Ac version 3 Observation 1: sq 4

U.S. Regs Key

U.S. Regs k Commercial Devp

The us is the global leader in regulation—additional progress is critical to the development of any form of nanotech

Salvi 2k8

(Aatish Salvi is vice president of the NanoBusiness Alliance, “Nano-protecting the public,” pg online @ http://www.latimes.com/news/custom/scimedemail/la-op-salvi-kimbrell28feb28,0,4954656.story //um-ef)

George, you imply that companies are shirking their responsibility as stewards of nanotechnology. This implication is patently false. For more than two years, the nanotech industry has called for significant increases in funding for environmental, health and safety research on nanotechnology. Nanotech companies been actively engaged with government agencies, having invited such agencies into their facilities sharing data for some time now. As a result of the data collected, agencies such as the National Institute for Occupational Safety and Health (NIOSH) have been able to make initial safety recommendations. If, as you say, "People overwhelmingly trust regulators with the job of protecting their health," then perhaps so should you. We don't need "nano-specific regulations" because nanomaterials and nanotech companies are answerable to the U.S. Environmental Protection Agency, the Occupation Safety and Health Administration and other regulatory agencies, and are governed (and punishable) by the same regulations and laws that apply to all other manufacturers. These laws regulate nanotech for everything from manufacturing, worker safety and transport to disposal and emissions. The need is for more information so that the agencies are better informed about the different types of nanomaterials and can interpret how the existing regulations should apply. The EPA has very recently published an extensive research plan (PDF) that details its initiatives to gather this data. Our call to lawmakers in Washington is to provide the EPA the necessary funding to execute this plan. There is a rational and good reason for companies to want agencies to be fully informed. We need to have certainty about exactly how the existing regulations apply to our products and materials. Without that certainty, raising capital, getting insurance and selling products to consumers are all made much more difficult. In Washington this week, representatives of nanotech companies and I met with Assistant James B. Gulliford, an assistant administrator at the EPA, and Charles M. Auer, director of the EPA's Office of Pollution Prevention and Toxics (OPPT), to discuss how companies can best work with government agencies. During that discussion, several of the companies agreed to share data on their materials with the EPA and to discuss further research they can perform to help the EPA understand how the class of materials they make work. Of course, companies need to know that their patents, trade secrets and other confidential information will be protected. Our strategy is to entrust the EPA and NIOSH with information in confidence, have the agencies review the data and report their conclusions to the public. George, you claim that the voluntary programs are "wholly inadequate." You claim that such programs "lack incentives for 'bad actors' or those with risky products to participate, leaving out the entities most in need of regulation." Laws are meant as a deterrent and retribution, but they cannot make people be good. If someone wanted to be a "bad actor," it wouldn't matter if the request to report was mandatory or voluntary. The disincentive to act badly for nanotech companies already exists in the forms of the Toxic Substances Control Act, Clean Air Act, Clean Water Act and others. These laws are strict in their punishment of any manufacturer that causes harm. You suggest that we follow the European Union's lead in terms of nanotech regulation. The United States has more research institutions, publishes more papers and has more nanotech companies than Europe by far. Our agencies and labs have done much more environmental, health and safety research to date than theirs have. Following them would be like the tail wagging the dog. I am glad to hear people think the U.S. agencies are trustworthy. I think so too. They have been dealing with technological change for decades and have a lot of institutional knowledge — both from their successes and mistakes. They have a plan to deal with nanotech, and the industry supports that plan. We want communication to the public to come from government agencies that rely on data, not from organizations that rely on rhetoric.

Key to Commercial.

Nanotechnic foreign aid promotes stability and helps to open up new markets for us companies

Lodwick et al 7

(T. Lodwick*, R. Rodrigues**, R. Sandler***, W.D. Kay**** * Nanotechnology and Society Research Group (NSRG), Northeastern University **Santa Clara University, School of Law, ***NSRG, Department of Philosophy and Religion, Northeastern University, ****NSRG, Deapartment of Political Science, Northeastern University, “nanotechnology and the global poor: the united states policy and international collaborations” pg online @ http://www.nsti.org/procs/Nanotech2007v1/8/T81.501, AC)

