Comment submitted by L. Hepting, Beyond Pesticides

Beyond Pesticides ? Center for Food Safety ? Friends of the Earth US ? Friends of the Earth Australia ? International Center for Technology Assessment April 23, 2007 Office of Pesticide Programs Regulatory Public Docket (7502P) U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington DC 20460-0001 Re. EPA-HQ-OPP-2006-0175 Pesticides; Food Packaging Treated with a Pesticide To Whom It May Concern: We the undersigned organizations jointly file these comments opposing the proposed EPA rule change. We have also requested a public comment period extension to the current truncated two week period for comment. We raise two specific concerns with this proposed rule change. First, this proposal categorically eliminates protections to children and infants provided by the Food Quality Protection Act (FQPA). Second, this proposal can significantly impact EPA oversight of nanosilver and other pesticides. We request EPA withdraw this proposed rule change. We also request EPA to clarify and properly assess the effects of the proposed rule on food packaging products impregnated with pesticides, especially nanosilver and other biocides. Background The Food Quality Protection Act of 1996 (FQPA) significantly amended both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) by mandating that health-based and child-protective standards drive decisions about acceptable levels of pesticide residues in food. Section 408 of FFDCA, as amended by the FQPA, authorizes EPA to set maximum allowable levels ? or tolerances ? for pesticide residues in food, or to grant exemptions from the requirement to have a tolerance. Accordingly, any pesticide chemical residue in or on food is deemed unsafe, unless EPA has established a tolerance or tolerance exemption that covers the pesticide chemical residue. A tolerance must be based on the determination that there is ?a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.? FQPA specifically requires that EPA, in establishing a tolerance, must assess the risk that it poses to infants and children in particular. In contrast, section 409 of the FFDCA regulates food additives, including food contact substances such as food packaging, and does not explicitly require that FDA assess potential risks to children and infants. On April 6, 2007, EPA proposed ?to give FDA sole jurisdiction under section 409 FFDCA over the packaging components of food packaging materials that have been treated with a pesticide by exempting these materials from the definition of ?pesticide chemical? and ?pesticide chemical residue.?? The proposed change applies to ?pesticide-treated food packaging that is distributed or sold with the purpose of controlling pests.? More specifically, the change will affect the regulation of treated package materials ?sold for the express purpose of providing ongoing protection from pests that may contaminate the products made with the treated packaging.? The Proposed Rule Exposes Infants and Children To More Pesticides Under EPA?s proposal, certain food packaging products treated with pesticides could no longer be required to comply with the FQPA tolerance requirements. As such, this proposed rule will allow certain substances to avoid the stringent risk assessment requirements of the FQPA to the detriment of the most vulnerable populations. The FQPA is the most direct and strongest protection for infants and children from the toxic effects of pesticides. Under the FQPA, Congress mandated that EPA apply an additional tenfold margin of safety to protect infants and children, based on the findings of the National Academy of Sciences 1993 Report. In other words, EPA must set the safe level of pesticide exposure for children at one-tenth the safe level for adults. This margin of safety is required by law to account for several matters: children?s exposure to pesticides, children?s vulnerability to pesticides, and the lack of complete data on both exposure and vulnerability. EPA can depart from this children?s safety factor only if ?reliable data? confirm that a different factor will be safe. EPA?s proposal to shift food packaging materials treated with pesticides from the more protective section 408 to the weaker section 409 of the FFDCA is an irresponsible abdication of EPA?s mandate to protect public health and the environment. This shift could prevent EPA from considering the health risks from countless products containing pesticides that come into contact with our food. Further, the health assessments and statutory standards that will be developed will not have explicitly accounted for the specialized vulnerabilities of infants and children. EPA must retain jurisdiction over any food packaging materials treated