All Published Articles

Bergeson & Campbell, P.C., "PEN Updates," Nanotechnology Industries Association Newsletter, March 12, 2011.

On the 10th March 2011, the Project on Emerging Nanotechnologies (PEN) announced that it had updated its nanotech consumer products inventory, and that it continues to grow to include over 1,300 manufacturer-identified, nanotechnology-enabled products that have entered the commercial marketplace around the world. The most recent update to the group's five-year-old inventory reflects the continuing use of the nanoscale materials in everything from conventional products like sports equipment to more unique items such as self-cleaning window treatments.

Bergeson & Campbell, P.C., "US-EU Workshop Literally Covers the Waterfront," Nanotechnology Industries Association Newsletter, March 12, 2011.

The National Nanotechnology Initiative (NNI) held a joint workshop in Washington, D.C., entitled 'US-EU Bridging Nano EHS Research Efforts' (10th - 11th March 2011). The workshop was intended to continue the robust dialogue between the United States (US) and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives.

Bergeson & Campbell, P.C., "US National Organic Program Approves Ban on Engineered Nanomaterials from Organic Products," Nanotechnology Industries Association Newsletter, March 5, 2011.

On December 17, 2010, the US National Organic Program (NOP) voted to accept the recommendation of the US National Organic Standards Board (NOSB) to prohibit engineered nanomaterials from the production, processing, and packaging of certified organic products. The decision was made with little fanfare, but has big implications. 

Bergeson & Campbell, P.C., "Nano Governance: The Current State of Federal, State, and International Regulation," Nanotechnology Industries Association Newsletter, March 3, 2011.

On May 19, 2011, the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER) Pesticides, Chemical Regulation, and Right-to-Know Committee will present a half-day webinar program on nano governance. Nanotechnology Industries Association's intrepid leader, Dr. Steffi Friedrichs, is scheduled to present at this important program.

Lynn L. Bergeson, "OSHA Updates PPE Standards," Chemical Processing, March 2010.

On February 15, 2011, the Occupational Safety and Health Administration (OSHA) issued a revised directive that provides enforcement guidance on determining whether employers have complied with OSHA's personal protective equipment (PPE) standards. The Enforcement Guidance for Personal Protective Equipment in General Industry, CPL 02-01-050, is the latest word from OSHA on PPE, and an important document for employers and employees alike.

Lynn L. Bergeson, "Selling Green: US FTC Releases Proposed Revisions to the ‘Green Guides’," Environmental Quality Management, Spring 2011.

After more than three years of discussion, research, review, and debate, the United States Federal Trade Commission (US FTC) released proposed revisions to its Guides for the Use of Environmental Marketing Claims (the “Green Guides”) in late 2010. The Green Guides provide FTC “guidance” on what is and is not appropriate in the ever-fluid area of environmental marketing. They are designed to help product marketers avoid making false and misleading environmental claims that might violate section 5 of the Federal Trade Commission (FTC) Act.

Lynn L. Bergeson, "2010 Elections Could Impact EPA Programs," Chemical Processing, December 2010.

The 2010 Congressional elections will likely significantly impact policy and legislative developments in the U.S. Environmental Protection Agency's (EPA) regulation of chemicals and pesticides. The decline in the number of elected House Democratic members will make for some significant differences in EPA's budget, legislative proposals and general operations. Meanwhile, some newly elected senators stridently oppose government expansion and want to rein in federal deficit spending, which could affect the future of EPA and other government agencies.

Lynn L. Bergeson, "Workplace Falls Get Fresh Attention," Chemical Processing, August 2010.

The U.S. Occupational Safety and Health Administration (OSHA) is tackling a major source of industrial injuries -- slips, trips and falls on workplace surfaces. On May 24, OSHA proposed significant revisions to Subparts D and I of the general industry standards dealing with walking-working surfaces and personal protective equipment (PPE), respectively. This column outlines the reasons why OSHA believes changes are needed to protect workers, and key revisions to these standards.

Bergeson & Campbell, P.C., "Nanotech and Jobs: Congress Weighs In," Nanotechnology Industries Association Newsletter, February 11, 2011.

The new Republication-led House of Representatives has expressed its concerns with what it refers to as the adverse impact of regulations on jobs and the economy.

Bergeson & Campbell, P.C., "South Korea Chemicals Program Targets Nanomaterials," Nanotechnology Industries Association Newsletter, February 4, 2011.

