All Published Articles

Lynn L. Bergeson, "Compliance: CDR Rule Shows Room for Improvement," Chemical Processing, September 19, 2018.

This summer, the U.S. Environmental Protection Agency’s Office of Inspector General (OIG) issued a report titled “EPA’s Chemical Data Reporting Rule Largely Implemented as Intended, but Opportunities for Improvement Exist.” The OIG conducted an audit to determine how the EPA is ensuring companies are compliant with the Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA), and whether the EPA uses CDR data to prioritize chemicals for the purpose of identifying their potential risks to human health and the environment. The OIG found that implementing policies for data quality checks will help tailor the information reported to meet the EPA’s needs. This column discusses the report.

Lynn L. Bergeson, Richard E. Engler, Charles M. Auer, and Kathleen M. Roberts, "New Chemicals Under New TSCA—Stalled Commercialization," Bloomberg Environment Insights, September 11-13, 2018.

Bergeson & Campbell has written extensively about the U.S. Environmental Protection Agency’s implementation of the 2016 Amendments to the Toxic Substances Control Act occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). On the whole, EPA implementation efforts have been timely, balanced, and defensible. Implementation of Section 5 (new chemicals) revisions has been less successful. To date, the EPA’s approach has impeded the commercialization of more sustainable new chemical technologies and thus has, ironically, extended the market presence of often less- sustainable legacy chemicals. This article was originally published as a three part series analyzing the implementation of TSCA Section 5 and its impact on chemical innovation.

Lynn L. Bergeson, "The Trump Administration and global chemical issues," Elements, the Magazine of Chemicals Northwest, Summer 2018.

This article reviews the Trump Administration’s engagement, to date, in key industrial chemical matters, domestically and internationally.  Topics include the Toxic Substances Control Act (TSCA), the UN’s Strategic Approach to International Chemicals Management (SAICM) and 2030 Agenda for Sustainable Development, and Ratification of the Stockholm Convention on Persistent Organic Pollutants.

Lynn L. Bergeson, "The New Administration and International Chemical Issues," Environmental Quality Management, Volume 27, Issue 4, Summer 2018.

As a candidate and now as president, President Trump has been uncharacteristically predictable in systematically dismantling signature environmental policies of prior administrations and ceding the United States’ leadership in combating climate change to other global powers. The administration’s industrial chemicals management policy has been less transparent and predictable, however. Some may have interpreted candidate Trump’s notable silence on the campaign trail as support for Toxic Substances Control Act (TSCA) reform, given the broad bipartisan support it enjoyed before its enactment on June 22, 2016. Others may have assumed that candidate Trump was simply unaware of the enactment of the most sweeping legislative changes to our domestic chemical management law in four decades and the significant commercial, legal, and trade implications occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). President Trump has kept his TSCA cards close to his vest, and the administration’s broader engagement in chemicals management on the world stage is similarly unclear. Some trends can be discerned, or at least inferred, as discussed in this article.

Lynn L. Bergeson, "EPA Clarifies Chemical Review Process," Chemical Processing, August 22, 2018.

The release of the Toxic Substances Control Act (TSCA) Section 5(a)(3)(C) determination for a new polymer, P-16-0510, represents a positive step in implementing the New Chemicals Program under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The new chemical is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays and other consumer products. This column explains why this is a significant development.

Lynn L. Bergeson, "U.S. Consumer Product Ingredient Disclosure Measures Pick Up Momentum," International Chemical Regulatory and Law Review, Volume 1, Issue 2, 2018.

The ‘right-to-know’ has been a foundational element of U.S. environmental law and policy for decades. As more information becomes known about the potential health and environmental impacts of chemical substances in industrial, commercial, and especially consumer products, the public’s interest in product ingredients has sharply increased. Recently this interest has taken a new direction, one targeting consumer cleaning products. Two state initiatives, originating in opposite sides of the country, reflect different approaches to compelling product ingredient disclosure, and portend similar state measures elsewhere. Consumer product manufacturers are bracing for renewed challenges in preserving consistent product labeling and maintaining confidential business information (CBI). Information-saturated consumers likely do not know what to think as they sort through ever more detailed product information. How these state measures might impact European manufacturers and trade and commerce in general remain to be seen. Here is an overview of the new measures and their implications.

Richard E. Engler, Ph.D., "EPA Includes Active-Inactive Designations on Updated TSCA Inventory," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 19, Issue 3, July 2018.

The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available (https://www.epa.gov/tsca-inventory/ how-access-tsca-inventory). For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce.

J. Brian Xu, M.D., Ph.D., DABT® and Scott J. Burya, Ph.D., "FCM regulations in China and the US - a comparison," CW+ AsiaHub, July 18, 2018.

While the intention of food contact regulations in both China and the US is to protect public health, the approaches taken, the obligations for industry and other facets of the regulations differ in notable ways. This article overviews the two regulatory systems, highlighting key similarities and differences between the emerging regulatory regime in China and the established US Food and Drug Administration (FDA) food contact regulations. 

Lynn L. Bergeson, "EPA Covers Confidential Chemicals," Chemical Processing, July 17, 2018.

On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance to assist companies in creating structurally descriptive chemical names for substances whose specific chemical identities are claimed confidential and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory. Because the need to retain chemical identity confidentiality is critical, this guidance is an essential read.

Lynn L. Bergeson, "Ongoing Concern: EPA Proposes to Lower Dust-Lead Hazard Standards," Manufacturing Today, Volume 18, Issue 5.

Reducing childhood lead exposure has long been a focus of the U.S. Environmental Protection Agency (EPA). The Flint, Mich., water crisis has inspired renewed concerns with lead exposure and heightened attention on the hazards occasioned by exposure to dust and dust-lead, especially exposure to children. On July 2, 2018, EPA proposed to lower the dust-lead hazard standards for homes with dust-lead issues. This column summarizes the proposal.

Lynn L. Bergeson, "EFSA Publishes New Guidance on Nanotechnologies in Food and Feed," Nanotechnology Now, July 5, 2018.

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications. The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011. 

Lynn L. Bergeson, "EPA Eyes Nonylphenol Ethoxylates," Chemical Processing, June 20, 2018.

The U.S. Environmental Protection Agency (EPA) expanded on June 12, 2018, the list of chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) Toxics Release Inventory (TRI). The list now includes a category containing 13 nonylphenol ethoxylates (NPE). NPEs are nonionic surfactants used in a variety of industrial applications and consumer products including adhesives, wetting agents, emulsifiers, stabilizers, dispersants, defoamers, cleaners, paints and coatings. The final rule will apply for the reporting year beginning January 1, 2019, with the first reporting forms due July 1, 2020. This development will impact chemical stakeholders in a range of commercial applications, as explained below.

Lynn L. Bergeson, "Environmentally Sound," Manufacturing Today, May 29, 2018.