with pesticides under section 408 of the FFDCA, to assure the continued protections that Congress sought to afford to infants and children. The Rule Change Will Impact Regulation of Nano-silver Particles The Potential Adverse Health Impacts of Nanosilver Particles Silver nanoparticles are being infused into an increasing number of consumer products, including a number of food packaging products, for their antibacterial and antimicrobial properties. Existing and emerging data underscore mounting concerns that silver nanoparticles pose an unacceptable toxicity risk to human health and the environment. Nano-scale silver ions are used increasingly as germ-killing agents in consumer products, including food packaging and food storage containers made by Sharper Image and also by BlueMoonGoods. At normal scale, silver has long been known to be a potent antimicrobial agent, toxic to fish and invertebrates and highly toxic to aquatic organisms and microbes. At the nano scale, silver is even more potent as an anti-bacterial agent than at normal-scale, suggesting that the widespread release of nano-scale silver ions into the waste stream will almost certainly have negative impacts on ecosystems by damaging beneficial microbes that are essential to life and adversely affecting complex food webs. A recent review by Friends of the Earth Australia summarizes available data on the hazard of nanosilver. (See Appendix A). We are concerned that materials impregnated with nanosilver could fall within the FDA?s regulatory purview under this proposal, and we do not believe that FDA is equipped to deal adequately with such materials. In the proposed rule, EPA states that it is appropriate to give FDA sole jurisdiction over these pesticide-treated food packaging products under section 409 of the FFDCA because such materials ?are more appropriately regulated by FDA under FFDCA,? particularly given ?FDA?s expertise and experience in regulating [these substances]? (emphasis added). We strongly disagree. FDA is not equipped to provide adequate protection to the public health and environment with respect to nanotechnology and nanomaterials in food packaging products?including nanosilver. EPA must not rely upon nor defer to FDA on this issue. In response to a 2006 legal petition, FDA is currently, albeit belatedly, re-assessing the adequacy of its regulatory framework as applied to nanomaterials in all consumer products. Currently FDA assumes that the safety of nanomaterials from bulk material safety and toxicity testing parameters. This stance directly contradicts the assessment of the scientific community at large. FDA is far behind the nanotechnology commercialization curve; in fact, FDA only began to consider the rapidly growing nanomaterial consumer product market and assess human health and environmental potential risks this past year. Interestingly, in a 1999 Final Rule, the FDA declared that ?all over- the-counter (OTC) drug products containing colloidal silver or silver salts are not recognized as safe?, and further, that they are misbranded when their labeling claims that they are safe and effective. Most importantly, in its notice, FDA alerted the public that, ?The indiscriminate use of colloidal silver solutions has resulted in cases of argyria, a permanent blue-gray discoloration of the skin and deep tissues.? These sharp warnings should alert EPA that its failure to regulate nanosilver is likely to result in significant harm to exposed populations. FDA Oversight Is Too Weak EPA is proposing to defer to a highly inadequate and very weak FDA food packaging process. We are concerned that the proposed change would exclude such nanomaterials from classification as pesticide chemicals and pesticide chemical residues and have them be overseen strictly by FDA as indirect food additives. FDA regulates indirect food additives in food packaging as ?food contact substances? under FFDCA section 409(h). This FDA ?oversight? is actually a lax and insubstantial premarket notification system. It simply requires a manufacturer to identify the substance and its intended use, and state that the substance is safe for that use to FDA 120 days before it is shipped. The manufacturer may begin marketing the substance 120 days after filing the notification, unless FDA determines that such use has not been shown to be safe. Further weakening this regulation, any new indirect additive ?Generally Recognized As Safe? is exempt from these lax standards. Accordingly, FDA is neither well situated nor appropriately equipped to oversee these materials alone. Furthermore, EPA?s ceding oversight to FDA?s weaker regulatory regime will increase human and environmental exposure to these toxic chemicals and be less protective of public