The United Nations' Strategic Approach to International Chemicals Management (SAICM) urges each nation to make efforts to reduce hazards associated with the use of chemicals. In response to this request, South Korea recently has taken steps to implement a process for the management of chemicals with the objective of minimizing the harmful effects that substances have on human health and the environment.

James V. Aidala, "Make My Day! - Registrant Gets Court To Order EPA To Cancel Their Product," Pesticide and Chemical Policy, February 4, 2011.

Reckitt Benckiser is a manufacturer of a variety of household cleaning and pesticide products, including rodenticides, sold widely under the D-Con brand. In recent years Reckitt Benckiser has formulated rodenticide products using what is known as a “second-generation” anti-coagulant, brodifacoum. The term second-generation refers to the lack of resistance in rodents, which has developed in some cases to earlier, “first-generation” anti-coagulant products, such as warfarin.

Lynn L. Bergeson, "2011 Predictions for US Chemicals Management," Chemical Watch, February 2011.

The trends established by the Obama Administration will continue despite the Congressional mid-term elections in November.

Lynn L. Bergeson, "Emerging Nanomaterial Governance Systems: The State of Play," Molecular Imaging, January-February 2011.

Domestic laws, their implementing regulations and policies, and government and private-party governance programs are now being carefully reviewed and revised to enhance their utility to manage the potential risks posed by nanoscale materials. Whether existing laws and their implementing programs are adequate to address such risks will continue to inspire debate and legislative and regulatory initiatives for years to come. This article reviews existing legal and governance oversight systems and analyzes their strengths and deficiencies in addressing the potential risks posed by nanoscale materials and in fostering nanotechnology's promise.

Bergeson & Campbell, P.C., "The NanoRelease Project," Nanotechnology Industries Association Newsletter, January 29, 2011.

There is an exciting and promising project underway that is being coordinated by the Research Foundation of the International Life Science Institute (ILSI-RF) called the NanoRelease Project.

Bergeson & Campbell, P.C., "Nano Regulation and the New US Congress," Nanotechnology Industries Association Newsletter, January 21, 2011.

The U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxic Substances (OPPT) and Office of Pesticide Programs (OPP) were both active with regard to nanoscale materials regulation and policy in 2010. The new year is expected to see comparable activity.

Lynn L. Bergeson and Charles M. Auer, "Nano Disclosures: Too Small to Matter or Too Big to Ignore?," Natural Resources & Environment, Winter 2011.

Determining whether the presence of nanoscale materials in chemical substances, mixtures, and articles triggers a disclosure obligation is complicated. The decision turns on a calculus that includes what law applies, what is known about the presence of nanoscale components, what knowledge standard applies, whether and how a nanoscale material is defined, and an entity’s interpretation of disclosure obligations. This article outlines the state of domestic environmental and securities law and regulatory policy regarding disclosure obligations pertinent to nanoscale materials. The article concludes that there are a growing number of potential disclosure obligations of which commercial entities should be aware, but that the nature of these requirements continues to be fluid and ill-defined.

Lynn L. Bergeson, "SCPA Delays Could Impact Industry," Chemical Processing, January 2011.

In response to concerns expressed by diverse stakeholders over the final draft of its Safer Consumer Product Alternatives (SCPA) regulations, the California Environmental Protection Agency (CalEPA) has delayed implementation of the regulations, which focus on chemicals and chemical ingredients in consumer products. The net effect of this recent development on the regulation of chemical substances in consumer products in California is uncertain. This column discusses the recent change in plans and its implications for the chemical community.

Bergeson & Campbell, P.C., "California DTSC Issues DCI for Nano Metals, Nano Metal Oxides, and Quantum Dots," Nanotechnology Industries Association Newsletter, January 12, 2011.

On December 21, 2010, the California Department of Toxic Substances Control (DTSC) issued a much anticipated data call-in (DCI) for information regarding analytical test methods, and other relevant information, from manufacturers of nano silver, nano zero valent iron, nano titanium dioxide, nano zinc oxide, nano cerium oxide, and quantum dots.

Bergeson & Campbell, P.C., "Delayed Implementation of Safer Consumer Product Alternatives Regulations: Implications for Nanoscal," Nanotechnology Industries Association Newsletter, January 1, 2011.

