ON Albert Lin, "Size Matters: Regulating Nanotechnology", UC Davis Legal Studies Research Paper Series, Research Paper 90, October 2006. MILDLY RECOMM

Albert Lin, "Size matters: Regulating nanotechnology," UC Davis Legal Studies Research Paper Series, Research Paper No. 90, OctoBer 2006 http://ssrn.com/abstract=934635 - MILDLY RECOMMENDED for a good discussion of bonding.

This is just another regulatory option. Davies wants onerous regulations. Marburger et al want the status quo. I want a hybrid regulation, liability and insurance system. Lin wants a hybrid labeling and bonding scheme.

First, there is little new here and the definition (p. 6) used for nanomaterials is size specific only which demonstrates little understanding of the complexities involved in defining alone. In terms of exposure, the author comments "Intake of engineered nanomaterials is likely to occur through various routes, including inhalation, ingestion, absorption through the skin, and injection" (p. 10) and footnotes Oberdorster (2005) when likeliness was not made by the Oberdorster. He continues nanoparticles "may penetrate the epidermis" (still unknown) and "may cross the blood brain barrier" reciting the rodent olfactory study.

While I am unconvinced all nanoparticles are safe, I an equally unconvinced all are dangerous. The author turns to cytotoxicIty studies without examining the exposure variables (like too many of my peers).

Second, he claims "harmful effect from real-world exposures have bee difficult to track" (p. 13). This is true, but until epidemiologists can survey exposed graduate students who had access over the last two decades, we will never know. He, then, returns to the Magic Nano story (which I recently detailed ad nauseum in the upcoming issue of Nanotechnology Perspectives) and notes that it was unclear whether the sealant "actually contained nanomaterials" (p. 14) when the consensus is clearly it did not.

Third, when reviewing TSCA and its role in reviewing nanomaterials he claims "yet as of October 2005, EPA had reviewed just one application under TSCA to make a product composed of nanomaterials" (pp. 18-19) when they have reviewed clearly more than a dozen and approved a dozen as well. When reviewing OSHA, he claims the Act "is an ineffective means of protecting workers" (p. 27) and cites three sources none of which are discussing nanoparticles in the work place, a typical division fallacy - The object O has the property P. Therefore, all of the parts of O have the property P.

Fourth, he appropriates the simile of GMOs "as a mistake for the nanotechnology to avoid" (p. 33) and while Lin-Easton may have found parallels the quality of this simile has been blown out of proportion and has become a rhetorical flourish that is misused and abused to draw hysteria about all things nanotechnological, and, if you have not noticed, this needs to be vetted (something I am ready to do some day soon).

Finally, his proposal does not necessarily flow from the antecedents of his argument. His solution (p. 52) involve requiring legislation such that "all products containing nanomaterials would be subject to mandatory notification and labeling requirements" (p. 52). He adds a second layer of regulation. "Products containing free nanomaterials, however, also would be subject to a screening process, post-market monitoring, and bonding requirements" (p. 53). In terms of notification, he is calling for a process similar to the premanufacture notice under TSCA. His labeling requirement has two elements: the label and information comparing the nanomaterial to the bulk version of the same material.

On notification, there would be more reporting and the process could be sufficiently onerous to foster technological paradises outside of the reach of American regulatory power. In addition, notification is meaningless without some implications. This brings us to labeling which is a bugaboo of its own. Labels need to be read. Labels need to be understood. Labels need to provide information without necessarily producing fear and labels tend to establish a reasonably high level of trepidation, if not distress, and translates into a broad series of purchasing phenomena from refusal to purchase because of the mere presence of a label regardless of the valence level or constituents of the message to outright ignoring the label altogether. There is even some evidence consumer never make it past the first word or two on the label. Finally, how to craft a message comparing bulk magnesium oxide to nanoized magnesium oxide for a label is an incredibly difficult task with limited utility.

In terms of premanufacturing notices, that is the status quo. In terms of monitoring, that is not though most companies will attempt to reduce both their liability and insurance rates by keeping an eye on their product and how the public interacts with it.

The bonding proviso seems like more administrative bureaucracy when the insurance industry already does this by assuming liability by establishing a rate for coverage. While the author claims "the tort system discourages manufacturers from undertaking toxicological research because the discovery of adverse effects may lead to liability" he is exaggerating the conclusions from the late 1980s work by Lyndon and Perrin. He admits (p. 64) serious limitations involving "moral hazard, liquidity restraint's, observability, adequacy, and administrative costs." Though he suggests "procedural mechanisms can also be put in place to limit the potential of abuse' (p. 65) I remain unconvinced. I am also unconvinced that start-ups will have the wherewithal to post bonds of the nature envisioned by the author. His response to this involves pooling risk at which point this proposal becomes little more than an insurance option (which I wrote about the the next issue of Nanotechnology Law and Business Journal (I expect a lot of critical debate from some of my recommendations as well).