All Published Articles

Lynn L. Bergeson, "Effectively Managing Supply Chain Communications Under TSCA," Bloomberg Environment Insights, April 28, 2020.

The EPA’s amendments to the Toxic Substances Control Act reporting requirements have increased the need for chemical stakeholders to manage actively supply chain communications. Lynn L. Bergeson, owner and managing partner of Bergeson & Campbell P.C., explores the upsides to be realized through these communications and the perils of failing to seize them. Download a PDF of this article here.

Lynn L. Bergeson, "Chemical Importers are on the Hook for TSCA Risk Evaluation Fees," Elements, the Magazine of Chemicals Northwest, Spring 2020.

Is your company potentially liable for a share of the U.S. Environmental Protection Agency (EPA) $1,350,000 fee for developing a Toxic Substances Control Act (TSCA) risk evaluation? This is a hot topic these days, given EPA’s notice dated January 27, 2020, identifying the “preliminary lists” of manufacturers, including importers, of the 20 chemical substances that EPA has designated as “high-priority” substances for risk evaluation and for which fees will be charged. Stakeholders are required by March 27, 2020, to “self-identify” as manufacturers of a highpriority substance irrespective of whether they are included on the preliminary lists identified by EPA.  

Lynn L. Bergeson and Christopher R. Blunck, "Expert Focus: What Are the Implications of the US EPA’s Expected Final Rule on Persistent, Bioaccumulative and Toxic Chemicals?," Chemical Watch, March 26, 2020.

PBT chemicals have long been recognised to behave differently in the environment and in biological systems from non-PBT substances. The US Congress acknowledged this when amending TSCA in 2016 by crafting special provisions under the Regulation’s Section 6(h) that were uniquely applicable to PBTs. Last July, the EPA proposed a rule that would implement the section, but this caused much controversy and led to comments from, among others, the retail, coatings and aerospace sectors and NGOs. It also raised several novel legal issues relating to TSCA’s interpretation.

 

Nevertheless, the EPA must issue a final rule within 18 months of the proposal, that is to say by December 2020. This article focuses on the novel issues that have arisen and the implications of their resolution on affected stakeholders.

Lynn L. Bergeson, "TSCA Fee Controversy Continues," Chemical Processing, March 20, 2020.

In last month’s column, we reported on the January 27, 2020, notice from the U.S. Environmental Protection Agency (EPA) identifying the preliminary lists of manufacturers, including importers, of the 20 chemical substances the EPA designated as high-priority for risk evaluation and for which fees will be charged. The notice created a firestorm of criticism over the lack of any exemptions from being considered potentially responsible for paying a share of the EPA’s $1,350,000 fee for conducting a risk evaluation of a high-priority chemical. This column updates the status of this fast-changing matter.

Lynn L. Bergeson, "The growing spectre of chemical product cancellations, and what to do about it," Financier Worldwide, February 2020.

Effective 1 January 2022, household cleaning, cosmetic and personal care products containing quantities of 1,4-dioxane over specified trivial levels will be prohibited from sale in the state of New York. The law imposing these restrictions, signed by governor Andrew M. Cuomo on 9 December 2019, is intended to protect drinking water supplies from contamination by the chemical. This product ban falls on the heels of the 15 March 2019 final rule issued by the US Environmental Protection Agency (EPA) banning the manufacture, import, processing and distribution, including e-commerce, of methylene chloride for consumer paint and coating removal. The EPA’s determination that the use of methylene chloride in consumer paint and coating removal presents an ‘unreasonable risk’ of injury to health prompted this decision. These commercial bans are not anomalies; they are the new normal. This article explains why, and the reasons corporate leaders, brand managers, investors and others in this commercial space need to understand this trend and plan accordingly.

Lynn L. Bergeson, "Toxic Substances: Are You On The List?," Chemical Processing, February 24, 2020.

The U.S. Environmental Protection Agency (EPA) published on January 27, 2020, a notice identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that the EPA designated as high-priority substances for risk evaluation and for which fees will be charged (85 Fed. Reg. 4661). The list and the EPA’s interpretation of the fee rule caught many off guard. This column explains why.

Lynn L. Bergeson, "EPA Revises “Working Approach” Document," Chemical Processing, January 14, 2020.