In response to concerns vigorously expressed by diverse stakeholders over the final draft of the Safer Consumer Product Alternatives (SCPA) Regulations, the California Environmental Protection Agency (CalEPA) has effectively delayed implementation of the much-anticipated regulations.

Lynn L. Bergeson, "The Proposed TSCA Inventory Update Reporting Rule: Big Changes Are in Store," Environmental Quality Management, Winter 2010.

While debate continues to swirl around whether, and to what extent, the Toxic Substances Control Act (TSCA) needs retooling, just about everyone agrees that the U.S. Environmental Protection Agency (US EPA) needs more information on chemical production, use, and exposure in order to make informed decisions about chemical risk management. Most also agree that TSCA could be put to greater use for these purposes.

Lynn L. Bergeson, "Revisions to the ‘Green Guides’," Pollution Engineering, December 2010.

Early in October, the Federal Trade Commission (FTC) released important revisions to its Guides for the Use of Environmental Marketing Claims (Green Guides) to make them easier for companies to use and understand.

Lynn L. Bergeson, "CPSC Moves Ahead on Harmful Products Database," Chemical Processing, November 2010.

The Consumer Product Safety Commission (CPSC) posted on its website on October 14, 2010, its draft final rule concerning the creation of a publicly available, searchable database on the safety of consumer products and other substances subject to CPSC regulation. The database is intended to provide a single point of access to reports of harm involving consumer products, manufacturer's comments on the reports, and recall information. This article discusses this important new database, and briefly considers its implications.

Lynn L. Bergeson, "U.S. Adopts Global Transportation Standards," Pollution Engineering, November 2010.

New proposed shipping rules that harmonize with international standards will require some study.

Lynn L. Bergeson and James V. Aidala, "How the Elections Could Impact the EPA," Law 360, November 9, 2010.

This article provides a summary outlook on possible implications of the 2010 congressional midterm elections on policy and legislative developments in the U.S. Environmental Protection Agency’s regulation of chemicals and pesticides.

Lynn L. Bergeson, "Facts and Consequences," The Environmental Forum, November/December 2010.
Lynn L. Bergeson, "New Inventory Update Rule Reporting Heads Our Way," Chemical Processing, October 2010.

The U.S. Environmental Protection Agency (EPA) proposed important revisions to the Toxic Substances Control Act (TSCA) Inventory Update Rule (IUR). This column explains why chemical manufacturers and other stakeholders must be aware of the proposal and prepare now for its implications.

Lynn L. Bergeson, "TSCA Reform: Legislative Action Begins," Environmental Quality Management, Autumn 2010.

On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, S. 3209 (SCA),1 which is intended to address the “core failings” of the Toxic Substances Control Act (TSCA).

Lynn L. Bergeson, "Toxicity Testing Moves Ahead," Chemical Processing, September 2010.

Who would have thought that an automated laboratory working around the clock could screen chemical substances for interactions with biological targets at speeds mere mortals could hardly consider — let alone match? Well, this is exactly what is occurring today thanks to a collaborative effort known as "Tox21" among the U.S. Environmental Protection Agency (EPA), the National Toxicology Program (NTP), and the National Institute of Health Chemical Genomics Center (NCGC). Recently, the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) joined the initiative. This column describes this ground-breaking partnership.

Lynn L. Bergeson, "Washington:  California Is Setting Precedent," Manufacturing Today, Fall 2010.

The California Department of Toxic Substances Control (DTSC) released on June 23, 2010, draft regulations implementing California’s precedent-setting and game-changing Green Chemistry Initiative. Manufacturers need to understand how this controversial regulatory program may operate, and why it will alter forever the way consumer products are designed and manufactured.

Lynn L. Bergeson, "Legal Lookout: EPA Issues Final “Tailoring” GHG Permitting Rule," Pollution Engineering, August 2010.

On June 3, 2010, the U.S. Environmental Protection Agency (EPA) issued a final rule addressing greenhouse gas (GHG) emissions from stationary sources under the Clean Air Act (CAA). This controversial rule set thresholds for GHG emissions that define when permits under the New Source Review Prevention of Significant Deterioration (PSD) and Title V operating permit programs are required for new and existing industrial facilities.

Lynn L. Bergeson, "What’s New in Nano?," Trends, July/August 2010.

