CHEMICAL PRODUCT DEVELOPMENT AND DEFENSE

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Lynn L. Bergeson, "EPA Proposes HPV Test Rule for Chemicals," Manufacturing Today, Summer 2008.
In July, the U.S. Environmental Protection Agency (EPA) published a proposed test rule under Section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) that would require manufacturers, importers and processors of certain high-production volume (HPV) chemicals to conduct testing. That EPA is renewing its focus on chemical testing, and use of its authority under TSCA Section 4 is noteworthy for the majority of the manufacturing industry.

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 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, "Court Sides with EPA on MACT," Pollution Engineering, August 2008.
On June 6, 2008, the U.S. Court of Appeals for the District of Columbia denied the Natural Resources Defense Council's (NRDC) petition for review of the U.S. Environmental Protection Agency's (EPA) 2006 national emissions standards for hazardous air pollutants (NESHAP) for the synthetic organic chemical manufacturing industry (SOCMI).

Lynn L. Bergeson, "New Bills Target Chemicals," Chemical Processing, July 2008.
As an influx of Democrats is expected in the new Congress, it surprises no one that Sen. Frank Lautenberg (D-N.J.) recently introduced a bill that would amend the Toxic Substances Control Act (TSCA) by adding a new Title V to reduce the exposure of children, workers, and consumers to “toxic chemical substances.” U.S. Rep. Hilda Solis (D-Calif.) introduced the same legislation, H.R. 6100, in the House of Representatives. The legislation has been referred to the Senate Committee on Environment and Public Works and the House Committee on Energy and Commerce. The bills would establish a national goal of by 2020 eliminating the exposure of all children, workers, consumers and sensitive subgroups to harmful chemicals distributed in commerce. If enacted, the bills could dramatically impact chemical manufacturing and processing.

Lynn L. Bergeson, "North American ChAMP Revealed," Pollution Engineering, June 2008.
In March, EPA announced that it intends to fulfill its Montebello commitments through the Chemical Assessment and Management Program (ChAMP).

Lynn L. Bergeson, "Avoiding the Costs of Non-Compliance," Manufacturing Today, March/April 2008.
Many manufacturers are focused on reducing costs and increasing sales. Typically, regulatory issues do neither. In fact, many believe that environmental, health and safety (EHS) issues come right out of the bottom line and do little to improve profit margins and generate revenue. This is incorrect.

Lynn L. Bergeson, "FTC Reviews Environmental Marketing Guides," Pollution Engineering, April 2008.
Green sells, but discerning between true environmentalism and an eco-feint for the sake of marketing is not as easy as it seems. This fact has not been lost on the Federal Trade Commission (FTC), which has updated its guide on claiming how to proclaim greenness.

Lynn L. Bergeson, "This Issue Carries Big Stakes," Chemical Processing, April 2008.
California's denied greenhouse gas waiver has ripple effect across nation.

Lynn L. Bergeson, "Concern Grows Over Products Containing Lead," Chemical Processing, March 2008.
EPA rule requires chemical manufacturers, processors to submit lists.

Lynn L. Bergeson, "Chemical Management, North American Style," Environmental Quality Management, Spring 2008.
This “Washington Watch” column discusses the Montebello Agreement, noting its origin in the Security and Prosperity Partnership of North America and explaining its potential implications for the future. The discussion also provides context on other chemical management schemes -- particularly REACH.

Lynn L. Bergeson, "2008 Outlook for Chemicals and Pesticides," Pollution Engineering, March 2008.
With this being an election year, little legislation is expected to be considered during 2008 on the environmental front. Endocrine disruptors, however, will be a main subject of review in 2008. The U.S. Environmental Protection Agency (EPA) seeks to impose the initial screening test requirements on a number of pesticides before the end of this year. Any test results will then be considered by the next administration, but even before that, the selection or removal from the list of pesticides to be tested may itself become controversial.

