The deadline for comments about the proposed one-time effort to report nanomaterials to the US Environmental Protection Agency (EPA) is July 6, 2015. As for details, there’s a March 25, 2015 US Environmental Protection Agency (EPA) news release,
The U.S. Environmental Protection Agency (EPA) is proposing one-time reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace. “Nanotechnology holds great promise for improving products, from TVs and vehicles to batteries and solar panels,” said Jim Jones, EPA’s Assistant Administrator for Chemical Safety and Pollution Prevention. “We want to continue to facilitate the trend toward this important technology. Today’s action will ensure that EPA also has information on nano-sized versions of chemicals that are already in the marketplace.” EPA currently reviews new chemical substances manufactured or processed as nanomaterials prior to introduction into the marketplace to ensure that they are safe. For the first time, the agency is proposing to use TSCA to collect existing exposure and health and safety information on chemicals currently in the marketplace when manufactured or processed as nanoscale materials. The proposal will require one-time reporting from companies that manufacture or process chemical substances as nanoscale materials. The companies will notify EPA of:
· certain information, including specific chemical identity;
· production volume;
· methods of manufacture; processing, use, exposure, and release information; and,
· available health and safety data.
Nanoscale materials have special properties related to their small size such as greater strength and lighter weight, however, they may take on different properties than their conventionally-sized counterpart. The proposal is not intended to conclude that nanoscale materials will cause harm to human health or the environment; Rather, EPA would use the information gathered to determine if any further action under the Toxic Substances Control Act (TSCA), including additional information collection, is needed.
The proposed reporting requirements are being issued under the authority of section 8(a) under TSCA. The agency is requesting public comment on the proposed reporting and recordkeeping requirements 90 days from publication in the Federal Register. EPA also anticipates holding a public meeting during the comment period. The time and place of the meeting will be announced on EPA’s web page at: http://www.epa.gov/oppt/nano/ Additional information and a fact sheet on the specifics of the proposed rule and what constitutes a nanoscale chemical material can be found at: http://www.epa.gov/oppt/nano/
You can find more information about this project and more on the EPA’s Control of Nanoscale Materials under the Toxic Substances Control Act webpage including this about international cooperation efforts,
International organizations such as the International Organization for Standardization (ISO) and the Organization for Economic Cooperation and Development (OECD), are engaged in nanotechnology issues.
Canada-U.S. Regulatory Cooperation Council (RCC) Nanotechnology Initiative
On February 4, 2011, Prime Minister Stephen Harper and U.S. President Barack Obama announced the creation of the Canada-U.S. Regulatory Cooperation Council to better align the two countries’ regulatory approaches in various areas, including nanotechnology. As part of this initiative, a Nanotechnology Work Plan (PDF) (3 pp, 77K) was developed to increase regulatory transparency and coordination between both countries with respect to nanomaterials.
An important outcome of the initiative was the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by Canada:
- Regulatory Cooperation Council (RCC) Nanotechnology Policy Principles for Decision-Making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials (PDF) (3 pp, 38K) [Unfortunately the link no longer to the document]
The final reports from this initiative address the issues listed below and include recommendations on ways Canada and the United States can align their work on nanomaterials that are classified as new substances, regulated in Canada and the United States under the Canadian Environmental Protection Act, 1999 (CEPA, 1999) and TSCA, respectively.
Organisation for Economic Cooperation and Development (OECD)
OECD has established a Working Party on Manufactured Nanomaterials (WPMN) that is engaged in a variety of projects to further understanding of the properties and potential risks of nanomaterials:
- Testing and assessment
- Risk assessment and regulatory programmes
- Exposure assessment and mitigation
- Cooperation on the environmentally sustainable use of nanotechnology
EPA is actively participating in the Working Party and contributes to all of the projects which help leverage international expertise and resources. EPA hosted the OECD Expert Meeting on Categorization of Manufactured Nanomaterials on September 17-19, 2014, in Washington, DC. The outcome of the workshop and these OECD projects will contribute to EPA’s efforts to evaluate the potential impacts of nanoscale materials on human health and the environment.
International Organization for Standardization (ISO)
The ISO has established a technical committee to develop international standards for nanotechnology. This technical committee, ISO/TC 229, is working to develop standards for terminology and nomenclature, metrology and instrumentation, including:
- Specifications for reference materials,
- Test methodologies,
- Modeling and simulation, and
- Science-based health, safety and environmental practices.
If you wish to to make comments, you can go here to the regulations.gov Chemical Substances When Manufactured or Processed as Nanoscale Materials: TSCA Reporting and Recordkeeping Requirements webpage (keep scrolling for the instructions) or click ‘Read the proposed rule’ link on the Control of Nanoscale Materials under the Toxic Substances Control Act webpage (it’s in two different spots on the page).
H/t to Lynn Bergeson’s April 6, 2015 news item on Nanotechnoloby Now.
One final note, Canada held a similar exercise (a Canadian nanomaterial reporting plan/scheme/inventory that was announced in Jan. 2009) for which I was not able to find much information. From my April 12, 2010 post,
I was trying to reference the song, Amazing Grace, in my headline but I’m beginning to think I should be talking about invisibility cloaks. Still, glory halleluiah! I do believe I have found some information about the Canadian nanomaterial reporting plan/scheme/inventory that was announced in Jan. 2009 and which I’ve discussed elsewhere in this blog (most recently here).
What follows is all the information I was ever able to find about this Canadian initiative and all of it from an OECD document. I did try to follow up with Health Canada and have that response in my April 26, 2010 post.
Getting back to the US effort I’m glad to see it’s being made public.