On March 16, 2018, the U.S. Environmental Protection Agency (EPA) proposed to add hazardous waste aerosol cans to the category of “universal wastes” regulated under the federal Resource Conservation and Recovery Act (RCRA) regulations, codified at Title 40 of the C.F.R., Part 273. 83 Fed. Reg. 11654. According to EPA, this action would benefit the many manufacturing facilities and others that generate and manage large quantities of hazardous waste aerosol cans.

Lynn L. Bergeson, "USDA Eyes Bioengineered Food Standard," Chemical Processing, May 21, 2018.

On May 4, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) proposed a rule to establish the first ever National Bioengineered Food Disclosure Standard (NBFDS) mandated by Congress in 2016. This column discusses the proposal, what it intends to achieve, and its implications.

Lynn L. Bergeson, "EPA Continues to Investigate Engineered Nanomaterials in Industrial Wastewater Discharge," Nanotechnology Now, May 2, 2018.

On May 2, 2018, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing publication of its Final 2016 Effluent Guidelines Program Plan. The Plan describes EPA's Clean Water Act rulemakings and other actions intended to control industrial wastewater pollution. 

Lynn L. Bergeson, "TSCA tips for European chemical stakeholders," Elements, the Magazine of Chemicals Northwest, Spring, 2018.

Changes to the Toxic Substances Control Act (TSCA) occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act have fundamentally changed the way the US Environmental Protection Agency (EPA) reviews new and assesses existing chemical substances in surprising and subtle ways. Our 26-professionals TSCA practice in Washington, D.C. has been “doing TSCA” for a very long time. We offer our European colleagues practical insights into the new law and EPA’s implementation efforts. As we represent many European companies that have business interests in the U.S., our views are offered from a practical perspective.

Lynn L. Bergeson, "Essential Materials: OSHA Delays Enforcement of Part of the Beryllium Standard," Manufacturing Today, Volume 18, Issue 4.

The U.S. Occupational Safety and Health Administration (OSHA) announced on March 2, 2018, that it will begin enforcing certain requirements of the 2017 final rule on occupational exposure to beryllium in general industry, construction, and shipyards on May 11, 2018, and that it will delay enforcement of certain other standards. This column discusses the final rule and OSHA’s recent enforcement policy. 

Lynn L. Bergeson, "EPA Proposes TSCA User Fees," Environmental Quality Management, Volume 27, Issue 3, Spring 2018.

We all knew it was coming, and the proposal has finally arrived. On February 8, 2018, the US Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides the EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law” (EPA, 2018a, p. 1). This column summarizes the proposal and explains why it is significant.

A downloadable and printable version of this article is available here

Lynn L. Bergeson, "Chemical Compliance: Deadline Looms for Prop 65," Chemical Processing, April 20, 2018.

In just a few short months, on August 30, 2018, the California Office of Environmental Health Hazard Assessment (OEHHA) revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations will come into force. By then, companies must be compliant with the revised regulations for consumer product, occupational and environmental exposures.

Lynn L. Bergeson, "OECD Evaluates Application of In Vitro Methods for Human Hazard Assessment in OECD Testing Program for Safety of Manufactured Nanomaterials," Nanotechnology Now, March 29, 2018.

The Organization for Economic Cooperation and Development (OECD) has published a March 23, 2018, report entitled Evaluation of in vitro methods for human hazard assessment applied in the OECD Testing Programme for the Safety of Manufactured Nanomaterials.

Lynn L. Bergeson, "Citizens Challenge EPA," Chemical Processing, March 21, 2018.

A petition filed under Section 21 of the Toxic Substances Control Act (TSCA) was one of the first actions reviewed by a federal district court since TSCA was substantially rewritten in June 2016.The rulings described below pose interesting and potentially formidable challenges for TSCA stakeholders.

Lynn L. Bergeson, "Proper Disposal," Manufacturing Today, March 16, 2018.

In December 2017, the U.S. Environmental Protection Agency (EPA) issued a final rule prohibiting entities from asserting claims of confidential business information (CBI) for certain documents related to the export, import, and transit of hazardous waste. Manufacturers that have historically relied on assertions of CBI should be aware of this change. 

Lynn L. Bergeson, "New TSCA inspires new litigation," Chemical Watch Global Business Briefing, March 2018.

When the Toxic Substances Control Act (TSCA) was legislatively ‘modernised’ in June 2016, no one in the legal community doubted litigation was in our collective future. We have not been disappointed.

The US Environmental Protection Agency (EPA) and its legal counsel for these purposes, the US Department of Justice (DoJ), are facing multiple lawsuits in several federal appeals courts and the very real possibility of more litigation deriving from TSCA Section 21 citizen petitions in the light of a recent decision. While none of this is especially unexpected, it is nonetheless disquieting. This article is a quick summary of where the cases stand and a discussion of what is at stake.

Lynn L. Bergeson, "EPA Proposes TSCA User Fees," Chemical Processing, February 21, 2018.

The cost of compliance with the Toxic Substances Control Act (TSCA) will soon rise. On February 8, 2018, the U.S. Environmental Protection Agency (EPA) signed off on proposed TSCA user fees. As amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA authorizes the EPA to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” This column summarizes the proposal and its significance.

Lynn L. Bergeson, "Prepare Now," Manufacturing Today, February 6, 2018.

Big changes are in store for regulated entities subject to Prop 65 based on a rule implemented in August 2016, but with a fast-approaching enforcement date of Aug. 30, 2018.

Lynn L. Bergeson, "Expect the EPA to Be Busy in 2018," Chemical Processing, January 23, 2018.

The new year promises to be a busy one in the chemical area. The U.S. Environmental Protection Agency (EPA) hit all of its new Toxic Substances Control Act (TSCA) marks in timely promulgating rules or taking other steps required by the new TSCA. 

Lynn L. Bergeson, "NIOSH Plans to Support Implementation of WHO Guidelines to Protect Workers from Nanomaterials," Nanotechnology Now, January 2, 2018.

On December 15, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled "WHO Guidelines to Protect Workers from Nanomaterials." As reported in our December 13, 2017, blog item (see https://nanotech.lawbc.com/2017/12/who-publishes-guidelines-on-protecting-workers-from-potential-risks-of-manufactured-nanomaterials/), the World Health Organization (WHO) recently published WHO Guidelines on Protecting Workers from Potential Risks of Manufactured Nanomaterials.

Lynn L. Bergeson, "EPA: Mercury Merits Attention," Chemical Processing, January 2, 2018.

The U.S. Environmental Protection Agency (EPA) continues to implement reporting requirements pertinent to the supply, use and trade of mercury in the United States. This column provides more information and a closer look into the EPA’s October 2017 proposed rule.

Lynn L. Bergeson, "Proposition 65 warning regulations must change—and soon!," Environmental Quality Management, Volume 27, Issue 2, Winter 2017.