There are many nanotechnology governance activities underway at the federal, state, and international levels of which nano aficionados should be aware. Here is a quick summary of key initiatives.

Lynn L. Bergeson, "Developments on Nanomaterial Governance in U.S. Gather Pace," Chemical Watch, July/August 2010.

Nanotechnology governance initiatives in the US abound and there is no reason to think the pace will slow. Lynn L. Bergeson offers a summary of key initiatives.

Lynn L. Bergeson, "Transportation Revisions Are Coming Down the Pipeline," Chemical Processing, July 2010.

The U.S. Department of Transportation's (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) recently signaled interest in revising the hazardous materials regulations (HMR) governing transportation of combustible materials. PHMSA seeks to harmonize domestic and international regulations applicable to transportation of combustible liquids.

Lynn L. Bergeson, "Washington: Safe for Humans?," Manufacturing Today, Summer 2010.

Hundreds of U.S. businesses have already received in the mail test orders issued by the U.S. Environmental Protection Agency (EPA) for initial endocrine screening under the Endocrine Disruptor Screening Program (EDSP). Hundreds more will receive orders later this year. How recipients respond to an EDSP test order can present challenging issues. This article explains why.

Lynn L. Bergeson, "Nanosilver Pesticide Products: What Does the Future Hold?," Environmental Quality Management, Summer 2010.

Last issue’s installment of the “Washington Watch” column discussed some key issues surrounding nanosilver and noted an ongoing review by the U.S. Environmental Protection Agency (US EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP). Now that the SAP has issued its much-anticipated report and recommendations, it is worth revisiting the topic of nanosilver pesticides.

Lynn L. Bergeson, "Tiny Particles Get Big Attention," Chemical Processing, June 2010.

Nanoscale materials may figure in Toxic Substances Control Act (TSCA) reform. While not mentioning "nanotechnology," a bill introduced on April 15, by Sen. Frank Lautenberg (D-NJ) addresses chemicals with "special substantive characteristics." The bill authorizes the U.S. Environmental Protection Agency (EPA) to evaluate and compel data on new/special uses of existing chemicals "separate from any use of the chemical substance that does not exhibit such special substance characteristics" or on new chemical substances exhibiting such characteristics.

Lynn L. Bergeson, "Legal Lookout: Endocrine Disruptors: Test Orders Abound," Pollution Engineering, June 2010.

In April 2009, EPA identified a final list of 67 chemicals for initial screening under the Endocrine Disruptor Screening Program (EDSP). From October 2009 to April 2010, the agency issued more than 700 test orders. Responding to an EDSP test order can present challenging issues. The agency began implementing this mandate well over a decade ago through the EDSP.

Lynn L. Bergeson, "Guest Editorial: The IRIS Assessment of Inorganic Arsenic: Is Science Being Hijacked?," Trends, Spring 2010.

The arsenic Integrated Risk Information System (IRIS) assessment exemplifies the current administration’s unwillingness to walk its own talk on transparency and scientific integrity.

Charles M. Auer, Lynn L. Bergeson, and Lisa R. Burchi, "TSCA Section 5(b)(4) ‘Chemicals of Concern’ List: Questions, Issues, Concerns," Daily Environment Report, May 24, 2010.

The Toxic Substances Control Act (TSCA) allows the U.S. Environmental Protection Agency (EPA) to keep a list of chemicals that present or may present ‘‘an unreasonable risk of injury to health or the environment.’’ This authority has not been used since TSCA was enacted in 1976. In April, EPA said it intends to propose a rule to add a category of eight phthalates, a category of polybrominated diphenyl ethers, and bisphenol A to such a list. In this article, the authors explore EPA’s authority under Section 5(b)(4) of the TSCA to create a ‘‘chemicals of concern’’ list and discuss legal and policy issues that may arise.

James V. Aidala, "The Toxic Substances Control Act: From the perspective of James V. Aidala," interviewed by Chemical Heritage Foundation, May 20, 2010.

James V. Aidala began working with the Environmental Protection Agency (EPA) as a college intern in the Office of Pesticide Programs; he returned as a policy analyst in the new Office of Pesticides and Toxic Substances (OPTS) after graduate school. From Aidala’s perspective, there was much uncertainty in the early years of Toxic Substances Control Act (TSCA), in part due to challenges with the law’s specificity regarding polychlorinated biphenyls and, later, asbestos and lead, and in part due to logistical, organizational, and legal difficulties in the early years of TSCA. He also felt that the Reagan Administration was fatal to a cohesive toxics program.