On December 20, 2019, the U.S. Environmental Protection Agency (EPA) released an updated “Working Approach” document that builds upon its November 2017 version. The EPA states that the updated version, “TSCA New Chemical Determinations: A Working Approach for Making Determinations under TSCA Section 5,” explains its approach for making affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA). This article highlights key changes in the document.

Lynn L. Bergeson, "Risk evaluations under TSCA: The state of play," Specialty Chemicals Magazine, December 2019/January 2020.

Among the changes when the Toxic Substances Control Act (TSCA) was amended by the Frank R. Lautenberg Chemical Safety Act for the 21st Century, also known as Lautenberg or ‘new TSCA’, none is more consequential than the requirement that the US Environmental Protection Agency (EPA) conduct risk evaluations for ‘high priority’ chemical substances. We are now three years into new TSCA and this is being done, amid spirited debate and, inevitably, litigation.

Lynn L. Bergeson, "EPA Issues New Accidental Release Rule," Chemical Processing, December 20, 2019.

On November 20, 2019, the U.S. Environmental Protection Agency (EPA) signed off on final changes to the risk management program (RMP) rule, most recently amended in January 2017. The regulations were promulgated under Section 112(r) of the Clean Air Act (CAA) when the law was amended in 1990. This section is intended to prevent or minimize the consequences of accidental chemical releases. A need to prevent or minimize the catastrophic consequences of accidental chemical release is a point few would argue. How best to “prevent or minimize,” however, has evoked exhausting debate and legal wrangling. This column summarizes key changes in the reissued final rule.

Lynn L. Bergeson, "SEC Proposes Changes To Reporting Rules," Chemical Processing, October 16, 2019.

Publicly traded companies must disclose certain legal proceedings and risk factors in registration statements and in annual and quarterly reports. These disclosures significantly help investors in assessing the financial integrity of a publicly traded company; formulating a disclosure precisely is critical to compliance, while at the same time accurately capturing the nature and extent of the potential risks. This article summarizes this Securities and Exchange Commission (SEC) proposed rule, which is intended to modernize the Regulation S-K obligations, particularly as they relate to environmental disclosures, and discusses the unique challenges these reporting obligations impose on the chemical industry.

Lynn L. Bergeson, "The Growing Influence of Chemical Risk Evaluation on the M&A Market," Financier Worldwide, October 2019.

In 2018, the global M&A market achieved a transaction volume of $4.1 trillion, the third highest year ever for M&A volumes. Divestitures, spin-offs and split-offs are essential to defining corporate identity, a key shareholder imperative. This brisk pace is expected to continue. Whatever the motivation, M&A activity demands razor-sharp due diligence. The premise of this article is that due diligence often underestimates or, worse, ignores the impact implementation of revisions to the Toxic Substances Control Act (TSCA), the US industrial chemical safety law, has on commercial transactions. Implementation of these revisions is now influencing key sectors of the economy, making it essential that TSCA chemical risk evaluations be routinely included in M&A due diligence protocols.

Lynn L. Bergeson, "Chemical Restrictions and TSCA’s Growing Commercial Influence," Environmental Quality Management, Volume 29, Issue 1, Fall 2019.

This past spring, the United States Environmental Protection Agency (EPA) issued a first-ever final rule under Section 6(a) of the Toxic Substances Control Act (TSCA) banning the use of methylene chloride in consumer paint and coating removal products. Although this rule was long in the making, this type of chemical ban of selected products is likely to be seen more routinely in the months and years ahead. This article reflects upon EPA’s broad authority under TSCA Section 6 and explores the reasons why chemical prohibitions, and the commercial complications they inspire, are expected to be the new normal.

Lynn L. Bergeson, "Chemical Compliance: Court Nullifies New York Disclosure Program," Chemical Processing, September 18, 2019.

In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program. The program is an example of the newest trend in state “information disclosure” programs intended to force product manufacturers to disclose the ingredients in products sold to consumers. This article discusses the program and explains why the court rescinded it.

Lynn L. Bergeson, "EPA Proposes PBT Chemicals Rule," Chemical Processing, August 27, 2019.

After many years of study, the U.S. Environmental Protection Agency (EPA), industry stakeholders, and the scientific community at large well know that chemicals that are persistent, bioaccumulative, and toxic (PBT) behave differently in the environment and in biological systems than non-PBT chemicals. Congress acknowledged this in updating the Toxic Substances Control Act (TSCA) in 2016 by specifying special provisions under TSCA Section 6(h) for PBT chemicals. In June of this year, the EPA proposed a rule implementing TSCA Section 6(h) review that elicits important insights on how the EPA intends to review such chemicals. The rule is a blueprint for its consideration of PBTs for years to come.