Proposition 65 (Prop 65) is very much a part of the “right-to-know” landscape in California and, as we all know, Prop 65 warnings are especially visible in that state. This much is clear. What may be less clear are the sweeping changes in the “clear and reasonable warning” requirements now scheduled to take effect from August 30, 2018. This date may seem like a long way off, but it is right around the corner in terms of coming into compliance with these dramatic changes. This Washington Watch column summarizes the new warning requirements and the reasons why companies need to focus now on these changes.

Zameer Qureshi, "Brexit: An examination of key developments and their potential influence on European chemical laws," Environmental Law & Management, Volume 29, Issue 4, 2017.

On 23 June 2016, more than 30 million people voted in a referendum to decide whether the United Kingdom (UK) should ‘Leave’ or ‘Remain’ in the European Union (EU). The referendum turnout was 71.8 per cent and the Leave campaign won by 52 per cent to 48 per cent, making ‘Brexit’ an important and imminent probability, with potentially substantial implications for a range of stakeholders, including the chemicals industry.

Between then and now, there have been significant developments in case law and statute, culminating in the triggering of Article 50 of the Lisbon Treaty and the issuing of a White Paper setting out the UK’s strategy for repealing the European Communities Act 1972 (ECA 1972) and ending the supremacy of EU law. The Brexit process and potential outcomes, including ‘knowns and unknowns’, are subject to change and are evolving at an exceptionally rapid pace, and will likely continue to do so. Terminology utilised for important documents and events has changed since the start of the Brexit story in June 2016. Many Brexit-related issues depend significantly or entirely on outcomes of political negotiations, and making any predictions has become a challenging endeavour. The global chemicals industry is well advised, as part of an effort to support regulatory and legal compliance, to monitor regularly news and consultations regarding Brexit

Lynn L. Bergeson, "Resetting the TSCA Inventory: Why This Is Important," Environmental Quality Management, Volume 27, Issue 1, Fall 2017.

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements (EPA, 2017). This final rule is now in effect. This Washington Watch column explains why the rule is important, and what stakeholders should be doing to protect their interests.

Lynn L. Bergeson, "Warning Labels: Q&A Clears Up Proposition 65," Chemical Processing, November 14, 2017.

California’s Proposition 65 (Prop 65) has been a keen area of client interest for years. One question repeatedly asked is “what is a clear and reasonable warning?” The California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document specifically covering “clear and reasonable warnings” requirements. The Q&A aims to help companies comply with new Prop 65 notice requirements that become effective next August. This column explains the significance of this Q&A document.

Lynn L. Bergeson, "Information Required," Manufacturing Today, November 1, 2017.

After a decade of trying, the U.S. Environmental Protection Agency (EPA) now has in effect a final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule focusing on nanoscale materials. This article explains the final rule, what stakeholders are required to do, and by when.

Lynn L. Bergeson, Richard E. Engler, Ph.D., and Lauren M. Graham, Ph.D., "TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses," Industrial Biotechnology, Volume 13, Issue 5, October 2017.

The Toxic Substances Control Act (TSCA) is the federal gap-filling chemical control law regulating chemical substances used in applications other than food, drugs, cosmetics, and pesticides, and other uses that are regulated by other federal authorities. Chemical product innovators need to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae), intermediates, and commercial products, and build TSCA compliance into business timelines and budgets. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.

Lynn L. Bergeson, "California Targets Cleaning Product Ingredients," Chemical Processing, October 30, 2017.

On October 15, 2017, California governor Jerry Brown (D) signed the Cleaning Product Right to Know Act of 2017. The law requires manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The online disclosure requirements apply to a designated product sold in California on or after January 1, 2020, while the product label disclosure requirements cover products sold in California on or after January 1, 2021.

Lynn L. Bergeson and Bethami Auerbach, "Innovation, Consumer Products, and Legal Risk: Points to Consider," Paper presented at the 2017 Retail Law Conference, October 12, 2017.

Products that embody tried, true, and especially cutting-edge technologies are generally embraced by retailers as sure-fire pathways to marketing success. What’s not to like about best sellers and newer, faster, cleaner, or otherwise improved products? Sometimes overlooked is what is hidden behind the technology curtain -- what is the secret sauce that makes the product faster, cleaner, or better? In marketing products with new modes of action and spiffy new attributes, retailers are part of a product liability chain of which they need to be aware. This paper provides an overview of emerging legal and practical issues pertinent to the inclusion of technologies supporting products marketed to the public.

Lynn L. Bergeson, "EPA Promulgates Final SNUR for Bimodal Mixture Consisting of MWCNTs and Other Classes of CNTs," Nanotechnology Now, October 4, 2017.

On October 3, 2017, the U.S. Environmental Protection Agency (EPA) promulgated a final significant new use rule (SNUR) under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified generically as bimodal mixture consisting of multi-walled carbon nanotubes (MWCNT) and other classes of carbon nanotubes (CNT), which was the subject of premanufacture notice (PMN) P-11-482.

Lynn L. Bergeson, "EPA Issues Final TSCA Inventory Notification Rule," Manufacturing Today, September 26, 2017.

On June 22, 2017, the U.S. Environmental Protection Agency (EPA) issued the final inventory notification rule under the amended Toxic Substances Control Act (TSCA). The rule establishes an electronic notification of chemical substances listed on the TSCA Inventory that were manufactured/imported for nonexempt commercial purposes during the 10-year time period ending on June 21, 2016, with provision to also allow processor notification. These notifications will be used to distinguish "active" from "inactive" substances. A summary of this rule follows.

Lynn L. Bergeson, "Chemical Compliance: Get Familiar with TSCA’s Inventory Rule," Chemical Processing, August 22, 2017.

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements. This final rule is now in effect. Here is why the rule is important, and what stakeholders should be doing to protect their interests.

Lynn L. Bergeson, "NIEHS Using Survey to Update 2012-2017 Strategic Plan," Nanotechnology Now, August 10th, 2017.

NIEHS is developing a plan to guide its next five years and seeks broad input. NIEHS has created an online survey, "Trends & Insights: Next Steps for NIEHS," through which stakeholders can provide feedback on the existing Strategic Plan, as well as offer any other relevant comments.

Lynn L. Bergeson, James V. Aidala, Jr., Charles M. Auer, Richard Engler, and Oscar Hernandez, "Practitioner Insights: Enhancing TSCA Reform Implementation," BNA Daily Environment Report, August 2, 2017.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amended the Toxic Substances Control Act. The act, which has been in force for just over a year, made substantive changes to multiple sections of TSCA that are proving to be even more consequential than anticipated (new TSCA is identified as Pub. L. No. 114-182 and old TSCA was identified as Pub. L. No. 94-469).