Nanotechnology and nanomanufacturing have tremendous potential for benefiting the global poor—the approximately 2.77 billion people in the world that live on less that 2 dollars per day (purchasing power parity). For example, nanotechnologies may help provide reliable local energy production and potable water availability, increased agricultural efficiency, inexpensive medical diagnostics and treatments, and greater access to technology and information more generally. This paper examines existing and potential pathways for promoting nanotechnology and nanomanufacturing that benefit the global poor either by directly meeting their needs or supporting nascent industries in developing countries. Informal international collaborations as well as formal international research partnerships are discussed, as is the role of international organizations. However, special attention is given to United States policy. Recommendations regarding intellectual property licensing, incentivizing research on pro-poor nanotechnologies, and promoting collaborations between United States and developing world researchers are made. In the long run, a nanotechnology research and development strategy conducive to realizing the possibilities for nanotechnology to benefit the global poor might constitute an effective form of foreign aid that would also benefit the United States by promoting stability and security in developing nations and creating new markets for United States companies.

Environment

Regulations on Mexico’s nanotech development key to prevent environmental degradation – only US framework solves

HLRCC 12 (High-Level Regulatory Cooperation Council, Executive Office of the President of the United States, “UNITED STATES-MEXICO HIGH-LEVEL REGULATORY COOPERATION COUNCIL WORK PLAN,” 02/28/2012, http://www.whitehouse.gov/sites/default/files/omb/oira/irc/united-states-mexico-high-level-regulatory-cooperation-council-work-plan.pdf, AC)
Why Should We Do This?¶ 1. Ensuring that the United States and Mexico share information regarding each other’s ¶ respective regulatory approaches to nanotechnology applications and nanomaterials at an ¶ early stage will be critical in reducing risks to environmental and human health while ¶ fostering innovation;¶ 2. Considering a joint framework to align regulatory approaches will ensure consistency for ¶ consumers and industry within and between both countries; and¶ 3. Consistency in a regulatory approach in this area will facilitate responsible manufacturing ¶ and trading of products between the two countries, and will foster the competitiveness of¶ the industry.

Regs Key – Enviro & Development

Regulated development key to boost competitiveness and avoid environmental and health issues – empirically true in Latin America

Kay and Shapira 8 (Luciano, research professional with Ph.D. degree in Public Policy, and Philip, professor in the School of Public Policy, “Developing nanotechnology in Latin America,” Journal of Nanoparticle Research, 09/18/2008, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2988220/, AC)
Any assessment of strategies for developing nanotechnology in Latin American countries needs to take into account broader considerations and debates about the potential impacts (both positive and negative) of nanotechnology. Although nanotechnology is anticipated to lead to advances in many technological fields, multiple risks and societal concerns have also been identified, including health and environmental risks and needs for improved regulation (Glanzel et al. 2003; Roco 2003; Maynard 2006; Besley et al. 2008). This has given rise to uncertainty about not only the scale but also the distribution of nanotechnology’s potential social, economic, health, and environmental impacts and risks (Cobb and Macoubrie 2004).¶ Reflecting these concerns and driven by desires to bolster the governance of nanotechnology development, initiatives have been sponsored in several advanced countries to analyze the broad range of impacts associated with nanotechnology and, in some cases, to engage stakeholders and the public, in dialogue and deliberation. How such efforts will constructively change the development of nanotechnology and its impacts remains to be seen (Bennett and Sarewitz 2006), but they are underway. For example, in the US, the consideration of “ethical, legal, environmental, and other appropriate societal concerns” in the development of nanotechnology is required by legislation,21 nanotechnology research centers are obliged to consider these issues, and new centers and projects have been sponsored to address these concerns (NSET 2004, 2005; Sarewitz and Guston 2004). Initiatives to consider the societal aspects of nanotechnology have also been launched in Europe and Japan (RAE 2004; Fogelberg and Sanden 2008; Ishizu et al. 2008).¶ In Latin America, the level of resources available for societal assessment is far lower than in developed countries. Yet, there is recognition that intermediate and developing countries could be vulnerable to risks associated with the application of nanotechnology, particularly given weaknesses in regulatory systems, yet may also lag behind developed economies in gaining economic benefits from this emerging technology (Invernizzi 2007; Invernizzi and Foladori 2005). For example, Invernizzi (2007) observes that nanotechnology in Brazil has been embraced and promoted by scientific elites as a mean for progress, efficiency, and competitiveness, but increasing social and economic inequalities in the country may actually prevent the technological benefits to be equally distributed. Indeed, in more general terms, Invernizzi and Foladori (2005) point out that the dominant socioeconomic structures in Latin American countries may hinder the deployment of nanotechnology applications that could provide benefits for the poorest groups. For example, these authors suggest that while quantum dot technologies have the potential to detect HIV/AIDS molecules at early onset, overstretched medical systems and an inability to afford expensive new treatments may limit use in developing countries. Moreover, they fear that even if nanotechnology in areas such as water filtration is applied in developing countries (including Latin America,) the poor majorities in these countries will not immediately benefit.

