TSCA

Charles M. Auer, "Old TSCA, New TSCA, and Chemical Testing," BNA Daily Environment Report, August 16, 2016.

It is the author’s view that the central failing of old TSCA was its inability to produce the testing needed by EPA to assess and understand the hazards, exposures, and risks of existing chemicals. New TSCA makes important changes to the authority available to EPA to compel industry to generate the information needed by EPA to meet the purposes articulated under the new law. This paper briefly reviews the issues and problems that EPA encountered in using old TSCA for this purpose, discusses the improvements in new TSCA, and discusses why the author believes they offer the potential of future success in the testing area.

Lynn L. Bergeson, Charles M. Auer, "An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders," Industrial Biotechnology, Volume 12, Issue 4, August 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182, significantly amends the Toxic Substances Control Act (TSCA). The Act was signed into law by President Obama on June 22, 2016. The date of signature is both the date of enactment and of entry into force of amended TSCA. New TSCA fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years.  The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.

Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, "An Analysis of Section 8 of the New Toxic Substances Control Act," BNA Daily Environment Report, August 9, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amends the Toxic Substances Control Act (TSCA), particularly with regard to Section 8 record keeping and reporting obligations. This article highlights a number of important changes and deadlines of which companies subject to TSCA should be aware.

Lynn L. Bergeson, "Grasp the Gravity of the New TSCA," Chemical Processing, July 13, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act makes seismic changes in domestic industrial chemical management. If you think the extensive revisions to the Toxic Substances Control Act (TSCA) enacted on June 22, 2016, don’t impact your business, think again. TSCA reform affects virtually every domestic business sector involving chemicals and manufactured goods containing chemicals, and will continue to do so for years to come.

Lynn L. Bergeson, "In-House Counsel Beware: TSCA Reform Impacts Everyone," Law360, June 15, 2016 .

In-house counsel unfamiliar with the tsunami-like changes in domestic chemical management headed our way soon may wish to read this article. If you think for a second that the extensive revisions to the Toxic Substances Control Act (TSCA) expected to be enacted imminently do not impact your legal practice or your client’s business operations, think again. TSCA reform impacts virtually every business sector in the United States, and will continue to do so for years to come. Here are the reasons why you should care.

Lynn L. Bergeson, "TSCA Reform: Is It Still in Our Future?," Industrial Biotechnology, April 5, 2016.

Toxic Substances Control Act (TSCA) reform has been a “work in progress” for years. House and Senate passage in 2015 of substantive TSCA reform measures considerably improved the odds that Congress would enact TSCA-reform legislation in 2016. Recent events suggest otherwise, however, and as of this writing in mid-March the fate of TSCA reform remains decidedly uncertain. Momentum has dissipated as a dithering House has been slow to engage with Senate counterparts to reconcile the different approaches contemplated under each bill. The surprisingly harsh Republican response to Associate Supreme Court Justice Scalia’s untimely demise has hardened the partisan divide that threatens to tank Congressional action on any important initiative, let alone legislation as significant and potentially divisive as TSCA reform. It is hoped that cooler heads will prevail and leverage the hard work and momentum that has brought us to this momentous place in history. This Commentary provides an update on the current state of TSCA reform efforts.

Charles M. Auer, Frank D. Kover, James V. Aidala, Mark Greenwood, "Toxic Substances: A Half Century of Progress," Protecting the Environment: A Half Century of Progress, EPA Alumni Association, March 1, 2016.

PUBLIC CONCERNS LEAD TO CHEMICAL LAW

In the 1960s and early to mid-1970s, new reports of chemicals causing cancer appeared in the press or on TV almost every month. Polychlorinated biphenyls (PCBs), used in electrical transformers for over 40 years, were being found in fish and environmental samples from around the country. Other chemicals, including those not thought to be harmful, caused serious health or environmental effects. Chlorofluorocarbons (CFCs) were depleting the earth’s protective ozone layer. Asbestos, a mineral fiber widely used in insulation, caused lung cancer, especially in workers. Polybrominated biphenyls used as flame retardants were mistakenly mixed into animal feed and poisoned people and cattle in Michigan. Eating fish contaminated with mercury caused a severe neurological syndrome in adults as well as birth defects in Minamata, Japan. And the list went on.

Although society reaps enormous benefits from chemicals, there was little or no knowledge of the effects on health or the environment of the thousands of chemicals used and released into the  environment. There was not even a list of the chemicals made and used in America. The drumbeat of concerns contributed to a growing realization that environmental chemicals might cause major problems. People were suddenly aware that a man-made chemical environment of unknown dimensions literally surrounded them. Other studies pointed to the large gap in existing laws for dealing with these problems. During the 1970s, the groundswell of public concern resulted in legislative action.

Ruth C. Downes-Norriss, Leslie S. MacDougall, "What is Happening with Chemical Regulation Outside of the European Union?," Elements, the Chemicals NorthWest Magazine, Autumn 2015.
James V. Aidala, Jr., Charles M. Auer, Lynn R. Goldman, M.D., and James B. Gulliford, "Practical Advice for TSCA Reform: An Insider Perspective," The American Bar Association Section of Environment, Energy, and Resources Special Committee on TSCA Reform, August 2010.
Charles M. Auer, James V. Aidala, Lynn L. Bergeson, "TSCA Reform Legislation and Its Workability: Thoughts on Steps to Help Ensure Successful Implementation at the Outset and Over Time," Bloomberg BNA Daily Environment Report, July 23, 2015.