Lynn L. Bergeson, Kathleen M. Roberts, and Richard E. Engler, Ph.D., "Protecting the Value of Health, Safety Studies—Emerging TSCA Issues," Bloomberg Environment Insights, August 22-23, 2019.

Health and safety studies provide invaluable insights into the hazards posed by chemical substances. The cost of generating these studies is also considerable, and access to them should be commensurate with the intellectual property interests they reflect. This article explores two current challenges under the Toxic Substances Control Act (TSCA) and offers practical tips for managing these issues.

J. Brian Xu, Jane S. Vergnes, and Carla N. Hutton, "China Drafts Changes to Chemical Registration Rules," Bloomberg Environment Insights, July 29, 2019.

Manufacturers and importers should weigh in on China’s planned changes to registration requirements for new chemical substances, write Brian Xu and Jane Vergnes of The Acta Group, and Carla Hutton of Bergeson & Campbell.

Lynn L. Bergeson, "Expert Focus: TSCA and Liability under the False Claims Act – a Potentially Promising Area," Chemical Watch, July 26, 2019.

A federal appellate court recently decided a case brought under the FCA’s reverse false claims provision premised on alleged non-compliance with a TSCA reporting obligation. Kasowitz Benson Torres LLP v. BASF Corp. As discussed in this article, while the court dismissed the case, it did so for fact-specific reasons and creative plaintiff lawyers can be expected to rely upon the FCA in the future to bring actions based on other TSCA provisions.

Lynn L. Bergeson, "USDA Enhances Biobased Procurement Program," Chemical Processing, July 16, 2019.

The U.S. Department of Agriculture (USDA) published a final rule on July 5, 2019, amending its “Guidelines for Designating Biobased Products for Federal Procurement” to include 30 more product categories for biobased products that may receive procurement preference by federal agencies and their contractors. These 30 product categories contain finished products made, in large part, from intermediate ingredients designated for federal procurement preference. This article explains why Chemical Processing readers should note this important development.

Lynn L. Bergeson, "EPA Prioritizes Chemicals for Risk Evaluation: Why This Matters," Environmental Quality Management, Volume 28, Issue 4, Summer 2019.

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 40 chemicals for which EPA is initiating the prioritization process for risk evaluation. This article explains why the prioritization process is critically important for product manufacturers to monitor and manage, and how best to do so.

Zameer Qureshi, "EU REACH: how’s life after the Registration deadlines?," Elements, the Magazine of Chemicals Northwest,, Spring 2019.

The registration deadlines for pre-registered “phase-in” chemical substances under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation presented for the chemicals industry a wide range of demanding tasks requiring substantial expertise from scientists, consultants, lawyers, and others. The transitional phase of REACH ended on 31 May 2018, and companies of all shapes and sizes are now engaged in a wide range of ongoing compliance activities. This column addresses certain important REACH-related activities being undertaken by numerous entitites in the ongoing post-deadline era, and provides comments on their significance. 

Lynn L. Bergeson, "Protecting Confidential Business Information: An Evolving Challenge," International Chemical Regulatory and Law Review, Volume 2, Issue 2, Summer 2019.

The concept of confidential business information (CBI) is sometimes considered at odds with the concept of the ‘right-to-know.’ When Congress amended the Toxic Substances Control Act (TSCA) in 2016 throughenactment oftheFrankR.LautenbergChemical Safety for the 21st Century Act (Lautenberg), it wasmindful ofthe public’s growing interestin knowing more about the identity of chemicals to which they may be exposed, but equally mindful of a business’ legitimate interest in protecting highly proprietary and commercially sensitive trade secret and other information entitled to protection from disclosure. Congress enacted several significant TSCA modifications in an effort to balance these competing interests, amendmentsthatthe U.S. Environmental Protection Agency (EPA) has been implementing through rulemaking and guidance documents over the past three years. This article discusses key CBI initiatives, and the stakeholder community’s response to them.

Lynn L. Bergeson, "Chemical Compliance: Get Ready for South Korean Deadline," Chemical Processing, May 17, 2019.