health. EPA Must Regulate Nanosilver Under FIFRA In the proposal, EPA explains that this rule will continue to regulate the active and inactive ingredients under FIFRA. However, to date, EPA has not taken steps to regulate nanosilver as a pesticide. As explained below, these nanosilver ingredients, and the products they are infused in, should be regulated by EPA as pesticides. Nanosilver health concerns are time sensitive and must be acted upon immediately. Because manufacturers of nanosilver-infused products are attempting to re-characterize their products to avoid FIFRA regulation, we request that EPA move quickly to regulate nanosilver as a pesticide. We are concerned about the effects of this regulatory change to EPA?s oversight of nanomaterials with pesticidal activity such as silver nanoparticles. EPA?s ceding of any of its authority over these products, which it may deem not to qualify as pesticides, and therefore not subject to FIFRA regulation, is particularly alarming. Regulation of Pesticides under FIFRA FIFRA requires that pesticides be registered before they can be legally sold in the United States. To comply with FIFRA, a pesticide must be evaluated through an extensive process to assess any potential risks it may pose to human health or the environment. If EPA makes a finding that a pesticide will cause unreasonable adverse effects on the environment, EPA must deny its registration. Under EPA?s regulations, a pesticide includes ?any substance? intended for? destroying?any pest,? and ?fungus, bacterium, virus, or other microorganisms? are considered pests. A pesticide product is ?a pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is, or is intended to be, distributed or sold.? Nanomaterials used for an anti-microbial purpose, such as nanosilver, are pesticides because they are ?substance[s] . . . intended for preventing, destroying, repelling, or mitigating any pest,? including bacteria and other micro-organisms. The registration requirement under these regulations applies to the broader category of ?pesticide products.? This registration sets strict requirements for how the pesticide must be labeled and used in order to comply with FIFRA. Exceptions to FIFRA Pesticide Registration Requirements Are Not Applicable to Nanosilver Products Among the various exceptions under FIFRA, manufacturers of nanosilver infused products have already attempted to use two to circumvent the FIFRA pesticide registration requirements. First, Samsung argued that its SilverCareTM washing machine qualified as a ?device? and as such was not subject to the rigorous evaluations required under FIFRA. FIFRA defines a device as ?any instrument or contrivance?which is intended for trapping, destroying, repelling, or mitigating any pest?; but not including equipment used for the application of pesticides when sold separately there from.? Furthermore, the regulations note that pesticide product ?includes any physical apparatus used to deliver or apply the pesticide if used to deliver or apply the pesticide if distributed or sold with the pesticide.? The Samsung washing machine explicitly releases nanosilver particles into the wash cycle, to kill bacteria on clothing. As such, it falls easily into the definition of a ?pesticide product? and is therefore subject to the rigorous FIFRA regulations. Second, Sharper Image has an anti-microbial product which qualified as a pesticide. In an attempt to avoid FIFRA regulation, the company re-characterized the product as a deodorant. They chose this tactic because generally deodorizers, bleaches and cleaners are not pesticides subject to FIFRA regulation. However, a ?pesticidal claim? on the label or in connection with the sale or distribution of the product will trigger the registration requirement for pesticides. Sharper Image attempted to circumvent the regulations further by removing all pesticidal claims from the product as well. However, this action was equally improper. EPA regulations impose certain labeling requirements for pesticide products. A statement identifying the name and percentage by weight of all active ingredients and all inert ingredients must be placed on any pesticide product. An ?active ingredient? is ?any substance?that will ?destroy?any pest?.? A pesticide is ?misbranded? if its label does not include any information that it is required to contain. Therefore, both removing mention of nanosilver from a label and then removing pesticidal claims are improper acts under FIFRA. Manufacturers are searching for ways to circumvent the stringent requirements under FIFRA and FFDCA. EPA should not be complicit in allowing them to do so. EPA?s proposal to downgrade the regulatory requirements for materials treated with pesticides that come into