Lynn L. Bergeson, “Nanosilver Conditionally Registered as New Active Ingredient,” Pollution Engineering, February 2012. In August 2010, EPA announced that it was considering allowing the Swiss company HeiQ Materials Ag to enter the U.S. market with a new nanosilver pesticide and textile preservative, HeiQ AGS-20. On Dec. 1, 2011, the EPA issued a conditional registration for a pesticide product.
Lisa R. Burchi, Charles M. Auer, Kathleen M. Roberts, and Lynn L. Bergeson, “Are TSCA Section 8(b)(2) Statutory Mixture Categories Subject to Reporting Under the Chemical Data Reporting Rule?,” Bloomberg BNA Daily Environment Report, January 26, 2012. Based on written communications from the Environmental Protection Agency’s Office of Pollution Prevention and Toxics, questions have been raised as to the agency’s interpretation of the six chemical categories created under Toxic Substances Control Act Section 8(b)(2) authority. Chemicals long considered part of these well-established categories identified decades ago are complex reaction products that fall under the TSCA Section 8(b)(2) category listing. Given the statements from EPA over the past several years and recognizing that reporting under the TSCA Chemical Data Reporting (CDR) rule is just around the corner, a critically important question is whether chemicals that would otherwise fit within the Section 8(b)(2) categories are subject to reporting under the CDR. This article examines this question by considering the regulatory history and guidance, prior reporting that has occurred, and business issues associated with the question.
Lynn L. Bergeson, James V. Aidala, co-authors, “2012 Predictions For TSCA Reform And EPA Initiatives,” Law360, January 19, 2012. We offer our thoughts on what may be headed our way in 2012 with regard to reform of the Toxic Substances Control Act (TSCA) and chemical management initiatives from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).
Lynn L. Bergeson, “EPA Proposes New Use Rules: Proposal could limit the use of 14 nanoscale substances,” Chemical Processing, January 2012. The US Environmental Protection Agency (EPA) proposed on December 28, 2011, significant new use rules (SNURs) for 17 chemical substances that were the subject of premanufacture notices (PMN), including seven substances with the term carbon nanotube (CNT) and seven substances with the term fullerene in their respective names. These 14 substances are subject to consent orders under Section 5(e) of the Toxic Substances Control Act (TSCA). This column provides background on, and the implications of, these proposed SNURs.
Lynn L. Bergeson, “Topical Briefing on recent Lawsuit filed against US FDA,” Nanotechnology Industries Association, January 7, 2012. On the 21st of December 2011, a U.S. coalition of nonprofit consumer safety and environmental groups filed a lawsuit against the U.S. Food and Drug Administration (FDA) for alleged failure to regulate what the coalition deems health and environmental risks stemming from nanotechnology-enabled products put on the market. The coalition was led by the International Center for Technology Assessment (ICTA) and represents the following plaintiffs: Friends of the Earth, Food and Water Watch, the Center for Environmental Health, the ETC Group, and the Institute for Agricultural and Trade Policy.
Lynn L. Bergeson, “FDA’s Regulation of Nanotechnology: Will the New Draft Guidance Help Industry?,” Nanotechnology Law & Business, Volume 8, Issue 3. The U.S. Food and Drug Administration’s (FDA) approach to nanotechnology is the subject of intense interest for at least three reasons. First, many promising and visible applications of nano-technology include cosmetics, sunscreens, pharmaceuticals, dietary supplements, and medical devices. These products are subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA). Second, FDA faces unique challenges in regulating products of nanotechnology be-cause of the product-based regulatory structure created under the FFDCA. The rapid increase in nanotechnology applications in FDA-regulated products raises questions regarding the adequacy of the FDA’s product-based approach given the differing statutory authorities FDA has over these product categories. Third, for regulatory purposes under the Act, FDA classifies medical products as drugs, devices, biologics, or combination products. A product’s mode of action determines which FDA Center has primary jurisdiction over the product. As nanotechnology matures, the distinctions between and among these classifications will blur, further stressing FDA’s ability effectively to oversee products of nanotechnology subject to its jurisdiction.