This paper, authored principally by former EPA officials and a practicing TSCA lawyer, all with long experience under old TSCA, provides suggestions for new approaches or ‘‘fixes’’ that could assist the agency and interested groups in moving toward smoother implementation of the new law, achieving policy goals, and ensuring greater transparency. These suggestions are presented in no particular order and in the spirit of urging other stakeholders to also think of creative ways to ensure that new TSCA fulfills Congress’s mandate to develop an effective domestic chemical management program.

Lynn L. Bergeson and Timothy D. Backstrom, "Appellate Court Vacates Conditional Nanosilver Registration," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 18, Issue 5, August 2017.

On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of a nanosilver pesticide product and vacated that conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC), the Center for Food Safety (CFS), and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside EPA’s final order granting a conditional registration for a nanosilver containing antimicrobial pesticide product named NSPW-L30SWS (NSPW). The court vacated the conditional registration because, according to the court, “EPA failed to support its finding that NSPW was in the public interest.”

Lisa M. Campbell, Timothy D. Backstrom, and James V. Aidala, "EPA’s Evaluation and Determination of Epidemiological Data for Chlorpyrifos," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, Volume 18, Issue 5, August 2017.

Among the many legal, regulatory, and policy issues being watched closely by pesticide registrants as the U.S. Environmental Protection Agency’s (EPA) long and contentious review of chlorpyrifos registrations continues is the controversy concerning when EPA may appropriately apply a tenfold uncertainty factor pursuant to the Food Quality Protection Act (FQPA 10X). This issue centers around EPA’s novel and unprecedented use of epidemiological data and the statutory requirements that govern EPA’s determination that sufficient uncertainty exists to warrant applying the FQPA 10X, not only to chlorpyrifos itself, but to all organophosphate (OP) pesticide products. This issue has drawn much attention and concern from pesticide registrants, and from other interested parties. The issues directly affecting chlorpyrifos have played out not only in EPA’s registration review process for chlorpyrifos, but also in a court challenge to EPA’s decision.

Lynn L. Bergeson, "The Montreal Protocol is Amended and Strengthened," Environmental Quality Management, Spring 2017.

Climate change watchers know that October, 15, 2016, was a historic day for international climate action. On that day, nearly 200 countries reached an agreement to phase down use of hydrofluorocarbons (HFCs) at the 28th Meeting of the Parties to the Montreal Protocol in Kigali, Rwanda. The meeting to discuss the Amendment took place from July 15-23, 2016. This seemingly impossible alignment of international interests reflects years of effort. This column summarizes this historic event and its implications.

Lynn L. Bergeson, "EC Publishes Final Report of Nanocomput Project," Nanotechnology Now, July 27, 2017.

In July 2017, the European Commission's (EC) Joint Research Center (JRC) published a report entitled Evaluation of the availability and applicability of computational approaches in the safety assessment of nanomaterials: Final report of the Nanocomput project.

Lynn L. Bergeson, "Years in the Making," Manufacturing Today, July 26, 2017.

The U.S. Environmental Protection Agency (EPA) made available on May 16, 2017, and requested comment on a draft guidance document, “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” This column discusses the draft guidance.

Lynn L. Bergeson, "EPA’s Regulatory Agenda Includes TSCA Section 8(a) Nanomaterials Rule with TBD Effective Date," Nanotechnology Now, July 24, 2017.

On July 20, 2017, the Trump Administration published its Unified Agenda of Regulatory and Deregulatory Actions. The Agenda includes a U.S. Environmental Protection Agency (EPA) item (RIN 2070-AJ54) concerning the Toxic Substances Control Act (TSCA) Section 8(a) reporting rule for nanoscale materials.

Lynn L. Bergeson, "The State of Play," Manufacturing Today, July 24, 2017.

Waters of the United States has been a “fluid” concept for years. It defines the jurisdictional limits of the authority of the United States under the Clean Water Act (CWA). President Trump’s Feb. 28, 2017, Executive Order (EO) directing the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) to rescind and replace the Clean Water Rule (CWR) is the latest development to resolve the question of which surface waters and wetlands may be federally regulated and subjected to CWA permitting. Many U.S. businesses objected to the rule, so this is one action that is less controversial than others the Trump Administration has taken. This article discusses its significance.

Lynn L. Bergeson, "The Final Rule," Manufacturing Today, July 21, 2017.

The U.S. Environmental Protection Agency (EPA) issued on Jan. 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. This column summarizes the rule.

Lynn L. Bergeson, "EPA Issues TSCA Framework Rules," Chemical Processing, July 18, 2017.

The U.S. Environmental Protection Agency (EPA) issued in June final framework rules under the Toxic Substances Control Act (TSCA). Each is summarized in the article.

Lynn L. Bergeson, "The Trump Administration and Likely Impacts on Environmental Law and Policy," Environmental Quality Management, Volume 26, Issue 4, Summer 2017.

2016 was full of surprises, two of which are driving much of the environmental agenda for the U.S. Environmental Protection Agency (EPA) in 2017.  First, Congress significantly amended the Toxic Substances Control Act (TSCA) in June of 2016.  The changes are intended to reform the program to address the widely recognized deficiencies in the law, especially regarding existing chemicals, chemical testing, Confidential Business Information (CBI) claims, and preemption of state actions.  EPA has been busy implementing the new law, as the all-important “framework rules” must be issued in final in June 2017.  The second surprise event was even more unexpected -- the election of Donald Trump as President.  His election is already having a significant impact on environmental law and policy.  This column briefly offers some thoughts and predictions on the impact of the new Administration on environmental issues of interest to our readers.

Lynn L. Bergeson, Daniel B. González, Anabela Aldaz, and Christopher J. McNevin, "Mini-Roundtable: Environmental Disputes," Corporate Disputes, July-September, 2017.

A major change, brought about by the November elections, is the uptick in citizen suit litigation, and lawsuits brought by third parties against the government. Given the current administration’s position on climate change, environmental regulation generally, and the perception that regulations impede economic growth and job development, there has been a significant slowdown in regulatory and administrative activity and the initiation of enforcement actions. NGOs and third-party activists will continue to fill this void by private lawsuits as citizen litigants.

Lynn L. Bergeson, "Regulation: Prepare for the TSCA Inventory Reset," Chemical Processing, June 20, 2017.

With the recent 2016 Chemical Data Reporting (CDR) dataset and the initial interim list of “active” substances released with the February 2017 copy of the Toxic Substances Control Act (TSCA) Inventory, the magnitude of effort needed for the TSCA Section 8(b)(4) Inventory Reset is becoming clear. Stakeholders should waste no time in preparing to meet their obligations; the final rule was issued in June.

Lynn L. Bergeson, "TSCA Implementation: What’s In Trump’s Playbook?," The ABA SEER Joint Newsletter: Energy, Climate Change, and Environmental Law under Trump, Volume 18, Issue 1, June 2017.

