July 2, 2019

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....
June 28, 2019

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...
June 19, 2019

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 through enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), it was mindful of the public’s growing interest in knowing more about the identity of chemicals to which they may be exposed, but equally mindful of a business’ legitimate interest in...
May 17, 2019

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....
April 19, 2019

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...
April 10, 2019

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....
March 29, 2019

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...
March 14, 2019

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...
March 11, 2019

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...
February 22, 2019

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....
February 18, 2019

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....
January 16, 2019

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...
January 9, 2019

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...
January 2, 2019

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....
December 14, 2018

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....
December 4, 2018

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)....
October 29, 2018

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....
October 24, 2018

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...
September 19, 2018

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...
September 11, 2018

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...
September 5, 2018

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....
August 23, 2018

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...
August 22, 2018

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...
August 10, 2018

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...
July 31, 2018

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....
July 18, 2018

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. ...
July 17, 2018

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....
July 16, 2018

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....
July 5, 2018

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. ...
June 20, 2018

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...
May 29, 2018

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....
May 21, 2018

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....
May 2, 2018

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. ...
May 1, 2018

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...
May 1, 2018

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. ...
April 23, 2018

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,...
April 20, 2018

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....
March 29, 2018

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....
March 12, 2018

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. ...
March 12, 2018

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...
February 21, 2018

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...
January 2, 2018

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...
December 31, 2017

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...