Lynn L. Bergeson, co-author, “Practical Advice for Product Steward Professionals on Remaining Competent, Socially Aware, and Scientifically Proficient,” BNA Daily Environment Report, January 6, 2012. Consumer product manufacturers are challenged today as never before. Materials selection for consumer products invites a dizzying range of considerations: Are the chemicals hormone disruptors, carcinogens, or persistent, bioaccumulative, or toxic? What toxicogenomic biomarkers might make the product the next celebrity tort case? What labeling requirements apply? What are the implications of genetic variations among the demographic to which the product is to be marketed? These considerations, in turn, invite legal, marketing, and technical issues that go well beyond questions of core compliance with the law. What exactly is the professional's role? How are regional differences in regulatory standards, consumer perceptions, ingredient restrictions, and related factors to be addressed? Given the complexity of the global issues and the high stakes involved, what must a professional do to remain competent, socially aware, and scientifically proficient? This article explores these thorny questions, not to resolve them as much as to flag them, and urge professionals -- whether lawyers, product stewards, scientists, or others in the field -- to remain vigilant and as prepared as possible in recognizing the constantly shifting demands on professionals in this area.
Lynn L. Bergeson, “California’s New Safer Consumer Products Regulations,” Pollution Engineering, January 2012. On October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of their Safer Consumer Products Regulations (SCPR). The proposal came after the California Secretary for Environmental Protection instructed DTSC to stop issuing proposed regulations and to instead “take additional time to be responsive to the concerns raised and revisit the proposed regulations.”
Lynn L. Bergeson, “The New Chemical Data Reporting Rule: It’s More Than You Think,” Environmental Quality Management, Winter 2011. Chemical data reporting under the Toxic Substances Control Act (TSCA) just got a lot harder. That’s because on August 16, 2011, the United States Environmental Protection Agency (US EPA) issued its final Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Rule.
Lynn L. Bergeson, “EPA Registers Nanosilver As Active Ingredient,” Chemical Processing, December 2011. The U.S. Environmental Protection Agency (EPA) announced on December 1, 2011, that it granted a conditional registration for a pesticide product containing nanosilver as a new active ingredient. This is a momentous regulatory decision and very good news for supporters of nanopesticides.
Lynn L. Bergeson, “Identifying Priority Chemicals Under TSCA,” Pollution Engineering, December 2011. On Aug. 18, 2011, EPA rolled out its new approach for identifying priority chemicals for review and assessment under the Toxic Substances Control Act (TSCA). EPA invited public input on its Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and Assessment (Discussion Guide), which is available at www.epa.gov/opptintr/existingchemicals/pubs/chempridiscguide.html, and convened a webinar on Sept. 7, 2011 to review the document.
James V. Aidala, Co-Author, “TSCA Reform: The Standard of Safety,” Environmental Law Reporter News & Analysis, December 2011. Several key issues have emerged as pivotal in ongoing efforts to reform TSCA. Progress on these complex issues is central to the success of TSCA reform. On July 21, 2011, ELI convened a panel of experts to examine the central issue of whether and what standard of safety should replace TSCA’s current “unreasonable risk” standard for regulating chemicals. Topics addressed included: hazard/exposure/risk criteria; burden of proof; judicial review of Agency decisions; sensitive populations; cost-benefit analysis; and application of the safety standard to new materials/technologies.
Lynn L. Bergeson, “Nanomaterials discussed at 23rd September REACH Conference on in Brussels,” Nanotechnology Industries Association, November 4, 2011. In addition to the definition of nanomaterials, at the REACH Conference on the 23rd September 2011 held in Brussels, the participants discussed the implications of REACH as concerns nanomaterials.
Lynn L. Bergeson, “NTP Proposes to Revise RoC Review Process,” Chemical Processing, November 2011. On October 31, 2011, the National Toxicology Program (NTP) published a notice inviting comments on its proposed Report on Carcinogens (RoC) review process and announcing a public listening session to receive oral comments. This is good news, as I'll explain.
Lynn L. Bergeson, “Identifying TSCA Priority Chemicals,” Pollution Engineering, November 2011. On Aug. 18, 2011, EPA rolled out and invited public input on its Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and Assessment (Discussion Guide), which is available online (or use a smartphone with the mobile tag). The document explains the agency’s proposed approach for identifying priority chemicals for review and assessment under Toxic Substances Control Act (TSCA).
Lynn L. Bergeson, "EPA Issues Final Weight-of-Evidence Guidance," Chemical Processing, October 2011. On September 28, 2011, the U.S. Environmental Protection Agency (EPA) published its final guidance on the weight-of-evidence (WoE) analysis it will use to evaluate the results of data submitted in response to test orders issued for Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP). What follows is a brief overview of the Final WoE Guidance, which is available at http://www.regulations.gov.
