SNURs for 17 Chemicals & Carbon Nanotubes

EPA is proposing significant new use rules (SNURs) under section 5(a)(2) of TSCA for rutile, tin zinc, calcium-doped and rutile, tin zinc, sodium-doped, and carbon nanotubes (CNTs). The proposed SNURs would designate as a significant new use the absence of the protective measures required in EPA issued consent orders.

Substances Subject to Proposed Rule EPA is proposing to establish significant new use and recordkeeping requirements for 17 chemical substances in 40 CFR part 721, subpart E.

Nanoparticles a Risk in Food?

A new study reveals that nanoparticles are being used in everything from beer to baby drinks despite a lack of safety information

Plastic imbued with clay nanoparticles helps make Miller Brewing Co. beer bottles less likely to break as well as improves how long the brew lasts in storage. Simply H's Toddler Health nutritional drink mix includes 300-nanometer (300 billionths of a meter) iron particles. And a wide range of cooking and cleaning items now employ nanosize silver particles to kill microbes.

Continued EPA Transparency: Confidentiality Removed for 150+ Chemicals

WASHINGTON – In order to ensure the public has as much information as possible about the health and the environmental impacts of chemicals, the U.S. Environmental Protection Agency has made public the identities of more than 150 chemicals contained in 104 health and safety studies that had been claimed confidential by industry. Today’s announcement is another in a series of unprecedented actions that EPA is taking to provide the public with greater access to information on the chemicals that are manufactured and used in the United States.

New Nano Titanium Dioxide Exposure Limit - NIOSH

A recently released NIOSH guidance document (NIOSH, 2011) on handling titanium dioxide (TiO2) powders in the workplace generated a high level of interest as it put forward an innovative approach that might have implications beyond TiO2. Specifically it may be the first document to recommend separate occupational exposure limits for the same material based on particle size.

Nano Educational Series Podcasts

The American Society of Mechanical Engineers (ASME) has developed a series of nanotechnology related educational podcasts. These podcasts are meant to improve technical literacy and provide information that will assist your career planning and skills development. While none of them cover TSCA, the general information should be useful to those dealing with TSCA and nano issues.

Nanomaterial Aquatic Toxicity Tests

Craig A. Calvert, Ph.D., C-CHO

Fuss & O'Neill EnviroScience

February 2011

In recent years the use of nanotechnology through the development of nanomaterials has increased rapidly. A graph of the number of papers published with nano used in the title is given below to illustrate the rapid growth from minimal pre-1990 level to a peak in 2009. The slight dip is likely due to the economic downturn. The increased use of the materials has sparked many debates over the toxicity of nanomaterials. Since size plays a large role in reactivity, groups are debating the need for regulating nanomaterials. The most likely regulation to oversee nanomaterials is EPA’s Toxic Substance Control Act (TSCA). TSCA regulates materials based on composition, and since most nanomaterials are the same composition as the bulk material, there was no immediate regulatory requirement. However, EPA has clarified that nanomaterials must follow TSCA testing requirements and reporting in Section 4 and 8. On September 17, 2010, EPA issued a significant new use rule (SNUR) notice under TSCA for single and multi-walled carbon nanotubes that are used in applications such as advanced composites, fuel cells, and electronics. www.tscaconsulting.blogspot.com/2010/09/epa-issues-final-snurs-for-carbon.html Because of the TSCA reporting requirements and the potential for increased reactivity, toxicity testing of nanomaterials is important in understanding the potential risks posed by these materials.

National Nanotechnology Initiative's Strategic Plan

The National Nanotechnology Initiative's (NNI) Strategic plan does not include any specifics on regulation of nanomaterials; however, it does mention a NNI Environmental, Health, and Safety Research Strategy that is due in "early 2011." This combined with the information gathered in the strategic plan will likely play a large role in the determining how nanomaterials are regulated. The full announcement is below along with a link to the pdf version of complete plan.

Nanomaterial Risk Analysis - Free Access

The Journal of Risk Analysis has dedicated a full issue to the topic of risk analysis of nanomaterials. I have not read the full issue, but from what I have looked over, there is a lot of interesting information. Below is a link to the online version of the journal. As of today (December 15th) you can view all the articles online for FREE.

Risk Analysis, November 2010, Volume 30, Issue 11.
© Society for Risk Analysis

Nanomaterial Case Studies and Workshop on Nanoscale Silver - EPA

The U.S. Environmental Protection Agency (EPA) announced in a December 13, 2010, Federal Register notice that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the studies as part of an ongoing process to refine a long-term research strategy to support the comprehensive environmental assessment of nanomaterials.

