Effective December 31, 2007, BSI British Standards issued "Public Document" PD 6694-2:2007, "Nanotechnologies -- Part 2: Guide to safe handling and disposal of manufactured nanomaterials." A short summary of this important standardization document follows.
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Effective December 31, 2007, BSI British Standards (BSI) issued "Public Document" PD 6694-1:2007 "Nanotechnologies -- Part 1: Good practice guide for specifying manufactured nanomaterials." A short summary of this important voluntary standardization document follows.
Effective December 31, 2007, BSI British Standards (BSI) issued "Publicly Available Specification" (PAS 130:2007), "Guidance on the labeling of manufactured nanoparticles and products containing manufactured nanoparticles." Although BSI's guidance document was funded by the UK Department of Innovation, Universities and Skills, it is only a guidance document and should not be treated as an "official" British standard.
BSI issued its guidance document because it believes "product specifications enable businesses to reliably select or avoid ingredients and other essential conditions of business such as insurance contracts. . . [and] . . . Appropriate consumer labeling is necessary to identify ingredients in nanoparticle form and to inform consumers of their presence in final products." BSI stresses at the outset that nano-labeling must take into consideration the level of consumer knowledge and understanding, and suggests applying a precautionary principle:
Lack of scientific evidence of risk should not prevent appropriate precautionary actions being take. These should be proportionate, non-discriminatory, and consistent with previous action, considering both costs and benefits and be subject to review. European Commission, Communication on the Precautionary Principle, 2 February 2000 - Com (2000) 1 Final [3]
BSI is clear that its guidance document does not apply to natural and/or incidental nanoparticles. Nor does it apply to nanoparticulates in liquid state [nanoemulsions], "unless encapsulated in a solid or gel shell." Rather, the document focuses solely on "manufactured nanoparticles," which it defines as a "solid entity with size from approximately 1 nm to 100 nm in at least two dimensions that has been produced by a manufacturing process." The guidance also covers products in which nanoparticles "are intentionally added, mixed, attached, embedded or suspended."
Reminiscent of the "Magic Nano" labeling fiasco in Germany in 2006, BSI prudently recommends that "nano" should only be used on product labels if products do in fact contain "nanoscale entities."
BSI further recommends the labeling of all manufactured nanoparticles and products using/incorporating same "except where the nanoparticulate component of the product is intimately bound and could not be released under reasonable and foreseeable conditions of use or disposal."
Getting to the core of the issue, BSI suggests that nanoproduct labels contain the following information: (i) instructions for use due to any new nanoenabled efficacy/features; (ii) instructions for any different handling, maintenance, cleaning, storage, or disposal resulting from nanoparticle content; (iii) information sufficient to allow tracing of the complete manufacturer and distribution chain for the product .
Examples of suggested labeling formats include: (i) "contains manufactured nanoparticles," (ii) "this product contains manufactured nanoparticles," (iii) "contains manufactured nanoparticles of X [chemical substance]," (iv) "this product contains manufactured nanoparticles of X," (v) "contains 0.1 g nanoparticles of X," (vi) "contains a dispersion of manufactured nanoparticles of X in Y," and/or (vii) "titanium oxide, size range Xnm - Ynm, specific surface area Zm2g-1."
Finally, BSI advises manufacturers to consider listing the following additional information in nanolabels where appropriate: (i) whether the nanoparticles are free or bound in a solid matrix; (ii) whether the product contains a mixture of various nanoparticles; (iii) whether the product has any special disposal requirements; (iv) the specific source of the nanoparticles; (v) a description of the specific function of the nanoparticles in the product; and (vi) any information necessary for safe opening of the product.
A new study published by the Project on Emerging Technologies at the Woodrow Wilson International Center for Scholars examines how public attitudes toward nanotechnology may evolve as public knowledge regarding the science increases. More specifically, the study researched how preconceived views regarding certain types of media sources may "affect public reactions to arguments about the risks and benefits of nanotechnology."
D. Kahan, et al., "Biased Assimilation, Polarization, and Cultural Credibility: An Experimental Study of Nanotechnology Risk Perceptions," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN Brief, No. 3, February 2008.
The study begins by noting that the vast majority of Americans have heard little about nanotechnology, but those relatively familiar with the science view it favorably. When supplied with information regarding the potential risks and benefits posed by the technology, individuals tend to polarize along cultural lines:
when exposed to the same body of balanced and accurate information, persons who hold relatively egalitarian and communitarian values infer that nanotechnology is risky, whereas persons who hold relatively individualistic values infer that it is not.