Lynn L. Bergeson, "EPA Modifies Chemical Data Reporting Rule," Pollution Engineering, October 2011.
On Aug. 2, 2011, EPA released the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, which was previously referred to as the Inventory Update Reporting (IUR) Modifications Rule.
Lynn L. Bergeson, "EPA Issues Chemical Data Reporting Rule," Chemical Processing, September 2011. The U.S. Environmental Protection Agency (EPA) issued on August 16, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. More information is available at http://www.epa.gov/cdr/. Set forth below are key components of the CDR Rule, how reporting will change from prior IUR reporting, and potential issues.
Lynn L. Bergeson, "Pipeline Awareness Website Launched," Pollution Engineering, September 2011. To say the United States’ natural gas pipeline infrastructure is a crucial component of the nation’s day-to-day operations would truly be an understatement. Within the United States, there are more than 302,110 miles of natural gas pipelines. The lines are owned by a variety of entities, including municipalities, local distribution companies, and inter and intrastate pipeline companies. This complex labyrinth of underground piping offers energy security but also presents potentially significant safety risks, which must be avoided.
Lisa R. Burchi, Charles M. Auer, and Lynn L. Bergeson, "EPA’s SNUR Authority and Key Points Regarding SNURs for Former New Chemicals," BNA Daily Environment Report, September 12, 2011. The U.S. Environmental Protection Agency’s use of its authority under the Toxic Substances Control Act is expanding. Its use of TSCA Section 5 ‘‘significant new use rule’’ (SNUR) authority is clearly on the increase, as most recently demonstrated by the important role that significant new use rules have in Chemical Action Plans. This article describes SNURs, their issuance and legal background, and a few key issues of which regulated entities need to be aware in responding to a proposed or promulgated SNUR.
Lynn L. Bergeson, "Targeting Priority Chemicals Under TSCA," Law360, September 2, 2011. Embracing new social media tools, the U.S. Environmental Protection Agency on Aug. 18, 2011, invited stakeholders to provide feedback on its new approach for identifying priority chemicals for review and assessment under the Toxic Substances Control Act (TSCA). Noting that the EPA’s online discussion forum will remain open until Sept. 14, 2011, the EPA invited public input on its “Discussion Guide: Background and Discussion Questions for Identifying Priority Chemicals for Review and Assessment” (available at http://www.epa.gov/opptintr/existingchemicals/pubs/chempridiscguide.html). The EPA has also scheduled a webinar on Sept. 7, 2011, to review and consider the Discussion Guide.
Lynn L. Bergeson, “Cleaning It Up: EPA Proposes Revisions to RCRA Definition of Solid Waste,” Manufacturing Today, Fall 2011.
Lynn L. Bergeson, "EPA Moves Ahead with BPA Action Plan," Chemical Processing, August 2011. The U.S. Environmental Protection Agency (EPA) issued on July 26, 2011, an advance notice of proposed rulemaking (ANPR) concerning testing of bisphenol A (BPA). The notice applies to EPA’s chemical action plan issued under the Toxic Substances Control Act (TSCA) on BPA in March 2010. The ANPR shows the EPA is moving forward, sending a strong message that the agency isn't backing off plans to regulate BPA under TSCA, or any other chemical action plans.
Lynn L. Bergeson and Kathleen M. Roberts, "Deconstructing EPA's Chemical Data Reporting Rule," Law360, August 17, 2011. The U.S. Environmental Protection Agency announced on Aug. 2, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. Proposed revisions to the rule were the subject of considerable debate, which helps explain the rule’s long (nearly a year and a half) gestation period and extensive review by the Office of Management and Budget. The rule was published on Aug. 16 in the Federal Register (76 Fed. Reg. 50816) and becomes effective on Sept. 15, 2011.
Lynn L. Bergeson, "Next IUR Reporting Period Suspended," Pollution Engineering, August 2011. On May 11, 2011, the U.S. Environmental Protection Agency (EPA) amended the Toxic Substances Control Act (TSCA) Section 8(a) Inventory Update Reporting (IUR) regulations by suspending the next IUR submission period, which otherwise would run from June 1 to Sept. 30, 2011.