contact with our food and continued silence on nanosilver specifically as a pesticide should not proceed. D. General Comments 1. Definition of inert. The proposed rule fails to define ?inert? and thus adopts the FIFRA definition. As interpreted by EPA, this definition casts such a wide net that materials considered toxic under other statutes like the Comprehensive Environmental Response, Compensation, and Liability Act, or certain pesticides under FIFRA, would be deemed ?inerts? here. More appropriately, these toxic chemicals should be reviewed by EPA under the strict FQPA tolerance setting guidelines rather than ignored under the FDA?s oversight. EPA?s controversial regulatory review of inert ingredients creates a hole in this proposed rule for many toxic pesticides to slip through and avoid necessary regulatory review. 2. FDA and sole jurisdiction FDA should not have sole jurisdiction over food packaging. However, even if FDA is given sole jurisdiction over food packaging, toxic pesticides in food packaging should not be exempted from section 408 of FFDCA, particularly for components that contain pesticides but no pesticidal claims are made. Section 408 of the FFDCA provides the strongest protections, particularly for infants and children, from pesticides. FDA?s regulatory framework is much weaker and FDA alone does not provide adequate oversight (see supra). 3. EPA jurisdiction While the rule justification states that EPA?s jurisdiction under FIFRA is retained under section 408, it does not require EPA to act in the case of pesticide components for which there are no pesticidal claims. CONCLUSION For the foregoing reasons, we request EPA publish a withdrawal in the Federal Register confirming this rule will not take effect. We urge the Agency to take the above comments into consideration and pursue broader review in the future if it deems the rule change necessary. Respectfully submitted, Beyond Pesticides (Jay Feldman, Laura Hepting) Center for Food Safety (Joseph Mendelson III) Friends of the Earth US (Erich Pica, Ian Illuminato) Friends of the Earth Australia (Georgia Miller, Rye Senjen) International Center for Technology Assessment (George Kimbrell) APPENDIX A Prepared by Dr Rye Senjen, Friends of the Earth Australia, March 2007 For more information visit nano.foe.org.au or email rye.senjen@foe.org.au Nanosilver ? a threat to soil, water and human health? Summary Silver nanoparticles are found in an increasing number of consumer products such as food packaging, odour resistant textiles, household appliances and medical devices including wound dressings (?Band Aids?). In recent months concerns have been mounting that silver nanoparticles pose an unacceptable toxicity risk to human health and the environment. The potential for nanosilver to adversely affect beneficial bacteria in the environment, especially in soil and water, is of particular concern. Conversely, there is also a risk that use of silver nanoparticles (?nanosilver?) will lead to the development of antibiotic resistance among harmful bacteria. As a powerful bactericide, silver nanoparticles threaten bacteria-dependent processes that underpin ecosystem function. Beneficial bacteria are of vital importance to soil, plant and animal health. Soil bacteria play a key role in nitrogen fixing and the breakdown of organic matter. Bacteria also form symbiotic relationships with legumes which provide a major source of fixed nitrogen for both these and other plants. Denitrification bacteria play an important role in keeping waterways clean by removing nitrate from water contaminated by excessive fertilizer use. Bacteria form symbiotic relationships with all animals from insects to humans. Many of these bacteria aid their animal hosts to digest food, others perform more unusual functions. Antibiotic-producing bacteria protect the European beewolf (wasp) from pathogenic fungal infestation. Light- producing bacteria help the Hawaiian squid to camouflage itself from predators. At the same time as threatening beneficial bacteria in natural systems, nanosilver may compromise our ability to control harmful bacteria. The potential for nanosilver to result in increased antibiotic resistance among harmful bacteria is a serious concern. Not only may certain harmful bacteria become resistant against nanosilver, but because of the type of resistance mechanism developed they may also potentially develop resistance to 50% of currently used antibiotics (beta-lactams). Silver occurs in a variety of natural environments, most often as a mineral ore in association with other elements. Yet even in its bulk form, silver is extremely toxic to fish , algae, crustaceans, some plants, fungi and bacteria (especially nitrogen fixing heterotrophic and