Lynn L. Bergeson, "Act Before There’s Not a Drop to Drink," Chemical Processing, February 2008.
Ground water protection is the responsibility of everyone including the chemical industry. An energetic group of state and federal ground water agencies, industry, environmentalists and other stakeholders, however, has made it a key area of their focus. The Ground Water Protection Council (GWPC) is a nonprofit Section 501(c)(6) organization dedicated to promoting and ensuring the use of best management practices and “fair but effective” laws regarding comprehensive groundwater protection.

Lynn L. Bergeson, "The Semiannual Regulatory Agenda: A Useful Document," Pollution Engineering, February 2008.
EPA’s Semiannual Regulatory Agenda is an excellent source of information on environmental regulatory and policy developments. As its names suggests, this document is issued twice a year, once in the spring and again around mid-December. It is chock full of information on EPA regulations and major policy initiatives that are under development, reviews of existing regulations, and major policy makings completed and/or cancelled since the previous agenda. For any environmental professional, the Regulatory Agenda, as it has come to be called, is indispensable.

Lynn L. Bergeson, "Get the Lead Out," Chemical Processing, January 2008.
By any independent standard, the federal government has made significant progress in reducing lead concentrations in ambient air. Average lead concentrations have dropped 96% since the 1980s, primarily due to the ban on lead in motor vehicle gasoline. Since the late 1970s, bloodlead concentrations for children ages 1 to 5 have decreased dramatically, from about 15 micrograms per deciliter to less than 2. The success has been so dramatic, the U.S. Environmental Protection Agency (EPA) is now considering whether to maintain, revise, or eliminate current lead National Ambient Air Quality Standards (NAAQS). EPA, in late December, issued an advance notice of proposed rulemaking (ANPR) and invited comment on all issues. This is the chemical industry’s opportunity to provide input.

Lynn L. Bergeson, "REACHing the Montebello Agreement," Pollution Engineering, January 2008.
In August, EPA, Canada and Mexico announced in Montebello, Quebec, new efforts to ensure the safe manufacture and use of industrial chemicals by entering into a regional partnership for assessing and managing potential chemical risks. As part of what is now referred to as the "Montebello Agreement" made at the Security and Prosperity Partnership (SPP) of North America Leaders' Summit, these countries agreed to coordinate efforts to assess approximately 9,000 industrial chemicals that are produced or imported in volumes above 25,000 pounds per year.

Lynn L. Bergeson, "Product Stewardship Grows Globally," Chemical Processing, December 2007.
Product stewardship can be expressed in many ways, and there’s no single best definition. According to the U. S. Environmental Protection Agency (EPA), “[p]roduct stewardship is a product-centered approach to environmental protection. Also known as extended product responsibility (EPR), product stewardship calls on those in the product life cycle -- manufacturers, retailers, users and disposers -- to share responsibility for reducing the environmental impacts of products (www.epa.gov/epaoswer/non-hw/reduce/epr/about/index.htm).”

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 and I. Dassa, "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 Clarifies Position on Ion-Generating Equipment," Chemical Processing, November 2007.

Lynn L. Bergeson, Ira Dassa, and Steven Green, "REACH and Pesticides: What U.S. Exporters May Not Realize," Daily Environment Report, Nov. 7, 2007.
Pesticide manufacturers and formulators may believe (blissfully so) that the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation is someone else’s headache. After all, it applies to industrial chemicals, not pesticides. Think again. Inert ingredients included in pesticide formulations are subject to REACH, as are nonpesticidal uses of active ingredients. This article discusses these aspects of REACH and outlines what pesticide formulators and others need to know about the new regulation.

