New Edition of Nanotechnology Law Report

Posted on July 23, 2009 by John C. Monica, Jr.

Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

  • EPA Issues Significant New Use Rules for Carbon Nanotubes
  • Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
  • Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
  • Are Nano Consumer Products Headed Underground?
  • Oversight of Next Generation Nanotechnology
  • Regulating Nanotechnologies
  • More Interesting Nano-Regulatory Developments
  • Nano Tug of War
  • Pumpkins & Nanoparticles
  • Green Nano
  • NanoBiotech 2009
  • Take two silver nanoparticles and call me in the morning
  • International Approaches to the Regulatory Governance of Nanotechnology
  • ETUC Resolution on Nanotechnologies and Nanomaterials
  • Private Spending on Nano Exceeds Government Spending
  • EMERGNANO Released
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Nano Insurance Conference

Posted on July 21, 2009 by John C. Monica, Jr.

Chubb Insurance is hosting a one-day nanotechnology insurance conference on October 13, 2009 in North Branch, New Jersey:

"Nanotechnology: What is the Best Safety and Risk Management Approach?" 

From the conference website:

"This conference brings together prominent nanotechnology speakers who will review nanotechnology background, health and safety, and potential insurance and liability issues. Current risk assessment and 'best practice' controls will be shared, helping attendees better recognize and manage potential nanotechnology risks. A nanotechnology toolkit will be provided to help attendees stay abreast of critical developments in this dynamic field."

Speakers include: Charles Geraci (NIOSH), Charles Kingdollar (General Reinsurance Corp.); John Monica (Porter Wright); Susan Berry (DRS Technologies); Ganesh Skandan (NEI Corp.); William Barr (Chubb); Erik Olsen (Chubb); and Louise Vallee (Chubb).

More from the conference website:

Emerging risks require new risk management practices. Nanotechnology applications have outpaced safety and health research. The big challenge is trying to figure out a risk management roadmap when there is a scientific and regulatory abyss with the potential for future litigation looming in the distance. Companies that delay nanotechnology innovation awaiting safety consensus or regulations risk falling behind the competition. While these tiny materials and processes are big business, many risk managers and insurance buyers haven’t fully considered potential risks to employees, consumers and the environment, resulting in workers compensation, product liability and environmental liability exposures. Company risk managers and insurance buyers would value and benefit from knowledgeable broker and agent guidance. Application and control strategies considered now may have far-reaching future implications.

Nano insurance issues have received a lot of renewed interest lately.  This should be a great conference on the topic and is open to the public.  Hope to see you there.

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Nanotechnology Law Report -- Spring 2009

Posted on April 21, 2009 by John C. Monica, Jr.

Nanotechnology Law Report -- Spring 2009

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NIOSH Guidance on Workplace Exposure

Posted on December 17, 2007 by Michael E. Heintz
The National Institute of Occupational Safety and Health (NIOSH) has just today released in "Interim Guidance for the Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles."  Before now, NIOSH was keeping mostly quiet on the issue of nanoparticles, and this report gives some insight into the agency's consideration of the issues.

You may remember that NIOSH last made news concerning nanotechnology when it publicly disagreed with EPA's determination to not treat nanoparticles as "new" chemicals under the Toxic Substances Control Act based on size only.  A review of that item appears here.

Today, NIOSH released its 35-page Current Intelligence Bulletin, and is also seeking comments concerning recommendations on exposure registries for nanoparticles.  However, like other agencies, NIOSH determined that there is not enough data to proceed to full regulation.  The Bulletin states, "Although increasing evidence indicates that exposure to some engineered nanoparticles can cause adverse health effects in laboratory animals, no studies of workers exposed to the few engineered nanoparticles tested in animals have been published.  The current body of evidence about the possible health risks of occupational exposure to engineered nanoparticles is quite small.  Insufficient scientific and medical evidence now exists to recommend the specific medical screening of workers potentially exposed to engineered nanoparticles." (emphasis original).  NIOSH even provides information on the limited data in Appendix D of the Bulletin.  However, the report is quick to point out that employers should not be precluded from considering "taking precautions beyond standard industrial hygiene measures."

The Bulletin provides insight into NIOSH's thoughts about nanotechnology, including its definition of nanotechnology, which had previously been mostly unknown.  Because NIOSH admits to the shortcomings in the available data and information, it is expected that more will be forthcoming from the agency.  In the meantime, however, NIOSH makes some simple recommendations for nanoparticle protection, including controlling exposure to nanoparticles, conducting hazard surveillance for implementing controls, and establishing medical surveillance to evaluate the effectiveness of any controls.
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NIOSH Urges EPA to Treat All Nanoscale Materials as New Chemical Substances Under TSCA

Posted on October 2, 2007 by John C. Monica, Jr.