Regs Key: Commercialization

Increased funding to understand the environmental effects of nanotech is needed

Lane et. al 7 (Neal Lane, professor of physics at Rice University, was director of NSF from 1993 to 1998 and science advisor to President Clinton beginning in 1998. Thomas Kalil, assistant to the chancellor for science and technology at the University of California at Berkeley, was deputy assistant to the president for technology and economic policy and deputy director of the National Economic Council during the Clinton administration, 2007, The National Nanotechnology Initiative: Present at the Creation, http://www.issues.org/21.4/lane.html)

Understand and mitigate the environmental and human health effects of nanomaterials. As Scott Walsh notes in his article in this issue, our current understanding of the environmental and human health effects of nanomaterials is limited. A failure to understand and manage these health risks could put the nanotechnology revolution on hold. Reinsurance companies such as Swiss Re have made it very clear that they do not wish to be left holding the bag if nanotechnology poses significant risks to human health. Although some research is already being done, increased funding for agencies such as the EPA, the National Institute for Occupational Safety and Health, and the National Institute for Environmental Health Sciences is clearly needed. Such activities at the EPA now account for less than 1 percent of the total NNI budget.

Effective Regs Key

Federal regulations key to effective nanotech

White House 11 (Executive Office of the President, “MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES,” 06/09/2011, http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf, AC)
The National Nanotechnology Initiative (NNI), one of the Obama Administration's top science and ¶ technology priorities, has invested almost $14 billion in research and development since its inception in ¶ FY 2001. A key goal of the NNI is the responsible development of nanotechnology, which requires ¶ maximizing the benefits of nanotechnology while understanding and managing the relevant risks. As the ¶ President's Council of Advisors on Science and Technology noted, "In the absence of sound science on ¶ the safe use of nanomaterials and of technologies and products containing them, the chance of ¶ unintentionally harming people and the environment increases. At the same time, uncertainty and ¶ speculation about potential risks threaten to undermine consumer and business confidence." Accordingly, ¶ the Federal Government has significantly increased funding on the environmental, health and safety ¶ dimensions of nanotechnology, from $37.7 million in FY 2006 to $123.5 million in FY 2012. ¶ The National Economic Council (NEC), the Office of Management and Budget (OMB), the Office of ¶ Science and Technology Policy (OSTP), and the Office of the U.S. Trade Representative (USTR) led a ¶ multi-agency consensus-based process to develop a set of principles to guide development and ¶ implementation of policies for the oversight of nanotechnology applications and nanomaterials. This ¶ document is intended to summarize generally applicable principles relevant to promoting a balanced, ¶ science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner ¶ that protects human health, safety, and the environment without prejudging new technologies or creating ¶ unnecessary barriers to trade or hampering innovation. These principles build on the foundation provided ¶ by current regulatory statutes and do not supersede existing legal authorities or hinder Federal agencies ¶ from enforcing or applying their existing statutory and regulatory authority as mandated by law. Federal ¶ agencies that have regulatory responsibilities, such as the U.S. Environmental Protection Agency, the U.S. ¶ Food and Drug Administration, and the Occupational Safety and Health Administration, must continue to ¶ implement sound policies to protect public health, safety, and the environment. ¶ The Federal Government is responsible for protecting human health and the environment and takes ¶ regulatory and oversight actions to ensure the safe production, processing, use, and disposal of many ¶ kinds of products - including foods and consumer products, chemicals used in the workplace, medical ¶ products, and pesticides. This framework for oversight and regulation of nanomaterials and applications ¶ of nanotechnology builds on existing laws and individual authorities, such as the risk-based approaches ¶ currently in use by some Federal agencies to meet this overarching responsibility. A fundamental element ¶ of these risk-based approaches is to examine those characteristics and properties of a material that are ¶ relevant to considerations about human and environmental safety-such as exposure, biodistribution ¶ (including absorption, distribution, metabolism, and excretion), persistence, bioaccumulation, toxicity, ¶ and pharmacokinetics- and therefore present issues of potential regulatory relevance. Such risk-based ¶ approaches reflect awareness that regulation should be grounded in the best available science and able to ¶ evolve as scientific insights mature and the body of evidence grows and evolves. Consistent with current ¶ law, regulatory agencies should take a science-based approach to risk management.

