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Nanotechnology, the buzzword of the 21st century, stirs continual debate around the issue of regulation. Two diverse schools of thought prevail. U.S. regulators maintain that the unique size and properties of nanoscale materials do not warrant new regulation. In the absence of scientific evidence to the contrary, their position is that current safety and health regulations are adequate to address the risks associated with nanotechnology, and advocate more research and study. In contrast to this argument are positions proffered by advocacy groups and non-government organizations, who allege that current regulations are not sufficiently elastic to address the unique and novel risks to people and the environment posed by nanoparticles. They reason that simply tinkering with existing regulations will not address the broad social, health, environmental and economic concerns of technologies converging at the nanoscale, and propose the drafting of new regulations. These differences in thought pervade international discourse. Nanotechnology products are commercially available today. Laboratory workers and consumers are exposed to nanoparticles in cosmetics, sunscreens, tennis balls and the fabric used for Dockers pants. However, there are no labeling requirements for nanoparticles, nor special toxicity assessment mandates. The long-term effects of applying nanoparticles to the skin are wholly unknown. Man-made structures less than 100 nanometers in size may exhibit unusual properties. One nanometer is one-billionth of a meter. Can the size, shape, surface chemistry and composition of a particle contribute to a changed level of toxicity at the nanoscale, thereby altering its effect? Is exposure to quantum properties of materials a risk? At the nanoscale, do the same regulations and laws apply — from international trade law, to treaties banning chemical and biological weapons, to regulations governing medicine and the environment? THE FDA The mission of the U.S. Food and Drug Administration (FDA) is to ensure the safety and efficacy of drugs, drug delivery systems, cosmetics, medical devices, vaccines and food products before reaching the marketplace. The FDA does not regulate processes or technology. It regulates products against claims as presented by the product sponsor. It does this by placing a product into one of three regulatory categories: pre-market approval, market clearance and post-market surveillance. Under pre-market approval, the FDA approves new pharmaceuticals, high-risk medical devices and biologicals prior to market entry after the producer or sponsor of the product has identified, assessed and addressed each risk and how it will be minimized in its application. The market clearance category requires the FDA receive and review notice that products will be marketed, oftentimes copies of similar products previously approved or products prepared to pre-approved specifications. In the post-market surveillance category, the FDA manages and monitors product risks that are generally recognized as safe, regulated by the application of good manufacturing practices, and takes action if adverse events threaten health. The FDA defines nanotechnology as: research and technology development, or products regulated by the FDA, that are at the atomic, molecular or macromolecular levels, and where at least one dimension, that affects the functional behavior of the product, is in the length scale of approximately 1-100 nanometers; creating and using structures, devices and systems that have novel properties and functions because of their small and/or intermediate size; and the ability to control or manipulate at the atomic scale. All three components must be present to be considered nanotechnology. Organized by product line, the FDA cites that it has traditionally regulated many products with particulate materials in the nano-size range and that the current pharmacotoxicity tests are sufficiently adequate for most nanotechnology products that it will regulate. But size is not the only issued, according to Donald E. Marlowe, agency standards coordinator at the FDA. “The FDA anticipates that many nanotechnology products will span the regulatory boundaries between pharmaceuticals, medical devices and biologicals, be regulated as ‘combination products,’ and the review will be coordinated by the Office of Combination Products,” he said. The FDA will determine the product’s primary mode of action — whether a drug, medical device, or biological product, subsequently establishing its regulatory framework. One of the uncertainties the FDA faces is determining when the performance of a product is a function of the size of the particular material. It recently confronted this challenge with Angstrom Medica, a life-sciences biomaterials company that applied to the FDA for market clearance approval for a new process for forming synthetic bone-based orthopedic implants. In February, for the first time, the FDA gave market clearance approval, within 29 days from date of application, to calcium phosphate nanocrystals �- NanOss — fully dense, nanocrystalline, transparent monoliths that can form complex shapes frequently used in orthopedic surgery, such as screws, pins, and Interbody fusion devices. Angstrom Medica harnessed its nanostructured material and used its processing to produce calcium phosphate nanocrystals similar in composition to human bone, for several orthopedic applications. “Nanotechnology has enabled Angstrom Medica to develop a biomaterial that otherwise would not be possible,” said Chairman and CEO Paul J. Mraz. Size did matter. While nanotechnology brings with it euphoria and promise, it equally generates caution