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, "Chemical Facility Anti-Terrorism Standards: Chemicals of Interest," Environmental Quality Management, Autumn 2007.
In the last issue of Environmental Quality Management, this column discussed the April 2, 2007, U.S. Department of Homeland Security (DHS) interim final rule on anti-terrorism standards for chemical facilities. On the same day the interim final rule was issued, DHS also issued (and requested comment on) a list of 344 “chemicals of interest,” included in Appendix A to the rule. This "Washington Watch" briefly reviews key issues associated with the chemicals of interest, as well as the comments received on the proposed chemical list, and the Department's likely next steps in this regard.

Lynn L. Bergeson, "The EPA’s Toxic Substances Control Act: What You Must Know," Small Times Magazine, September/October 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, "EPA Identifies Endocrine Disruptor Chemicals," Pollution Engineering, September 2007.
On June 18, 2007, EPA issued its long-awaited draft list of chemicals selected for so-called “Tier 1” screening under the Endocrine Disruptor Screening Program (EDSP). EPA repeatedly emphasized in the notice, as well as in other statements it prepared relating to the notice, that the list should not be construed as a list of known or likely endocrine disruptors. The final list of chemicals will be issued after the comment period closes and the agency reconsiders the list of 73 chemicals.

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 at http://www.epa.gov/opptintr/nano/nmspfr.htm.

Lynn L. Bergeson, "Nanotechnology, Boom or Bust," Pollution Engineering, August 2007.
A well-known consumer organization now believes that the government should provide more funds for risk research and regulation of nanotechnology, and should require manufacturers to report health problems linked with nano-ingredients.

Lynn L. Bergeson, "Redefining Solid Waste -- Again," Pollution Engineering, July 2007.
On March 26, 2007, EPA announced the issuance of a sweeping proposal to modify the RCRA definition of solid waste. The proposal seeks to streamline regulation of hazardous secondary materials, and revise the definition of solid waste to exclude certain secondary materials from RCRA regulation to promote the legitimate recycling of these materials. The proposed rule is available at http://www.epa.gov/fedrgstr/EPA-WASTE/2007/March/Day-26/f5159.pdf, and comments were due on or before May 25, 2007.

Lynn L. Bergeson, "State and Local Governments Step Into Toxics Regulation," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 8, No. 2, June 2007.
According to the Center for International Environmental Law (CIEL), federal inaction on chemicals management and regulation has spurred state and even local government entities to step into toxics regulation. CIEL issued a position paper last May, Cloudy Skies, Chance of Sun: A Forecast for U.S. Reform of Chemicals Policy, predicting exactly this result. CIEL points to the fact that at least six states that have enacted legislation or issued some other state initiative to restrict certain polybrominated flame retardants. As discussed below, several recent initiatives tend to support the view that state and local governments are more willing now than previously to consider legislation on and issue regulations pertinent to chemical substances.

Lynn L. Bergeson, "Chemical Facility Anti-Terrorism Standards: The Final Rule is Out, but the Debate Continues," Environmental Quality Management, Summer 2007.
On April 2, 2007, the U.S. Department of Homeland Security (DHS) issued its much-awaited interim final rule on anti-terrorism standards for chemical facilities. The rule was published a week later in the Federal Register. The interim final rule is quite similar to the proposed rule that DHS published under an Advance Notice of Proposed Rulemaking in December 2006. The interim final rule does manage to address several of the more controversial issues generated by the December proposal. As is usually the case, however, not everyone is happy with the outcome. This column briefly reviews the legislative mandate authorizing the rule, summarizes the interim final regulation, and outlines the key issues that continue to inspire debate on the hot topic of chemical plant security.

Lynn L. Bergeson, "'Innocent Report Shows How Regs Vary Around the World," Manufacturing Today, May/June 2007.

Lynn L. Bergeson, "EPA Speeds Alternative Method Approvals," Pollution Engineering, June 2007.
As anyone in the water business will tell you, standard analytical methods are critically important. On April 10, 2007, the EPA announced its intent to implement an expedited process for approving alternative analytical testing methods under various federal water programs.