Lynn L. Bergeson, "EPA Seeks to Lift Stay," Chemical Processing, May 2010.

Earlier this year, the U.S. Environmental Protection Agency (EPA) proposed lifting its 1994 administrative stay of Emergency Planning and Community Right-to-Know Act (EPCRA) Section 313 reporting requirements for hydrogen sulfide (H2S). Following is an explanation of why some are concerned, why EPA proposed lifting the stay, and why reporting may be unnecessary in the first place.

Lynn L. Bergeson, "Chemical Pollutants in Water Emerge," Chemical Processing, April 2010.

Recent advances in contaminant identification methodologies, sampling instrumentation, and analytical chemistry have caused an explosion of knowledge about the presence of previously undetected organic micropollutants. While it doesn't follow that the mere presence of chemical contaminants results in harm, public health experts, regulators, and others aren't sitting idly by.

Charles M. Auer, "Periodic Reporting of Hazard Data, Exposure Information on Existing Chemicals," Daily Environment Report, Apr. 14, 2010.

A Recent co-authored paper discussed a number of fundamental changes in U.S. regulation of commercial chemicals that should be considered in revising the Toxic Substances Control Act. As discussed in that paper, while the Environmental Protection Agency under TSCA has broad authority to require testing and reporting of hazard and exposure information on existing chemicals via rulemaking, deploying these authorities have proven cumbersome and inadequate for dealing effectively with the thousands of chemicals in commerce.

Lynn L. Bergeson, "Nanosilver: EPA's Pesticide Office Considers How Best to Proceed," Environmental Quality Management, Spring 2010.

In the super-hyped world of nano, nanosilver is the proverbial poster child for all things good and evil, depending upon your perspective. Silver enjoys many commercial applications, and its well recognized antimicrobial properties have been utilized since the beginnings of recorded history. Perhaps because of this success and high visibility, some are taking aim at silver and questioning whether there is too much silver used in industrial applications -- and in particular whether there is too much silver used in consumer product applications in the form of nanoscale silver.

Charles M. Auer, Lynn L. Bergeson, and James V. Aidala, "EPA's Action Plans Signal a New Chapter for TSCA While Informing the Future Legislative Debate on Chemicals," Environmental Law Reporter, March 2010.

Late last December, U.S. Environmental Protection Agency (EPA) Administrator Lisa P. Jackson announced action plans on phthalates, long-chain chlorinated paraffins (LCCPs), and short-chain chlorinated paraffins (SCCPs). The four action plans are the first of many, as EPA intends to issue eight more or so in 2010. This EPA initiative announces actions that are almost breathtaking in scope, and its development and implementation of the action plan items will set a number of new precedents -- and possibly shape future legislative proposals -- that industry will need to participate in and monitor closely.

Lynn L. Bergeson, "Aligning Chemicals Labeling with Global Rules Involves Major Efforts," Chemical Processing, March 2010.

The Occupational Safety and Health Administration (OSHA) began the Herculean task of aligning the U.S.'s Hazardous Communication Standard (HCS) with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) in September 2009. GHS provides harmonized criteria for classifying chemicals according to their health and physical hazards, and specifies hazard communication elements for labeling and creating safety data sheets (SDS).

Lynn L. Bergeson, "Disclosure Protection May Narrow," Chemical Processing, February 2010.

A business' ability to claim information as confidential when submitted to the U.S. Environmental Protection Agency (EPA) may soon be at risk, based on several EPA initiatives rolled out over the past year. As Congress gears up for Toxic Substances Control Act (TSCA) legislative reform, stakeholders are preparing for changes in the scope of confidential business information (CBI) protection under TSCA.

Lynn L. Bergeson, "EPA Moves Closer to GHG Control," Pollution Engineering, February 2010.

EPA has put itself on the path toward greenhouse gas regulation, but in Congress, the courts, and the international community, the debate rages on. On Dec. 7, 2009, EPA moved one step closer to imposing the first ever set of enforceable greenhouse gas (GHG) standards on tailpipe emissions from vehicles, and a requirement that large power plants and industrial emitters install best available control technology (BACT) to reduce emissions.

Lynn L. Bergeson, "OSHA Kicks Off the 'Chemical NEP'," Environmental Quarterly Management, Winter 2009.