New chemical substances that are not on EPA's existing Toxic Substances Control Act (TSCA)chemical inventory are subject to premanufacturing notice and approval requirements.  Many NGOs have urged EPA to treat all nanoscale materials as new chemical substances under TSCA because of potential environmental, health, and safety concerns shown in laboratory settings.  Such treatment would trigger TSCA's premanufacturing notice and approval requirements.  This past July, EPA indicated it did not currently intend to accept this approach because it considers "new" chemicals as those that have molecular identities that are not reflected on the inventory.

 

On September 7, the National Institute of Occupational Health and Safety (NIOSH) submitted written comments on EPA's new Nanoscale Materials Stewardship Program in which it urged EPA to change its position and treat all nanoscale materials as new chemical substances under TSCA. In support of its position, NIOSH suggested that "EPA consider particle size . . . in its decision criteria for determining if a nanoscale material is considered a new chemical for the TSCA Inventory. Reducing the particle size to the nanoscale can result in unique or enhanced properties of the nanoscale substance, which can also alter or increase the biological activity and potential toxicity. Thus, the hazard potential of a nanoscale form of a substance may differ substantially (qualitatively and/or quantitatively) from the parent/bulk material that may be listed on the Inventory."
This sets up a possible showdown between EPA and NIOSH on the future treatment of nanomaterials under TSCA. Stay tuned.

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NIOSH Guidance For Nanotechnology Employers

Posted on December 15, 2006 by Michael E. Heintz

By, Jaime T. Landrum:

As the impact of nanotechnology grows, more companies are considering the utilization of nanotech products and processes in the workplace. Questions regarding nanotechnology's effect on the American worker, however, come side-by-side with these business decisions. As reported at Occupational Hazards, The National Institute for Occupational Safety and Health (NIOSH) is expected to issue guidance for employers facing these problems.

Doug Trout, Associate Director for Science for the Division of Surveillance, Hazard Evaluations and Field Studies discussed this issue at the International Conference on Nanotechnology Occupational and Environmental Health and Safety last week. According to the article, NIOSH will recommend that all nanotechnology employers implement an occupational health surveillance program designed to help employers evaluate the risks and necessary protections resulting from nanotechnology's use. The necessity for such guidance is apparent, considering "the growth of nanotechnology in the workplace, the unique physical and chemical properties of nanomaterials and early evidence suggesting that 'nanoparticles may have toxic effects greater than larger-size particles and at lower doses.'"

For those unaccustomed to the field of occupational health, the article explains that an occupational health surveillance program includes hazard surveillance and/or medical surveillance. These two components are designed to identify and monitor workplace hazards and occupational health problems.

The first step in any health surveillance program is a needs assessment. NIOSH intends to provide a needs assessment framework for employers, including recommendations for the evaluation of various risk factors. We know, however, that the needs assessment will contain a hazard assessment and an exposure assessment. The article quotes Trout as stating "The purpose of this needs assessment in an occupational setting is to determine – by performing hazard and exposure assessments – whether a health risk due to occupational exposure [to nanomaterials] exists in the workplace."

As most employers already realize, the research on the risks and effects of nanotechnology is still evolving. Trout is quoted as acknowledging that "information may not be available to make a well-informed determination of risk." For that reason, "periodic reassessment" will be of vital importance in the workplace.

Even NIOSH cannot provide definitive answers to nanotechnology employers- at least not yet. Everyone agrees, however, that the use of nanotechnology may pose a significant risk to employees. The NIOSH guidance will provide some welcome relief to employers struggling to understand what the dangers of nanotechnology are and how to avoid them.

For the full article, see here.
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NIOSH to Test Certified Respirators

Posted on November 14, 2006 by John C. Monica, Jr.

The National Institute of Occupational Health and Saftety's (NIOSH)National Personal Protective Technology Laboratory (NPPTL) at NIOSH recently announced it intent to test currently certified repirators to determine whether they protect wearers against nanoparticle inhalation.  The NIOSH testing follows up on a University of Minnesota study pointing to the effecacy electrostatically charged filters in screening out nano-sized particles.  NPPTL also intends to conduct tests to determine whether nanoparticles will penetrate approved personal protective clothing.  Along with its announcement, NPPTL also noted that there are currently no specific exposure limits for nanoparticles, and that the decision to wear repirators is left to professional judgment. 

Inside OSHA, November 13, 2006, Vol. 13 No.23.

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