Lynn L. Bergeson, "EPA Issues Proposed Revisions to Definition of Solid Waste," Environmental Expert Newsletter, June 2007.
The definition of “solid waste” under the federal Resource Conservation and Recovery Act (RCRA) is unquestionably one of the most difficult environmental concepts to get one's head around. Even after 27 years, the U.S. Environmental Protection Agency (EPA) is still tinkering with revisions to the definition to better define the types of recycling activities that fall within the scope of the definition, and those that fall outside of its scope. In March, EPA announced issuance of a sweeping and long-awaited proposal to modify the RCRA definition of solid waste. The proposal seeks to streamline regulation of so-called hazardous “secondary” materials, and revise the all-important definition of solid waste to exclude certain secondary materials, such as solvents, metals and certain other chemicals, from RCRA regulation to promote the legitimate recycling of such materials.

Lynn L. Bergeson, "EPA Issues Metals Risk Assessment Framework," Pollution Engineering, May 2007.
Businesses have long believed that assessing potential risks from metal and inorganic chemical exposures are qualitatively and quantitatively different from assessing potential risks from organic chemical substances. On March 8, EPA capped off an intensive effort that fundamentally recognized these differences in announcing the availability of its final Framework for Metals Risk Assessment. The framework is available at http://www.epa.gov/osa/metalsframework/pdfs/metals-risk-assessment-final-3-8-07.pdf.

Lynn L. Bergeson, "EPA Issues Proposed Revisions to Definition of Solid Waste," Manufacturing Today, March/April 2007.
The definition of “solid waste” under the federal Resource Conservation and Recovery Act (RCRA) is unquestionably one of the most difficult environmental concepts to get one's head around. Even after 27 years, the U.S. Environmental Protection Agency (EPA) is still tinkering with revisions to the definition to better define the types of recycling activities that fall within the scope of the definition, and those that fall outside of its scope. In March, EPA announced issuance of a sweeping and long-awaited proposal to modify the RCRA definition of solid waste. The proposal seeks to streamline regulation of so-called hazardous “secondary” materials, and revise the all-important definition of solid waste to exclude certain secondary materials, such as solvents, metals and certain other chemicals, from RCRA regulation to promote the legitimate recycling of such materials.

Lynn L. Bergeson, "Executive Order Supports Alternative Fuel Use," Pollution Engineering, April 2007.
On January 24, 2007, President Bush signed Executive Order (EO) 13423, Strengthening Federal Environmental, Energy and Transportation Management, which mandates that federal agencies reduce oil consumption, use more alternative fuels and curb greenhouse gas emissions. In his 2007 State of the Union address, Bush announced plans to reduce U.S. gasoline usage by 20 percent in 10 years. The EO also renews the administration's commitment to environmentally friendly procurement practices.

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, 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 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, "EPA Issues Final SPCC Plan Amendments," Pollution Engineering, March 2007.
Last December, EPA issued final amendments to the Spill Prevention, Control and Countermeasure (SPCC) plan requirements. The final rule included new provisions outlining requirements for various classes of oil, revised the applicability of the regulation, and amended requirements for completing the plans, among other modifications. EPA plans to add further adjustments in 2007.

Lynn L. Bergeson, "'REACH' Has Arrived: U.S. Manufacturers Need To Be Ready," Manufacturing Today, January/February 2007.

Lynn L. Bergeson, "EPA's 'Tips' Website Is a Hit," Pollution Engineering, February 2007.
When the Senate Environment and Public Works Committee confirmed Granta Nakayama as Assistant Administrator of EPA’s Office of Enforcement and Compliance Assurance (OECA), it was unclear what his agenda might include. Few predicted, then, that EPA’s top enforcement official would reinvigorate the EPA tip website as a means for prompting compliance.

Lynn L. Bergeson, "GHS: Federal Agencies Step Up Efforts," Pollution Engineering, January 2007.
Now that the United Nations has adopted the Global Harmonization System of Classification and Labeling of Chemicals (GHS), there is an international goal for as many countries as possible to implement GHS by 2008. GHS is an important global system of hazard classification, communication and labeling which, if implemented, is expected to bring much needed consistency and harmony to the workplace. Domestically, federal agencies are stepping up efforts to get with the program.