Most people knew candidate Trump was no fan of climate change regulation or the Clean Water Rule (CWR). Mr. Trump’s views on chemical management were never clearly articulated, however. Some may have interpreted this notable silence as support for Toxic Substances Control Act (TSCA) reform, given the broad bipartisan support it enjoyed before its enactment last June. Others may have assumed candidate Trump, in the heat of the campaign, was unaware of the significant commercial, legal, and trade implications occasioned by enactment of the Frank R. Lautenberg Chemical Safety of the 21st Century Act (Lautenberg), the most sweeping legislative overhaul to our domestic chemical management law in four decades. Similar to candidate Trump, President Trump has kept his TSCA cards close to his vest. To the extent money talks, the President’s fiscal year 2018 budget doubles down on slashing the U.S. Environmental Protection Agency’s (EPA) budget by over 30 percent. The chemicals program, however, would largely be spared cuts and in fact would get a boost under the Trump budget submitted to Congress in late May, suggesting solid support for ensuring the new law is implemented timely.

Lynn L. Bergeson, "EPA Eyes ‘Burdensome’ Rules," Chemical Processing, May 19, 2017.

On February 24, 2017, President Trump issued Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda. The EO offers opportunities for stakeholders to improve regulations. This article summarizes efforts to implement this EO, and identifies opportunities stakeholders may wish to pursue to eliminate or amend regulatory initiatives they feel have outlived their utility or were ill-conceived from the get-go.

Lynn L. Bergeson, "EPA TechDirect Reports Availability of NanoRem Toolbox," Nanotechnology Now, May 8, 2017.

The May 1, 2017, issue of the U.S. Environmental Protection Agency's (EPA) TechDirect includes an item on the availability of the Taking Nanotechnological Remediation Processes from Lab Scale to End User Applications for the Restoration of a Clean Environment (NanoRem) Toolbox.

Lynn L. Bergeson, "TSCA Reform: Key Provisions and Implications," Environmental Quality Management, Winter 2016.

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The text of the law is available at: http://www.congress.gov/bill/114th-congress/house-bill/2576/text. The law substantially amends the Toxic Substances Control Act (TSCA), and in so doing, fundamentally alters the domestic management of industrial chemicals, the lifeblood of many manufacturing processes. This article summarizes key changes and explains their likely impacts on the manufacturing sector. For the purposes of this article, reference is made to the amended TSCA as “new TSCA.”

Lynn L. Bergeson, "TSCA Targets Mercury: EPA regulation aims to minimize mercury use," Chemical Processing, April 14, 2017.

On March 29, 2017, the U.S. Environmental Protection Agency (EPA) released its initial inventory report of mercury supply, use and trade in the United States pursuant to the requirements of the amended Toxic Substances Control Act (TSCA). This article outlines this development in the context of mercury regulation under the TSCA.

Lynn L. Bergeson, Douglas Bryden, and Kindra L. Kirkeby, "Chemical Management: What All Environmental, Energy, and Resources Lawyers Need to Know about TSCA Reform and Why," American Bar Association Section of Environment, Energy, and Resources, March 30, 2017.

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). The new law amended significantly the Toxic Substances Control Act (TSCA) and in so doing, is redefining supply chain relationships, rewriting the rules of engagement for due diligence in mergers and acquisitions, reopening debate on new avenues in product liability and tort law, and raising important questions regarding right-to-know vs. confidential business information (CBI). TSCA, as amended, is no longer an arcane chemical statute that only chemists, consultants, and counsel for chemical manufacturers need to understand. We discuss below the significant changes in commercial transactions, supply chain relationships, and related legal areas of which Section members need to be aware, anticipate, and address. We also briefly consider TSCA and its alignment and differences with the European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, and speculate on the impact Brexit might have on chemical management.

Lynn L. Bergeson, "TSCA Implementation Remains On Target: The EPA is issuing framework rules on a timely basis," Chemical Processing, March 22, 2017.

Implementation of the newly amended Toxic Substances Control Act (TSCA), signed into law last June, is in full swing. The U.S. Environmental Protection Agency (EPA) has been working hard to meet statutorily imposed deadlines for promulgating three “framework” rules by June 2017. To date, the EPA is on target. This column discusses the three framework rules.

Lynn L. Bergeson, "Report Your Nanoscale Materials," Chemical Processing, February 17, 2017.

The U.S. Environmental Protection Agency (EPA) finally concluded January 12, 2017, a ten-year effort to issue a Toxic Substances Control Act (TSCA) Section 8(a) rule establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances manufactured or processed at nanoscale. This column summarizes the rule. Reports are due to the EPA no later than May 12, 2018. The final rule is effective May 12, 2017.

Lynn L. Bergeson, "NIOSH Seeks Comment on Proposed Survey of Engineered Nanomaterial OSH Practices," Nanotechnology Now, February 15, 2017.

The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on February 10, 2017, inviting comment on a proposed information collection plan, "Survey of Engineered Nanomaterial Occupational Safety and Health (OSH) Practices." The goal of the project is to assess the relevance and impact of NIOSH's contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace. The intended use of the data is to inform NIOSH's research agenda to enhance its relevance and impact on worker safety and health in the context of engineered nanomaterials. 

Lynn L. Bergeson, Timothy D. Backstrom, and Bethami Auerbach, "Something Inside That Shoebox Really Stinks," Focus, February 2017.

Each year, millions of consumers, including large numbers of children, are exposed to unknown quantities of anti-mold pesticides when they open a shoebox. Although the active ingredient in these mostly unregistered anti-mold pesticides is undisclosed and the products are marketed as all natural, many stickers contain allyl isothiocyanate (AITC). These stickers have not been registered for this use, nor has this use, or the resulting exposure to consumers, been reviewed for safety by the U.S. Environmental Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), or by any other regulatory agency. 

It’s unlikely that shoe retailers and distributors are aware of the staggering tort liability that could be hibernating in shoeboxes. Someday, millions of unsuspecting and unprotected consumers, including children, could allege they were harmed by products few ever noticed. Even more alarming is that any consumer claims of injury from exposure to an unregistered pesticidal agent cannot be subject to preemption under FIFRA Section 24(b), 7 U.S.C. § 136v(b) because the products are unregistered and have not been reviewed by EPA. This puts U.S. distributors or retailers at risk, especially if they knew that an unregistered pesticide was present in the product and failed to warn consumers. 

Lynn L. Bergeson, "OECD Publishes Report on Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials," Nanotechnology Now, February 1, 2017.

The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials: Current State of Knowledge and Research Needs to Advance Their Use.

Lynn L. Bergeson, Charles M. Auer, and Carla Hutton, "Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials," BNA Daily Environment Report, January 26, 2017.

