Ac version 3 Observation 1: sq 4

Regulations Bad

No Legal Definition

Regulations fail – no legal definition

Suppan 11 [Steve Suppan, a policy analyst at IATP since 1994, “Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation”, Institute of Agriculture and Trade Policy, June 29, 2011, http://www.iatp.org/documents/racing-ahead-us-agri-nanotechnology-in-the-absence-of-regulation”]//PP

But none of these products are regulated by U.S. federal agencies. Research and development for agricultural and food applications of nanotechnology has expanded rapidly in recent years, with over $50 billion in global public investment and at least as much in privately funded research. At least 1,300 products with Engineered Nanotechnology Materials (ENMs) have been commercialized, despite myriad uncertainties about the public health and environmental effects of ENMs. These uncertainties result, in part, from novel physical, chemical and biological properties that are due to the extremely small size of these particles, which may range from 1 to 300 nanometers (the diameter of a human hair is about 80,000 nanometers). The exponentially greater surface-to-mass ratio of nanoscale materials results in different properties and uses than what is possible for the macro-scale counterparts of those materials. It is not yet clear what human health hazards may be created when nano-particles are ingested, or the extent to which ENMs might migrate from food packaging to the food and hence through the entire human body. Several steps are needed to arrive at an operative and mandatory regulatory structure for nanotechnology products and processes. There is no agreed legal definition of what constitutes an ENM. Regulators do not have an official registry needed to regulate products already in the market nor an inventory of products in development. As of March 2011, the nongovernmental Project on Emerging Nanotechnologies (PEN) had registered more than 1,300 products whose manufacturers claim to include ENMs, and estimates that the number could grow to 3,400 by 2020. The lack of definition is not just a technical issue, but also a political challenge. The decision to commit to binding legal definitions would be predicated on related decisions to regulate and a commitment to ensure the human, technical and financial resources to implement and enforce regulations. Even if, after the June EPA guidance on submitting ENMs for EPA review, definitions could be determined, and adequate resources provided, it will be difficult to require product data from commercialization applicants. A research project to estimate ENM production levels found that most companies surveyed regarded production levels as confidential business information (CBI) that they refused to disclose, even after the researchers guaranteed company confidentiality. There are EHS risks that regulators could begin to assess, if they had nanotech product data, on the basis of current peer-reviewed scientific literature. Chinese researchers, for example, have discovered in animal testing that absorption of nano-silver may interfere with the replication of DNA molecules and can reroute molecular networks that could create genetic mutations. Nano-silver, among myriad other uses, is incorporated into food packaging materials to kill pathogenic bacteria and thereby extend a food’s shelf life.

Regulations Fail

Regulations fail – we need to reframe the debate

Vaughan 12 [Steven Vaughan, SET Lecturer in Obligations at the Law School, Cardiff University and a former associate with Latham & Watkins and Freshfields, “Laying down the law on nanotechnology”, The Guardian, 11 June 2012, http://www.guardian.co.uk/law/2012/jun/11/law-nanotechnology-regulation]//PP

Regulating nanotechnology is difficult because of the myriad ways in which nanomaterials can be used and due to their global impact - the fact that product X made in the US can travel via Europe and be sold in China. There is also a real issue in knowing when and how to regulate: with hindsight it may be too little, too late or too much, too soon. A balance needs to be struck between the benefits from nano (societal, environmental and economic) and the potential risks. How we as a society deal with uncertainty, how we respond to scientific innovation and how we frame the debate on risk and regulation – these are all so very important. As we saw with asbestos, it may be the difference between life and death. Sometimes, size really does matter.

Regulations bad – too many nuances within the market to be effective

Suppan 11 [Steve Suppan, a policy analyst at IATP since 1994, “Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation”, Institute of Agriculture and Trade Policy, June 29, 2011, http://www.iatp.org/documents/racing-ahead-us-agri-nanotechnology-in-the-absence-of-regulation”]//PP

