International Cooperation in the Regulation of Nanotechnology

The executive branch's policy is reflected in the approach of the major regulatory agencies with oversight of products and processes that contain nanomaterials. The Food and Drug Administration (FDA), for example, regulates products containing nanomaterials under existing statutory regimes not specific to nanotechnology. Like all products within the FDA's jurisdiction, nanomaterial-containing products are regulated by the nature of the product, grouped into product classes, such as food additives, drugs, etc. Products containing nanomaterials may or may not be subjected to premarket review, depending upon the type and nature of the product. The premarket review process is generally not dependent upon whether a product contains nanomaterials, although the presence of nanomaterials could be a marker for requiring additional safety data from an applicant.

Manufacturers of nanomaterial-containing products not requiring premarket review are simply “encouraged” to consult with the FDA. To this end, the agency has provided general guidance to industry to assist in determining whether and to what extent nanomaterials are present in FDA-regulated products and to encourage the voluntary reporting and provision of data to the FDA. These guidance documents generally encourage manufacturers to consult with the agency before taking their products to market so that industry may benefit from FDA expertise on questions of safety or current regulatory status. The documents suggest that where products contain nanomaterials, companies should perform additional safety testing or resubmit such products for approval. Notably these guidance documents do not contain any mandatory directives from the FDA, and companies may consider whether to abide by the advice.

The Environmental Protection Agency (EPA) has utilized existing statutory framework, although it has issued nanotechnology-specific reporting rules. Under Section 5 of the Toxic Substances Control Act (TSCA), the EPA may determine that certain chemical substances constitute “significant new use” and may direct manufacturers, importers, or processors of such substances to submit prior notice so the EPA can review relevant data and restrict the manufacture, import, or processing of that substance if warranted. In 2011 and 2012, the EPA issued such rules for certain carbon nanostructures. The agency is proposing to require, under TSCA Sections 4 and 8, reporting of information relating to nanomaterials such as production volume, methods of manufacture and processing, exposure and release information, and health and safety data both going forward and retroactively for products already in the marketplace. In June 2011, the EPA proposed requiring that use of nanomaterials be reported under the adverse effect reporting requirement of Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act.

Canadian and European Oversight of Nanomaterials

Like the U.S., Canada oversees nanomaterials under laws existing prior to the onset of nanotechnology. Environment Canada, the department roughly analogous to the U.S. EPA, oversees nanomaterials under its existing environmental protection law, the Canadian Environmental Protection Act, 1999 (CEPA). The Act requires manufacturers
or importers of “new substances” to notify Environment Canada and provide prescribed information. Environment Canada has not adopted a specific definition or nomenclature for nanomaterials, despite early indications it would do so. Thus, it is up to individual manufacturers or importers to determine whether their substance is “new.” For guidance, Environment Canada advises that chemicals or polymers with unique structures or molecular arrangements are considered new. “Existing” substances are on Canada's Domestic Substances List (DSL). But if a substance on the DSL takes on unique structures or molecular arrangements, it must be reported under this regime. Although many nanomaterials fit these criteria, not all do. Nanoscale titanium dioxide, for example, does not require notification because its nanoscale form is deemed not to have unique structures or molecular arrangements.

Environment Canada acknowledges the challenge posed by monitoring nanomaterials under the general regime due to unique effects and behaviors and that it may be insufficient for risk assessment. It has proposed a regulatory framework specific to nanomaterials, including amending CEPA and its regulations to regulate nanomaterials specifically and retroactive application of notice provisions to products containing nanomaterials already in the market. At present, this remains just a proposal.

Health Canada, the department roughly analogous to the U.S. FDA, oversees nanomaterials under existing legislative and regulatory frameworks, including CEPA and the Food and Drugs Act. Though none of the many statutes under which Health Canada has authority explicitly reference nanomaterial, like the FDA, Health Canada regulates products containing nanomaterials by product type rather than as nanotechnology. Health Canada is requesting information from manufacturers and sponsors of nanomaterials regarding intended use and function, manufacturing methods, and characteristics and physical chemical properties. To this end, it recently promulgated a working definition of nanomaterials that does not have the force of law, but rather is for the purpose of the information gathering.

The European Union's REACH regime requires manufacturers and importers of chemicals above a certain threshold for quantity to collaborate with other manufacturers and importers of like substances for the submission of health and safety data about those substances. Such data is made public and enables the European chemicals authority to regulate the continued manufacture and importation of those substances. REACH does not explicitly cover nanomaterials as such, but does apply to nanomaterials to the extent they are regulated chemical substances generally, regardless of size.

