Organizations Involved in Nanotechnology Regulation - dummies

Organizations Involved in Nanotechnology Regulation

By Earl Boysen, Nancy C. Muir, Desiree Dudley, Christine Peterson

The benefits of nanotechnology are just beginning to be fully understood. And so are the downsides. It is important that applications of nanotechnology be regulated smartly. Several government organizations are involved in nanotechnology regulations, as are a few non-governmental organizations. Here are a few highlights:

Government nanotechnology regulation is multi-national

The U.S. Environmental Protection Agency is developing a Significant New Use Rule (SNUR) which they state will

“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 put in place regulations to ensure that any new substance 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 whether a nanomaterial is considered a new substance.

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

The U.S. National Institute for Occupational Safety and Health has published interim guidelines for working with nanomaterials in a report titled “Managing the Health and Safety Concerns Associated with Engineered Nanomaterials.” NIOSH 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 has the responsibility of reviewing many types of new products such as food additives and pharmaceuticals. They have summarized their stance on nanotechnology and such products on the web page titled FDA Regulation of Nanotechnology Products, which you can find by going to the FDA web page and searching for regulation of nanotechnology.

Private organizations add to nanotech regulatory body of knowledge

Several nongovernmental organizations are also producing studies related to nano regulations, including the following:

  • The London School of Economics has begun a Comparative Study of Nanotechnology project in which they are studying nanotechnology policies in some countries in Asia and the European Union.

  • 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.” You can find the report on their website by searching for nanomaterials. This is only for those who are serious about their research because the report costs more than $100.

Securing the Promise of Nanotechnologies: Towards Transatlantic Regulatory Cooperation,” is a report from the Royal Institute of International Affairs. This report summarizes the approaches toward regulation of nanomaterials in the European Union and the United States in an attempt to promote trans-Atlantic cooperation and consistency in the regulation of nanomaterials.