With little fanfare, the United States Occupational Safety and Health Administration (OSHA) has rolled out its much anticipated “PSM Covered Chemical Facilities National Emphasis Program.” This one-year pilot program, launched in July 2009, focuses on facilities’ compliance with the OSHA Process Safety Management (PSM) standard,1 which aims to blunt the hazard of fires or explosions resulting from releases of “highly hazardous chemicals.” This “Washington Watch” column reviews the new pilot program and assesses the implications of the program for regulated facilities.

Lynn L. Bergeson, "FIFRA SAP Convenes First Nano Review," NanoBusiness Alliance Newsletter, Issue 13, January 18, 2010.

On November 3-5, 2009, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) met to consider for the first time scientific issues related to the assessment of potential hazard and exposure associated with nanosilver and other nanometal pesticide products. This column briefly summarizes the discussion, and speculates on the outcome.

Lynn L. Bergeson and Leslie Scott MacDougall, co-authors, "Turkey Enacts REACH-Like Chemical Program," Chemical Regulation Reporter, January 18, 2010.

In December 2008, Turkey enacted the Inventory and Control of Chemicals Regulation, a scaled-down version of the European Union’s REACH regulation to establish an inventory of chemicals produced and imported into Turkey and to better control potential risks posed by those chemical substances. Adoption of the regulation is one of many steps Turkey is required to take to secure membership in the European Union. The authors of this article advise chemical manufacturers and importers to obtain as much information as possible on the regulation and its implementation and to stay abreast of forthcoming clarifications.

Lynn L. Bergeson, "EPA Takes Unprecedented Action," Chemical Processing, January 2010.

The U.S. Environmental Protection Agency (EPA) on December 30, 2009, issued a breathtaking series of action plans on "Risk List" chemicals that will shape future legislative proposals which industry will need to participate in and monitor.

Lynn L. Bergeson, "Hazard Standards," Manufacturing Today, Winter 2010.

The Occupational Safety and Health Administration (OSHA) proposed on Sept. 30, 2009, to align the Hazard Communication Standard (HCS) with provisions of the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The HCS requires chemical manufacturers and importers to evaluate chemical hazards and provide information to subsequent users. The standard now requires employers to establish a hazard communication program for employees who are exposed to chemicals in the workplace. Elements of the program include container labels, safety data sheets (SDS), and employee training.

Lynn L. Bergeson, "Prepare to Report Climate Risks," Chemical Processing, December 2009.

Publicly traded companies are required, under Securities and Exchange Commission (SEC) regulations, to disclose known and contingent material liabilities to ensure investors have reliable information on which to base their investment decisions. Increasingly, investor groups, nongovernment organizations (NGO), and others demand companies assess and disclose their financial risks from climate change. Following are recent developments advising that companies carefully consider how best to address their SEC climate change disclosure obligations.

Lynn L. Bergeson, "The Endocrine Disruptor Screening Program: Where Are We?," Environmental Quarterly Management, Autumn 2009.

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 implications of the program for industry stakeholders.

Lynn L. Bergeson, "EPA Targets Electric Utilities," Chemical Processing, November 2009.

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 by coal ash staged in some 584 units at approximately 219 domestic electric utilities.

Lynn L. Bergeson, "FIFRA Scientific Advisory Panel Considers Nanosilver," Environmental Law Reporter, December 2009.

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 registration of products containing nanosilver-based active ingredients.

Lynn L. Bergeson, "EPA Launches Online Discussion," Chemical Processing, October 2009.

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.

Lynn L. Bergeson, "Washington: Marketing Green," Manufacturing Today, September 2009.

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.”

Lynn L. Bergeson, "Conquering Heroic Challenges: A Look at Hot Legal and Regulatory Issues You Need to Know," NACD Chemical Distributor, September, 2009.

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 unmistakable S of Superman (and Superwoman, of course) to survive, let alone flourish, in this harsh economic climate.

Lynn L. Bergeson, "Green Nanotechnology: Straddling Promise and Uncertainty," Natural Resources & Environment, Fall, 2009.

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.

Lynn L. Bergeson, "New on the Horizon: Nanotechnology," The John Liner Review, Summer 2009.

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.

Lynn L. Bergeson, "2009 and Beyond: Outlook for Environmental Issues," Environmental Quality Management, Summer 2009.