Lynn L. Bergeson, "U.S. Issues Guidance for Regulating Nanotechnology," Chemical Processing, July 2011. On June 9, 2011, the Office of Science and Technology Policy (OSTP) released principles specific to the regulation and oversight of nanotechnology applications. The principles are intended to guide the development and implementation of policies, as described in “U.S. Decision-Making Concerning Regulation and Oversight of Application of Nanotechnology and Nanomaterials.” This column discusses the principles and outlines their role in the governance of nanotechnology in the United States.
Lynn L. Bergeson, "Protect Yourself: OSHA Releases a New Guidance," Manufacturing Today, Summer 2011. For the manufacturing work force, selecting and requiring the use of personal protective equipment (PPE) is one of the most important elements of assuring a safe and healthful work environment. What PPE to wear, who pays for it and how to determine which is the right PPE to protect against a known hazard in the workplace are all critically important issues, both from the perspective of an employee’s personal safety and an employer’s freedom from allegations of non-compliance. Eliminating the guesswork and ensuring compliance in this area just became a bit easier, as on Feb. 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 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 is a must read for employers and employees alike.
Lynn L. Bergeson, "State Chemical Reform Initiatives: Advocates Press for Change," Environmental Quality Management, Summer 2011. The federal Toxic Substances Control Act (TSCA) has remained largely unchanged since its adoption in 1976, some 35 years ago. Congressional inaction has not gone unnoticed by state governments, which are increasingly dismayed by their federal counterpart’s seeming indifference to the public’s demand for stricter chemical controls and its growing distrust of federal chemical-control measures. As a result, states are taking matters into their own hands by adopting laws, resolutions, and related chemical-control measures.
Lynn L. Bergeson, "Inter-Atlantic EPA," Pollution Engineering, July 2011. In an important and under-appreciated May 3, 2011, Federal Register notice, the U.S. Department of Commerce International Trade Administration (ITA) requested public comments concerning regulatory cooperation between the U.S. and the E.U. that would help eliminate or reduce unnecessary divergences in regulation and in standards used in regulation that impede U.S. exports. Of critical importance, ITA acknowledged that the main impediments to greater trade and investment between the nations "are not tariffs or quotas, but rather differences in regulatory measures." This could be an important opportunity.
Lynn L. Bergeson, James V. Aidala, Charles M. Auer, “The Nuances of ‘Nano’ in Pesticide Products,” Law360, July 1, 2011. On June 17, 2011, the U.S. Environmental Protection Agency released a much-anticipated notice describing possible approaches for obtaining information on the potential presence of nanoscale materials in registered pesticide products.
Lynn L. Bergeson, James V. Aidala, and Charles M. Auer, “Principles For Regulating Nanotech,” Law 360, June 15, 2011. On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. decision-making concerning regulation and oversight of nanotechnology and nanomaterials” that occur at the agency level.
Lynn L. Bergeson, “U.S. Wants More Transparency in Trade,” Chemical Processing, June 2011. On May 19, 2011, the Office of the U.S. Trade Representative (USTR) and the Office of Information and Regulatory Affairs (OIRA) jointly issued a memorandum to U.S. departments and agencies highlighting the importance of regulatory transparency and openness to promoting international trade. The memorandum telegraphs the Administration’s renewed emphasis on the significant role international collaboration has in domestic policy development.
Lynn L. Bergeson, “Pipeline Safety Action Plan,” Pollution Engineering, June 2011. According to Transportation Secretary Ray LaHood, more than 2.5 million miles of pipelines are responsible for delivering oil and gas to communities and businesses across the United States. Much of the pipeline network is old and in a state of disrepair. The Obama Administration launched on April 4, 2011, a national pipeline safety initiative to repair and replace aging pipelines to prevent potentially catastrophic incidents. As discussed below, the initiative contains other elements comprising its pipeline safety action plan.
Lisa R. Burchi, Lisa M. Campbell, Leslie S. MacDougall, and Lynn L. Bergeson, co-authors, “Data Citation and Compensation: How REACH Compares With the FIFRA Scheme,” BNA Daily Environment Report, June 1, 2011.
The European Union’s REACH regulation is a complex chemical management regulation intended to replace approximately 40 previously existing legal instruments with a single EU regulatory scheme for all chemical substances (both new and existing substances). It also creates a data compensation scheme for entities that must rely upon studies another entity generated to complete their registration for a particular chemical substance. This article provides background on REACH registration, data compensation and sharing procedures, and compares REACH’s data compensation principles with how similar issues are addressed in the context of FIFRA data compensation arbitration.