Global chemical substance notification deadlines continue to populate the regulatory horizon. For companies active in worldwide markets, it’s crucial to review and meet all important notification and registration deadlines in each country. This article focuses on South Korea’s policy and explains why it’s essential to meet these deadlines.

Lynn L. Bergeson, "The Rise of Ingredient Disclosure: The California and New York Experience," Environmental Quality Management, Volume 28, Issue 3, Spring 2019.

In the recent past, two important states—California and New York—have launched extensive and precedent‐setting ingredient disclosure laws regarding cleaning products with the clear goal of prompting the deselection of certain chemical substances and forcing product reformulation. Industry prefers to refer to this trend as “ingredient communication,” a goal we can all agree is desirable. By whatever name, these state measures will have a significant impact on ingredient disclosure trends across product lines, likely well beyond their stated application to cleaning products. These state laws are summarized in this article, followed by a discussion of their similarities, key differences, and their implications.

Lynn L. Bergeson, "EPA Updates the TSCA Inventory: Impact on chemical importers," Elements, the Magazine of Chemicals Northwest, Spring 2019.

On February 19, 2019, the U.S. Environmental Protection Agency (EPA) released a much anticipated “updated” Toxic Substances Control Act (TSCA) Inventory. The updated TSCA Inventory now lists chemicals that are “active” versus “inactive” in commerce in the U.S. This development has important legal and transactional implications for foreign companies importing chemicals into the U.S. This column explains why.

Lynn L. Bergeson, "Regulatory Opportunities and Challenges in Commercialising Biobased Chemicals," International Chemical Regulatory and Law Review, Volume 2, Issue 1, Spring 2019.

The 21st Century has witnessed intense renewed interest in commercialising new biobased chemicals, defined generally to include chemicals that are derived fromplants and otherrenewablematerials. The Toxic Substances Control Act (TSCA) is the U.S. law thatregulatesindustrial chemicalsubstances,including biobased chemicals, used in applications other than food, drugs, cosmetics, and pesticides, or uses that are regulated by other federal authorities. TSCA wassignificantly amended in 2016, and stakeholders need now more than ever to understand how TSCA applies to biobased chemicals to appreciate the implications of new TSCA on their commercial operations. Doing so will better assure uninterrupted business operations and consistent TSCA compliance.

Lynn L. Bergeson, "GAO Evaluates EPA Performance," Chemical Processing, March 18, 2019.

The U.S. Government Accountability Office (GAO) released on March 6, 2019, a report titled “High-Risk Series: Substantial Efforts Needed to Achieve Greater Progress on High-Risk Areas.” This column discusses the report and its implications on chemical management policy.

Cheryl B. Cleveland, Carrie R. Fleming, Jason E. Johnston, Angela S. Klemens, and Bruce M. Young, "Benchmarking the Current Codex Alimentarius International Estimated Short-Term Intake Equations and the Proposed New Equations," Journal of Agricultural and Food Chemistry, March 14, 2019.

The International Estimated Short-Term Intake IESTI equations are used during the establishment of Codex Maximum Residue Limits. A recent proposal to revise the equations sparked international debate regarding selection of residue inputs and the appropriate level of consumer protection. The 49th Codex Committee on Pesticide Residues meeting recommended benchmarking the IESTI equations against distributions of actual exposures. Using publicly available data and models, this work compares dietary exposures for strawberries, tomatoes, and apples at five levels of refinement to place these equations into context relative to real-world exposures. Case studies were based on availability of robust USDA PDP monitoring data, which is uniquely suited to refine dietary exposures for a population. Benchmarking dietary exposure involves several decision points. Alternate methodology choices are not expected to impact the large margins observed between the probabilistic estimates and the IESTI equations or to change the overall conclusion that existing IESTI equations are conservative and health-protective.

Lynn L. Bergeson and Karin F. Baron, "Expert Focus: A Glimpse at US OSHA’s Updated Hazard Communication Standard," Chemical Watch, March 11, 2019.

The Hazard Communication Standard (HCS) is, by its very nature, perennially a work in progress. The US is committed to global harmonisation in classifying chemical hazards, and the US Department of Labor’s Occupational Safety and Health Administration (Osha) 2012 incorporation of the Globally Harmonized System (GHS) of classification and labelling of chemicals into the Hazard Communication Standard (HCS) was a big step forward in achieving global harmonisation. The road is long, however, and the administration recognises much work remains to be done. This article reports on Osha's efforts to continue the harmonisation process.