Competing proposals are working their way through the House and Senate to amend the Toxic Substances Control Act, the nation’s primary law for managing chemicals in commerce. In this article, former senior Environmental Protection Agency officials Charles Auer and James Aidala and attorney Lynn Bergeson discuss making the bill clearer and how congressional direction can be provided on what EPA is to do with certain new provisions to implement them in the first years of any amended TSCA.

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.

Lynn L. Bergeson, "TSCA Reform May Be Closer Than You Think," Chemical Processing, May 18, 2015.

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Since then, S. 697 has gained additional backing from both Republicans and Democrats. These events are important because they demonstrate significant bipartisan support for reform of the Toxic Substances Control Act (TSCA), and suggest TSCA reform actually may be in our future.

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, "EPA Eyes Nanoscale Materials," Chemical Processing, April 13, 2015.

On April 6, 2015, the U.S. Environmental Protection Agency (EPA) proposed a Toxic Substances Control Act (TSCA) Section 8(a) rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. 

Lynn L. Bergeson, "EPA Proposes Significant New Use Rule for Certain Nonylphenol and Nonylphenol Ethoxylates," Environmental Quality Management, Spring 2015.
On October 1, 2014, the US Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for certain related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE) (Federal Register [Fed. Reg.], 2014). For 13 NPs and NPEs, the EPA would designate any use as a “significant new use,” and for two additional NPs, the EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a "significant new use" (Fed. Reg., 2014, p. 59186). For a variety of reasons, which are discussed next, the proposed rule is interesting and significant. The EPA has already agreed to extend the comment period to mid-January in response to several industry-trade groups’ requests for more time.
Lynn L. Bergeson, "Comments Due July 6 On Proposed Reporting And Recordkeeping Requirements For Nanoscale Materials," Nanotechnology Now, April 6, 2015.

The U.S. Environmental Protection Agency's (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register. 

Lynn L. Bergeson, "New Technologies and an Old Law: Renewable Chemicals Invite Challenges under TSCA," Natural Resources & Environment Volume 29, Number 4, Spring 2015.

The resurgence of chemical production derived from renewable feedstocks reflects the new business imperatives of which chemical product manufacturers are all keenly aware: produce greener chemicals and reduce carbon footprints. Careful review of the Toxic Substances Control Act (TSCA), a law enacted almost forty years ago during the heyday of petroleum-derived chemical production, suggests that more can be done now to promote the commercialization of renewable chemicals to achieve these imperatives. This article describes renewable chemicals, provides a brief overview of TSCA, discusses key TSCA challenges as applied to them, and suggests actions to ensure TSCA’s implementation now and potential future TSCA revisions to facilitate the commercialization of renewable chemicals. 

Lynn L. Bergeson, "Nine Hazardous Chemicals Go On Watch List To Prevent Their Import," Chemical Processing, January 20, 2015.

On December 29, 2014, the U.S. Environmental Protection Agency (EPA) published a final rule signaling renewed interest in asserting Toxic Substances Control Act (TSCA) jurisdiction over finished goods. The final rule adds nine benzidine-based chemical substances to the existing significant new use rule (SNUR) on these substances, and, with respect to both the newly added and previously-listed substances, makes inapplicable the exemption relating to persons that import or process the substances as part of an article. 

Lynn L. Bergeson, "EPA’s New, Final Work Plan Assessments And What They Mean To You," Environmental Quality Management, December 22, 2014.

The United States Environmental Protection Agency (EPA) released on June 25, 2014, and on August 28, 2014, final risk assessments for targeted uses of four Toxic Substances Control Act (TSCA) Work Plan chemicals. The June Assessment consists of certain uses of trichloroethylene (TCE), and the assessments released in August are for uses of methylene chloride or dichloromethane (DCM), antimony trioxide (ATO), and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB). The much anticipated release of these assessments marks a real milestone for the EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), and the EPA is to be commended for its significant efforts in completing these assessments relatively quickly.  

Lynn L. Bergeson, "EPA Proposes New Rule for Toxic Chemicals," Chemical Processing, November 5, 2014.

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). These substances are recognized as persistent and toxic in the environment. This article discusses this important move.

Lynn L. Bergeson, "Evolving Global Chemical Management Programs and Why They Matter," Trends, the ABA Section of Environment, Energy, and Resources Newsletter, November 2014.

Chemicals play a central role in our personal and professional lives. As consumers, we focus keenly on the chemicals in the products we use and with which we come into contact. Globalization and the emergence worldwide of sophisticated chemical management programs invite complex legal, commercial, and scientific challenges. These challenges extend far beyond compliance questions that, by comparison, seem now nostalgically straightforward. Understanding these programs and their evolution can only help inform our judgment as lawyers, consultants, and educated consumers.

Lynn L. Bergeson, "EPA Assessing Utility of Toxic Substances Control Act to Obtain Information on Hydraulic Fracturing," Environmental Quality Management, Fall 2014.

The United States Environmental Protection Agency (EPA) published in the May 19, 2014, Federal Register an advance notice of proposed rulemaking (ANPR) to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information. According to EPA, this mechanism could be regulatory (under Sections 8(a) and/or 8(d) of the Toxic Substances Control Act (TSCA)), voluntary, or a combination of both. It could include best management practices, third-party certification and collection, and incentives for disclosure of information.
 

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.

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