soil forming chemolithotrophic). Silver also inhibits microbial growth at concentrations far below that of other heavy metals. As with many substances, the toxicity of nanosilver is greater than that of silver in bulk form; silver is comparatively more toxic then other heavy metals when in nanoparticle form. In vitro (test tube) studies demonstrate that nanosilver is toxic to mammalian liver cells , stem cells and even brain cells. Silver is also toxic when ingested, even when particle size is greater than nano. The United States Food and Drug Administration (FDA) has warned as early as 1999 that the ?use of colloidal silver solutions has resulted in cases of argyria, a permanent blue-gray discoloration of the skin and deep tissues.? Ingestion of colloidal silver (a suspension of silver in microparticles and/ or nanoparticles in a gelatinous base) has also been linked with neurological problems, kidney damage, stomach upset, headaches, fatigue, and skin irritation. , Nanosilver has become one of the most commonly used nanomaterial in consumer products Silver has well known antibacterial properties and has been used for this purpose as early as the Roman times. It was used during the First World War as an aid in wound dressing, but was superseded as an antibacterial with the advent of antibiotics. However, it is in the last few years that silver, in the form of silver nanoparticles, has made a remarkable comeback as an antibacterial, antiviral and antimicrobial compound. Among the products listed in the Inventory of Nanotechnology Consumer Products compiled by the US Woodrow Wilson Center for International Scholar?s Project on Emerging Nanotechnologies, silver nanoparticles are now the most prevalent nanomaterial used in consumer products (67 out of 381 products) . Silver nanoparticles are used in products ranging from vacuum cleaners and washing machines to wound dressing and medical devices. It is also popular as a coating in antibacterial kitchenware, socks and other textiles, used in cleaning products and air filters, teeth cleaners and toothpaste, baby pacifiers and other baby products, condoms and nutritional supplements. Silver nanoparticles are also used, in combination with titanium dioxide coating (NSTDC) by the MTR Corporation in Hong Kong to ?enhance hygiene? and is applied to surfaces in MTR train stations, inside train compartments, as well as MTR-managed shopping malls, staff offices and recreational facilities. Scientific studies demonstrate nanosilver toxicity to bacteria, mammalian cells in vitro Silver nanoparticles are typically used in the size range of 1-50nm. At this very small size, the particles? surface area is large comparative to its volume. The comparatively large surface area of nanoparticles increases their reactivity, which in many instances also increases toxicity. For instance, Elechiguerra et al showed that interaction with the HIV-I virus is highly size dependent, with silver nanoparticles in the 1-10nm range exclusively attaching to the virus and consequently inhibiting it from binding to hosts cells. It is this increased surface area that is credited with enabling the destruction of bacteria and other microbes. The actual mechanism by which silver nanoparticles interfere with bacteria is as yet unclear. Some researchers suggest that silver nanoparticles damage bacterial cells by destroying the enzymes that transport the cell nutrient and weakening the cell membrane or cell wall . In their study of E. coli bacteria, Sondi and Salopek-Sondi found that nanosilver damaged and pitted the bacteria?s cell walls and accumulated in the cell wall, leading to increased cell permeability and ultimately cell death . E. coli is often used as a model for gram negative bacteria, suggesting that these results could be more broadly relevant. However, other researchers believe nanosilver destroys the ability of the bacteria?s DNA to replicate. In addition to being an effective bactericide, silver nanoparticles are also toxic to mammalian cells in vitro (in test tube studies). Hussain et al found that silver nanoparticles were highly toxic to BRL 3A rat liver cells. Mitochondrial function, an indicator of energy available to the cells decreased and LDH or lactic hydrogenase function increased significantly in cells exposed to silver nanoparticles at 5?50 ?g/ml. Other metal oxides (magnetite, aluminium, molybdenum trioxide and titanium dioxide) had no measurable effect at these doses. The LDH function is commonly used to indicate cell death and the release of cytoplasm parts. In a further study, silver nanoparticles were toxic to a cultured neuroendocrine cell line (phenotype PC-12), used as an in vitro model for brain cells . Cellular morphology, mitochondrial function (i.e. how much energy the cell can produce) and dopamine depletion rates (an indicator of Parkinson?s disease) were assessed after 24 hours exposure. Additionally silver nanoparticles depleted dopamine at high and cytotoxic rates (50 lg/ml). Mitochondrial activity was reduced at doses ranging from 10 to 50 lg/ml compared to control, untreated cells. Cells treated with silver nanoparticles decreased in size and became irregular in shape. Silver nanoparticles were also toxic to mammalian germline stem cells in an in vitro study. A study investigating the cytotoxicity of silver nanoparticles in mammalian germline stem cells showed that silver nanoparticles were more toxic than other metal oxides. Silver nanoparticles significantly reduced mitochondrial function and interfered with cell metabolism leading to cell leakage. The authors of the study also pointed out that while silver nanoparticles are proposed to be used as antimicrobial agents in bone cement or other implantable devices, they may in fact be toxic to the bone-lining cells and other tissues. Furthermore, the significant toxicity of silver nanoparticles to mammalian germline stem cells indicates the potential of these particles to interfere in general with the male reproductive system. Scientific studies demonstrate the potential for silver to disrupt key soil microbial communities There is currently very little research on the effect of silver nanoparticles on soil microbial communities in situ, that is, in real soils. But in situ studies have demonstrated that silver, even in larger particle form, inhibits microbial growth below concentrations of other heavy metals. It is especially toxic to heterotrophic (ammonifying/ nitrogen fixing) and chemolithotrophic bacteria. Chemolithotropic bacteria belong to the lithotropic family of microbes and consume inorganic material. These organisms liberate many crucial nutrients, and are essential in the formation of soil. The toxic effect of silver on bacteria also appears to disrupt denitrification processes , with the potential to cause ecosystem-level disruption. Denitrification is a bacteria-driven process where nitrates are converted to nitrogen gas in some soils, wetlands and other wet environments. For example, denitrification bacteria play an important role in removing nitrate from water contaminated by excessive fertilizer use. Denitrification is important because excess nitrates reduce plant productivity, can result in eutrophication in rivers, lakes and marine ecosystems, and are a drinking water pollutant. The persistence of nanomaterials and their potential for bioaccumulation is poorly understood, however early studies suggest that microorganisms and plants may be able to produce, modify and concentrate nanoparticles that can then bioaccumulate (or even biomagnify) along the food chain. The impact of nanomaterial exposure on plant growth remains largely uninvestigated, however high levels of exposure to nanoscale aluminium have been found to stunt root growth in five plant species. No such studies have been performed on silver nanoparticles. Case study: the silver nano washing machine in Sweden In 2005 Samsung released its nanosilver washing machine in Sweden (and has also released it in many other countries, including Australia). Samsung claim that despite low wash temperatures the silver nanoparticles acts as a bactericide resulting in cleaner clothes that will keep fresh longer. Samsung claims that its technology will ?sterilize over 650 types of bacteria and serves a better world up to you in style.? Samsung views the benefit to the customer as paramount and claims that the impact on the environment is negligible. Astonishingly Samsung claims that the silver electrolization system used in their washing machine was chosen because it has been proven safe for humans and is environmentally friendly. No peer reviewed publication was made public proving these claims. After complaints from the Swedish Environmental Protection Agency, the Swedish Water and Waste Water Association and the Stockholm Water Authority, Samsung briefly withdrew the washing machine, but it is now back on the market. The Swedish government authorities have expressed concern that the nanosilver will cause damage to water organisms and result in higher costs for government (due to the need to remove the silver nanoparticles from effluent sludge), while being only marginally more energy efficient. Additionally the Swedish Farmers Federation opposes the use of silver sewage sludge/wastewater contaminated with silver because of its uncertain soil toxicity and its very fast doubling time (40 years versus the required 500 years, doubling time is the time it takes for the substance in the soil to double