Lynn L. Bergeson, "Changing of the Guard," Specialty Chemicals Magazine, March 2019.

The 2018 US mid-term elections have redefined the political winds in Washington, DC. What these currents mean for domestic chemical policy, and its impact on global chemical policy initiatives, is unclear. 

Lynn L, Bergeson, "FDA Proposed Rule for OTC Sunscreen Drug Products Addresses Sunscreens Containing Nanomaterials," Nanotechnology Now, February 22, 2019.

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.

Lynn L. Bergeson, "New York Disclosure Program Hits A Snag," Chemical Processing, February 18, 2019.

On January 9, 2019, the New York Department of Environmental Conservation (NYDEC) announced it was delaying its enforcement of the New York Household Cleansing Product Information Disclosure Program (NYDP) to October 2, 2019. NYDEC’s announcement was published in the Environmental Notice Bulletin. This article explains the significance of this development.

Lynn L. Bergeson, "Political Turmoil Muddies Regulatory Moves," Chemical Processing, January 16, 2019.

2019 started with a political bang. The President’s decision to allow a partial government shutdown in the absence of funding for the “wall” will continue to inspire federal administrative and regulatory havoc for months to come. This is particularly true of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) as it administers the programs under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), both of which maintain hugely important fees-for-service programs.

Lynn L. Bergeson, "A Glimpse of Things to Come: OSHA’s Soon to Be Updated Hazard Communication Standard," Environmental Quality Management, Volume 28, Issue 2, Winter 2018.

In the Trump Administration’s Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda) issued on October 17, 2018, the US Department of Labor’s Occupational Safety and Health Administration (OSHA) published a Proposed Rule Stage item titled, “Update to the Hazard Communication Standard,” RIN 1218-AC93 (OSHA, 2018), and scheduled the Notice of Proposed Rulemaking (NPRM) to be issued by March, 2019. This could be an important regulatory development for all entities subject to Hazard Communication Standard (HCS) requirements, which is just about everyone. This column explains why this development is significant.

Zameer Qureshi, "Brexit: REACHing Compliance Goals Under Evolving Circumstances," Elements, the Magazine of Chemicals Northwest, Winter 2018.

Brexit is a moving target from a political viewpoint, but many matters for regulatory compliance and product stewardship teams globally appear clearer than before. This article suggests timely REACH compliance strategies companies should adopt and implement that account for wide-ranging Brexit repercussions.

Lynn L. Bergeson, "Amazon Issues Restricted Substance List," Chemical Processing, December 14, 2018.

Big retailers strive to source products responsibly. This typically includes recognition of chemicals in the products they market. As part of its commitment to responsible sourcing, Amazon recently posted its Chemicals Policy, which includes its first Restricted Substance List (RSL). This column discusses this milestone.

Lynn L. Bergeson, "EPA Will Withdraw SNUR for Carbon Nanomaterial (Generic)," Nanotechnology Now, December 4, 2018.

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on December 4, 2018, withdrawing significant new use rules (SNUR) promulgated under the Toxic Substances Control Act (TSCA) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN).

Lynn L. Bergeson, "California Adds Soluble Nickel To Prop 65," Chemical Processing, November 27, 2018.

The State of California now has over 900 chemical substances for which warning and labeling is required under Proposition 65 (Prop 65). Recently added to this list are soluble nickel compounds. Given the potential ubiquity of the substance, this could have big implications.

Lynn L. Bergeson, "EPA Issues Final TSCA Fees Rule," Chemical Processing, October 29, 2018.

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued a final fees rule under the Toxic Substances Control Act (TSCA). The final rule largely tracks the proposed rule. The EPA will host a series of webinars focusing on TSCA submissions and fee payments under the final rule. The agency has posted a pre-publication version of the final rule, as well as its response to public comments on the proposed rule.

Lynn L. Bergeson, "EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory," Environmental Quality Management, Volume 28, Issue 1, Fall 2018.

Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), directs that “[n]ot later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish” (Environmental Protection Agency [EPA], 2018a, p. 30056) an inventory of mercury or mercury-added products or uses of mercury in a manufacturing process. On June 27, 2018, the U.S. Environmental Protection Agency (EPA) published a final rule responding to this legislative mandate. The rule requires certain entities to provide information to assist in the preparation of this inventory. This column outlines the final rule and discusses its implications.

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. 

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