Green Chemistry

Lynn L. Bergeson, "Extended producer responsibility for packaging: and so it begins in the US," Financier Worldwide, October 2021.

On 13 July 2021, Maine became the first state in the US to enact extended producer responsibility (EPR) legislation for packaging. Quickly thereafter, on 6 August, Oregon became the second state to enact a similar EPR law applicable to packaging. Other states are poised to enact similar legislation, following trends more mature in the European Union (EU) and elsewhere around the world.

Lynn L. Bergeson, "Environmental Justice: Operationalizing TSCA to Fulfill Its Destiny," American College of Environmental Lawyers (ACOEL) Blog, February 4, 2021.

The Biden Administration has embraced environmental justice with unprecedented gusto.  In its July 2020 Plan to Secure Environmental Justice and Equitable Economic Opportunity (Plan), the Biden Administration sets out in broad terms how it intends to use an “All-of-Government” approach to “rooting out systemic racism in our laws, policies, institutions, and hearts.”

Lynn L. Bergeson and Richard E. Engler, Ph.D., "Chemical Innovation and New TSCA: The Good, the Bad, and the Evolving," International Chemical Regulatory and Law Review, Volume 2, Issue 4, Winter 2019.

New chemical innovation is not as celebrated as innovation in electronics, materials, software, or other sectors, but it is every bit as important. Many believe, as do we, that new chemical innovation is essential to achieving sustainable development. For this reason, a close look at the 2016 amendments to the Toxic Substances Control Act (TSCA) and the U.S. Environmental Protection Agency’s (EPA) implementation of them offers valuable insights into whether the new U.S. industrial chemical management law and EPA policy initiatives implementing it are aligned with this goal. This article discusses EPA’s implementation of the TSCA amendments as they relate to new chemical innovation and highlights EPA policy positions and institutional practices that EPA should reconsider to alignmore closely with the goal of more sustainable new chemical technologies.

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, "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, "White House Targets Biotechnology," Chemical Processing, July 16, 2015.

With little fanfare, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum could have significant implications for innovators in the biotechnology and synthetic biology commercial space.

Richard E. Engler, Ph.D., "The Impact of Toxic Substances Control Act Nomenclature on the Commercialization of Biobased Chemicals," AOCS Inform, July/August, 2015.

Imagine receiving a certified letter from the US Environmental Protection Agency (EPA) announcing that it plans to conduct an audit of your company’s facility in two weeks. The audit will focus on your company’s compliance obligations as a chemical manufacturer under the Toxic Substances Control Act (TSCA). Would you be prepared or are you unsure of what TSCA is and whether it applies to you? This article explains how TSCA applies to biobased chemicals and how nomenclature and chemical identity can impact commercialization.

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 3, Call to Action," Biofuels Digest, May 18, 2015.

In the second installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products across a manufacturing process, from feedstock to product. In this last installment, I present options for updating TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered in as part of the original TSCA Inventory. The key is to find a way to level the field without compromising the U. S. Environmental Protection Agency’s (EPA) mission and authority to protect human health and the environment.

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," Biofuels Digest, May 1, 2015.

In the first installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products. In this article, we will look across a manufacturing process. TSCA applies to chemical substances that are used for purposes other than food, food additives, animal feed, cosmetics, drugs, tobacco and tobacco products, pesticides, munitions, and nuclear source materials. Biobased chemicals, that is, chemicals made from lignocellulose or other biomass, are finding markets in food and cosmetic markets, but much of the recent innovation focuses on biobased fuels and commodity chemicals. For these final products, TSCA applies. Chemical products must be listed on the TSCA Inventory of Chemical Substances (the Inventory) or be eligible for an exemption. If the product is not listed on the Inventory, the manufacturer must file a premanufacture notification 90 days before manufacturing (or importing) that substance or qualify for an appropriate exemption.

Richard E. Engler, Ph.D., "The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," Biofuels Digest, April 26, 2015.

Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable Fuel Standard, fuel additive registration, or other CAA submissions. TSCA also applies to bioproducts used in industrial, commercial, and most consumer products, including fuels. TSCA reporting requirements are in addition to, and separate from, CAA reporting.

Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, "Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act," Industrial Biotechnology, October 2014.

Synthetic biology is delivering on its promise as an emerging scientific field in providing society with effective new sustainable products in diverse areas including renewable energy, contamination remediation, and medical applications, among others. As is the case with any rapidly evolving technology, the pace of technological innovation challenges regulators’ ability to identify and address adequately the substantial uncertainties they confront when discharging their legal obligations under controlling laws to ensure human and environmental safety. This article provides a brief description of synthetic biology, discusses the current domestic regulatory framework that governs the regulation of products of synthetic biology, and focuses narrowly on options and opportunities the US Environmental Protection Agency (EPA), innovators in the area of synthetic biology, and the Toxic Substances Control Act (TSCA)-regulated community at large may wish to consider to enhance TSCA’s core adaptive capacity to identify and address potential health and environmental risk implications posed by the commercialization of products of synthetic biology.

