All Published Articles

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. 

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.

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