James V. Aidala, "Tracking Disease Clusters and Environmental Health," Law360, April 7, 2011. On March 29, the U.S. Senate Committee on Environment and Public Works held a hearing entitled “Oversight Hearing on Disease Clusters and Environmental Health.” Committee Chairwoman Barbara Boxer, D-Calif., and Senator Mike Crapo, R-Idaho, ranking member of the Superfund, Toxics and Environmental Health Subcommittee, introduced the Strengthening Protections for Children and Communities from Disease Clusters Act (S. 76), also known as Trevor’s Law, on Jan. 25, 2011.
Lynn L. Bergeson, "TSCA Reform: Is It Likely This Term?," Chemical Distributor, Vol. 35, No. 2. The Toxic Substances Control Act (TSCA) has remained largely unchanged since its enactment in 1976. After years of failed efforts to revise TSCA, and with the help of a motivated Democratic-lead Congress, TSCA legislative reform was off to a brisk start in 2009-2010, during which time over a dozen hearings were convened on how to improve the law. The momentum has slowed considerably since the mid-term elections and, as discussed below, meaningful action this term is far from certain. Some think Congressional inaction is the preferred outcome. Others, however, are increasingly alarmed by the number of state chemical control laws and private-sector retail initiatives that are filling the void. This column reviews the prospects for TSCA reform, and what Congressional inaction may mean for the National Association of Chemical Distributors (NACD) member companies.
Lynn L. Bergeson, co-author, “RoHS Recast: How Did Nanomaterials Fare?,” Nanotechnology Law & Business, Volume 7, Issue 4. Several types of nanoscale materials recently dodged a bullet as the European Parliament declined to ban nanosilver and long multi-walled carbon nanotubes in the European Union’s Directive on the Restriction and Use of Certain Hazardous Substances in Electrical and Electronic Equipment, (more commonly known as “RoHS”). For reasons not entirely clear, detractors of these nanoscale materials tried, and failed, to ban them outright in the RoHS Recast initiative. For nano stakeholders, while the news is good, the process serves as a cautionary tale of the shape of things to come in forthcoming legislative initiatives in the European Union, and likely elsewhere.
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, “More 2011 Predictions,” Pollution Engineering, March 2011. The New Year offers both promise and trepidation in 2011 from EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP).
Lynn L. Bergeson, “Expanding TRI Section 313,” Pollution Engineering, February 2011. On Nov. 26, 2010, EPA issued a final rule adding 16 chemicals to the list of chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), and Section 6607 of the Pollution Prevention Act of 1990.
Lynn L. Bergeson, “EPA Expands Endocrine Disruptor Testing,” Chemical Processing, February 2011. On November 17, 2010, the U.S. Environmental Protection Agency (EPA) announced the second list of chemicals for which EPA intends to issue test orders under the Endocrine Disruptor Screening Program (EDSP). EPA also released its draft policies and procedures for requiring Tier 1 screening under the EDSP, and a new guidance document outlining weight-of-evidence (WoE) policies. This column explains why the issuance of the second list of EDSP screening chemicals, and the proposed policies and procedures for obtaining testing, are important developments.
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.
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 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.
Lynn L. Bergeson, “Synopsis of the 2010 Congressional Mid-Term Elections,” Pollution Engineering, January 2011. The decline in the number of elected Democratic members, especially the loss of the majority in the House of Representatives, will decidedly change EPA operations in 2011 and beyond. Significant differences are in the prospects for the agency’s budget, legislative proposals and policy initiatives. In the Senate, the Democrats lost much of their plurality, and some of the newly elected members have indicated a hard-line attitude against any expansion in the role of government and a concern on federal deficit spending; commitments that could also affect EPA.
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, “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, “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,” Law360, November 9, 2010. The dramatic decline in the number of elected Democrats, especially the loss of the majority in the House of Representatives, will make for some significant differences in the prospects for the U.S. Environmental Protection Agency’s budget, legislative proposals and general operations.
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, “When is Material ‘Spent?,’” Pollution Engineering, October 2010. The definition of solid waste has been frequently tested in the courts. A recent court decision provides new guidance on this meaning, and might have made things tougher for well-meaning enterprises.