for the societal implications of the technology itself, and the alleged shortcomings of societal institutions to place effective controls on its technological evolution. Preliminary studies speculate that some nanoscale substances may be harmful to health or the environment. THE EPA One of the statutes under which commercial applications of nanotechnology is likely to be regulated is the Toxic Substances Control Act, 15 U.S.C. s/s 2601 et seq. (TSCA). Passed by Congress in 1976, TSCA gives the Environmental Protection Agency (EPA) the authority to prohibit or limit the manufacture of particular chemicals based on risk assessments, and the power to regulate and control new and existing chemical substances in commercial use with risk or potential risk to the environment. In 15 U.S.C. 2602 �(2)(a), TSCA defines a chemical substance as: “any organic or inorganic substance of a particular molecular identity, including any combination of such substance occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical.” In 15 U.S.C. 2602 �(9), it defines a new chemical substance as “any chemical substance which is not included in the chemicals substance list compiled and published under Section 2607(b) of the TSCA Chemical Substance Inventory.” “EPA would appear to share the better view that size alone does not functionally ‘delist’ a chemical from its inventory status,” said Lynn L. Bergeson, a founding shareholder of Washington’s Bergeson & Campbell. “EPA’s Office of Pollution Prevention and Toxics is very much engaged in the review of nanomaterials consisting of chemical substances and their implications under TSCA.” “Nanotechnology is the newest technology that the government must evaluate for its benefits and risks,” said Jim Alwood, associate branch chief of the existing chemicals branch in the Chemical Control Division of the EPA. “While nanotechnology is not a known hazard, it encompasses a broad category, where basic information such as effective and clear chemical nomenclature, risk assessment tools, and standards for evaluation are in short supply.” At issue is whether nanoscale materials in the TSCA inventory are defined as new or existing chemicals; as well as the possible revision to test guidelines, and standards development in conducting human and environmental toxicity testing of nanoscale materials. Just as there is the potential for risk, so are there possible environmental benefits. Nanotechnology could help bring about the development of new tools to detect, monitor, and reduce pollution through applications such as nanosensors and smart dust; as well as the establishment of environmentally benign manufacturing processes; and the creation of cleaner and more cost-efficient energy. However, while nanotechnology is touted as the driving force behind the next industrial revolution, John H. Marburger III, science advisor to President George W. Bush and chief of the White House Office of Science and Technology, recently announced that the toxicity studies currently being conducted are “a drop in the bucket compared to what needs to be done.” CONCLUSION With any innovation, there are benefits accompanied by anticipated, unintended or unknown risks. These contingent risks are not going unnoticed. In 2004, an estimated $106 million in research on the health and environmental aspects of nanoscale materials was funded by agencies participating in the National Nanotechnology Initiative, to study and evaluate the potential risks associated with exposure to nanomaterials. To date, the results are inconclusive and speculative. While the FDA regulates 20 percent of consumer purchases, and $50 billion of medical research and development, it is attentive to the concerns associated with nanotechnology, claiming that its current regulatory structure is adequate to ensure product safety, and well-prepared to address unidentified nanoscale issues as they develop. The EPA is hoping to convene a one-day stakeholder meeting in Washington to discuss whether and how best to address potential risks posed by nanotechnology applications involving chemical substances. To date, it is still unclear whether TSCA, in its existing form, can effectively address the alleged challenges posed by nanotechnology. As Bergeson has stated: “A key question is whether a nanoconfiguration of a chemical, carbon, for example, which is intended to impart new chemical and/or physical properties, should be considered a new chemical, a significant new use of an existing chemical, a modified but not significant new use of an existing chemical, or none of the above because the TSCA framework is ill-suited to address these issues.” As nanotechnology advances, continued research and monitoring of possible risks, coupled with flexible and collaborative federal agency-run regulatory structures, as well as dialogue with interested stakeholders, may result in the modification of current regulatory regimes. The FDA and the EPA are only two such agencies under which nanotechnology may be regulated. However, the burden is not just on regulatory agencies, but also on companies developing new products and devices utilizing nanoscale materials. Industry must be an active participant and take responsibility for potential unintended consequences resulting from their research and development, and manufacturing processes of nanomaterials. It is also important to recognize that an aggressive call for regulation could aggravate and stifle the very development and promising opportunities of nanotechnology. Sonia E. Miller, an attorney in private practice in New York and Washington, D.C., is the founder and president of the Converging Technologies Bar Association.

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