Kathleen M. Roberts, "How to Make Friends and Win EPA Approvals: tips for biobased chemicals," Biofuels Digest, May 28, 2014.

In last week’s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to “avoid an afterthought approach to regulatory compliance.” As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive involved with biobased chemicals at a session titled “Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process.” This article highlights the top tips for gaining EPA regulatory approval shared by EPA’s Dr. Tracy Williamson and Dr. David Widawsky at the session.

Lynn L. Bergeson, "Brave New World: California Finalizes Safer Consumer Products Regulations," Environmental Quality Management, Spring 2014.

It is official. California’s Office of Administrative Law (OAL) approved the California Department of Toxic Substances Control (DTSC) Safer Consumer Products regulations, and the program went into effect on October 1, 2013. The regulations mark the much-anticipated regulatory implementation of California’s Green Chemistry Initiative. The regulations and final statement of reasons are available at http://www.dtsc.ca.gov/SCPRegulations.cfm. This new program is a true game-changer, and it will have profound national and international business, regulatory, and commercial implications for consumer product manufacturers and others for the reasons noted in this Washington Watch article. 

Lynn L. Bergeson, "EPA Targets Flame Retardants DecaBDE and BPA," Chemical Processing, February 13, 2014.

On January 29, 2014, the U.S. Environmental Protection Agency (EPA) released two final Alternatives Assessment Reports for the flame retardant decabromodiphenyl ether (DecaBDE) and bisphenol A (BPA) in thermal paper. The EPA’s Design for the Environment (DfE) program developed the assessments, which profile the environmental and human health hazards for DecaBDE, BPA, and their alternatives. This article explains why these assessments are important.

Lynn L. Bergeson, Kathleen M. Roberts, "Promoting Renewable Chemicals," The Environmental Forum, January/February, 2014.

Biofuels have gotten all the press. But biobased chemicals have equal environmental and health potential, and also the most exposure under the Toxic Substances Control Act. Implications range from irritating to crippling, depending upon a manufacturer’s response.

Lynn L. Bergeson, "Toxic Chemicals: Prepare for Product Regulations," Chemical Processing, October 15, 2013.

The California Department of Toxic Substances Control (DTSC) Safer Consumer Products Regulations are now in effect (See "California Cracks Down on Chemicals"). While the most onerous requirements for "responsible entities" (manufacturers, importers, assemblers and retailers) will not hit for a while, companies should consider taking some initial steps now to understand how these regulations may affect operations in the future.

Lynn L. Bergeson, "The Regulation of Renewable Chemicals Under the Toxic Substance Control Act (TSCA)," Environmental Quality Management, Fall 2013.

The application of the Toxic Substances Control Act (TSCA) to biobased chemicals is sometimes overlooked, given the enthusiasm supporting the commercialization of biobased products. This “Washington Watch” article explains TSCA’s application to these products and outlines strategies to ensure the successful marketing of biobased chemical products.

Lynn L. Bergeson, "California Cracks Down On Chemicals," Chemical Processing, September 16, 2013.

On August 23, 2013, the California Department of Toxic Substances Control (DTSC) released changes to the near final Safer Consumer Products Regulations (SCPR). These game-changing regulations took effect October 1, 2013. This column broadly outlines the rule and summarizes the changes.

Lynn L. Bergeson, Charles M. Auer, and R. David Peveler, "TSCA and the Regulation of Renewable Chemicals," American Oil Chemists, July/August, 2013.

While regulators are generally supportive of new chemistries that can replace older, petroleum-based ones, biobased chemicals are subject to the same Toxic Substances Control Act (TSCA) that governs every other chemical substance in the United States. Surprisingly, biobased chemicals that are considered to be “new chemicals” may actually receive more scrutiny under this law than established chemicals do. The following article provides practical information about the TSCA provisions that are most relevant to biobased chemicals, regulatory outcomes of Premanufacture Notification (PMN) review, and strategies stakeholders can use to assure compliance and successful commercialization of biobased chemicals.

Lynn L. Bergeson, Kathleen M. Roberts, and Heidi B. Lewis, "Why BRAG Before You Go to Market? The Biobased and Renewable Products Advocacy Group (BRAG) Helps Companies Commercialize Their Products," Industrial Biotechnology, August 2013.

Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. The renewable chemicals’ market is estimated to reach $83.4 billion by 2018 in applications ranging from transportation and agriculture to textiles and cosmetics. In addition to all the elements great companies need to succeed -- a great product, a great brand, inspiring leadership, and vision -- biobased product companies need to understand how the U.S. Environmental Protection Agency (EPA) occupies a virtual seat at their management table, whether or not they know it.

Lynn L. Bergeson, "OECD Publishes Report on Nanotechnology for Green Innovation," Nanotechnology Now, June 13, 2013.

On June 13, 2013, the Organization for Economic Cooperation and Development's (OECD) Working Party on Nanotechnology (WPN) published the final report Nanotechnology for Green Innovation. The report summarizes information collected from various projects undertaken by the WPN regarding the use of nanotechnology for green innovation.

Lynn L. Bergeson, "EPA Targets Renewable Fuel Fraud," Chemical Processing, March 12, 2013.

On February 21, 2013, the U.S. Environmental Protection Agency (EPA) proposed a new approach to assure compliance with renewable fuel volume standards and minimize fraud. The proposal offers an alternative voluntary quality assurance program (QAP) to combat fraudulently procured Renewable Identification Numbers (RINs), which have been the source of problems in the past. Comments on the proposal are due April 18, 2013. This column explains the proposal and why a new option is needed.

Lynn L. Bergeson, "One Step Closer:  California Proposes Safer Consumer Products Regulations," Environmental Quality Management, Winter 2012.

The California Department of Toxic Substances Control (CDTSC) is one step closer to implementing the state’s Green Chemistry Initiative (GCI), which directs regulators to evaluate safer alternatives to chemicals that are believed to be toxic. These are not “garden variety” chemical regulations that impose a restriction here or there to prevent a perceived risk. Far from it. These regulations are game-changers. They ultimately will transform the way manufacturers select raw materials and make consumer products. As a result, these regulations are likely to influence significantly — and permanently — the way consumer products are conceived, formulated, and distributed. This “Washington Watch” column summarizes the core elements of the proposed Safer Consumer Products Regulations, highlighting significant changes from prior proposals.

Lynn L. Bergeson, "Safer Consumer Products Regulations: One Step Closer," Pollution Engineering, October 2012.

In July, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products regulations, the newest iteration of the much-anticipated regulatory implementation of the state’s Green Chemistry Initiative.

Lynn L. Bergeson, Charles M. Auer, and R. David Peveler, "TSCA and the Regulation of Renewable Chemicals," Industrial Biotechnology, October 2012.

The dual national goals of reducing America’s dependence on foreign oil and greening the economy converge in biobased chemicals, the promising and rapidly evolving field of technology that produces commercial chemicals from renewable feedstocks. Although biobased chemicals have a long history, increasing sensitivity to reliance on nonrenewable feedstocks and the environmental impact of petroleum-derived chemicals have hastened the commercialization of biobased chemicals, and today they are in production as never before. According to one estimate, biobased chemicals’ share of the global chemical industry is expected to grow from 2% in 2008 to 22% by 2025. Lux Research reports that biobased chemicals capacity will double in market potential to $19.7 billion in 2016.

Lynn L. Bergeson, "California Aims For Safer Consumer Products," Chemical Processing, August 2012.

In July, the California Department of Toxic Substances Control (DTSC) released proposed Safer Consumer Products regulations, the newest iteration of the much anticipated regulatory implementation of California's Green Chemistry Initiative. Below is a summary of the core elements of the proposed regulations -- chemicals of concern (COC), priority products (PP), alternative analysis (AA), and regulatory responses.

Lynn L. Bergeson, "White House Eyes Biobased Products," Chemical Processing, May 2012.

On April 26, 2012, the Obama Administration released its National Bioeconomy Blueprint, which is intended to provide a comprehensive approach to harnessing innovations in biological research to address national challenges in health, food, energy and the environment. In a related development, the U.S. Department of Agriculture (USDA) proposed on May 1, 2012, amendments to 7 C.F.R. Part 3201, Guidelines for Designating Biobased Products for Federal Procurement.

Lynn L. Bergeson, "EO Increases Procurement of Biobased Products," Pollution Engineering, May 2012.

The BioPreferred Program was established by the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation and Energy Act of 2008. It is intended to increase federal procurement of biobased products, promote rural economic development, create new jobs, and provide new markets for farm commodities. The USDA manages the program.

Lynn L. Bergeson, "Dreaming No Longer:  California Issues Draft Safer Consumer Products Regulations," Environmental Quality Management, Spring 2012.