Lynn L. Bergeson, “TSCA IUR Revision Poses Challenges for Firms,” Chemical Watch European Business Briefing, October 2010. The US Environmental Protection Agency (EPA) recently proposed revisions to the Toxic Substances Control Act (TSCA) Inventory Update Rule (IUR), the consultation on which closes in October. Lynn L. Bergeson explains why domestic chemical manufacturers and importers must be aware of the proposal and prepare 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, "Legal Lookout: California to Control Chemicals of Concern," Pollution Engineering, September 2010. California has a well-established reputation as a trendsetter, but the gargantuan state may have outdone itself with the June 23 draft regulation released from the California Department of Toxic Substances Control (DTSC) for safer consumer product alternatives. The regulations are intended to implement the Green Chemistry Initiative signed into law by Gov. Schwarzenegger in 2008.
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, "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.
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, "Legal Lookout: Competing Coal Ash Proposals," Pollution Engineering, July 2010. On May 4, 2010, the U.S. Environmental Protection Agency (EPA) issued its long-awaited proposal to manage coal ash – the byproduct of burning coal to generate power. The agency proposed two quite different approaches for regulating coal ash, somewhat to the consternation of critics, who had hoped for more stringent regulation.
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.
Charles M. Auer, Lynn L. Bergeson, and Lisa R. Burchi, "TSCA Section 5(b)(4) ‘Chemicals of Concern’ List: Questions, Issues, Concerns," BNA 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, as interviewed by Chemical Heritage Foundation, “The Toxic Substances Control Act: From the Perspective of James V. Aidala,” 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, "DOT Eases Requirements for Security Plans," Pollution Engineering, May 2010. On March 9, 2010, the Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) narrowed its list of hazardous materials, or hazmats, that require security plans when transported in commerce. The new rule is effective on October 1, 2010.
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.
Lynn L. Bergeson, "EPA Now Talking Nano," Pollution Engineering, April 2010. EPA's Scientific Advisory Panel (SAP) released in January the minutes of its November 2009 meeting regarding evaluation of nanosilver and other nanometal pesticide products. The report is available at www.epa.gov/scipoly/sap/meetings/2009/november/110309ameetingminutes.pdf. For prospective nanosilver Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registrants, the news is not encouraging.
Charles M. Auer, "Periodic Reporting of Hazard Data, Exposure Information on Existing Chemicals," BNA 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, "EPA Publishes Final Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes," Pollution Engineering, March 2010.
The EPA published its final clarification under which certain activated phosphors that are not on the Toxic Substances Control Act (TSCA) Section 8(b) Chemical Substance Inventory (TSCA Inventory) will be considered to be "new" chemical substances under TSCA Section 5, and thus will be subject to applicable notification requirements under TSCA Section 5. According to EPA, the clarification is necessary because EPA’s statements in this area have not been consistent. EPA states that, in certain letters and other statements issued by EPA from 1978 to 2003, the agency erroneously indicated that activated phosphors constitute mixtures of phosphors and dopants for purposes of the TSCA Inventory, and thus were not separately reportable as chemical substances under TSCA Section 5(a) new chemical notification requirements. The final clarification is effective August 24, 2011.
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, "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, "Meet the GHG Rule," Pollution Engineering, January 2010. On October 30, 2009, EPA issued a final rule that requires reporting of greenhouse gas (GHG) emissions from all sectors of the economy. The final rule applies to fossil fuel suppliers and industrial gas suppliers, direct GHG emitters, and manufacturers of heavy-duty and off-road vehicles and engines. The rule requires only that "sources above certain threshold levels monitor and report emissions." According to EPA's fact sheet, the threshold for reporting is 25,000 metric tons or more of CO2 equivalent per year.
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, "OSHA Revises Haz-Com Standard," Pollution Engineering, December 2009. On Sept. 30, 2009, the U.S. Occupational Safety and Health Administration (OSHA) proposed revisions to the Hazard Communication Standard (HCS) to align it with the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
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, "OSHA Kicks Off the 'Chemical NEP,'" Environmental Quality 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, "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, "Legal Lookout: IRIS Redux," Pollution Engineering, October 2009. EPA announced on May 21, 2009, that it has reformed the Integrated Risk Information System (IRIS). According to the agency, the revisions are intended to "revitalize the program and ensure its scientific quality, integrity, transparency and timeliness."
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, "Legal Lookout: EPA Grants California GHG Waiver Request," Pollution Engineering, September 2009. Oh what a difference a new administration makes! On June 30, 2009, EPA reversed its controversial Feb. 29, 2008, denial of California’s waiver request for its greenhouse gas (GHG) program for new motor vehicles. The reversal, as its predecessor denial decision, has broad national implications.
