Articles

Approximately 5.4 million cubic yards, or 1.1 billion gallons, of coal ash from the Tennessee Valley Authority (TVA) plant near Knoxville, Tenn., in December 2008 flooded some 300 acres of land, damaging property, polluting waterways, and killing fish. TVA will likely spend more than $500 million and perhaps as much as $1 billion dollars on the cleanup, says the U.S. Environmental Protection Agency (EPA). The TVA debacle was EPA’s wake-up call for potential hazards presented...

On April 15, 2009, the U.S. Environmental Protection Agency (EPA) issued its final list of chemicals in the first group of substances that will be screened under the Endocrine Disruptor Screening Program (EDSP). Development of this list caps a long, thoughtful, and arduous administrative process that spans over a decade. This “Washington Watch” column briefly reviews the development of the program, with emphasis on key elements of the current EDSP. The discussion also highlights the...

On November 3-5, 2009, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met “to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.” The decision to convene an SAP was nominally motivated by the U.S. Environmental Protection Agency’s (EPA’s) need to consider four applications pending at the Office of Pesticide Programs (OPP) seeking...

Ever read a U.S. Environmental Protection Agency (EPA) press release and say to yourself or others, “Gee, why is EPA pursuing that matter – there are a lot of other more important enforcement priorities?” Well, now is your chance to help shape EPA’s 2011- 2013 fiscal years enforcement priorities. EPA launched an online discussion forum on August 31 to receive input on future priorities for EPA’s National Enforcement Program....

This article describes green nanotechnology and discusses the reasons why traditional chemicals-assessment and management approaches may not be adequate in all cases in the near term when applied to nanomaterials. It outlines the reasons why green nanotechnology may serve as an alternative approach to chemicals assessment when applied to nanomaterials and suggests some measures to advance the goals of green nanotechnology....

If the National Association of Chemical Distributors (NACD) had to select a song today that best reflects a typical member’s profile, it would have to be “It’s Not Easy To Be Me”. Challenged commercially by the credit crunch, escalating energy, labor, and raw material costs, squeezed by market pressures spawned by a badly damaged economy, and reeling from legal and regulatory challenges that are mushrooming exponentially, NACD members really do need red capes emblazoned with...

The growth in green marketing is getting a lot of attention these days, especially from the Federal Trade Commission (FTC), the federal agency tasked with preventing unfair and deceptive trade practices. Mindful of potential false and misleading advertising, FTC has been revising its Guides for the Use of Environmental Marketing Claims, known as the “Green Guides.”...

Managing any business is tough. Managing a nanotechnology (nanotech) business is tougher than most. This article briefly discusses this new and rapidly expanding field of applied science, outlines key risk management issues that companies engaged in the manufacture of nanoscale materials and nanotechnology-enabled products confront, and reviews existing and proposed governance and risk management mechanisms intended to address potential nanotechnology risks....

Earlier this year, the International Council on Nanotechnology (ICON), Houston, launched the GoodNanoGuide, which is available online. To cater to all audiences, the guide provides basic, intermediate and advanced options to choose from to contribute to or search within the online forum. This innovative approach sets a new standard for creative, interactive, Internet-based product stewardship tools. This column explains why you may want to take a look at the GoodNanoGuide and consider the...

With a new Congress in town and a new administration in charge of the U.S. Environmental Protection Agency (US EPA), 2009 promises to be an exciting and eventful year. This “Washington Watch” column provides a summary outlook on possible directional trends and developments in the regulation of key environmental issues over the coming months and years....

The U.S. Environmental Protection Agency (EPA) issued three important Federal Register notices April 15, 2009, laying the foundation for the Endocrine Disruptor Screening Program (EDSP), EPA’s next major data development initiative. This article focuses on those aspects of EPA’sFederal Register notices concerning how EPA will address joint data development, cost sharing, data compensation, and data protection under the EDSP (EDSP Policy Notice)...

As you may know, twice each year the U.S. Environmental Protection Agency (EPA) publishes a detailed listing of all matters on which it is working. The document is referred to as the Semiannual Regulatory Agenda, and is published each spring and fall. The most recent spring issue was published on May 11, 2009....

Congress is currently focusing on a key piece of legislation to reauthorize the Chemical Facility Anti-Terrorism Standards (CFATS), set to expire on October 4. This may lead to measures that are more far reaching and have a more significant impact upon the chemical industry....

The U.S. Environmental Protection Agency (EPA) announced on May 21, 2009, that it has reformed the Integrated Risk Information System (IRIS), again. According to EPA, the revisions are intended to “revitalize the program and ensure its scientific quality, integrity, transparency and timeliness.” In a May 21, 2009, memorandum, Administrator Jackson states that recent changes, including procedures formalized in an April 21, 2008, memorandum, “have reduced the transparency, timeliness, and...