its concentration). Stockholm Vatten, the Stockholm Water Authority claimed that every household using the nano silver washing machine will emit 2-3 times more silver than at present, as the nano silver ions will readily dissolve in water. One of the main concerns of the Swedish Water and Waste Water Association was that nanosilver will end up in the water system. This would then require the separation of nanosilver from effluent during the sewage treatment process because of the danger that nanosilver would adversely affect beneficial bacteria in general and soil bacteria in particular (digested sludge is sold as an agricultural fertilizer). Additionally, unextracted nanosilver could pollute the sea, rivers and lakes, poisoning a variety of water organisms. Clearly silver nanoparticles could and should be classified as hazardous waste and the use of silver nanoparticles in consumer products should be subject to tough new safety tests. Yet as silver rods are structurally incorporated into the Samsung nanosilver washing machines it is unlikely even that the precautionary Swedish Environmental Code enacted in 1999 can be applied to this product. An unfortunate loophole in the Swedish legislation means that the Code does not cover material built into products, which when activated is released into environment. Other loopholes in the existing European Union regulation (directive 2000/76/EG) in relation to waste recycling and in the new REACh chemicals legislation leave nanomaterials effectively unregulated. This is discussed in detail below. FoE Australia has called for the Australian recall of Samsung?s nanosilver appliance range (washing machine, vacuum cleaner, refrigerator, air conditioner etc) until publicly available, peer-reviewed studies can demonstrate its safety for the environment and human health. This follows calls from BUND (FoE Germany) for the German recall of the Samsung range. Nanosilver may increase antibiotic resistance The use of silver nanoparticles has also substantially risen in the area of medical device coatings, wound care dressings and as an enhancement to bandages. The wound care market (salves and wound dressings) was worth approximately US$3 billion in 2004. . ?Acticoat?, a silver nanoparticle based wound dressing (Nucryst, Wakefield, MA,USA), captured US$25 million in sales in 2004 alone. Interestingly some manufacturers market nanosilver as having ?antimicrobial effect against antibiotic resistant germs, without conveying the formation of resistances? and as a ?highly effective and natural alternative to antibiotics? and ?precluding the spread of further resistances against antibiotics?. However in a recent paper Melhus pointed out that ?silver can ?constitute a part of selective pressure and may actively contribute to the spread of antibiotic resistance. Silver resistance associated with antibiotic resistance has been observed in isolated bacteria from birds and in salmonella spp.? It can also be induced under laboratory conditions, and ?is most easily developed in bacteria with already documented resistance mechanisms to antibiotics, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin- resistant enterococci (VRE), enterobacteria with production of extended spectrum beta-lactamases (ESBL), multiresistant Pseudomonas aeruginosa. ? It is therefore a positive initiative that Swedish pharmacies decided to stop the sale of ?Band Aids? containing silver in April 2006. Regulatory inadequacy permits continued sale of many products containing silver nanoparticles There are two main reasons why nanomaterials remain effectively unregulated by existing chemicals and waste regulatory systems world-wide. Firstly, existing regulatory systems fail to treat nanomaterials as new chemicals, and remain based on the flawed assumption that the toxicity of nanomaterials can be predicted from the same materials in their bulk form. That is, regulatory systems assume that materials are substantially equivalent whether in bulk form or nanoparticle form ? despite the known higher reactivity, and often greater toxicity, of nanomaterials. This means that if a nanomaterial has already been subject to safety assessment in bulk form ? as many metal oxides and carbon based nanomaterials have ? there is no trigger for new safety assessment. Recognising this as a critical problem, in its 2004 report on nanotechnology, the United Kingdom?s Royal Society made an explicit recommendation for nanomaterials to be assessed as new chemicals . The second reason that existing regulatory systems fail to deal adequately with nanomaterials is that they use a standard mass as the appropriate ?dose? characteristic. That is, regulatory requirements (including the need for new safety assessments) are