Thursday, June 22, 2006

On EuroBarometer 64.3

Starting with the Executive Summary.

Number in ( ) are page numbers.

Highlights -

(3) There is no evidence that opposition to GM food is a manifestation of a wider disenchantment with science and technology in general. IF TRUE, then I suspect the linkage between GM food and nanotechnology despite the claims that both did not involve substantial citizen participation.

(4) Optimism about nanotechnology has increased since 2002 - the ratio of optimists to pessimists in 8 to 1. NOT TRUE. Simply put, this is an insufficient data set to draw this conclusion beyond the difficulties associated with categorizing optimists from pessimists.

(4) Europeans support the development of nanotechnology.... Neither nanotechnology nor pharmcogenetics are perceived to be risky. IF TRUE, there are dozens of ramifications. For example, it might demonstrate risk with technology is becoming unbundled. CONCERN: there might be some bundling occurring between nano and medicine which would depress risk estimates.

(5)... [T]he majority of Europeans ... opt for the principle of scientific delegation [decisions made on scientific evidence based on expert opinion].... Of the four principle of governance, scientific delegation is associated with higher levels of optimism about technology and support for nanotechnology.... IF TRUE, slow down the participation exercises and re-examine trust research. And if the association between "scientific delegation" and optimism is valid, stop it!

On the text

(9) Surveys provide low-resolution portraits of the broad panorama. Enough said. I have a lot of problems with methodology but leaving them aside, all conclusions drawn from this research should be conservative.

(10) Figure 1 shows a relatively low level of optimism for nanotechnology only beating out nuclear energy though nearly one-half were unsure and I expect the no effect response category reflects uncertainty as well. Hence, I would claim over half. It is unclear how many respondents had opinions without understanding what nanotechnology was in which case there may be more uncertainty. [I will address the definition and the concept of uncertainty below].

(15) Definition - Nanotechnology: involves the construction of tiny structures and devices by manipulating individual molecules and atoms. This is the leading sentence and from what I know about defining categories in surveys, very few of the respondents read further and even if they did read further they discounted what they read, esp. given this full sentence. Are we talking about bots again? What follows? Some applications of nanotechnology include: turning sea water into drinking water [opti-bias with high positive valence], implantable surgical devices to measure things like blood pressure [opti-bias with high positive valence since it tags transference from other medical uses], molecules to make wrinkle resistant clothes [low opti-bias], and cosmetics that are absorbed by the skin [low pessi-bias or probably moot, though absorption is a risky term to use]. In general, the definition becomes self-fulfilling and it ignores that use of embedded nanoparticles in dozens of product lines and free nanoparticles in some remediation.

(16) Figure 3 - FASCINATING. Someone should try to explain the nanotechnology familiarity ranking. Why does Denmark, Sweden, Austria and Luxembourg rank in the top five? I will refrain from some generalization about Scandinavians. And why does Ireland rank last? The snapshot picture of results by country is disturbing.

(17) Figure 4 - While it would be nice if the negative riskiness factor was positively associated with whether nanotechnology should be encouraged, was there a multivariate analysis of the data sets? Of course as indicated on p. 18, the data reflects all responses ...for both those who say they have heard of the applications before the interview, and those who have not. As such some leading had to occur. The remark that people who knew about nanotechnology were more positive is interesting and worth investigating since it would support the anchoring heuristic in perception research and would justify a strong positive PR campaign by the industry AND SOON before opinions set [think concrete].

(19) Figure 5 is about support for nanotechnology. It is once again puzzling when attempting to determine why some nations rank higher than others and worth more research with the Czechs on top and the Irish in the dumps.

(20) Table 2 will get some spin in the media. You have 91 percent support for nanotechnology (even though about over one quarter is soft support). That still is very impressive. Here it is especially noteworthy that this data set includes responses independent on knowledge base so we are measuring an interesting multi-faceted variable here.

(82) Table 13 - optimism in new technologies. When asked whether nanotechnology would improve our way of life in the next 20 years, 70/71/68 percent support across Europe/US/Canada. This is very encouraging and dampens the excessive rhetorical flourishes by the doomsayers and recalibrates the effect of the protestations from some groups. The report continues and concludes with support for nanotechnology and regulations [an aspect I will examine later].

CONCLUSIONS -

1. Don't overclaim the results but it is cheerier than anticipated. It behooves us to note there is some general support for nanotechnology and some confidence in current regulations and regulatory authorities.

2. Don't overclaim how solid or hard fast these opinions may be. We might learn they are soft and highly vulnerable to some epiphanic event which once amplified by the media could cause this support to tumble like a house of cards [JM, I agree with GG on this]. We need to test how resilient these opinions are and how to best turn them into attitudes.