Effective Regulations

Gov’t key to effective R&D and development regulations

Kay and Shapira 8 (Luciano, research professional with Ph.D. degree in Public Policy, and Philip, professor in the School of Public Policy, “Developing nanotechnology in Latin America,” Journal of Nanoparticle Research, 09/18/2008, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2988220/, AC)

Moreover, our data shows relatively low government involvement in nanotechnology research publication, except for Argentina where there are several governmental labs that are actively involved in research. However, the role of government clearly may extends beyond this. Nanotechnology policies may give the role of broker to government agencies to enable knowledge transfer, sharing, and exchange between industry and academia. These agencies may also help in coordinating national R&D efforts and promote broader participation and citizen input on the use of nanotechnology applications (Chiancone et al. 2007; Invernizzi 2007). Furthermore, they can design regulation schemes to ensure the development of nanotechnology according to social and environmental standards

Regs/Assistance Key

Squo development is focused solely on competitiveness – govt regulations key to solve structural problems

Foladori and Invernizzi 12 (Guillermo Foladori and Noela Invernizzi, ReLANS coordinators, Doctoral Program in Development Studies, “Social and Environmental Implications of Nanotechnology Development in Latin America and the Caribbean,” 2012, AC)
The science and technology policy of the majority of countries¶ in Latin America explicitly affirms that the priority function of¶ nanotechnology is to promote international competiveness. The search¶ for market niches and the orientation towards the global market are clear¶ and explicit objectives in the national policies of the region. Although¶ there are research groups that work on aspects of nanotechnology that¶ have a direct impact on society and the environment, such as research¶ groups on nanotechnology on health, on environmental protection, on¶ alternatives for potable water, and alternative energies, the fact that the¶ political orientation has been towards competiveness, in addition to the¶ strong pressure that public research is conducted with the participation¶ of private companies, raises doubts that if the potential impact will not¶ end with simply increasing the profits of the companies involved. In¶ addition, the only way that the science and technology policy responds¶ to interests more directed towards society is if unions, consumers¶ groups, environmental organizations, and other social organizations¶ participate in the decision making, something which is absent in these¶ countries.¶ The second issue of concern is the absence of training programs for the¶ work force, and also at the different educational levels. Nanotechnology¶ policy is oriented towards the idea of “centers of excellence” staffed by¶ highly skilled and educated employees. It is presumed that these centers¶ of excellence will provide increased opportunities for innovation. But¶ no country develops without supporting laborers with all levels of¶ educational background, and without preparing and qualifying its¶ workforce. There exists a strong contradiction between the processes¶ of privatization and deterioration of elementary, secondary, and¶ university education, and the idea of developing centers of excellence /¶ specialization. The United States, Japan and the European Union stated¶ the necessity of educating about nanotechnology in the curriculum of¶ elementary and secondary schools. There have been no similar plans¶ made for any Latin America or the Caribbean countries’ educational¶ system; hence, the manner in which nanotechnology comes solely¶ from the centers of excellence only can orient it towards the foreign¶ market and competitiveness, thereby losing the vision of the role that¶ this technology could have to relieve basic problems of the population¶ in general.¶

Leadership & Regs Key

New regulations and US leadership key to spur nanotech development

Lane et. al 7 (Neal Lane, professor of physics at Rice University, was director of NSF from 1993 to 1998 and science advisor to President Clinton beginning in 1998. Thomas Kalil, assistant to the chancellor for science and technology at the University of California at Berkeley, was deputy assistant to the president for technology and economic policy and deputy director of the National Economic Council during the Clinton administration, 2007, The National Nanotechnology Initiative: Present at the Creation, http://www.issues.org/21.4/lane.html)
Although the research community and companies involved in nanotechnology must be careful not to overpromise and underdeliver, the technology’s long-term potential is awe-inspiring. Although we will inevitably be surprised by the future course of nanotechnology, with continued investments in high-risk research many of the grand challenges that have been established will eventually be met. However, we cannot expect the United States to lead this technological revolution with the current policies that short-change research. It is our sincere hope that we will respond to the growing challenges to U.S. scientific, technological, and economic leadership before it is too late.