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, "The Chemical Safety and Hazard Investigation Board: Thinking Strategically in Investigating (and Preventing) Chemical Accidents," Environmental Quality Management, Winter 2006.
Chemical accidents are always unwanted, and almost always the subject of considerable media attention and public scrutiny. Investigating the causes of chemical accidents is not an easy task, nor is the job of communicating the results of such investigations. Given the significant importance of the mission and day-to-day work of the U.S. Chemical Safety and Hazard Investigation Board (the "CSB" or "Board"), whose job is to investigate and prevent accidents, the release in August of its draft strategic plan for fiscal years 2007-20121 received remarkably little fanfare. This "Washington Watch" column provides some background on the CSB, and outlines key elements of its draft strategic plan.

Lynn L. Bergeson, "The Globalization of Product Stewardship Is Under Way," Manufacturing Today, November/December 2006.
Product stewardship is critically important these days as international stewardship initiatives and directives involving specific products -- typically consumer products -- are sprouting up everywhere. In Europe, for example, several directives are likely to greatly influence global product stewardship. Environmental regulation historically has been expressed through command-and-control mechanisms of governance.

Lynn L. Bergeson, "Get Answers to Your Biomonitoring Questions," Chemical Processing, November 2006.
Guidance for chemical manufacturers, processors, and distributors about Section 8(e) of the Toxic Substances control act was issued on September 14, 2006, by the U.S. Environmental Protection Agency (EPA). The guidance is available in new Q&As at http://www.epa.gov/oppt/tsca8e/pubs/qatsca.htm.

Lynn L. Bergeson, "Getting to Harmonization," Pollution Engineering, November 2006.
On September 12, 2006, the Occupational Safety and Health Administration (OSHA) issued an advance notice of proposed rulemaking (ANPR) for the implementation of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The agency also made available a Guide to the Globally Harmonized System of Classification and Labeling of Chemicals. On October 18, 2006, the U.S. Environmental Protection Agency (EPA) convened a public meeting to discuss the GHS and pesticide labeling issues.

Lynn L. Bergeson, "Expect Tighter Particulate Matter Standards," Chemical Processing, October 2006.
Particulate matter (PM) is a hot button issue poised to raise business costs and litigation. The U.S. Environmental Protection Agency (EPA) was recently due to issue final PM standard revisions. EPA last year proposed stronger National Ambient Air Quality Standards (NAAQSs) for fine PM (2.5 micrometers or less in diameter (PM2.5)) and the 24-hour PM2.5 standard. However, EPA sought to keep annual PM2.5 NAAQS of 15 μg/m3. EPA’s proposal was inconsistent with a Clean Air Scientific Advisory Committee (CASAC) recommendation to reduce standards to a 13 to 14 μg/m3 range. How EPA decides to proceed and which standards it selects are closely watched topics.

Lynn L. Bergeson, "EPA Meets FQPA Deadline," Pollution Engineering, October 2006.
August 3, 2006, marked the end of the 10-year deadline EPA was given under the 1996 Food Quality Protection Act (FQPA) to complete a review and reassessment of all tolerances (maximum permitted residues) for all food use pesticides. The agency claims to have completed over 99 percent of the reassessments. Despite its important implications for domestic food safety, the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended by FQPA a decade ago, remains one of the least understood federal environmental statutes. EPA is responsible for regulating the sale and use of pesticides, and the allowable levels in and on food. Their authority is set forth in FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA), both of which were amended by FQPA. FIFRA provides the overall framework for EPA’s regulation of pesticides. The FFDCA governs the establishment of pesticide tolerances for food and feed products.

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 at http://www.abanet.org/environ.

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.