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.

Lynn L. Bergeson, "Safety Comes First for Nanotechnology," Chemical Processing, July 2009.

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 implications of this wonderful new stewardship tool.

Lynn L. Bergeson, Lisa M. Campbell, and Lisa R. Burchi, "Endocrine Disruptor Screening Program: Data Sharing, Compensation, Protection," BNA Daily Environment Report, June 29, 2009.

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)

Lynn L. Bergeson, "EPA Working on Test Rule for Multi-Wall Carbon Nanotubes/TSCA Section 8(a) Rule for Several Nanoscale Substances," NanoBusiness Alliance Newsletter, Issue 8, June 18, 2009.

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.

Lynn L. Bergeson, "Anti-Terrorism Mandates Face Major Revision: Prospective legislation may put more emphasis on inherent safety," Chemical Processing, June 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.

Lynn L. Bergeson, "EPA Updates IRIS Process, Again," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 10, No. 4, June 2009.

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 scientific integrity of the IRIS process.”

Lynn L. Bergeson, "What’s New in Nanotechnology Regulations," Manufacturing Today, Spring 2009.

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.

Lynn L. Bergeson, "Chemical Regulation: Preparing to Address the Challenges Ahead," Environmental Law Reporter, January 2009.

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 thoughts on how best to prepare for effective chemical regulation reform. 

Lynn L. Bergeson, "Legislators Set Agenda for Change," Chemical Processing, January 2009.

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.

Lynn L. Bergeson and Michael F. Cole, "Food and Drug Administration’s Regulation of Nanotechnology," Daily Environment Report, Sep. 22, 2008.

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 correlate the information from submissions required for certain products. When the facts clearly warrant it, the authors recommend FDA issue guidance documents that set forth the issues to address in making filing determinations, but the need for such filings should follow the established, existing framework unless and until that framework is proven inadequate.

Lynn L. Bergeson, "EPA Seeks Big Help with Nanomaterials Data," Chemical Processing, October 2008.

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.

Lynn L. Bergeson, "The New Business of Nanotechnology: Exploring Commercial Opportunities and Risks," Environmental Claims Journal, April 2008.

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 potential risks and regulatory challenges nanotechnology invites. While research is progressing briskly on key hazard and exposure nanotechnology issues, much remains to be done leaving commercial applications of nanotechnology in new, unsettled waters. This article identifies some of these challenges and the non-conventional, innovative ways that lawyers, business managers, risk assessors, and others must embrace to manage risk and avoid liability effectively.

Lynn L. Bergeson, "Good Governance: Evolution of the Nanoscale Materials Stewardship Program," Nanotechnology Law & Business, Winter 2007.

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 under the Toxic Substances Control Act (TSCA) to mandate the submission of information and data, and to do so quickly. This article discusses the origins and current status of EPA’s voluntary Nanoscale Materials Stewardship Program (NMSP), outlines the key issues EPA confronted in developing the Program, and discusses the reasons why it is critically important for nanotechnology stakeholders to participate in the Program early and robustly. While stakeholders may not agree on what is the best way for EPA to obtain information on nanoscale materials, there is broad consensus that NMSP participation is critically important to maintain the public trust and confidence in this emerging technology, to provide EPA with needed information and data, and to demonstrate that potentially more burdensome rulemaking initiatives are not needed to achieve these goals. 

Lynn L. Bergeson, "The EPA’s Toxic Substances Control Act: What you must know," Environmental Expert Newsletter, November 2007.

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?” 

Lynn L. Bergeson, co-author, "TSCA and Engineered Nanoscale Substances," Sustainable Development Law and Policy, Fall 2007.

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 environment, health, and safety (“EHS”) issues associated with ENM.

Lynn L. Bergeson, "EPA Issues Draft NMSP Concept Paper and TSCA Inventory Paper," Small Times Magazine, August 10, 2007.

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 particular molecular identity." 

Lynn L. Bergeson, "TSCA Inventory Status of Nanoscale Substances a Must-Read for Materials Developers," Small Times Magazine, August 10, 2007.

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 particular molecular identity." 

Lynn L. Bergeson, "EPA Issues Draft NMSP Concept Paper and TSCA Inventory Paper," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 8, No. 3, August 2007.

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.

