanding the risks from MNMs have ranged from more qualitative, such as the use of expert elicitation to perform a relative risk ranking, to more quantitative, which can include "bridging" to toxicity data from existing materials, such as ultrafine particles. Applications of these approaches have ranged from more theoretical and descriptive to more practical and prescriptive, such as the use of engineering controls at manufacturing facilities.

Drive For Good Governance

Regulatory oversight of nanotechnologies requires good governance based on efficient and effective regulation responding to the needs and concerns of both industry and the public. Efficient regulation exists where total benefits to some exceed total costs to others, while effective regulation maximizes compliance with minimal resources and/or requirements. Data gaps associated with emerging nanotechnologies, however, make it difficult to propose and optimize efficient and effective regulation.

To fill the data gaps, good governance should strive toward internationally harmonized regulatory practices, with sufficient flexibility, to allow innovation and product development while maintaining the protection of human health and the environment and building public trust and confidence. This requires outreach and education to familiarize the public with the safe and responsible application of nanotechnologies and their benefits. Failure to engage with stakeholders and consumers early and often can yield to precautionary bans, such as recent decisions on acceptable organic standards in the U.S., Canada, UK, Australia, and Austria.

Principles comprising good governance of MNMs are not materially different for any other emerging technology. However, differences in existing laws, even within the same jurisdiction, can have an effect on how these products are regulated and if regulatory approval is even sought.
A good example is the U.S. standard, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which was recently described as "comparatively well-suited for assessing and managing risks from pesticides, including those containing nanomaterials" and, thus offers a "greater level of oversight and a more precautionary approach than [the Toxic Substances Control Act, TSCA] and several other statues." FIFRA requires a very data-intensive registration process and, unlike TSCA, FIFRA has been used to justify an enforcement action on an unlabeled antimicrobial-treated product making a pesticidal claim. To date, only a handful of companies have even attempted to get an EPA registration for nanopesticide, the most notable was a recent decision to issue conditional approval to a nanosilver-based antimicrobial pesticide intended for textile preservation.

Fundamental needs

Before efficient and effective regulation of nanotechnology can be actualized, universally accepted "generic" definitions for MNMs are needed.
Definitions need to be broadly applicable, practical (legally clear and unambiguous), and achievable (enforceable using existing methods or easily adapted methods) - based on international consent. This is not currently the case, and it is unclear whether the existing multitude of definitions can be harmonized on the international level. For example, the lower end of the size range for nanomaterials is usually 1 nanometer (nm), but the upper bound can vary considerably, with some as high as 1,000 nm in diameter. As testament to the difficulty of this process, it should be noted that International Standards Organization (ISO TC 229) initiated work in 2005 and only recently released "Nanotechnologies - Vocabulary - Part 1: Core Terms" in 2010 (see ISO/TS 80004-1:2010).

Another fundamental need is the establishment of "essential elements" of the MNM hazard and exposure databases for regulatory needs. Currently, such databases are not publicly available for any single MNM. Equally important are developing exposure data and validating standardized approaches to measurement, interpretation, and application of such data.

Present Policies and Governance Initiatives in Europe

In the European Union, the existing legal framework contains both horizontal and vertical legislative measures, which are also applicable to nanotechnology. The horizontal measures apply to all industries and cover general fields, such as the environment, waste, chemicals or general product safety and product liability, while the vertical measures address specific industry sectors.

One of the most relevant horizontal legislation for nanomaterials is Reach, which does not specifically mention nanomaterials but covers all substances under its scope, whether in "bulk" or nano-form. For registration purposes, Reach does not consider the nano-scale forms of existing bulk substances as "new" substances. Therefore it is expected that for the first registration deadline of the high production volume (above 1,000 MT) bulk substances, relevant toxicological data for the nano-forms, manufactured in much lower quantities, will need to have been submitted by the end of November as well. Discussions whether it is necessary to update Reach and specifically address MNMs is ongoing.

There are several existing vertical directives and regulations that cover potential nanotechnology applications without specifically addressing MNMs (i.e. cosmetics, food contact uses also in active and intelligent packaging applications), and these are now individually revised and amended to specifically address nanotechnology. These amendments include several proposed definitions of nanomaterials, which collectively may lead to difficulties of compliance and with enforcement without thoughtful consideration.

The Role Of Industry

If companies wish to sell products made with or including MNMs in the global marketplace it is imperative they perform due diligence regarding product stewardship, including use of safe manufacturing practices, product testing, and assessment of potential environmental releases when products are disposed.

To ensure full knowledge of how properties can be harnessed for maximum efficacy and minimum "contamination" across a product's life cycle, "up front" thinking is required about product need, use and composition. Data available from early product development and materials research may serve quite useful to the global knowledgebase. These could be contributed under some voluntary data provision initiative similar to the former EPA Nanomaterials Stewardship Program. While it is recognized that past voluntary efforts in both the U.S. and in some EU Member States might not have met the expectations of authorities, they can "play a constructive role in nanotechnology oversight as well" if managed properly with clear consequences and practical milestones for success.

There are other novel approaches that could be taken more globally, such as the "safe harbor" approach that U.S. Food and Drug Administration has taken with its regulated community. In this case, discussion of MNM data from early in the discovery process could be crucial to the success of later data submissions and help build the necessary minimal hazard and exposure datasets. In addition, such a forum would be ideal to discuss the utility of "bridging" to existing toxicological data to satisfy certain specific regulatory requirements.

Recommendations And Conclusions

With regard to MNMs, global regulatory oversight and international harmonization of definitions, reference materials, testing strategies and risk assessment methods are needed to secure consumer trust and prevent precautionary over-reactions. Possible reactions include blanket prohibitions that impede free market movement of goods and stifle innovation in ways that can lead to trade barriers.

Industry has a role in providing regulators the necessary data and in assisting in the implementation and application of these data through transparent, participatory and collaborative policy development. Effective and efficient governance requires a wealth of data yet should include all viable existing regulatory options and voluntary measures along with mandatory requirements, and should be based on international consensus. It should be in the interest of industry to contribute towards the development of hazard and exposure databases and place safe MNM products on the market. This can drive "good" cooperative governance and ensure MNMs can be sustainably applied in the global marketplace.

References are available from the authors upon request.