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and in so doing significantly revised the Toxic Substances Control Act (TSCA) for the first time since its enactment in 1976. This article reviews and analyzes TSCA as amended and focuses narrowly on how new TSCA specifically impacts nanoscale materials. Although the new TSCA dramatically changes how the Environmental Protection Agency (EPA) evaluates and manages industrial chemicals, including nanoscale chemicals, the absence of words or phrases such as nano or nanoscale materials means that there are no specific or additional requirements that apply explicitly to such materials. This was a significant shift from many of the earlier TSCA reform bills, which explicitly addressed nanoscale materials by proposing new definitions such as “substance characteristics” and “special substance characteristics” that included concepts such as size or size distribution; shape; surface structure; and reactivity. The new TSCA is noticeably silent on this subject and does not distinguish nanoscale materials or treat such materials differently from other chemical substances regulated under TSCA.

Lynn L. Bergeson, "The EPA Seems Set for a Busy 2017 Under Trump Administration," Chemical Processing, January 24, 2017.

Last year was full of surprises, two of which will drive much of the agenda in 2017 for the Office of Chemical Safety and Pollution Prevention (OCSPP) of the U.S. Environmental Protection Agency (EPA). First, Congress significantly amended the Toxic Substances Control Act (TSCA). Although many thought the chances of successful TSCA legislation were slim, the second surprise event was even more unexpected — the election of Donald Trump as President.

Lynn L. Bergeson, "Enlisting Modern Technologies to Ensure a Safe Food Supply," Natural Resources & Environment, Volume 31, Issue 3, Winter 2017.

Nanotechnology, biotechnology, and synthetic biology are the ploughs and tractors of the twenty-first century. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges. Genetically modified E. coli is being used to produce synthetically derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Nanopesticides and nanofertilizers are being effectively used in drought-stricken regions, eliminating or minimizing the need for conventional agricultural chemicals. These and similar technologies are essential to enable today’s agricultural professionals to compete with an increasingly unforgiving Mother Nature and an ever-increasing demand for food.

 

These emerging technologies do not come without potential risks, however. How to regulate them is a  subject upon which stakeholders disagree.

 

Against this backdrop, this article considers emerging agricultural technologies, and discusses domestic agricultural oversight systems and their ability to keep pace with innovation. As discussed below, the domestic governance system is capable of addressing comprehensively the potential risks posed by these evolving technologies. The system, however, could be improved by better integration of measures  to educate policy makers and regulators on these technologies, and greater involvement by the private  sector in facilitating a predictable flow of information on these technologies to all stakeholders.

Lynn L. Bergeson, "EPA Targets Formaldehyde Vapors," Chemical Processing, January 2, 2017.

On December 12, 2016, the U.S. Environmental Protection Agency (EPA) issued a long-awaited final rule to reduce exposure to formaldehyde vapors from certain wood products produced domestically or imported into the United States. Formaldehyde is found in the adhesives used in a range of composite wood products. This column summarizes the new rule.

Lynn L. Bergeson, "OSHA Sustainability Paper Notes Opportunity to Integrate Sustainability and Nanotechnology Research," Nanotechnology Now, December 21, 2016.

The Occupational Safety and Health Administration (OSHA) released on December 20, 2016, a white paper entitled Sustainability in the Workplace: A New Approach for Advancing Worker Safety and Health. See https://www.osha.gov/sustainability/docs/OSHA_sustainability_paper.pdf The paper highlights the importance of including worker safety and health in the growing movement toward sustainability and corporate responsibility. According to the paper, research on sustainability does not include occupational safety and health.

Lynn L. Bergeson, "Australian Draft National Standard for the Environmental Risk Management of Industrial Chemicals Addresses Nanomaterials," Nanotechnology Now, December 1, 2016.

On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document. See http://www.environment.gov.au/protection/chemicals-management/national-standard/draft-national-standard-environmental-risk-management-industrial-chemicals  According to the Department, the primary purpose of the papers is to outline the design and operation of the National Standard. 

Lynn L. Bergeson, "Chemical Compliance: Montreal Protocol Addresses HFCs," Chemical Processing, November 28, 2016.

October 15, 2016, was a historic day for international climate action: nearly 200 countries reached an agreement to phase out use of hydrofluorocarbons (HFC) at the 28th meeting of the parties to the Montreal Protocol in Kigali, Rwanda. This column summarizes this historic event and its implications.

The Montreal Protocol is the international treaty designed to protect the earth’s ozone layer by requiring the phasing out of production and use of chlorofluorocarbons (CFC), substances believed to contribute to ozone depletion, many of which also contribute to greenhouse gas (GHG) production. By many accounts, the Montreal Protocol is one of the most successful international agreements ever implemented.

Lynn L. Bergeson, "Next Generation Compliance and Its Implications for Industry," Environmental Quality Management, Volume 26, Issue 1, Fall 2016.

“Next Generation Compliance” is the U.S. Environmental Protection Agency’s (EPA) signature initiative intended to increase compliance with environmental regulations by using advances in pollution monitoring and information technology and by more effectively using and designing regulations and permits to reduce pollution and enhance compliance.  This column describes EPA’s initiative, discusses several examples of its applications in rulemakings and civil enforcement settlements, discusses another new compliance-related tool, eDisclosure, and outlines the implications for industry of these novel approaches to incentivizing compliance.

Zameer Qureshi, "The REACH Implementing Regulation on joint submission of data and data sharing: is it fair, transparent and non-discriminatory?," Elements, the Magazine of Chemicals Northwest, Autumn, 2016.

Commission Implementing Regulation (EU) 2016/9 (Implementing Regulation) entered into force with retroactive effect on 26 January 2016, providing several new and important considerations and obligations for companies sharing data under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The Implementing Regulation aspires to: (1) provide useful clarity on data sharing and data compensation under REACH by providing detail on the “fair, transparent and non-discriminatory” standard; and (2) reinforce the “One Substance, One Registration” (OSOR) principle.

Lynn L. Bergeson, "EPA Speeds Review of Chemicals," Chemical Processing, October 24, 2016.

The U.S. Environmental Protection Agency (EPA) is continuing its brisk pace to be on target with implementing the new requirements of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (see “Grasp the Gravity of the New TSCA,” and “EPA Releases Q&As on New TSCA”). Congress has in its sights persistent, bioaccumulative, and toxic (PBT) chemicals — with the goal to reduce exposures to them. The EPA’s recent action to fast track review of five such chemicals does just that. Here’s what the EPA announced, and its impact on industry.

Charles M. Auer, Lynn L. Bergeson, "Role of ‘Conditions of Use’ Under Sections 5 and 6 of Amended Toxics Law," BNA Daily Environment Report, October 14, 2016.

President Barack Obama signed into law amendments to the Toxic Substances Control Act on June 22. The amendments bring sweeping changes to the nation’s primary chemicals law. In this Bloomberg BNA Insights, Charles M. Auer and Lynn L. Bergeson look specifically at the role of ‘‘conditions of use’’ in Sections 5 and 6 under the amended law and other chemical exposure considerations.