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, co-author, "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, "EPA Updates IRIS Process, Again," Pollution Engineering, August 2009. EPA announced in a May 21, 2009, memorandum that it has reformed the Integrated Risk Information System (IRIS), again. According to the agency, the revisions are intended to "revitalize the program and ensure its scientific quality, integrity, transparency and timeliness." In the memo, Administrator Jackson stated 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, "Compliance Advisor: Think Small for Water Management," Chemical Processing, August 2009. The U.S. Environmental Protection Agency (EPA) sponsors more than 70 partnerships with a variety of stakeholders on a wide range of topics. An interesting partnership, included within the Water Partnerships, is Decentralized Wastewater Treatment Systems (http://cfpub.epa.gov/owm/septic/index.cfm). The website includes links to: guidance, manuals and policies, partners and EPA contacts, tools and resources, education and outreach, demonstration projects and technical information.
Lynn L. Bergeson, "OECD Conference on Fostering Safe, Innovation-Led Growth in Nanotechnology," Environmental Law Reporter, September 2009. There is little doubt that nanotechnology is delivering on its promise to revolutionize many sectors of the global economy.As nano-enabled products populate the commercial landscape at an accelerated pace, there is growing interest in developing tools that can be used to assess more precisely the benefits to the environment of nanotechnology and/or nano-enabled products.Largely in response to this growing interest, the Organization for Economic Cooperation and Development (OECD) convened on July 15-17, 2009, a fascinating three-day conference in Paris, France, titled OECD Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth.
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, "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, "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 at http://www.goodnanoguide.org/. 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, "Legal Lookout: Settling on a Definition for DSW," Pollution Engineering, July 2009. EPA announced on May 5, 2009, the next steps on two hazardous waste rules issued under the Resource Conservation and Recovery Act (RCRA), both addressing the definition of solid waste (DSW). This column provides background on the shape of things to come.
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, 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, "Legal Lookout: Evaluating Chemicals: EPA Rolls Out Its Plan," Pollution Engineering, June 2009. On March 25, 2009, EPA announced the availability of a document entitled The U.S. Environmental Protection Agency's Strategic Plan for Evaluating the Toxicity of Chemicals. According to the agency, the purpose of the plan is to serve as a blueprint for the agency in incorporating advances in molecular biology and computational sciences into toxicity testing and risk assessment practices across the agency. This is an important document as it sets forth the agency's game plan for conducting chemical and risk assessments.
Lynn L. Bergeson, "EPA Responds to Coal Ash Release," Pollution Engineering, May 2009. Dec. 22, 2008, was a nightmare for federal and state regulators, electrical utilities, and most particularly the residents of Kingston, Tenn. On this day, approximately 5.4 million cubic yards (or 1.1 billion gallons) of coal ash from the Tennessee Valley Authority (TVA) plant collection pond near Knoxville flooded some 300 acres of land, damaging property, polluting waterways, and killing fish. This article describes the efforts the agency has initiated to prevent similar incidents.
Lynn L. Bergeson, "Vehicle Emissions May Prove Costly," Chemical Processing, May 2009. A proposed rule regarding greenhouse gases (GHG) impact on public health under Clean Air Act (CAA) Section 202(a) was issued April 24, by the U.S. Environmental Protection Agency (EPA). This is a significant proposal that could pave the way for more restrictions on GHG emissions from new motor vehicles. Any chemical producer, formulator, distributor, or other stakeholder could be subject to GHG emission limitations that, depending upon the legislative/regulatory vehicle, could incur costs for compliance.
Lynn L. Bergeson, "Lisa Jackson, What's In Store?," Pollution Engineering, April 2009. A new administration means a new team with new ideas. What can our industry expect from all this newness?
Lynn L. Bergeson, "Program Targets Toxic ‘Hot Spots,’" Chemical Processing, April 2009. An initiative intended to measure levels of air pollution near schools was announced on March 2 by the U.S. Environmental Protection Agency (EPA). The Schools Air Toxics Monitoring Initiative is being undertaken in partnership with state, local, and tribal governments and has implications manufacturing facilities need to know.
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, "EPA Issues ANPRM on Defining Solid Waste," Pollution Engineering, March 2009. Secondary materials are defined, as is legitimate recycling and other important factors in the U.S. Environmental Protection Agency’s (EPA) latest proposed rule changes.