International Divergence

Perhaps the most fundamental aspect of regulation involves the definition of what is to be regulated. Here, to the extent they have set forth definitions of nanomaterials, the various leading governmental authorities diverge considerably on definitions. Because these definitions tend to seek to encompass materials for the purpose of information gathering rather than explicit regulation, they tend to be broader than what might be expected.

International Cooperation In the Nanotechnology Oversight

In recent years, there are signs the U.S. may be looking to the international arena for information sharing on regulatory issues relating to nanotechnology and nanomaterials. In a 2011 policy statement on emerging technologies, the White House stated that the federal government should engage the international community to share data relating to the costs and benefits of regulation and oversight, communicate the U.S. approach to regulation with others, and participate in the development of international standards. In May 2012, the White House directed federal regulatory agencies to pay heed to the development of regulatory approaches through international regulatory cooperation particularly in areas of emerging technologies and to consider reforming existing regulations to address unnecessary differences in regulatory requirements between the U.S. and its major trading partners.

The U.S. approach is exemplified by its initiatives with Canada. In 2011, the U.S. and Canada formed the Regulatory Cooperation Council (RCC) for the purpose of aligning the regulatory policies of the two countries to the extent possible. The goals include increased technical collaboration, eliminating unnecessary regulatory differences, and mutual reliance on the other's standards with respect to regulatory rule-making. The belief is that such cooperation will benefit both countries by increasing efficiency, lowering costs to business and consumers, as well as promoting health and safety. The nanotechnology field is among the areas of cooperation. The two governments agreed to share information and develop joint approaches on regulatory aspects of nanomaterials including terminology and nomenclature, and risk assessment and management.

In May 2012, the RCC Nanotechnology Working Group published its plan for the following 18 months. The two countries will move towards a common statement on principles underlying policies concerning regulatory oversight of nanomaterials. They will share experiences under CEPA and TSCA in the field of nanomaterials with a view to identifying opportunities and barriers to regulatory alignment. The ultimate goal is to develop joint initiatives to align regulatory approaches to provide consistency for consumers and industry between the U.S. and Canada.

The European Commission looks to international cooperation to the extent possible in the field of regulation of nanotechnology. It has declared that international cooperation is an integral part of the Commission's policy in virtually all areas of its central plan for the development of nanotechnology and that regulatory convergence is a standing issue in the dialogues with the European Union's main trading partners. To this end, the Commission participates in the work of the OECD (Organisation for Economic Co-operation and Development) Working Party on Nanotechnology on the governance of nanotechnology; is actively engaged in the OECD Working Party on Manufactured Nanomaterials (WPMN), which develops test guidelines and strategies needed for the proper implementation of regulation; and contributes to International Organization for Standardization (ISO) and European Committee for Standardization (CEN) activities toward globally agreed standards on nanotechnology to create a basis for a convergent approach in the testing of nanomaterials.

The activities of the OECD, ISO, and CEN exemplify the international consensus toward cooperation regarding nanomaterials. The OECD's WPMN, for example, is concerned with human health and environmental safety implications of manufactured nanomaterials and works toward ensuring that the approach to hazard management meets a science-based, internationally harmonized standard. Though these entities are largely concerned with standardization as opposed to regulation, standardization is a sine qua non of regulatory convergence. These organizations include representatives of many developed and developing nations.

Conclusion

There is a good deal of activity on an international basis in the area of regulation of nanomaterials. While any international “standards” may be a way off, cooperation, at least for now, seems to be the operative factor so that approaches and regulations do not confound and slow implementation of new rules and regulations. As the terrain becomes increasingly traveled, we expect the activity will increase and the dialogue will continue to evolve.

The nanotechnology industry and other interested stakeholders have kept a keen eye on various governmental regulatory bodies regarding the regulation and oversight of nanotechnology and nanomaterials. Since the mid-2000s, such bodies have generally taken a cautious approach. They have tended to utilize existing regulatory frameworks and have generally eschewed creating new frameworks or issuing regulations specific to nanotechnology. It is unlikely that this approach will continue forever as political pressure may ultimately lead to the creation of nanotechnology-specific regulatory regimes. What will such regulation look like? What would be the parameters? What definitions may be employed? To answer these questions, we may look not only to individual country's regulatory authorities but also to international bodies and various countries' steps toward cooperation in the field of nanotechnology. This article provides a broad overview of the general approach taken by major countries in the field of nanotechnology. It also describes steps taken in international cooperation in this area and suggests possible areas of international regulatory convergence.