David B. Fischer, "Making 'the Best' Better: Toward a More Useful Method of Reporting," Risk Policy Report, September 26, 2006.
On October 29, 1999, EPA published a final rule on reporting releases of persistent, bioaccumulative, and toxic (PBT) substances under the Toxics Release Inventory (TRI). This rulemaking was controversial for a host of reasons, not the least of which was EPA’s decision to create the astonishingly low reporting threshold of 0.1 grams for the newly added dioxin and dioxin-like compounds category -- over 10,000 times lower than the next lowest threshold level of 10 pounds. Facilities that inadvertently manufacture dioxin and dioxin-like compounds above the 0.1 gram threshold, through combustion for example, may now be subject to reporting release data and other waste management information for this category of compounds. In this rulemaking, and as described below, EPA chose an uncommon method of reporting dioxin and dioxin-like compounds, a method that EPA has recently acknowledged is not the “best way.” After years of contemplating a change, EPA is now poised to make the “best way” better.

Lynn L. Bergeson, "RoHS, WEEE and Related EU Directives," Pollution Engineering, September 2006.
Product stewardship is becoming increasingly important as international regulatory requirements involving product lifecycles become more prevalent. In Europe, several directives are likely to influence global product stewardship.

Lynn L. Bergeson, "EPA Expands Mercury Reduction Program," Pollution Engineering, August 2006.
Mercury is a naturally occurring metal found in the Earth’s crust. At high doses, mercury is known to cause adverse human health effects. Over the past several years, the U.S. Environmental Protection Agency (EPA) has focused on mercury exposures because of its potential to cause adverse human health and environmental effects, and because of its persistence and widespread distribution in the environment.

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, "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, "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, "The Coming of Low-Sulfur Diesel Fuels," Pollution Engineering, July 2006.
In May 2006, the U.S. Environmental Protection Agency (EPA) published new rules expanding upon its earlier suite of rules requiring the reduction of sulfur content in diesel fuels. This column reviews generally the diesel rules, and provides an overview of the opportunities they present.

Lynn L. Bergeson, "National Partnership for Environmental Priorities: Rewarding Waste Minimization," Pollution Engineering, June 2006.
The U.S. Environmental Protection Agency (EPA) seeks to reward efforts to reduce waste generation and emissions of chemicals that it believes are harmful. Its general strategy is to bestow public recognition and other rewards upon companies and other entities that choose to partner with it in a varied and growing number of partnership opportunities. This column describes one such partnership program, the National Partnership for Environmental Priorities (NPEP). This program is intended to recognize and publicly honor companies that choose to retool their operations to diminish the use or release of 31 priority chemicals.

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, "Tapping into EPA Innovations," Pollution Engineering, May 2006.
The U.S. Environmental Protection Agency (EPA) employs some of the most innovative scientists in the world. The federal government takes an interest in marketing the inventions that these world-class scientists develop while employed by the federal government. A 1986 amendment to the Federal Technology Transfer Act (FTTA) directed federal government agencies to allow inventors to patent inventions if agencies elected not to do so. EPA’s TechMatch is a new patent website available at http://www.epatechmatch.com/. The public has access to view and search EPA patents to facilitate partnership opportunities between non-federal entities and EPA laboratories.

Lynn L. Bergeson, "Develop an Air-Tight Defense," Chemical Processing, April 2006.
Plants are challenged now more than ever to control fugitive emissions. The emissions escape from valves, compressors, pumps, piping components, etc. Controlling them is often not easy, but failure to do so can lead to penalties and other liability. This column focuses on the challenges chemical processors face, but in many respects the pressure to control fugitive emissions are just as acute in other manufacturing sectors.

