Tuesday, August 14, 2007

RE: Nanotechnology Report of the US FDA, Jule 25, 2007 - HIGHLY RECOMMENDED

Nanotechnology: A Report of the U.S. Food and Drug Administration, Nanotechnology Task Force, July 25, 2007, http://www.fda.gov/nanotechnology/taskforce/report2007.pdf.

If you are following the debate over nanoproducts, you simply must read this report. Even if you do not agree with the conclusion, this is an important document.

The report admits "products might change repeatedly as size enter into or varies within the nanoscale range." At the same time concluding "the agency's authorities are generally comprehensive" though admitting "for products not subject to premarket authorization requirements...oversight capacity is less c0mprehensive." I have been working on a new piece that looks at the two approaches to protecting safety: standards versus screening. There was a seminal article on this subject in the Virginia Law Review by Peter Huber in 1983 entitled The Old-New Division in Risk Regulation and it might be worth re-examining as we get deeper into reforms appropriate for dietary supplements, cosmetics, and food ingredients. I hope to have a draft of this piece which I am presenting at NanoTX (http://www.nanotx.biz) in October out soon.

I have a few closing concerns relating to this report.
  • On pp. 5-6 the call on the task force included a consideration of "appropriate vehicles for communicating with the public about the use of nanoscale materials in FDA-regulated products" was completed poorly.

RE Health & SAfety Executive NanoAlert Service - RECOMMENDED

Health & Safety Laboratory, Health & Safety Executive NanoAlert Service, Issue 1, December 2006. http://www.hse.gov.uk/horizons/nanotech/nanoalert001.pdf.

The only negative thing to say about this report is that its ignores the toxicological impacts on the environment. It is about two issues: measurement, characterization, and control of exposure and potential toxic effects of nanoparticles in humans (p. 2). You might want to check the criteria for screening the search results (p. 3 and Appendix 5.2).

Regarding measurement, exposure and control, the reports selected 285 papers and categorizes them (p. 4). I was surprised and found the 11 papers on control techniques reported in the environmental waste industry worth a follow-up. The report has no qualms about stating "the instruments monitoring mass, number or surface area concentration are not capable of measuing in real-time the level of engineered nanoparticles and discriminating them from by-product aerosol entering the workplace from outside" (p. 13). I also liked the how the bibliography was presented under separate categories (pp. 18-20) adding to the value of the report as a guide for research. As this field is very challenging to me, I appreciate the effort taken to present the material usefully.

Regarding health effects, the report focuses on human effect of engineered nanoparticles. Most of the data comes from in vivo animal studies but that is to be expected. Once again, as expected, there remains too little data on translocation of nanoparticles which is not an indictment of the report just an indictment of research to date. Thanks for the bibliography (pp. 32-37).

This project should be encouraged and I am waiting for the next issue.

RE: NanoFrontiers - A Newsletter - RECOMMENDED IN PART

NanoFrontiers Newsletter should not be confused with the NanoFrontiers report published earlier this year by Woodrow Wilson/PEW and written by Karen Schmidt (reviewed elsewhere).

These newsletters are distinct from the podcasts which are also available at the Woodrow Wilson/PEW site (http://www.nanotechproject.com) which will be reviewed later.

The Newsletter is written by Mark Bello, a science fellow from Commerce who is temporary associated with Woodrow Wilson/PEW and while I have some complaints, there are relatively minor and do not indict the project or the issues.

There are two published issues to date: Nanotechnology and Low-Income Nations (Summer 2007) see www.nanotechproject.org/134 and On the Horizons of Medicine and Health Care (Issue 1, May 2007) see www.nanotechproject.org/114.

For some reason, these were not easy to open from the Woodrow Wilson/PEW site and the download frozen a few times.

The layout of the publication is strong with colorful graphics and endnotes in the left margin. In terms of the Low-Income Nations, my review has more to do with the willingness to take issue with some of the arguments and reported potentials. This complaint is hardly unique to this publication. The discussion improving health and access to care was superficial. While the data on India's Mission on Nano Science is interesting the focus of the discussion needed to be on getting developments to low-income nations. In addition, there is the never ending problem of finding a true nano-application, such as the Indian HIV and the TB diagnostic kits. At other times we read statements like "four U.S, universities are teaming up to develop micro-arrays"(p. 7) (Who are they? Where does the promotional rhetoric end and the effectiveness data begin?). Finally, the section on water hardly did justice to this issue.