U.S. Oversight of Nanomaterials

It is the present policy of the United States to work within existing statutory regimes. This was made clear in 2011 when the White House indicated that existing regulatory statutes provide a firm foundation for the regulation and oversight of nanomaterials and that federal agencies presently have the authority to evaluate the safety, effectiveness, and health and environmental impacts of nanomaterials. Although the White House also stated that improved understanding of risks and benefits may allow this approach to evolve and that legislative or administrative modifications could be necessary, nevertheless it proposed no new nanotechnology-specific legislative or regulatory action and gave no indication that any action would be taken outside existing frameworks.

The executive branch's policy is reflected in the approach of the major regulatory agencies with oversight of products and processes that contain nanomaterials. The Food and Drug Administration (FDA), for example, regulates products containing nanomaterials under existing statutory regimes not specific to nanotechnology. Like all products within the FDA's jurisdiction, nanomaterial-containing products are regulated by the nature of the product, grouped into product classes, such as food additives, drugs, etc. Products containing nanomaterials may or may not be subjected to premarket review, depending upon the type and nature of the product. The premarket review process is generally not dependent upon whether a product contains nanomaterials, although the presence of nanomaterials could be a marker for requiring additional safety data from an applicant.

Manufacturers of nanomaterial-containing products not requiring premarket review are simply “encouraged” to consult with the FDA. To this end, the agency has provided general guidance to industry to assist in determining whether and to what extent nanomaterials are present in FDA-regulated products and to encourage the voluntary reporting and provision of data to the FDA. These guidance documents generally encourage manufacturers to consult with the agency before taking their products to market so that industry may benefit from FDA expertise on questions of safety or current regulatory status. The documents suggest that where products contain nanomaterials, companies should perform additional safety testing or resubmit such products for approval. Notably these guidance documents do not contain any mandatory directives from the FDA, and companies may consider whether to abide by the advice.

The Environmental Protection Agency (EPA) has utilized existing statutory framework, although it has issued nanotechnology-specific reporting rules. Under Section 5 of the Toxic Substances Control Act (TSCA), the EPA may determine that certain chemical substances constitute “significant new use” and may direct manufacturers, importers, or processors of such substances to submit prior notice so the EPA can review relevant data and restrict the manufacture, import, or processing of that substance if warranted. In 2011 and 2012, the EPA issued such rules for certain carbon nanostructures. The agency is proposing to require, under TSCA Sections 4 and 8, reporting of information relating to nanomaterials such as production volume, methods of manufacture and processing, exposure and release information, and health and safety data both going forward and retroactively for products already in the marketplace. In June 2011, the EPA proposed requiring that use of nanomaterials be reported under the adverse effect reporting requirement of Section 6 of the Federal Insecticide, Fungicide, and Rodenticide Act.

Canadian and European Oversight of Nanomaterials

Like the U.S., Canada oversees nanomaterials under laws existing prior to the onset of nanotechnology. Environment Canada, the department roughly analogous to the U.S. EPA, oversees nanomaterials under its existing environmental protection law, the Canadian Environmental Protection Act, 1999 (CEPA). The Act requires manufacturers
or importers of “new substances” to notify Environment Canada and provide prescribed information. Environment Canada has not adopted a specific definition or nomenclature for nanomaterials, despite early indications it would do so. Thus, it is up to individual manufacturers or importers to determine whether their substance is “new.” For guidance, Environment Canada advises that chemicals or polymers with unique structures or molecular arrangements are considered new. “Existing” substances are on Canada's Domestic Substances List (DSL). But if a substance on the DSL takes on unique structures or molecular arrangements, it must be reported under this regime. Although many nanomaterials fit these criteria, not all do. Nanoscale titanium dioxide, for example, does not require notification because its nanoscale form is deemed not to have unique structures or molecular arrangements.

Environment Canada acknowledges the challenge posed by monitoring nanomaterials under the general regime due to unique effects and behaviors and that it may be insufficient for risk assessment. It has proposed a regulatory framework specific to nanomaterials, including amending CEPA and its regulations to regulate nanomaterials specifically and retroactive application of notice provisions to products containing nanomaterials already in the market. At present, this remains just a proposal.