Lynn L. Bergeson, "Changing the Guard: Implications of the Democratic Midterm Election Win on Environment, Energy, and Resources Legislation," Environmental Quality Management, Spring 2007.

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.

Lynn L. Bergeson and Joseph E. Plamondon, "TSCA and Engineered Nanoscale Substances," Nanotechnology Law & Business, March 2007.

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 it relates to new and existing chemical substances, and discusses how EPA may go about discharging its significant TSCA authority with respect to engineered nanoscale substances. 

Lynn L. Bergeson, panel expert, "Emerging Environmental Risk: A Global View," Risk Talk: Environmental Risk, Vol. 1, Issue 2.

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. 

Lynn L. Bergeson, "EPA Advances Voluntary Nanoscale Materials Stewardship Program," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 8, No. 1, January 2007.

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

Lynn L. Bergeson, "ABA SEER’S Review of Existing Laws and Nanotechnology," Gradient Corporation EH&S Nano News, October 2006.

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 identifies the legal and regulatory issues EPA will likely encounter as it considers how best to address issues arising in connection with nanotechnology. All seven briefing documents, which are solely the product of SEER and do not purport to represent the opinions of EPA, are available online

Lynn L. Bergeson, "Environmental Accountability: Keeping Pace with the Evolving Role of Responsible Environmental Corporate Stewardship," Environmental Quality Management, Autumn 2006.

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 accountability will increasingly serve as a key driving force to compel higher standards of corporate environmental accountability.

Lynn L. Bergeson and Michael F. Cole, "NanoBioConvergence—Emerging Diagnostic and Therapeutic Applications," Bioprocessing & Biopartnering 2006: Featuring NanoBiotechnology, 2006.

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 change radically the provision of healthcare in the decades ahead. 

Lynn L. Bergeson, "Small Sensors Promise Big Impact," Chemical Processing, July 2006.

. 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.

Lynn L. Bergeson, "Nanotechnologies and FIFRA," ChemADVISORY, July 2006.

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). 

Lynn L. Bergeson, "Views from the Chair: The Section’s Contributions to Nanotechnology," Trends: ABA Section of Environment, Energy, and Resources Newsletter, July/August 2006.
Lynn L. Bergeson, "Key Environmental Issues: Views from Inside the Beltway and Beyond," Environmental Quality Management, Summer 2006.

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. 

Lynn L. Bergeson, "Nanotechnologies and FIFRA," Gradient Corporation EH&S Nano News, April 2006.

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).

Lynn L. Bergeson and Michael F. Cole, "FDA Regulation of Food Packaging Produced Using Nanotechnology," Food Safety Magazine, April/May 2006.

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 additives without the need for clearance, and there is a regulatory process in place to review additives that require approval. The critical question in the food packaging area, as in every regulated industry, is whether existing precedents and process will be sufficient to address any issues that arise as the application of nanotechnology matures.

Lynn L. Bergeson, "Nanoscale Materials and TSCA:  EPA’s NPPTAC Recommends a Framework for a Voluntary Program," Environmental Quality Management, Spring 2006.

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 promulgated under the Toxic Substances Control Act (TSCA).

Lynn L. Bergeson, "EPA’s NPPTAC Recommends Framework for Voluntary Nanomaterials Program," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 7, No. 1, February 2006.

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 requirement under the Toxic Substances Control Act (TSCA), and is a must read for those wishing to stay abreast of nano developments.

Michael F. Cole, "RFID, Nano-Tools and the Electronic Safety Net: Nanotechnology may revolutionize the use of RFID in the battle against counterfeit drug imports," Health & Personal Care Magazine, February 2006.

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 distributors. 

Lynn L. Bergeson, "GAO Recommends TSCA Improvements, and a Senate Bill Responds with a Proposal," Environmental Quality Management, Winter 2005.

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 consumer products and otherwise address the deficiencies in TSCA outlined in the report. This column reviews the GAO report, the proposed Kid Safe Chemicals Act, and the outlook for both.

Lynn L. Bergeson, "EPA Considers How Best to Regulate Nanoscale Materials," Environmental Quality Management, Autumn 2005.

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).

Lynn L. Bergeson, "TSCA and Nanoscale Materials Update," Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 6, No. 4, August 2005.
Lynn L. Bergeson, "Avoid Mistakes of Past: Develop Nano Responsibly," The Environmental Forum, July/August 2005.
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