Thus, the study notes that dissemination of accurate information is not enough by itself to overcome long-held biases regarding credibility of information sources:
The delivery of arguments by qualified experts will not necessarily counteract this effect, and indeed could easily accentuate it, because of the tendency of persons to assign greater credibility to policy advocates who share their values and who, as a result, are likely to be espousing positions that fit listeners' cultural predispositions.
According to the authors, people "are disposed to screen information in a biased way based on its consistency with their prior beliefs or dispositions." Accordingly, the study recommends taking concrete steps to create a deliberative climate that neutralizes predisposition bias. Credibility in the public's mind depends on trust, which in turn depends on shared cultural outlooks. The study takes the point of view that risk-communication techniques are as important as the truth of the message itself. The authors believe enlightened response to sound information cannot be taken for granted, nor should the expertise of messenger necessarily be expected to generate enlightened consensus about nanotechnology's potential risks and benefits. Judgment of likeness and cultural affinity with the messenger/media communicating the information may be the most important factors in educating the public about nanotechnology.
T. Long, et al., "Nanosize Titanium Dioxide Stimulates Reactive Oxygen Species in Brain Microglia and Damages Neurons in Vitro," Environmental Health Perspectives, Vol. 115, No. 11 (Nov. 2007).
The authors of this study note nanoscale titanium dioxide is used in a variety of applications that come into contact with people and the environment: toothpastes, sunscreens, cosmetics, food products, paints, surface coatings, and in environmental decontamination of air, soil, and water.
The study was designed to test the response of human nerve cells to exposure to nanoscale titanium dioxide. The authors theorized that the particles have an unusual size and unusual properties allowing them to enter body, cross biological barriers, enter systemic circulation, migrate to tissues and organs, bioaccumulate, and cause oxidative stress and cell damage. The study used Degussa P25 which is an uncoated, photoactive, largely anatase form of nanoscale titanium dioxide -- which is "not to be confused with nonphotoactive nanomaterial currently used in sunblocks and cosmetics." The authors note that Degussa P25 is most currently used in waster treatment, self-cleaning windows, and antimicrobial coatings and paint. The study found reactive oxygen species in brain microglia exposed to nanoscale titanium dioxide under special test conditions, as well as some neuron damage in another in vitro test.
nanoSAFE is a European consortium of twenty-four academic, research, and commercial bodies concerned with nanoscale material safety which is supported in part by the European Commission through its Sixth Framework Programme for Research and Technological Development. Members include BASF, P&G, Oxford University, and other premier European organizations.
The group recently released a report on the efficacy of respirators, personal protective clothing, and gloves in protecting against potential exposure to nanoparticles in the workplace -- "Efficiency of fibrous filters and personal protective equipment against nanoaerosols," January 2008.
Three scientists from the French Energy Commission unofficially answered the question are "conventional protective devices such as fibrous filter media, respirator cartridges, protective clothing and gloves also efficient for nanoaerosols?"
The scientists first suggested that we must "[r]emove from our minds the vision of a skimmer-like behavior: only particles larger than holes tend to be stopped." Importantly, they noted that even though filter media fibers are micro-sized, they are very efficient in trapping nanoscale particles.
The study maintains that nanoparticles between 150-300 nm experience maximum penetration of filtration material, while nanoparticles smaller than 100 nm are subject to "random displacements due to Brownian motion which enhances collision probability with fibres." The scientists conclude that these random displacements make the fibrous filters even more efficient for nanoparticles.
Regarding the performance of protective clothing, the scientists found woven fabrics act similarly to fiber filter material. Nanoparticles between 100-500 nm maximum experience maximum penetration, and fabric screening efficiency increases as particle size decreases. The study also found that non-woven polyethylene textile (Tyvex) provided a superior barrier to nanoparticles than cotton and paper. Accordingly, the study suggested avoiding use of non-woven fabrics and clothing made with cotton when working with nanoparticles.
Finally, the study was less reassuring regarding hand protection. Particle penetration of commercially available latex gloves was significant in 30 to 80 nm particle size range. Thus, the scientists recommended using 2 layers of gloves when handling nanoparticles. Latex gloves from Kimberly Clark performed the best in tests along with vinyl gloves from DAK Tech. However, latex from other manufacturers performed poorly.