K Investor Confidence

Federal leadership key to investor confidence in nanotechnology

Lane et. al 7 (Neal Lane, professor of physics at Rice University, was director of NSF from 1993 to 1998 and science advisor to President Clinton beginning in 1998. Thomas Kalil, assistant to the chancellor for science and technology at the University of California at Berkeley, was deputy assistant to the president for technology and economic policy and deputy director of the National Economic Council during the Clinton administration, 2007, The National Nanotechnology Initiative: Present at the Creation, http://www.issues.org/21.4/lane.html)

Help nanotechnology start-ups cross the “valley of death.”Part of the argument for increased funding for research is that it will eventually fuel the creation of new companies, new industries, and high-wage jobs. Moving ideas from the lab to the marketplace is never easy, particularly in nanotechnology. A big gap exists between showing that a nanostructure has some novel and useful property and demonstrating high-volume cost-effective manufacturing. Although one might argue that venture capitalists should fund this “reduction to practice,” most of them are reluctant to invest in early-stage technology development. With institutional investors still counting their losses from the “dot com” era, they are urging venture capitalists to shift to later-stage, less risky investments, reducing the capital available for seed investments in spinoffs from universities and national labs. We believe that the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Program should be used more aggressively to help nanotechnology start-ups cross the chasm between proof of principle and reduction to practice. NIH has done this by increasing the duration and size of its SBIR grants for nanotechnology and allowing entrepreneurs to submit a broad range of ideas for using nanotechnology to help prevent, detect, diagnose, and treat disease. Other agencies should adopt a similar approach in applications of nanotechnology that are related to their mission.

Commercialization

Federal leadership and commitment key to motivate companies to commercialize the nanotech industry

Theodore and Kunz 5 (Louis Theodore, EngScD, a professor of chemical engineering for fifty years, Robert G. Kunz, environmental engineering manager at a major industrial gas and chemical company before retiring after twenty-six years. He also worked in the petroleum industry, on plant design/construction, and for a manufacturer of air pollution control catalyst. He is currently an independent environmental consultant. Dr. Kunz earned a BChE degree in chemical engineering from Manhattan College, a PhD in chemical engineering from Rensselaer Polytechnic Institute, an MS in environmental engineering from Newark College of Engineering, and an MBA from Temple University, April 22, 2005, “Nanotechnology: Environmental Implications and Solutions,” p. 64)

For nanotechnology’s most ardent supporters, the scope of this emerging held seems¶ to be limited only by the imaginations of those who would dream at these unprecedented dimensions. However, considerable technological and financial obstacles¶ still need to be reconciled before nanotechnology’s full promise can be realized.¶ Ranking high among the challenges is the ongoing need to develop and perfect¶ reliable techniques to produce (and mass produce) nanoscaled particles that have¶ not just the desirable particle sizes and particle size distributions but also a¶ minimal number of structural defects and acceptable purity levels, since these¶ latter attributes can drastically alter the anticipated behavior of the nanoscaled particles. Experience to date shows that the scale up issues associated with moving¶ today's promising nanotechnology-related developments from laboratory- and¶ pilot-scale demonstrations to full-scale commercialization can be considerable.¶ The prevailing technologies for producing nanoscaled particles and carbon nano-¶ tubes are discussed in Section 2.3. In addition to the inherent challenges associated with designing and scaling up¶ various methodologies to produce nanoscaled materials that have the right particle¶ attributes, additional challenges arise in terms of handling and using these minute¶ particles as functional additives in other matrix materials. For instance, the extremely high surface area of these minute particles creates problems that must be¶ reconciled related to excessive attractive or repulsive surface charges. unwanted¶ nanoparticle agglomeration, problems with dispersion and blending, and so on.¶ Meanwhile, nanoscaled materials generally command very high prices compared¶ to conventional, macroscopic particles that have essentially the same chemical com-¶ position. Such high costs result from energy that is required to reduce the particle¶ size and from the high research and development and prototyping costs that are¶ incurred during the discovery phase of any novel materials and the related manufacturing processes. However, many industry observers acknowledge that the current¶ prices for many nanoscaled materials represent experimental quantities produced¶ at pilot facilities, and predict that the prices are likely to come down, once steady-¶ state, commercial-scale manufacturing conditions are perfected and pursued.7¶ Ultimately, premium costs associated with nanoscaled particles, devices, and¶ systems will have to be proven and justified in performance. For instance, if a¶ low-cost, micron-scale powder will suffice in a particular application, the end user¶ is not likely to pay a premium price for its nanoscaled counterpart, whose cost¶ may be orders of magnitude higher.". Companies need a strong motivation for¶ why they should replace an existing approach with a newer, nanotechnology-¶ based approach.' Such capacity and cost issues will be key factors that will continue¶ to influence market development and commercial adoption of nanotechnology-¶ based materials and processes into the future.