Charles M. Auer, Lynn L. Bergeson, "Is The Section 5 Review Period Fixed Or Flexible In New TSCA?," ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, September, 2016.

 Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions. Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions. This article analyzes that question.

Lynn L. Bergeson, "Minnesota Adds Several Nanomaterials to List of Chemicals of High Concern," Nanotechnology Now, September 29, 2016.

On September 13, 2016, the Minnesota Department of Health (MDH) announced the availability of an updated list of chemicals of high concern. See http://www.health.state.mn.us/divs/eh/hazardous/topics/toxfreekids/highconcern.html#list

Lynn L. Bergeson, "EPA Releases Q&As on New TSCA," Chemical Processing, September 20, 2016.

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&As). This column explains the significance of this guidance.

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act, ushering in a significantly enhanced, and effective immediately, chemical management law. (See “Grasp the Gravity of the New TSCA.")

The EPA has wasted no time in beginning the challenging process of implementing the law. This first step consists of preparing rulemakings and issuing guidance documents in the form of useful Q&As on a variety of topics.

Lynn L. Bergeson, "Pollution Monitoring: New Tools Help Speed Compliance," Chemical Processing, August 17, 2016.

The U.S. Environmental Protection Agency (EPA) has made much of its “Next Generation Compliance” initiative, created “to increase compliance with environmental regulations by using advances in pollutant monitoring and information technology combined with a focus on designing more effective regulations and permits to reduce pollution.” This involves more effective regulations and permits that include built-in compliance mechanisms, such as continuous monitoring for stationary sources; advanced monitoring, including fence-line monitoring and infrared camera systems; greater transparency, including public availability of electronic data and third-party audits; and “innovative” enforcement, including incorporating these elements in administrative and judicial settlements and injunctive relief demands. This column briefly outlines these new initiatives so Chemical Processing readers can take advantage of these programs.

Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.

It is the author’s view that the central failing of old TSCA was its inability to produce the testing needed by EPA to assess and understand the hazards, exposures, and risks of existing chemicals. New TSCA makes important changes to the authority available to EPA to compel industry to generate the information needed by EPA to meet the purposes articulated under the new law. This paper briefly reviews the issues and problems that EPA encountered in using old TSCA for this purpose, discusses the improvements in new TSCA, and discusses why the author believes they offer the potential of future success in the testing area.

Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182, significantly amends the Toxic Substances Control Act (TSCA). The Act was signed into law by President Obama on June 22, 2016. The date of signature is both the date of enactment and of entry into force of amended TSCA. New TSCA fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years.  The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.

Lynn L. Bergeson, "Two Workshops Will Be Held Before October 2016 OpenTox Euro Conference," Nanotechnology Now, August 11, 2016.

Two workshops, a European Union (EU)-U.S. Nano Environmental and Health Safety (NanoEHS) workshop and a nano modeling workshop, will be held in advance of the October 2016 OpenTox Euro Conference.

Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amends the Toxic Substances Control Act (TSCA), particularly with regard to Section 8 record keeping and reporting obligations. This article highlights a number of important changes and deadlines of which companies subject to TSCA should be aware.

Lynn L. Bergeson, "Canada Begins Consultation On Proposed Prioritization Approach For Nanoscale Forms Of DSL Substances," Nanotechnology Now, August 4, 2016.

On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL).

Lynn L. Bergeson, "EC Amends Cosmetics Regulation To Allow Use Of Titanium Dioxide (Nano) as UV Filter," Nanotechnology Now, July 21, 2016.

The European Commission (EC) published on July 14, 2016, a regulation in the Official Journal of the European Union that amends Annex VI, the list of ultraviolet (UV) filters allowed in cosmetic products, of the cosmetics regulation.

Lynn L. Bergeson, "Grasp the Gravity of the New TSCA," Chemical Processing, July 13, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act makes seismic changes in domestic industrial chemical management. If you think the extensive revisions to the Toxic Substances Control Act (TSCA) enacted on June 22, 2016, don’t impact your business, think again. TSCA reform affects virtually every domestic business sector involving chemicals and manufactured goods containing chemicals, and will continue to do so for years to come.

Lynn L. Bergeson, "EC Denies 2014 Petition Seeking EU-Wide Ban on Nanoparticles," Nanotechnology Now, July 12, 2016.

On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles. The petition summary states: "Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer. Because the precautionary principle applies in the EU, the petitioner urges a ban on these small particles as soon as possible."

Lynn L. Bergeson, "CRS Prepares “Policy Primer” on Nanotechnology," Nanotechnology Now, July 6, 2016.

The Congressional Research Service (CRS) prepared a June 28, 2016, report, Nanotechnology: A Policy Primer. The report provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness in the field, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. According to the report, while more than 60 nations established similar programs after the launch of the National Nanotechnology Initiative (NNI), "it appears that several have moved away from centralized, coordinated nanotechnology-focused programs (e.g., the United Kingdom, Japan, Russia), some in favor of market- or application-oriented topic areas (e.g., health care technologies)."

Emma L. Jackson, Louise C. Boardall, Zameer Qureshi, "Top Questions for Substance Information Exchange Forum (SIEF) Participation," Elements, the Magazine of Chemicals Northwest, Summer, 2016.

The global chemicals industry has been presented with significant, often unfamiliar, challenges by the concept and functioning of SIEFs under REACH.  Through years of experience in SIEF participation on our clients’ behalf, Acta has identified the following questions to consider when participating in a SIEF.

Lynn L. Bergeson, "In-House Counsel Beware: TSCA Reform Impacts Everyone," Law360, June 15, 2016 .

In-house counsel unfamiliar with the tsunami-like changes in domestic chemical management headed our way soon may wish to read this article. If you think for a second that the extensive revisions to the Toxic Substances Control Act (TSCA) expected to be enacted imminently do not impact your legal practice or your client’s business operations, think again. TSCA reform impacts virtually every business sector in the United States, and will continue to do so for years to come. Here are the reasons why you should care.

Lynn L. Bergeson, "Mexico Begins Public Consultation on Draft Nanotechnology Standards," Nanotechnology Now, June 7, 2016.

On May 3, 3016, Mexico's Ministry of Economy published a notice beginning a public consultation on two draft nanotechnology standards. ISO/TS 80004-5:2011 lists terms and definitions related to the interface between nanomaterials and biology. It is intended to facilitate communications between scientists, engineers, technologists, designers, manufacturers, regulators, non-governmental organizations (NGO), consumer organizations, members of the public, and others.

Lynn L. Bergeson, "Proposed Harmonized Classification and Labeling Would Apply to Nanosized Titanium Dioxide," Nanotechnology Now, June 1, 2016.

