Regulation of Nanotechnology Materials and Products

The lead in your pencil is a larger scale or bulk version of carbon that has different properties than carbon nanotubes and buckballs, even though all three share the same chemical composition. Because these bulk versions of materials  are not considered hazardous, many regulatatory agencies did not initially put in place different regulations on the use  nanosized versions of the same substances. However, because nanomaterials can have significantly different properties than the bulk form of the same material, governments are now evaluating special regulations for their use. The  bottom line is, different rules regarding the safe manufacture and everyday materials and their nano counterparts may be necessary.

The regulations governing nanomaterials will be evolving over the next several years, the summaries below give a snapshot of this process in its early stages.

Nanotechnology Regulation: Government Efforts

There is much government interest in regulating nanotechnology. Here are a few highlights.

The U.S. Environmental Protection Agency (EPA) is developing a Significant New Use Rule (SNUR) to: 

"ensure that nanoscale materials receive appropriate regulatory review. The SNUR would require persons who intend to manufacture, import, or process new nanoscale materials based on chemical substances listed on the TSCA (Toxic Substances Control Act) Inventory to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before commencing that activity. The SNUR would identify existing uses of nanoscale materials based on information submitted under the Agency's voluntary Nanoscale Materials Stewardship Program (NMSP) and other information.

The SNURs would provide the Agency with a basic set of information on nanoscale materials, such as chemical identification, material characterization, physical/chemical properties, commercial uses, production volume, exposure and fate data, and toxicity data. This information would help the Agency evaluate the intended uses of these nanoscale materials and to take action to prohibit or limit activities that may present an unreasonable risk to human health or the environment."

Canada has regulations to ensure that any new substance being manufactured in Canada or imported into Canada undergoes a risk assessment of its potential effects on the environment and human health.  Environment Canadian has issued guidelines to help determine if a nanomaterial is considered a new substance.

The European Union is implementing a new Classification, Labeling and Packaging (CLP)Regulation. CLP includes the requirement that if the form or physical state of a substance is changed, an evaluation must be done to determine if the hazard classification should be changed. This could result in a different classification and labeling requirements for bulk forms and nano forms of the same chemical substances. The documents for CLP indicate that the classification and labeling of nanomaterials will be done on a case-by-case basis.

The EU has also published a directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment that includes the following statement:

" As soon as scientific evidence is available, and taking into account the precautionary principle, the restriction of other hazardous substances, including any substances of very small size or with a very small internal or surface structure (nanomaterials) which may be hazardous due to properties relating to their size or structure, and their substitution by more environmentally friendly alternatives which ensure at least the same level of protection of consumers should be examined."

The U.S. National Institute for Occupational Safety and Health (NIOSH) has published interim guidelines for working with nanomaterials; Managing the Health and Safety Concerns Associated with Engineered Nanomaterials and has created a Nanotechnology Field Research Effort to "assess workplace processes, materials, and control technologies associated with nanotechnology and conduct on-site assessments of potential occupational exposure to a variety of nanomaterials."

The U.S. Food and Drug Administration (FDA) has the responsibility to review many types of new products such as food additives and  pharmaceuticals. They have summarized their stance on nanotechnology and such products in the report FDA Regulation of Nanotechnology Products. The FDA has also released a draft document that, when finalized, is intended to "to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products."

Nanotechnology Regulation: Industry  and University Efforts

Several organizations are currently working on nano-regulations, including:

Regulating Nanotechnologies in the EU and US. This is a study being preformed by the London School of Economics, the Environmental Law Institute and other organizations that will result in recommendations on how to have uniform regulation of nanomaterials in the European Union and United States.

The International Organization for Standardization (ISO) has published a report called; Nanotechnologies – Methodology for the classification and categorization of nanomaterials  that is intended to "promote clear and useful communication amongst industry consumers, governments and regulatory bodies."

Nanotechnology Regulation: Reports

Here are several interesting reports you can read to learn more about what's going on with regulations for use of nanotechnology:

Securing the Promise of Nanotechnologies: Towards Transatlantic Regulatory Cooperation This report from the Royal Institute of International Affairs summarizes the approaches toward regulation of nanomaterials in the E.U. and the U.S. in a attempt to foster trans-Atlantic cooperation and consistency in the regulation of nanomaterials.

Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges This is a report to the United States Congress on regulatory challenges for nanomaterials.

Draft Nanomaterial Research Strategy An EPA strategy covering research needed to address environmental risks of nanomaterials.

Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials A report by the National Science and Technology Council.

Managing the Health and Safety Concerns Associated with Engineered Nanomaterials A report by the National Institute for Occupational Safety and Health (NIOSH).