The range of food and agricultural nanotechnology applications includes making toxins more bio-available in pesticides, targeting nutrients in smaller doses, improving the texture of ice cream and detecting bacteria in packaged foods. Under current rules, companies have the discretion to determine whether a macro-substance already considered by the company to be safe and therefore not reportable to the FDA, deemed to be likewise safe and hence non-reportable in its nano-scale form. In addition, the exponentially larger surface-to-mass ratio of ENMs, compared to that of macro-versions of the “same” materials, will make the determination of Acceptable Daily Intakes impossible if companies are not required to submit data to regulators for their independent assessment. In 2008, the Project on Emerging Nanotechnologies (PEN) and the Grocery Manufacturer’s Association (GMA) brought together industry representatives, government regulators and NGOs to consider how EPA and FDA might regulate generic and hypothetical food packaging incorporating ENMs. The project revealed challenges to FDA’s present regulatory process for food packaging materials, including: 1.) validating methodologies to characterize ENM properties to determine whether ENMs might migrate into food; 2.) validating migration study protocols that would determine consumer exposure to ENMs; 3.) evaluating whether current FDA set dietary concentration triggers for toxicity testing are adequate for ENMs; and 4.) determining whether toxicological data for the macro-scale counterparts of ENMs have any utility for predictive toxicology and safety assessment. But these challenges are not just theoretical. The Pulitzer Prize–winning journalist Andrew Schneider has reported that some fruits and vegetables exported from Latin America are coated with nano-particles to extend their shelf life. Based on a review of patent filings, regulators have some knowledge of the ingredients of food nano-coatings. These ingredients include nano-silver and nano-zinc oxide as anti-microbials to combat bacteria; nano-silica to prevent water content loss and to ensure the film’s transparency; and nano-titanium dioxide to prevent deterioration due to ultraviolet rays. The macro forms of these ingredients are permitted food additives, but testing has not yet been done to assess their safety at nano-scale. Administrative, technical and resources constraints create enormous hurdles to effective import inspection of food nano-coatings and food packaging using ENMs. Because of, or perhaps despite, the scientific, budgetary and infrastructural difficulties of developing methods to simply and reliably measure the presence of ENMs in food, feed and food packaging materials, the Codex Alimentarius Commission, the international food standards body, may consider in July whether or not to include nanotechnology in its strategic plan for 2013–2018. Codex standards are presumed to be authoritative by the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures for the purpose of trade facilitation. There are many reasons why the commission should undertake work on agri-nanotechnology, not the least of which is that such products are already being traded without regulation or risk assessment on which to base regulations. At the same time, Codex standards require the scientific advice of FAO/WHO expert meetings and/or standing committees, such as the Joint FAO/WHO Committee on Food Additives. However, FAO and WHO member governments have not made the funding of such scientific advice a Codex priority. There is a risk, however, that if standards are developed before member countries have effective rules and resources to do mandatory pre-market safety assessments and post-market surveillance of foods with ENMs, Codex standards would only facilitate greater trade without adequate regulatory enforcement capacity.

U.S. Regs Ineffective

US nanotech regulations fail – low safety standards, no testing for risks, no monitored research

Soliman 12 - agricultural economist, attorney, and researcher focused on legal and economic issues in the Agriculture, Resource and Food sectors (Adam, “The Need for Stronger Nanotechnology Regulation”, Food Safety News, 10/16/2012, http://www.foodsafetynews.com/2012/10/why-we-should-have-more-regulations-on-nanotechnology/#.UfV_zI21F6I)//BD

Legislation governing the use of nanoparticles is limited around the world, particularly in the U.S. In 2007, a report released by the U.S. Food and Drug Administration’s Nanotechnology Task Force 33 stated that despite the ‘special properties’ of nanomaterials, no further regulation is needed (3).¶ This report was opposed by environmental group Friends of the Earth and the International Center for Technology Assessment. The organizations filed a petition with FDA urging it to take action to highlight the risks associated with nanotechnology (4). As a result, the federal Nanotechnology Research and Development Act was passed in 2003.¶ The Toxic Substances Control Act (TSCA) was also developed to assess the risk posed by substances, and to provide authority to the Environmental Protection Agency (EPA) in regulating them (5). The TSCA set out provisions to protect living systems against unknown risks of new or engineered substances by regulating and testing new and existing chemicals. However, the EPA does not hold much sway in the American political sphere. In fact, the U.S. legislature does not even require pre-market approval of consumer goods; the FDA relies solely on manufacturers to ensure product safety (6). Moreover, only evidence of a very specific harm associated with a product can elicit legal restrictions, and nanoparticles have not yet been tested for such specific risks.¶ The EU organization Strategy for Nanotechnology asserts that nanotechnology has the potential to enhance quality of life and industrial competitiveness, and therefore lobbies aggressively for minimal legislation on nanotechnology. Current laws state that anyone producing or importing nanomaterials into Europe is required to provide written notification to public authorities; this notification requires the manufacturer to conduct research illustrating the properties and dangers of the product (7). However, this research is not monitored, making the data difficult to validate and allowing manufacturers to exaggerate, forge or omit crucial information.¶ In Hong Kong, the Centre for Food Safety has referred to the World Health Organization’s (WHO) requirement for risk assessment on nano-scale materials for assessing nanoparticles before they can be used in food (8). Additionally, the Public Health and Municipal Services Ordinance requires all food sold in Hong Kong to be fit for human consumption. But consumer goods lack specific legislation monitoring nanotechnology’s expanding applications. Furthermore, no comprehensive and compulsory danger assessment scheme has been introduced to manage the potential risks posed by nanoparticles to public and environmental health.¶ Demand for Legislation