Lynn L. Bergeson, "Chemical Leasing is a Viable Option," Chemical Processing, March 2009. The United Nations Industrial Development Organization (UNIDO) on Feb. 12, released its annual report on chemical leasing (ChL). The report is available at http://www.chemicalleasing.com/docs/news/AnnualReport2008.pdf. For those of you unfamiliar with the concept, ChL as a commercial business model may enjoy greater application in the future as a tool to cut risk and waste. Experiences show that applying these new models reduces ineffective use and over-consumption of chemicals and helps companies to enhance their economic performance, says the ChL Web site.
Lynn L. Bergeson, "Chemicals Up for Discussion," Pollution Engineering, February 2009. The U.S. Environmental Protection Agency (EPA) offered up several big chemical intiatives for discussion in November.
Lynn L. Bergeson, "Court Strikes Down Key Emissions Exemption," Chemical Processing, February 2009. The U.S. Court of Appeals for the D.C. Circuit handed down an important and little-noticed decision late last year that impacts virtually all major air sources in the United States that are subject to the Clean Air Act (CAA) Section 112. In the decision, the court vacated an exemption from CAA rules that allowed refineries, chemical plants and other industrial facilities to exceed emissions standards for hazardous air pollutants (HAP) during startup, shutdown, and malfunctions (SSM) of equipment (Sierra Club v. EPA, D.C. Cir. No. 02-1135, December 19, 2008). Following is a summary of that decision and what it may mean for regulated entities.
Lynn L. Bergeson, "Redefining Solid Waste," Pollution Engineering, January 2009. The definition of solid waste has long been the subject of controversy. At the heart of the debate is what constitutes "discard," versus legitimate recycle or reuse such that the Resource Conservation and Recovery Act (RCRA) regulation should not apply. This question has been especially vexing for secondary materials, including spent materials, listed sludges and listed byproducts.
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, "Initiatives to Watch," Manufacturing Today, January 2009. On Nov. 25, 2008, the U.S. Environmental Protection Agency (EPA) released for public comment two background discussion documents, one on EPA’s Toxic Substances Control Act (TSCA) Inventory Reset initiative and the other on EPA’s proposed approach for the Inorganic High Production Volume (IHPV) Challenge Program. Both initiatives are important, and readers are urged to monitor these programs carefully as they evolve, for many reasons.
Lynn L. Bergeson, "The Explosion of Green Marketing Claims: FTC Jumps into the Fray," Environmental Quality Management, Winter 2008. This "Washington Watch" column briefly reviews the TerraChoice report, and then discusses some of the legal issues surrounding the growing avalanche of green marketing claims, including Federal Trade Commision’s Green Guides and the Commission’s efforts to revise them.
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, "EPA Finally Amends Definition of Solid Waste," Chemical Processing, November 2008. The long-awaited final rule amending the definition of solid waste under the Resource Conservation and Recovery Act (RCRA) was signed by the U.S. Environmental Protection Agency (EPA) on Oct. 7. Because materials considered "hazardous waste" under RCRA are a subset of materials deemed "solid waste," this rule is critically important to the chemical industry.
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, "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, "EPA Offers Compliance Incentives," Chemical Processing, September 2008. The U.S. Environmental Protection Agency’s (EPA) recently published "Interim Approach to Applying the Audit Policy to New Owners" (Interim Approach, 73 Fed. Reg. 44991, August 1), which describes how it will apply its April 11, 2000 policy on "Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations." Known as the Audit Policy to new owners of regulated facilities, it’s designed to enhance the protection of human health and the environment by encouraging regulated entities to voluntarily discover, promptly disclose, correct and prevent the recurring violations of federal environmental law.
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, "Workplace Safety is a Shared Responsibility," Chemical Processing, August 2008. Workplace safety is very much a responsibility shared by employer and employee alike. Environment, health, and safety (EHS) professionals are well aware of federal "standards" issued by the Occupational Safety and Health Administration (OSHA), compliance with which goes a long way to assure workplace safety. An equally important legal standard all EHS professionals must be aware of is the "general duty clause" under Section 5(a)(1) of the Occupational Safety and Health Act (OSH Act). The general duty clause and its requirements present ramifications for the chemicals industry.
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, "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, "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, "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, 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 and Steven Green, co-authors, "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
, 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.
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 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, "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, "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, "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, "TSCA and Nanoscale Materials Update," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, Vol. 6, No. 4, August 2005.