Over the last several months, there have been a number of significant nano regulatory developments. The U.S. Environmental Protection Agency (EPA) released on Jan. 12, 2009, its interim report on the Nanoscale Materials Stewardship Program (NMSP). On Jan. 22, 2009, the California Department of Toxic Substances Control (CDTSC) issued a data call-in for certain nanoscale substances....

The environment has enjoyed unprecedented attention as a presidential campaign issue. While climate change, energy, and resource issues dominate, chemical regulation reform is plainly a topic gathering steam. As we approach a new year, a new Administration, and a new Congress, there is much to consider. Issues pertinent to chemical management are complicated, the rhetoric is strident, and areas on which stakeholders agree appear to be few and far between. This Article offers a few...

Regulations are expected to target the chemical industry in 2009. The new Administration and Congress promise an eventful new year — It may result in significant changes in direction for regulation of chemicals by the U.S. Environmental Protection Agency (EPA). Here’s a look at possible trends....

The Food and Drug Administration is considering further implementation of the recommendations made by its Nanotechnology Task Force in July 2007. The authors of this article note that nanotechnology will be a fact of life for FDA-regulated products for years to come. They say nanotechnology is an important issue, but only one among many that FDA must address, and FDA’s limited resources must be allocated sensibly. The authors suggest FDA build on existing databases and...

The U.S. Food and Drug Administration’s (FDA) approach to nanotechnology is the subject of intense interest for at least three reasons. First, many promising and visible applications of nano-technology include cosmetics, sunscreens, pharmaceuticals, dietary supplements, and medical devices. These products are subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA). Second, FDA faces unique challenges in regulating products of nanotechnology be-cause of the...

The nominal deadline to submit basic information on nanoscale materials under the Nanoscale Materials Stewardship Program (NMSP) of the U.S. Environmental Protection Agency (EPA) was July 28. While the deadline has passed, EPA is encouraging entities to submit information on an ongoing basis. The program objectives and how EPA will use the information to assess additional regulatory steps applicable to nanoscale materials deserve some attention....

There is an Alice-in-Wonderland awe associated with nanotechnology. While the technology is both exciting and hopeful for many good reasons, for businesses, and the lawyers who counsel them, the lack of certainty in areas involving potential risk is unsettling. The U.S. Environmental Protection Agency (EPA) is only now beginning to think through how best to apply the authority it has under the traditional environmental statutes, and to adopt regulatory programs and policies to address the...

Governance issues are seldom the subject of wide consensus, and the question of how best the U.S. Environmental Protection Agency (EPA) should obtain needed information and data on the human health and environmental implications of nanoscale materials is no exception. EPA has considered the issue carefully and believes, with good reason, that a voluntary approach makes the most sense at this time. Not everyone agrees, however, and some urge EPA to exercise its statutory authority...

Does the nanoscale substance you are producing or using require approval under the U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA)? It does if it’s new. But what exactly is “new?” ...

Nanotechnology is now the subject of much excitement and attention, with applications proliferating quickly. Thus, engineered nanoscale materials’ (“ENM”) implications for human health and the environment, and the critical need for governments throughout the world to get the policy and regulatory framework right has garnered much attention. Most would agree that the ultimate goal for society is to enable nanotechnology to realize its potential while effectively addressing the pertinent...

The EPA’s recently released paper, TSCA Inventory Status of Nanoscale Substances — General Approach, is important for developers of nanotechnologies. Nanomaterials that meet the Toxic Substances Control Act (TSCA) definition of “chemical substance” are subject to TSCA reporting requirements because they may exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part, “any organic or inorganic substance of a...

The EPA’s recently released paper, TSCA Inventory Status of Nanoscale Substances — General Approach, is important for developers of nanotechnologies. Nanomaterials that meet the Toxic Substances Control Act (TSCA) definition of “chemical substance” are subject to TSCA reporting requirements because they may exhibit properties different from the same substances in the bulk scale. A chemical substance means, in relevant part, “any organic or inorganic substance of a...

On July 12, 2007, the U.S. Environmental Protection Agency (EPA) published in the Federal Register three separate notices related to the long-awaited Nanoscale Materials Stewardship Program (NMSP) under the Toxic Substances Control Act (TSCA). All of the notices and accompanying documents are available online....

The November 2006 mid-term elections portend a number of significant Congressional changes. There is no doubt that Democratic leadership in both the House and Senate will shake things up. Some in the business community are buckling their seat belts and preparing for a bumpy ride. Here are a few thoughts on the shape of things to come....

This edition of Risk Talk focuses on emerging environmental risks from a global perspective. From local pollution problems to global warming, companies face a wide variety of environmental risks. The increasingly global economy requires that companies adopt a comprehensive environmental risk management strategy. Properly executed, such a strategy can give a company a competitive advantage. ...

