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EPA Seeks Nanoscale Reporting Rule

Wednesday, April 15, 2015

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WASHINGTON, DC—Federal regulators want to know more about those teeny, tiny chemical substances now pervading paints, construction materials and numerous other products.

At up to 100,000 times smaller than the width of a human hair, nanoscale materials have become increasingly popular thanks to properties such as increased strength, lighter weight and greater chemical reactivity.

However, these minuscule substances also may take on different properties than their conventionally sized counterparts. Thus, the U.S. Environmental Protection Agency has proposed one-time reporting and recordkeeping requirements on nanoscale chemical substances already in use in the marketplace.

Collecting Information

Currently, the EPA reviews new chemical substances manufactured or processed as nanomaterials to make sure they are safe before they are introduced into the marketplace.

EPA nanotechnology

The EPA is requesting public comment on a proposed rule that would require one-time reporting and recordkeeping from companies that manufacture or process chemical substances as nanoscale materials.

Now, for the first time, the agency is proposing to use the Toxic Substances Control Act to collect existing exposure and health and safety information on chemicals already in the marketplace when they are manufactured or processed as nanoscale materials.

The proposed rule, "Chemical Substances When Manufactured or Processed as Nanoscale Materials: TSCA Reporting and Recordkeeping Requirements," was published April 6.

The EPA is requesting public comment on the proposal by July 6. Comments may be submitted via the Federal eRulemaking Portal, www.regulations.gov.

The agency also plans to hold a public meeting during the comment period. Details will be announced here.

One-Time Reporting

The proposal would require one-time reporting from companies that manufacture or process chemical substances as nanoscale materials.

According to the EPA, the proposal is not intended to conclude that nanoscale materials will cause harm to human health or the environment. Rather, the EPA would use the information to determine if any further action under the TSCA, including additional information, is needed.

Companies would be required to notify EPA of:

  • Specific chemical identity;
  • Production volume;
  • Methods of manufacturing, processing, use, exposure and release information; and
  • Available health and safety data.

10 Years, 160+ Chemicals

Since 2005, the EPA has received and reviewed more than 160 new chemical notices under TSCA for nanoscale materials, including carbon nanotubes.

nanoscale carbontubes EPA proposed rules
Images: NIOSH

Determining potential health and environmental harm from nanoscale chemicals has been the focus of numerous federal research efforts in recent years. In 2013, NIOSH recommended sharply reducing worker exposure to carbon nanotubes and nanofibers, calling them potential "cancer promoters."

By 2020, the National Science Foundation estimates that nanotechnology will have a $3 trillion impact on the global economy.

"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."

Eyes on Nano

The last few years have seen a push from federal agencies to monitor nanotechnology and develop standards for their use.

In 2010, the EPA began developing a Significant New Use Rule (SNUR) and other regulations to address potential health and environmental risks from nanoscale materials.

In 2012, the EPA and the U.S. Consumer Product Safety Commission undertook research to assess the potential impact of nanomaterials on human health and the environment.

The research was part of a larger international effort that focused on identifying the origins of nanomaterials, determining how they interact with the human body and the environment, and developing sustainable manufacturing processes.

In 2013, the National Institute for Occupational Safety and Health published guidelines that recommended limiting worker exposure to one microgram per cubic meter of air per eight-hour workday.

According to NIOSH, animal studies indicated that carbon nanotubes and carbon nanofibers potentially posed respiratory hazards and suggested that nanotubes could be a possible "cancer promoter."

Last year, the EPA announced a $10 million investment in research aimed at understanding nanomaterials throughout their life cycle. A $5 million grant was awarded to Arizona State University (Tempe), and a $4.9 million grant went to the University of California, Santa Barbara.


Tagged categories: EPA; Health and safety; Nano and hybrid coatings; Nanotechnology; NIOSH

Comment from William Gusnard, (4/15/2015, 9:23 AM)

Anybody remember asbestos when it first came. Nanotechnology is the new asbestos.