Health Canada, the department roughly analogous to the U.S. FDA, oversees nanomaterials under existing legislative and regulatory frameworks, including CEPA and the Food and Drugs Act. Though none of the many statutes under which Health Canada has authority explicitly reference nanomaterial, like the FDA, Health Canada regulates products containing nanomaterials by product type rather than as nanotechnology. Health Canada is requesting information from manufacturers and sponsors of nanomaterials regarding intended use and function, manufacturing methods, and characteristics and physical chemical properties. To this end, it recently promulgated a working definition of nanomaterials that does not have the force of law, but rather is for the purpose of the information gathering.

The European Union's REACH regime requires manufacturers and importers of chemicals above a certain threshold for quantity to collaborate with other manufacturers and importers of like substances for the submission of health and safety data about those substances. Such data is made public and enables the European chemicals authority to regulate the continued manufacture and importation of those substances. REACH does not explicitly cover nanomaterials as such, but does apply to nanomaterials to the extent they are regulated chemical substances generally, regardless of size.

International Divergence

Perhaps the most fundamental aspect of regulation involves the definition of what is to be regulated. Here, to the extent they have set forth definitions of nanomaterials, the various leading governmental authorities diverge considerably on definitions. Because these definitions tend to seek to encompass materials for the purpose of information gathering rather than explicit regulation, they tend to be broader than what might be expected.

International Cooperation In the Nanotechnology Oversight

In recent years, there are signs the U.S. may be looking to the international arena for information sharing on regulatory issues relating to nanotechnology and nanomaterials. In a 2011 policy statement on emerging technologies, the White House stated that the federal government should engage the international community to share data relating to the costs and benefits of regulation and oversight, communicate the U.S. approach to regulation with others, and participate in the development of international standards. In May 2012, the White House directed federal regulatory agencies to pay heed to the development of regulatory approaches through international regulatory cooperation particularly in areas of emerging technologies and to consider reforming existing regulations to address unnecessary differences in regulatory requirements between the U.S. and its major trading partners.

The U.S. approach is exemplified by its initiatives with Canada. In 2011, the U.S. and Canada formed the Regulatory Cooperation Council (RCC) for the purpose of aligning the regulatory policies of the two countries to the extent possible. The goals include increased technical collaboration, eliminating unnecessary regulatory differences, and mutual reliance on the other's standards with respect to regulatory rule-making. The belief is that such cooperation will benefit both countries by increasing efficiency, lowering costs to business and consumers, as well as promoting health and safety. The nanotechnology field is among the areas of cooperation. The two governments agreed to share information and develop joint approaches on regulatory aspects of nanomaterials including terminology and nomenclature, and risk assessment and management.

In May 2012, the RCC Nanotechnology Working Group published its plan for the following 18 months. The two countries will move towards a common statement on principles underlying policies concerning regulatory oversight of nanomaterials. They will share experiences under CEPA and TSCA in the field of nanomaterials with a view to identifying opportunities and barriers to regulatory alignment. The ultimate goal is to develop joint initiatives to align regulatory approaches to provide consistency for consumers and industry between the U.S. and Canada.

The European Commission looks to international cooperation to the extent possible in the field of regulation of nanotechnology. It has declared that international cooperation is an integral part of the Commission's policy in virtually all areas of its central plan for the development of nanotechnology and that regulatory convergence is a standing issue in the dialogues with the European Union's main trading partners. To this end, the Commission participates in the work of the OECD (Organisation for Economic Co-operation and Development) Working Party on Nanotechnology on the governance of nanotechnology; is actively engaged in the OECD Working Party on Manufactured Nanomaterials (WPMN), which develops test guidelines and strategies needed for the proper implementation of regulation; and contributes to International Organization for Standardization (ISO) and European Committee for Standardization (CEN) activities toward globally agreed standards on nanotechnology to create a basis for a convergent approach in the testing of nanomaterials.

The activities of the OECD, ISO, and CEN exemplify the international consensus toward cooperation regarding nanomaterials. The OECD's WPMN, for example, is concerned with human health and environmental safety implications of manufactured nanomaterials and works toward ensuring that the approach to hazard management meets a science-based, internationally harmonized standard. Though these entities are largely concerned with standardization as opposed to regulation, standardization is a sine qua non of regulatory convergence. These organizations include representatives of many developed and developing nations.

Conclusion

There is a good deal of activity on an international basis in the area of regulation of nanomaterials. While any international “standards” may be a way off, cooperation, at least for now, seems to be the operative factor so that approaches and regulations do not confound and slow implementation of new rules and regulations. As the terrain becomes increasingly traveled, we expect the activity will increase and the dialogue will continue to evolve.