triggered by the production of a standard weight of any chemical or waste product. However, the extremely high reactivity and very small mass of nanomaterials means that nanomaterials can be toxic in far lesser weights than bulk materials. In 2006 a large group of leading nanotoxicologists called for nanomaterials to be screened using particle number and surface area, in addition to mass, as critical dose characteristics. Despite the growing international discussion about the urgent need for regulations to protect the environment and human health from the risks of nanotoxicity, there are still no national-level laws governing the use of nanomaterials anywhere in the world. This means that despite serious concerns about nanotoxicity being raised at the highest scientific levels, manufacturers of new nanoproducts are not required to demonstrate the safety of their product for the environment or for human health prior to releasing their product onto the market. In a world first, the United States Environmental Protection Agency (USEPA) announced in late 2006 that it would investigate regulating as pesticides products that contain silver nanoparticles and that make claims of antimicrobial action. The USEPA has said that the Samsung nanosilver washing machine will soon be regulated under the Federal Insecticide, Fungicide and Rodenticide Act, or FIFRA. This was a reversal of an earlier decision which claimed that the washing machine was a device, rather than a pesticide, and therefore not subject to regulation. The Agency now says that if a product ?incorporates a substance intended to prevent, destroy or mitigate pests,? it is considered a pesticide and is required to be registered. As silver nanoparticles are also used as a bactericide in many other consumer products, such as food-storage containers, air fresheners, and shoe liners, it seems a logical conclusion that these should also be registered as pesticides. In a November 22, 2006 letter to the director of the US EPA?s Office of Pesticide Programs, environmental action organization Natural Resources Defense Council (NRDC) said ?....there are currently more than 40 consumer products in the marketplace that contain nanosilver, some of which either expressly make pesticidal claims or imply pesticidal effectiveness and none of which are currently registered with EPA.? The NRDC says the Agency is ?obligated to examine these products and require registration for any product that uses nanosilver as a biocide.? The wastewater treatment industry in California also pointed out that widespread use of household products, like the Samsung washing machine, will increase the release of nanosilver into sanitary sewer systems. This in turn will greatly increase silver concentrations in treatment-plant discharges, leading to adverse effects, such as bioaccumulation in fish and killing of aquatic life. Furthermore, there is a possibility that nanoparticles and persistent organic pollutants and other hazardous metals may form associations and spread together, thereby amplifying their toxicity. It is as yet not known whether nanosilver particles exhibit this behaviour. However, in a wholly illogical and highly unsatisfactory loophole, the USEPA decision will only apply to products whose manufacturers make claims of antimicrobial action. This means that if a manufacturer withdraws marketing claims of nanosilver?s antimicrobial activity, but changes nothing about the nanosilver component of a product, then that product will escape regulation as a pesticide. Many companies will simply remove all references to antimicrobial action from product labels, rather than registering their product as a pesticide and the being required to provide evidence of product safety. Manufacturer Sharper Image has already removed statements of pesticidal claims from its products treated with nanosilver, including slippers, socks and food containers, an action that NRDC quite rightly states ?denies the public?s right to know the active ingredient of these products.? Friends of the Earth Australia calls for an immediate moratorium on the further release, and the immediate withdrawal from the market, of all products containing nanosilver Given the poorly understood toxicity risks of silver nanoparticles, the threat they pose to the public and environmental systems, and the failure of regulatory systems to manage these risks, Friends of the Earth Australia repeats our call for an immediate moratorium on the further release, and the immediate withdrawal from the market, of products containing silver nanoparticles. Appendix For a list of consumer products containing nanosilver, please visit the Nanotechnology Consumer Products Inventory at http://www.nanotechproject.org/44 References