All Published Articles

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, 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, "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, "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, "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."

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