No Risk/No Impact

Nanomaterials are no risk

Lin 6 [Patrick Lin, director of the Ethics + Emerging Sciences Group, based at California Polytechnic State University, “Nanotechnology Bound: Evaluating the Case for More Regulation” Nanoethics 31 March 2007, pg. SpringerLink, 105-122]//PP

This objection asserts that existing laws and regulations are adequate to account for nanotechnology, because nanomaterials are essentially the same kinds of substances that we have been using for decades. That is to say, a carbon nanotube is still only made up of carbon, and nano-sunblock is still only made up of zinc or titanium oxide – and these are materials that current regulations have proven sufficient to handle. In some cases, nanomaterials are simply much smaller versions of the familiar thing. In other cases, they are the same material with a different molecular arrangement. Therefore, we do not need stricter laws to account for nanotechnology. In fact, nanotechnology is something that has arguably existed since the beginning of the world, if not earlier: “Nanostructures – objects with nanometer scale features – are not new nor were they first created by man. There are many examples of nanostructures in nature in the way that plants and animals have evolved. Similarly there are many natural nanoscale materials...catalysts, porous materials, certain minerals, soot particles, etc. that have unique properties particularly because of the nanoscale features” [19].

Status Quo Solves Regs

Status quo

Lin 6 [Patrick Lin, director of the Ethics + Emerging Sciences Group, based at California Polytechnic State University, “Nanotechnology Bound: Evaluating the Case for More Regulation” Nanoethics 31 March 2007, pg. SpringerLink, 105-122]//PP

This objection to the stricter-law argument asserts that, as a matter of fact, current regulations are enough to safeguard the public from these harms. They have served us well over the years, and without definitive proof that nanomaterials are actually harmful in consumer products or manufacturing, it is premature to subject the nanotechnology industry to more regulations. Analysis This objection disputes premise P2 in our formalized argument, thereby throwing into question all conclusions from C1 to C3. Our evaluation of this objection has already been discussed in the preceding section, where we pointed out that today’s controversy over Teflon, as just one example, shows that current laws and regulations are fallible and probably do not fully protect us from EHS risks in all consumer products or their manufacturing. Further, even if current laws are adequate to account for nanomaterials in production today and in the near future, the industry is still learning about the science and working on new materials, and these materials may slip past existing laws. Either way, it is also prudent to believe that the processes we have established to regulate business in general are imperfect and will continue to be a work in progress, as long as businesses and research organizations continue to innovate.

Precautionary principle

Lin 6 [Patrick Lin, director of the Ethics + Emerging Sciences Group, based at California Polytechnic State University, “Nanotechnology Bound: Evaluating the Case for More Regulation” Nanoethics 31 March 2007, pg. SpringerLink, 105-122]//PP

This objection maintains that the Precautionary Principle (PP) is not an obviously-correct or commonsense rule that we should follow, and therefore the stricter-law argument falls apart, since it depends critically on the PP. The most serious criticism we examine here is that the PP represents a risk-averse strategy that is too conservative, at least as it applies to the considered case of nanotechnology where the EHS risk is still unclear [22]. Risk aversion, the argument goes, is not the only workable strategy in life, business or politics. After all, if Americans never took unnecessary or perhaps unreasonable risks, then we never would have accomplished such things as expanding the country westward to California, inventing the airplane and putting a man on the moon. In fact, America was built on the backs of explorers and frontiersman, such as Christopher Columbus and Captain John Smith, who risked and sometimes lost everything. And many other nations can say similar things about their forebearers, pioneers and inventors. Such may be the case with nanotechnology: it is a new frontier in science that, while admittedly contains unknown danger, also holds much promise. However, if we were to follow the PP, we may lose a great opportunity to develop a science that has been called “the Next Industrial Revolution” [23].

Self Regulation

Self-regulation solves comparatively better than governmental regulation

Lin 6 [Patrick Lin, director of the Ethics + Emerging Sciences Group, based at California Polytechnic State University, “Nanotechnology Bound: Evaluating the Case for More Regulation” Nanoethics 31 March 2007, pg. SpringerLink, 105-122]//PP

