Technology Law Source

Congress to Consider Nano-Liability Limits?

As discussed on this site, here and here, an idea was presented concerning liability caps on the nanotechnology industry.  Professor David M. Berube, in an article appearing in the journal Nanotechnology Law & Business, suggests that the federal government should cap liability of nanoparticle industries in an attempt to spur development.

Now, Inside OSHA reports that Congress is considering the concepts put forth by Professor Berube.  The report has the attention of Senator Mark Pryor (D-AR), chairman of the subcommittee overseeing product safety and the insurance industry.  While Senator Pryor’s office has not commented on the report, inside sources confirm that he is reviewing it.

MEH:  As John and I discussed, final enactment of such limits may be premature given the infancy of the nano-industry.  While a liability cap may help develop nano related businesses, it raises questions concerning how lawmakers are treating workplace safety and the message sent to the public at-large.  While Congress should consider all feasible alternatives in developing legislation, especially for nanotechnology, legislation limiting liability should be thoroughly considered before acting.

Canary In A Coal Mine?

In support of a proposal for a dramatic increase in federal funding for nano-related EHS research, a top nanoscientist was recently quoted as saying:  "Workers are society’s canaries-in-the-coal mines when it comes to the environmental, health and safety effects of new materials — and nanoscale materials are no different."  Inside OSHA, Vol. 14 No. 2, January 22, 2007.

JCM:  This analogy misses the mark in my book.  Workers are the often first to face exposure to health risks from new technologies, and often also experience exposure at higher rates than the rest of the population.  However, the canary concept could be misconstrued as implying nano-companies are indifferent to possible worker exposure and will only take action once the canary gets sick or dies. 

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Dermal Uptake of Nanoparticles

North Carolina State and Rice University researchers recently published the results of their in vivo skin penetration experiments using fullerenes on pig skin. The researchers tested fullerene penetration on stationary skin and skin that was flexed for an hour or an hour and a half. They found the longer the skin was flexed, the greater and deeper the particle uptake. Additionally, they found greater uptake 24 hours after flexion than that measured eight hours after flexion. N Monteiro-Riviere, et al., Nano Letters, American Chemical Society, January 10, 2007.

It is interesting to compare the Cosmetic, Toiletry and Fragrance Association’s October 10, 2006 "Nanotechnology White Paper: The Use of Nanotechnology in Personal Care Products," (maintaining scientific evidence confirms a lack of dermal absorption of nanoparticles), as well as recent efforts by the Pharmos Corporation to develop a dermal drug delivery nano-emulsion

Monica To Speak On Pre-emptive Regulation

I am pleased to announce that John Monica will be speaking on "The Possible Adverse Consequences of Pre-emptive Nanotechnology Regulation" at the two-day conference and workshop, Regulations for Nanotechnology in Consumer Products, February 8-9, 2007, Washington Marriott, Washington, D.C.  This conference is aimed at those interested in doing more than simply scratching the surface of nanotechnology regulatory concerns.  A copy of the preliminary agenda can be found here.

Speakers will include:

  • Dr. Linda Katz, M.P.H., Director, Office of Cosmetics and Colors, FDA, US
  • David Rejeski, Director, Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars, US
  • Dr. Peter Hatto, Chairman International Standards Committee (ISO)TC229 Nanotechnologies, Director of Research, UK
  • George Kimbrell, Staff Attorney, THE INTERNATIONAL CENTER FOR TECHNOLOGY ASSESMENT, US
  • Dr. Christoph Meili, CEO, THE INNOVATION SOCIETY, Switzerland
  • Christopher Murray, Manager, Nanoscale Materials and Devices, IBM, US
  • Ruben Serrato, Managing Editor, NANOTECHNOLOGY LAW & BUSINESS and Venture Partner, TEL VENTURE CAPITAL, US
  • Dr. Kristen M Kulinowski, Executive Director for Education and Public Policy, Center for Biological and Environmental Nanotechnology, Director, International Council on Nanotechnology (ICON), Rice University, US
  • Dr. Brent Segal, Co-Founder and CEO, NANTERO, US
  • Dr. Sandy Weinberg, VP Regulations, Tikvah Therapeutics, US
  • Dr. Justin Teeguarden, Senior Research Scientist, PACIFIC NORTHWEST NATIONAL LABORATORY, US
  • Alan Gotcher, CEO, ALTAIRNANO, US
  • Matt Hull, Principal Investigator, LUNA INNOVATIONS INC, US
  • Dr. Annette Santamaria, Senior Manager, ENVlRON INTERNATIONAL CORPORATION, US
  • Alissa Havens, Communications Director, DITTUS COMMUNICATIONS, US

Conference: Regulations for Nanotechnology in Consumer Products — Presentation: The Possible Adverse Consequences of Pre-emptive Nanotechnology Legislation. February 8-9, 2007.