Lynn L. Bergeson, "EPA Proposes Tighter PM Standards," Pollution Engineering, April 2006.
The U.S. Environmental Protection Agency (EPA) has been busy addressing particulate matter (PM), a mixture of very fine particles and/or liquid droplets to which exposure is, according to the agency, directly linked to health problems. In January, EPA proposed revisions to the primary and secondary national ambient air quality standards (NAAQS) for PM. On February 3, 2006, EPA issued an advance notice of proposed rulemaking (ANPR) for implementation of the NAAQS for PM.

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, "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 Proposes Lead-Based Paint Removal Requirements," Pollution Engineering, March 2006.
On Jan 10, 2006, the U.S. Environmental Protection Agency (EPA) proposed extensive requirements to minimize the introduction of lead hazards resulting from the disturbance of lead-based paint during renovation, repair and painting activities in most housing built before 1978.  The proposal introduced lead-based paint training, certification and safe work-practice requirements for contractors involved in these activities.  According to EPA, it is one component of a comprehensive program to ensure the use of lead-safe work practices that will also include training, and an education and outreach campaign targeted at both workers and consumers.

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, "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.

Lynn L. Bergeson, "EPA Proposes Amendment to SPCC Plan Requirements," Pollution Engineering, February 2006.
On December 12, 2005, EPA proposed to amend Spill Prevention, Control, and Countermeasure (SPCC) plan requirements to reduce the regulatory burden these requirements impose on covered entities. EPA also released a document entitled SPCC Guidance for Regional Inspectors to assist regional inspectors in assessing a facility’s implementation of SPCC requirements. As such, the document is an important how-to guide for ensuring compliance with SPCC plan requirements.

Lynn L. Bergeson, "Mercury Rising:  EPA Regulates Emissions for Power Plants," Pollution Engineering, January 2006.
The Clean Air Act (CAA) established a deadline for the U.S. Environmental Protection Agency (EPA) to decide whether and how to regulate mercury emissions from coal-burning electric utilities. As several public interest groups had earlier sued EPA over the perceived inaction, the agency was required under a settlement agreement to issue a final rule by December 2004. This date was later extended to March 2005. EPA issued a rule to permanently cap and reduce mercury emissions from coal-fired power plants on March 15, 2005.

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.

Lisa M. Campbell, "Rhetoric That Hides the Issues at Stake," The Environmental Forum, November/December 2005.
The debate over whether human data should be used to assess potential risk from chemical products, and in particular pesticide products, has been raging for at least seven years. Before it became controversial in the late 1990s, EPA routinely relied on studies of human subjects for some pesticide products and many other substances, and, in fact, acknowledged, along with many other government agencies and other scientific entities, the superiority of such studies in evaluating potential risks to humans.

Lynn L. Bergeson, "Proposed Rule on Human Studies," Pollution Engineering, November 2005.
On Sept. 12, 2005, EPA issued its human studies proposed rule, and led a stakeholder briefing on the proposal on Sept. 7. The proposed rule focuses on third-party intentional dosing studies involving pesticides, although EPA seeks comment on alternative approaches with a broader scope. The rule, as proposed, would prohibit new third-party intentional dosing studies for pesticides involving pregnant women or children as subjects, as well as all first- and second-party intentional dosing studies of any substance involving pregnant women or children as subjects.

Lynn L. Bergeson, "Hurricane Havoc Has Hit Regulators, Too," Manufacturing Today, September/October 2005.
Hurricanes Katrina and Rita have inspired environmental havoc and strained the capacity of every government agency impacted by these natural disasters. According to some, this is only the beginning. The aftermath of these storms has everyone’s attention now, especially the U.S. Environmental Protection Agency (EPA) and the state and local government agencies that must now deal with the aftermath. Issues include EPA's environmental priorities; health and infrastructure; EPA authority to waive environmental statutes and regulations; and collateral EPA impacts.