This position opposes more governmental regulation as a way to mitigate EHS risks. Rather, it advocates self-regulation as an alternative, such that if any additional regulation is needed, it should be left up to the industry to decide what measures are appropriate. There are several reasons why this view is attractive to many [27]. First, it promotes a smaller governmental footprint in business and individual lives, so it instantly appeals to libertarians and some conservatives. Also, it may make more sense for the nanotechnology industry, that presumably knows its field the better than lawmakers do and have a real stake in its work-processes, to devise and implement any regulations, rather than some distant bureaucracy whose edicts are inevitably borne from political compromise. By monitoring one’s own work, selfregulation fosters a sense of responsibility within the industry. Further, self-regulation seems to work, as evidenced by any number of professional code of ethics. Analysis A persistent criticism to the idea of self-regulation is that it seems to let the proverbial fox guard the hen-house, or in other words, there is a sizable conflict of interest [28]. Can we trust an industry – any industry – to make its own rules when money is involved? Can they fairly create processes that protect EHS interests of the public, even at the expense of their own interests, financial or otherwise? Some have called it a pragmatic paradox to ask a person or organization to obey the law and, at the same time, be the law [29]. Because there is no real separation between those enforcing regulations and those subject to the regulations, the door seems to be open for self-imposed regulations to be selectively enforced and for potentially covering up illegal or unsafe practices. Of course, an enlightened company might see that it is in their best interest to deliver only safe products, since harming one’s own customers is counterproductive to one’s reputation and business as well as opens the company to possible litigation. But will every company arrive at the same conclusion, ignore shortterm gains for long-term interests and follow the rules? For self-regulation to work, nearly every industry actor needs to comply, since all it takes is one clever company to sidestep industry-imposed regulations for possible catastrophe to occur, i.e., the EHS risks may still exist and are not sufficiently mitigated by self-regulation. The diagnosis of why actors fail to cooperate even though it is in their better interests to do so – also known as a “Prisoners’ Dilemma” – is well covered in literature [30]. As groups such as OPEC have shown – whose members are notorious for ignoring their own self-imposed quotas for oil production, even though compliance gives them a means to control greater oil prices – it is a real challenge to get organizations to do what they have committed to, even if breaking that commitment will make them worse off in the long run. Further, if governmental regulations are believed to be imperfect because they contain political compromise, it is unclear why matters should be different with self-regulation.

Regs Kill Devp

Regulation hinders nanotechnology development

Lin 6 [Patrick Lin, director of the Ethics + Emerging Sciences Group, based at California Polytechnic State University, “Nanotechnology Bound: Evaluating the Case for More Regulation” Nanoethics 31 March 2007, pg. SpringerLink, 105-122]//PP

This objection, perhaps the most popular of the seven considered, suggests that if stricter laws were imposed, there would be unacceptable costs or harms to the nanotechnology industry now. Few objectors have specified these costs, but we can imagine what some might be. If tougher regulation makes it more difficult for a nanotechnology product to be delivered to market, e.g. due to extended product testing cycles or more comprehensive environmental impact reports, then a business can reasonably expect to generate less revenue over a given period, since they no longer or won’t as quickly have that product on the shelves. This also means businesses might not be able to afford to keep the same number of researchers or other employees on staff, leading to a loss of jobs. Without as many active researchers – including those in academic or other non-business labs, to the extent that these new laws affect their work – nanotechnology will not advance as quickly as it might otherwise have. And if other nations do not have the same stringent restrictions that we do, the US may suffer a real competitive disadvantage globally. (We will discuss other potential costs later, but these seem to be the primary ones associated with this objection.) Indeed, a recent report from Cientifica argues that today, even without the stronger regulations proposed, the pace of funding, research and development in the US is not fast enough to sustain business efforts and compete with other nations [31]. The report warns that not enough government spending in nanotechnology is focused on areas of immediate commercial impact. And accessing this funding is a slow process, taking an average of 2 to 3 years before it even reaches the lab. The report also finds that, as a proportion of its gross domestic product, the Japanese government spends three times as much on the technology than the US does. As it applies to the Other Harms Objection, this report would lend defense to the claim that the nanotechnology industry needs more support, not more hurdles that would slow it down further.

Regulations bad prevents us from realizing future benefits

Lin 6 [Patrick Lin, director of the Ethics + Emerging Sciences Group, based at California Polytechnic State University, “Nanotechnology Bound: Evaluating the Case for More Regulation” Nanoethics 31 March 2007, pg. SpringerLink, 105-122]//PP

If there is something reasonable, but not completely convincing, about the Other Harms Objection, then we can perhaps strengthen it here by pushing its time horizon farther out, giving the argument more consideration [36]. In doing so, we can suggest that the preceding objection really did not consider enough harms: it looked only at immediate or shortterm harms associated with stricter laws. But nanotechnology is something that is forecasted to give humanity profound benefits once it matures, and we have yet to consider those goals in pursuing nanotechnology. If we slow the industry down today, will that prevent or hinder us from realizing these benefits later – benefits that may plausibly outweigh EHS risks that exist either today or in the future? In the following, we will briefly present some of the risks of moving too slowly in nanotechnology that could be advanced by the Future Harms Objection, which is not an objection we commonly see but is a view held or implied by at least some nanotechnology advocates. Taken together, these risks raise the stakes involved in the stricter-law debate and may present a more compelling challenge.