Wednesday, June 21, 2006

Veronesi study and SCIENCE and NATURE

On June 15th, Science published an article "New Nano-headache" discussing research by B. Veronesi and on the following day, not to be out done, Nature published a similar article with the less fanciful title "Nanoparticles in sun creams can stress brain cells."

The source is Veronesi's research published in Environmental Science and Technology on June 7th. In her results and discussions she makes the following claims. "...[T]hese data demonstrate that nanosize P25 particles stimulate microglia to produce ROS (reactive oxygen species) through the oxidative burst and through intefererence with mitochondrial ETC (electron transport chain). Neverthless, the microglia remained viable at all concentrations of P25....

Whether the microglia's release of ROS translates into neuronal damage in situ is not addressed in this study, but pilot data indicates P25 stimulates apoptotic ( a genetically directed process of cell self-destruction that is marked by the fragmentation of nuclear DNA) pathways in cultured neurons (she references pilot data by Long et al, in The Toxicologist 2006). It is an abstract from the SOT 2006 Annual Meeting and in it Veronesi and team claim "both FeO (zero valent iron and TiO2 (both bare and surface modified with sodium dodecylbenezene sulfonate) ... stimulated the oxidation burst in both neurons and microglia." Presumably, the microglia results were presented at the meeting. It is difficult to discern how the findings associated with this abstract better evidence the claim of neuronal damage per se. We will be looking forward to more data being published.

Based on observations made from airborne particulate matter, she argues that it is "plausible that similar physical properties of engineered nanoparticles could affect biological targets...."

Then she writes that a primary focus of nanotoxicity studies should involve defining the causal mechanisms linking the physical properties of engineered nanoparticles with biological effects which is being done in a series of studies though more funded research may be prudent.

Technically, the TiO2 may affect microglia. Microglia are phagocytic cells, generally inactive, unless confronted by some exogenous stimuli. Even Veronesi reports they remained viable though stimulated by the presence nanosized titanium oxide, even viable after 18 hours of exposure.

SCIENCE - While there may have been some oxidative stress, it is unclear how the engaged microglia translates into Noreen Park's (SCIENCE) nano-headache! Free radicals are not harmful if they activate microglia and the response chemical reactions are transitory (oxygen anions to hydrogen peroxide to H2O). Presumably, this team found that the response was more prolonged.

Park adds that prolonged exposure [to free radicals] can damage neurons which seems at odds with the language in the EST article ..."not addressed in this study." True, unless they are dispatched. Park then adds a reference to both Parkinson's and Alzheimer's as rhetorical fear tags.

NATURE - Ball (NATURE) begins his article with the caveat "[t]he research does not necessarily imply that these microscopic grains (see above) ... are harmful in the human body." And adds that size matters in many cases because size affects reactivity.

Ball's metaphor is charming. "It's a bit like releasing poison gas in a room containing invaders (microglia) and hoping (actually the process is a little less random than that) that it won't seep out into the rest of the building." While I wouldn't characterize microglia as invaders, the metaphor allows me to approach the exposure issue.

If TiO2 are problematic to microglia and neurons, they need to get there first and we have not seen anything close to definitiveness in terms of exposure pathways. Applying a sunscreen and brain damage from damaged neurons remains a major leap.

Finally Ball adds references to both Parkinson's and Alzheimer's as well. If you add that poison reference that gives him three fear tags to two from Park. He wins??

OBSERVATIONS

The last sentence in Ball's article is worth repeating here. "And there is no firm evidence that this oxidative stress could damage neurons, although Veronesia says they have preliminary results showing that titania nanoparticles can trigger cell death in neurons."

Gunter Oberdorster, a sound mind, added it was "premature to conclude TiO2 damges the brain" and care must be used in "extrapolating [the results] to live organisms."

This is not to say the research should not be taken seriously. It should and needs to be vetted and replicated and extended.

Friday, June 16, 2006

Summary of Petition from ICTA, FOE, ETC and others to the FDA

Here is summary of the petition to the FDA

The participants in the petition are -

International Center for Technology Assessment
Friends of the Earth
Greenpeace
ETC Group
Clean Production Action
Center for Environmental Health
Our Bodies Ourselves
Silicon Valley toxics Coalition

The primary six calls are (numbers are p. nos. and f refers to footnote) -

1. Calls for an advisory opinion.
2. Treat nanoparticles as new substances.
3. Label all nanoparticles ingredients.
4. Conduct of Programmatic EIS (justification 37).
5. Reopen the OTC Sunscreen Monograph and amend it to address all engineered nanoparticles as new substances (1999 monograph is inadequate and needs to be revised (51)).
6. Declare all sunscreens products will nanoparticles imminent hazards (photo-reactivity (60)) and request a recall until new drug applications submitted.