Lynn L. Bergeson, "HPV Challenge Program:  EPA Goes After Orphan Chemicals," Pollution Engineering, October 2005
"EPA recently posted on its Chemical Right-to-Know website a new policy, entitled Policy Regarding Acceptance of New Commitments to the High Production Volume (HPV) Challenge Program, available at www.epa.gov/chemrtk/hpvpolcy.pdf. The policy outlines how companies can commit to sponsor any of the remaining so-called 'orphan chemicals,' which include the 300 chemicals that are currently unsponsored under the HPV Chemical Challenge Program."

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, "EPA Staff Urges Changes in PM Standards," Pollution Engineering, September 2005.

Lynn L. Bergeson, "TSCA and Nanoscale Materials Update," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 6, No. 4, August 2005.

Lisa M. Campbell, "Debate on EPA’s Use of Human Data Flares Again," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 6, No. 4, August 2005.

Lynn L. Bergeson, "EPA Pushes Material-Management Challenges," Chemical Processing, August 2005.

Lynn L. Bergeson, "Workplace Safety and Enforcement Scrutiny Measures Get Teeth," Manufacturing Today, July/August 2005.

Lynn L. Bergeson, "Life after Aviall: Its Impact on Voluntary Cleanup," Pollution Engineering, August 2005.

Lynn L. Bergeson, "Biomonitoring Assumes Growing Significance," Chemical Processing, July 2005.

Lynn L. Bergeson, "Avoid Mistakes of Past: Develop Nano Responsibly," The Environmental Forum, July/August 2005.

Lynn L. Bergeson, "Toxicogenomic Data and Federal Regulatory Settings: Managing the Avalanche of Data," Environmental Quality Management, Summer 2005.

Lynn L. Bergeson, "Water Quality Trading:  What's It All About?," Pollution Engineering, July 2005. 

Lynn L. Bergeson, "Nanotechnology Readies for a Wastewater Role," Chemical Processing, June 2005.

Lynn L. Bergeson, "Nanotechnology: EPA Considers How to Proceed," Pollution Engineering, June 2005.

Lynn L. Bergeson, "The Essentiality of Process-Safety Management," Chemical Processing, May 2005. 

Lynn L. Bergeson, "The Importance of Environmental Management Systems," Pollution Engineering, May 2005.

Lynn L. Bergeson, "The Volatile Debate Over Regulation of Reactive Chemicals," Manufacturing Today, March/April 2005.

Lynn L. Bergeson, "Green Products Get Green Light," Chemical Processing, April 2005. 

Lynn L. Bergeson, "Nanotechnology and TSCA," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 6, No. 3, April 2005.

Lynn L. Bergeson, "When a Parent's Involvement May Be Too Much," Pollution Engineering, April 2005.

Lynn L. Bergeson, "Making a List and Checking It Twice:  A Precautionary Approach to Schools," Environmental Quality Management, Spring 2005. 

Lynn L. Bergeson, "The Shape of Things to Come at EPA," Pollution Engineering, March 2005.

Lynn L. Bergeson, "EPA Encourages Adoption of HPV Chemicals," Chemical Processing, March 2005. 

Lynn L. Bergeson and Carla N. Hutton, "FIFRA -- Chemical Testing Issues," ELR News & Analysis, March 2005.

Lynn L. Bergeson, "EPA Seeks to Curb PBDEs," Pollution Engineering, February 2005.

Lynn L. Bergeson, "Fugitives on the Loose," Chemical Processing, February 2005. 

Lynn L. Bergeson, Lisa M. Campbell, and Carla N. Hutton, "TSCA -- Chemical Testing Issues," ELR News & Analysis, February 2005.

Lynn L. Bergeson, "Nanomaterials and Protecting Health Risk," Environmental Expert Newsletter, February 2005.

Lynn L. Bergeson, "EPA Defines 'All Appropriate Inquiry,'" Pollution Engineering, January 2005.

Lynn L. Bergeson, "Chemicals Get a Bad Reaction in Washington," Chemical Processing, January 2005.

Lynn L. Bergeson and Bethami Auerbach, "Reading the Small Print," The Environmental Forum, March/April 2004.