On the Horizons of Medicine and Healthcare is replete with "could" and "should" claims which undercuts the validity of the claims being made. This problems haunts reviewers of nanotechnology. The sources out there are often promotional and journalists become talking head for the industry.

The entire issue of personalized medicine might sound good but the economics of the pharmaceutical industry is based on consumption of products that are ineffective. Much of the time, the drugs you take will not work for you and your physician is forced to try another compound or another mix of drugs until you can benefit on any level. Every time you use a drug that does not work, you fund the industry. Personalized treatments will be incredibly expensive to produce and may not be sufficiently profitable for the industry. This is a major issue.

I did find the Medicine issue better than the Low-Income Nations issue and believe this is a interesting project. TO BE FAIR AND OBJECTIVE, I have begun writing a series called THE CITIZENS GUIDE TO NANOTECHNOLOGY. While these guides are less glitzy, my goal was to provide a readable review of nanoscience and nanotechnology for the general public written in a registry that is common in publication like USA Today. I wrote for Knight-Ridden and am accustomed to this format. To date, we have three in internal circulation: COSMETICS, FOOD (covering food products), and NATURE (covering food production).
They will be posted on web sites at South Carolina and North Carolina State in the new month.

These Woodrow Wilson/PEW newsletters make no claims to cover the breadth of these issues. Indeed, on the cover page of each newsletter, we get "Issues will provide a sampling of recent developments..."and I can appreciate how difficult that can be. The grounds for sampling needs to be re-examined.

PLEASE CONTINUE these newsletters. They will be wonderful additions to the public clearinghouse on nanotechnology if anyone gets one of them up (which is grist for another complaint).

RE: Nanotechnology: The Future in Coming Sooner Than You Think - RECOMMENDED

Nanotechnology: The Future is Coming Sooner Than You Think. A Joint Economic Committee Study, U.S. Congress. Prepared by Joseph Kennedy, chief economist. March 2007. http://www.house.gov/jec/publications/110/nanotechnology_03-22-07.pdf.

I am recommending this short piece because we are considering including it in a reading packet given to over 2500 undergraduate students who are involved with our NUE at U. South Carolina.

It is one of the few pieces that covers the breadth of the nanodebate and is well footnoted. It takes you through the defining process and the develops in microscopy. It uses the four systems organization schema to historicize the narrative. AND it does not shy away from some of the more radical or speculative materials. We plan to use the piece as a way to generate discussion and it does this very well. You will not agree with everything found in this piece but that is fine. I know that was not the author's intent.

On p. 7, in a paragraph following the bullets, you find a critically important discussion of the peculiarities of academic disciplines and how they may not act effectively to maximize the potential of applied nanoscience. In an academic setting like mine, I can attest to these issues and find them at many other universities in the USA.

The policy discussion is introduced on p. 7 and I applaud the author for mentioning "possible long-term existential threats to mankind" (though I would have said humankind) because this is the rhetoric to which the public is exposed. Given sufficient time, I would like to do a true content analysis of rhetoric associated with the "dark side" of nanoscience. I am fairly confident that we would find that the rhetoric falls into these categories.
  1. human risks associated with toxicological properties of nanoparticles;
  2. societal risks associated with advanced molecular manufacturing (i.e., dehumanization, post-humanism, etc);
  3. other societal risks (legal, privacy, etc.); and
  4. risks to the environment.
While 4 could be a subset of 3, it behooves us to separate it because of all the negative issues associated with applied nanoscience, it is amazing how little has been written on soil and water. I remain perplexed why that is so and hope the new Center for the Health and Safety of Nanoparticles will turn this around.

On p. 18, there is a wonderful rhetorical counterfactual. "Had the development of the World Wide Web waited for a full understanding of its socio-economic effects it would probably not exist today." An interesting supposition and worth teasing out.

Congrats to Mr. Kennedy. This piece will join a handful of others in my must read reading list for an introduction to nanoscience and nanotechnology.