Conference: Regulations for Nanotechnology in Consumer Products —  Presentation: The Possible Adverse Consequences of Pre-emptive Nanotechnology Legislation.  February 8-9, 2007.

Washington Marriott, Washington, D.C.

Register online at www.intertechpira.com or call (207) 781-2150.

The Week(s) In Review

Ed. note: every Friday (more or less) Nanotechnology Law Report’s David Fischer will look back at the week’s news and analysis of nano related issues.  If you have something you’d like to bring to our attention, email him

There was no Week In Review last week (let’s blame the three day weekend, shall we?), so this week we a have special double-stuffed, two week review.  Let’s get started:

Nano-Insurance Underwriting Challenges

Robert Blaunstein recently published an article in Insurance Networking News: “Unfamiliar Exposure: Nanotechnology deals in tiny particles, but its potential risk to insurers is sizable and nearly impossible to calculate.”   The article begins by noting the "enabling" role the insurance industry has often taken with new technologies. Dr. Blaunstein argues this "enabling" function is fulfilled by when insurance companies help businesses manage product risks. In order to play this role with the nanotechnology industry, Dr. Blaunstein argues insurers need to better understand nanotechnology and “have access to accurate data and information that permit a questionable evaluation of the probability and severity of losses.”  He also advocates government regulation over the use and disposal of harmful nanomaterials.

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Inhaled Nanoparticle Research

For us non-scientists, a useful rule of thumb in inhalation toxicology is the finer the substance, the greater the possibility for adverse health effects — and vice versa. Preliminary studies indicate this may hold true for nanoparticles which have been shown to have fewer potential adverse health effects when they occur in cluster form (aggregates and/or agglomerates).  In the "good news" department, scientists studying aerosol dispersion of nanoparticles have found they tend to cling together when dispersed into the environment.  Curious scientists ask logical follow up questions:  What happens to these nanoclusters if they somehow make it into the lung? Do they react with the body and end up breaking back down into smaller (and theoretically more toxic) sizes?

A new study by four German researchers makes some in-roads on these questions. M. Maier, et al., “Does lung surfactant promote disaggregation of nanostructured titanium dioxide?,” Journal of Occupational and Environmental Medicine, Vol. 48, No. 12 (December 2006). 

Maier looked at the theoretical interaction between the primary substance found in lung wall lubricant/fluid — dipalmitoyl phosphatidylcholine (DPPC) — and titanium dioxide nanoclusters to determine whether DPPC facilitates their breakdown into smaller sizes. Apparently, it does not. The researchers conducted two tests to reach this conclusion.  The first used computer simulation to determine that the DCCP did not have enough energy to break the bonds between individual nanoparticles in the clusters.  In the second test, the researchers exposed titanium dioxide nanoclusters to a simulated biological lung fluid containing DPPC.  The test results showed no disaggregation in the clusters from exposure to increasing amounts of DPPC, nor did it show any time dependent disaggregation.

The authors “conclude that DPPC only covers [titanium dioxide] aggregates and agglomerates instead of splitting them, i.e., lung surfactant does not promote the disaggregation of [titanium dioxide] agglomerates and aggregates."

American Public Health Association Adopts Nano-Policy

The American Public Health Association (APHA) recently held its 134th annual meeting in Boston, Massachusetts, at which it adopted policies addressing 22 important public health issues, including nanotechnology.  APHA’s key policy recommendations are:

  • Increase federal funding for nano-related EHS research to $100 million.
  • Encourage the voluntary participation by nanomanufacturers in the (i) collection of nano-related safety data and (ii) prevention of human and environmental exposure unless positive information exists to show it is safe.
  • Have federal agencies (i) require the collection and submission of workplace and environmental safety data by nanotechnology businesses/manufacturers; (ii) recommend interim risk management measures; and (iii) "assure the education, health and safety of workers, consumers and the general public through promulgation of protective standards and regulations."

 

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