EPA's Office of Research and Development recently awarded $7.34 in nano-related EHS research grants to 21 recipients. The grants were awarded through EPA's STAR (Science to Achieve Results) program for the following research projects:
The European Commission recently awarded a $587,000 grant to the London School of Economics and Political Science, Chatham House, Environmental Law Institute, and the Project on Emerging Nanotechnologies, an initiative of Woodrow Wilson International Center for Scholars and The Pew Charitable Trusts to study how to promote EHS best practices and avoid trade conflicts in the field of nanotechnology. According to a Woodrow Wilson press release, the project has three goals:
Let's hope this more-than-able group of policy advocates moves beyond simply arguing "the US needs to ditch TSCA and adopt new REACH-like regulations."
NumaDerm is a new line of skin care products manufactured by efoodsafety.com in Scottsdale, Arizona. The product claims to subcutaneously deliver proprietary blend of bioactive compounds and other ingredients deep beneath the skin's surface into individual cells. efoodsafety.com claims its nanospheres "are small enough to penetrate the skin's surface" in order to deliver their active ingredients. Luckily the nanospheres that encapsulate the ingredients are biodegradable "food grade" compounds that minimize toxicity.
Evidently the folks at efoodsafety.com are unaware of the tremendous efforts the Cosmetic, Toiletry, and Fragrance Association and mainline companies such as L'Oreal have made trying to convince the FDA and the general public that nanoscale materials do not penetrate beneath the stratum corneum -- and certainly not down into subcutaneous skin layers.
ABC Science Online is reporting that two new studies on the safety of zinc oxide nanoparticles will be presented at the International Conference on Nanoscience and Nanotechnology in Melbourne, Australia on February 25-29, 2008.
In the first in vivo study, researchers applied sunscreen containing nanoscale zinc oxide particles to human test subjects and then tested blood and urine samples for several following days. Evidently, the scientists found "very little" nanoscale zinc oxide in the subject blood and urine. We will definitely take a closer look at their study once it is formally released. Finding any nanoscale zinc oxide in blood and urine samples presumably indicates at least some dermal penetration is occurring.
In a second in vitro study, researchers found nanoscale zinc oxide particles are highly toxic to human immune cells. The nanoscale zinc oxide particles were found to be more cytotoxic than silver, diesel exhaust, and silica dioxide nanoparticles -- however, a very high dose was required to cause any cellular response.
Analyzing their possible combine implications, the researches theorize that any nanoscale zinc oxide possibly absorbed by the body in the first study will be cleared by the body before accumulating to toxic levels.
This morning's New York Times features an editorial discussing Peter Barton Hutt's before the House subcommittee responsible for FDA oversight. Mr. Hutt warned that the FDA was "barely hanging on by its fingertips;" others testifying before the subcommittee suggested the agency lacked funds and staffing to do its job:
In a hearing before a House Energy and Commerce subcommittee, members of the agency’s own scientific advisory board outlined the F.D.A.’s many weaknesses. It lacks scientists who understand rapidly emerging technologies — including genomics and nanotechnology — relevant to product safety. The agency is further hobbled by a high turnover rate of scientists, a decrepit information technology system, a weak organizational structure, and a shrinking inspection force.
That said, FDA has been researching nanotechnology issues for some time -- it formed its Nanotechnology Task Force in August 2006. Still, it's interesting that nanotechnology safety issues have even found their way to the editorial page of the New York Times.
Nanotechnology was among the many hot topics discussed at this year's World Economic Forum in Davos, Switzerland. Among the five conceptual pillars for this year's Forum was the topic: "Exploring Nature's New Frontiers," which is described here. It's a nice concept, I believe, because it highlights the diverse areas -- everything from global climate change to disease eradication -- in which nanotechnology and other emerging technologies may play a role.
In addition, as reported by Nanowerk, the World Economic Forum-founded "Global Risk Network" released its 2008 annual report [1.6mb pdf] that described nanotechnology risk as a "Core Risk." Unsurprisingly, the driver for characterizing nanotechnology as a "Core Risk" appeared to be the still-preliminary state of the research into nanotechnology safety:
The report notes that studies reveal health impairment due to exposure to widely used nanoparticles (paint, cosmetics, healthcare). The primary impacts of a potential problem would be on public health, with secondary impacts on investment in a range of nanotechnologies.
It also states that increasing human exposure to nanotechnology will increase severity should an event occur, but this has to be balanced against the multiple opportunities created by nanotechnology.
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