On May 31, 2016, the European Chemicals Agency (ECHA) began a public consultation on a harmonized classification and labeling (CLH) proposal submitted by France for titanium dioxide. The CLH report states: "Based on available evidence and information in the registration dossier (e.g. mechanism of carcinogenicity, characterization of the particles), the proposed scope for the Annex VI entry is: ‘Titanium dioxide in all phases and phase combinations; particles in all sizes/morphologies.'"

Lynn L. Bergeson, "EPA Seeks to Revise Risk Management Program," Chemical Processing, June 1, 2016.

On March 14, 2016, the U.S. Environmental Protection Agency (EPA) proposed much-anticipated amendments to the Risk Management Program (RMP) regulations. This column summarizes the proposed amendments and industry’s response to them.

 

The genesis of the proposal is President Obama’s Executive Order (EO) 13650, which was issued in the aftermath of the catastrophic explosion that occurred in April 2013 that claimed 15 lives in West, Texas. The EO requires various federal agencies to develop options for better chemical facility safety and security that identify “improvements to existing risk management practices through agency programs, private sector initiatives, government guidance, outreach, standards, and regulations.” The EPA’s RMP regulations fall squarely in the zone of interest for purposes of the EO. Required under Section 112(r) of the Clean Air Act, these regulations, codified at 40 C.F.R. Part 68, apply to stationary sources that hold specified regulated substances in excess of certain thresholds. These “facilities” are required to assess their potential release impacts, undertake steps to prevent releases, plan for emergency response to releases, and summarize this information in a risk management plan submitted to the EPA.

Lynn L. Bergeson, "Australia Addresses Nanomaterials in Third NICNAS Reforms Consultation Paper," Nanotechnology Now, May 10, 2016.

On April 29, 2016, Australia's National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published the third consultation paper on its reform initiative. See https://www.nicnas.gov.au/about-nicnas/nicnas-reforms/consultation-paper-3 and https://www.nicnas.gov.au/about-nicnas/nicnas-reforms Under the reforms, the requirements to establish that a new chemical can be classified as being not hazardous to human health or the environment, and therefore falls in Hazard Band A, include consideration of several factors, including whether the chemical is a nanomaterial. The consultation paper states that the risk matrix applies to chemicals (and their nanoforms) that are not listed on the Australian Inventory of Chemical Substances (AICS).

Lynn L. Bergeson, "NNCO Accepting Registrations for SME and NanoEHS Webinars," Nanotechnology Now, May 4, 2016.

On May 11, 2016, the National Nanotechnology Coordination Office (NNCO) will hold a webinar for small- and medium-sized enterprises (SME) that will focus on the experiences, successes, and challenges for SMEs working in nanotechnology and on issues of interest to the business community. See http://www.nano.gov/node/160  The National Science Foundation's Center for High-rate Nanomanufacturing, at Northeastern University's College of Engineering in Boston, will host the webinar.

Lynn L. Bergeson, "Registration Now Open for 2016 U.S.-EU: Bridging NanoEHS Research Efforts Joint Workshop," Nanotechnology Now, April 28, 2016.

Registration is now open for the June 6-7, 2016, U.S.-European Union (EU) "Bridging NanoEHS Research Efforts" joint workshop. See https://docs.google.com/forms/d/1-wZatJVQ3b9LSx9rrJeeEZqFO-8DZVs-80txK-9DBmQ/viewform and http://us-eu.org/2016%20-us-eu-nanoehs-workshop/ The workshop will bring together the U.S.-EU Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nanotechnology environmental, health, and safety (nanoEHS) research.

Lynn L. Bergeson, "SNWG Submits Comments on NIOSH Draft CIB on Silver Nanomaterials," Nanotechnology Now, April 21, 2016.

On April 18, 2016, the Silver Nanotechnology Working Group (SNWG) submitted comments on the National Institute for Occupational Safety and Health's (NIOSH) draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. See https://www.regulations.gov/#!documentDetail;D=CDC-2016-0001-0017 and https://www.regulations.gov/#!documentDetail;D=CDC-2016-0001-0002 The draft Current Intelligence Bulletin (CIB) includes a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects.

Lynn L. Bergeson, "OSHA Revises Silica Standards," Chemical Processing, April 15, 2016.

On March 25, 2016, the U.S. Occupational Safety and Health Administration (OSHA) issued its long-awaited revised standards for occupational exposure to respirable crystalline silica (81 Fed. Reg. 16286). OSHA issued two separate standards — one for general industry and maritime, and the other for the construction industry — to tailor requirements to the unique circumstances found in these sectors. The rule impacts more than 2.3-million American workers across a wide spectrum of industries, according to OSHA, and is expected to save the lives of more than 600 workers per year. Its implementation will likely have broad logistical and cost implications for many employers in numerous industry sectors. This article provides highlights of the final rule.

Lynn L. Bergeson, "TSCA Reform: Is It Still in Our Future?," Industrial Biotechnology, April 5, 2016.

Toxic Substances Control Act (TSCA) reform has been a “work in progress” for years. House and Senate passage in 2015 of substantive TSCA reform measures considerably improved the odds that Congress would enact TSCA-reform legislation in 2016. Recent events suggest otherwise, however, and as of this writing in mid-March the fate of TSCA reform remains decidedly uncertain. Momentum has dissipated as a dithering House has been slow to engage with Senate counterparts to reconcile the different approaches contemplated under each bill. The surprisingly harsh Republican response to Associate Supreme Court Justice Scalia’s untimely demise has hardened the partisan divide that threatens to tank Congressional action on any important initiative, let alone legislation as significant and potentially divisive as TSCA reform. It is hoped that cooler heads will prevail and leverage the hard work and momentum that has brought us to this momentous place in history. This Commentary provides an update on the current state of TSCA reform efforts.

Susan M. Kirsch, "Pesticides and NPDES: Increased Environmental Protection, or Just More Paperwork?," ABA SEER Pesticides, Chemical Regulation, and Right-To-Know Committee Newsletter, April, 2016.

On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published a draft National Pollutant Discharge Elimination System (NPDES) pesticide general permit (PGP) for public comment. The publication marks the first reissuance of the PGP since its inception in 2011. The Sixth Circuit’s decision in National Cotton Council v. EPA, F.3d 927 (6th Cir. 2009), which vacated EPA’s 2007 rule exempting pesticides from NPDES permitting, required EPA to issue the PGP. In October 2011, EPA published a five-year PGP, which expires on October 31, 2016. Additionally, all states with delegated NPDES program authority developed and issued state versions of the PGP.

 1 2 3 >  Last › View 10 | 25 | 50 | 100 per page
 
BERGESON & CAMPBELL, P.C.
2200 Pennsylvania Avenue, NW, Suite 100W
Washington, D.C. 20037
(202) 557-3800 • (202) 557-3836 (fax) | lawbc.com
Contact • Twitter
 
Privacy and Terms of Use | Attorney Advertising | Trademarks
©2018 Bergeson & Campbell, P.C.
All Rights Reserved.