On October 31, 2011, the California Department of Toxic Substances Control (CDTSC) released an “informal draft” of its Safer Consumer Products Regulations. The draft does a good job of outlining how CDTSC intends to implement key mandates contained in the state’s Green Chemistry Initiative, which directs regulators to evaluate safer alternatives to chemicals that are believed to be toxic. This “Washington Watch” column summarizes key provisions of this precedent-setting, game-changing regulatory development.

Lynn L. Bergeson, "Predictions for EPA’s Office of Chemical Safety and Pollution Prevention," ABA Section of Environment, Energy, and Resources, Pesticides, Chemical Regulation, and Right-To-Know Committee Newsletter, February 2012.
Lynn L. Bergeson, "TSCA Reform:  Business Strategies in Times of Political Gridlock," CHEManager Europe, March 2012.

Most would agree that legislative reform of the U.S. Toxic Substances Control Act (TSCA) is long overdue. Few agree on what to change and how best to proceed. If you throw in the 2012 presidential election, you have gridlock. Commerce marches on, however, and with the Environmental Protection Agency reinventing TSCA implementation in innovative and effective ways, Reach setting the new global tone, and California creating a new template for sustainable consumer products, TSCA reform is at risk of becoming a distracting afterthought. Stakeholders must develop new strategies to survive and flourish in these fast-changing times.

Lynn L. Bergeson, co-author, "Practical Advice for Product Steward Professionals on Remaining Competent, Socially Aware, and Scientifically Proficient," BNA Daily Environment Report, January 6, 2012.

Consumer product manufacturers are challenged today as never before. Materials selection for consumer products invites a dizzying range of considerations: Are the chemicals hormone disruptors, carcinogens, or persistent, bioaccumulative, or toxic? What toxicogenomic biomarkers might make the product the next celebrity tort case? What labeling requirements apply? What are the implications of genetic variations among the demographic to which the product is to be marketed? These considerations, in turn, invite legal, marketing, and technical issues that go well beyond questions of core compliance with the law. What exactly is the professional's role? How are regional differences in regulatory standards, consumer perceptions, ingredient restrictions, and related factors to be addressed? Given the complexity of the global issues and the high stakes involved, what must a professional do to remain competent, socially aware, and scientifically proficient? This article explores these thorny questions, not to resolve them as much as to flag them, and urge professionals -- whether lawyers, product stewards, scientists, or others in the field -- to remain vigilant and as prepared as possible in recognizing the constantly shifting demands on professionals in this area.

Lynn L. Bergeson, "California’s New Safer Consumer Products Regulations," Pollution Engineering, January 2012.

On October 31, 2011, the California Department of Toxic Substances Control (DTSC) released an informal draft of their Safer Consumer Products Regulations (SCPR). The proposal came after the California Secretary for Environmental Protection instructed DTSC to stop issuing proposed regulations and to instead “take additional time to be responsive to the concerns raised and revisit the proposed regulations.”

Lynn L. Bergeson, "Selling Green: US FTC Releases Proposed Revisions to the ‘Green Guides’," Environmental Quality Management, Spring 2011.

After more than three years of discussion, research, review, and debate, the United States Federal Trade Commission (US FTC) released proposed revisions to its Guides for the Use of Environmental Marketing Claims (the “Green Guides”) in late 2010. The Green Guides provide FTC “guidance” on what is and is not appropriate in the ever-fluid area of environmental marketing. They are designed to help product marketers avoid making false and misleading environmental claims that might violate section 5 of the Federal Trade Commission (FTC) Act.

Lynn L. Bergeson, "Revisions to the ‘Green Guides’," Pollution Engineering, December 2010.

Early in October, the Federal Trade Commission (FTC) released important revisions to its Guides for the Use of Environmental Marketing Claims (Green Guides) to make them easier for companies to use and understand.

Lynn L. Bergeson, "Washington:  California Is Setting Precedent," Manufacturing Today, Fall 2010.

The California Department of Toxic Substances Control (DTSC) released on June 23, 2010, draft regulations implementing California’s precedent-setting and game-changing Green Chemistry Initiative. Manufacturers need to understand how this controversial regulatory program may operate, and why it will alter forever the way consumer products are designed and manufactured.

Lynn L. Bergeson, "Washington: Marketing Green," Manufacturing Today, September 2009.

The growth in green marketing is getting a lot of attention these days, especially from the Federal Trade Commission (FTC), the federal agency tasked with preventing unfair and deceptive trade practices. Mindful of potential false and misleading advertising, FTC has been revising its Guides for the Use of Environmental Marketing Claims, known as the “Green Guides.”


 
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