Comment from Ujjval Vyas, (4/16/2015, 7:44 PM)

Anybody remember brain cancer from cell phone use, or demonizing the MMR vaccine, or NaCl as evil? This is a highly complex area and made more so because of EPA and related agencies using the precautionary principle as a reason to fund all kinds of research with not very clear outcomes. Often enough, the selection of the organization to get the monies, in this case, Arizona State, are part of their "endocrine disruptor" bevy of researchers actively looking for demonizing various substances at levels, often below even ppb to blame for all kinds of things. Generally the data shows some fugitive correlations and on the basis of this they can get more money while serving the agenda of EPA and others that there is "some" evidence to suggest toxicity at extremely high lab dosages. One wonders why things like aerosolized pet fecal matter which pose a much large threat to babies and adults are simply ignored, but chemicals and technology are seen as the engines of evil. Nanotechnology is not the new asbestos and for those who are familiar with the asbestos issues, it is commonly known that only very specific kinds of asbestos are a concern and there was no need to ban all versions and applications. But of course for all those companies that can now eliminate certain types of competitors with the help of EPA and other regulatory agencies, all attempts to demonize asbestos or nanomaterials should be funded and supported. In the end, the continued use of false hazard analyses combined with a precautionary principle policy base leads to poor outcomes for the aggregate good. This laddered technique that EPA has deployed including funding grants to those that will create "evidence" of possible harm, then announcing a new ruling regime as in the offing, then asking for public comments (that are ignored), and finally creating a basis for regulatory control of an industry has been very successful. Witness the Prop 65 fiasco and the funding of highly questionable eco-labels such as USGBC's LEED or Energy Star. It is important for the paints and coatings industry to realize that this is a common and repeated pattern by certain types of agencies (whether during Democratic or Republican administrations) and capitulating to EPA "directed" research without strong and fundamental challenges is not useful for the industry or the public.

Comment from Glen Finkel, (4/19/2015, 4:25 PM)

Ujjval – thank you for highlighting the difference between fear based demonization of new materials and fact based science. The cost to our health and well-being from the careless over application of the precautionary principle have begun to outweigh the protection these so-called safety initiatives claim to offer. Photocatalytic nano titanium dioxide (TiO2) provides an excellent case in point. This well researched (> 50 international conferences on the use of photocatalytic TiO2 to treat air and water pollution and >40,000 scientific articles) self-cleaning and air purifying technology is nearly 50 years old. Photocatalysis is most easily understood as the light activated reversal of photosynthesis and it is that basic and fundamental. Photocatalytic TiO2 is being safely and broadly used in Japan (its birthplace) to control infection in hospitals and schools, in China to improve IAQ and reduce indoor formaldehyde levels in homes and offices, and in Europe to reverse NOx pollution and keep buildings clean. As a common mineral widely used in cosmetics, TiO2 has been extensively studied in the nano form and found to be safe when used appropriately. Studies have found no damage to humans from skin penetration. NIOSH has established RELs for respiratory exposure. Life Cycle Analyses have found this technology to be significantly beneficial to the environment. The vast preponderance of scientific evidence has found photocatalytic TiO2 technology to be a tremendous new tool for sustainability, infection control and environmental benefit and the world – outside of America – agrees. Our firm – a NASA Dual Use Technology Partner - has developed water and nano TiO2 formulations that have been tested and found safe in solution, in spray and on surface. The nano division of NIOSH tested our professional spray application for buildings and roads and found exposure levels well below their occupational REL for nano TiO2. Bureau Veritas tested our water and nano TiO2 formulation for consumer use on windows and found it to fall 97% below any reasonable No Significant Risk Level for consumers (this NSRL is 1000 times stricter than the NIOSH REL). No intermediates or dangerous by-products have ever been found – only the benefits that accrue when you use light to clean air and surfaces. In America, well-meaning groups have established RED lists of “potentially harmful” materials to protect us. In most cases – and in the case of nano TiO2 – these lists are published without any statement of acceptable levels of usage; without any balance or perspective that takes into consideration the scientific concept of dosage. Like the Black Lists of the Fifties, these RED lists make wholesale condemnations that tar and feather with too broad a brush. Any material without consideration of dosage can be deemed potentially harmful. Water is a perfect example. H2O in sufficient quantities is deadly. It’s called drowning. Photocatalytic TiO2 technology is being embraced around the world. In America, its progress – and its ability to deliver benefit - has been seriously slowed by the RED lists and the press, legislators and advocacy groups that cite them and rely on them without any scientific scrutiny or any countervailing view point or perspective. Photocatalytic TiO2 technology will prevail in America – the benefits are too compelling and the science is overwhelmingly on its side – but years of benefit will have been wasted in the process by the broad acquiescence to fear based demonization……and by the mistrust/misunderstanding of science displayed in the first comment. We need more voices like yours, Ujjval, to step up and speak rationally about how to evaluate and integrate the advances in material science we so urgently need. Thank you again.

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