Nanotechnology: A Dead End for Plant Cells?

New Study Examines Nanoparticles’ Effects on Plants

Using particles that are 1/100,000 the width of a human hair to deliver drugs to cells or assist plants in fighting off pests may sound like something out of a science fiction movie, but these scenarios may be a common occurrence in the near future.

Carbon nanotubes, cylindrically shaped carbon molecules with a diameter of about 1 nanometer, have many potential applications in a variety of fields, such as biomedical engineering and medical chemistry. Proteins, nucleic acids, and drugs can be attached to these nanotubes and delivered to cells and organs. Carbon nanotubes can be used to recognize and fight viruses and other pathogens. However, results of studies in animals have also raised concerns about the potential toxicity of nanoparticles.

Characterization Necessary for Nanotoxicity?

The article referenced below points out the importance of material characterization as part of the process to determine nanotoxicity. The properties that are important are:

• Particle size and size distribution (wet state) and surface area (dry state) in the relevant media being utilized—depending upon the route of exposure
• Crystal structure/crystallinity
• Aggregation status in the relevant media
• Composition/surface coatings
• Surface reactivity
• Method of nanomaterial synthesis and/or preparation including postsynthetic modifications
• Purity of sample

The absence of such data would result in misleading information, as chemical composition or chemical formula alone is not sufficient. TSCA does not currently make such a distinction, so any changes to the regulation must take this into consideration. Please read the entire article for a more detail discussion.

EPA Issues Final SNURs for Carbon Nanotubes

EPA is issuing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances which were the subject of Premanufacture Notices (PMNs). The two chemical substances are identified generically as multi-walled carbon nanotubes (MWCNT) (PMN P–08–177) and single-walled carbon nanotubes (SWCNT) (PMN P–08–328).

This action requires persons who intend to manufacture, import, or process either of these two chemical

Nano Material Safety

These two articles discuss nano material safety.  Although not directly related to TSCA, which regulates materials before production, they are interesting to help put the nano material issue in perspective.

OTA Technology Guidance Document: Nanotechnology — Considerations for Safe Development

By: MA OTA

Taking the NanoPulse -- Toxic Substance Meets Poison Thinking

New toxics legislation aims for safe. But is it sound?

In April, the Safe Chemicals bills were introduced into the U.S. Senate and House of Representatives, designed to oveahaul the 1976 Toxic Substances Control Act, or TSCA. This is probably old news to most of you. Since your business has probably been laboring under the regulations of the Environmental Protection Agency for decades when it comes to formulations of your products, you're already anticipating what's to come -- the good, the bad and the ugly. But for those of us in the nanotechnology field, there's an additional wrinkle beyond the chemical formula of our products. Both the House and Senate version of the bill now include size, size distribution, shape and surface structure in the definition of a chemical's "substance characteristic." That means that over and above concerns about the chemical formula a nanotechnology company may be using, it may become suspect simply because of its nanoscale characteristics.

What Do We Know about Nano?

Nanotechnology involves manipulating the unimaginably small. A nanometer is about five carbon atoms in a row, or the distance your fingernail grows in one second. Matter behaves fundamentally differently at that scale, opening up new possibilities for products and processes. Nanotech is a vast emerging field of research, full of possibilities, and the media and the public are starting to take notice.

“One promise of nanotech is the idea of building molecule-sized machines to haul atoms. You could ‘grow’ anything you wanted. You could grow a house. Or a t-bone steak,” said Arizona State University (ASU) law professor Joel Garreau at a science café, “Facts or Hype: What is the Media Telling Us about Nano & Other New Technologies?” at the Arizona Science Center on March 19, 2010.

EPA Adds 6,300 Chemicals and 3,800 Chemical Facilities to Public Database

EPA has announced that it added more than 6,300 chemicals and 3,800 chemical facilities regulated under the Toxic Substances Control Act (TSCA) to a public database called Envirofacts.

The Envirofacts database is EPA's single point of access on the Internet for information about environmental activities that may affect air, water, and land in the United States and provides tools for analyzing the data. It includes facility name and address information, aerial image of the facility and surrounding area, map location of the facility, and links to other EPA information on the facility, such as EPA's inspection and compliance reports that are available through the Enforcement Compliance History Online database. EPA is also adding historic facility information for another 2,500 facilities.