The textual arguments in the position highlight -

1. Enforcing appropriate nomenclature (8)
2. 720 products worldwide (13f) with 212 self-identified (WWC 13f).
3. Size reduction enhances intrinsic toxicity (15f, 16, 18).
4. Increased exposure levels and new routes of exposure (22f).
5. Call for predictive toxicity (see Nel 25)
6. FFDCA misbranding and mislabeling (drugs, devices, foods, cosmetics) (26-27).
7. Nanoparticles as a new class of non-biodegradable pollutants (30).
8. Laundry list of pathophysiological outcomes from exposure (59-60).

Major questions -

1. Some misrepresentation of study findings and conclusions.
2. Question of jurisdiction since labeling has shared jurisdictions between the FTC and the FDA.
3. FOE report on their own website covers cosmetics and sunscreens while the FTC petition is specific to sunscreens.

Wednesday, June 14, 2006

Are we nearing a tipping point?

Are we?

We had two products introduced and receiving a lot of negative press: Kleinmann's Magic Nano and Samsung Nano Silver Washers. In both cases (though more true of the first) there is little likelihood this is nano specific. Nonetheless, responses were nano specific.

We also have a ICTA and FOE document calling on the FDA to make an official statement on nano and act on sunscreens that include nanoparticles and are currently marketed. Just a few days ago, we have a protest in Grenoble, France, involving technology and nanotechnology specifically.

The ETC Group and our bare-assed friends from THONG have been joined in a sense by FOE and Earth First! In addition the FDA petition includes many other self-proclaimed public interest groups. The dissent sphere is becoming more colorful and animated.

The confluence of these events is instructive and I will have more to say about this very soon.

Thursday, June 8, 2006

Samsung, Silver ions and NACWA and TriTAC

The EPA’s Office of Enforcement Compliance and Assistance either has not directed the Office of Pesticides on what steps EPA need to be taken regarding silver ions in Samsung Washers or they have and the EPA will announce soon.

This was precipitated by a request by NACWA (National Association of Clean Water Agencies) [point person seems to be Norman LeBlanc]; attached is a PDF from their office, see p 10] and TriTAC (a California group with similar charge; point person seems to be Phil Bobel; attached is their letter to EPA and EPA’s response as well).

NACWA calls for life cycle analysis and sent the complaint to its Emerging Contaminants Workgroup. Tri-TAC complains of increasing silver concentrations at publicly owned treatment works though they remarks are not addressing nanoparticles per se. You have a scan of the response by the Director of the Office of Pesticides to Chuck Weir of Tri-TAC AND importantly a follow-up letter from Tobi Jones who says they are now taking a second look at their original decision to treat the Samsung washers as a device. Also, note that this regulatory effort comes under FIFRA (see below).

The product is SilverCare advertised as nano in Australia and not so in the USA. Samsung’s SilverCare washing machines are being sold of Loew’s and Best Buy here and abroad (http://www.samsung.com/au/products/washingmachines/frontloading/j1045av.asp and at this site I recommend you download the brochure) injects silver ions into the wash cycle to kill bacteria without the need for hot water or bleach. Hence, 92 percent less energy used and effluents associated with commercial bleach products are reduced as well. Hence, there is a comparative risk analysis that needs to be done.

Samsung claims the silver ions will quickly bind to organic matter and become inactive in waste. However, current treatment would remove only 50 to 90 percent of the silver. The rest remains in sludge which is commonly placed on farm land or in landfills according to Bobel.

Samsung claims to have completed five toxicity studies on water fleas, fish and earthworms and claims “minimal risk to the environment.”

Phibbs reported earlier the machine was classified as a pesticide device and not a pesticide per se. However, the petitioners want is classified as a co-pack meaning it would be both a pesticide and a pesticide device. That means the studies and tests required for marketing a new pesticide under FIFRA (Federal Insecticide Fungicide and Rodenticide Act) would need to be done. As a pesticide device there are some labeling, recordkeeping and other requirements but much less onerous than as a pesticide.

And very importantly, Maynard has already suggested that it is unclear whether the silver ions are intentionally engineered nanoparticles with any special properties that might trigger concerns noted above. The process in the washer calls for nano-shaving two silver plates and no one I know has any idea what this means and no one seems certain this has anything to do with nano.

Finally silver ions are used in brooms, food storage containers, drywall and point for surfaces to reduce mold, curtain coatings in hospitals, wound treatments, and coating for some surgical tools. LG Electronics and Daewoo are selling silver-lines refrigerators and vacuum cleaners. And the sports industry (Adidas, Polartec, Brooks Sports, ARC Outdoors) has and are ready to mount silver particles as a disinfectant for clothing. Even a Yoga company, Plank, is selling silver particles as a disinfectant in their Cor soap.