The federal law that regulates new and existing chemical substances, including engineered nanoscale chemical substances, is the Toxic Substances Control Act (TSCA). While there is much debate over how the U.S. Environmental Protection Agency (EPA) should deploy its significant TSCA authority to address potential risks to human health and the environment posed by engineered nanoscale materials, there is no doubt that EPA is already doing so. This article provides a general overview of TSCA as...

Over the past several months, the U.S. Environmental Protection Agency (EPA) has made significant progress advancing its Nanoscale Materials Stewardship Program (NMSP). ...

The American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) offered to brief representatives of the US Environmental Protection Agency’s (EPA) Office of General Counsel on legal and regulatory issues arising in connection with the application of existing statutory and regulatory authorities to engineered nanoscale materials. SEER prepared briefing documents on each statute, and a separate briefing document on innovative governance mechanisms. Each document...

This “Washington Watch” column outlines the concept of environmental accountability, provides a summary overview of the many mechanisms that are included within this broad topic, and discusses the role that environmental accountability plays in influencing corporate business standards pertinent to environmental performance. As government resources earmarked for more traditional environmental enforcement and compliance-assistance initiatives continue to dwindle, environmental...

Many people regard nanotechnology as a “stand-alone” technology. While the technology itself is of great interest, the most intriguing aspect of nanotechnology is that it is increasingly being utilised as an integral part of a more complicated convergence matrix. The intersection of nanotechnology, biotechnology, information technology, and cognitive science, otherwise referred to as ‘NBIC convergence’, is leading to the development of nanobiotechnology products that promise to...

. In the past year, there has been an appreciable upswing in new products developed and commercialized pertinent to “intelligent” water monitoring tools and devices involving nanotechnology. Because many environmental applications of nanotechnology will almost certainly revolutionize the science, law, and regulation of water pollution, readers are urged to keep abreast of this fast-changing area....

This column explores applications of nanotechnologies in the agricultural sector, and a few of the issues the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is now considering regarding nanotechnologies and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). ...

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With the mid-term elections fast approaching, the Bush Administration is probably feeling a bit unsettled about its ability to defend its record on environmental accomplishments. The Bush Administration’s record on environmental accomplishments is, according to most environmental groups, weak if not downright bad. This column identifies several key environmental issues that may elicit potential voter response. ...

This column explores applications of nanotechnologies in the agricultural sector, and a few of the issues the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is now considering regarding nanotechnologies and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)....

Food packaging materials must comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Nanopackaging for the most part involves the use of materials that are not intended to have any effect on the food in the package, but may contact the food if the material migrates from the packaging. Such materials are regulated as indirect food additives or food contact substances. There are precedents that permit the marketing of indirect food...

The U.S. Environmental Protection Agency (EPA) National Pollution Prevention and Toxics Advisory Committee (NPPTAC) forwarded to EPA Administrator Stephen L. Johnson on November 22, 2005, its document entitled Overview of Issues for Consideration by NPPTAC. The Overview of Issues document sets forth NPPTAC’s “analysis and views” on a framework for a voluntary program on existing engineered nanoscale materials. The framework is intended to complement the new nanoscale chemicals requirements...

In November 2005, the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) forwarded to U.S. Environmental Protection Agency (EPA) Administrator Johnson its document entitled Overview of Issues for Consideration by NPPTAC. The Overview of Issues document sets forth the NPPTAC’s analysis and views on a framework for an approach to a voluntary program for existing engineered nanoscale materials. The framework is intended to complement the approach to the new nanoscale chemicals...

Radio frequency identification (RFID) technology is revolutionizing the business of tracking inventory and, soon, the U.S. Food and Drug Administration (FDA) will use it to combat counterfeit drugs. The challenges of RFID adoption, in turn, might act as an additional impetus to the development of nanotechnology solutions. FDA views RFID as the most promising technology to combat the flow of counterfeit drugs to U.S. consumers, and encourages the adoption of RFID by manufacturers and...

In June 2005, the Government Accountability Office (GAO) issued a report critical of the federal government’s ability under the Toxic Substances Control Act (TSCA) to assess and prevent risks from new and existing chemical substances. Release of the GAO report coincided with the introduction by Senators Frank Lautenberg and James Jeffords of the Kid Safe Chemicals Act (S. 1391), a bill intended to improve children’s health by reducing exposure to harmful toxic chemicals in everyday...

In a May 10, 2005, Federal Register notice, EPA announced, in an understated way, its decision to convene a public meeting on ‘nanoscale materials.’ The meeting notice represents the Agency’s first public foray into harnessing some of nanotechnology’s promise within a regulatory framework created almost three decades ago with the enactment of the Toxic Substances Control Act (TSCA)....

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